After almost five years of controversy, Ethiopia is a step closer to establish its own national algorithm for HIV Rapid Testing Kit.
A number of allegations have surfaced regarding the procurement of the Kit in the last two years resulting in a severe shortage of HIV Kits in the country. The shortage led Pharmaceutical Fund Supply Agency (PFSA) to procure 16 million HIV Kits, not based on an established algorithm but on the basis of pre-qualified status with the World Health Organization (WHO).
In this respect, it is to be recalled that PFAS has made the latest purchase from a Chinese manufacturer, Beijing Wanti Biological Enterprise, which delivered 11 million Kits at the cost of 5.5 million dollars.
This delivery was criticized by those who are close to the testing process.
“Following the latest delivery we were told to conduct HIV testing of any individual twice,” a physician from Afar Regional State told The Reporter.
“Because of this, we have been facing a shortage of HIV Kits,” said the same physician whose name has been withheld given the sensitiveness of the case.
Another medical doctor also told The Reporter that because of the controversy, they no longer receive HIV Testing Kits and that they are unable to conduct blood tests.
The controversies have created a nationwide shortage of HIV Kits.
The delivery from the Chinese company was said to complement the 2017 HIV campaign that aims to reach 700,000 people exposed to HIV which is expected to run until June 2017.
In the latest attempt to establish the national algorithm, Ethiopian Public Health Institute (EPHI) has floated an international tender in March, 2017, inviting companies to bring samples.
Close to seven companies involved in the manufacturing of HIV Test kits have shown an interest in the bid.
According to a letter issued by Tsigereda Kifle, deputy director of EPHI, HIV Kits including First Response HIV 1-2.0, Uni-Gold HIV, VIKIA HIV-1/2, Beijing Wanta HIV-1/2 are said to be under evaluation.
Beijing Wanti was registered by the Food, Medicine, Healthcare Administration and Control Authority on July 5, 2016 representing by a local company called GeZ Chemicals and Pharmaceutical PLC.
First Response is one name marred by controversy in earlier attempts by concerned government agencies to establish the national algorithm.
A local company called Biotech PLC represents First Response, whereas an Indian based company, Premier Medical, is manufacturer of the Kit.
In a bid to clear the fogs, this year, the government has established a national task force which will oversee the whole procurement process.
Last year, Premier Medical, won the bid to supply over seven billion birr worth of HIV Kits. At the time, to evaluate the applicability of the Kits in all of Ethiopia, two of the harshest extremes were chosen as test sites – Afar and Debre Berhan.
However, the Kits from Premier were found to be far below the minimum standards.
Field-testing for the First Response HIV1-2.0 Card Test showed that its sensitivity is 91.3pc efficient, while the minimum allowed is 99pc, according to testing carried out by the Public Health Institute.
A veteran in the industry, Medica Pharam, is left out of the latest procurement process.
“We have been asking for the clarification of the latest tender,” Dawit Gebregizabher, a notable businessman and major shareholder of Medica told The Reporter.
“No clarification has been given as per our request,” he said.
The Reporter was unable to get a response from EPHI despite repeated attempts.
“The process is still under evaluation,” reads a short response from communication office of the Institute.
The purchase is expected to be financed by the Global Fund.