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Cross-platform analysis of HIV-1 RNA data generated by a multicenter assay validation study with wide geographic representation.

Publication ,  Journal Article
Jennings, C; Harty, B; Granger, S; Wager, C; Crump, JA; Fiscus, SA; Bremer, JW
Published in: J Clin Microbiol
August 2012

HIV-1 RNA quantitation continues to be extremely important for monitoring patients infected with HIV-1, and a number of assays have been utilized for this purpose. Differences in assay performance with respect to log(10) recovery and HIV-1 subtype specificity have been well documented for commercially available assays, although comparisons are usually limited to one or two assay platforms. Two new FDA-approved assays, the Roche Cobas AmpliPrep/Cobas TaqMan HIV-1 test (RT) and the Abbott RealTime HIV-1 assay (AR), that utilize real-time PCR have replaced previous HIV-1 RNA platforms. Inadequate detection of some strains of HIV-1 resulted in the addition of a new primer/probe set and the introduction of a second version of the RT assay. In this study, comparisons of assay performance between the different FDA-approved HIV-1 RNA assay platforms (both new and existing) were performed by using validation data that included both well-characterized virus stock and locally collected clinical samples. Laboratories across diverse geographical regions performed the validation testing and submitted data to the Virology Quality Assurance program (VQA) for analysis. Correlation values for clinical sample testing varied across the assay platforms (r = 0.832 to 0.986), and average log(10) recoveries for HIV-1 RNA controls (compared to the nominal value) ranged from -0.215 to 0.181. These data demonstrate the need for use of one assay platform for longitudinal patient monitoring, but the data also reinforce the notion that no one assay is superior and that testing across platforms may be required for discordance reconciliation.

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Published In

J Clin Microbiol

DOI

EISSN

1098-660X

Publication Date

August 2012

Volume

50

Issue

8

Start / End Page

2737 / 2747

Location

United States

Related Subject Headings

  • Viral Load
  • Real-Time Polymerase Chain Reaction
  • RNA, Viral
  • Quality Assurance, Health Care
  • Microbiology
  • Humans
  • HIV-1
  • HIV Infections
  • 3207 Medical microbiology
  • 3202 Clinical sciences
 

Citation

APA
Chicago
ICMJE
MLA
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Jennings, C., Harty, B., Granger, S., Wager, C., Crump, J. A., Fiscus, S. A., & Bremer, J. W. (2012). Cross-platform analysis of HIV-1 RNA data generated by a multicenter assay validation study with wide geographic representation. J Clin Microbiol, 50(8), 2737–2747. https://doi.org/10.1128/JCM.00578-12
Jennings, Cheryl, Brian Harty, Suzanne Granger, Carrie Wager, John A. Crump, Susan A. Fiscus, and James W. Bremer. “Cross-platform analysis of HIV-1 RNA data generated by a multicenter assay validation study with wide geographic representation.J Clin Microbiol 50, no. 8 (August 2012): 2737–47. https://doi.org/10.1128/JCM.00578-12.
Jennings C, Harty B, Granger S, Wager C, Crump JA, Fiscus SA, et al. Cross-platform analysis of HIV-1 RNA data generated by a multicenter assay validation study with wide geographic representation. J Clin Microbiol. 2012 Aug;50(8):2737–47.
Jennings, Cheryl, et al. “Cross-platform analysis of HIV-1 RNA data generated by a multicenter assay validation study with wide geographic representation.J Clin Microbiol, vol. 50, no. 8, Aug. 2012, pp. 2737–47. Pubmed, doi:10.1128/JCM.00578-12.
Jennings C, Harty B, Granger S, Wager C, Crump JA, Fiscus SA, Bremer JW. Cross-platform analysis of HIV-1 RNA data generated by a multicenter assay validation study with wide geographic representation. J Clin Microbiol. 2012 Aug;50(8):2737–2747.

Published In

J Clin Microbiol

DOI

EISSN

1098-660X

Publication Date

August 2012

Volume

50

Issue

8

Start / End Page

2737 / 2747

Location

United States

Related Subject Headings

  • Viral Load
  • Real-Time Polymerase Chain Reaction
  • RNA, Viral
  • Quality Assurance, Health Care
  • Microbiology
  • Humans
  • HIV-1
  • HIV Infections
  • 3207 Medical microbiology
  • 3202 Clinical sciences