title: The Lumipulse G HBsAg-Quant assay for screening and quantification of the hepatitis B surface antigen.
abstract: Qualitative HBsAg assay is used to screen HBV infection for decades. The utility of quantitative assay is also rejuvenated recently. We aimed to evaluate and compare the performance of a novel ultra-sensitive and quantitative assay, the Lumipulse assay, with the Architect and Elecsys assays. As screening methods, specificity was compared using 2043 consecutive clinical routine samples. As quantitative assays, precision and accuracy were assessed. Sera from 112 treatment-naïve chronic hepatitis B patients, four patients undergoing antiviral therapy and one patient with acute infection were tested to compare the correlations. Samples with concurrent HBsAg/anti-HBs were also quantified. The Lumipulse assay precisely quantified ultra-low level of HBsAg (0.004 IU/mL). It identified additional 0.98% (20/2043) clinical samples with trance amount of HBsAg. Three assays displayed excellent linear correlations irrespective of genotypes and S-gene mutations (R(2)>0.95, P<0.0001), while minor quantitative biases existed. The Lumipulse assay did not yield higher HBsAg concentrations in samples with concomitant anti-HBs. Compared with other assays, the Lumipulse assay is sensitive and specific for detecting HBsAg. The interpretation of the extremely low-level results, however, is challenging. Quantitative HBsAg results by different assays are highly correlated, but they should be interpreted interchangeably only after conversion to eliminate the biases.
authors.affiliation: Peking University People's Hospital, Peking University Hepatology Institute, Beijing Key Laboratory of Hepatitis C and Immunotherapy for Liver Diseases, Beijing, China. Electronic address: yangruifeng103@163.com.
authors.forename: Ruifeng
authors.initials: R
authors.lastname: Yang
authors.affiliation: Peking University People's Hospital, Peking University Hepatology Institute, Beijing Key Laboratory of Hepatitis C and Immunotherapy for Liver Diseases, Beijing, China. Electronic address: sguangjun2013@163.com.
authors.forename: Guangjun
authors.initials: G
authors.lastname: Song
authors.affiliation: Peking University People's Hospital, Peking University Hepatology Institute, Beijing Key Laboratory of Hepatitis C and Immunotherapy for Liver Diseases, Beijing, China. Electronic address: 1282071984@qq.com.
authors.forename: Wenli
authors.initials: W
authors.lastname: Guan
authors.affiliation: Peking University People's Hospital, Peking University Hepatology Institute, Beijing Key Laboratory of Hepatitis C and Immunotherapy for Liver Diseases, Beijing, China. Electronic address: 1520219971@qq.com.
authors.forename: Qian
authors.initials: Q
authors.lastname: Wang
authors.affiliation: Peking University People's Hospital, Peking University Hepatology Institute, Beijing Key Laboratory of Hepatitis C and Immunotherapy for Liver Diseases, Beijing, China. Electronic address: helen_yan320@sohu.com.
authors.forename: Yan
authors.initials: Y
authors.lastname: Liu
authors.affiliation: Peking University People's Hospital, Peking University Hepatology Institute, Beijing Key Laboratory of Hepatitis C and Immunotherapy for Liver Diseases, Beijing, China. Electronic address: weilai@pkuph.edu.cn.
authors.forename: Lai
authors.initials: L
authors.lastname: Wei
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D005838:Genotype; D006510:Hepatitis B Antibodies / Q000097:blood; D006514:Hepatitis B Surface Antigens / Q000097:blood* / Q000276:immunology; D006515:Hepatitis B virus / Q000235:genetics / Q000276:immunology; D019694:Hepatitis B, Chronic / Q000175:diagnosis / Q000276:immunology; D006801:Humans; D007223:Infant; D057230:Limit of Detection; D008163:Luminescent Measurements / Q000379:methods*; D008297:Male; D008875:Middle Aged; D009154:Mutation; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity
chemical_list: D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D011933:Reagent Kits, Diagnostic
keywords: Diagnosis; HBsAg; Hepatitis B virus; Performance evaluation; Quantitative