Dataset Information


Highly sensitive detection of hepatitis B virus surface antigen by use of a semiautomated immune complex transfer chemiluminescence enzyme immunoassay.

ABSTRACT: The performance of hepatitis B surface antigen (HBsAg) screening assays is continuously improved to reduce the risk of transfusion-associated hepatitis B. In this study, a semiautomated immune complex transfer chemiluminescence enzyme immunoassay (ICT-CLEIA) for the detection of HBsAg, which is as sensitive as hepatitis B virus (HBV) DNA PCR, was developed; the ICT-CLEIA assay performance was compared with the performance of the Architect HBsAg QT assay and HBV DNA PCR. The specificities in the initial assay and after retesting were 99.50% (1,988/1,998 samples) and 99.95% (1,997/1,998 samples), respectively. The analytical detection limit was determined to be 0.2 mIU/ml using the 2nd International WHO HBsAg standard, and the cutoff value (0.5 mIU/ml) of the ICT-CLEIA assay was 8.0 standard deviations (SD) above the mean of the HBsAg-negative specimens. The ICT-CLEIA assay could detect HBsAg even in the presence of anti-HBs antibodies and demonstrated a 23.6-day-shorter window period using commercially available HBsAg seroconversion panels than the Architect HBsAg QT assay. Furthermore, the monitoring of the viral kinetics by the ICT-CLEIA assay and the HBV DNA PCR produced very similarly shaped curves during both the HBsAg seroconversion and reverse seroconversion periods. Therefore, the ICT-CLEIA assay may be useful not only for an earlier detection of HBV reactivation but also for the monitoring of hepatitis B patients.


PROVIDER: S-EPMC3697675 | BioStudies | 2013-01-01

REPOSITORIES: biostudies

Similar Datasets

2020-01-01 | S-EPMC7290535 | BioStudies
2017-01-01 | S-EPMC5699832 | BioStudies
1000-01-01 | S-EPMC6056386 | BioStudies
2017-01-01 | S-EPMC5378923 | BioStudies
2019-01-01 | S-EPMC6609197 | BioStudies
2019-01-01 | S-EPMC7384397 | BioStudies
2014-01-01 | S-EPMC4051672 | BioStudies
2019-01-01 | S-EPMC7157657 | BioStudies
2018-01-01 | S-EPMC6817178 | BioStudies
2017-01-01 | S-EPMC5645387 | BioStudies