Improved Detection of Hepatitis B Virus Surface Antigen by a New Rapid Automated Assay
| Autor: | Walter Melchior, Volker Schlüter, Bernard Weber, Anja Bayer, Peter Kirch, Dietmar Schlieper |
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| Rok vydání: | 1999 |
| Předmět: |
Male
Microbiology (medical) Hepatitis B virus HBsAg medicine.disease_cause Sensitivity and Specificity Orthohepadnavirus Pregnancy Virology medicine Humans Hepatitis B Antibodies Seroconversion Immunoassay Hepatitis Hepatitis B Surface Antigens biology medicine.diagnostic_test business.industry Antibodies Monoclonal virus diseases Hepatitis B biology.organism_classification medicine.disease digestive system diseases Hepadnaviridae Immunology Female business |
| Zdroj: | Journal of Clinical Microbiology. 37:2639-2647 |
| ISSN: | 1098-660X 0095-1137 |
| Popis: | The performance of hepatitis B virus (HBV) surface antigen (HBsAg) screening assays is continuously improved in order to reduce the residual risk of transfusion-associated hepatitis B. In a multicenter study, a new automated rapid screening assay, Elecsys HBsAg (Roche Diagnostics), was compared to well-established tests (Auszyme Monoclonal [overnight incubation] version B and IMx HBsAg [Abbott]). Included in the evaluation were 23 seroconversion panels; sera from the acute and chronic phases of infection; dilution series of various HBsAg standards, HBV subtypes, and S gene mutants; and isolated anti-HBV core antigen-positive samples. To challenge the specificity of the new assay, sera from HBsAg-negative blood donors, pregnant women, and dialysis and hospitalized patients and potentially cross-reactive samples were investigated. Elecsys HBsAg showed a higher sensitivity for HBsAg subtypes ad, ay, adw2, adw4, ayw1, ayw2, ayw4, and adr detection in dilution series of different standards or sera than Auszyme Monoclonal version B and/or IMx HBsAg. Acute hepatitis B was detected in 11 to 16 of 23 seroconversion panels between 2 and 16 days earlier with Elecsys HBsAg than with the alternative assays. Elecsys HBsAg and Auszyme Monoclonal version B detected HBsAg surface mutants with equal sensitivity. The sensitivity and specificity of Elecsys HBsAg were 100%. Auszyme Monoclonal version B had a 99.9% specificity, and its sensitivity was 96.6%. IMx HBsAg showed a poorer sensitivity and specificity than the other assays. In conclusion, Elecsys HBsAg permits earlier detection of acute hepatitis B and different HBV subtypes than the alternative assays. By using highly sensitive HBsAg screening assays, low-level HBsAg carriers among isolated anti-HBV core antigen-positive individuals can be detected. |
| Databáze: | OpenAIRE |
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