The Report to the Minister of Health in Tanzania

EXECUTIVE SUMMARY OF THE REPORT ON THE EVALUATION OF THE CYFLOW CD4 COUNTING MACHINE AND THE SD BIOLINE HIV RAPID ANTIBODY TEST KITS
BACKGROUND



This investigation stems from a serious concern about how MUCHS (Muhimbili University College of Health Sciences), Dar es Salaam, and MoHSW (Ministry of Health and Social Welfare) officials handled the issue of the evaluation of a new CD4-counting machine used in monitoring HIV patients receiving ART (Antiretroviral therapy) known as the CyFlow® SL Blue 5 Parameters which is manufactured by Partec Essential Healthcare company of Germany. The only CD4-counting machine which has been in use in Tanzania is the FACSCount which is manufactured by the Becton-Dickinson company of USA, whose local representative here is Mr.Bharat Rajani of Health Biocare Ltd. The CyFlow machine which was sent to MoHSW for evaluation was evaluated by MUCHS who ended up disqualifying it and consequently the MoHSW ordered to rid Tanzania of this and all other versions of CyFlow machines which were in use in Tanzania, ordered the replacement of all CyFlow machines with FACSCount machines, and stopped any further importation of CyFlows. This made the supplier of CyFlow machines, Partec to complain bitterly that the disqualification of the CyFlow was based on false or incorrect analysis results, and the banning of CyFlows en masse and replacing them with FACSCounts is indicative of a conspiracy to perpetuate the over 10 years monopoly of FACSCounts. This Probe Team was to investigate the truth of Partec’s complaints which have been given more and more prominence by news media for the past eight months.
Another serious concern tackled by this Probe Team is how MoHSW, MUCHS, and AMREF officials dealt with the evaluation of an HIV Rapid Test Kit called SD Bioline which is manufactured by Standard Diagnostics Inc. of South Korea, which is represented locally by SD (Africa) Ltd. The SD Bioline HIV Test Kit was sent to MoHSW in 2002 for evaluation, and SD Africa complains that although SD Bioline passed successfully all the mandatory evaluations, there was a delay of nearly four years to announce that SD Bioline has been registered after performing well enough to be included in the long awaited National HIV Testing Algorithm. But SD Africa complains that although MoHSW admitted in its Press Release of 10/11/2006 (see Annex 2.64) that the only HIV Test Kits which has monopolized the HIV Tests market for over 10 years, Capillus, has been found to be unsuitable/unreliable and has been replaced by SD Bioline, various pretexts have been used to continue using Capillus as a first line HIV Test until now, notwithstanding the possibility of Capillus testing positive an uninfected person and vice versa.
By sheer coincidence, Mr.B.Rajani’s company, Biocare Health Products Ltd., has been supplying this Capillus too for over 10 years and SD Africa and news media suspect that his illegal influence is instigating MoHSW to be taking this risk of letting Capillus be used so that it tests an infected patient negative when he/she is actually negative, and vice versa.
Blood CD4 cells testing is considered by clinicians to be the essential element of monitoring HIV infected patients receiving ART (antiretroviral therapy/treatment). According to current regulations, an infected patient must have a count of less than 200 CD4 cells per microlitre (µl) of blood, before doctors prescribe those patients to take ARVs (antiretroviral drugs). Above this cut-off point, the patient is not eligible to start ART. There are many CD4 counting technologies nowadays (see Annex 2.23), and the availability of the lowest-cost technology is essential for diagnosing HIV infection and for monitoring ART. Significant progress has been made in reducing both the cost and training required for HIV diagnostic testing. Competition among manufacturers of CD4 counters, and production of rapid HIV tests has culminated into costs as low as US$ 1.6 to US$ 2.1 per test. So far, CyFlow technology has reached this limit, while the cost of say the FACSCount is US$ 5-20 (Annex 2.23).
One of the first chorus of disapproval came from the Rai weekly newspaper (see Annex 2.60.1), whose issue dated 31/08/2006 blazed a front page headline: "Corruption of MoHSW is Shaking the World–Muhimbili is Involved in This".
It quoted Dr.Roland Godhe, an International Director of Partec as having informed the scientific world and the international public at large how Partec is considering taking legal action against the Tanzanian MoHSW for the corruption that led to the banning of all the CyFlow® CD4 counting machines in Tanzania.
One of the recipients of this E-mailed information in Canada said that the MoHSW rushed unduly to ban all versions of CyFlow machines without ascertaining their unsuitability by hundreds of positive reports of the CyFlow machines available in the internet. When asked by another Rai reporter about what was now termed the "CyFlow saga", the former Minister for Health, Hon. Mrs. Anna Abdallah, M.P. she said that if the reason for banning the CyFlow machines is its imprecision when determining low CD4 count samples of < 200 cells/μl (see Annex 2.60.2), when she searched the internet, she found a number of reports on the CyFlow which contradict the MUCHS findings. In effect, the MoHSW and MUCHS are telling the world that the CyFlow is a killer because it gives false test results, but the scientific world is heaping positive praises for the performance of all the CyFlow machines. She said she thought it is often prudent to seek a second opinion whenever a sharp controversy like this arises.
She also said that, she has always preferred to have more varieties of important life saving machines, so that one can fall back onto another machine provided by a different supplier in case the first machine or its supplier misbehaves.
All this prompted the Hon. Minister for Health and Social Welfare of the United Republic of Tanzania, Professor David Mwakyusa, M.P. to appoint a three man Probe Team to look into the allegations of corruption leveled against some officials of the MoHSW, as well as some researchers and technicians of the Microbiology/Immunology Department of MUCHS.
Members of the Probe Team are:
1. Prof. Philip R.Hiza, Retired Consultant Surgeon/Chief Medical Officer,
Ministry of Health and Social Welfare, Dar es Salaam.Tanzania.
2. Prof. Raphael A.Lema, Retired Consultant Pathologist, currently Vice
Chancellor of IMTU, Dar es Salaam. Tanzania.
3. Dr. Jumah P. Madati, Retired Chief Government Chemist,
Ministry of Health and Social Welfare, Dar es Salaam. Tanzania.
The Hon. Minister for Health gave the Probe Team eight Terms of Reference, (see Annex 11.2) seven of which deal with the CyFlow saga only, and the last one deals with the SD Bioline HIV 1/2 Rapid Antibody Test Kit.
The style of reporting of this extensive, and difficult investigation is to have a short Executive Summary which will have in the text some bibliographic references written in parentheses and whose list will be appended at its back together with the list of Terms of Reference, and a list of Interviewees. For a reader of the Executive Summary to actually see part or the whole of the reference document, one will have to go to the back of the longer main Probe Team Report, although the end notes of ANNEX 2 give substantial explanations of the contents of the reference documents.











INVESTIGATION RESULTS, OBSERVATIONS, AND CONCLUSIONS
1. WAS THERE ANY DELIBARATE DELAY IN EVALUATING THE CYFLOW MACHINE?
The answer is yes, there were two separate delays of 10 months duration (from 27/09/2004 when the CyFlow arrived in Dar to 24/07/2005 when the evaluation started) which were unwarranted or deliberate, as shown hereunder.
The CyFlow Machine saga started at the XV International AIDS Conference which was held in Bangkok, Thailand, on 11-16/07/2004. At the Conference Exhibition, the Tanzanian Delegation led by the then MoHSW PS (Permanent Secretary), Mrs. Mariam Mwafisi met Prof. Wolfgang Gohde, one of the founders of Partec company of Munster, Germany, who offered to send one CyFlow SL Blue 5 Parameter CD4 T-cells counting machine for evaluation.
On 22/9/2004 Partec dispatched one CyFlow machine to Tanzania, complete with its Starter Kit (of reagents) enough for 200 tests, and 100 vacuettes (see Annex 2.11), from Germany, to the MoHSW, Dar es Salaam, Tanzania, vide Invoice No.04093571 (see Annex 2.1) dated 22/9/2004, and Air Waybill No.724/DUS/4286 4356 (see Annex 2.2) dated 23/09/2004. On 27/9/2004, the CyFlow SL Blue CD4 machine arrived at DIA (Dar es Salaam International Airport), vide the same Air Waybill No.724/ DUS/4286 4356 . At DIA, the CyFlow machine with its sensitive reagents lay stranded and unattended for 1.5 months before the then MoHSW PS, Mrs. Mariam Mwafisi sent the MSD (Medical Stores Department) to clear it on 11/11/2004 and MSD sent it to NACP (National AIDS Control Programme) on 12/11/2004. The same machine was transferred to MUCHS Microbiology/Immunology Laboratories on 15/11/2004 by the Partec Nairobi based Application Specialist/Engineer Mr. Joseph Khisa accompanied by Dr. Benedict Mbawala, a local Partec representative.
From 15 – 18/11/2004 Mr. Khisa installed the CyFlow machine and used it to conduct a detailed 3-days training of Technicians successfully. The Technicians including Dr. Said Aboud, whom Mr. Khisa trained were:
J.Sufi (in charge), S.Mgonja, Doto Kalovya, Viola Msangi, and Asha Shah.
From this time onward, Partec and its agents, especially the Dar based Dr. B. Mbawala, kept on enquiring about the progress of the evaluation of the CyFlow machine regularly, and was always told it was on track, and would soon be completed, the same answer they gave even when it was still stranded at DIA. These frequent follow ups/enquiries kept on upsetting some officials of MoHSW and especially of MUCHS so much that:
(a) Prof. Matee of MUCHS ordered Mr. Khisa Joseph and all Partec agents that:
"No body from Partec should follow up the progress. He particularly cautioned Dr.Mbawala should keep off the University campus." (see Annex 2.6)
(b) The then MoHSW PS, Mrs. M.Mwafisi personally kept on enquiring and she too was being told the evaluation is proceeding well even when it was still stranded at DIA. She convened Meetings of relevant officials, and chastised some for not doing enough follow ups of the CyFlow Evaluation, and therefore slowing down its pace. She even warned some officials against keeping letters which are addressed to the PS without informing or showing her and/or replying to some without her knowledge. (see Annex 1.4.4). She emphasized that MoHSW officials are there to help expedite the evaluations not to obstruct them.
(c) In one Interview, Ms.Mwafisi said that she summoned Prof. Lyamuya who was so unhappy about these follow ups that he complained to her that she was "bullying and harassing" him. Mr.Khisa’s also allude to this (see Annex 2.6).
(d) The anger sparked off by these regular follow ups by Partec people was so pervasive among some MoHSW and MUCHS officials that, for instance, Prof. Matee of MUCHS could not resist the urge to ban all Partec people from going to the MUCHS campus at all (see Annex 2.6), and he briefly but categorically declared that the evaluation of the CyFlow would not be possible without payments. Since payment was not arranged, evaluation took the official stand (delaying tactics), and therefore the evaluation was not performed until 24/07/2005! (see Annex 2.6, page 1). Clearly MUCHS evaluators were mysteriously determined to let no Partec person see what they were doing, as if to hide something, and the evaluators were very payment/s for this evaluation.
(e) In spite of Prof. Matee banning all Partec people, MUCHS called Partec’s Mr. Khisa on 23/07/2005 to help them rectify a failure of the CyFlow’s screen to display, which turned out to have been caused by fungal growth and dirt in the instrument tubings. Furthermore, some MUCHS staff told Mr. Khisa that they were using old blood samples from a certain VCT were collected and analyzed on this CyFlow, and no fresh samples were compared as required by the standard instructions and procedure. These MUCHS people told Mr. Khisa that, they were doing all that as a form of protest! (see Annex 2.6).
(f) All what is said in point (a)–(e) above, about MUCHS banning all Partec people from following up the evaluation progress, not caring even to clean the equipment and keeping the reagents at 2-8oC, not using fresh samples, not ordering reference reagents early and having to wait for 6.5 months for them to be procured, doing all this negligence as a form of protest (because they had not received their payment?), giving contradictory statements and dates, using the 10 months old CyFlow reagents way past their 6 months shelf life and comparing them with new and fresh BD reference reagents - added together, all this smacks of a conspiracy to delay and/or mess up the whole evaluation exercise.
All this certainly shows no intent whatsoever of doing the evaluation work seriously and assiduously. And when the evaluators finally decided to start the CyFlow evaluation in earnest, the plan was to go about it deliberately haphazardly, which would definitely give topsy turvy results which can always be blamed on the "shortcomings" of the CyFlow. This would in turn disqualify the CyFlow, which would complete the vicious circle whose main goal appear to have been to remove the CyFlow from the competition so as to leave the market wide open for the very wealthy Mr. Bharat Rajani, the BD (Becton-Dickinson) local representative to continue monopolizing the CD4 counters market, without any competition!
(g) The oft repeated threat of some MUCHS staff of "no payment no evaluation" which delayed the start of the CyFlow evaluation until 24/7/05, instead of starting the evaluation immediately after Mr. Khisa completed the CyFlow "repairs" on 23/07/2005 and after the 3 days training of Technicians on 18/11/2004, culminated into causing a further 8.5 months delay, over and above the 1.5 months delay caused by the unwarranted act of getting the CyFlow stranded at DIA that long. This totals up to a delay of 10 months which could have been prevented, had there been genuine resolve and lack of negligence.
(h) Prof. Lyamuya’s rebuttal letter of 30/01/2006 (see Annex 2.9, page 1-2) possess several inconsistencies, such as giving a wrong date of delivery of the CyFlow to MUCHS as 24/12/2004 (instead of 15/11/2004 mentioned by Mr.Khisa (see Annex 2.6), and then Prof.Lyamuya himself correcting his error (see Annex 2.22). Also giving the wrong name of the deliverer of the CyFlow as Mr. Khalid (Mr.Khisa accompanied by Dr.Mbawala - see Annex 2.6.1). Also stating that the "Calibration Beads" were missing while the Partec Delivery Note and Packaging Check List (Annex 2.11) shows that the complete set of reagents were delivered to MUCHS without which Mr.Khisa could not use the CyFlow to train technicians. All these and more are indicative of some unadmitted remorse for MUCHS’s role it played in overdelaying the evaluation, and overdramatizing the CyFlow’s imprecision fault despite Partec and the bulk of the scientific community refuting them by many scientific proofs.
(i) All this reminds one of the above mentioned article of Rai newspaper dated 31/08/2006 (Annex 2.60.1) which quoted Dr.R.Gohde of Partec saying that, right from the beginning, some officials of MoHSW and MUCHS appeared to prefer to let BD (Becton-Dickinson) company of USA alone, through its local agent Mr. Bharat Rajani to be the sole supplier of the BD CD4 counting machines like the FACSCount. And this indicates possible motivation of suspected bribery:
(i) For every delay, frustration, or outright disqualification which may drive Partec out of the competition for Tanzanian market for CD4 counting machines, the people who effect these delays feel sure to be rewarded immediately or afterwards.
(ii) Every threat like "no money no evaluation", or every "go slow or protest" action like using old unfresh sample or reagents, sends a message to prospective competitors like Partec to out-bribe the incumbent like BD or else perish.
(iii) The more Partec appears to be stubborn or uncompromising in this issue, the more pressure was increased till Partec realizes, softens up, and pays the bribe.

2. WERE REAGENTS USED FOR CYFLOW EVALUATION EXPIRED? DIDN’T MUCHS EVALUATORS KNOW ABOUT THEIR SHELF LIVES?
The answer to this question is certainly yes, the reagents that were used for the CyFlow evaluation had nearly reached their "Expiry dates", but their "Shelf Lives" had already expired.
(a) As shown in the table below the expiry dates shown on this table were given by Prof. Lyamuya’s letter dated 30/01/2006 (Annex 2.9, page 2).
EXPIRY DATES OF REAGENTS USED FOR THE CYFLOW MACHINE
NAME OF THE REAGENT WRITTEN
ON THE CONTAINER LABEL
EXPIRY DATE
WRITTEN ON THE
CONTAINER LABEL
TIME USED
BEFORE
EXPIRY DATE*
CyTecs CD4 Easy Count Dilution Buffer
Code No. CY-R-1004; Lot No. 041020wd
December 2005
Four
Months
CD4 Easy Count CD4 PE
Code No. CY-R-104; Lot No. X27008
February 2006
Five
Months
Calibration Beads
Code No. 9544000
October 2005
Two
Months
* Assume that the expiry date given as October 2005 means the reagent expired on 30/10/ 2005,
and assume that when it is said that the evaluation ended in late August, it means 30/08/2005.
Therefore, as seen on this table, even the Calibration Beads whose expiry date was the first to elapse, were last used about two months before their expiry date. In other words, technically, any claim that these reagents had expired by the time the CyFlow made its last run with them, is null and void.
(b) But is it true that these types of reagents used by similar "flow cytometers" like FACSCount do not have a "Half Life" of 6 months as MUCHS implies? Partec says no, as it made clear at different occasions that CyFlow reagents, the same as the reagents of BD FACSCount, with which MUCHS is more familiar, do have a 5 months shelf life by the time its reagents reach Africa, as stated in the "FACSCount CD4 Machine Logistics Fact Sheets" (see Annex 2.21.1), which they must have known that they state as follows, under the heading of SHELF LIFE:
"Reagents are guaranteed to have six months shelf life when leaving
San Jose, Puerto Rico, and five months when arriving in Africa".
Therefore, even if it is true that MUCHS evaluators were never told nor read somewhere that the CyFlow reagents too have a 6 months Shelf Life, they had no reason to assume that the CyFlow reagents have no Shelf Life of 6 months too, which had certainly elapsed by the beginning of the CyFlow evaluation on 24/07/2005 when the reagents had already spent about 10 months in the tropical Dar heat, i.e. their "Shelf Life" had already expired by 4 months, having arrived at DIA on 27/09/2004, and the CyFlow evaluation did not commence until 24/07/2005. Clearly, by any Standard of Operation (SOP) those CyFlow reagents were unfit for use after 24/04/2005, the date of expiry of their shelf life, and so their analytical results could not be relied upon. MUCHS deliberately forgot this, or decided to ignore it, for reasons best known to themselves.
(c) Be that as it may, it is difficult to understand the rationale of anyone buying a vial of eye drops today, and wait for months until it is two months only from its expiry date before using it. Why not procure fresh eye drops, if one had really compelling reasons not to use the eye drops immediately after buying them? Partec says that, MUCHS ordered and Partec gave them reagents more than once, and would have gladly given MUCHS fresh CyFlow reagents if they asked for them and explained their compelling reasons. Perhaps this was not in the vicious circle, and may disturb their pre-arranged plans, which included such a lengthy deliberate delaying of the CyFlow evaluation.

