Performance evaluation of the ADVIA Centaur® anti-HBe and HBeAg assays

• Published in: Journal of clinical virology 2008-10, Vol.43 (2), p.169-175
• Main Authors: van Helden, Josef, Cornely, Carl, Dati, Francesco, Levy, H. Roma, Bal, Tricia, Seeger, Mary, Wright, Theodore, Baker, Lawrence
• Format: Article
• Language: English
• Subjects: Abbott AxSYM; ADVIA Centaur; Allergy and Immunology; Anti-HBe; Automation; Biological and medical sciences; Fundamental and applied biological sciences. Psychology; HBeAg; HBV; Hepatitis B - diagnosis; Hepatitis B - immunology; Hepatitis B - virology; Hepatitis B Antibodies - blood; Hepatitis B e Antigens - blood; Hepatitis B e Antigens - immunology; Hepatitis B virus; Hepatitis B virus - immunology; Hepatitis B, Chronic - diagnosis; Hepatitis B, Chronic - immunology; Hepatitis B, Chronic - virology; Human viral diseases; Humans; Immunoassay - instrumentation; Immunoassay - methods; Infectious Disease; Infectious diseases; Medical sciences; Microbiology; Miscellaneous; Reagent Kits, Diagnostic; Sensitivity and Specificity; Siemens Healthcare Diagnostics; Tandem MS; Viral diseases; Virology
• ISSN: 1386-6532; 1873-5967
• DOI: 10.1016/j.jcv.2008.05.008

Abstract Background Detection of HBeAg and anti-HBe is valuable for the evaluation and therapeutic management of hepatitis B infection. Objectives To determine the clinical performance of the newly CE-approved HBeAg and anti-HBe assays on the fully automated, random access ADVIA Centaur® immunoassay system. Study design Patient samples collected at two sites were used to compare the ADVIA Centaur assays to Abbott AxSYM™ assays. Consensus of discordant results was reached using Roche Elecsys® assays. Additionally, two well-characterized seroconversion panels were evaluated. Results The ADVIA Centaur HBeAg assay sensitivity was 100% and specificity was 99.5%. The ADVIA Centaur anti-HBe assay sensitivity was 100% and the resolved specificity was 98.2%. Fewer samples required retesting with the ADVIA Centaur assays than with the AxSYM. In two well-characterized seroconversion panels, the ADVIA Centaur anti-HBe assay detected anti-HBe 20–25 days earlier than the AxSYM assay; the ADVIA Centaur and AxSYM HBeAg assays detected HBe reactivity on the same day. Conclusions The ADVIA Centaur HBeAg and anti-HBe assays demonstrated good sensitivity and specificity, and thus are suitable for clinical use. Their novel algorithms require reduced retesting, suggesting these assays may be more cost effective.