Performance of a new HIV 1/O/2 assay on the Bayer ADVIA Centaur immunoassay system

Bayer HealthCare LLC, Diagnostics Division, has developed a new third-generation assay for the detection of antibodies to HIV 1, including group O, and HIV 2 in human serum and plasma on the ADVIA Centaur immunoassay system. The ADVIA Centaur HIV 1/O/22 Assay employs magnetic particle separation technology with direct chemiluminescence for optimal assay performance. The assay is fully automated, requires a sample volume of 50 microl and has a throughput of up to 120 tests per hour. The ADVIA Centaur HIV 1/O/2 Assay was tested in an extensive performance evaluation at two sites in Europe. Samples from HIV-1 and HIV-2 infected individuals, blood donors, hospitalized patients, and high-risk individuals were utilized to generate performance data in support of obtaining the Communautés Européennes (CE) mark for European market distribution. The comparison assay for the performance evaluation was the Abbott AxSYM HIV 1+2 gO Assay. The performance evaluation resulted in an overall diagnostic specificity of 99.9 % and a diagnostic sensitivity of 100%. Assay performance was further evaluated using HIV seroconversion panels. Equivalent results were obtained when the ADVIA Centaur HIV 1/O/2 Assay was compared to the comparison assay. The performance evaluation data demonstrate that the ADVIA Centaur HIV 1/O/2 Assay is a specific and sensitive automated immunoassay for detection of antibodies to HIV-1, including group O, and HIV-2 with performance that is comparable to that of currently marketed assays. Additionally, the ADVIA Centaur HIV 1/O/2 Assay has the advantage of being on an immunoassay system, which provides the flexibility of high throughput and full automation.