3. WHAT TYPE OF CYFLOW MACHINES ARE USED IN TANZANIA, IN WHICH CENTRES, AND HOW DID THEY ENTER TANZANIA?
The short answer to these two questions is that no one knows, and the Probe Team was unfortunately not given the means and the mandate to visit all the many centers all over Tanzania; and enquiries by telephones and mails revealed virtually nothing about this.
(a) This kind of information should be on the fingertips of a perfectly functioning Board (PHLB). But answers to a long questionnaire we had to send to its Registrar, Mr. Sabas Mrina showed that PHLB knows too little about this:
"Our records show that only 3 machines passed through PHLB – one for Bulongwa, another for Muheza, and another for Oysterbay Hospital. The machine for Oysterbay was released on the condition that it should be used for demonstration purposes only. The other machines could have passed through TFDA. The Board agreed with NACP that the existing CyFlow machines be replaced with FACSCount machines. It has been impossible for the Board to take strong measures to Laboratory Centers with these machines, because replacement has not yet been implemented. Only Bulongwa Hospital has been replaced by a new FACSCount machine."

The Registrar did not know even the information I gathered by telephone that actually Bulongwa had two CyFlow machines, and I strongly doubt if Bulongwa or any other possessers of other CyFlow machines have ceased using their CyFlow machines which we were rested assured that they are operating very successfully ever since they entered Tanzania.
(b) The following are the few Health Facilities about which we were able to find out, which possess and use CyFlow CD4 counting machines:
(1) Oysterbay Hospital,Dar es Salaam,which uses the CyFlow SL Green model.
(2) Consolata Hospital, Ikonda.
(3) Lutheran Hospital, Bulongwa, which apparently has two CyFlow machines.
(4) PIUMA, Makete.
(5) Village of Hope, Dodoma, where the Hon. Prime Minister Lowassa, M.P.,
personally inaugurated their CyFlow CD4 counting machine, not long ago.
(6) Consolata Hospital, Iringa.
(7) Aids Working Group, Tanga.
(8) D.D.Hospital, Muheza.
(9) RDTC, KCMC Hospital, Moshi.
Dr. Rainer Brandl, formerly of Bulongwa Hospital said in one of his short Reports that there are over 18 CyFlow machines currently in use in Tanzania. Most likely these are of different models or versions of CyFlow CD4 cell counting machines, whose exact specifics no one appear to have bothered to record until now.
(c) In answer to another questionnaire questions we sent him, the Registrar of PHLB, Mr. Mrina said simply that:
"The other (CyFlow) machines could probably have passed through TFDA."
This PHLB answer shows more of the weakness of the PHLB, and also the inherent confusion of some of the Acts which establish Boards/Agencies such as PHLB (Private Health Laboratories Board), TFDA (Tanzania Food and Drugs Authority), GCL (Government Chemist Laboratory), all of which are "Health Laboratories"-related. One solution to this dangerous confusion, off hand, may be to have a strong well planned and organized body uniting all such health laboratories possessing Agencies and Boards like these together somehow.
Instead of being dealt with by PHLB, some Laboratory supplies are dealt with (issued permit for importation, registration, approval to use as laboratory equipment, etc.) by TFDA if or when these CyFlow machines were treated as a medical devises. Alternatively, the same items may be dealt with by the GLC if or when the substances/reagents therein were treated as industrial chemicals. And when we talk of foods and drugs, we find things like milk, meat, verterinary drugs, agricultural drugs which may be used as pesticides, avicides, herbicides, etc. which may be claimed to be the exclusive domains of Ministries of: Agriculture, Livestock, Forestry, Fisheries, Water, etc. and their respective Laboratories. An organ joining these somehow could be referred to whenever there is an unsurmountable controversy as to which item should be dealt with by which particular Laboratory.
But to the best of my knowledge – confirmed by a telephone call to TDFA and GCL – TFDA is mandated to deal with machines or devices and drugs which are made to enter into a human body somehow, and CD4 counting machines only assay fluids like blood specimens when they are outside the body. Therefore these CyFlow CD4 cell counting machines could not have been given Importation or Registration Certificates by TFDA. And it is only by physically visiting these centers that we could have learnt first hand which types of CyFlow were being used by who, and how they were imported into Tanzania. Similarly GCL hazarded a guess only that GCL could not deal with the CyFlow reagents even if they were separated from the CyFlow machine, because they are not likely to be categorized as industrial chemicals. But isn’t the line of demarcation here very thin – a chemical like alcohol can be an industrial chemical (GLC’s domain), a reagent/reagent-making solvent (PHLB’s domain), and solvent for compounding drugs (TFDA’s domain).
(e) Since we have not been able to establish which types of CyFlow machines are in use in Tanzania, it is futile to give names/characteristics of all CyFlow machines currently available in the world market, until we know which of them entered Tanzania.

4. WHICH TYPE OF CYFLOW MACHINE WAS TESTED IN THE SPECIAL HIV AIDS LABORATORY AT MUCHS?
The answer to this question is the "CyFlow® SL, Blue, 5 Parameters", often abbreviated as CyFlow®, or CyFlow® SL, or CyFlow® SL Blue.
(a) In the Partec Invoice No. 04093571 dated 22/09/2004, (see Annex 2.1), the Item Description of the instrument which MUCHS evaluated, is written as: "CyFlow® SL, Blue, 5 Parameters"; the back of this instrument is written the date of manufacture as 2004, Serial Number as 040814517, and the manufacturer’s address: "CyTecs GmbH, Am Flugplatz 13, D-02828 Görlitz". CyTecs is the name of the section of the company which houses the manufactures of the CyFlow machines which is located in Görlitz, East Germany. Partec is the research and administration section which is located in Munster, West Germany. CyFlow is the registered trade mark of CyTecs. I have gone into such details because Prof. Lyamuya’s letter of 30/01/2006 (see Annex 2.9, page 1-2) appears uncertain of the exact name or version of the CyFlow machine which MUCHS were evaluating.
(b) This CyFlow® instrument is equipped with a blue solid state laser (power: 20mW, wavelength: 48nm); and it is fitted with 5 optical parameters (forward scatter, side scatter, fluorescence channel 1, fluorescence channel 2, and fluorescence channel 3)."
(c) This CyFlow® counting machine differs in its configuration from the dedicated CD4 counting machines also manufactured by Partec, such as: "CyFlow® Counter", and "CyFlow® SL_3" – these last two CyFlows were unfortunately banned by MoHSW from entering Tanzania, although they are versions of CyFlow machines quite distinct from the CyFlow® SL Blue 5 Parameters which MUCHS had evaluated.. It is still inconceivable why these two and all other CyFlow machines have received a total ban en-masse without even being evaluated - a case of judgment without trial!
It is particularly pitiful that donations of CyFlow units dedicated for humanitarian support of NGOs which treat children, have been banned from importation, notwithstanding all competitive instruments like BD FACSCount (which has reigned without competition for over 10 years, and of which there are over 40 units currently in use in Tanzania, half of which are non-functional most of the time), have several drawbacks including their incapability to perform CD4% analysis which is imperative in the treatment of AIDS infected children below 7 years of age. This is causing hundreds of children to remain without essential reliable monitoring and treatment.
(d) The CyFlow® SL Blue 5 Parameters machine is one of the many versions of CyFlow multipurpose CD4+ T-cell counter, comparable to other CD4 counters which use the assay principle of "flow cytometry", whose characteristics are summarized in the following tables compiled by a joint UNICEF-UNAIDS-WHO-MSF Project in June 2005, and were revised in August 2005. The CyFlow® is acknowledged as being as good as the reference counters such as FACSCount, FACSCalibur, etc. as shown below.
SOURCES AND PRICES OF SELECTED MEDICINES AND
DIAGNOSTICS FOR PEOPLE LIVING WITH HIV/AIDS
Summary of CD4+ T-cell enumeration technologies
Instrument
FACSCount CD4 Counting Machine
CyFlow SL CD4 Counting Machine
Manufacturer
Becton-Dickinson, CA, USA
Partec GmbH (Munster, Germany)
Assay principle
Flow cytometry
Flow cytometry
Instrumentation
Dedicated CD4 counter
Dedicated CD4 & CD4% counter
Detection system
Fluorchrome labeled anti-CD3,
CD4 and CD8
Fluorchrome labeled anti-CD4/ anti-CD45,MAbs,(CD3/CD4), (CD3/CD8), CD4/CD8
Specimen
Whole blood
Whole blood
Results
Absolute CD4&CD8 count, CD4/CD8, ratio,CD4% , andCD8% among T-cells
Absolute CD4 and CD45 count, Absolute lymphocyte count,CD4% among lymphocytes, CD4% among T-lymphocytes
Correlation with flow cytometry
r value = 0.93 – 0.98
r value = 0.95 – 0.99
Cost of the CD4 instrument, US$
27,000
26,975
Cost of reagents
US$/test 5 – 20
US$/test 2.26 - 3.23
Advantages
Automated, fewer steps, less human error, low biohazard risk, Absolute CD4 and CD8 counts, Quick results, EQA (External Quality Assessment) available
Reagents available at low cost, Equipment includes reagents for 200 CD4% tests, Quick results, EQA (External Quality Assessment) available
Disadvantages
Reagent prices vary widely, CD4% among lymphocytes not reported, can be calculated from haematology data
Limited data available
N.B. Partec claims that some of the characteristics of their CyFlow machines in the above table of June 2005 are erroneous and/or missing, and WHO corrected these in the August 2005 version which I have not seen yet. (see Annex 2.23, and 2.40 and 2.41).
(c) The CyFlow®SL Blue 5 Parameters is a relatively big yet compact machine, which is versatile, easier and faster to operate, affordable, and an ideal reliable medical technology for developing countries with resource limited settings, according to many researchers who have worked with CyFlow machine, often comparing CyFlows with other CD4 counting machines manufactured by other companies like BD (Becton Dickinson) of USA, Coulter Corporation of USA, Guava Technologies of USA, etc.

5. WERE THE PROCEDURES USED IN EVALUATING THE CYFLOW® MACHINE IN THE SPECIAL HIV/AIDS LABORATORY REALLY SCIENTIFIC, AND CAPABLE OF PRODUCING ACCURATE RESULTS
The short answer to this loaded question is simply no, the procedures used by MUCHS leave much to be desired, and were not expected to produce reliable accurate scientific results of the CyFlow® evaluation.
(a) The whole aim behind concocting the phrase SOP (Standard Operating Procedure) was so that any analyst anywhere in this global village (world), is able to replicate or repeat that same analysis in exactly the same way and expect to get the same or similar answer, providing he/she can read, understand, and follow every step exactly as instructed by the standard methodology.
Once an analyst departs from the SOP however minutely, he/she should expect a departure from the expected results. When this happens, there are absolutely no two ways or quid pro quo about this, but the analyst has to start all over again.
(b) During that CyFlow evaluation exercise, MUCHS evaluators took uncalled for short cuts, because they forgot or ignored the correct way, and they never started all over again so as to do it correctly. For example:
(i) Having been using BD FACSCount machine which applies the principle of "flow cytometry", even if they never read somewhere or they were not told so, MUCHS evaluators must have known that reagents of CyFlow, like the reagents of FACSCount, should never be exposed to temperature below 2oC nor above 8oC. But, despite the concise labeling of the Partec reagent bottles (see Annex 2.21.2), despite the instructions of the Partec packet insert for reagent kits (see Annex 2.42), and despite instructions of FACSCount CD4 Machine Logistics Fact Sheets (see Annex 2.21.1), MUCHS allowed the reagents to remain unattended for about 10 months at temperatures as high as 25-35oC. Even if MUCHS did not personally allow this. They knew that is what happened to the CyFlow reagents. Ideally therefore, after such mistreatment of the CyFlow® reagents, MUCHS should not have gone ahead and use those overheated reagents for the CyFlow® evaluation, particularly since MUCHS well knew that they will have to compare their performance with that of the very fresh and brand new reagents of the reference FACSCount machine. That was against SOP by any standards.
(ii) MUCHS did not use SOP (Standard Operating Procedure) also when they forgot or ignored the fact that, like the reagents of FACSCount the Partec CyFlow® reagents too had a "Shelf Life" of six months (see Annex 2.21.1), which had already elapsed by 4 months by the time the CyFlow® evaluation commenced on 24/07/2004. So MUCHS was not following SOP to go ahead and use reagents whose shelf life has expired like this. MUCHS should have asked Partec to give them fresh reagents with which they could then perform a trustworthy CyFlow evaluation. But they did not observe this simple SOP either.
(iii) For about 10 months MUCHS ignored to observe the standard maintenance instructions which directs the user to regularly clean the instrument, the negligence of which cost them the blockage of the instrument tubings by fungal growth, which in turn jammed the mechanism of the CyFlow®. By any language, this was far from SOP, which is not conducive to producing correct results.
(iv) The magnitude of negligence shown by MUCHS evaluators using old (unfresh) samples while all standard procedures demand samples to be fresh, was certainly uncalled for, unscientific, and were also likely to give incorrect results (see Annex 2.6).
(v) What MUCHS technicians told Mr. Khisa and his E-mail quoted them (Annex 2.6), had the following mind-boggling unscientific and unpatriotic statement:


"Due to this scenario (of refusing to borrow and use the reference method BD machines’ reagents for the CyFlow® evaluation) I understand from the staff that old samples from a certain VCT were collected and analyzed on the CyFlow®. I want to point out that no fresh samples were compared as required by the procedures, and that the exercise was carried out in protest."
Most certainly alleged use of blood samples which are not fresh (older than 8 hours) was a ready recipe for unscientific, inaccurate and unreliable results. And the mere thought that the evaluators at an august institution like MUCHS could allegedly stoop so low as to engage in all types of negligence and non-observance of proper procedures – all as form of protest is stunningly unjust and unpatriotic, especially since the whole exercise is one of the "fight (jihad)" against the HIV/AIDS scourge, and of prolonging or saving precious lives of our people.
(vi) After Partec returned the CyFlow® (from Tanzania back to Germany) which MUCHS had evaluated, and reprinted the results which fortunately remained intact in the CyFlow black-box (harddisk), Partec discovered that the CyFlow® instrument setting was manually altered, and MUCHS performed the CD4 counts on their 240 samples using this manipulated incorrect setting (see Annex 2.54), which automatically used the wrong detection channel, ‘FL1’ (see Annex 2.54, Fig. 6 & 7’) to read the results which were obviously incorrect too. A look at the retrieved printouts (which MUCHS had refused to release) would have shown that the instrument setting was wrong and so bring down the correct predefined setting which would automatically bring in line the correct detection channel ‘FL2’ (see Annex 2.54, Fig. 5), and so read the incorrect CD4 cell counts. This is too damning an evidence anyone would find hard to refute. The mere thought that someone out there could go to these extents to falsify so important analysis results of HIV patients is truly mind-blowing and unimaginable.
(vii) There are many items which MUCHS claimed that it had the right to deny Partec access to, which could have shown even to MUCHS itself, if the cause of the odd results was the instrument setting or the blood preparation protocols or the spoilage of old samples and reagents, they would promptly set the instrument right and repeat the evaluation exercise successfully, before releasing that odd final CyFlow® Evaluation Report. MUCHS did not do so.
(viii) All these incidences of neglecting to observe standard operating procedures, of refusing assistance from various Partec experts like the Nairobi based Partec engineer Mr. Khisa (see the Service Reports Mr.Khisa, Annex 2.5 and 2.6, and see the Germany based Partec Chief Engineer Dr. Ost’s Technical Service Report, Annex 2.17), and the banning of all Partec people from ever showing up at the MUCHS campus, indicates that MUCHS knew about the deliberate mistakes or damages they were inflicting on the CyFlow®, and they knew that any Partec expert would recognize these, and then MUCHS would not be able to blame it on the inherent "faults or shortcomings" of the CyFlow® machine as they eventually did.
All these incidents show that the procedures MUCH used in the CyFlow evaluation were unscientific and certainly should not have been expected to produce reliable CyFlow evaluation results, by any standards.

6.IS THERE ANY EVIDENCE OF BRIBERY OFFERED TO PRESSURIZE EVALUATORS TO GIVE THE RESULTS THEY GAVE?
The answer is yes, there is evidence in the form of indications that bribery in its various manifestations was given to the MUCHS evaluators and MoHSW supporters to influence the CyFlow evaluation results one way or the other.
(a) It goes without saying that to catch a person red handed giving a bribe or receiving a bribe, or to get the briber or the bribed to admit or confess to the act of bribery, is virtually impossible. Even the professionals like the officials of an anti-bribery organization like PCB, who are far better equipped, have to resort to laying a trap with tagged paper money, long before the bribery act takes place, in order to catch the bribery pair red handed, and even they sometimes don’t succeed. As for our Probe Team which was selected long after this CyFlow® saga unfolded, and being so ill equipped, all that our Probe Team could find as "evidence of bribery" were implications, inclinations, insinuations, allegations, allusions, connotations, and the like, which may not be admitted in the cheapest court of law as proof beyond reasonable doubt. Let us recap acts of frustrating the evaluation which culminated into the final Report which disqualified this CyFlow® and banned all other CyFlows existing in Tanzania:
(b) In countries that are steeped in the habit of bribing such as Tanzania nowadays, one is expected to know, as the MUCHS evaluators told Mr. Khisa, "no payment no evaluation". In order to get a clerk or messenger to locate your file, you need to reward them. To put you letter into that file, you need to reward someone. To send that file to get various officials to read you letter and act on it, you need to reward each movement to each desk to which your file needs to be sent. If you do not "cooperate" and keep giving these bribes, your letter will not be sent to its appropriate destinations, and eventually you will discover your letter is lost in the maze of their registry where you cannot locate your letter nor file even if you were allowed to enter that registry. Sometimes doing the wrong thing serves as a message for you to do the needful, i.e. cough up a bribe. Similarly:
(i) No one bothered to go to the airport (DIA) to clear the CyFlow until the then PS used an iron-fist or threatening gesture. But if there were someone ready to grease somebody’s palm, that CyFlow would have been out of DIA in no time, instead of being stranded there for 1.5 months. And if the bribe were substantial enough, or if additional bribe were given, no one would need to remind any MUCHS or MoHSW official to carry out the next step.
(ii) Someone wanted to be rewarded in order to use the reference methods reagents used for MUCHS other projects and return equal amount of the reagents borrowed. Offering no reward cost a good 6.5 months delay of the CyFlow evaluation, waiting for MoHSW to deliver these long promised reagents.
(iii) Even if it were true that MUCHS was missing certain reagents like "Calibrating beads", if someone’s palm were greased, MUCHS would have ordered these earlier as soon the CyFlow arrived at MUCHS without the beads.
(iv) To cut a long story short, even the faults alleged to have been discovered by MUCHS in this CyFlow® which led to MoHSW banning not only the single CyFlow®, but ban all other types of CyFlow machines. Either the instrument setting would not have been altered, or fresh samples and fresh reagents would have been, and all would turn out hanky dory without any hitches.
(v) Who would be dishing out these rewards? Of course it was that firm which stood to gain by any delay or frustration of the CyFlow evaluation or even its outright disqualification, i.e. the supplier of the FACSCount CD4 counting machine, namely Biocare Health Products Ltd. owned by Mr. Bharat Rajani. As for those who stand to be vexed or disappointed by any undue delay or frustration or disqualification of the CyFlow evaluation, i.e. Partec, such delaying tactics, frustration, or disqualification serve as a message for Partec to "be in Rome and do what the Romans do" i.e. out-bribe Biocare Health Products Ltd. or face the consequences of continued delays.

