The Star (Nairobi)

2 January 2012

Kenya: Banned HIV Test Kit Still Used in Nyanza

The government has denied media reports that it procured unapproved HIV test kits. ( Resource: Kenya Denies Sub-Standard HIV Kits

HEALTH officials in Nyanza province have approved the use of the standard diagnostic Bioline kits for HIV testing despite a state and World Health Organisation ban on the gadgets over inaccuracy.

The Ministry of Public Health recalled over one million of the South Korea made HIV testing kits after a global alert by WHO.

However yesterday the kits were still in use at major health and testing facilities in Nyanza province despite a circular from the ministry to replace them with Unigold, which was previously used as a first line test kit.

Nyanza provincial director of public health and sanitation Jackson Kioko defended the use of the banned test kits in the province saying the faulty gadgets were never dispatched to the province. "We are aware of the recall but in the case of Nyanza there is no need to fear since the batch that had the faulty gadgets were not dispatched here," said Kioko.

He said those who were tested using Bioline have no reason to fear since the kits in the province have not shown any discrepancies. While withdrawing the gadgtes, director in the ministry of Public Health and Sanitation Shanaz Sharif argued that the Standard Diagnostic Bioline, one of the three kits used for HIV testing in the country, had diagnosed patients as HIV negative when they were positive.

However, the provincial director said cases of discrepancies have never been detected by the use of the Bioline kits delivered in the province for the last two years hence the need to continue using them. "What we did we withdraw were some ARVs and that was long time ago, our kits are not among the faulty one, so we will continue using them unless advised otherwise by the Ministry", added Kioko. The ministry had earlier directed provincial directors and Aids and sexually transmitted diseases sector stakeholders to withdraw the kits estimated to be over 10 million from the facilities and replace them with Unigold as a first line test.

However, health experts said the faulty of the Bioline kits has less impact since it is only used in confirming positive results which is less than 5 percent of the total test carried in health facilities. Bioline is among the three test kits used to check the presence of the HIV.The first test is done by the Determine kit, and confirmed with Bio line in case of positive results and subsequently Unigold in case of contradicting result in the two first steps. With withdrawal, Unigold will be used as confirmatory test kit and the Elisa method as a tie breaker in case of discrepancies.

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InFocus

Kenya Denies Claims of Unapproved HIV Kits

The Ministry of Public Health and Sanitation has refuted claims by the media that it procured sub-standard HIV test kits that were not recommended by the World Health Organization. Read more »