Journal article
Performance of the COBAS ® AmpliPrep/COBAS TaqMan ® automated system for hepatitis C virus (HCV) quantification in a multi-center comparison
Journal of clinical virology, Vol.50(2), pp.100-103
2011
DOI: 10.1016/j.jcv.2010.10.020
PMID: 21145783
Abstract
Quantitative HCV RNA testing is considered standard of care for monitoring during treatment of patients infected with HCV. The COBAS
® AmpliPrep/COBAS
® TaqMan
® HCV Test fully automates specimen processing and reaction assembly for HCV viral load testing using reverse transcription and real-time PCR amplification.
The performance of the COBAS
® AmpliPrep/COBAS
® TaqMan
® HCV Test was evaluated in a multi-center study.
Typical plasma based specimens were tested for accuracy, analytic range of measurement, reproducibility and genotype specific quantitation.
Linear regression analysis of the quantitative results demonstrated a linear range of detection from 50 to 5
million (1.7–6.7 log
10)
IU/mL and a coefficient of determination (
R
2) of 0.9948. The precision of the assay was highly reproducible within and between runs and among laboratories with coefficients of variance (CV) ranging from 6.7% to 40.0% across the seven laboratories. A representative sample for each of the six major HCV genotypes demonstrated reproducible quantitation between the seven laboratories
.
The COBAS
® AmpliPrep/COBAS
® TaqMan
® HCV Test is a reliable and sensitive assay for HCV RNA quantitation.
Details
- Title: Subtitle
- Performance of the COBAS ® AmpliPrep/COBAS TaqMan ® automated system for hepatitis C virus (HCV) quantification in a multi-center comparison
- Creators
- Aaron Bossler - University of Iowa, Roy J and Lucille A. Carver College of Medicine, Department of Pathology, 200 Hawkins Drive, Iowa City, IA 52242, United StatesCynthia Gunsolly - University of Iowa, Roy J and Lucille A. Carver College of Medicine, Department of Pathology, 200 Hawkins Drive, Iowa City, IA 52242, United StatesMichael T Pyne - ARUP Institute for Clinical and Experimental Pathology, 500 Chipeta Way, Salt Lake City, UT 84108, United StatesAngela Rendo - Mount Sinai Medical Center, Mount Sinai School of Medicine, New York-Presbyterian Hospital, 525 E. 68th Street, New York, NY 10029, United StatesJane Rachel - Saint Luke's Hospital, Department of Pathology, 4401 Wornall Rd, Kansas City, MO 64111, United StatesRay Mills - TriCore Reference Laboratories, 1001 Woodward Place, N.E., Albuquerque, NM 87102, United StatesMarjorie Miller - University of California at Los Angeles, Pathology & Laboratory Medicine, Box 951732, 10833 Le Conte Avenue, Los Angeles, CA 90095, United StatesJohn Sipley - New York Presbyterian Hospital, 525 East 68th Street, New York, NY 10021, United StatesDavid Hillyard - ARUP Institute for Clinical and Experimental Pathology, 500 Chipeta Way, Salt Lake City, UT 84108, United StatesStephen Jenkins - New York Presbyterian Hospital, 525 East 68th Street, New York, NY 10021, United StatesCynthia Essmyer - Saint Luke's Hospital, Department of Pathology, 4401 Wornall Rd, Kansas City, MO 64111, United StatesSteve Young - TriCore Reference Laboratories, 1001 Woodward Place, N.E., Albuquerque, NM 87102, United StatesMichael Lewinski - University of California at Los Angeles, Pathology & Laboratory Medicine, Box 951732, 10833 Le Conte Avenue, Los Angeles, CA 90095, United StatesHanna Rennert - New York Presbyterian Hospital, 525 East 68th Street, New York, NY 10021, United States
- Resource Type
- Journal article
- Publication Details
- Journal of clinical virology, Vol.50(2), pp.100-103
- DOI
- 10.1016/j.jcv.2010.10.020
- PMID
- 21145783
- NLM abbreviation
- J Clin Virol
- ISSN
- 1386-6532
- eISSN
- 1873-5967
- Publisher
- Elsevier B.V
- Language
- English
- Date published
- 2011
- Academic Unit
- Pathology
- Record Identifier
- 9984047898902771
Metrics
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