title: A novel immunoassay for PreS1 and/or core-related antigens for detection of HBsAg variants.
abstract: A novel immunoassay that detects simultaneously hepatitis B virus (HBV) PreS1 and/or core-related antigens was developed and evaluated for its potential for detecting hepatitis B surface antigen (HBsAg) variants. The detection limits of the assay was 10(2.9+/-0.5)copies/mL (mean+/-SD) for HBsAg-positive sera with different genotypes, and 10(3.5+/-1.2)copies/mL for HBsAg variants sera. The specificity of the assay was 99.9% (95% CI: 99.7-99.9%, 4551 healthy individuals). The sensitivities were 93.9% (95% CI: 92.8-94.9%), 59.3% (95% CI: 38.7-77.6%) and 80% (95% CI: 44.4-97.5%) in three independent groups which include: 2065 hepatitis patients, 27 patients with occult hepatitis B and 10 HBsAg variants, respectively. In addition, a novel premature stop code mutation at position 112 of HBsAg was observed in two patients with chronic hepatitis B with different genotypes.
authors.affiliation: National Institute of Diagnostics and Vaccine Development in Infectious Diseases, School of Life Sciences, Xiamen University, Xiamen, China.
authors.forename: Quan
authors.initials: Q
authors.lastname: Yuan
authors.forename: Shengxiang
authors.initials: S
authors.lastname: Ge
authors.forename: Junhui
authors.initials: J
authors.lastname: Xiong
authors.forename: Qiang
authors.initials: Q
authors.lastname: Yan
authors.forename: Zhuo
authors.initials: Z
authors.lastname: Li
authors.forename: Xiaoke
authors.initials: X
authors.lastname: Hao
authors.forename: Deying
authors.initials: D
authors.lastname: Tian
authors.forename: Jianjun
authors.initials: J
authors.lastname: Niu
authors.forename: Zhijun
authors.initials: Z
authors.lastname: Su
authors.forename: Changrong
authors.initials: C
authors.lastname: Chen
authors.forename: J Wai-Kuo
authors.initials: JW
authors.lastname: Shih
authors.forename: Jun
authors.initials: J
authors.lastname: Zhang
authors.forename: Ningshao
authors.initials: N
authors.lastname: Xia
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D018389:Codon, Nonsense; D005260:Female; D006512:Hepatitis B Core Antigens / Q000097:blood; D006514:Hepatitis B Surface Antigens / Q000097:blood* / Q000235:genetics; D019694:Hepatitis B, Chronic / Q000175:diagnosis* / Q000235:genetics / Q000276:immunology; D006801:Humans; D007118:Immunoassay / Q000379:methods; D008297:Male; D008875:Middle Aged; D020125:Mutation, Missense; D012680:Sensitivity and Specificity; D014773:Virology / Q000379:methods*; D055815:Young Adult
chemical_list: D018389:Codon, Nonsense; D006512:Hepatitis B Core Antigens; D006514:Hepatitis B Surface Antigens