Performance of the HIV-1 +O/HIV-2 assay on the Bayer ADVIA Centaur é «.
Int Conf AIDS 2002 Jul 7-12; 14:(abstract no.. B10168)
Freeman J, Patel M, Baker L Bayer Corporation, Tarrytown, United States
A new assay is under development for anti-HIV types 1, 2 and subtype "O" has been developed for the ADVIA Centaur é «, a fully random access immunoassay analyzer. The assay utilizes a two step, two wash protocol in which patient specimen IgG and/or IgM is HIV antigen linked to paramagnetic microparticles in the first step. In the second step, acridinium ester labeled HIV antigen is added followed by generation of the chemiluminescent signal. The assay uses 50 ml of specimen and has a maximum throughput of 120 test/hour. Results are reported as Index values read from a stored mastercurve; the positive cutoff is an index of 1.0. Assay performance was evaluated by testing random blood donor populations, HIV type 1 and 2 positive patient populations, and commercially available seroconversion panels. In the 21seroconversion panels tested, the ADVIA Centaur assay became positive at the same time or earlier than the HIV 1/2 tests used for comparison. In a study of 6867 random blood donors, 179 HIV-1 positive patient specimens, 213 HIV-2 positive patient specimens, and two subtype "O" positive specimens, specificity and sensitivity were 99.98% and 99.8% respectively. In addition, specimens with potentially interfering substances, including HAMA, rheumatoid factor and other infections were tested and shown to not cause false positive results. Other interferents such as hemoglobin, bilirubin, cholesterol, triglyceride, and human serum albumin were also demonstrated to not interfere with assay results. Within run and total assay precision (%CVs) ranged from 4.2% to 6.0% and from 6.9% to 9.4% respectively. In conclusion, the ADVIA Centaur HIV-1 +"O"/HIV-2 assay is a specific and precise automated immunoassay for the detection of antibody specific for the Human Immunodeficiency virus type 1, type 2, and subtype "O".
Keywords: AEGIS, HIV-2, HIV-1, HIV Infections, HIV Antigens, HIV Seropositivity, Immunoenzyme Techniques, Blood Donors, Sensitivity and Specificity, Immunoassay, Enzyme-Linked Immunosorbent Assay, Reproducibility of Results, Human, immunology
