Open AccessEvaluation of the highly sensitive chemiluminescent enzyme immunoassay “Lumipulse HB sAg‐ HQ ” for hepatitis B virus screening
Author(s) -
Deguchi Matsuo,
Kagita Masanori,
Yoshioka Nori,
Tsukamoto Hiroko,
Takao Miyuki,
Tahara Kazuko,
Maeda Ikuhiro,
Hidaka Yoh,
Yamauchi Satoshi,
Kaneko Atsushi,
Miyakoshi Hideo,
Isomura Mitsuo
Publication year - 2018
Publication title -
journal of clinical laboratory analysis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.536
H-Index - 50
eISSN - 1098-2825
pISSN - 0887-8013
DOI - 10.1002/jcla.22334
Subject(s) - immunoassay , seroconversion , chemiluminescence , detection limit , chromatography , microbiology and biotechnology , chemistry , medicine , virology , immunology , antibody , virus , biology
Background Ongoing efforts in the development of HB sAg detection kits are focused on improving sensitivity and specificity. The purpose of this study was to evaluate an improved, highly sensitive quantitative assay, “Lumipulse HB sAg‐ HQ ”, a chemiluminescent enzyme immunoassay designed for a fully automated instrument, the “Lumipulse G1200”. Methods Serum samples for reproducibility, dilution, correlation, sensitivity, and specificity studies were obtained from patients at the Osaka University Hospital. Seroconversion and sensitivity panels were purchased from a commercial vender. Subtype, sensitivity panels, and HB sAg recombinant proteins with one or two amino acid substitutions were prepared in‐house. Results The coefficients of variation for the low, medium, and high concentration samples ranged from 1.93 to 2.55%. The HB sAg‐ HQ reagent for dilution testing showed good linearity in the 0.005‐150 HB sAg IU / mL range and no prozone phenomenon. All 102 HBV carrier samples were positive by HB sAg‐ HQ , while other commercial reagents showed one or more to be negative. In the seroconversion panel, the 14‐day blood sample was positive. The sensitivity against HB sAg‐ HQ “ad” and “ay” subtypes was 0.025 ng/mL. Comparisons among the HB sAg‐ HQ , HISCL , and Architect HB sAg reagents were performed using the Bland‐Altman plot. Specificity for 1000 seronegative individuals was 99.7%. HB sAg‐ HQ detected 29 positive serum among 12 231 routinely obtained serum samples, which showed concentrations of 0.005‐0.05 HB sAg IU / mL . Conclusions According to these results, the Lumipulse HB sAg‐ HQ assay, with a highly sensitive limit of detection of 0.005 IU / mL , may facilitate the development of a better management strategy for a considerable proportion of infected patients.