The
U.S. FDA has approved the Bio-Rad BioPlex 2200 HIV Ag-Ab assay that could
differentiate between HIV-1 antibodies, HIV-2 antibodies, and HIV-1 p24 antigen
in human serum or plasma specimens. The assay may be used in adults or children
above the age of two years as well as in pregnant women; and may also be used
to screen organ donors for HIV-1/2 when the blood specimen is collected while
the donor's heart is still beating. However, the agency has not approved the
assay for use in screening blood or plasma donors, except in urgent situations
where traditional licensed blood donor screening tests are unavailable or their
use is impractical.
Posted by Tim Sandle
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