European performance evaluations of the ADVIA Centaur infectious disease assays: requirements for performance evaluation according to the European directive on in vitro diagnostics.

The following article reports on newly developed ADVIA Centaur immunoassays (Bayer HealthCare LLC, Diagnostics Division; Tarrytown, NY, USA) for the detection of markers of hepatitis B infection in human serum and plasma. These fully automated assays detect antibodies to hepatitis B surface antigen (anti-HBs), total antibodies to hepatitis B core antigen (anti-HBc Total) and IgM antibodies to hepatitis B core antigen (anti-HBc IgM). The ADVIA Centaur HBV assays employ magnetic particle separation technology with direct chemiluminescence for optimal assay performance. The three ADVIA Centaur HBV assays were tested in extensive performance evaluations at two sites in Europe. Prospectively collected specimens from HBV infected subjects, blood donors, hospitalized/clinical patients and HBV vaccinees were tested under routine laboratory conditions to generate performance data. The studies resulted in the following clinical performance: overall diagnostic specificity > 99.9%, i.e. 100% for ADVIA Centaur Anti-HBs, 100% for ADVIA Centaur HBcIgM and 99.94% for ADVIA Centaur HBc Total. All of the assays showed excellent diagnostic sensitivity, as follows: 99.0% for ADVIA Centaur Anti-HBs, 98.5% for ADVIA Centaur HBcIgM and 100% for ADVIA Centaur HBc Total. Interfering substances and potential cross-reacting samples produced no effects on the results in any of the three ADVIA Centaur HBV assays. Evaluations using HBV seroconversion panels resulted in comparable or better results as compared to the reference assay(s). The performance evaluation data clearly demonstrate that the three ADVIA Centaur HBV assays are specific and sensitive automated immunoassays for the detection of antibodies to hepatitis B virus. Furthermore, these data indicate that assay performance is comparable, if not better, than the performance of currently marketed assays. Additionally, these assays have all of the advantages of being on the ADVIA Centaur immunoassay system including high throughput and full automation. Finally, these data, which had been submitted to the appropriate regulatory agencies (Notified Bodies) in Europe, have resulted in these assays now being CE marked and, thus, being readily available in the European market.