High correlation between the Roche COBAS® AmpliPrep/COBAS® TaqMan® HIV-1, v2.0 and the Abbott m2000 RealTime HIV-1 assays for quantification of viral load in HIV-1 B and non-B subtypes

Karasi, Jean Claude; Dziezuk, F; Quennery, L; Forster, S. M.; Reischl, Udo; Colucci, Giuseppe; Schoener, Daniel; Seguin-Devaux, Carole; Schmit, Jean Claude

doi:10.1016/j.jcv.2011.07.002

Cited by 31 publications

(26 citation statements)

References 33 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Discordance decreased when a threshold of 200 copies/ml was used rather than when a 50-copy threshold was used. As was previously reported (19,36), we confirm that the TaqMan version 2 assay does not appear to have the severe underquantification reported with the TaqMan version 1 assay. However, both TaqMan assays have higher rates of detectability than the Amplicor and RealTime assays.…”

Section: Discussionsupporting

confidence: 90%

See 1 more Smart Citation

Comparative Performances of HIV-1 RNA Load Assays at Low Viral Load Levels: Results of an International Collaboration

et al. 2014

View full text Add to dashboard Cite

Low-level viremia during antiretroviral therapy and its accurate measurement are increasingly relevant. Here, we present an international collaboration of 4,221 paired blood plasma viral load (pVL) results from four commercial assays, emphasizing the data with low pVL. The assays compared were the Abbott RealTime assay, the Roche Amplicor assay, and the Roche TaqMan version 1 and version 2 assays. The correlation between the assays was 0.90 to 0.97. However, at a low pVL, the correlation fell to 0.45 to 0.85. The observed interassay concordance was higher when detectability was defined as 200 copies/ml than when it was defined as 50 copies/ml. A pVL of ϳ100 to 125 copies/ml by the TaqMan version 1 and version 2 assays corresponded best to a 50-copies/ml threshold with the Amplicor assay. Correlation and concordance between the viral load assays were lower at a low pVL. Clear guidelines are needed on the clinical significance of low-level viremia.

show abstract

Section: Discussionsupporting

confidence: 90%

“…Furthermore, there have been reports that real-time PCRbased assays tend to identify more patients as having low-level viremia than does the Amplicor test (10)(11)(12)(13)(14)(15). Multiple studies have documented variation between these assays when measuring samples with low viral load levels (6,13,(15)(16)(17)(18)(19)(20)(21).…”

mentioning

confidence: 99%

Comparative Performances of HIV-1 RNA Load Assays at Low Viral Load Levels: Results of an International Collaboration

et al. 2014

View full text Add to dashboard Cite

show abstract

“…Parameters of assay performance that must be understood include accuracy, precision, sensitivity, specificity, and reproducibility across laboratories. More recent studies have shown good correlation among the current versions of the realtime PCR assays (6,14,29); the results of these studies demonstrate how comparative testing has forced assay improvement.…”

mentioning

confidence: 93%

“…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). The high cost associated with the full automation of new real-time PCR assays has forced manufacturers to offer manual versions of the assays, but the impact of using manual extraction methods on precision across laboratories is not fully understood (5,19).…”

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

View full text Add to dashboard Cite

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.

show abstract

“…These tests are highly automated, with a lower limit of quantification of 20 to 40 copies/ml, and a 6 to 7 log 10 linear range. There is excellent agreement in viral load values between the COBAS TaqMan and Abbott RealTime tests (35), although the agreement is decreased at the lower limit of quantification of the tests (35,36). An important difference between the two realtime tests is the gene target: the COBAS TaqMan test targets both the gag gene and the long terminal repeat, while the Abbott RealTime test targets the integrase gene.…”

Section: Quantitative Hiv-1 Viral Load Testingmentioning

confidence: 87%

Human Immunodeficiency Virus

et al. 2016

View full text Add to dashboard Cite

In this chapter we will discuss the diagnosis and monitoring of individuals with HIV infection. The application and interpretation of these tests does not change dramatically when used in the immunocompromised host. The principal approach to the diagnosis of HIV infection involves serologic testing, although nucleic acid amplification tests play an important role in the diagnosis of acute HIV infection. The algorithm for diagnosis of HIV continues to evolve with newer assays that are able to detect infection within an earlier timeframe after HIV transmission. Viral load testing for HIV-1 is the cornerstone for monitoring patients on antiretroviral therapy. Genotypic and phenotypic resistance tests are employed when antiretroviral resistance is suspected and results help guide therapy. The tropism assay must be performed to determine the efficacy of CCR5 chemokine receptor antagonists. Next-generation sequencing methods are an innovative approach to assessing archived antiretroviral resistance in patients with virologic suppression. The success of antiretroviral therapy with improved long-term outcomes has made transplantation in HIV-infected patients a reality.

show abstract

High correlation between the Roche COBAS® AmpliPrep/COBAS® TaqMan® HIV-1, v2.0 and the Abbott m2000 RealTime HIV-1 assays for quantification of viral load in HIV-1 B and non-B subtypes

Cited by 31 publications

References 33 publications

Comparative Performances of HIV-1 RNA Load Assays at Low Viral Load Levels: Results of an International Collaboration

Comparative Performances of HIV-1 RNA Load Assays at Low Viral Load Levels: Results of an International Collaboration

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

Human Immunodeficiency Virus

Contact Info

Product

Resources

About