Calypte receives approval to market rapid HIV test in South Africa

By Lisa Kerner

Erie, Pa., April 24 - Calypte Biomedical Corp. said it is now permitted to begin sales of its Aware HIV-½ Oral Fluid (OMT) rapid test product in South Africa following the recent completion of clinical studies by the University of KwaZulu-Natal in Durban, South Africa.

Studies of the Aware HIV-½ OMT in 600 subjects attending voluntary counseling and testing services showed sensitivity of 99.62% and specificity of 100%.

Adcock Ingram's Scientific Group (AIS) will distribute the Aware HIV-½ OMT test in South Africa.

"The conclusion of this clinical study allows the company to market oral fluid rapid tests within the private markets in South Africa and to participate in government tenders as they are announced," chairman and chief executive officer Roger Gale said in a company news release.

"AIS' 22 years of serving the South African clinical markets makes them an ideal partner to introduce Calypte's new non-invasive HIV-½ oral fluid test that we believe is ideally suited for the South African market."

The prevalence of HIV infection in South Africa grew from less than 1% in 1990 to almost 25% in 10 years, the company said.

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

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