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Intended Use
The Calypte® Aware™
HIV-1/2 OMT test is a single use, qualitative,
visually read, in vitro immunoassay for the
detection of antibodies to Human Immunodeficiency
Virus Type 1 (HIV-1) and Type 2 (HIV-2) in human
oral fluid specimens (oral mucosal transudate). It
is intended for use as a point-of-care aid in the
clinical diagnosis of HIV infection. This test may
be used as a component of a multi-test rapid
algorithm in conjunction with other approved HIV
antibody assays. |
