J Clin Pathol Qual Control.  1999 Dec;21(2):363-369.

An Evaluation of DONG-A HCV 3.2 and Genedia HCV ELISA 3.0 Detecting HCV Antibody

• Um T
• Bae HJ
• Shin BM

Abstract

BACKGROUND: The third-generation enzyme immunoassay (EIA) is now generally used to diagnose HCV infection, after the first-generation Enzyme immunoassay had been developed. We evaluated the third-generation EIA, Genedia HCV ELISA 3.0 (Genedia) and Dong-A HCV 3.2 (Dong-A).
METHODS
We performed anti-HCV test using Abbott HCV EIA 3.0 (Abbott), Genedia and Dong-A with 392 serum samples, 324 of them from hospitalized patients and 68 of them from hemodialysis unit form chronic renal failure. The discrepant samples were tested with three immunoblot assays, which were HCV BLOT 3.0, INNO-LIA HCV Ab III and Genedia HCV Confirm 4.0.
RESULTS
The concordance rates among three EIA kits were 97.4% (382/392), and 4.8% was all positive and 92.6%, all negative. The concordance rates between Genedia and Dong-A was 99.0%. Abbott and Genedia, 98.2%, Abbott and Dong-A 97.7%. Among ten discordant samples, two showed positive result(s) in more than one immunoblot kits. If the three EIA all positives and the indeterminates or positives in any of tree immunoblots are considered as true positive samples, the sensitivity and specificity of three immunoblots are considered as true positivee samples, the sensitivity and specificity of each EIA kits were abbott 92.3%, 99.5%, Genedia 88.5%, 100%, Dong-A 76.9%, 99.7%.
CONCLUSIONS
Genedia and Dong-A showed lower sensitivity but better specificity, compared with Abbott. Considering the high mutation rate of HCV, it would be more reliable and appropriate to use domestic commercial HCV EIA kits, which are based on Korean virus strains.

MeSH Terms

Enzyme-Linked Immunosorbent Assay*
Humans
Immunoenzyme Techniques
Kidney Failure, Chronic
Mutation Rate
Renal Dialysis
Sensitivity and Specificity