Real-time detection system for quantitation of hepatitis C virus RNA: a comparison with the other three methods

Real-time detection (RTD) system for quantitation of hepatitis C virus (I-I CV) was developed. Its sensitivity and usefulness were compared with the ot her three commercially available methods for quantitation of HCV. The sera of 166 patients positive for serum HCV RNA by Amplicor HCV test were assess ed. HCV was detected in 78.5% (128/163) by branched DNA assay, in 88.8%(111 /125) by HCV core protein assay, in 94.5% (156/165) by Amplicor HCV Monitor test, and in 97.0% (161/166) by the RTD system. The values of viral load b y the RTD system were significantly well correlated with these obtained by the other three methods. In the 50 patients treated by interferons (IFNs), the range which predicts the highest sustained response rate was less than 0.5 Meq/ml for branched DNA assay (sustained response rate: 57.9%(11/19)), less than 1 kcopies/ml for Amplicor HCV Monitor test (85.7% (6/7)), and les s than 10(4) copies/ml for RTD system (100% (7/7). None of the patients wit h greater than or equal to 2.8 Meq/ml by branched DNA assay (n = 14), great er than or equal to 250 kcopies/ml by Amplicor I-ICV Monitor test (n = 19), or greater than or equal to 2 x 10(6) copies/ml by RTD system (n = 16) obt ained sustained response. In conclusion, RTD system was demonstrated to be the most sensitive method for quantitation of HCV, and useful For the predi ction of sustained response to IFN therapy. (C) 2001 Elsevier Science Irela nd Ltd. All rights reserved.