FDA approves Bio-Rad BioPlex 2200 HIV Ag-Ab assay- Bio-Rad Laboratories
The FDA has approved the Bio-Rad BioPlex 2200 HIV Ag-Ab assay, the first FDA-approved diagnostic that differentiates between HIV-1 antibodies, HIV-2 antibodies, and HIV-1 p24 antigen in human serum or plasma specimens. Two major types of HIV have been identified: HIV-1 and HIV-2.
HIV-1 is responsible for most HIV infections throughout the world. HIV-2 is found primarily in West Africa; however, cases of HIV-2 infection have been identified in the United States. HIV-1 and HIV-2 are similar, but distinct viruses. The BioPlex 2200 HIV Ag-Ab assay is intended for use with the BioPlex 2200 System, which was cleared by the FDA in 2004.
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