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KMID : 0985420130350020093
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Laboratory Medicine and Quality Assurance
2013 Volume.35 No. 2 p.93 ~ p.99
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Comparison of COBAS AmpliPrep/COBAS TaqMan HCV Qualitative Test v2.0 with COBAS AMPLICOR Hepatitis C Virus Test v2.0 for the Qualitative Detection of Hepatitis C Virus RNA in Korean Clinical Samples
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Yoo Soo-Hun
Park Youn-Hee
Lim Hwan-Sub
Kim Young-Ran
Shim Jung-Eun
Kim Hyon-Suk
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Abstract
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Background: We comparatively evaluated the performance of the conventional COBAS Amplicor HCV test v2.0 (CAM; Roche Molecular Systems, USA) and the newly developed COBAS AmpliPrep/COBAS TaqMan HCV test v2.0 (CAP/CTM; Roche Molecular Systems) for qualitative detection of hepatitis C virus (HCV) RNA in clinical samples.
Methods: Six hundred serum samples (100 HCV-positive, 500 HCV-negative, as determined by CAM) were selected and analysed using the new qualitative HCV RNA test, CAP/CTM qualitative test. Results were compared by confirmatory CAP/CTM quantitative test, which is a quantitative HCV RNA real-time polymerase chain reaction by Roche Molecular Systems, and anti-HCV test (Roche Diagnostics GmbH, Germany). Twenty-two additional serum samples, which gave a gray zone result by CAM, were selected for comparison.
Results: The two qualitative HCV RNA assays yielded concordant results for 586 of 600 tested samples (concordance rate, 97.7%; kappa coefficient, 0.92; 95% confidence interval [CI], 0.87 to 0.96; P<0.001). Upon re-testing by CAM, we found that the concordance rate increased to 98.2% (kappa coefficient, 0.93; 95% CI, 0.89 to 0.97; P<0.001). The additional 22 samples showing gray zone results for CAM were retested and were also tested by CAP/CTM. The results for 13 of these samples changed to negative and were now concordant with the CAP/CTM and confirmatory CAP/CTM quantitative results. For the remaining samples, the results were variable. For all the 22 samples, the results of the new CAP/CTM were in agreement with those obtained by confirmatory CAP/CTM quantitative test.
Conclusion: The results of the two assays were in good agreement, with 97.7% concordance rate. However, CAP/CTM is more sensitive than CAM and showed no gray zone results. Therefore, it can be a more efficient and useful test for the qualitative detection of HCV RNA in clinical samples.
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KEYWORD
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Hepatitis C virus, Qualitative HCV RNA assay, COBAS Amplicor, COBAS AmpliPrep/Cobas TaqMan, Quantitative HCV RNA real-time polymerase chain reaction (PCR)
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