12 April 2018

Ethiopia: Mechanics Behind Rapid HIV Test Kits Assessment

Throughout its history, Ethiopia has only twice applied fast HIV test kits algorithm. HIV-rapid test kits like 'Determine', 'Capillus' and 'Uni-Gold' were used by the country in that order. After local assessment of kits was carried out for the second time 'KHB', 'Stat-Pak' and 'Uni-Gold' kits were put in place in that order.

Local test kit assessment has not been conducted in between those times due to various reasons. After World Health Organization (WHO) banned KHB kit, which was the first choice of the country to conduct HIV test, the government has looked into other options. By assessing various factors, like WHO quality recognition and price, the government has decided to purchase 'First response', 'Uni-Gold' and 'Vikia' for primary test. 'Beijing Wantai', 'Uni-Gold' and 'Vikia' were chosen for the second and will continue to serve in algorithm transition period.

Any country has no other option than to conduct national assessment as per WHO standard and guideline to select kits conducive to apply national algorithm. The main objective of this assessment is to fill the gap, and to enable the existing transform algorithm maintain international standard.

Ethiopia Public Health Institute; MOH HIV/AIDS Prevention Control Office; ICAP Ethiopia; Food, Medicine Health Care Administration and Control Authority; WHO representative, UNAIDS, CDC Ethiopia, USAID and CHAI are participated in the process of test kit assessment as a task force.

After starting its operation, the task force has prepared job description, and engaged in two major tasks. These are; preparing protocol and establishing bio-bank that is crucial to conduct the assessment. The task force has prepared protocol based on WHO guidelines and standard after conducting an in-depth deliberation. Then, the protocol has been reviewed by well experienced professionals to make it more accurate and complete. Besides, professionals working in CDC Atlanta, WHO, Clinton Health Foundation main office have added their own feedback to ultimately strengthen the protocol.

According to WHO guidelines, such a survey needs 500 samples to get acceptance. In line with this, 200 antibodies that contain HIV and 300 HIV free antibody samples were organized.

In a bid to involve large organizations and make the process transparent, the Ethiopian Public Health Institute has invited interested suppliers, who have a capacity of delivering test kits to conduct 800 examinations. As the core point of this issue is inspecting whether fast HIV test kits has a capacity of identifying the existence of antibody in human or not, the presence of free and HIV carrier antibody samples are decisive.

Accordingly, the institute has received nine test kits. All are known in identified code. This is done to handle the issue secretly. After the examination process is completed, those who passed and failed are clearly identified; the kits are commencing to the task force. Of the ninth kit providers, based on the advertised criteria, seventh of them are identified for laboratory test. The remaining two are failed to go to laboratory test.

The remaining seven kits each has included in the survey. Indeed 200 virus antibodies samples have shown sensitivity. And the 300 HIV free antibodies are also shown specificity. The sensitivity and specificity of antibodies is tested by laboratories.

After conducting an in-depth analysis, of seven kits four of them were found fit with WHO standard and get acceptance. Accordingly, Vikia HIV 1/2 (BioMeneux), Abon HIV 1/2/0 (Abone Biopharm),SD Bioline HIV ½ 3.0 (Standard Diagnostics) and HIV ½ Stat-pak (Chembio) have shown equivalent capacity of identifying antibodies who have the Virus or not.

Of the seven kits, three of them were not able to fit with the standard set by WHO; so, it was decided for the kits to be out of the algorithm.

All in all, as per the guidelines set by WHO, the task force has passed the following decisions. Formerly, First response HIV 1/2/0 (Premier Medical Corporation), Insti HIV-1/HIV-2 (Biolytical) and Colloidal Gold (Beijing Wanti) decided not to included in the national HIV kit test algorithm. Secondly, Abon HIV 1/2/0 (Abon Biopharm), SD Bioline HIV 1/2 3.0 (standard diagnostic) and HIV ½ Stat-Pak (Chemibio) can be included in the algorithm which will be conducted.

And everyone in the mean time has the opportunity to serve as HIV test kit to make primary, secondary and tertiary examination, and the price difference should be decided in the purchasing process. Given that it shows the result in long duration (30 minutes) and of the total blood it needed (75 micro liter), the Biomerieux company's Vikia HIV ½ was ranked first to conduct HIV test.

After ranking them from one to three, the remaining test kits would be put as a reserve in case the supplier stops production, or if WHO withdraw the recognition given to the supplier. In addition, as it is stated, the algorithm test is carried out as per WHO strategy, it would be applied in places where there is low HIV prevalence rate. The main point of the strategy is; one examine can assure its HIV status after taking examination with three kits and if the result is positive in all tests.

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