7. DID WHO EVER DO AN EVALUATION OR MULTICENTER STUDY OF THE CYFLOW MACHINE? WHAT RESULTS DID THEY GET?
(a) The short answer is no, WHO never did any evaluation or multi center study of the CyFlow® CD4 machine. And to the best of my knowledge, WHO has not done any evaluation or multi center study of the FACSCount, FACSCalibur, nor any other CD4 machine, simply because that is not one of its current duties. All that WHO can do and often does, is to coordinate different laboratories who opt to do some studies, or recognize good studies done by them. WHO can recommend and/or procure equipment and reagents for various laboratories and/or occasionally fund portions of studies, and disseminate scientific data and information on any medico-technological topic which can help advance medical knowledge and/or improve the health of man anywhere any time. If WHO were evaluating CD4 counting machines, we would all wish to entrust WHO as a reputable international health organization, and avoid all these headaches of establishing expensive laboratories and policing them to keep bribery out of one organization only.
(b) The implications behind the above stated question presumably is, whether WHO recognizes Partec’s CyFlow technology or not. Indeed some adversaries of Partec and its CyFlow systems put that question this way:
"Has WHO ‘validated’, ‘approved’, or ‘certified’ the CyFlow systems or not?" The answer to this question too is negative, because no CD4 counting system has ever been given a certificate, approval, or registration of any kind by WHO– not Partec’s CyFlow nor BD FACSCount systems. It is simply not their responsibility right now. But WHO has done a lot which show that it fully recognizes the Partec CyFlow CD4 enumeration technology just as it recognizes BD FACSCount technology and other technologies as demonstrated by the following table which was compiled jointly by WHO, UNICEF, UNAIDS, and MSF (Medecins sans Frontieres) in June 2005, and revised in August 2005 (see Annex 2.23).
A SUMMARY OF CD4+ ENUMERATION TECHNOLOGIES
COMPILED BY A JOINT UNICEF/UNAIDS/WHO/MSF PROJECT, JUNE 2005
Parameter
Double - Platform
S I n g l e - P l a t f o r m
Volumetric Bead-based
Instrument
Flow cytometer
Flow cytometer
Flow cytometer
Manufacturer
Partec GmbH (Germany)
Becton-Dickinson (USA)
Coulter Corporation (US
PartecGmbH Germany)
GuavaTechnology(USA
Becton-Dickinson(USA
CoulterCorporation(US)
Cost in US$
20 – 95,000
20 – 70,000
20 – 95,000
Cost Reagent
per test US$
2 – 11
1 - 10
3 – 25
Specimen
Whole blood
Whole blood
Whole blood
Results
AbsoluteCD4/CD8 count CD4%/CD8% in lymphcts
CD4/CD8 ratio. B and NK cells are possible
AbsoluteCD4/CD8 cont
CD4%/CD8% in lymph
CD4/CD8 ratio. B and NK cells are possible
AbsoluteCD4/CD8 cont
CD4%/CD8% in lymph
CD4/CD8 ratio. B and
NK cells are possible
Samples/day
Up to 250
Up to 250
Up to 250
Advantages
One tube assay possible
without QC problems
EQA (External Quality Assessment) available
No need for extra beads or hematology analyzer.
Protocols for aged
samples available
EQA available
No need of hematology analyzer. Protocols for aged samples available
EQA available
Disadvantages
Needs use of hematology
Analyzer. More prone to clerical errors. Fresh samples needed in order to obtain absolute counts
Internal QC for pipetting needs 2 tubes assay. Instruments not yet proven in an independent multi center study
Internal QC for pipetting needs 2 tubes assay. Beads are expensive and require careful handling
N.B. Partec claims that some of the characteristics of their CyFlow machines on this table were erroneous and/or missing, and WHO corrected those errors in the August 2005 Revision.
The above table, in whose compilation WHO fully participated, shows that:
(i) WHO fully recognizes the Partec CyFlow technology, or else WHO would not be a party to this compilation which has included CyFlow technology.
(ii) Such honest compilations by reputable organizations like these, could not possibly hide any faults of any one of the technologies they have listed.
(iii) So the alleged faults of CyFlow such as: "less precision when assaying low CD4 count specimens of <200 cells/μl)”, if it were exhibited by any of the flow cytometers in column 1 of the table shown above, it would have been recorded in the "Disadvantages row". Since there is no shortcoming recorded in the Disadvantage column, then it is correct to assume that none of the flow cytometers shown in this table, including the CyFlow machines, possess such a fault.
(c) Because of this joint recognition, WHO and many other International Aid Agencies have, been willingly purchasing CyFlow CD4 cell counting machines many times, something they would never do had CyFlow machines been proven to have any such faults. The following are a few of the examples of such purchases:
(1) WHO, Supply Division, Geneva, Requisitioner: WHO, AFRO-BRAZZAVILLE, CONGO, date of approval of order 29/06/2006, ordered 2 units, as WHO donation to Harare, ZIMBABWE (see Annex 2.28).
(2) UNICEF: Supply Division of UNICEF, Copenhagen, Denmark,ordered one unit on 11/10/2006 for Sanaa,YEMEN, a CyFlow SL-3. (see Annex 2.25)
(3) WHO: Supply Division, WHO, Geneva, ordered three units of CyFlow FL-1, on 01/05/2006, for Khartoum, SUDAN (see ANNEX 2.26).
(4) WHO: Supply Division, WHO, Geneva, ordered two units of Cyn Fl;ow FL-1, on 25/11/2005, for Cairo, EGYPT (see ANNEX 2.27).
(5) WHO: Supply Division, WHO, Geneva, ordered one unit of CyFlow FL-1, on 14/02/2006, for Brazzaville, CONGO (see ANNEX 2.28).
(d) As it was stated clearly in (a) above, WHO’s responsibilities so far do not include doing joint or solo studies of CD4 counting machines, therefore WHO has never done any multi-center studies of CyFlow. Therefore, the question to address is whether there are any multi-center studies involving CyFlow machines or not.
And the answer is yes, there are hundreds of multi-center and international studies, in some of which famous international research centers like USA based CDC (Center for Disease Control), or famous Universities like Stanford or Havard of USA, have participated (see Annex 2.58; 2.44; 2.29-40). WHO cannot go round participating in, supporting, or coordinating all such multi center studies.
►The Results, Observations, and conclusions of such multi-center studies were similar in extolling the close correlations between the CyFlow and the FACS machines performances, as shown by the following example of a joint Senegal and Belgium study (see Annex 2.30):
"Conclusion: Direct volumetric and bead-based single platform measurement on
the CyFlow showed good correlations with gold standards cytometers. The precision of volumetric measurements on the CyFlow can be improved by including a time versus fluorescence and a time versus total cell count plot as an additional internal quality control measure."
► And the Stanford University/Zimbabwe University Study (see Annex 2.29) had this to report:
"Objective: To evaluate CyFlow cytometry using CyFlow SL machine of Partec,
Munster, Germany for enumeration of Absolute CD4+ T-lymhocytes in subtype C HIV-1 seropositive subjects, and using FACSCount of Becton-Dickinson, San Jose, CA, USA, as ‘predicate method’.
- Results: Using linear regression analysis, there was a very strong correlation
(R = 0.991), between the overall CD4+ T-lymphocyte counts obtained by FACSCount and those obtained by CyFlow.
- Conclusion: The CyFlow counter is as accurate as the FACSCount in
enumerating Absolute CD4+ T-lymphocytes in the range 1 – 1,200 cells/µl. CyFlow cytometry is relatively affordable, easy to use technology that is useful not only in identifying HIV seropositive individual who require ART, but also for monitoring immunologic responses to ART.
- Cost- currently in Zimbabwe, the cost of CD4+ T-lymphocyte count is US$56.
This cost is revised upward quarterly. According to the manufacturer of CyFlow, a CD4+ T-lymphocyte count using their machine and reagents should cost only US$2.50 (2 Euros). Although the purchasing price of FACSCount and CyFlow machines are comparable (US$30,000 – 50,000), the FACSCount reagents are more expensive than those for the CyFlow. The CyFlow counter also has a higher throughput, and as many as 200 specimens can be run per day, making it ideal for use in Zimbabwe, a country with one of the highest prevalence of HIV globally."
► Let us now quote the latest study: "Evaluation of the CyFlow SL_3 system against the FACSCalibur system in the determination of CD4 absolute counts and percentages in the immune monitoring of HIV infected patients in Zimbabwe", published in Clin Vaccine Immunol, 31/1/2007 (Annex 2.39):
"In the measurement of CD4 lymphocytes, total lymphocytes, and CD4% while monitoring the immune system of HIV/AIDS patients, statistical analysis for precision, correlation, and agreement were performed. Coefficient of Variations (CVs) of 5.8, 4.6, and 3.9% were obtained for low, medium, and high CD4 cell counts, respectively, using the CyFlow SL_3; and the CVs of 3.7, 4.0, and 0.94 were obtained for the same categories using the BD FACSCalibur. Significant correlations (p<0.005) between the two assays for CD4 counts, total counts, and CD4% were obtained, correlation coefficients (R(2) of 0.99, 0.96, and 0.95, respectively (n=229. Using the Bland Altman plot, mean bias of -18; cell/µl (95% CI:-91 to 54 cells/µl), -0.85% (95% CI: -3.6 to 2 cells/µl), -36.8 cells/µl (95% CI: -477 to 404 cells/µl), were obtained in comparing CD4 counts, CD4%, and total lymphocyte count respectively.
This data showed that the Partec CyFlow SL_3 assay method is comparable to the BD FACSCalibur/Sysmex XT 1800i dual platform method, in the measurement of CD4+ cells, total lymphocytes, and CD4%, for the purposes of monitoring of HIV/AIDS patients."
► Yet another study which compared the CyFlow FCM (Flow Cytometer) and the Guava PCA (Personal Cell Analysis), captioned as: "Evaluation of two volumetric flow cytometers for the quantitation of CD4+ T cells in Thai HIV-1 infected patients", by Phuang-ngem, Y., et al, published by International AIDS Society, on 15th August 2006 (Annex 2.40). Conclusion: The volumetric CyFlow Green FCM and the Guava PCA system performed well relative to the two standard bead-based systems. Use of these new technologies could make CD4+ T cell enumeration more affordable in Thailand and other resource-poor settings."

8. HAS THERE BEEN AN UNNECESSARY DELAY IN ONGOING EVALUATIONS OF HIV TEST KITS INCLUDING SD BIOLINE SO AS TO ENTER SUCCESSFUL ONES INTO THE NATIONAL ALGORITHM?
Background to the SD Bioline saga
In this SD Bioline investigation, we encountered two opposing forces. On one side was "SD (Africa) Ltd.", a local company representing "Standard Diagnostics Inc." of Kyonggi-do, South Korea, the manufacturer of diagnostics including the SD Bioline HIV 1/2 Rapid Test Kit, which SD (Africa) sent to the MoHSW for evaluation. The President of the mother company, Standard Diagnostics is Dr. Young-Shik, Cho, while the Managing Director of SD (Africa) is Mr. James Chae, P.S., and the local representative of Mr. Poong Suk Chae is Lt. H.G.Chifupa (Retired), General Manager of another company called "Tega International Communication and Supplies Ltd." who was the one following up the progress of the SD Bioline evaluation most of the time.
The SD Bioline HIV Test Kit underwent Phase I evaluation successfully, and obtained a lot of very positive Reports such as:
►Ref.No.ACD.T/083/02/03 dated 14/03/2003 (Annex 2.61) from AMREF.
►Ref. No. MIM/022/A.5 dated 03/04/2003 (Annex 2.61) from MUCHS.
On the opposite side, there are the MoHSW, MUCHS, NACP (National AIDS Control Programme), MSD (Medical Stores Department), AMREF, and their various officials who performed the evaluations and exchanged many frequent correspondences with SD (Africa) about this SD Bioline evaluation which lasted 4 years (2000-2006).
Some of the Many Available HIV Rapid Test Kits and Their Specifications
The fast spread of this awful pandemic HIV/AIDS has raised an acute need of appropriate regularly evaluated HIV rapid testing algorithms and protocols, to support the many national HIV programmes in both urban and rural areas. The selected HIV Tests in appropriate algorithms must be thoroughly and regularly evaluated and registered. There exist over 100 HIV Rapid Test Kits on the market today, only a few of which are shown in the table hereunder (see Annex 2.63).
HIV TEST KITS AND THEIR SPECIFICATION
SIMPLE RAPID ASSAY KITS
Rapid Assay Test Kit Name
(Manufacturer)
Tests
/Kit
HIV
Type
Assay Type
Antigen
Sample Type
Cost/Test
US $
SD Bioline HIV 1/2 3.0
{Standard Diagnostic Inc.
(SEAR & WPR only)}
30
HIV-1
HIV-2
Lateral flow
Recombinant proteins
Whole blood
Serum/Plasma
0.92
Determine HIV 1/2
{Abbott}
100
HIV-1
HIV-2
Lateral flow
recomb pro
synth peptds
Whole blood
Serum/Plasma
0.80-1.00
Capillus HIV 1/2
{Trinity Biotech plc}
20
100
HIV-1
HIV-2
Agglutination
Recombinant proteins
Whole blood
Serum/Plasma
1.10
UNI-GOLD HIV 1/2
{Trinity Biotech plc}
20
HIV-1
HIV-2
Lateral flow
Recombinant proteins
Whole blood
Serum/Plasma
1.25
SERODIA HIV 1/2
{Fujirebio}
100
220
HIV-1
HIV-2
Agglutination
Recombinant proteins
Serum/Plasma
1.11
1.11
ADVANCED QUALITY
Rapid HIV Test{InTec Products
Inc} SEAR WPR only
40
HIV-1
HIV-2
Lateral flow
Recombinant proteins
Whole blood
Serum/Plasma
0.50
FIRST RESPONSE HIV
WB Card Test {Premier Medical Corporation (SEAR & WPR)}
30
HIV-1
HIV-2
Lateral flow
Recombinant
Proteins
Whole blood
Serum/Plasma
0.70
INSTANTCHECK HIV 1/2
Rapid Test {EY Laboratories
SEAR & WPR Only}
40
100
HIV-1
HIV-2
Lateral flow
Whole blood
Serum/Plasma
1.07
1.00
HIV 1/2 DOUBLECHECK
{Orgenics Ltd.}
40
HIV-1
HIV-2
Lateral flow
Recombinant
proteins
Serum/Plasma
1.00
IMMUNOCOMB II BISPOT
HIV 1/2 {Orgenics Ltd.}
36
HIV-1
HIV-2
Dipstick
Sythetic
peptides
Serum/Plasma
1.00
ELISA ASSAY KITS
VIRONOSTIKA HIV
UNIFORM II PLUS O
{Biomerieux BV}
192
576
HIV-1
HIV-2
HIV-0
Recombinant proteins. Syn
thetic peptide
450 nm
0.69
0.49
UBI HIV 1/2 EIA
{United Biomedical}
192
HIV-1
HIV-2
Snthetic
Peptides
492 nm
0.40
ENZYGNOST ANTIHIV 1/2
plus {Dade Behring AG}
Enzygnost/TMB Reagent Kit
2x96
10x96
HIV-1
HIV-2
HIV-0
Recombinant
Proteins
450 nm
0.99
0.75

