Integrated Regional Information Networks - January 5, 2012
NAIROBI, 5 January 2012 (PlusNews) - 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
In December, WHO removed the Standard Diagnostics Bioline(R) 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.
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,
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.
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
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.