The RAPID 1-2- 3® HEMA HIV ½ EXPRESS® TEST (the TEST) is an in vitro, rapid, qualitative two site sandwich immunoassay used for the detection of antibodies to HIV ½ virus in human serum, plasma and in freshly-collected human fingerstick whole blood. It is designed to aid in the diagnosis of infection in those individuals who may be infected with HIV ½.

The RAPID 1-2- 3® HEMA EXPRESS® HIV ½ Test Device (Serum/Plasma/Whole Blood) is a qualitative, membrane-based immunoassay for the detection of antibody to HIV ½ in Serum, Plasma or Whole Blood. The membrane is coated with recombinant HIV ½ antigens on the test line region of the Device. When a Serum, Plasma or Whole Blood specimen is applied at one end of the membrane, it reacts with recombinant HIV ½ antigen coated particle that has already been applied to the specimen pad at the same end. The mixture then migrates chromatographically towards the other end of the membrane and reacts with the recombinant HIV ½ antigens on the membrane in the test line region. If the Serum, Plasma or Whole Blood contains antibodies to HIV-1 or HIV-2, a colored line will appear in the test line region, showing a positive result. The absence of the colored line indicates that the Serum, Plasma or Whole Blood does not contain the anti-HIV antibodies, showing a negative result. To serve as a procedural control, a colored line will always appear at the control line region if the test has been performed properly.