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GUIDANCE DOCUMENT

In the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Nucleic Acid Sequences of Human Immunodeficiency Viruses Types 1 and 2 Guidance for Industry December 1999

Final
Docket Number:
98D-0483
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

In March 1985, the U.S. Food and Drug Administration (FDA) licensed the first screening test for the detection of antibodies to Human Immunodeficiency Virus (HIV) in serum and plasma from infected individuals. As of October 1999, there were 27 licensed kits and 5 premarket approvals (PMAs) for detection of antibodies to HIV-1 or HIV-2 in blood, saliva, or urine, which included: 19 Enzyme-Linked Immunosorbent Assays (ELISAs), 3 Western Blots, 1 Particle Agglutination Assay, and 1 Indirect Immunofluorescence Assay (IFA) for detection of antibodies to HIV-1, as well as 3 ELISAs for detection of HIV-1 p24 antigen, 2 of which are for use in donor screening. The ELISAs include 4 combination tests for detection of antibodies to HIV-1 and HIV-2 in blood specimens.


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All written comments should be identified with this document's docket number: 98D-0483.

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