Korean J Clin Pathol.  1997 Apr;17(2):313-320.

Evaluation of ES-300 for the Detection of Anti-HCV Antibody

• Park JW
• Song JH
• Park HS
• Kang HJ
• Lee KM

Abstract

BACKGROUND: A fully automated enzyme-immunoassay (EIA) analyzer, Enzymun System, ES-300 (Boehringer Mannheim, Germany) uses streptavidin technology and performs single test or panels of up to 12 tests per run. We evaluated the results of ES-300 for anti-HCV by comparing the results with microplate-EIA, radioimmunoassay (RIA), and confirmatory test.
METHODS
Total 79 sera (51 positive, 24 negative, 4 indeterminate results confirmed by Lucky HCD Confirm) were analysed. ES-300 with Enzymun-Test(R) Anti-HCV (Boehringer Mannheim, Germany) and microplate-EIA (Green Cross Center Innotest HCV 3.0(R)) were used. Fifty one sera were examined additionally by 2nd-generation RIA method, NANBDINE 125C(General Biologicals Corp., R.O.C.). And all results were compared to the results of Lucky HCD Confirm.
RESULTS
The overall concordance rate of ES-300 and Innotest(R) was 72/79 (91.1%). The results of Lucky HCD Confirm on seven discrepant samples were five negative and two indeterminate. The results of ES-300 and NANBDINE 125C showed concordance rate of 90.2%. The sensitivity and specificity of ES-300 with regard to Lucky HCD Confirm were 94.5%, and 87.5%, respectively, and that of Innotest(R) were 98.2% and 66.7%, respectively. Clear distinction of positive and negative results by signal/cut off ratio was available in both EIAs. The positive predictive values of ES-300 and Innotest(R) were 94.5%, and 87.1%, respectively.
CONCLUSIONS
ES-300 showed relatively good results in sensitivity and positive predictive value with regard to confirmatory test. In EIA-positive persons, however, follow-up study would be necessary for reliable evaluation of HCV infection.

MeSH Terms

Humans
Radioimmunoassay
Sensitivity and Specificity
Streptavidin
Streptavidin