Oral Fluid HIV - 1/2 Rapid Test Receives Approval for South Africa
Calypte Biomedical Corporation have completed some clinical studies in South Africa, the results of which permit the sales of Aware HIV-1/2 Oral Fluid (OMT) rapid test in that country. This is a new approval for OMT in addition to the Company's already-approved blood test.
Studies conducted by the University of KwaZulu-Natal in Durban, South Africa on the Aware HIV-1/2 OMT rapid test for oral fluid specimens showed sensitivity of 99.62% and specificity of 100% for a total of 600 subjects attending voluntary counseling and testing services in two Durban municipality clinics.
The National Institute for Communicable Diseases (NICD) issued a statement noting "that the design and execution of the study is in keeping with the standard approach used by the NICD reference lab to assess HIV-1/2 rapid kits for evaluation as part of the National Department of Health tender procedures." Therefore, "the results of the study are in keeping with the defined limits of acceptability and as such [the test] can be considered for tender purposes."
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