Evaluation of two generations of HCV RNA quantitative kits: a comparative study of 556 cases of hepatitis C

Objective To evaluate the clinical application of two generations of HCV nucleic acid quantitative kits: COBASAmpli Prep /COBASTaq Man HCV, v2. 0 and COBASAmpli Prep / COBASTaq Man HCV Test. Methods HCV RNA levels in 556 samples that were collected in our hospital were measured using the COBASAmpli Prep / COBASTaq Man HCV, v2. 0 and COBASAmpli Prep / COBASTaq Man HCV Test. The samples included 93 ones that were HCV RNA negative, 350 ones that were HCV RNA positive, 52 paired plasma and serum samples, and 61 ones with previous interferon therapy. HCV RNA-positive samples were divided into low-concentration group (≤103, 61 cases) , medium-concentration group (104-105, 191 cases) , and high-concentration group (≥106, 89 cases) . Comparison between groups was made by linear analysis to compute the correlation coefficient (r) and establish the regression equation. Results There was a significant correlation between the two generations of HCV nucleic acid quantitative kits (r = 0. 948, P < 0. 05) . The correlation between the two kits in the low-concentration group (y = 0. 9809 x + 0. 1359, r = 0. 8047, P > 0. 06) was higher than that in the medium-concentration group (y = 0. 8130 x + 1. 0727, r = 0. 6956, P < 0. 01) and that in the high-concentration group (y = 0. 6746 x + 1. 8914, r =0. 3088, P < 0. 01) . A high correlation between the two kits in paired serum and plasma samples was observed (y = 0. 9368 x + 0. 4469, r =0. 9698, P > 0. 05) . Conclusion The two generations of HCV RNA quantitative kits produce consistent results. A stronger correlation was shown in the low-concentration group, suggesting that the quantitative kits are more sensitive in detecting low level of HCV RNA in the clinical setting.