Multicenter Evaluation of the Performance Characteristics of the NucliSens HIV-1 QT Assay Used for Quantitation of Human Immunodeficiency Virus Type 1 RNA

Ginocchio, Christine C.; Kemper, Marti; Stellrecht, Kathleen A.; Witt, Donald J.

doi:10.1128/jcm.41.1.164-173.2003

Cited by 31 publications

(23 citation statements)

References 26 publications

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“…It performed well in multicenter evaluation compared with other commercially available assays (Ginocchio et al, 2003;Murphy et al, 2000). The NucliSens HIV-1 QT is a NASBA with end-point electro-chemiluminesence (ECL) detection (Deiman et al, 2002).…”

Section: Introductionmentioning

confidence: 71%

Quantitative detection of HIV-1 RNA using NucliSens EasyQ HIV-1 assay

Yao

Liu²,

et al. 2005

Journal of Virological Methods

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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 500 IU/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 6 h. 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.

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Section: Introductionmentioning

confidence: 71%

Quantitative detection of HIV-1 RNA using NucliSens EasyQ HIV-1 assay

Yao

Liu²,

et al. 2005

Journal of Virological Methods

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“…More recently developed NASBA tests, including some with molecular beacons allowing real-time capabilities, have considerably better reactivity with non-B subtypes including group O [56,215,226,253,261,273,288,310]. The LCR based tests have strong cross-clade reactivity due to utilization of a highly conserved region of pol [71,72,77,116,333]. Indeed, until the recent development of the RT capable NASBA assays, LCR was the only test capable of detecting group O strains [13,136,[288][289][290].…”

Section: Monitoringmentioning

confidence: 99%

HIV Genetic Diversity: Biological and Public Health Consequences

Butler¹,

Pandrea²,

Marx³

et al. 2007

CHR

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The devastating consequences of AIDS pandemic will probably only be controlled when a vaccine is developed that is safe, effective, affordable, and simple enough to permit implementation in developing countries where the impact of AIDS is most severe. However, the major obstacle for the control of the spread of AIDS lies in the diversity of HIV and its enormous evolutionary potential. Numerous HIV forms contribute to the AIDS pandemic. Two viral types (HIV-1 and HIV-2), numerous groups (M, N and O for HIV-1 and A through H for HIV-2) and numerous subtypes, sub-subtypes and circulating recombinant forms (CRF) have emerged during the last 50 years. At least nine different genetic HIV-1 subtypes and over 20 CRFs were defined within group M, which accounts for the majority of cases in the AIDS pandemic. Even though HIV-1 subtype C and A predominate globally, the other viral forms co-circulate all over the world and may have a major impact for the strategies of pandemic control. Here we discuss the distribution of these divergent viral forms worldwide and the potential consequences of such a tremendous viral diversity for diagnostic, monitoring, treatment and the development of an effective vaccine.

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“…Another report quantifying 10 non-B subtypes observed that the mean difference between viremia detected by Cobas AmpliPrep/Cobas TaqMan HIV-1 test and bDNA v3.0 was 0.360-log RNA copies (24), increasing to 0.553 log when Cobas and NucliSens were compared (24). Other authors published that the coefficients of variance in testing NucliSens EasyQ in 35 clade B specimens ranged from 2.3 to 10.4% (21), increasing to differences of 0.32 viremia log at low-end HIV-1 RNA concentrations (13). In our study, 14.5 and 60% of the 55 plasma samples from naive subjects carrying non-B and recombinant variants provided viral load differences above Ն1 log and Ն0.5 log, respectively, when two of those techniques were compared.…”

Section: Discussionmentioning

confidence: 99%

“…The Cobas AmpliPrep/ Cobas TaqMan HIV-1 test (Roche Diagnostics, Branchburg, NJ) uses the Cobas AmpliPrep instrument for automated sample preparation and the Cobas TaqMan analyzer for automated real-time PCR amplification and detection, according to the manufacturer's recommendations. The Versant assay targets highly conserved regions of the pol gene, and both the TaqMan and NucliSens tests target the gag coding region (6,13,30). At the time of our study, according to the manufacturers, the assays could quantify HIV-1 RNA over the ranges of 50 to 500,000 (Versant), 50 to 3,000,000 (NucliSens), and 40 to 10,000,000 (TaqMan) HIV-1 RNA copies/ml.…”

