Multicenter evaluation of the Bayer ADVIA Centaur HIV 1/O/2 enhanced (EHIV) assay.

BACKGROUND: It is important that serological assays detect antibodies to human immunodeficiency virus (HIV) in all infected individuals, including those infected with less prevalent, more diverse subtypes. METHODS: Performance of the ADVIA Centaur HIV 1/O/2 Enhanced (EHIV) Assay was tested on 1344 samples from HIV-positive subjects, 6061 samples from groups at low-risk for HIV infection, and 1042 samples from groups at high-risk for HIV-1 and HIV-2 infection. Results were compared with those of an FDA-approved predicate assay. RESULTS: The ADVIA Centaur EHIV Assay showed good precision with a diagnostic specificity of 99.9% and diagnostic sensitivity of 100%. HIV seroconversion was detected earlier in 6 panels, at the same time in 13 panels and later in only 1 of the panels when compared to the predicate assay, thereby narrowing the window period between infection and antibody detection. Of clinical significance, a blood donor sample that was indeterminate by HIV-1 Western blot and non-reactive by the predicate assay was repeatedly reactive in the ADVIA Centaur Assay and confirmed as positive by HIV-2 immunoblot. CONCLUSIONS: The ADVIA Centaur EHIV Assay is useful as an aid in the diagnosis of individuals infected with HIV-1 and/or HIV-2.

Performance of hepatitis B assays on the Bayer ADVIA Centaur Immunoassay System.

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 microl to 100 microl (with the exception of the ADVIA Centaur HBsAg Confirmatory Assay, which requires 2 x 100 microl), 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.

Performance of a new hepatitis C 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 hepatitis C (anti-HCV) in human serum and plasma on the ADVIA Centaur immunoassay system. This assay employs magnetic particle separation technology with direct chemiluminescence for optimal assay performance. The assay is fully automated, requires a sample volume of 10 microl and has a throughput of up to 120 tests per hour. The ADVIA Centaur HCV2 Assay was tested with samples from HCV-infected individuals, blood donors, and hospitalized patients in an extensive performance evaluation at two sites in Europe in order to generate performance data in support of obtaining the Communautés Européennes (CE) mark for European market distribution. The HCV performance evaluation resulted in an overall diagnostic specificity of 99.9% and a diagnostic sensitivity of 100%. Assay performance evaluation, using HCV seroconversion performance panels, resulted in comparable or better results when compared to the comparison assay (Abbott AxSYM3 HCV Version 3.0 Assay). Data from the performance evaluation demonstrate that the ADVIA Centaur HCV Assay is a specific and sensitive automated immunoassay for detection of antibodies to hepatitis C virus with performance that is comparable to that of currently marketed assays. Additionally, this assay has the advantage of being on the ADVIA Centaur immunoassay system, which provides the flexibility of high throughput and full automation.

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.