Evaluation of the Roche Cobas AmpliPrep/Cobas TaqMan HIV-1 Test and Identification of Rare Polymorphisms Potentially Affecting Assay Performance

• Published in: Journal of Clinical Microbiology Vol. 48; no. 8; pp. 2852 - 2858
• Main Authors: Pyne, Michael T, Brown, Katherine L, Hillyard, David R
• Format: Journal Article
• Language: English
• Published: Washington, DC American Society for Microbiology 01.08.2010; American Society for Microbiology (ASM)
• Subjects: Base Pair Mismatch; Biological and medical sciences; Diagnostic Errors; DNA Primers - genetics; Fundamental and applied biological sciences. Psychology; Genotype; HIV Infections - virology; HIV-1 - classification; HIV-1 - genetics; HIV-1 - isolation & purification; Human immunodeficiency virus 1; Humans; Microbiology; Miscellaneous; Molecular Diagnostic Techniques - methods; Oligonucleotide Probes - genetics; Reagent Kits, Diagnostic; Reproducibility of Results; RNA, Viral - genetics; Sensitivity and Specificity; Viral Load - methods; Virology; Virus; HIV-1 virus; Retroviridae; Identification; Human immunodeficiency virus; Lentivirus; Polymorphism

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 analys...