Apr 16, 2010 - compared its performance to those of the Roche Amplicor ... testing. Prior to being tested in the CAP/CTM assay, the samples were thawed at.
Evaluation of the Roche Cobas AmpliPrep/Cobas TaqMan HIV-1 Test and Identification of Rare Polymorphisms Potentially Affecting Assay Performance䌤 Michael T. Pyne,1* Katherine L. Brown,2 and David R. Hillyard1,3 ARUP Institute for Clinical and Experimental Pathology, 500 Chipeta Way, Salt Lake City, Utah 841081; Roche Molecular Systems, Inc., 4300 Hacienda Drive, Pleasanton, California 945882; and University of Utah Department of Pathology, 15 N. Medical Drive East, Salt Lake City, Utah 841123 Received 16 April 2010/Returned for modification 10 June 2010/Accepted 17 June 2010
We evaluated the FDA-approved Roche Cobas AmpliPrep/Cobas TaqMan (CAP/CTM) HIV-1 viral load assay for sensitivity, reproducibility, linearity, HIV-1 subtype detection, and correlation to the Roche Amplicor HIV-1 monitor test, version 1.5 (Amplicor). The limit of detection calculated by probit analysis was 23.8 copies/ml using the 2nd International WHO Standard and 30.8 copies/ml using Viral Quality Assurance (VQA) standard material. Serial dilutions of six patient samples were used to determine inter- and intra-assay reproducibility and linearity, which were very good (
