title: Multicenter evaluation of the NucliSens EasyQ HIV-1 v1.1 assay for the quantitative detection of HIV-1 RNA in plasma.
abstract: The Nuclisens EasyQ HIV-1 v1.1 assay (Biomerieux) is a real-time detection method combined with NASBA technology designed to measure plasma HIV-RNA. Its performance was assessed in 1008 clinical specimens collected from individuals infected with clade B (774) and non-B (234) HIV-1 variants at four European laboratories. The results were compared with those obtained using three other commercial viral load assays: Cobas Amplicor Monitor HIV-1 v1.5 (Roche), Versant HIV-1 RNA assay (Bayer) and Nuclisens HIV-1 QT (Biomerieux). Overall, the linearity, specificity and reproducibility of the EasyQ assay was comparable with that from the other tests. The correlation coefficient (R) between methodologies was 0.85 for Amplicor; 0.87 for Versant; and 0.91 for Nuclisens. The specificity of the assay was 99.4%. Of note, Versant missed 17% of specimens with non-B subtypes which could be detected by EasyQ, while Amplicor provided similar results than EasyQ. HIV-1 group O specimens were only detected by the EasyQ assay. In conclusion, the performance of the EasyQ assay seems to be similar to that of other HIV-1 viral load tests currently on the market, but it is more sensitive than Versant for HIV-1 non-B subtypes and shows a wider dynamic range than Amplicor. Moreover, as it incorporates the advantage of real-time detection procedures, it facilitates high throughput and short turnaround time.
authors.affiliation: Department of Infectious Diseases, Hospital Carlos III, C/ Sinesio Delgado 10, 28029 Madrid. Spain. cmendoza@teleline.es
authors.forename: C
authors.initials: C
authors.lastname: de Mendoza
authors.forename: M
authors.initials: M
authors.lastname: Koppelman
authors.forename: B
authors.initials: B
authors.lastname: Montès
authors.forename: V
authors.initials: V
authors.lastname: Ferre
authors.forename: V
authors.initials: V
authors.lastname: Soriano
authors.forename: H
authors.initials: H
authors.lastname: Cuypers
authors.forename: M
authors.initials: M
authors.lastname: Segondy
authors.forename: T
authors.initials: T
authors.lastname: Oosterlaken
mesh_terms: D005602:France; D015658:HIV Infections / Q000097:blood*; D015497:HIV-1 / Q000235:genetics / Q000302:isolation & purification*; D006801:Humans; D009426:Netherlands; D012367:RNA, Viral / Q000097:blood*; D011933:Reagent Kits, Diagnostic / Q000592:standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013030:Spain; D019562:Viral Load / Q000379:methods*
chemical_list: D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic