1. The HIV test kit under procurement through a competitive bidding process (KHB) was delisted by the World Health Organization (WHO), followed by a cancellation of the procurement of this particular product.
2. The subsequent procurement process through Pharmaceutical Fund and Supply Agency (PFSA) has taken longer lead time than anticipated.
Since availability of rapid HIV test kits is a critical path towards our long-term aim of ending AIDS, the Federal Ministry of Health (FMOH) submitted a request to the Global Fund to Fight HIV, TB and Malaria (GF) to procure rapid HIV test kits as an interim solution. In the process, there has been clear understanding between FMOH and GF that the kit to be procured should be ISO 13485 certified, should fulfil the requirements of GF establishing countries (US, EU, Japan, Canada and Australia) and should be WHO pre-qualified. Through nationally and internationally accepted bidding process, Premier Media Corporation First Response® HIV ½ Card was selected and procured. This kit had least price, had shortest lead time among all competitors and WHO has evaluated its sensitivity and specificity as 100% which is above the acceptable international standards. Subsequently, it was partly shipped into the country.
Guided by our government’s stringent regulation on imports of medicines and other supplies, the FMOH requested Ethiopian Public Health Institute (EPHI) to verify theconformity of the kitto Ethiopian context. EPHI conducted a quick evaluation of the test kit at the national reference laboratory and did field tests at Debrebirhan and Dubti Hospitals, Amhara and Afar regions, respectively; two sites representing extreme weather conditions in the country. The evaluation findings indicated that the test kit performed well on the plasma specimens but the sensitivity appeared to be unusually low on whole blood, 91.3%. WHO recommends sensitivity of at least 99% for any test kit to be considered for HIV screening. Previously, Premier Media Corporation First Response® HIV ½ Card was evaluated in similar settings including Zambia, Ghana, South Africa and India and found to be suitable for HIV screening. The kit is WHO pre-qualified based on its 100% sensitivity and specificity.
Although the evaluation finding by EPHIis in complete contrast to WHO evaluation and all assessment results reported from similar settings, the FMOH cautiously accepted the report. The FMOH gave guidance to PFSA not to distribute the kit. Further, subsequent deliveries of the kit into the country were put on hold. As the Centers for Disease Control and Prevention (CDC) has a global role in laboratory quality assurance, the FMOH requested EPHI and CDC-Ethiopia to validate the assessment results and technically inform the Ministry on a final decision.
The joint evaluation by EPHI and CDC- Ethiopia in consultation with CDC-Atlantahas showed the kit has a sensitivity and specificity of 100%, reproducing WHO evaluation. All the samples reported to be false-positive and false-negative in the previous EPHI evaluationreports were actually found to be true-positive and true negative, respectively. Consequently, EPHI has officially communicatedthe Ethiopian Food, Medicines and Health Administration Authority (EFMHACA) strongly recommending the use of Premier Media Corporation First Response® HIV ½ Card for HIV screening followed by routine post-marketing surveillance. Similar strong recommendation has been provided by CDC-Ethiopiain consultation with CDC-Atlanta. CDC-Ethiopia report showed that the first evaluation by EPHI fell short of meeting the WHO recommendation of using gold standard or reference for confirmation of HIV positivity for test kit evaluation. Specifically, the previous evaluation by EPHI had the following limitations:
1. The first EPHI HIV test kit evaluation didn’t followthe protocolrecommended by WHO and the Joint United Nations Programme on HIV/AIDS (UNAIDS).
2. Gross human errors were found in the field evaluation of the test kit.
3. The right check and balance was not followed during the evaluation of the kit.
The FMOH is currently investigating the nature of the human error that occurred during the first EPHI evaluation. Appropriate consequenceswill follow any deliberate manipulation of the results and intentional attempt to disrupt national HIV service delivery.Since the joint evaluation by EPHI and CDC-Ethiopia has definitively shown that Premier Media Corporation First Response® HIV ½ Card has excellent performance in Ethiopia, this kit will be immediately distributed to each service delivery point. The FMOH has also planned to accelerate service delivery including HIV testing and prompt linking HIV-positive individuals to care and treatment in the coming weeks and months.
The FMOH is currently revising its HIV test methods using quality and prices of the kits. Lot testing and post-marketing surveillance will be conducted in a strict adherence to international guidelines. These will prevent any potential shortage of rapid HIV test kits in the future.