title: Quantitative detection of HIV-1 RNA using NucliSens EasyQ HIV-1 assay.
abstract: HIV-1 RNA viral load has become the major biological marker for disease prognosis and outcome of antiretroviral therapy in the treatment of HIV-infected individuals. The aim of this study was to compare the performance of the new CE marked NucliSens EasyQ HIV-1 assay with NucliSens HIV-1 QT assay (reference method). NucliSens EasyQ HIV-1 (EasyQ) couples nucleic acid sequence-based amplification (NASBA) with real-time detection using molecular beacons utilizing the NucliSens EasyQ analyzer. NASBA is a sensitive, isothermal, transcription-based amplification system designed specifically for the detection of RNA targets. There was significant correlation (r = 0.878, P < 0.0001) between the two different assays in the analysis of clinical samples and the frequency of concordant results (log difference <0.5) was 74%. The two assays detected HIV-1 RNA in 81 specimens, and neither detected (below the lower detection limit, 400 copies/ml for NucliSens HIV-1 QT and 500IU/ml for EasyQ) HIV-1 RNA in 12 specimens. Three clinical specimens had detectable HIV-1 RNA using the EasyQ only, and two specimens had detectable HIV-1 RNA using the NucliSens HIV-1 QT only. The EasyQ procedure can analyze 48 clinical samples within 6h. The coefficient of variation of EasyQ ranged from 3.0 to 9.5% (3% at 4.9 log; 5.7% at 3.7 log; 9.5% at 2.7 log). The new assay is shown to be a rapid, convenient, and reliable procedure for HIV-1 RNA viral load monitoring.
authors.affiliation: National AIDS Reference Laboratory, National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention, Xuan Wu District, Beijing 100050, PR China.
authors.forename: Jun
authors.initials: J
authors.lastname: Yao
authors.forename: Zhen
authors.initials: Z
authors.lastname: Liu
authors.forename: Lung-Sang
authors.initials: LS
authors.lastname: Ko
authors.forename: Gang
authors.initials: G
authors.lastname: Pan
authors.forename: Yan
authors.initials: Y
authors.lastname: Jiang
mesh_terms: D015658:HIV Infections / Q000097:blood* / Q000821:virology; D015497:HIV-1 / Q000235:genetics / Q000302:isolation & purification*; D006801:Humans; D008828:Microbiological Techniques; D012367:RNA, Viral / Q000097:blood*; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D019562:Viral Load
chemical_list: D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic