Calypte's Aware Rapid HIV-½ rapid test for AIDS approved for use in Kenya

By Lisa Kerner

Erie, Pa., March 28 - Calypte Biomedical Corp. said the Kenyan National Public Health Laboratory Services has issued notification of registration and approval for the Calypte Aware HIV-½ BSP (blood) and Aware HIV-½ OMT (oral fluid) rapid tests in the Republic of Kenya.

A formal evaluation of the products by The National AIDS Control Programme of the Kenyan Ministry of Health found the tests to "meet the requirements for sensitivity and specificity for HIV test kits in Kenya," according to a company news release.

The Aware HIV-½ BSP and Aware HIV-½ OMT will be sold in Kenya through Calypte's distributor, UltraLab, and Allied Services, a medical diagnostics company based in Nairobi.

"With this announcement Calypte continues to expand the breadth of countries where we can market our rapid HIV-½ diagnostic tests," chairman and chief executive officer Roger Gale said in the release.

"Kenya is an important milestone as a key country in the fight against AIDS in sub-Saharan Africa. Further, the positive clinical result from Kenya adds an important base to our worldwide clinical results, building to our planned upcoming application to the USAID Waiver list."

There are about 1.2 million HIV-infected adults and children, as well as 650,000 AIDS orphans in Kenya, the release stated.

Calypte develops and commercializes diagnostic testing products for the detection of sexually transmitted diseases. The company is located in Lake Oswego, Ore.

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