title: Quality of human immunodeficiency virus viral load testing in Australia.
abstract: This study determined the proficiencies of laboratories measuring human immunodeficiency virus type 1 (HIV-1) viral loads and the accuracies of two assays used for HIV-1 viral load measurement in Australia and investigated the variability of the new versions of these assays. Quality assessment program panels containing (i) dilutions of HIV-1 subtype B, (ii) replicates of identical samples of HIV-1 subtype B, and (iii) samples of subtype E and B were tested by laboratories. Total variability (within and between laboratories) was tested with quality control samples. The coefficients of variation (CVs) for the Roche AMPLICOR HIV-1 MONITOR version (v) 1.0 and Chiron Quantiplex bDNA 2.0 assays ranged from 53 to 87% and 22 to 31%, respectively. The widespread occurrence of invalid runs with the AMPLICOR HIV-1 MONITOR 1.0 assay was identified. The CVs of the new versions of the assays were 82 to 86% for the AMPLICOR HIV-1 MONITOR v 1.5 assay and 16 to 23% for the Quantiplex bDNA 3.0 assay. For virus dilution samples, all but 5 of 19 laboratories obtained results within 2 standard deviations of the mean. The Quantiplex bDNA 2.0 assay reported values lower than those reported by the AMPLICOR HIV-1 MONITOR version 1.0 assay for samples containing HIV-1 subtype B, whereas the reverse was true for subtype E. Identification and resolution of the problem of invalid runs markedly improved the quality of HIV-1 viral load testing. The variability observed between laboratories and between assays, even the most recent versions, dictates that monitoring of viral load in an individual should always be by the same laboratory and by the same assay. Results for an individual which differ by less than 0.5 log(10) HIV-1 RNA copy number/ml should not be considered clinically significant.
authors.affiliation: National Serology Reference Laboratory, Australia, at St Vincent's Institute of Medical Research, Fitzroy, Victoria 3065, Australia.
authors.forename: S J
authors.initials: SJ
authors.lastname: Best
authors.forename: A P
authors.initials: AP
authors.lastname: Gust
authors.forename: E I
authors.initials: EI
authors.lastname: Johnson
authors.forename: C H
authors.initials: CH
authors.lastname: McGavin
authors.forename: E M
authors.initials: EM
authors.lastname: Dax
mesh_terms: D001315:Australia; D015658:HIV Infections / Q000821:virology*; D015497:HIV-1 / Q000302:isolation & purification* / Q000502:physiology*; D006801:Humans; D007753:Laboratories / Q000592:standards*; D011786:Quality Control; D012367:RNA, Viral / Q000097:blood; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D019562:Viral Load
chemical_list: D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic