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KMID : 0375319930150010237
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Journal of Clinical Pathology and Quality Control
1993 Volume.15 No. 1 p.237 ~ p.246
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Evaluation of Enzyme Immunoassay Kit :Lucky HCD" for the Detection of Antibody to hepatitis C Virus
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Abstract
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An evaluation study of a domestic enzyme immunoassay(EIA) kit "Lucky IICD" for the detection of antibody to hepatitis C virus(anti-HCV) was performed in parellel with three imported EIA kits: Abbott-2(second generation). Ortho-2 and UBI. The
concordance-rate of test results between Lucky and Abbott-2 was 98% for 1428 patient samples and 99.7% for 664 blood donor samples. All four EIA kits were compared for 400 selected patient samples and concordance rates between three imported kits
and
Lucky kit(97.3-98.0%) were similar to those among three imported kits(97.0-98.3%). Clear distinction of positive and negative results by signal/cut off ratio was best for Ortho kit, whereas Lucky and UBI kit showed higher proportion of high S/C
ratio(>0.5) for negative sampes. Confirmatory tests using 4-antigen RIBA and INNO-LIA reagents were performed for 67 seleted patient samples. When both reactive and indeterminate results were ?as positive. Abbott was most sensitive for detecting
RIBA
positive samples and the other three kits failed to detect some of RIBA-indeterminate samples. Abbott, Ortho and UBI were more sensitive than Ortho for detecting INNO-LIA positive samples. Detection sensitivity was compared for serial dilution of
a
positive pooled serum and Abbott, Ortho and Lucky showed higher dilutional sensitivity (1:200-1:400) compared to UBI(1:50). It is concluded that Abbott EIA kit appears to be most sensitive and Lucky EIA kit shows relatively satisfactory
performance
for
the detection of anti-HCV.
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KEYWORD
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