Objectives of the Evaluations
The overall goal is to evaluate groups of five commercially available simple HIV Rapid Test Kits, which are as affordable, fast, easy to operate, and user-friendly as possible, using the following three-phase approach, for each:
1. Validate their Sensitivity and Specificity of the Rapid Test Kits within a Reference Laboratory setting. This is called Phase I of the evaluation.
2. Determine the Sensitivity and Specificity of the Rapid Test Kits when used at points of service, and develop algorithms of established testing characteristics. This is called Phase II of the evaluation.
3. Implement quality-assured testing Algorithms in multiple points of service testing sites (Phase III).
The advantage of having more than one Algorithms, which keep on being re-evaluated regularly, cannot be overemphasized. It ensures that always one has a reliable Algorithm to fall back to, within minimum phasing out/in period, in case one or more of the combination members of the incumbent Algorithm is found to be wanting or if another Algorithm proves to be better than the incumbent one.
How Many HIV Rapid Test Kits Were Involved in the Evaluation? Which?
Chorus of disapproval from the populace and news media compelled the MoHSW to issue a Press Release dated 10/11/2006 (Annex 2.64) to announce the long awaited "Change of National HIV Rapid Testing Algorithm". This Press Release talked of some 18 different Tests without mentioning their names. AMREF and MUCHS had evaluated 8 HIV Tests as shown in the table below.
Test
Capillus
Determine
Hemastrip
Oraquick
Unigold
SD Bioline
Sensitivity
98.89%
98.52%
95.20%
97.79%
99.26
100.00%
Specificity
99.91%
100.00%
100.00%
100.00%
99.91%
99.50%
Considering that detailed Phase I Evaluations for at least six HIV Rapid Test Kits available in the market in Tanzania were already conducted officially by MUCHS and AMREF by the years 2002/2003, and if Phase II and III Evaluations were well coordinated and seriously conducted, they should have taken weeks or a few months only, instead of nearly four years (2002-2006) for the new National HIV Testing Algorithm to be concluded and announced.
Evaluation, Registration, and Inclusion of HIV Tests in the New Algorithm
A glance at the correspondence between the suppliers and the MoHSW and PHLB shown hereunder gives the chronological order of events leading to the evaluation and issuing of their final Evaluations, which will help in detecting whether, when and how the new National HIV Rapid Testing Algorithm was delayed or expedited
(a) An encouraging letter from Dr.R.Swai, NACP Director dated 20/04/03
(see Annex 2.65) to Mr.Chae, Director of SD Africa, praising the SD Bioline.
(c) Another very positive letter Ref.No.GA.134/209/07/ dated 1/7/2003 (see Annex 2.66), which was signed by Dr.G.Upunda, the CMO, on behalf of the PS, to SD Africa Ltd., (see Annex 2.65) putting on record what these two discussed:
(i) That SD Africa showed the CMO a formal Registration of their SD Bioline.
(ii) That this Registration followed tests performed by the Tanzanian researchers
who were satisfied with the performance of the SD Bioline Test Strips.
(iii) The CMO liked to put on record the fact that the registration of SD Bioline by the PHLB, means that this product is now allowed to circulate and be used by the Health facilities in Tanzania, both public and private.
(iv) In conclusion, the CMO strongly advised SD Africa to market its product (SD
Bioline); and as for its use in public Institutions, the CMO advised SD Africa to wait until the Medical Tender Boards called for Tenders for such items and SD Africa could bid like any other company.
{It is surprising how, after all these high praises from top MoHSW officials, SD Africa met constant delaying tacticts and obstacles to the point of failing to bid in Tenders for such items because all the Tender Invitations, without any compunction, persistently used only trade names of Capillus and Determine, although these two Tests have never been registered and are therefore ineligible for bidding at any Tender, while SD Bioline is registered as the CMO stressed above.}
(d) On 14/02/2003, a "Report on the Evaluation of SD Bioline HIV 1/2 3.0 Rapid Antibody Test", Ref.No. ACD.T/083/02/03, from AMREF to NACP (see ANNEX 2.61) was issued which made the following 8 concluding strong points, 1 weak points, and recommendations – all highly praising SD Bioline:
Strong Points:
1. The Test Kit was user friendly – no reagent preparations, 2 step procedure for whole blood.
2. The Test Kit was ideal for small batch testing (VCT sites, Small transfusion sites).
3. The Test Device may be stored for future reference.
4. Minimum training is required.
5. Disposal of Test end products is easy – only plastic device (no glass products i.e. bottles, vials,
pipettes, carcinogenic or corrosive chemicals).
6. Refrigerator is not essential, though may be required.
7. Storage conditions 2-30oC.
8. Based on this limited evaluation, it is assumed that the SD Bioline HIV 1/2 3.0 Rapid Antibody
Test may conform to the nationally acceptable standards (Sensitivity 100%, and Specificity 100%).
Weak Points:
Materials supplied were not adequate for 30 clients i.e. lancet, capillary dropper and pipette dropper – only one of each was supplied.
Recommendations:
The sample size was too small for a comprehensive evaluation. It is recommended that proper evaluation should be conducted to determine the sensitivity and specificity based on local situation in Tanzania.
(e) On 03/04/2003, a "Report of Phase I Evaluation of SD Bioline HIV 1/2 3.0 Test Kit", Ref.No. MIM/022/A.5, from MUCHS to SD Africa (see Annex 2.62), giving it 9 Merits, 3 Shortfalls, and a good Conclusion similar to AMREF’s:
Conclusion:
These findings indicate that the Test has excellent performance characteristics and has several advantages that make it a good Test for use in HIV Testing Sites in hard to reach settings.
(e) For some unknown reasons, from about this time onwards, things began to take a "U" turn, and various officials traded rather discouraging letters with SD Africa:
› Ref.No.HC.49/421/Vol.11/170 dated 6/2/2004 (see Annex 2.68), captioned: "Board Response on the Evaluation of SD Bioline HIV 1/2 3.0 Rapid Test Kit, performed by MUCHS and AMREF", in which the PHLB Registrar contradicted AMREF, MUCHS, and even the CMO’s positive reports above and said:
Conclusion: In view of the information basing on the short comings reflected in the evaluation report for the two Test Kits, that is SD (Bioline) HIV 1/2, and Syphilis Test Kits, the Board does not approve the two Test Kits in their present form. Further evaluation will be needed as recommended by the Technical Team".
› A letter dated 20/05/2004 (Annex 2.69), signed by Dr.Z.Berege for MoHSW PS, captioned "Evaluation of SD Bioline SD HIV Kits and Others", to the Managing Director of TEGA Ltd., representative of SD Africa, informing him that:
(i) SD Africa was to submit additional 18 Kits (540 tests) for further evaluation.
(ii) SD Africa’s request on the use of AMREF’s evaluation results was refused.
(iii) The issue of a temporary registration permit SD Bioline was also refused.
› Another letter from the Registrar, dated 21/05/2004 (Annex 2.70), addressed to SD Africa was still negative and mixing rather irrelevant issues of the resignation of SD Africa’s Technician Mr. Hatibu Mritta.
› A letter dated 11/06/2004 captioned "Report on a field evaluation of Bioline SD HIV 1/2 Rapid Antibody Test" (Annex 2.71), from Dr. Awene Gavyole, Ag. AMREF Country Director, addressed to NACP. This Final Phase II Evaluation Report gave another excellent performance of SD Bioline, as it was for its Phase I Evaluation, unsurpassed by any other HIV Rapid Test Kits.
N.B.: The following results appear not to have been submitted with this Report until later when it was requested :
Spec
No.
Oral
Quick
Deter
mine
Uni
gold
Hema
strip
Capi
llus
Vironostica Uniform II
Ag/Ab
OD CO OD/CO
Vironostica Uniform II
Plus O
OD CO OD/OC
3067
N
N
N
N
N
0.056
0.176
0.320
0.037
0.167
0.220
3172
N
N
N
N
N
0.044
0.174
0.250
0.043
0.177
0.250
3187
P
P
P
P
P
3.466
0.174
19.92
2.778
0.165
16.84
3080
P
P
P
P
P
3.268
0.159
20.55
2.489
0.167
14.90
3114
P
P
P
P
P
3.236
0.159
20.35
3.748
0.177
21.18
3124
P
P
P
P
P
2.741
0.159
17.24
03.56
0.177
20.11
3344
N
N
N
N
N
0.066
0.171
00.39
00.04
0.144
00.28
AMREF’s Phase II SD Bioline Evaluation Recommendations: It is recommended that the rapid SD Bioline HIV 1/2 3.0 Rapid Antibody Test be considered for inclusion into the List of potential Rapid HIV Test Kits to be used in the country (i.e. the new HIV Rapid Testing Algorithm).
› Then, after a month, all of a sudden AMREF decided to revise its very positive Report of 11/06/2004, and issue a revised Report, captioned: "Report on field evaluation of Bioline SD HIV 1/2 3.0 Rapid Antibody Test: AN AMENDMENT OF RESULTS." (see Annex 2.72) by a letter written by the same Dr. Awene Gavyole from AMREF to NACP, dated 13/7/2004, and gave the following reasons for so doing:
"This Report compliments the earlier Report dated 11/06/2004. There is an upward adjustment in the sensitivity and specificity when compared with results received from MUCHS."
And our efforts to have access to the "MUCHS’s Phase II Evaluation of SD Bioline HIV 1/2 3.0 Rapid Test Kit", and/or to get AMREF to explain this Report revision of the original Report of 11/06/2004, were in vain up to now!
This amended Report introduced the following changes in the results:
AMREF SD Bioline Field Evaluation Result
Sensitivity
Specificity
Original Report dated 11/06/2004
95.7%
99.5
Amended Report dated 13/07/2004
97.8%
99.8%
Change effected by the amendment
+ 2.1%
+ 0.3%
Someone in the MoHSW hierarchy reprimanded AMREF for this ‘blunder’, although no one at AMREF agreed to avail us a copy of that letter of reprimand.
› The 3 page letter Ref.No.HC.49/421/Vol.II/240 dated 25/06/2004 and another letter HC.49/421/Vol.II/247 dated 28/07/2004 from PHLB Registrar to SD Africa gave the following similar negative reaction to the amendment of the Phase II Evaluation Report of SD Bioline HIV 1/2 Rapid Test:
"~And in the revised report the sensitivity of Bioline SD HIV 1/2 3.0 Rapid Test was updated from 95.7% to 97.8%, which PHLB still considers to be unacceptable. Gold standard must be 100%.
~ Conclusion: The Committee decided to hold on the earlier decision that from the results provided, Bioline SD HIV 1/2 Rapid Test does not qualify for use in Tanzania in its present form."
This is strange and revealing in many ways:
(a)Since MUCHS’s Phase I Results dated 23/10/2002 appeared good, as shown in the following Table, for reasons best known to SD Bioline adversaries, AMREF appear to have been expected NOT to give any results that are better than those of the other 5 Kits:
HIV Kit
Capillus
Determine
Hemastrip
Oraquick
Unigold
SD Bioline
Sensitivity %
98.89
98.52
95.20
97.79
99.26
97.80
Specificity %
99.91
100.00
100.00
100.00
99.91
99.50
Even then, the Sensitivity of 97.8% for SD Bioline was still lower than those
of Capillus, Determine and Unigold, which could make a handsome Algorithm
(provided they also pass Phase II Evaluation, WHICH THEY DID NOT!), and at the same time this conspiracy would eliminate SD Bioline which has been the main goal right from the beginning.
But since the Press Release of MoHSW dated 10/11/2006 finally declared SD
Bioline as the best of all these six Test Kits, SD Bioline must have undergone further
evaluations, whose results this time round, surpassed those of the other five Tests, which the adversaries of SD Africa’s SD Bioline badly wanted to win. (see ANNEX 2.64).
Unfotunately, we were not privileged to even peep at the results of these further evaluations (and that may be why we were never given access to MoHSW files).
› Nonetheless we do know that finally, a letter Ref.No.HC.49/421/Vol.IV/190 (see Annex 2.73) dated 30/01/2005, captioned "Report of Phase II Evaluation of SD Bioline HIV 1/2 3.0 Rapid Test", from the PHLB Registrar to SD Africa, announced that:
"The MoHSW has seen the importance of having such a Test Kit and therefore has decided to include it in the planned National HIV Diagnostic Test Algorithm Evaluation. This will help to decide on which simple rapid combination of tests will be used in the country"
FINAL CONCLUSIONS
The whole exercise of evaluating the CyFlow® SL Blue 5 Parameters CD4 cell counting machine was delayed by one and a half months when it was stranded at DIA (Dar es Salaam International Airport) while no one cared to do and clear it. It was delayed again by another eight and a half months while the CyFlow was waiting for the reference methods reagents to be procured, because no one cared to plan the evaluation and get these reagents ordered as so as MoHSW and MUCHS learnt of its arrival in Dar. This total delay of 10 months could be delayed given enough will power on the part of all concerned. When MUCHS finally decided to start the evaluation exercise in earnest, it took about one month only. Therefore it is fair to say that that 10 months delay was unwarranted and deliberate.
The reagents which were used for the CyFlow® machine evaluation had nearly reached their "Expiry dates", but their "Shelf life" of six months had already expired by the time they were used in the evaluation exercise when they were about 10 months old. MUCHS cannot deny that they are familiar with the FACSCount CD4 counting machine, which they have been using for many years and which uses flow cytometry technology just like the CyFlow machine and whose reagents have a "Shelf life" of 6 months too. But even if MUCHS claim they were not told or they never read in CyFlow and FACSCount literature about their "Shelf life", it was unprofessional of them to use those reagents when they were a few weeks only from their "Expiry dates" and after spending 10 months in the tropical temperatures of 25-35oC when they were to be kept at 2o-8oC only.
The answer to the question of which type of CyFlow® machines are in use in Tanzania, where and how they entered Tanzania is, no one knows, not even the mighty PHLB (Private Health Laboratories Board). To be able to answer those questions, the Probe Team should have been enabled to visit a great number of Centers, Hospitals, or Dispensaries, which we were not. The fact that we missed visiting even a few Centers within Tanzania and even outside was a pity, because we could have learnt a lot about their status and characteristics too.
The type of CyFlow CD4 machine that was evaluated at MUCHS in August 2005 is a CyFlow® SL Blue 5 Parameters , its name often abbreviated as CyFlow®, CyFlow® SL, CyFlow® SL Blue. It is the one which is equipped with a blue solid state laser (power 20mW, wavelength: 48nm), and it is fitted with 5 optical parameters – forward scatter, side scatter, fluorescence channel 1, fluorescence channel 2, and fluorescence channel 3. This CyFlow machine differs from the dedicated CD4 counting machines also manufactured by Partec such as: CyFlow® Counter, and CyFlow® SL_3. These last two CyFlows were unfortunately banned by MoHSW from entering Tanzania although they were never evaluated, and they are versions quite distinct from the CyFlow® SL Blue 5 Parameters which MUCHS had evaluated. It is inconceivable whay these two plus other CyFlow machineshave received a total ban en masse, without even being evaluate – a case of judgment without trial.
The answer to whether the procedures used in evaluating the CyFlow® machine at MUCHS were really scientific and capable of producing accurate results, is no, MUCHS procedures leave much to be desired, and they were not expected to give reliable, accurate, scientific results of the CyFlow evaluation. They may have been pipetting blood samples and reagents as instructed. But their use of 10 months old reagents which were overheated for all those months by tropical temperatures 4 months after their shelf life had elapsed and compare them with reference methods reagents which were brand new and fresh, were unscientific and were not conducive to producing reliable results. Their use of over 8 hours old blood specimens, their carelessness and negligence of leaving the CyFlow with its reagents stranded at DIA, their failure to maintain and clean the equipment for month on end till the CyFlow’s tubings grew fungi and jammed the instrument’s display system was not scientific procedure. And the confessed acts of all these negligence and professing that it was all in aid of protesting their non-payment, is unscientific, unethical, and unpatriotic, to say the least.
Given that it is well nigh impossible to catch a briber offering a bribe, ot catch a bribed person receiving a bribe, all this Probe Team obtained were indications, clews, connotations, insinuations, signs, and such like.
Soliciting a bribe is done not only by saying point blank you want payment, but you can continue withholding a service someone is entitled to until that someone realizes, softens up, and offers a bribe. If any Partec people had the cheek to grease the palm of someone at MoHSW, MSD, NACP, or MUCHS the would have cleared the CyFlow much sooner. If one were daring enough to persuade someone at MUCHS with something, the reference reagents would have been lent from the stock of MUCHS other projects and save the 6.5 months delay of waiting for reference regents. Apart from Partec people bribing their way into expediting the evaluation, Mr. Bharat Rajani could be bribing workers to delay or mess up the whole evaluation exercise.
No, WHO didn’t do any evaluation or multi-center study of the CyFlow machine nor indeed any other CD4 counting machine, because that is not currently their responsibility. But if this question implies whether WHO recognizes the CyFlow technology, the answer is certainly yes, she recognizes the CyFlow very much. This is why WHO, along with other international aid agencies, have been procuring CyFlow systems regularly, something they would never do if the CyFlow is known to have any shortcomings. That is why WHO has recognized hundreds of multi-center studies. That is why WHO jointly with UNICEF, UNAIDS, and MSF selected CD4 enumerating technologies, including the CyFlow machines and published their tabulated summaries.
As far as the SD Bioline HIV 1/2 3.0 Rapid Antibody Test Kits is concerned, there have been all sorts of pretexts to prolong the duration of the evaluation of HIV Test Kits aimed at entering the successful Kits into the new HIV Testing Algorithm. Just like indications show that the FACS CD4 counting machines supplier greased the palms of some officials of MUCHS and MoHSW to somehow delay or mess up the CyFlow machine evaluation, so as to prolong the duration of Mr. Bharat Rajani’s monopoly, indications show also that officials have been persuaded by certain things to delay or mess up the SD Bioline evaluation. Evaluation appeared to show very promising results for SD Bioline at the beginning. As time went on, these officials appeared to drag their feet and finding all sorts of excuses to fail SD Bioline in certain tests. When people and news medis began choruses of disapproval and outcries of unfair play, after evaluating it for four years, last year SD Bioline was passed and registered. But in spite of SD Bioline passing, the old unregistered HIV Test Kit Capillus is still being used as a first line Test until the MoHSW says the SD Bioline gets phased in and Capillus gets phased out, next July 2007.



















(n) Invitation for Tender No. 08-MoHSW of 2006/2007, and Invitation for Bids No. MSD/T.02/2006/2007, for the Supply of HIV Rapid Test Kits
As usual, the Ministerial Tender Board put out a public announcement that it wished to use part of the Global Fund monies for payments under the contract for the supply of HIV Rapid Test Kits which we have been talking about up to this minute. This Ministerial Tender Board announcement given in October 2006 invited interested eligible tenderers, and said that tendering will be conducted through the International Competitive Tendering Procedures specified in the Procurement (Goods, Works, Non-Consultancy, and Disposal of Public Asset) Regulation, 2005, Government Notices No. 97 of 15th April 2005.
Of the many requirements and specifications, I will quote a few only, on which I would wish to comment:
SECTION VI: SCHEDULE OF REQUIREMENTS AND SPECIFICATIONS
Name of
Item
Unit
Number of
Packages
Arrive Dec 2006
Arrive March 2007
Arrive June
2007
Capillus
Test Kit
Kit/ 100 Tests
3285
3285
3284
Determine
Test Kit
Kit/ 100 Tests
530
530
530
SECTION III: TENDER DATA SHEET
Whenever there is a conflict, the provisions in the TDS (Tender Data Sheet) shall prevail over those in the ITT (Instruction to Tenders). ITT 6.4(b) All products tendered MUST BE REGISTERED BY THE PHLB to allow them circulate in the market. BIDDERS MUST therefore submit copies of REGISTRATION CERTIFICATES of products tendered issued by PHLB AND/OR Documentary evidence to prove the manufacturer conforms to the United Nations Pre-Qualification System (WHO) approved standard for HIV Rapid Test Kits…
PREPARATION OF TENDERS
Copies of Registration Certificates of registered products for products tendering issued by the PHLB (Private Health Laboratories Board) OR otherwise the products should appear under the National Health Laboratory Supplies List.
This Tender invitation appears to have been tailor-fitted for particular firm/individual who can fulfill the conditions. For instance:
(a) With Section IV giving trade name of Capillus and Determine so openly, this is no longer a competitive tender. It was a waste of time and funds to advertise a tender this way. The MoHSW should have simply walked to Mr.Bharat Rajani and hand him the "tender" on a silver platter, because only tenders with product names of Capillus and Determine will be allowed to bid. By any standard, this is an illegal/unethical move, and that is why newspapers voiced the public’s disapproval (Annex 2.60.3-14), and the PPRA, and even the State House intervened.
(b) All that the US Embassy’s explanation of 07/04/2007 has done (see Rai report of 7/4/2007, Annex 2.60.14) is to confuse this issue to criminal levels:
(i) The Tanzania public cannot be deceived for 8 solid months that the MoHSW’s shoddy Tender was stopped, and donor agencies like Glogal Fund to Fight AIDS tell us donors money is never used to purchase substandard Capillus HIV Test Kit, and some wise man comes now to tell us that:
"the decision to buy the Kit was considered critical to allow people to continue being tested by Capillus country wide and thus seek timely medication if found to be HIV positive"
(ii) Mr.Salaiz, that is where you have missed the point. When MoHSW and we all say that Capillus is a faulty in areas where cold storage is not available, we mean in such areas (which are many), doctors/technicians will have a choice of closing shop and leave patients untested, or test with Capillus at the risk of testing negative a patient who is infected and vice versa. Don’t we care about the untimely deaths of patients who will get tested mal-tested by Capillus this way?
(iii) We started debating this issue over 8 months ago which was more than enough time to train technicians on the use of SD Bioline (which would require less than one month) which works on the "lateral flow" principle exactly like Determine which all technicians are familiar with after using it for many years.
(iv) Besides why didn’t MoHSW have a back-up or alternate HIV Testing Algorithm all these years, if it was not intended to prolong Mr.Rajani’s monopoly?
(v) If someone deems it fit after 8 months of pregnant silence to tell us things we should have been told 8 months ago, does it mean all Tanzanians were considered not ‘mature’ enough then to understand the rationale they are telling us now? What about the rationale of selecting HIV Test Kits like Capillus from the very start ten years ago to include in the old HIV Algorithm, can’t we understand it even now?
(vi) One day I hope we shall learn the truth about what is below the tip the iceberg.
(c) To announce a Tender in October 2006 and expect the tenderers to comply by 17/11/2006, i.e. within one month, after fulfilling all the 5 conditions stipulated by
Private Health Laboratories (Conditions Pre-Requisite to Registration and Management of Private Health Laboratories)], whose GN No. 226 sub-section No. 2.5.2 (The Health Laboratory Products or Supplies to undergo Phase I and Phase II evaluation), conditions (i) – (v), is impossible to fulfill in time except for a specially prepared candidate.
Contradiction of ITT
(a) If the process of evaluating SD Bioline has taken over 4 years, it is ludicrous to announce the Tender in October 2006 and expect the product tendered to be registered by the PHLB by 17th November 2006 (within about one month only) [after fulfilling all the the 5 conditions stipulated by the (See page 42 of "The Private Health Laboratories Regulations, ACT, 1997 (No. 10 of 1997) appended as Annex 2.75 at the end of this Main Report which all the Tender Boards always quote but they never observe it this at all. They advertise the Tenders in such a way that they list the names of the tendered product by their trade-names of Capillus and Determine (see the Table under: SECTION VI: SCHEDULE OF REQUIREMENTS AND SPECIFICATIONS) instead uf using their generic names or descriptions, which means that only these two unregistered HIV Test Kits can tender. This is a great taboo and illegal, according to the PPRA (Publuc Procurement Regulatory Aouthority) Act, Regulations 22 of the PPRA Regulation of 2005 as the Dr. R.S. Mlinga, the Chief Executive Officer of PPRA when trying to stop those Shoddy Tenders (see newspapers reports, Annex 2.60.3-13 herewith.)
(b) Section III of this Tender Data Sheet states specifically that "ITT 6.4(b) – All the Products tendered MUST BE REGISTERED BT PHLB". But the real super powers of MoHSW have all this time been tendering Capillus and Determine although the MoHSW admitted at its Press Release of 10/11/2006 that these two HIV Kits were never registered. This too is grossly illegal, and although PPRA has often times tried to halt this Tender, MoHSW has ended up finding an excuse to defy the PPRA and the PHLB Acts quite openly, and so far have gotten away with all this! There was a time when rumours circulated that that MoHSW officials bamboozled PPRA to permit them (MoHSW) to float that Tender and they did!
(c) The same Section III announced by MoHSW did state that: BIDDERS MUST THEREFORE SUBMIT COPIES OF REGISTRATION CERTIFICATES OF PRODUCT TENDERED ISSUED BY PHLB , but tried to water this down by squeezing in the phrase "AND/OR" following it with the statement that: "AND/OR Documentary evidence to prove the manufacturer comforms to the United Nations Pre-Qualification System (WHO) approved standard for HIV Rapid Test Kits…" But Aid Agencies like WHO have always emphasized that each country has the onus to decide which Laws and Regulations their nation can use after they (and not the Aid Agency) evaluate a bunch of them and select the best one/s most suitable for their resource strained settings. Once a nation promulgates a Law or regulation and a product does not conform to it, no one can "the tenderer can use the national one OR can use an outside one." Either this AND/OR is a misprint.
(d) Again another OR occurs inappropriately in the following section – and all these can give pretexes for some adversaries to flout the laws and regulations in order to favour rotten products at the expense of better performance products:


"PREPARATION OF TENDERS
Copies of Registration Certificates of registered products for products tendering issued by the PHLB (Private Health Laboratories Board) OR otherwise the products should appear under the National Health Laboratory Supplies List."
For Health Laboratory supplies, our mother promulgation to constantly consult is the PHLB Act and Regulations. For the above mentioned Preparation of Tenders, let us peruse through sub-section 2.5.2 (iii) on the same page 42 which states that:
"The PHLB after receiving the evaluation or technology trial Report which may consider necessary, and if it is satisfied that the Health Laboratory Product or Suppliy is suitable for the purpose which was intended, and if it complies with the quality requirements, shall approve the registration of the Health Laboratory Product or Supply, subject to such conditions as it may impose, and enter it in the "National H ealth Laboratory Service Supplies List", whose latest List of 2005 has amazingly included Capillus and Determine (see Annex 2.76), although these two HIV Test Kits have never passed the Evaluation or Technology Trial, as the MoHSW admits in her Press Release dated 10/11/2006 (see Annex 2.64). For reasons best known to the MoHSW, this "National Health Laboratory Service Supplies List 2005" was kept confidential even to some officials of the MoHSW e.g. MSD, who were sometimes given misleading and confusing information, by PHLB and MoHSW.
(o) Some of the PHLB and MoHSW Officials Gave Misleading Information
MSD (Medical Stores Department) is certainly one of the MoHSW Departments which must be kept fully uptodate with the National List of Health Laboratory Supplies and Procuts, so that they may procure laboratory supplies and products for the whole of Tanzania according to the latest laws and regulations. It was with this aim Ms. Nderimo, the Quality Assurance Manager of MSD wrote a short and commendable letter Ref.No. MSD/003/73/2006/2007 dated 24/08/2006 asking the PHLB Registrar to be availed the full "National Health Laboratory Service Supplies List 2005".
PHLB Gives Misleading Half Truths
Two weeks later she got a reply full of half truths, Ref.No. HC/49/421/Vol.V/60 dated 11/08/2006, which did not give her the "National Health Laboratory Service Supplies List 2005" which the MoHSW had already released the previous year, in 2005, about which the PHLB must have known. Instead Mr.Mrina replies that: "The completed National Health Laboratory Services Supplies List SHALL BE PROVIDED LATER BY THE MINISTRY", which is not true, because this National List had been released by the MoHSW since the previous year, 2005. And so as to ensure no one should dare to even think of supplanting from the monopolistic position which Capillus and Determine has been enjoying all these past 10 or so years, Mr. Mrina’s letter added that: "The National HIV Algorithm is still Capillus and Determine", although this is not what Ms. Nderimo asked for!
Since Mr.Mrina’s letter did not dare to state if and how Capillus and Determine were eligible to be in the "National HIV Algorithm" without first passing both Phase I and II of the mandatory Evaluations and obtaining the mandatory PHLB Registration Certificate, and if and how these two pet HIV Test Kits deserve to be included in the "National Health Laboratory Service Supplies List 2005", naturally Ms. Nderimo and her colleagues continued gallantly asking for correct information in order to discharge their duties correctly and legally.
PHLB prepares "Orion Trading Company" to supplant SD Bioline supplier, SDA
On 07/09/2006, Orion Trading Co. Ltd. wrtote a ‘Complaint’ letter to the current MoHSW PS, Mrs. Hilda Gondwe asking for: "In conclusion, through you Madam, I request the Registrar to provide ORION with the following: (1) Ammended Permit which will include SD HIV and other Rapid Diagnostic Kits, EXACTLY like the one he issued to SD Sfrica Ltd." (2) The HIV Evaluation Report for Phase I and Phase II (although Orion had never submitted any laboratory supply for evaluation at all!). This complaint letter is one of the many letters I do not possess because we had no access to MoHSW files.
In order to prepare Orion for a ‘coup de tat’ against SD Africa:
(i) Dr. F.Ndugulile, the then MoHSW Head of Diagnostic, gave Orion the Permit to import SD Bioline HIV 1/2 3.0 Test Kit even before the PHLB authorized this.
(ii) On 18/09/2006, the PHLB Registrar Mr.Mrina wrote a letter REF.No. PHL/D/34/13 to MSD certifying Orion Trading Company Ltd. as a registered importer of Rapid Diagnostic Kits and Laboratory Consumables.
(iii) Mr. Mrina also gave Orion Phase II Evaluation Report of SD Africa for which Orion paid $ 4,500. When SD Africa complained, the then MoHSW PS Mrs. Mwafisi intervened by convening a PHLB Emergency Meeting on 09/01/2006, and Orion was paid back their $4,500 after returning the SD Bioline Phase II Evaluation Report. God only knows how and why a firm which did not submit Test Kits for evaluation could be given their Evaluation Report! Were any steps taken to reprimand the culprit and ensure such open corruption doesn’t recur?
(iv) On 11/09/2006 Dr.Z.Berege signed a letter on behalf of the PS, Ref.No. HE.270/426/Vol.1/76 addressed to Orion Trading Co. Ltd. which included the following remarks: "Regarding HIV Evaluation Reports for Phase I and II, the Ministry is reluctant to provide you with that information since it is restricted to SD Africa Ltd. who provided the Kits for evaluation. The beneficiary of the Evaluation include the Orion Trading Co. Ltd., as well as all Tanzania in general. On the other hand, if you are not satisfied , the Ministry is ready to discuss the issues with you at your most convenient time." This another one of the letters I do not possess because we were not given access to MoHSW files!
(v) All this was done despite the fact that SD Africa did possess a "Certificate of Registration" (PHL Cert.6) dated 21/06/2006, and SD Africa also possessed an SD Africa-SD Korea Contract, as authenticated later by an Authorization letter dated 02/11/2006, from the President of SD Korea (authorizing SD Africa) to MSD.
Orion never possessed any of these certifications, other that the letter Ref.No PHL/D/34/13 dated 18/09/2006 which Mr. Mrina gave Orion in confusing circumstances.
The Chivalrous Ag. Director of Pharmaceuticals & Technical Services and Quality Assurance Officer (Diagnostics) Respond to PHLB Granting Orion Dealeship
On 12/10/2006 the conciensous MSD officials Ms.L.Nderimo and Mr. Hezron Shayo wrote a letter Ref.No. MSD/003/1372006/2007, addressed to the PHLB Registrar captioned:
"Certificate of Registration for Health Laboratory Products/Supplies" in response to the PHLB Registrar’s letter REF.No. PHL/D/34/13 certifying Orion Trading Company Ltd. as a registered importer of Rapid Diagnostic Kits and Laboratory Consumables. These two conscientious MSD officials reminded the PHLB Registrar, Mr. Sabas Mrina that, instead of submitting their Test Kits with the PHLB issued PHL.Cert.6 (Certificate of Registration), some of the applicants submit only Permits. This is contrary to the Section 2.5.2, (i) - (v) of the "Private Health Laboratories (Conditions Pre-Requisite to Registration, 2005, Govt. Notice No. 226 published om 05/08/2005)". For the health laboratory products/supplies to be eligible to enter the "National Health Laboratory Supplies/Services List", they must conform to the above stated PHLB , AND be issued a Certificate of Registration, pursuant to the sub-section 2.5.2 (iv) of the above stated Regulations. We kindly request you to urgently avail us of the "National Health Laboratory Supplies/Services List". You may recall that they had already asked for this same thing, but the Registrar offered them other things they did not even ask for.
After not getting the "National Health Laboratory Supplies/Services List" from the PHLB, they resorted to the MoHSW Assistant Director of Diagnostics
On 19/10/2006 MSD’s Ms. L.Nderimo and Mt. H.Shayo wrote a letter Ref.No.MSD/003/151/2008/2007, captioned "National Algorithm for HIV Rapid Test Kits", and asked ADD to urgently give them with the registered products of HIV Rapid Test Kits as per National Algorithmas well, so that they may know which Test Kit has been evaluated completely and satisfactorily and also given the PHLB Certificate of Registration. This letter was short because they had sent many letters such as these without mentioning any names of health laboratory products/supplies. But the Assistant Director of Diagnostics knew that hid duty was to defend Capillus and Determine only, and so he replied as follows:
The MoHSW Assistant Director of Diagnostics Defends the use of Trade Names
On 19/10/2006 the Assistant Director of Diagnostics, Dr.C.G.Massambu, wrote a letter Ref.No. HE.270/381/01/ captioned: "National Algorithm for HIV Rapid Test Kits", in response to the above letter of Ms.Nderimo and Mr. H.Shayo of 19/10/2006. This letter was so blunt in its support for maintaining the monopoly of Capillus and Determine that it is worth quoting him verbatim as follows:
"Ministry of Health and Social Welfare is in the process of looking for a new National Algorithm for HIV rapid tests.
At the moment until when decided the old National Algorithm of Capillus and Determine continue to be used with the ‘serial’ method of HIV testing. Because of maintaining laboratory quality standards and accuracy throughout the country, BRANDED NAMED ARE used, since these rapid tests were selected out of several HIV rapid tests AND WE DO NOT HAVE GENERIC NAMES SO FAR SO THESE TWO TESTS."
Although some of the words are comprehensible, the gist is clear that the good Doctor’s main intent is to defend the monopoly of the unregistered Capillus and Determine by hook or by crook.
If this good doctor did not have or know generic names/description to use instead of brand names, and he did not know that it is a cardinal PPA (Public Procurement Act) taboo to use brand names in competitive Tenders, here below is how we and even MSD had adroitly gone around this good doctor’s artificial dilemma in inviting Tenders without using brand (trade or proprietary) names. We use an all inclusive "generic description" like: "Particle agglutination type HIV 1 & 2 Rapid Antibody Test Kit", which will allow not only Capillus but any other HIV Rapid Test Kit which uses the principle of particle agglutination in its operation. And this is the true and just spirit of any Competitive Tender System.
Similarly we use the "generic description" of "Lateral flow chromatographic type HIV 1 & 2 Rapid Antibody Test Kit", which will allow not only Determine but any other HIV Rapid Test Kit which uses the principle of lateral flow chromatographic its operation, such as SD Bioline. This is the spirit of even field competitive bidding which any decent inviter of Tender ought to adhere to. The following is one example of Invitation for Bids (ofcourse without the advisory column on the right hand side).

N
o.
Item Names
Or Item
Description
Details of Specifications
Trade Names
should never be
used in Invitations
1.
HIV 1&2
Rapid Antibody
Test Kit, Particle
Agglutination
Type
In vitro, visually read, simple, rapid qualitative
Immunoassays for the detection of antibodies to
Human Immunodeficiency Virus (HIV) Type One
and Two in human serum, plasma, and whole
blood, using Particle Agglutination Technology.
Samples should be submitted along with the
Following PHLB documents: (a) Phase I and II
Evaluation Reports of the Kit. (b) Approval of its
Registration.. (c) Its inclusion in the National
Health Laboratory Service Supplies List of 2005.
and (d) PHLB Certificate of Registration.
Only Bidders may give
the name of principle or
technology which is
used by this Kit and may
mention its Trade Name
in parenthesis, e.g.
Particle Agglutination
(Capillus)
2.
HIV 1&2 Rapid
Antibody Test
Kit, Lateral Flow
Chromatographic
Type
In vitro, visually read, simple, rapid qualitative
Immunoassays for the detection of antibodies to
Human Immunodeficiency Virus (HIV) Type One
and Two in human serum, plasma, and whole
blood, using Lateral Flow Immuno-
chcromatographic Technology. Samples should
be submitted along with the Following PHLB
documents: (a) Phase I and II Evaluation
Reports of the Kit. (b) Approval of its
Registration.. (c) Its inclusion in the National
Health Laboratory Service Supplies List of 2005.
and (d) PHLB Certificate of Registration.
Only Bidders may give
the principle or
technology which is
used by this Kit and may
mention its Trade Name
in parenthesis, e.g.
Immunochromatographic
(Determine or
SD Bioline)

The use of brand names is a major PPA (Public Procurement Act) taboo because it allows no other, perhaps better, Test Kits to enter the competition and let the best one win the Tender.
The Medical Stores Invitation for Bids, IFB No. MSD/T.02/2006/2007 whose Invitation was exactly like the one illustrated above was perfect except for a few minor inconsequential errors such as the use of "Or" instead of "and" highlighted above.
But the Ministerial Tender Board No. 08-MoHSW of 2006/2007 was wrong in using brand names of the infamous Capillus and Determine, and we deemed it fit to mince no words in requesting the MoHSW to readvertise it in a proper legal manner. But our advise was not heeded.
This doctor’s letter was grossly mistaken about the reason why many officials of the PHLB, NACP, and MoHSW of late have developed the habit of using the brand names of Capillus and Determine in their orders of HIV 1/2 Rapid Antibody Test Kits using Tender Boards or otherwise. The reason is not "because of maintaining laboratory quality standards and accuracy throughout the country" as the good doctor claims.It is purely to illegally protect suppliers of Capillus and Determine and continue giving them the monopoly ("cooperation") to supply Capillus and Determine throughout Tanzania for months or years to come, and reaping billions, while preventing the suppliers of such Kits as the SD Bioline from tendering its better HIV 1/2 Test Kit, the SD Bioline, by delaying the announcement of the new National Algorithm and such other pretexes.
As it was with Partec CyFlow CD4 cells counting Machines, this habit of using only one set equipment or Kits comprising two or three only diagnostic Kits is too hazardous. The healthier policy is to use more than these, say 4 or more sets so that they may function competitively, and they can be cross checked against each other. And when one set goes wrong, we can always resort to another set from another supplier. By 24/2/2003, Kenya was using 36 different HIV Test Kits, while Tanzania, for undoubtedly iladvised or outright illegal reasons elected to have a National Algorithm of only Capillus and Determine, supplied by Bharat Rajani’s Biocare Health Products Ltd. and Mr. Mehebob Poptan’s Kas Medics respectively. Had we had competitors to these two suppliers, each supplier will be kept on his/her toes for fear of being replaced immediately his/her Test Kits function imprecisely.

(q) Public Procurement Regulatory Authority (PPRA) Tries to Stop the MoHSW Tender No. 08 for the Supply of HIV Rapid Test Kits
(i) On 27/10/2006, a letter Ref.No. PPRA/PPC/45/Vol.III/87 was written from Dr. Ramadhani S.Mlinga, the PPRA Chief Executive Officer, to the Permanent Secretary of the MoHSW, captioned: "Tender No. 08 of 2006/2007 for the Supply of HIV Rapid Test Kits". It mentioned that it was acting on complaints from Pharmavet Tanzania Ltd., M/S TEGA International Communication and Supplies Ltd., and from an anonymous citizen regarding the specifications of the HIV Rapid Test Kits. The letters complained that, the specifications provided were directed to a specific trade mark or producer which, if it is true, is contrary to Regulation 22 of the Public Procurement (Goods, Works, Non-Consultancy Services and Disposal of Public Assets by Tender) Regulations of 2005. It directed the MoHSW PS to extend the deadline for submission and opening of Tenders for the tender in reference so as to amend the said specifications and furnish the PPRA with the clarification on the above referred complaints.
(ii) A few days before this PPRA letter, I sent an E-mail to the PPRA suggesting they ask MoHSW to change their Tender Invitation and Specifications and use "generic description" like "particle agglutination" instead of trade name like Capillus, and use "lateral flow" instead of "Determine", but I got no response.
(iii) I later heard the PPRA advised the MoHSW Tender Board to halt floating that Tender as it stood, but they ignored the advise, or perhaps PPRA exempted them.
(iv) Even the newspapers were confused – many times believing that MoHSW’s Tender had been halted, and each time mentioning a different halting authority. Out of the 13 newspapers I collected in 13 different days, front page headlines of 11 of them scream foul play by the MoHSW. But inspite of these news media reports, as well as many repeated stern efforts to suspend these lop-sided Tenders favouring Mr. Bharat Rajani, nothing seems to be happening – and the unregistered HIV Test Kits Capillus and Determine (which MoHSW’s own Press release admitted are unsuitable) continue to be supplied by Mr. B.Rajani, instead of the SD Africa’s registered and better HIV Kit SD Bioline, as outlined below:
14/09/2006, THISDAY – "Supplier of HIV Kits Shuts Up on Media". The supplier
being the famous Mr.Bharat Rajani who also supplied over 40 FACSCount
CD4 cell counting machines of the CyFlow saga.
26/10/2006, THISDAY – "Health Ministry At It Again", saying that the HIV Test
Kits Capillus and Determine never passed Phase II evaluation and was thus not registered; and as such was not eligible to bid, as the Tender Invitation stipulates. It blamed MoHSW for introducing the old Algorithm and Tender Invitation which favours only Capillus and Determine.
16/11/2006, Rai, "Ministry of Health is playing Dangerous Games with
Tanzanians" by advertising Tenders for Capillus and Determine which have been declared unsuitable by the same MoHSW’s Press Release.
23/11/2006, Rai, "Remove Professor Mwakyusa" before these corrupt officials of
the MoHSW tarnish his good reputation and ruin the nation. This was said by some senior MoHSW officials in a letter they sent to H.E. the President. They said these corrupt officials’ goal is to enrich more their friend, Mr.B.Rajani by giving him lopsided uncontested Tenders to supply unsuitable HIV Test Kits.
30/11/2006, Rai, "German Scientists Divulge Secrets of MoHSW in the Country".
MUCHS evaluated CyFlow, amachine used to monitor the treatment of AIDS which they disqualified because they said it was unsuitable. When the Germans took back this machine to Germany and reprinted thr MUCHS results from the machine’s "black box (Harddisk)" they discover MUCHS had manipulated the machine to read false results.This disqualifications (which made MoHSW ban all CyFlow machines) the writer says leaves the field open for the supplier of the rival CD4 counting machine, the FACSCount (Mr.B.Rajani) to continue with its 10 year monopoly, in the same way they let Mr.B.Rajani have the monopoly of supplying the faulty unregistered HIV Test Kits Capillus and Determine instead of a better and registered HIV Test Kit SD Bioline supplied by SD Africa.
07/12/2006, Rai, "The Chaos of the Tender for AIDS Test Kits–MoHSW STOPS
THE TENDER", and some of their officials suspected of corruption are in
the hands of PCB. The MoHSW said the stopped this Tender after PPRA advised them against floating this Tender, because they used trade names instead of using generic descriptions.
12/12/2006, THISDAY, "HIV Rapid Test Kits – FRESH PROBING IN THE
OFFING". It said a stop order coming straight from the State House has bungled a spanner into plans of MoHSW to purchase 10,000 more HIV Test Kits of Capillus and Determine valued at 2.08 billion shillings. The Treasury was directed to suspend this procurement forthwith, and form a Probe Team.
14/12/2006, THISDAY, "Report says: HIV Rapid Test Kits are used illegally –
Medical Authorities Probe Team shows". HIV Test Kits Capillus and Determine should not be purchased directly nor through Tenders, because they had never passed Phase II evaluation nor possess a PHLB Registration Certificate, whereas the HIBV Test Kit SD Bioline passed all Phase and is registered by PHLB, but is not allowed to bid simply because Tender specification mentions the trade names of Capillus and Determine only as being eligible to tender, when the reverse is true. This was said by the Probe Team members Dr.P.J.Madati, Prof.P.Hiza, and Prof. R. Lema.
25/01/2007, THISDAY, "Authority blocks Shoddy Tenders at Health Ministry ." It
says the PPRA (Public Procurement Regulatory Authority) has sto[pped the Tender which was to be opened on 26/01/2007. Donors such as the Global Fund , and President Bush’s Emergency Fund had since threatened to withdraw the funds. Some suppliers have complained that Tender specification are favouring only Mr.Bharat Rajani the supplier of the unregistered unsuitable Kits of Capillus and Determine. Mr.B.Rajani appers to be favoured to supply many other HIV machine like the FACSCounts valued at 20 billion shillings, and other health laboratory suppliesThe PPRA has since formed a Probe Team.
23/02/2007, THISDAY, "HIV Rapid Test Kits: New Scandal in the Air". It says a
bid by the PPRA and various donors to put a stop to the continuing importation of Capillus and Determine appear to have floundered indefinitely as a result of intervention by higher Government Officials. Despite open disapproval by donor institutes, some politicians (names withheld by the paper) and MoHSW went ahead and and offered a Tender to the famous Mr. Bharat Rajani to supply 10,000 Test Kits of Capillus and Determine valued at 2.08 billion shillings. The MoHSW Probe Team of Dr.P.J.Madati, Prof.P.Hiza, and Prof.R.Lema had already said these particular Test Kits are being used illegally since they have not been registered as required by PHLB Regulations.
17/03/2007, THISDAY, "Anti-AIDS Fund not used to buy Capillus ". It said that
officials of the Global Fund to fight AIDS, Malaria, and Tuberculosis regularly make follow ups on the procurements of drugs and medical equipment by MoHSW, and that there is no evidence that its hgrants are used to buy substandard ARVs and medical equipment including Capillus.
The news that all the many efforts of the PPRA, and of higher Government offices as well as the donor agencies to stop MoHSW from floating those Tenders using trade names purely to help Mr. B.Rajani keep on supplying unsuitable HIV Test Kits dangerous to out AIDS patients keep on floundering or falling on deaf ears, is simply mind boggling, to say the least! I cannot comprehend how it can be allowed in a bribe free and good governance country like Tanzania.
(r) The MoH Press Release – Change of National HIV Rapid Testing Algorithm Dated 10th November, 2006 and How it Contradicts MoH’s Actions
Before we review the honoured Press Release, let us remind ourselves what the PHLB’s Private Health Laboratories Regulations Act 1997 says about the "National Health Laboratory Service Supplies List", since I have not located the place in this Regulations Act where it mentions "National Algorithm":
"The Board after receiving the Evaluation or Technology Trials Report" … shall approve the Registration of the Health Laboratory Product or Supplies … and enter it in the "National Health Laboratory Service Supplies List".
Then the Board shall issue a Certificate of Registration to the applicant.
Where the Board refuses to approve Registration… it shall inform the applicant in writing of such a decision and reasons thereof.
(see these pertinent Regulations in Section 2.5.2 (iii), (iv) & (v), Annex 2.75)"
The fact is that all this did not happen to Capillus and Determine at all because they did not have any full (Phase I & II) Evaluation, therefore no Report, and therefore were not approved nor issued a Registration Certificate, and therefore should not have been entered into the "National Health Laboratory Service Supplies List 2005" (see the List in Annex 2.76 where Capillus and Determine have been mysteriously inserted!), and so should never have been in the "National HIV Rapid Testing Algorithm", old or new! It is flabbergasting to see Capillus and Determine break all those Regulation (i)-(v), and yet the MoHSW hasn’t even issued Mr. Bharat Rajani a written notification of the PHLB’s refusal to register him and why!! And he and the officials who have disobeyed all these Regulations remain absolutelu unscathed!!
Where is the proof that Capillus and Determine are unsuitable and unregistered?
The answer is, either ask Mr.B.Rajani to show proof that his Capillus and Determine were registered. But for now let us get the proof straight from the horse’s mouth:
Press Release – Change of National HIV Rapid Testing Algorithm
The Press Release on "Change of National HIV Rapid Testing Algorithm" given by the MoHSW on 10/11/2006 said only this:
"The MoHSW in collaboration with the MUCHS conducted an evaluation of the new Tests with the view of identifying those that are most suitable for the Tanzanian environment. Some 18 different Tests that are currently on the market were considered in the evaluation. The evaluation took into consideration not only storage issues but also costs, shelf life apart from specificity and sensitivity issues and came up with a new testing Algorithm as shown below (paragraph 4 of the Press Release):
1. The first Kit will be ‘SD Bioline’. If the results are HIV negative, the results
will be communicated to the client that he/she is HIV negative. "
2. If ‘SD Bioline’ gives a positive HIV result, another test will be conducted
using ‘Determine’, and if the results are the same (positive), the client will
be given his/her results as positive.
3. If both tests, ‘SD Bioline’ and ‘Determine’ show HIV positive results, the
client will be told with confidence that he/she is HIV positive.
4. Likewise, if results of ‘SD Bioline’ and ‘Determine’ will not tally, another
test using ‘Unigold’ will be conducted.
5. If there is a problem of results’ compliance between ‘SD Bioline’ and
‘SD Bioline’, results resulting from ‘Unigod’ test will be taken as final
and communicated to the client."
In spite of the same MoHSW Press Release earlier on (in paragraph 3) stating that:
"The system of ‘Capillus’ test has, of late, proved a problem for use in some parts of the country as they require cold storage…."
The same MoHSW Press Release’s conclusion reads as follows:
"The ongoing system of ‘Capillus’ followed by ‘Determine’ will continue for some time pending preparations by the MoHSW to introduce ‘SD Bioline’ and ‘Unigold’. Preparations include procurement of the new tests and training of technical staff on the new algorithm. MoHSW will announce a date the use of the old algorithm will cease."
Such are the contradictions and audacity all Tanzanians are having to swallow without even asking: If Capillus has OF LATE proved a problem (i.e. unsuitable) because they require cold storage (and temperatures in tropical Tanzania are between 20-35oC), then why use it at all – so as to fatten Mr.B.Rajani’s pockets while his Capillus lies about the HIV status of every patient tested with it? Lord have mercy. Does even a clear issue like this require a public debate or a referendum or a vote for an urgent remedial action to be taken to save infected Tanzanians?












E. SOME CONCLUSIONS AND NEGATIVE AND POSITIVE STATEMENTS OF THE CYFLOW
THE TERM OF REFERENCE NO.1:
To investigate if there was a deliberate delay in evaluating the Cyflow.
(a) Following the agreement reached at the XV International AIDS Conference in Bangkok from 11-16/07/2004 between the Tanzanian MoHSW delegation and Partec of Germany, one complete CyFlow CD4 counting machine was sent to the MoHSW on 22/09/2004 from Munster, Germany, so that it may be evaluated. The fact that this instrument was not evaluated untilAugust 2005, shows indisputably that there was a delay in evaluating this instrument. Even several MoHSW and MUCHS officials admit that there was a delay, but they give all sorts of justifications for these small delays which totaled up to over one year. All that remains now is to detail the events which demonstrate how the delays occurred, and show whether these delays were deliberate or not.
(b) The Partec Invoice No. 04093571 (see ANNEX 2.1) confirms that the CyFlow instrument complete with all its reagents, left Germany on 22/09/2004, and the Air Waybill No. 724/DUS/42864356 (see ANNEX 2.2) confirms that it reached DIA (Dar es Salaam International Airport) on 27/09/2004. The clearance of the CyFlow from DIA did not start until 11/11/2004, as shown by the Import Declaration Form (see ANNEX 2.3) No. TRA/477391 of MSD (Medical Stores Department); and then it was handed over to NACP (National AIDS Control Programme) on 12/11/2004, by MSD Delivery Note No.14193 (see ANNEX 2.4).
This was the first delay. And although no one has agreed to bear the responsibility of carelessly leaving the CyFlow iits reagents stranded in rather bad conditions at DIA for 1.5 months, inspite of Partec’s several reminders for MUCHS to hurry up, the fault was squarely on this side not on Partec’s side. And since ignorance or forgetfulness is no defence, this first delay may well be termed a deliberate delay.
(c) The two E-mails of the Partec’s Nairobi based Application Specialist Engineer, Mr.Joseph Khisa (see ANNEX 5 & 6) state clearly that this Engineer accompaned by Dr. Benedict Mbawala finally transported the CyFlow complete with its reagents from NACP to MUCHS (Muhimbili University College of Health Sciences), Microbiology /Immunology Department on 15/11/2004, and Mr.Khisa then spent 3 days installing the instrument and training technicians on how to use it (see Mr.Khisa’s E-mails, ANNEX 5 and 6). If any of the reagents were missing (as MUCHS claimed), the installation and the training would not have taken place.




