THIS TEST IS INTENDED FOR USE AS AN AID IN THE MANAGEMENT OF HIV 1 INFECTED PATIENTS AND IS NOT INTENDED FOR USE IN THE INITIAL DIAGNOSIS OR CONFIRMATION OF HIV 1 INFECTION. THIS TEST IS USED TO ASSESS PATIENT PROGNOSIS AND MONITOR THE EFFECT OF ANTI-RETROVIRAL THERAPY.

THIS TEST USES AN ENZYME-LINKED IMMUNOSORBENT ASSAY (ELISA) TO SCREEN FOR ANTIBODIES TO HIV-1 AND HIV-2. THE PRESENCE OF THESE ANTIBODIES INDICATES A PAST OR PRESENT INFECTION WITH HIV. A POSITIVE RESULT REQUIRES CONFIRMATION WITH A MORE SPECIFIC TEST, AS THIS IS A SCREENING METHOD.

THIS TEST MEASURES THE NUMBER OF CD4+ AND CD8+ T-CELLS IN THE BLOOD USING FLOW CYTOMETRY. THE RATIO OF THESE CELLS IS A KEY INDICATOR OF IMMUNE SYSTEM HEALTH AND IS PRIMARILY USED TO MONITOR DISEASE PROGRESSION AND THE EFFECTIVENESS OF TREATMENT IN PATIENTS WITH HIV/AIDS.