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Intended Use
The Calypte® Aware™
HIV-1/2 BSP 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
whole blood (finger-stick), serum, or plasma
specimens. 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. |
