Description:
Determine HIV Early Detect is an in vitro, visually read, qualitative immunoassay for the detection of antibodies (Ab) to HIV-1 and HIV-2 and the detection of non-immuno complexed (free) HIV-1 p24 antigen (Ag) in human capillary and venous whole blood, plasma or serum.
Therefore, any reactivity on 1) the Ab bar alone 2) the Ag bar alone or 3) both the Ab and Ag bars simultaneously, is considered a reactive result suggestive of infection with HIV.
The test is for professional use only and intended to be used as an aid in the diagnosis of HIV-1/HIV-2 infection in adults and children over the age of 18 months.