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.