New guidelines follow recall of faulty HIV test

The Kenyan government has changed its HIV testing algorithm following the withdrawal of a widely used brand of HIV test on warnings from UN World Health Organization (WHO).

In November, WHO removed the Standard Diagnostics Bioline® HIV 1/2 3.0 Rapid HIV Test Kit from its list of approved rapid test kits with immediate effect; the alert was issued after Bioline failed quality assurance tests.

The Kenyan government estimates one million kits were in circulation at the time of the recall, about one-tenth of all the HIV kits available in the country.

"We followed the World Health Organization alert and have in turn ordered all health facilities and voluntary counselling and testing centres to stop using the kit," said Shahnaz Sharif, Kenya's director of public health at the Ministry of Public Health and Sanitation.

New guidelines

Bioline, which is manufactured in South Korea, was in use as a confirmatory test, the second conducted during standard HIV testing, which uses three tests - an initial screening test, a confirmatory test and if there is a discrepancy, a third, tie-breaker test.

As a result of the recall, Unigold, the brand used in Kenya as a tie-breaker, now replaces Bioline as the confirmatory test, and the enzyme-linked immunosorbent assay (ELISA) test - which requires a blood sample be sent to a laboratory and takes significantly longer than the rapid tests - becomes the tie-breaker. A brand known as Determine retains its place as the official screening test.

"We have already engaged the services of a supply chain management organization to help with collecting the Bioline kit from facilities countrywide and at the same time, replace it with Unigold; it [the supply chain management firm] has the database of all the health facilities that received the faulty Bioline kit," said Peter Cherutich, deputy director of the National AIDS and Sexually transmitted infections Control Programme.

"Health facilities will commence working with the various partners to help trace people who might have been tested with the faulty kit so that they can come for repeat tests," said Jackson Kioko, director of public health and sanitation in Kenya's Nyanza Province, which has the country's highest HIV prevalence levels - 14.8 percent compared with a national average of 7.4 percent.

Concern

However, health workers are concerned that the use of the ELISA test will discourage nervous testers. "Except in the cases of infants, HIV tests results have always been instant and that has been the beauty of it; the process of having to wait for your result in case of discrepancies might be very agonizing for many people," said Julie Nasirembe, a nurse at a health facility in Nairobi.

There is also concern about the impact the recall will have on public confidence in HIV testing, especially as the country pushes for universal access to HIV counselling and testing.

"We don't know how widely this Bioline kit might have been used but it definitely eroded your confidence, not only in the health facilities but even in yourself, because if you test negative you are not sure if you are accurately negative," said Dan Mutisya, a resident of Kenya's capital Nairobi.

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