Fully automated quantification of human immunodeficiency virus (HIV) type 1 RNA in human plasma by the COBAS® AmpliPrep/COBAS® TaqMan® system

Schumacher, W; Frick, Edmund; Kauselmann, Mirko; Maier-Hoyle, Viola; Vliet, Reinier van der; Babiel, Reiner

doi:10.1016/j.jcv.2006.12.022

Cited by 84 publications

(56 citation statements)

References 30 publications

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“…In fact, from 10 to 40% of the HIV-1 non-B subtypes and from 17.5 to 28.6% of recombinants infecting naive subjects could not be quantified for some of the three tests (Table 1). Previous studies quantifying 15 different non-B HIV-1 variants revealed that viremia values comparing the Cobas AmpliPrep/Cobas TaqMan HIV-1 test and bDNA v3.0 yielded results within the accuracy limits of Ϯ0.3 log, being lower (Ϯ0.1 log) when only subtype B specimens were analyzed (27). 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).…”

Section: Discussionmentioning

confidence: 94%

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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Section: Discussionmentioning

confidence: 94%

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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“…IV-1 RNA quantitation (virus load testing) continues to be an important tool for monitoring HIV-1 infection (16,29), and a number of different commercially available HIV-1 RNA assays are available for this purpose (1,9,10,12,20,21,26,27,28). HIV-1 RNA results are used to determine antiretroviral treatment efficacy, monitor safety and adherence, stratify patients enrolled in clinical trials, and predict virologic outcomes, such as motherto-child transmission, treatment failure, and viral persistence in body compartments.…”

mentioning

confidence: 99%

“…HIV-1 RNA results are used to determine antiretroviral treatment efficacy, monitor safety and adherence, stratify patients enrolled in clinical trials, and predict virologic outcomes, such as motherto-child transmission, treatment failure, and viral persistence in body compartments. In recent years, there has been a change in virus load methodologies, from endpoint PCR determinations to real-time PCR (10,21,27). The new real-time PCR methodologies offer a broad range of benefits over the traditional endpoint PCR, including higher precision, full automation with high throughput, expanded reportable range capabilities, and ever-decreasing lower limits of detection (20 to 40 copies/ml).…”

mentioning

confidence: 99%

Cross-Platform Analysis of HIV-1 RNA Data Generated by a Multicenter Assay Validation Study with Wide Geographic Representation

et al. 2012

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HIV-1 RNA quantitation continues to be extremely important for monitoring patients infected with HIV-1, and a number of assays have been utilized for this purpose. Differences in assay performance with respect to log 10 recovery and HIV-1 subtype specificity have been well documented for commercially available assays, although comparisons are usually limited to one or two assay platforms. Two new FDA-approved assays, the Roche Cobas AmpliPrep/Cobas TaqMan HIV-1 test (RT) and the Abbott RealTime HIV-1 assay (AR), that utilize real-time PCR have replaced previous HIV-1 RNA platforms. Inadequate detection of some strains of HIV-1 resulted in the addition of a new primer/probe set and the introduction of a second version of the RT assay. In this study, comparisons of assay performance between the different FDA-approved HIV-1 RNA assay platforms (both new and existing) were performed by using validation data that included both well-characterized virus stock and locally collected clinical samples. Laboratories across diverse geographical regions performed the validation testing and submitted data to the Virology Quality Assurance program (VQA) for analysis. Correlation values for clinical sample testing varied across the assay platforms ( r = 0.832 to 0.986), and average log 10 recoveries for HIV-1 RNA controls (compared to the nominal value) ranged from −0.215 to 0.181. These data demonstrate the need for use of one assay platform for longitudinal patient monitoring, but the data also reinforce the notion that no one assay is superior and that testing across platforms may be required for discordance reconciliation.

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“…Previous publications reported on the performance of CAP/CTM HIV-1 (12,17,25,26,28) and NucliSENS HIV-1 (8,13,32,33). RealTime HIV-1 has previously been validated against the Roche HIV-1 Monitor assay (which uses a manual RNA extraction step) and CAP/CTM HIV-1 with the m1000 system, which is less automated than the m2000sp system used in this study (6,15).…”

mentioning

confidence: 99%

Evaluation of the Abbott m 2000 RealTi m e Human Immunodeficiency Virus Type 1 (HIV-1) Assay for HIV Load Monitoring in South Africa Compared to the Roche Cobas AmpliPrep-Cobas Amplicor, Roche Cobas AmpliPrep-Cobas TaqMan HIV-1, and BioMerieux NucliSENS EasyQ HIV-1 Assays

et al. 2009

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The implementation of antiretroviral therapy demands the need for increased access to viral load (VL) monitoring. Newer real-time VL testing technologies are faster and have larger dynamic ranges and fully automated extraction to benefit higher throughputs in resource-poor environments. The Abbott RealTime human immunodeficiency virus type 1 (HIV-1) assay was evaluated as a new option for testing for HIV-1 subtype C in South Africa, and its performance was compared to the performance of existing assays (the Cobas AmpliPrep-Cobas TaqMan HIV-1, version 1, assay; the AmpliPrep-Cobas Monitor standard HIV-1 assay; and the NucliSENS EasyQ-EasyMag HIV-1 assay) in a high-throughput laboratory. The total precision of the RealTime HIV-1 assay was acceptable over all viral load ranges. This assay compared most favorably with the Cobas AmpliPrep-Cobas TaqMan HIV-1 assay (R 2 ‫؍‬ 0.904), with a low standard deviation of difference being detected (0.323 copies/ml). The bias against comparator assays ranged from ؊0.001 copies/ml to ؊0.228 copies/ml. Variability in the reporting of VLs for a 20-member subtype panel compared to the variability of other assays was noted with subtypes G and CRF02-AG. The RealTime HIV-1 assay can test 93 samples per day with minimal manual preparation, less staff, and the minimization of contamination through automation. This assay is suitable for HIV-1 subtype C VL quantification in South Africa.

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Fully automated quantification of human immunodeficiency virus (HIV) type 1 RNA in human plasma by the COBAS® AmpliPrep/COBAS® TaqMan® system

Cited by 84 publications

References 30 publications

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

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

Cross-Platform Analysis of HIV-1 RNA Data Generated by a Multicenter Assay Validation Study with Wide Geographic Representation

Evaluation of the Abbott m 2000 RealTi m e Human Immunodeficiency Virus Type 1 (HIV-1) Assay for HIV Load Monitoring in South Africa Compared to the Roche Cobas AmpliPrep-Cobas Amplicor, Roche Cobas AmpliPrep-Cobas TaqMan HIV-1, and BioMerieux NucliSENS EasyQ HIV-1 Assays

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