Comparative RNA Quantification of HIV-1 Group M and Non-M With the Roche Cobas AmpliPrep/Cobas TaqMan HIV-1 v2.0 and Abbott Real-Time HIV-1 PCR Assays

Sire, Jean-Marie; Vray, Muriel; Merzouk, Mourad; Plantier, Jean‐Christophe; Pavie, Juliette; Maylin, Sarah; Timsit, Julie; Lascoux-Combe, Caroline; Molina, Jean‐Michel; Simon, François; Delaugerre, Constance

doi:10.1097/qai.0b013e3182099891

Cited by 56 publications

(49 citation statements)

References 16 publications

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“…A good assay validation plan must include the use of a well-characterized control material for purposes of verifying assay specifications as well as use of locally collected clinical samples for purposes of clinical correlation studies. A number of investigators have reported significantly discordant virus load results in samples containing non-B HIV-1 subtypes across the new HIV-1 RNA real-time PCR assays (4,11,13,23,26,31). Such correlation studies are extremely important and actually resulted in the modification from the RTv1 to the RTv2 assay (6,7,12).…”

Section: Discussionmentioning

confidence: 99%

“…assay. An understanding of how the results generated from the different HIV-1 RNA assays compare is critical for all HIV-1 subtypes, especially since the genetic diversity of HIV-1 continues to evolve and underquantitation of HIV-1 continues to be documented (4,11,13,23). Surveillance and comparative studies worldwide (2,17,22,25,30,31) are extremely important for documenting potential problems and forcing manufacturers to improve their assays in response to deficiencies (6,7,14).…”

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confidence: 99%

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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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Section: Discussionmentioning

confidence: 99%

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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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“…In the United States, the most commonly performed virus load test is the Cobas AmpliPrep/ Cobas TaqMan HIV-1 Test v2.0 (CAP/CTM) (Roche Molecular Systems, Pleasanton, CA), a U.S. Food and Drug Administration (FDA) in vitro diagnostic (IVD) that provides high-throughput, sample-to-answer testing with real-time, reverse transcriptase PCR (RT-PCR)-based quantitation. This assay is well studied and provides a benchmark for virus load testing performance in the United States and globally (8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24). A recently developed test for virus load is the Aptima HIV-1 Quant Dx assay (Aptima) performed on the fully automated Panther system (both from Hologic Inc., San Diego, CA).…”

Section: Nfection With Human Immunodeficiency Virus Type 1 (Hiv-1)mentioning

confidence: 99%

Evaluation of the Aptima HIV-1 Quant Dx Assay using plasma and dried blood spots

Sahoo

Varghese

White

et al. 2016

Journal of Clinical Virology

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“…It should also be noted that a viral load threshold of 100,000 copies/ml (that currently defines in practice the 'high viral load') includes values ranging from 100,000 copies/ml to >10,000,000 copies/ml (the latter measurements made possible by the new HIV RNA detection methods based on real-time PCR) [22,23]. Thus, a better definition of pre-HAART viraemia (especially in the context of viraemia values >100,000 copies/ml) may help in providing explanations about the delay in the achievement of virological suppression and/or of virological rebounds observed in some individuals during HAART.…”

Section: Impact Of Pre-therapy Viral Load On Virological Response To mentioning

confidence: 99%

Impact of Pre-Therapy Viral Load on Virological Response to Modern First-Line Haart

et al. 2013

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Background: We tested whether pre-HAART viraemia affects the achievement and maintenance of virological success in HIV-1-infected patients starting modern firstline therapies. Methods: A total of 1,430 patients starting their first HAART (genotype-tailored) in 2008 (median; IQR: 2006-2009) were grouped according to levels of pre-HAART viraemia (≤30,000, 30,001-100,000, 100,001-300,000, 300,001-500,000 and >500,000 copies/ml). The impact of pre-therapy viraemia on the time to virological success (viraemia ≤50 copies/ml) and on the time to virological rebound (first of two consecutive viraemia values >50 copies/ml after virological success) were evaluated by Kaplan-Meier curves and Cox regression analyses. Results: Median pre-HAART viraemia was 5.1 log 10 copies/ml (IQR 4.5-5.5), and 53% of patients had viraemia >100,000 copies/ml. By week 48, the prevalence of patients reaching virological success was >90% in all pre-HAART viraemia ranges, with the only exception of range >500,000 copies/ml (virological success =83%; P<0.001). Higher pre-HAART viraemia was tightly correlated with longer median time to achieve virological success. Cox multivariable estimates confirmed this result: patients with pre-HAART viraemia >500,000 copies/ml showed the lowest hazard of virological undetectability after adjusting for age, gender, pre-HAART CD4 + T-cell count, transmitted drug resistance, calendar year and third drug administered (adjusted hazard ratio [95% CI]: 0.27 [0.21, 0.35]; P<0.001). Pre-HAART viraemia >500,000 copies/ml was also associated with higher probability of virological rebound compared with patients belonging to lower viraemia strata at weeks 4, 12 and 24 (P=0.050). Conclusions: At the time of modern HAART, and even though an average >90% of virological success, high pre-HAART viraemia remains an independent factor associated with delayed and decreased virological success. Patients starting HAART with >500,000 copies/ml represent a significant population that may deserve special attention.HAART has significantly extended the time to development of AIDS and to death in HIV-infected individuals [1,2]. Its efficacy in suppression of plasma HIV-1 RNA to undetectable levels, and in increasing CD4 + T-cell count, is well documented in several clinical trials [3][4][5][6].Despite years of great progress in treating AIDS, however, in some patients starting their first treatment; the effectiveness of HAART is still not sufficient, with consequent virological failures [7][8][9]. These failures can be caused by several factors, such as drug potency, drug

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Comparative RNA Quantification of HIV-1 Group M and Non-M With the Roche Cobas AmpliPrep/Cobas TaqMan HIV-1 v2.0 and Abbott Real-Time HIV-1 PCR Assays

Abstract: The results of the Roche Cobas CA/CTM v2.0 and Abbott RealTime HIV-1 assays correlate well. The new version of the CA/CTM assay shows improved sensitivity. Nevertheless, the 2 assays differ by more than 0.5 log₁₀ copies per milliliter for some samples.

Cited by 56 publications

References 16 publications

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

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

Evaluation of the Aptima HIV-1 Quant Dx Assay using plasma and dried blood spots

Impact of Pre-Therapy Viral Load on Virological Response to Modern First-Line Haart

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