INTENDED USE

HIV (I+II+O) Antibody Rapid Test Kit (Trilines) is an in vitro diagnostic rapid immunochromatographic assay for the qualitative detection of antibodies to HIV-1, including subtype O, and HIV-2 in venous and capillary whole blood, serum and plasma specimens. The product may be used as an aid in the diagnosis of HIV infection.
A reactive result should be confirmed by supplemental testing as part of a validated HIV testing algorithm. This product has not been evaluated on paediatric and neonatal specimens.

PRINCIPLE

HIV (I+II+O) Antibody Rapid Test Kit (Trilines) test strip is pre-coated with HIV-1 and subtype O antigens on T1 test line and HIV-2 antigen on T2 test line. Firstly, specimen and then buer is added to the specimen well, thus starting the migration of the specimen/buer. The specimen/buer passes the conjugate pad which contains a mixture of HIV-1 envelope and capsid antigen and HIV-2 envelope antigen. These detection antigens are conjugated to latex particles. If present, the HIV-1 of HIV-2 antibodies react and bind to the detection antigen-conjugate. The antibody/antigen-conjugate mixture then migrates further and binds to antigens present on the test lines. If the specimen contains antibodies to HIV-1, the specimen will bind to the T1 test line and produce a line, if specimen contains antibodies to HIV-2, the specimen will bind to the T2 test line. As liquid continues to migrate down the test strip, the control line will appear. If the control line is present, in addition to either or both test lines, then the test is reactive for HIV1/2 antibodies. If the specimen does not contain HIV-1 or HIV-2 antibodies, no colored lines will appear for either of the test lines region indicating a non-reactive result. Please note that the appearance of colored lines at T1 and T2 is highly unlikely to be indicative of co-infection with HIV-1 and HIV-2 but rather is a result of cross-reactivity between antigens. A colored line will appear in the control line region if the migration of liquid has been successful, and must be present for the test to be valid. If the control line does not appear, the test result is not valid.