Performance of HBsAg quantification assays for detection of Hepatitis B virus genotypes and diagnostic escape-variants in clinical samples |
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| Institution: | 1. Department of Medical Microbiology, Istanbul Faculty of Medicine, Istanbul University, Fatih, Istanbul 34093, Turkey;2. Department of Internal Medicine, Istanbul Faculty of Medicine, Division of Gastroenterohepatology, Istanbul University, Istanbul, Turkey;3. Department of Genetics, Aziz Sancar Institute for Experimental Medical Research, Istanbul University, Istanbul, Turkey;4. Department of Radiology, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey;5. Department of Pathology, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey;6. Department of Medical Microbiology, Faculty of Medicine, Kirklareli University, Kirklareli, Turkey;7. Department of Biophysics Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey;8. School of Medicine, Istanbul University, Istanbul, Turkey;9. Regenerative and Restorative Medicine Research Center (REMER), Research Institute for Health Sciences and Technologies (SABITA), Istanbul Medipol University, Istanbul, Turkey;1. Department of Medicine, School of Clinical Medicine, The University of Hong Kong, Queen Mary Hospital, Hong Kong;2. State Key Laboratory of Liver Research, The University of Hong Kong, Hong Kong;3. Department of Clinical Laboratory Medicine, Nagoya City University Hospital, Nagoya, Japan;4. Department of Gastroenterology and Hepatology, Kumamoto University, Kumamoto, Japan |
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| Abstract: | BackgroundThe impact of hepatitis B virus (HBV) genomic variability on the measurement of HBsAg level has been poorly evaluated.ObjectiveThis study was designed to compare the performance of all the available assays measuring HBsAg level in this setting.Study designA large selection of wild type HBV genotypes (n = 184) and HBsAg strains harboring mutations in the S gene (n = 81) from clinical samples was studied with three HBsAg quantification assays: Architect HBsAg (Abbott), LiaisonXL Murex HBsAg Quant (DiaSorin) and the Elecsys HBsAgII (Roche).ResultsThe overall percentage of positive results was 99.2% for Abbott, 98.9% for DiaSorin and 98.1% for Roche. Abbott and Roche assays provided an excellent concordance in HBsAg quantification (global mean bias of ?0.006 logIU/mL). By contrast, DiaSorin underestimated HBsAg level with values 0.112 logIU/ml and 0.103 logIU/ml lower than Abbott and Roche, respectively. By contrast, DiaSorin slightly over quantified gtC (2.5% over the expected value) while Abbott provided values 6.2% lower than expected and 16.2% lower than what observed for the other genotypes. HBsAg quantitative assays were influenced by HBs protein substitutions irrespective to the genotype but no specific protein pattern that would particularly impair the quantification by one technique has been identified. However, Roche seemed to be particularly impacted by substitutions at 145 residue: 75% of under quantified samples carried a substituted 145 residue.ConclusionThis head-to-head comparison indicates a good correlation between all current systems used to quantify HBsAg but clearly shows an influence of both the genotype and the presence of “a” determinant variants in the absolute quantification of HBsAg. While these discrepancies may not translate into major clinical consequence, they may explain an absence of detection of weak concentration of HBsAg on some systems. |
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| Keywords: | HBV HBsAg quantification Genotype Mutations |
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