J Clin Pathol Qual Control.  2001 Jun;23(1):227-231.

Performance Evaluation of LG Anti-HBs Enzyme lmmunoassay Kit

• Sung H
• Oh HB
• Kim BC
• Sohn MJ

Abstract

BACKGROUND: HBV infection is highly endemic in Korea. Precise evaluation of the prevalence of anti-HBs immunity can contribute to cutting of public health costs by reducing unnecessary HBV vaccination or booster doses. Moreover, some investigators have insisted that inclusion of anti-HBs in donor screening test might improve the safety of donated bloods. This study was intended to evaluate LG Anti-HBs EIA (LG Chemicals, Korea) kit by comparing with COBAS CORE Anti-HBs Quant EIA ll (Roche Diagnostics, Basel, Switzerland).
METHODS
Prevalence of anti-HBs was estimated in 2,014 blood donors using LG Anti-HBs EIA. With another 261 samples from blood donors and 62 FANA-positive samples, the reactivities to LG Anti-HBs EIA were compared with those of COBAS CORE. The precision and the detection limit of LG Anti-HBs EIA kit were also evaluated.
RESULTS
Of 2,014 blood donors, 1,639 (81.4%) were positive for anti-HBs. The concordance rate of LG Anti-HBs EIA and COBAS CORE was 98.5% (318/323). The sensitivity and specificity were 99.6% and 94.7%, respectively. The range of intra-run and inter-run coefficient of variation was 2.1-3.8% and 2.9-4.5%, respectively. The detection limit of the assay was 5 mIU/mL.
CONCLUSIONS
Our study shows that the LG Anti-HBs kit is a reproducible, sensitive, specific and rapid EIA kit for the detection of anti-HBs. Therefore LG anti-HBs would be helpful in Korean Blood Donation program and HBV vaccination program as a anti-HBs screening test.

MeSH Terms

Blood Donors
Donor Selection
Humans
Korea
Limit of Detection
Mass Screening
Prevalence
Public Health
Research Personnel
Sensitivity and Specificity
Vaccination