Abstract

HCV RNA quantitation is the primary method by which active HCV infections are identified and the response to direct acting antiviral therapy is monitored. This study describes evaluation of the Aptima HCV Quant Dx assay (Aptima HCV) performed on the Panther system. The clinical performance of Aptima HCV was compared to the COBAS AmpliPrep/COBAS TaqMan HCV Test v2.0 (CAP/CTM). Overall agreement was 84.9% (186/219) with a kappa statistic of 0.755 [Standard Error 0.037; 95% confidence interval (CI) 0.682 to 0.828]. Passing-Bablok regression of log10 IU/mL values revealed a regression line of Y = 1.163*X - 0.991 [95% CI of the slope (1.103 to 1.221) and intercept (-1.341to -0.642)]. The 95% LLOD for Aptima HCV on DBS samples was calculated to be 2.43 log10 IU/mL (267 IU/mL) [95% confidence interval, 2.31 to 2.73 log10 IU/mL (204 to 540 IU/mL)]. Comparison of Aptima HCV testing on paired dried blood spot (DBS) and serum specimens collected from patients at the time of routine blood collection for CAP/CTM demonstrated an overall agreement of 90.1% (82/91) with a kappa statistic of 0.657 (Standard Error 0.101; 95% confidence interval 0.458 to 0.855) In conclusion, Aptima HCV provides a suitable alternative for HCV RNA testing on serum and DBS.

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