Evaluation of the COBAS(®) AmpliPrep/COBAS(®) TaqMan(®) HCV Test, v2.0 and comparison to assays used in routine clinical practice in an international multicenter clinical trial: The ExPECT study.

Abstract Background The COBAS ® AmpliPrep ® /COBAS ® TaqMan ® HCV Test, v2.0 (CAP/CTM2) is used for HCV RNA viral load monitoring. Objectives The performance of the CAP/CTM2 was compared to other widely used tests, including a manual version of the assay (the COBAS ® TaqMan ® HCV Test, v2.0 for use with the High Pure System, HPS/CTM2) predominantly used during phase III clinical trials for the new direct acting antiviral therapies. Study design Low HCV RNA level comparisons were performed across tests (Abbott Realtime HCV Test, ART; COBAS ® AmpliPrep ® /COBAS ® TaqMan ® HCV Test, v1.0, CAP/CTM1; CAP/CTM2; and HPS/CTM2) using dilutions of the 2nd HCV WHO International Standard. Additionally, the clinical performance of the CAP/CTM2 was evaluated with 421 leftover HCV RNA-positive routine clinical samples. Results All quantifiable WHO dilutions were within ±0.3 log 10  IU/mL of the expected results across tests and the analytical sensitivity resulted in a limit of detection of 12 IU/mL (95% confidence interval, 10, 15). When clinical samples were tested the results for 87% (367 of 421) of all sample comparisons were within ±0.5 log 10  IU/mL. When low viral load results (25–3500 IU/mL) were compared, values obtained by the ART assay were significantly lower ( p  Conclusions The new CAP/CTM2 showed good accuracy with comparable sensitivity to comparator assays. The new kit is well-suited for use in the routine diagnostic laboratory, especially for accurate monitoring of patients receiving triple therapy or interferone-free regimens.