Open AccessDetection of Hepatitis B Virus Large Surface Protein Using a Time‐Resolved Immunofluorometric Assay
Author(s) -
Hu Zhigang,
Li Mei,
Liu Jie,
Yu Lei,
Xue Yifeng,
Chen Yu
Publication year - 2015
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.21800
Subject(s) - medicine , coefficient of variation , hepatitis b virus , virus , rheumatoid arthritis , hepatitis c virus , virology , microbiology and biotechnology , chemistry , biology , chromatography
Background To establish a novel method based on time‐resolved immunofluorometric assay (TR‐IFMA) with higher sensitivity and a broader detection range for detecting serum hepatitis B virus large surface protein (L protein). Methods The precision, sensitivity, specificity, coefficient of recovery, and stability of the assay were evaluated and comparison with the classical enzyme‐linked immunosorbent assay (ELISA) was also executed. Results The precision, specificity, and sensitivity of the TR‐IFMA were clearly better than ELISA. Particularly, the sensitivity was 0.1 ng/ml; moreover, the specificity was 100%, 96%, 92.5%, 96.9%, 97.8%, and 100% in the sera of healthy blood donors, systemic lupus erythematosus (SLE) patients, rheumatoid arthritis (RA) patients, hepatitis C virus (HCV) patients, cytomegalovirus (CMV) infection patients, and pregnant patients, respectively. Meanwhile, we observed that the established TR‐IFMA kit has a wider acceptable linear range of 0.63–10,367 ng/ml rather than the regular commercial ELISA kit having range of only 10.12–1095.9 ng/ml. Subsequently, correlation coefficient between the TR‐IFMA and ELISA was 0.8009. The intra‐ and interassay precision rates were less than 5% for three different concentrations. The average recovery rate for L protein was 101.17%. In sum, the established assay kit performed better in terms of stability than the commercial ELISA kit. Conclusion The TR‐IFMA that we developed for L protein presented a higher sensitivity and wider detecting range than regular commercial ELISA. Therefore, this TR‐IFMA has promising value both in the screening of HBV and monitoring of antiviral therapy.