The FDA has approved a diagnostic test able to specify HIV infection type from human serum or plasma specimens, according to a press release.
Manufactured by Bio-Rad Laboratories, the BioPlex 2200 HIV Ag-Ab assay is the first FDA-approved diagnostic able to differentiate between HIV-1 antibodies, HIV-2 antibodies and HIV-1 p24 antigen. The test is able to report these results separately, and is intended for use with the BioPlex 2200 System.
The BioPlex 2200 HIV Ag-Ab assay is intended for use in adults, children aged 2 years and older, and pregnant women. It can be used to screen organ donors for HIV-1 and HIV-2 when collected from a donor whose heart is beating, but is not approved for use in screening blood or plasma donors other than in urgent situations.