An Evaluation of Commercial Reagent Kits for Detecting HCV Antibodies - GenediaTM HCV ELISA 3.0, GenediaTM HCV Rapid and GenediaTMHCV Confirm 4.0 -

Abstract

Background : This study was conducted to evaluate accuracy of newly developed

HCV Ab test kits by Korea Green Cross Co., namely GenediaTM HCV

ELISA 3.0 (ELISA) for routine test, GenediaTM HCV Rapid (RAPID) for

quick screening and GenediaTM HCV Confirm 4.0 (CONFIRM) for

confirmation.

Methods : Performance of ELISA was compared with that of Ortho HCV 3.0 ELISA

using 990 patients' sera. Accuracy of RAPID was evaluated by testing on 114 HCV Ab

negative and 86 positive specimens by ELISA. Discrepant results obtained by RAPID

were confirmed by Chiron RIBA HCV 3.0 Strip Immunoblot Assay and HCV Blot 3.0.

Accuracy of CONFIRM test was compared between RIBA and BLOT using 78 ELISA

positive sera. To elucidate prevalence of viremia, RT-PCR was performed on 165 serum

samples and results were compared with that of ELISA and RAPID.

Results : Agreement of test results between ELISA and ORTHO ELISA was 99.6%

(986/990). On HCV Ab negative specimens 991% (113/114) agreed among RAPID, ELISA

and ORTHO ELISA. However, on seropositive specimens 91.7% (79/86) agreed between

RAPID and ELISA. Agreement between CONFIRM and RIBA was 83.3% (65/78). Core

antigen showed the highest reactivity and NS5 antigen showed the lowest reactivity

tilth CONFIRM. HCV RNA was detected in 58.3% (28/48) of ELISA positive specimens,

However, it was not detected in ELISA negative specimens. There was no correlation

between prevalence of HCV RNA and 5 antigens used in ELISA test.

Conclusions : Newly developed Korea Green Cross GenediaTM HCV

ELISA 3.0, Rapid anti HCV Confirm were considered to be clinically accurate routine,

quick screening anti confirmatory test for defecting HCV Ab in serum samples.