Rapid HIV Test Kits To Be Released

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Ministry announces new rapid HIV test kit would be distributed

The Ministry of Health announced that the new rapid HIV test kit has been released and would be distributed as fast as possible for public use.

Briefing journalists on the supply of Rapid HIV Test Kits, State Minister's Office Head Dr. Taye Tolera said that since availability of rapid HIV test kits is a critical path towards for long term aim of ending AIDS, the Ministry submitted a request to the global fund to fight HIV, TB and malaria GF to procure rapid HIV test kits as an interim solution. Through nationally and internationally accepted bidding process, Premier Media Corporation First Response HIV 1/2 Card was selected and procured.

Then the Ministry requested Ethiopian Public Health Institute(EPHI) to verify the conformity of the kit as per the Ethiopian context. The finding indicated that the test kit performed well on the plasma specimens but the sensitivity appeared to be usually low on whole blood, 93.3 per cent. WHO recommends sensitivity of at least 99 per cent for any test kit to be considered for HIV screening. The ministry accepted the report and gave order to PFSA not to distribute the kit and subsequent deliveries of the kit into the country were put on hold. And the ministry requested EPHI and center for disease and control and prevention(CDC) to validate the assessment results.

Ethiopian Public Health Institute(EPHI) Director General Dr Amaha Kebede on his part said that the joint evaluation showed the kit has sensitivity and specificity of 100 per cent, reproducing WHO evaluation. All the samples reported to be false-positive and false-negative in the previous EPHI evaluation reports were actually found to be true positive and true negative, respectively. Consequently the institute officially communicated the Ethiopian food medicine and administration(EFMHACA) strongly recommending the use of Premier Media Corporation First Response HIV 1/2 Card for HIV screening followed by routine post marketing surveillance. CDC-Ethiopia report showed that the first evaluation by EPHI fell short of meeting the WHO recommendation of using Gold standard or reference for conformation of HIV positive for test kit evaluation.

He also said that the previous evaluation did not follow protocol recommended by WHO and the joint united nations programme on HIV and AIDS, there were operational errors in the field testing and the right check and balance was not followed during the evaluation kit

Dr. Taye further said that the Ministry is investigating the nature of the human error that occured during the first EPHI evaluation. Appropriate consequences will follow any deliberate manipulation of the result and international attempt to disturb national HIV service delivery. Since the joint evaluation by EPHI and CDC Ethiopia, this kit be immediately distributed to each service delivery point.


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