Blinded, multicenter quality control study for the quantification of human immunodeficiency virus type 1 RNA in plasma by the Belgian AIDS reference laboratories.
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.
Muyldermans
G
G
Belgian AIDS Reference Laboratories, Academisch Ziekenhuis - Vrije Universiteit Brussel, Brussels; Universiteé Libre de Bruxelles, Brussels. lmikmsg@az.vub.ac.be
Debaisieux
L
L
Fransen
K
K
Marissens
D
D
Miller
K
K
Vaira
D
D
Vandamme
A M
AM
Vandenbroucke
A T
AT
Verhofstede
C
C
Schuurman
R
R
Zissis
G
G
Lauwers
S
S
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
D012367:RNA, Viral