J Clin Pathol Qual Control.  2001 Dec;23(2):265-268.

Evaluation of the Usefulness of Techzyme(R) HBsAg and Anti-HBs

Affiliations
  • 1Department of Clinical Pathology, College of Medicine, Chungnam National University, Taejeon, Korea.

Abstract

BACKGROUND: The hepatitis B virus was one of the most prevalent infectious agent in Korea. Serologic assays of the detection for hepatitis B surface antigen (HBsAg) and hepatitis B antibody(Anti-HBs) were useful markers for the diagnosis of viral hepatitis. Some of domestic hepatitis enzyme immunoassay (EIA) reagents have been developed. We analyzed one of them, Techzyme(R) ELISA 3.0 HBsAg and Anti-HBs (Asan, Korea), to evaluate the clinical usefulness.
METHODS
The precision, linearity, sensitivity and specificity of Techzyme(R) HBsAg and Anti-HBs were evaluated with 150 clinical specimens from January to March, 2001.
RESULTS
The within-run and between-run coefficient of variance (C.V.) HBsAg were 7.48% and 11.12% in negative control and were 2.34% and 4.14% in positive control, respectively. The within-run and between-run CV for Anti-HBs were 7.02% and 14.6% in negative control and 2.43% and 4.97% in positive control. On linearity test, the R2 for HBsAg was 0.9903 and the R2 for Anti-HBs was 0.9977. The concordant results were 94% and 92% for HBsAg and Anti-HBs with conventional reagents, respectively. The sensitivity and specificity for HBsAg were 100%, both. And the sensitivity and specificity for Anti-HBs were 95.6% and 96.3%, respectively.
CONCLUSIONS
In conclusion, because of high sensitivity, specificity and high linearity, Techzyme(R) ELISA 3.0 HBsAg and Anti-HBs appeared to be suitable for detecting HBs Ag and Anti-HBs in clinical laboratories.

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