Abstract

Bayer HealthCare LLC, Diagnostics Division, has developed several new assays on the ADVIA Centaur® immunoassay system for the detection of markers of hepatitis B virus infection in human serum and plasma. This panel includes assays for: hepatitis B surface antigen (HBsAg), a confirmatory test method for HBsAg, antibodies to hepatitis B surface antigen (anti-HBs), IgM and IgG antibodies to hepatitis B core antigen (anti-HBc Total) and IgM antibodies to hepatitis B core antigen (anti-HBc IgM). These assays employ magnetic particle separation technology with direct chemiluminescence for optimal assay performance. All of the assays are fully automated, require sample volumes ranging from 15 μl to 100 μl (with the exception of the ADVIA Centaur® HBsAg Confirmatory Assay, which requires 2 x 100 μl), and have throughputs of up to 240 tests per hour. The five ADVIA Centaur HBV assays were tested in extensive performance evaluations conducted at two sites in Europe. The performance evaluations, which included samples from HBV-infected individuals, blood donors, hospitalized/clinical patients, and HBV vaccinees (for Anti-HBs evaluation), generated performance data in support of obtaining the Communautés Européennes (CE) mark for European market distribution. The HBV performance evaluations resulted in an overall diagnostic specificity > 99%, i.e. 99.94% for the ADVIA Centaur HBsAg Assay, 100% for the ADVIA Centaur Anti-HBs Assay, 100% for the ADVIA Centaur HBc IgM Assay and 99.94% for the ADVIA Centaur HBc Total Assay. All of the ADVIA Centaur assays showed a very good diagnostic sensitivity on these populations with 100% for the ADVIA Centaur HBsAg Assay, 99.0% for the ADVIA Centaur Anti-HBs Assay, 98.53% for the ADVIA Centaur HBc IgM Assay and 100% for the ADVIA Centaur HBc Total Assay. The ADVIA Centaur HBsAg Confirmatory Test confirmed 100% of the positive HBsAg samples. Testing of interfering substances and potential cross-reacting samples for all ADVIA Centaur HBV assays resulted in no change in interpretation of the results. Assay performance was further evaluated using HBV seroconversion panels with comparable or better results when compared to the comparison assays. The performance evaluation data demonstrate that the ADVIA Centaur HBV assays are specific and sensitive automated immunoassays for detection of antigens and antibodies to hepatitis B virus with performance that is comparable to those of currently marketed assays. Additionally, these assays have the advantage of being available on the ADVIA Centaur immunoassay system, which provides for the flexibility of high throughput and full automation.

DOI: Clin. Lab. 2004;50:63-73