(d) Although no one told us when and who requested for the Reference Methods reagents, the evaluation was delayed further until 24/06/2005 when the MoHSW delivered them to MUCHS, and further delayed until 12/07/2005 when the Calibration Beads which MUCHS claimed were missing were donated by Dr.Mbawala and delivered to MUCHS by the PLHB (Private Health Laboratories Board) Registrar, Mr. Mrina (see Prof. Lyamuya’s letter, ANNEX 2.9, page 1). When on 19/07/2005 the CyFlow screen refused to display, the evaluation had to be delayed again until Partec’s Mr.Khisa came from Nairobi on 23/07/2005 and resolved the problem which was caused by fungal growth (due to the instrument lying idle, unattended, and uncleaned for all these months) blocking the instrument tubings. (see Prof. Lyamuya’s letter ANNEX 2.9, page 1-2; and Mr. Khisa’s E-mails ANNEX 2.5 & 6). Prof.Lyamuya’s letter then says, "subsequently" they commenced evaluating the CyFlow (see ANNEX 2.9, page 2) possibly from 24/07/2005.
This constituted the second delay of 8.5 months (from 15/11/2004 when the CyFlow was delivered to MUCHS to 24/07/2005 when MUCHS finally started evaluating the CyFlow). This made the delay to total up to 10 months (1.5 + 8.5). Whether MUCHS was late to request or the MoHSW was late to order, or who was responsible for leaving the CyFlow and its reagents idle and unattended and uncleaned for all those months, the fault here too is on this side and not on Partec’s side, and so this may be termed a deliberate/unwarranted delay.
This is also born by the fact that once they seriously commenced evaluation, they completed the evaluation by late August 2005, barely one month since they started the evaluation on 24/07/2005, showing that if they were better organized, this evaluation could have taken at most 2 months. Instead, it took about 13 months from the date the CyFlow reached DIA, 27/09/2004, to the date MoHSW issued the CyFlow Evaluation Report on 24/10/2005. Although the MoHSW stipulated 6-12 months total duration of the evaluation, all MoHSW and MUCHS officials were busy giving justifications for the indisputable and unwarranted delays in evaluating the CyFlow, showing that they too realized that the delays were rather overdone and unrationalized.
(e) When the delaying tactics did not appear to succeed to frustrate Partec out of the competition for the Tanzania market for CD4 counters, the strategy resorted to was to opt for an ultimate solution of disqualifying the CyFlow as well as discredit the CyFlow so as to ensure that it forever does not get a market in Tanzania as well as the world ovr. Hence several MoHSW and MUCHS officials, aided by some officials of NACP, AMREF, MSD, and even WHO, jumped on the band wagon of repeatedly discrediting CyFlow and justifying its disqualification by calling it "imprecise" when determining the very important low CD4 count samples (<200 cells/µl), in spite of the numerous positive multicentre studies having exactly the opposite (positive) opinion of the CyFlow.
Since this "imprecision" story constituted 4.5 pages out of the 6 pages of Prof.Lyamuya’s letter (ANNEX 2.9, p.1-2), and comprised 12 out of the 18 pages of Dr.Berege’s final CyFlow Evaluation Report (ANNEX 2.14, p.1-2), and since all the adverse assertions against CyFlow were the basis of disqualifying the CyFlow SL Blue as well as all other CyFlows, I deem it fit to dwell on this point for a substantially long time. First we will start with the negative reports. Then we will end up with the numerous positive scientific reports of the CyFlow.
Negative Reports of the CyFlow System
As if it were not enough to release the negative CyFlow Evaluation Report on 24/10/2005, MoHSW officials kept on exchanging several documents and convening several Meetings to "discuss the CyFlow systems" many months later. One cannot help wondering why:
(i)The CyFlow Evaluation Report of 24/10/2005 (ANNEX 2.14, p.2) signed by Dr.Z.Berege, says: "CyFlow has low accuracy and precision in CD4 count < 200."
(ii) E-mails of 23/12/2005 from Dr.F.Ndugulile (former Director of Diagnostics) to Dr.G.Vercauteren, of the Essential Health Technologies of WHO, Geneva, (see ANNEX 2.41, p.1-2), says: "Findings from evaluation has shown the CyFlow to have less precision with low count samples <200 cells/µl." {It is perplexing what motives Dr.F.Ndugulile had in leaking this CyFlow information to WHO in Geneva barely 2 months after the final CyFlow Evaluation Report was released!}
(iii) Minutes of the Special Meeting dated 19/06/2006 (8 months after the final CyFlow Evaluation Report) (ANNEX 2.43, p.2) says: "Performance of CyFlow was compared to reference methods (FACSCount and FACSCalibur) for 3 categories of CD4 T cell ranges, and the results indicated for CD4 T cell levels <200 cells/µl misclassified 48% of the samples."
{N.B. MUCHS appear to have corroborated their claim that the CyFlow is imprecise for low CD4 count samples by articles which have been contradicted by the same or other authors. We will mention these in the Positive Reports of the CyFlow systems}
(iv) Minutes of the Emergency Board Meeting dated 03/07/2006 (8.5 months after the final CyFlow Evaluation Report) (ANNEX 2.45, p.2), chaired by Prof. Mhalu, says: "The machine is not reliable in counting CD4 less than 200."
(v) A Minute from Dr.G.Upunda, CHO, dated 12/06/2006 (8 months after the final CyFlow Evaluation Report) to the PHLB Registrar, Mr.S.Mrina, says (ANNEX 2.46): "in the evaluation done at the Reference Laboratory, this machine (CyFlow) was faulty in measuring CD4 between 0-200."
(vi) The PHLB Registrar, Mr. Mrina’s undated reply (replied say on 15/06/2008) to the CHO’s Minute (8.5 months after the final CyFlow Evaluation Report), (See ANNEX 2.47) said some eye opening revelations of how the PHLB functions or does not function:
(1) The 27th PHLB’s decision stands that "CyFlows should be used in Referral Hospitals since their performance may be better quality controlled in that level"
(2) The quality of all CyFlows in Tanzania should be followed from July 2006.
(3) Ban any further importation of all CyFlow machines.
(4) The PHLB will communicate with the MoHSW as the recommended actions which will be taking place.
{None of these decisions by the Board were ever implemented. Instead several Meetings were convened to cancel these decisions!}
(vi) A Minute of the Ag.DHS, Dr.E.Mung’ong’o to the PS dated 17/07/2006 (8.5 months after the final CyFlow Evaluation Report) (ANNEX 2.48) says:
(1) This is a summary of the advisory Meeting on the banning of use of all CyFlow machines because it is unsatisfactory.
(2) Many CyFlows were imported here before completing the evaluation.
(3) Research by Luc Kestens in J AIDS Vol.39(1) 1 May 2005, pp 32-37 says:
"Single parameter CD4 gating using a single monoclonal antibody is indisputably more affordable than any multiparameter CD4 measurement, but accuracy and precision MAY be seriously affected as a result of the interference of monocytes, particularly in samples with low CD4 countd (<200 cells/µl). Results of this research resemble the results of the evaluation which was carried out here."
{This article is authored by Dr.T.N.Doieye, and Dr. Luc Kestens is only one of the co-authors (see ANNEX 2.49, p.36-37)}
(4) Also, WHO has not evaluated/validated it. From the WHO Consultation on Technical Operational Recommendation for Scale up of Laboratory Services and Monitoring HIV Anti-Retroviral Therapy (ART) in Resource Limited Settings, Geneva 13-15 December 2004: Partec has the CyFlow Counter, which is a self-contained flow cytometer with one parameter, and the CyFlow Green which has 2 parameters. Both can run on a car battery. More powerful cytometers can be ordered from Partec and are built on order. Field experience has shown that the CyFlow systems MAY NOT YET have overcome technical challenges related to robustness of the equipment or reproducibility of results. The 1 parameter CyFlow counter instrument may also be inappropriate for TB co-infected patients.
(5) The evaluation which was done here shows that: Countinting CD4 cells below 200 shows weak results by 48%. And because results of less than 200 CD4 counts is used to enter patients into AIDS treatment of lengthening life, many people may be barred from getting the treatment. Therefore this machine is unsuitable.
(6) The CyFlow which was imported here has no capability of measuring %CD4 for children.
(7) Therefore the decision as to whether on not this machine should be allowed to be used in Tanzania, should be based on the evaluation which was done here as was explained.
(8) I suggest that the manufacturer should improve the machine and then bring it here to evaluate if it is suitable, according to the existing regulations.
Dr.E.Mung’ong’o
Ag. DHS.
(vii) The article dated 01/05/2005 (6 months before the final CyFlow Evaluation Report was released) written by Dr.Tandakha Ndiaye Dieye, et al (see ANNEX 2.49, p.36-37) has been construed by some MoHSW and MUCHS officials to bear negative reports of the CyFlow performance is infact mostly praising the CyFlow more than the other CD4 counting instruments. As we shall show in the following section on the Positive Reports of the CyFlow Dr. Ndieye has authored other articles (with Dr. Luc Kestens as a co-athor), on studies which compare the CyFlow with other CD4 counters, and the correlations between them is astoundingly close.
(viii) Similarly, some officials of MoHSW and MUCHS have misconstrued the following WHO document dated 13-15/12/2004 (10 months before the final CyFlow Evaluation Report) to be criticizing the CyFlow systems. Infact, the "WHO Consultation on Technical and Operational Recommendations for Scale-Up of Laboratory Services and Monitoring HIV Anti-Retroviral Therapy (ART)in Resource-Limited Settings – Geneva – 13-15 2004" (ANNEX 2.50) is no more than a draft write up of ideas brain-stormed by a few scientists, and its recommendation are neither final nor binding. That is why the names of the scientists consulted are not given; and that is why also this WHO report carries a lot of noncommittal and rather vague terms like "may" or "may not" to show that the Reccommendations are not definitive nor final. Indeed, the final crystallization and revamping of these draft recommendations of that first WHO consultation Committee ciulminated into: "Summary of CD4+ T-Cell Enumeration Technologies" which were compiled and published in June 2005 and revised in August 2005, by a Joint UNICEF-UNAIDS-WHO-MSF Project (see ANNEX 2.23), which includes positive appraisal of the CyFlow technology.
(ix) A Minute dated 22/07/2006 (8.5 months after the final CyFlow Evaluation Report) from Ag. PS, Dr.G.Upunda, the CMO, to the Hon. Minister for Health (see ANNEX 2.51), advising him to agree with MUCHS’ verdict of disqualifying the Partec CyFlow and perhaps consider re-evaluating the CyFlow after its manufacturer rectifies its short comings. Dr. Upunda limited his criticism of the CyFlow to only 3 points written on half a page as follows:
"Please refer to your Minute Ref.No.WAUJ/JUN/06/106 to the DHS,concerning the CyFlow machine. Together with this Minute, I am enclosing the report which made us consider this machine unsuitable for our country setting. {Ofcourse we never saw these enclosures, nor the Hon. Minister’s Minute to the DHS.}
(a) The CyFlow gives unreliable results for CD4 below 200, which is our limit for deciding whether or not to start therapy on our patients. {From quite a lot of evidence we have given above, it has been made crystal clear that:
(1) Since the evaluators of the CyFlow appear not to have read and/or follow the instructions of the Package Inserts, Intrument Operation Manual, nor preparation, protocol and other procedures, it is futile to expect to get correct results.
For instance, handling and storage conditions demand that are stored at 2-8oC in the dark, but theCyFlow machine and its reagents were left lying in the tropical heat at DIA for 1.5 months and on MUCHS bench for a further 6.5 months, well after their 6 months Shelf Life expiry, and ultimately used to evaluate the CyFlow using two BD reference instruments whose reagents were freshly procured! This is contrary to all SOP (Standard Operating Procedures). (see Reagent Insert ANNEX 2.42; see the FACSCount CD4 Machine Logistics Fact Sheets (see ANNEX 2.21.1); and see Partec CD4 Easy Count Kit label ANNEX 2.21.2).}
(b) These machines do not measure well in environments where there is TB infection. This finding has come from WHO. {Clearly Dr.Upunga is referring to the statement on page 9 of the WHO paper on ""WHO Consultation on Technical and Operational Recommendations for Scale-Up of Laboratory Services and Monitoring HIV Anti-Retroviral Therapy (ART)in Resource-Limited Settings – Geneva – 13-15 2004" (ANNEX 2.50)", which states simply that:
"The one parameter CyFlow counter instrument MAY also be INAPPROPRIATE FOR TB CO-INFECTED patients". (ANNEX 2.50, p 9)
And ofcourse, if this were CERTAIN it would be catastrophic, since most patients who are HIV positive in Tanzania also suffer from TB. But:
(1) This WHO paper’s statement is far from certain, i.e. it means that the CyFlow machine MAY OR MAY NOT be inappropriate.
(2) This WHO paper was describing the "CyFlow Counter 1 Parameter". Neither Dr.Upunda nor Prof. Lyamuya looked at the back of the instrument, and at its literature to know that the version of CyFlow machine MUCHS evaluated was the "CyFlow SL Blue, 5 Parameter", it was not a one parameter CyFlow machine.
(3) As we said in No. (viii) above, The recommendations which the WHO Consultative Committee made in Geneva on 13-15/12/2004 were preliminary brain-stormings and its recommendation are neither final nor binding, but they were refurbished and crystallized until they ended up as a more certain and more accurate compilation of the Joint UNICEF-UNAIDS-WHO-MSF Project which is captioned : "Summary of CD4+ T-Cell Enumeration Technologies" of June 2005 and revised in August 2005 (see ANNEX 2.50), which includes positive appraisal of the CyFlow technology. This final WHO/UNICEF/UNAIDS/MSF compilation ofcourse there is no mention of any shortcomings of the CyFlow technology, proving again that Dr. Upunda and his collegues did not understand that WHO consultative Committee statement and/or quoted it out of context. All this will be corroborated in the Positive CyFlow Reports we will give hereunder.
(c) The other Study which the CyFlow manufacturers quoted at length {Dr.Upunda has not mentioned which study!} is one in which he (the manufacturer) or his agents participated. {This full Report of the Probe Committee, above and below here, will end up mentioning nearly hundreds of Multi Center Studies, most of which compare the CyFlow technology with other flow cytometric and manual technologies.
And in all those studies, the CyFlow systems have proved to be as good as if at times not better than all the other CD4 counting systems.
Besides, what precisely is wrong with an expert to contribute his/her expertise in a joint study? It is ludicrous to even think that one scientist can possibly deceive/pressurize (bribe) all other scientists with whom he/she participates in joint studies all the time. And what about those hundreds of other studies in which Partec people did not participate – is it not absurd for anyone to insinuate that all those people who give positive reports of the CyFlows performances in all those joint studies must have been bribed by Partec?}
I suggest that we should accept the suggestion we were given by our researchers (MUCHS) that these machines are unsuitable for our settings right now. If the manufacturer can improve its performance, them we shall re-evaluate it and make decisions at that time.
Dr. Gabriel L.Upunda
Ag. Permanent Secretary.
Now let us try to find out the rationale or motive of this many meetings and communications about the already condemned CyFlow machine.
(x) Raison d'être Behind Discussing the CyFlow Long After Disqualifying It
After a judge convicts and condemns a person to the gallows it is utterly futile to start discussing that persons case 8 months or even one hour after the guilty verdict, unless there is proof beyond reasonable doubt that there was a mistrial. Similarly, after the final CyFlow Evaluation Report dated 24/10/2005 there was no point in discussing the CyFlow nor ask the Hon. Minister to accept the highly orchestrated guilty verdict 8 months after MUCHS’s verdict, because obviously MUCHS would not easily withdraw its verdict, even if there were too many popular outcries of unfair play. The following table attempts to fathom out the rationale behind these hurried Meetings on the already convicted CyFlow:
Chronological Order and Reasons for the flurry of Meetings to Discuss the
CyFlow several months after releasing the final CyFlow Evaluation Report
No.
Date and Title
Criticisms/Faults of the
CyFlows reported by
Articles/Minutes,&Answers
The rebuttals of criticisms of the CyFlow
by MUCHS and interpretations of belated
Meetings and Minutes concerning CyFlow
1
24/10/2004
CyFlow
Evaluation
Report by
Dr.Berege
(a) Partec CyFlow has low
accuracy & precision with
low CD4 count.
(b) Needs samples to be stored at 4oC overnight.
(c) Daily Internal QC not
incorporated.
(d) Local technical support
is not available.
The following are answers to the above criticisms.
à{(a) Precission and accuracy has not been CyFlow’s fault, since many multicentre studies which compared CyFlow systems and the FACS as well as other CD4 counters show very good correlation between them (see Partec insert of CD4 Easy Count Kit, ANNEX 2.42,p 2-3); also Zimbabwe-CDC Study (see ANNEX 2.39); Nigeria-Havard, Boston Study (ANNEX 2.36); Zimbabwe-Stanford Study, (ANNEX 2.29). The cause of this fault may be due to MUCHS not observing SOP e.g. by keeping its reagents for 8 months (well beyond their prescribed 6 months Shelf Life), while the reagents were exposed to tropical heat of >30oC instead of 2- 8oC}
à Continue to next column
{(b) Like the FACSCount’s CD4 Logistics Sheets (ANNEX 2.21.1), both the CyFlow Sheets for Partec CD4 Easy Count Kit do have "Handling and Storage" conditions instructing to storereagents at 2-8oC and in dark (see ANNEX 2.42); and the storage temperature is repeated in the Reagent Bottle Label (see ANNEX 2.21.2). It is strange to expect perfect analysis results when this simplest operating procedure of storing reagents at 2-8oC is turned into exposing reagents to 30oC heat for 8 months (well beyond their Shelf Life of 6 months)?
(c) A glance at Operation Manual and other literature of CyFlow clearly shows that CyFlows do incorporate QC, and any trained Technician uses this every time they wish to count CD4 T-cells.
(d) "Local technical support not available" is a strange requirement for a Ministry which signed a Contract of Technical Support with a local BD FACSCount supplier, yet over 50% of the 50 or so FACSCounts are constantly out of order! Besides, the Nairobi based Partec Engineer jetted to MUCHS to run a 3 day training session for Technicians, and the second time he came to MUCHS’s rescue when the CyFlow’s dirt and fungi in its tubing stopped its screen displaying. And in spite of many offers for him to assist MUCHS, he and all Partec people were banned from visiting MUCHS ever again! Wasn’t it wiser to expect Partec to establish a local technical support at least after and not before the CyFlow was evaluated?}
2
13-15/12/2004
WHO article titled:
"Consultations
on Monitoring
HIV ART in
poor settings",
which MoH &
MUCHS quote as evidence of
CyFliws’ faults.
This article’s statements which they quote are:
"CyFlow MAY NOT be
appropriate for TB co-
infected patients. Field
experience shows that
CyFlow MAY NOT YET
have overcome technical
challenges of robustness or reproducibility of results."
The answer is as follows: à Continue reading to the next column.
{The expression MAY is not a definitive
or precise word, and can mean "May" or "May not" be inappropriate for TB, and may or may not have overcome robustness and reproducibility. The truth is, these WHO consultants’ recommendations were
not finalized in December 13-15/12/2004 until June 2005 (and they were revised in August 2005), when a Joint WHO-UNICEF-UNAIDS/MSF Project compiled
the approved/recognized CD4 enumeration technologies which included the CyFlow technology (see ANNEX 2.23); and this definitive concise compilation did not mention any such CyFlow faults at all.}
3
01/05/2005
Article by Dr.
Dieye,TN et al
co-authored by
Luc Kestens
and is quoted a lot byMoHSW /MUCHS as their evidence of the CyFlow systems faults, is published in J Acquir Defic Syndr, Vol. 39 No. 1, 01/05/2005.
Various officials of MoH &
MUCHS have quoted
statements of Luc Kestens’ article (which is the same as Dieye,T.N. et al’s as evidence of the CyFlow systems being faulty. Infact it gives mainly positive attribuites of the CyFlow. The statements they often quote are on page 37 of ANNEX 2.49 saying that: "Single-parameter gating using single monoclonal antibody is indisputably more affordable than any multiparameter CD4 counte but accuracy & precision of the CyFlow MAY be affected by the monocytes especially in low CD4 counts of <200 cells/μl, because the Monocytes do express CD4 molecules."
There are many answers:
{(a)‘May’ is a tentative and word which can mean ‘may’ or ‘may not’. Thus it is not worth quoting it.
(b) DrDieye and DrKestens have also written other very positive articles about CyFlow with no mention of this criticism of CyFlows:
(i) Journal Scan dated 18/08/2005, together with its more positive comments by Dr. Art Ammann (see ANNEX 2.38).
(ii) International AIDS Society, dated 16/07/2003 in which they conclude that: "Direct volumetic and bead-based single platform CyFlow correlated very well with gold standard cytometers (FACSCalibur & FACSCount)."
àcontinue to next column
(c) Dr.Suzanne Crowe’s pdf files illustrate how easily CyFlows separate the monocyte from the CD4 T-cells and from backgroung fluorescence (ANNEX 2.59.3)
(d) See in the ANNEX 2.54, the screen shot of the correct (setting) QC run (Fig.5), done using the CyFlow returned from MUCHS, in which the T-cell (taller) peak is well separated from the monocytes peak (shorter, of weaker fluorescence). Cf. Fig.6 and 7 when the same returned CyFlow is using incorrect setting, and so fails to separate the monocytes.
(e) The application note of Partec "CD4 Easy Count Kit" (see ANNEX 2.42, pp2-3) shows the same type of picture of a direct counting result by using CD4 Easy Count Kit, successfully separating the monocytes from CD4 T-cells. This application note has a: "NOTE: Please always refer to package insert of the CD4 Easy Count, to check the preparation procedure of the whole blood (fresh) samples and the dilution factor – about which the evaluators of the CyFlow did very little of.
(f) ANNEX 2.16 shows printouts of samples from a CyFlow SL Green, belonging to Dr. Mbawala, showing all 3 categories of CD4 cell counts, low, medium and high, all showing perfect separation of monocytes from CD4 T-cells, using FACSCount as a control.
(g) Partec Application Note (ANNEX 2.15), on page marked 2/4 shows a similar picture of analysis of a sample from a health donor using a 3 parameter CyFlow SL_3, with the monocytes well separated from the CD4 T-cell cluster.
(h) The imprecision observed by MUCHS may have been caused by non observance of SOP e.g. use of 8 months old reagents whose 6 months shelf life had expired, and the same reagents were left unattended, and exposed to the tropical heat of >30oC (instead of being kept at 2-8oC, as the Operating Procedures in the inserts and Instrument Manual stipulates) for many (about 8) months.}
4
06/10/2005
Prof. Lyamuya of MUCHS
submitted
his final
CyFlow
Evaluation
Report to the MoHSW.
Presumably, this Report (we did not have access to MoH files) cited the "imprecision" of the
CyFlow system when determining Low CD4 count samples <200 cells/μl.
à continue on the next
column
{Having known about these two above
Articles: "WHO Consultation on Technical … Recommendations … in Geneva, dated 13-15/12/2004 (ANNEX2.50)" and "Dieye et al’s ‘Absolute CD4 T-cell Counting …’ dated 01/05/2005 (ANNEX 2.49)", and enterpreted them as being anti-CyFlow, what followed was obviously to quote that CyFlow was faulty and quote these two articles, as well as Suzzane Crowe’s pdf file (ANNEX 2.59) as evidence that MUCHS’ results were corroborated by those two articles. But in actual fact, these 3 articles were very pro-CyFlows, and their statements preceded by "MAY" were misunderstood to be anti-CyFlow.}
5
23/12/2005
Dr. Ndugulile
Of MoHSW E-mailed Dr.
Vercauteren of WHO telling him about Tanzanian findings on CyFlow show
that the
CyFlow machine is
flawed.
Dr.F.Ndugulile, former
Director of Diagnostics of
Tanzanian MoH leaked to
Dr.G.Vercauteren of WHO EssentialHealth Technolgy, Geneva, by E-mail, this same story of CyFlow’s imprecision at low CD4 count. It is unclear if he was quoting the MoH’s final CyFlow Evaluation Report and/or Luc Kestens’ article that other MoH officials kept on quoting as evidence of CyFlow’s imprecision.
{(a) Dr.Ndugulile "leaked" to our Probe Team these E-mails (ANNEX 2.41) in confidence, and asked us not to quote them nor him! Whatever his motives were in leaking CyFlow’s Report to a third party as far away as Geneva, one thing is clear that from that time onwards, WHO tended to be against CyFlow systems.Dr.R.Gohde of Partec had to complain to Dr.Vercauteren several times, and later to the two WHO Assistant Director Generals before things cooled down a bit (see ANNEX 2.52.1-4).
(b) This claim of CyFlow’s imprecision at low CD4 count (<200 cells/μl) which has been voiced too often by many officials of MoH and MUCHS has been rebutted more than enough in all the points 1-4 above. Since many multicenter Studies to compare CyFlow systems and many other CD4 counting systems show close correlation between them (see ANNEX 2.59.1-3; 22.56; 2.35; 2.39; 2.29), either all these CD4 counters including the CyFlows are faulty, or none of them are faulty at all.
(c) Dr. Ndugulile is the one who also tried hard to prevent Dr.Mbawala from importing his CyFlow SL Green machine but when comfronted by the then PS he gave in. He then resorted to using some
WHO officials to poison International organizations’ opinions against CyFlow
with little success.}
6
12/06/2006
Dr.Upunda,
CMO, minuted
Mr.Mrina,PHL
BoardRegistrar
to advise MoH
Dr.Upunda’s letter started by saying the Reference Laboratory found CyFlow to be faulty when testing CD4 between 0-200. Dr.Upunda therefore asked
PHLB to advise MoH what to do about the 5-6 CyFlow
Machines which are already
imported into Tanzania.
{Although MUCHS had evaluated only
one CyFlow, and although it was known
that there are various versions of them,
this Minute appears to want the PHLB to condemn all the CyFlow machines! Observe what follows, particularly when Mr.Mrina’s reply seemed to soften this Minute’s very rigid stand.}
7
ca 15/06/2006
Mr.Mrina, the
PHLB Registrar
Returns a reply to the CMO’s
Minute.
Mr.Mrina replied that:
(a) The advise of the 27th PHLB Meeting that the CyFlows should be allowed to be used in Tanzania, but only in Referral Hospitals. (b) All the CyFlows already here, should be evaluated, and the results of their evaluations should be discussed by the PHLB on 30/09/2006.
(c) All further importations of CyFlow machines be banned until the requested evaluations are completed.
(d) The PHLB will liase with the MoHSW as the evaluation results of those CyFlows are released.
This is what followed:
{(i) Mr.Mrina’s reply was too bitter to swallow, as it would disturb the status quo and bring competition, albeit a lop sided one, of the CyFlows versus the FACSCount. This would jeopardize the over 10 years of FACSCount’s monopoly
(ii) If PHLB’s advice were applied, the CyFlows would supply one unit to each region, ie. 20 CyFlows only in all; against FACSCounts which will supply well over 100 units – one unit to each District!
(iii) But even this lop sided distribution of these affordable CyFlows versus the very expensive and difficult to use FACSCounts having several disadvantages over the CyFlows, did not satisfy some people whose objective was to rid Tanzania of all CyFlows somehow.
(iv) From this time on, the PHLB Chairman and Registrar missed quite a few Meetings convened to "discuss" the CyFlow machines.
(v)The decisions of the 27th BoardMeeting
(a) To use CyFlow machines in Referral Hospital was reversed.
(b) To evaluate the other CyFlow machines was overturned.
(c) Instead, all those 6 or so CyFlows should be banned, and replaced by FACSCounts!! (To implement this new decision, so far Bulongwa has received its FACSCount, and it is doubtful if they would stop using their two CyFlows which were more satisfactory for their setting than the FACSCount which was often breaking down).
(d) Can suppliers of FACSCount forget to return/reward such acts of favouring BD FACSCount?}
8
19/06/2006
A Special
Meeting was
called to
discuss the
use of CyFlow
machines in Tanzania
This Special Meeting was not attended by the PHLB Registrar nor by the PHLB
Chairman. It was attended by only 5 members including Dr.F.Ndugulile of MoH, Prof.E.Lyamuya of MUCHS and Dr.R.Swai of NACP. and one invitee, Partec’s Dr. Mbawala.
à Dr.Ndugulile gave the history saying that:
(i)The delay in evaluating CyFlow was due to failure of suppliers to supply reagents in time
{This is untrue, since the
CyFlow came with a full Starter Kit, i.e. a complete set of supplies (see packing list ANNEX 2.11}.
à He said that when evaluated, the CyFlow was found misclassifying 48% of low CD4 count samples below 200 cells/μl.
{This was not caused by CyFlow’s fault, as stated in all the above points 1-5 above. Besides, many studies (see the Positive CyFlow Reports below, also see multicentre studies, which compare CyFlow systems with FACSCount and other CD4 counters, and didn’t come across this fault (ANNEX 2.44)}.
Continue to next column à
~ The Meeting grilled Dr.Mbawala to
the point of asking him to elaborate the
criteria he used to make his assessment
on the accuracy of the CyFlow system!
{If these Minutes are correct, I wonder
why Dr.Mbawala didn’t tell them he
owns a CyFlow whose results are
comparable to those of a FACSCount
which assayed same samples. But what
criteria were used to test the accuracy
of FACSCount?}.
~ Prof.Lyamuya concluded by asking
Dr.Mbawala to: (a) submit evidence of
WHO Multicenter evaluation, and
(b) submit list of other countries using
CyFlows other than Africa!
{(a) WHO has no Laboratories to
evaluate CyFlow or any other
counters. WHO recognizes studies
made by one or more centers which
then invite WHO to recognize or
validate them. Proofs of WHO
recognition of CyFlow systems is:
(i) WHO continues to procured many
CyFlow units (see ANNEX 2.25;
2.26; 2.27; 2.28).
(ii) WHO, UNICEF, UNAIDS, MSF
jointly published lists of CD4
counting Technologies and their
good attributes which they recognize,
including CyFlow systems
(see ANNEX 2.23).
(b) Countries, other than Africa,
which are using CyFlows are
numerous. ANNEX 2.58 gives the
result of a rapid search of the
Internet: http://www.partec.com/distributors
Performance.htlm only which has 35 centres in Africa; 3 centres in Asia; 14 centres in Europe; 1 centre in Latin America; and 3 centres in USA, which use various Partec systems including the CyFlow SL Blue which MUCHS evaluated.
~ And there are quite a few more. But so what do we conclude by all this evidence? That therefore MUCHS’ claims against CyFlow are null and void?}
9
03/07/2006
Emergency Meeting to
discuss what
THISDAY and
KULIKONI
alleged about
HIV Rapid
Test Kits
This Meeting was chaired by Prof F.Mhalu in the absence of Dr.Z.Berege.
Not surprisingly, they also discussed CyFlow (Partec),
and made fundamental
changes to their previous
decisions concerning the
CyFlow shown on the
next column à.

