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.

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.

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.

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.

Improved serologic detection of hepatitis C virus with a paramagnetic microparticle assay using multiple antigenic sequences.

A paramagnetic microparticle (MP) assay for antibody to hepatitis C virus (anti-HCV) was developed, in which the probe for antibody consisted of synthetic peptides corresponding to HCV capsid and nonstructural c-100 regions, as well as a recombinant protein corresponding to the nonstructural c33c region. Assay performance was evaluated by testing serum from 108 geographically diverse patients with non-A, non-B hepatitis (NANBH). The frequency of anti-HCV reactivity detected with the MP assay and with an enzyme-linked immunosorbent assay (ELISA) for c-100 was 91 and 70 percent, respectively.

A novel semi-automated paramagnetic microparticle based enzyme immunoassay for hepatitis C virus: its application to serologic testing.

A new rapid serologic enzyme immunoassay for antibodies to hepatitis C virus (HCV) is described. The assay combines synthetic peptide and recombinant antigens representing putative structural and non structural HCV gene products with paramagnetic microparticle assay (MP assay) technology. Assay readout is based upon an enzymatically generated fluorescent product which is quantified with a novel semi-automated washer/reader instrument system.