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Blinded, multicenter quality control study for the quantification of human immunodeficiency virus type 1 RNA in plasma by the Belgian AIDS reference laboratories

par Muyldermans, Gaëtan;Lauwers, Sabine;Debaisieux, Laurent ;Fransen, Katrien;Marissens, Denise;Zissis, Georges ;Miller, Kurt;Vaira, Dolores;Vandamme, Anne-Mieke;Vandenbroucke, Anne Thérèse;Verhofstede, Chris;Schuurman, Rob
Référence Clinical microbiology and infection, 6, 4, page (213-217)
Publication Publié, 2000-04

Article révisé par les pairs

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Résumé :

Objective. In order to evaluate the interlaboratory variation of HIV-1 RNA measurements in plasma, the Belgian AIDS reference laboratories organized a blinded multicenter quality control study. Methods. A test panel of coded spiked HIV-1 plasma samples reflecting the dynamic range of the assay was composed and distributed. The HIV-1 RNA concentration of these samples was determined by the eight Belgian AIDS reference laboratories by means of the Amplicor HIV-1 Monitor version 1.5 assay. Results. Analysis of the results demonstrated that there was little interlaboratory variation for the high concentration range (4.0-5.7 log10 copies/mL), never exceeding 0.2 log10 copies/mL. However the standard deviation for the low concentration range (2.6-3.9 log10 copies/mL) reached up to 0.22 log10 copies/mL. Conclusions. Since interlaboratory variability never reached 0.5 log10 copies/mL and each of the laboratories was able to detect four-fold differences in plasma HIV-1 RNA levels, the Amplicor assay can be used in multicenter studies without a centralized analysis of samples. Furthermore, this well-characterized proficiency panel of spiked plasma samples could be used as a standard in the study of interassay comparisons.