VioOne™ HIV Profile™
Supplemental Assay

For In Vitro Diagnostic Use

Serologic assay for detection and differentiation of antibodies directed to
different gene products of HIV-1 and HIV-2

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HIV Profile Intended Use
The VioOne™ HIV Profile™ Supplemental Assay is an enzyme-linked immunosorbent assay (ELISA) for
confirmation and differentiation of individual antibodies directed to various gene products of
HIV-1 (Group M & Group O) and HIV-2 in human serum or plasma. It is a more specific test used to
confirm the presence of HIV-1 and/or HIV-2 antibodies from specimens that
were repeatedly reactive in diagnostic screening procedures.

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