Section: Methodsmentioning

confidence: 99%

“…The Versant HIV-1 RNA bDNA v3.0 (Bayer Diagnostic, Tarrytown, NY) uses the semiautomated Bayer system 340 (automated incubations, automated washing, and manual addition of reagents) (6). The NucliSens EasyQ HIV-1 v1.2 assay (BioMérieux, Inc., Durham, NC) measures plasma HIV-1 RNA extracted automatically with easyMAG Magnetic silica, followed by a real-time detection method combined with NASBA technology (13,29). The Cobas AmpliPrep/ Cobas TaqMan HIV-1 test (Roche Diagnostics, Branchburg, NJ) uses the Cobas AmpliPrep instrument for automated sample preparation and the Cobas TaqMan analyzer for automated real-time PCR amplification and detection, according to the manufacturer's recommendations.…”

Section: Methodsmentioning

confidence: 99%

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Performance of Three Commercial Viral Load Assays, Versant Human Immunodeficiency Virus Type 1 (HIV-1) RNA bDNA v3.0, Cobas AmpliPrep/Cobas TaqMan HIV-1, and NucliSens HIV-1 EasyQ v1.2, Testing HIV-1 Non-B Subtypes and Recombinant Variants

Holguín

López²,

Molinero³

et al. 2008

J Clin Microbiol

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Monitoring antiretroviral therapy requires that human immunodeficiency virus type 1 (HIV-1) viremia assays are applicable to all distinct variants. This study evaluates the performance of three commercial viral load assays-Versant HIV-1 RNA bDNA v3.0, Cobas AmpliPrep/Cobas TaqMan HIV-1, and NucliSens HIV-1 EasyQ v1.2-in testing 83 plasma specimens from patients carrying HIV-1 non-B subtypes and recombinants previously defined by phylogenetic analysis of the pol gene. All 28 specimens from patients under treatment presented viremia values below the detection limit with the three methods. In the remaining 55 specimens from naive individuals viremia could not be detected in 32.7, 20, and 14.6% using the NucliSens, Versant, or TaqMan tests, respectively, suggesting potential viral load underestimation of some samples by all techniques. Only 32 (58.2%) samples from naive subjects were quantified by the three methods; the NucliSens test provided the highest HIV RNA values (mean, 4.87 log copies/ml), and the Versant test provided the lowest (mean, 4.16 log copies/ml). Viremia differences of greater than 1 log were seen in 8 (14.5%) of 55 specimens, occurring in 10.9, 7.3, and 5.4%, respectively, of the specimens in comparisons of Versant versus NucliSens, Versant versus TaqMan, and TaqMan versus NucliSens. Differences greater than 0.5 log, considered significant for clinicians, occurred in 45.5, 27.3, and 29% when the same assays were compared. Some HIV-1 strains, such as subtype G and CRF02_AG, showed more discrepancies in distinct quantification methods than others. In summary, an adequate design of primers and probes is needed for optimal quantitation of plasma HIV-RNA in non-B subtypes. Our data emphasize the need to use the same method for monitoring patients on therapy and also the convenience of HIV-1 subtyping.

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Multicenter Evaluation of the Performance Characteristics of the NucliSens HIV-1 QT Assay Used for Quantitation of Human Immunodeficiency Virus Type 1 RNA

Cited by 31 publications

References 26 publications

Quantitative detection of HIV-1 RNA using NucliSens EasyQ HIV-1 assay

Quantitative detection of HIV-1 RNA using NucliSens EasyQ HIV-1 assay

HIV Genetic Diversity: Biological and Public Health Consequences

Performance of Three Commercial Viral Load Assays, Versant Human Immunodeficiency Virus Type 1 (HIV-1) RNA bDNA v3.0, Cobas AmpliPrep/Cobas TaqMan HIV-1, and NucliSens HIV-1 EasyQ v1.2, Testing HIV-1 Non-B Subtypes and Recombinant Variants

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