An International Collaboration To Standardize HIV-2 Viral Load Assays: Results from the 2009 ACHI(E)V(2E) Quality Control Study

作者:Damond F*; Benard A; Balotta Claudia; Boeni Juerg; Cotten Matthew; Duque Vitor; Ferns Bridget; Garson Jeremy; Gomes Perpetua; Goncalves Fatima; Gottlieb Geoffrey; Kupfer Bernd; Ruelle Jean; Rodes Berta; Soriano Vicente; Wainberg Mark; Taieb Audrey; Matheron Sophie; Chene Genevieve; Brun Vezinet Francoise
来源:Journal of Clinical Microbiology, 2011, 49(10): 3491-3497.
DOI:10.1128/JCM.02389-10

摘要

Accurate HIV-2 plasma viral load quantification is crucial for adequate HIV-2 patient management and for the proper conduct of clinical trials and international cohort collaborations. This study compared the homogeneity of HIV-2 RNA quantification when using HIV-2 assays from ACHI(E)V(2E) study sites and either in-house PCR calibration standards or common viral load standards supplied to all collaborators. Each of the 12 participating laboratories quantified blinded HIV-2 samples, using its own HIV-2 viral load assay and standard as well as centrally validated and distributed common HIV-2 group A and B standards (http://www.hiv.lanl.gov/content/sequence/HelpDocs/subtypes-more.html). Aliquots of HIV-2 group A and B strains, each at 2 theoretical concentrations (2.7 and 3.7 log(10) copies/ml), were tested. Intralaboratory, interlaboratory, and overall variances of quantification results obtained with both standards were compared using F tests. For HIV-2 group A quantifications, overall and interlaboratory and/or intralaboratory variances were significantly lower when using the common standard than when using in-house standards at the concentration levels of 2.7 log(10) copies/ml and 3.7 log(10) copies/ml, respectively. For HIV-2 group B, a high heterogeneity was observed and the variances did not differ according to the type of standard used. In this international collaboration, the use of a common standard improved the homogeneity of HIV-2 group A RNA quantification only. The diversity of HIV-2 group B, particularly in PCR primer-binding regions, may explain the heterogeneity in quantification of this strain. Development of a validated HIV-2 viral load assay that accurately quantifies distinct circulating strains is needed.

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