{(a) They said that: this CyFlow is incorrect below 200. {The answers to this are well covered in points 1-7 above.}
(b) The Budget Meeting of 26/06/2006 also discussed the CyFlow {I didn’t have access to its Minutes}.
(c) Centres which possess CyFlows in Tanzania have proven faulty, and some didn’t participate at all in the evaluations. {I wonder why these were not named, nor wer there 18 pages CyFlow Evaluation Reports for each of them}.
(d) The Board withdrew its decision of 26/06/2006 which allowed CyFlows to be used in Referral Hospitals.
(e) CyFlow machines are unsuitable, and before removing them, NACP should replace them with FACSCounts {So far
Bulongwa has already been given one FACSCount machine}




10
17/07/2006
A 4 page
Minute from
Dr. E.P.
Mung’ong’o
Ag. DHS to
The PS on
CyFlow
Machine
Dr. Mung’ong’o refers to
The PHLB Emergency
Meeting of 03/07/2006.
(a)He refuted Partec’s claim that the reagents for CyFlow Evaluation were not expired.
{(i) He did not mention the 6 months Shelf Life which certainly had elapsed.
(ii) But even if there were only "Expiry date" to consider, you don’t buy a medicine and wait until 1 or 2 months before the expiry date to use the medicine. And in this case, the 8 months old reagents (whose 6 months’ Shelf Life had expired) which was exposed to tropical temperatures of > 30oC instead of keeping them at 2-8oC, were compared to FACS machines reagents which were new and fresh! How can one expect reasonable results from this abrogation of SOP? }.
(iii) He said although it was cheap, the CyFlow gives incorrect measurements at low CD4 counts, and quoted JAIDS Vol 39(1) of
1/5/2005, pp 32-37
{This journal article is exactly the same as Dieye, et al’s, as explained above.
As is the issue of separation of monocytes from T-cells in order to avoid imprecision at low CD4 counts.}. Continue next column à
(iv) He said WHO has never validated/evaluated the CyFlow.
{The answer is simply ‘neither has FACSCount nor any other counter been validated by WHO, because WHO, having got no laboratories, merely validates /recognizes studies which have been done by centres recognized by it. And certainly WHO recognizes/approves the CyFlow system and included it in a list of Systems selected by a Joint WHO-UNICEF-MSF-
UNAIDS Project in June 2005 (and revised in August 2005 (see ANNEX 2.23)}.
(v) He said that CyFlow MAY NOT be
appropriate for TB co-infected patients, quoting as evidence the WHO Consultative
Committee’s Recommendations (see ANNEX 2.50) which were draft ones and not final until June 2005 when WHO-UNICEF-UNAIDS-MSF jointly published
the lists of recognized CD4 counting technologies which included the CyFlow technology (see ANNEX 2.23).
(vi) He repeated the claim that counting CD4 cells below 200 gives poor results, thus this machine is unsuitable.
{This has been well argued in all yhe above numbers 1-9.}
(vii) he said that this CyFlow cannot do CD4% for children.
{This too is caused by a lack of reading the Operation Manual, reragent inserts, and other CyFlow literature.Unlike FACSCount
the CyFlow systems do have capability to do CD4%.}.
11
22/07/2006
A one page
Minute from
Dr.G.Upunda
the then Ag.
PS and CMO, to the Hon.
Minister for
Health and
SocialWelfare.
Dr.Upunda is referring to a
Minute Ref.No. WAUJ
/JUN/06/106 {We did not see this Minute, nor the attachments he gave him}.
(a) He said that CyFlow is
unreliable at CD4 - 200 {This claim has been answered well in No. 1-8}.
(b) He said that CyFlows are unreliable for TB co-infected patients, quoting as his evidence WHO Consultative Committee’s draft Recommendations. {This claim too has been answered in No. 2 above}.
Continue next column à
(c) He said another Study which Partec referred to is unreliable because the Partec person himself was a co-participant in the study. {This claim too was answered earlier. Very few of these 300+ Studies involved Partec people, and even those few comprised many researchers and centers of repute to be able to be influenced (bribed) by bending the joint Reports.}.
(d) Consequently Dr. G.Upunda advised the Hon Minister to accept MUCHS’s verdict of the faults of the CyFlow such as imprecision and failure to separate monocytes from CD4 cells.


Positive Reports of the CyFlow System
1. While detailing the faults of the CyFlow, Prof. Lyamuya’s letter of 30/01/2006 (ANNEX 2.6, page 3) quoted Dr. Suzzane Crowe’s pdf file as his evidence. On the contrary, Dr. Suzzane’s is one of the many documents which praises the CyFlow System very highly, as the following graphs/plots demonstrate:
› The Cameroon plot captioned: CD4 Counting: CyFlow vs. FACSCount plot (see ANNEX 2.59.1) shows excellent correlation (r=0.9899) when comparing the CyFlow and the FACSCount techniques. As it is clear from the plot, in fact the correlation between these two is better at low levels of 0-200 cells/μl than at higher levels of 500-1500 cells/μl. So, if anyone claims that CyFlow is imprecise at low CD4 counts (<200 cells/μl), then FACSCount is also imprecise, which no one has ever admitted.
› Statistical analyses of these two instruments for precission, correlation and agreement/comparability were performed, and as shown by the Cameroon: CyFlow vs FACSCount Bland-Altman Plot, mean bias obtained was 8 CD4/μl (see ANNEX 2.59.2).
› To clear any lingering doubts about the CyFlow’s capability to differentiate the monocytes from the CD4 T-cells, which would lead to imprecision and inaccuracy in determining CD4+ counts in low CD4 count levels < 200 cells/μl, Dr. Suzzane Crowe has given an excellent plot of the separation of the monocytes from the CD4 T-cells and from the Background fluorescence (see ANNEX 2.59.3).
› These authentic plots clear the main two or three allegations of the CyFlow’s imprecision, inaccuracy, and the separation of the CD4 monocytes from the CD4 T-cells, on which MUCHS and MoH based their ban on all (!?) CyFlows.
› The ANNEX 2.58.4 demonstrates that the protocol for CD4 counts is simple and
it requires only three pipetting steps of blood, anti-CD4 antibody and
buffer. Incubation time at room temperature in the dark is 10 minutes for CD4 counting. The whole test procedure from pipetting, incubation, and counting to obtain CD4 results, takes about 15 minutes only (cf. 70 minutes for FACSCount).
~ When the MUCHS CyFlow Evaluation Report (ANNEX 2.14) talks of faults of the CyFlow as being its imprecision in low CD4 samples of <200 CD4 cells /μl, caused by the failure to separate the CD4 monocytes and CD4 T-cells, Dr. Suzzane’s print out (ANNEX 2.59.3) answers that claim. And when the final CyFlow Evaluation Report complains of the need of samples to be stored at 4oC, and daily internal QC being absent, it makes one wonder if the evaluators ever read and followed the instructions of inserts like of CD4 Easy Count Kit – Handling and Storage, as well as Protocol for CD4+ T-cell counting (see ANNEX 2.42, and 2.59.4), operating manuals, and the short and easy instructions of CyFlow’s Word file on the PC desktop named: "CD4 PE PROCEDURE". If and when instructions demand that storage of reagents be between 2-8oC in the dark, and samples should be assayed while fresh (ANNEX 2.41), and MUCHS is leaving the reagents stranded in this tropical Dar heat for about 8 months, no one should expect MUCHS’ CyFlow Evaluation data to be perfect. And if they are imperfect, the blame should not be laid on the CyFlow’s imprecision or other faults, but should be placed on this blatant neglect of SOP.
› And ANNEX 2.58.5 & 6 shows positive qualities of the CyFlow technology in resource restrained settings that prevail in developing countries including Tanzania, i.e. versatility, simplicity, portability, ease of operation, lowest reagent costs and lower capital instrument costs.
› Dr. Suzzane’s pdf file corroborates a number of multicenter studies which compared the CyFlow systems with the other CD4 and CD4% counting systems. Any academic should know how to search for literature on Partec and CyFlows, e.g. online at PUBMED, http://www.pubmed.org and high-wire hosted journals, http://ajp.amjpathol.org/searchall/, which provides references on more than 300 studies for Partec FCM technology. All these studies are satisfactorily successful, with correlation between CyFlow systems and FACS and other CD4 counting systems being very good. I am not sure if officials of MUCHS and MoHSW have seen Reports of these 300+ Studies. For example:
(1) The Zimbabwe-CDC Study published on 31/01/2007 reports the Evaluation of
Partec CyFlow SL_3, which is a single platform volumetric FC, against the
BD FACSCalibur/Sysmex XT1800i dual platform assay system in the determination of CD4 absolute counts, and CD4% in the immune monitoring of HIV infected patients in Zimbabwe (See ANNEX 2.39), which concludes that:
"Data showed that the Partec CyFlow SL_3 is comparable to the BD FACSCalibur/Sysmex XT1800i." This answers claims that CyFlows cannot perform a CD4% count.
(2) The German aid organization, the Deutsches Medikamenten-Hilfswerk action
medeor’ e.V.’s positive statement concludes as follows:
"We are very satisfied with Partec CyFlow technology because it is reliable, easy to use, and most dedicated for CD4 and CD4% counting. We will continue using Partec CyFlow technology successfully in developing countries for the treatment of HIV/AIDS infected patients." Date: 15/03/2006. (see ANNEX 2.57).
(3) The APIN (AIDS Prevention Initiative)/PEPFAR (President’s Emergency Plan
for AIDS Relief) of Jos University Teaching Hospital, Nigeria, in
collaboration with Havard School of Public Health, Boston, USA, which is jointly funded by Bill and Melinda Gates, have published their study in an indexed scientific journal, titled: "Comparison of a new, affordable flow cytometric method (CyFlow) and the Manual Magnetic bead technique for CD4 T-lymphocyte counting in a northern Nigerian setting", by Imade,G.E., et al, Clin Diagn Lab Immunol. 2005 Jan. (see ANNEX 2.55), which concludes:
"The CyFlow instrument is robust and ragged, assaying as many as 70 samples per analyst per day, and it has a capacity to do up to 200 samples per day without instrument fatigue and errors. It is very stable, and CD4 measurements are accurate and precise (for 0-1200 CD4 cells/μl). The CyFlow is user friendly, very easy to operate, and requires short training session, using very simple protocol – the whole tesating procedure taking 15 minutes only."
(4) Another study titled: "Evaluation of a new single platform volumetric flow
cytometer for enumeration of absolute CD4 T-Lyphocyte counts in HIV-1
infected Thai patients", by Pattanapanyasat, K., et al, in International Aid
Society, 12/07/2004 reports as follows (see ANNEX 2.34):
"HIV-1 infected Thai patients’ blood samples were tested in parallel by 4 techniques: a single platform volumetric CyFlow Green and Guava Personal Cell Analysis (PCA), and two standard SP bead-based methods, TriTest/TruCOUNTTM tube using a FACSCaliburTM FCM, and 2-colour FACSCountTM system. Correlation and agreement were analysed using linear regression and Blamd-Altman analysis.
Results: When compared with the standard TriTEST/TruCOUNTTM and FACSCountTM , the CD4+ T-cell counts obtained from the CyFlow Green showed excellent correlation (R2 = 0.97 and 0.97 respectively). (see ANNEX 2.40).
Conclusion: The volumetric CyFlow Green FCM and Guava PCA system performed well relative to the two standard bead-based systems.
Use of these technologies could make CD4+ T-cell enumeration more affordable in Thailand and other resource-poor settings.
Date: 15/08/2006.
(5) HIV-1 infected and uninfected Senegalese subjects’ blood samples were tested using a research/clinical flow cytometer (FACScan); a dedicated clinical instrument (FACSCount); and a volumetric, mobile, open-system flow cytometer equipped with 3 fluorescence and 2 light scatter detectors (CyFlow SL Blue), and this study was published by Dieye, T.N., et al, as: "Absolute CD4 T-cell counting in resource-poor settings: Direct volumetric measurements versus Bead-based Clinical Flow Cytometry Instruments", in J Acquir Immune Defic Syndr 2005, May 1, 39(1): 32-7 (see ANNEX 2.38).
The results given by the least expensive CD4 counter manufactured by Partec of Munster, Germany, CyFlow SL Blue, had a high correlation (R2 = 0.99) with those produced by the more expensive and technically complicated counters (FACScan and FACSCounter). The CyFlow SL Blue had several additional advantages, such as:
It is easily transportable, and potentially could be transported among clinics in rural settings.
It can use lysed or unlysed whole blood samples, reducing the need for additional supplies.
Unlike other machines, it can provide absolute CD4 counts without having to perform a whole blood cell and total lymphocyte cell count as well, further reducing the costs of each test.
The results reported by Dieye, T.N., et al, are similar to those obtained by Shepherd et al, in their evaluation of 3 low cost instruments, namely:
~ Guava
~ BD Multi Test
~ Partec
These studies are encouraging, and it is hoped that similar progress will be made in developing` low cost testing for viral load