PMID- 20637687
OWN - NLM
STAT- MEDLINE
DCOM- 20101216
LR  - 20191210
IS  - 1873-5967 (Electronic)
IS  - 1386-6532 (Linking)
VI  - 49
IP  - 1
DP  - 2010 Sep
TI  - Improved HIV-1 RNA quantitation by COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, v2.0 
      using a novel dual-target approach.
PG  - 41-6
LID - 10.1016/j.jcv.2010.06.004 [doi]
AB  - BACKGROUND: HIV-1 RNA viral load is a key parameter for reliable treatment 
      monitoring of HIV-1 infection. Accurate HIV-1 RNA quantitation can be impaired by 
      primer and probe sequence polymorphisms as a result of tremendous genetic 
      diversity and ongoing evolution of HIV-1. A novel dual HIV-1 target amplification 
      approach was realized in the quantitative COBAS AmpliPrep/COBAS TaqMan HIV-1 
      Test, v2.0 (HIV-1 TaqMan test v2.0) to cope with the high genetic diversity of 
      the virus. OBJECTIVES AND STUDY DESIGN: The performance of the new assay was 
      evaluated for sensitivity, dynamic range, precision, subtype inclusivity, 
      diagnostic and analytical specificity, interfering substances, and correlation 
      with the COBAS AmpliPrep/COBAS TaqMan HIV-1 (HIV-1 TaqMan test v1.0) predecessor 
      test in patients specimens. RESULTS: The new assay demonstrated a sensitivity of 
      20 copies/mL, a linear measuring range of 20-10,000,000 copies/mL, with a lower 
      limit of quantitation of 20 copies/mL. HIV-1 Group M subtypes and HIV-1 Group O 
      were quantified within +/-0.3 log(10) of the assigned titers. Specificity was 
      100% in 660 tested specimens, no cross reactivity was found for 15 pathogens nor 
      any interference for endogenous substances or 29 drugs. Good comparability with 
      the predecessor assay was demonstrated in 82 positive patient samples. In 
      selected clinical samples 35/66 specimens were found underquantitated in the 
      predecessor assay; all were quantitated correctly in the new assay. CONCLUSIONS: 
      The dual-target approach for the HIV-1 TaqMan test v2.0 enables superior HIV-1 
      Group M subtype coverage including HIV-1 Group O detection. Correct quantitation 
      of specimens underquantitated in the HIV-1 TaqMan test v1.0 test was 
      demonstrated.
CI  - Copyright (c) 2010 Elsevier B.V. All rights reserved.
FAU - Sizmann, Dorothea
AU  - Sizmann D
AD  - Roche Diagnostics Ltd., Forrenstrasse, CH-6343 Rotkreuz, Switzerland. 
      dorothea.sizmann@roche.com
FAU - Glaubitz, Joachim
AU  - Glaubitz J
FAU - Simon, Christian O
AU  - Simon CO
FAU - Goedel, Sebastian
AU  - Goedel S
FAU - Buergisser, Philippe
AU  - Buergisser P
FAU - Drogan, Daniel
AU  - Drogan D
FAU - Hesse, Martin
AU  - Hesse M
FAU - Kroh, Michael
AU  - Kroh M
FAU - Simmler, Pascale
AU  - Simmler P
FAU - Dewald, Manuela
AU  - Dewald M
FAU - Gilsdorf, Marion
AU  - Gilsdorf M
FAU - Fuerst, Marion
AU  - Fuerst M
FAU - Ineichen, Ralph
AU  - Ineichen R
FAU - Kirn, Anette
AU  - Kirn A
FAU - Pasche, Paul
AU  - Pasche P
FAU - Wang, Zhijun
AU  - Wang Z
FAU - Weisshaar, Sabrina
AU  - Weisshaar S
FAU - Young, Karen
AU  - Young K
FAU - Haberhausen, Gerd
AU  - Haberhausen G
FAU - Babiel, Reiner
AU  - Babiel R
LA  - eng
PT  - Evaluation Study
PT  - Journal Article
DEP - 20100715
PL  - Netherlands
TA  - J Clin Virol
JT  - Journal of clinical virology : the official publication of the Pan American 
      Society for Clinical Virology
JID - 9815671
RN  - 0 (RNA, Viral)
RN  - 0 (Reagent Kits, Diagnostic)
SB  - IM
MH  - HIV Infections/*diagnosis/*virology
MH  - HIV-1/*genetics/isolation & purification
MH  - Humans
MH  - Polymerase Chain Reaction/*methods
MH  - RNA, Viral/*analysis
MH  - *Reagent Kits, Diagnostic
MH  - Sensitivity and Specificity
MH  - *Viral Load
EDAT- 2010/07/20 06:00
MHDA- 2010/12/17 06:00
CRDT- 2010/07/20 06:00
PHST- 2010/03/10 00:00 [received]
PHST- 2010/06/02 00:00 [revised]
PHST- 2010/06/04 00:00 [accepted]
PHST- 2010/07/20 06:00 [entrez]
PHST- 2010/07/20 06:00 [pubmed]
PHST- 2010/12/17 06:00 [medline]
AID - S1386-6532(10)00229-5 [pii]
AID - 10.1016/j.jcv.2010.06.004 [doi]
PST - ppublish
SO  - J Clin Virol. 2010 Sep;49(1):41-6. doi: 10.1016/j.jcv.2010.06.004. Epub 2010 Jul 
      15.