Calypte says early study shows sensitivity of its rapid blood test for HIV

By Lisa Kerner

Charlotte, N.C., Aug. 14 - Calypte Biomedical Corp. said preliminary results from a study of its Aware2 HIV-½ rapid blood test show's its sensitivity is equal to or exceeds that of most Food and Drug Administrations-approved EIA tests, as does its current Aware HIV-½ rapid blood and oral fluid tests.

Specifically, Calypte's study demonstrated excellent concordance for matched blood-based and oral fluid specimens with the Aware2 HIV-½ prototype test, according to a company news release.

The company will present an abstract on its research to develop a new HIV ½ rapid test format for use on whole blood and plasma and oral fluid specimens at the XVI International AIDS Conference in Toronto.

"We plan to use the Aware2 platform to develop a line of diagnostic tests for STDs, with the initial test expected to be syphilis," chairman and chief executive officer Roger I. Gale said in the release.

"Initial feasibility research is underway in collaboration with the Centers for Disease Control and Prevention."

The company plans a future, formal submission to the FDA for its Aware2 HIV-½ rapid BSP (blood) and OMT (oral fluid) tests.

Calypte's second-generation rapid testing platform is based on technology licensed from Ani Biotech Oy of Finland.

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

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