The INSTI HIV Self Test is a single use, rapid, in vitro diagnostic qualitative immunoassay for the detection of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and/or Type 2 (HIV-2) in human fingerstick whole blood. This test is intended for over-the-counter (OTC) consumer use as an aid in the diagnosis of infection with HIV-1 and HIV-2. The test is intended for use as a self test by users 18 years or older. It is not intended to be used with specimens other than fingerstick whole blood.
A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antibodies to human immunodeficiency virus 1 and 2 (HIV1/HIV2) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test intended to be used for self-testing by a layperson in the home or similar environment.