Multicenter study of a new fully automated HBsAg screening assay with enhanced sensitivity for the detection of HBV mutants.

Détails

ID Serval
serval:BIB_D73A743C41F7
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Institution
Titre
Multicenter study of a new fully automated HBsAg screening assay with enhanced sensitivity for the detection of HBV mutants.
Périodique
Medical Microbiology and Immunology
Auteur⸱e⸱s
Mühlbacher A., Weber B., Bürgisser P., Eiras A., Cabrera J., Louisirirotchanakul S., Tiller F.W., Kim H.S., v Helden J., Bossi V., Echevarria J.M.
ISSN
0300-8584
Statut éditorial
Publié
Date de publication
2008
Volume
197
Numéro
1
Pages
55-64
Langue
anglais
Résumé
In a multicenter study a new, fully automated Roche Diagnostics Elecsys HBsAg II screening assay with improved sensitivity to HBsAg mutant detection was compared to well-established HBsAg tests: AxSYM HBsAg V2 (Abbott), Architect HBsAg (Abbott), Advia Centaur HBsAg (Bayer) Enzygnost HBsAg 5.0 (Dade-Behring), and Vitros Eci HBsAg (Ortho). A total of 16 seroconversion panels, samples of 60 HBsAg native mutants, and 31 HBsAg recombinant mutants, dilution series of NIBSC and PEI standards, 156 HBV positive samples comprising genotypes A to G, 686 preselected HBsAg positive samples from different stages of infection, 3,593 samples from daily routine, and 6,360 unselected blood donations were tested to evaluate the analytical and clinical sensitivity, the detection of mutants, and the specificity of the new assay. Elecsys HBsAg II showed a statistically significant better sensitivity in seroconversion panels to the compared tests. Fifty-seven out of 60 native mutants and all recombinant mutants were found positive. Among 156 HBV samples with different genotypes and 696 preselected HBsAg positive samples Elecsys HBsAg II achieved a sensitivity of 100%. The lower detection limit for NIBSC standard was calculated to be 0.025 IU/ml and for the PEI standards ad and ay it was <0.001 and <0.005 U/ml, respectively. Within 2,724 daily routine specimens and 6.360 unselected blood donations Elecsys HBsAg II showed a specificity of 99.97 and 99.88%, respectively. In conclusion the new Elecsys HBsAg II shows a high sensitivity for the detection of all stages of HBV infection and HBsAg mutants paired together with a high specificity in blood donors, daily routine samples, and potentially interfering sera.
Mots-clé
Automation, Blood Donors, Genotype, Hepatitis B Surface Antigens, Hepatitis B virus, Hepatitis B, Chronic, Humans, Immunosorbent Techniques, Sensitivity and Specificity
Pubmed
Web of science
Création de la notice
23/03/2009 12:00
Dernière modification de la notice
20/08/2019 16:56
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