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Analytical and clinical evaluation of a novel assay for anti-HBc IgG measurement in serum of subjects with overt and occult HBV infection.

Abstract：

OBJECTIVES:We assessed the analytical and clinical performance of the Lumipulse® G HBcAb-N (Fujirebio, Japan) assay for IgG antibodies to hepatitis B core antigen (anti-HBc IgG) measurement in serum of subjects with overt and occult HBV infection (OBI). MATERIALS/METHODS:Serum anti-HBc IgG was assessed in 181 anti-HBc-positive subjects: 119 chronic hepatitis B (CHB) patients in different infection phases and 62 subjects (35 CHB and 27 OBI) with available liver specimens for HBV covalently-close-circular (ccc) DNA analysis. RESULTS:The anti-HBc IgG assay showed a linear dynamic range (R2 = 0.9967); lower limit of detection and quantitation were 0.5 IU/mL and 0.8 IU/mL. Reproducibility was 4.9% and accuracy 98.7%. Anti-HBc IgG levels varied according to HBV infection phase, linearly declined during antiviral treatment and resulted correlated to intrahepatic HBV cccDNA (r = 0.752, P < 0.001). CONCLUSIONS:The quantitative anti-HBc IgG assay exhibited appropriate analytical performance and may represent a diagnostic complement in CHB patients and OBI subjects.

journal_name

Diagn Microbiol Infect Dis

journal_title

Diagnostic microbiology and infectious disease

authors

Caviglia GP,Olivero A,Ciancio A,Tandoi F,Troshina G,Rosso C,Abate ML,Younes R,Ribaldone DG,Smedile A,Rizzetto M,Romagnoli R,Saracco GM,Bugianesi E

doi

10.1016/j.diagmicrobio.2020.114985

subject

Has Abstract

pub_date

2020-04-01 00:00:00

pages

114985

issue

4

eissn

0732-8893

issn

1879-0070

pii

S0732-8893(19)31173-3

journal_volume

96

pub_type

杂志文章

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