BACKGROUND: Natural variation and mutations in the envelope protein (S) of hepatitis B virus can translate into HBsAg variants no longer detectable by conventional HBsAg assays. OBJECTIVES: The aim of the study was to assess the performance of 13 commercial assays currently used for screening and clinical analysis of HBsAg variants. STUDY DESIGN: The limit of detection (LOD) for each assay was established using two reference standards (WHO HBsAg 00/588 and the SFTS French reference). Sensitivity was evaluated using different panels. Panel 1 included 25 recombinant HBs variants at three concentrations, panels 2 and 4 included 8 recombinant HBsAg variants and 9 wild-type proteins (genotypes A-F), respectively, panel 3 included 16 natural HBsAg variants. RESULTS: LODs ranged from 0.011 to 0.095 IU/ml with the WHO standard, and from 0.021 to 0.326 ng/ml with the French reference. The overall percentage of positive signals using HBsAg variants ranged from 62.9% to 97.9%. Three substitutions: T123, D144A and G145, were negative at all concentrations with at least one assay. DISCUSSION: Our findings show that, although they fulfil CE requirements for analytical sensitivity (LODs below 0.13 IU/ml), HBsAg assays may vary in their capacity to detect HBsAg variants. This limit in diagnosis performance should encourage the health regulatory agencies to include HBsAg variant panels in the evaluation process. Copyright Â
BACKGROUND: Natural variation and mutations in the envelope protein (S) of hepatitis B virus can translate into HBsAg variants no longer detectable by conventional HBsAg assays. OBJECTIVES: The aim of the study was to assess the performance of 13 commercial assays currently used for screening and clinical analysis of HBsAg variants. STUDY DESIGN: The limit of detection (LOD) for each assay was established using two reference standards (WHO HBsAg 00/588 and the SFTS French reference). Sensitivity was evaluated using different panels. Panel 1 included 25 recombinant HBs variants at three concentrations, panels 2 and 4 included 8 recombinant HBsAg variants and 9 wild-type proteins (genotypes A-F), respectively, panel 3 included 16 natural HBsAg variants. RESULTS: LODs ranged from 0.011 to 0.095 IU/ml with the WHO standard, and from 0.021 to 0.326 ng/ml with the French reference. The overall percentage of positive signals using HBsAg variants ranged from 62.9% to 97.9%. Three substitutions: T123, D144A and G145, were negative at all concentrations with at least one assay. DISCUSSION: Our findings show that, although they fulfil CE requirements for analytical sensitivity (LODs below 0.13 IU/ml), HBsAg assays may vary in their capacity to detect HBsAg variants. This limit in diagnosis performance should encourage the health regulatory agencies to include HBsAg variant panels in the evaluation process. Copyright Â
Authors: Timothy Na Archampong; Ceejay L Boyce; Margaret Lartey; Kwamena W Sagoe; Adjoa Obo-Akwa; Ernest Kenu; Jason T Blackard; Awewura Kwara Journal: Antivir Ther Date: 2016-05-11
Authors: Nicola Coppola; Lorenzo Onorato; Carmine Minichini; Giovanni Di Caprio; Mario Starace; Caterina Sagnelli; Evangelista Sagnelli Journal: World J Hepatol Date: 2015-11-28
Authors: Dahlene N Fusco; Lilia Ganova-Raeva; Yury Khudyakov; Lili Punkova; Aisha Mohamed; Scarlett Se Yun Cheon; Prapti Koirala; Karin L Andersson; Gonzague Jourdain; Camille Sureau; Raymond T Chung; Georg Lauer Journal: Front Med (Lausanne) Date: 2018-04-30