title: Blinded, multicenter quality control study for the quantification of human immunodeficiency virus type 1 RNA in plasma by the Belgian AIDS reference laboratories.
abstract: 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
  Atest 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.
authors.affiliation: Belgian AIDS Reference Laboratories, Academisch Ziekenhuis - Vrije Universiteit Brussel, Brussels; Universiteé Libre de Bruxelles, Brussels. lmikmsg@az.vub.ac.be
authors.forename: G
authors.initials: G
authors.lastname: Muyldermans
authors.forename: L
authors.initials: L
authors.lastname: Debaisieux
authors.forename: K
authors.initials: K
authors.lastname: Fransen
authors.forename: D
authors.initials: D
authors.lastname: Marissens
authors.forename: K
authors.initials: K
authors.lastname: Miller
authors.forename: D
authors.initials: D
authors.lastname: Vaira
authors.forename: A M
authors.initials: AM
authors.lastname: Vandamme
authors.forename: A T
authors.initials: AT
authors.lastname: Vandenbroucke
authors.forename: C
authors.initials: C
authors.lastname: Verhofstede
authors.forename: R
authors.initials: R
authors.lastname: Schuurman
authors.forename: G
authors.initials: G
authors.lastname: Zissis
authors.forename: S
authors.initials: S
authors.lastname: Lauwers
mesh_terms: D001530:Belgium; D015658:HIV Infections / Q000097:blood / Q000821:virology*; D015497:HIV-1 / Q000235:genetics / Q000302:isolation & purification*; D006801:Humans; D007753:Laboratories / Q000592:standards*; D016133:Polymerase Chain Reaction / Q000592:standards*; D011786:Quality Control; D012367:RNA, Viral / Q000097:blood*; D012016:Reference Values; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D019562:Viral Load
chemical_list: D012367:RNA, Viral