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

Jennings, Cheryl; Harty, Brian; Granger, Suzanne; Wager, Carrie; Crump, John A.; Fiscus, Susan A.; Bremer, James W.

doi:10.1128/jcm.00578-12

Cited by 18 publications

(14 citation statements)

References 31 publications

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“…The CAP/CTM v2.0 measured consistently higher than the Amplicor v1.5 with a bias of m = 0.2603 log cp/ml which is consistent with other studies [18], [19].…”

Section: Discussionsupporting

confidence: 91%

Evaluation of the NucliSens EasyQ v2.0 Assay in Comparison with the Roche Amplicor v1.5 and the Roche CAP/CTM HIV-1 Test v2.0 in Quantification of C-Clade HIV-1 in Plasma

Muenchhoff

Madurai²,

Hempenstall

et al. 2014

PLoS ONE

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Human immunodeficiency virus type 1 (HIV-1) genetic diversity poses a challenge to reliable viral load monitoring. Discrepancies between different testing platforms have been observed, especially for non-clade-B virus. Therefore we compare, in antiretroviral therapy (ART)-naïve South African subjects predominantly infected with HIV-1 clade-C, three commercially available assays: the COBAS AmpliPrep/COBAS TaqMan HIV-1 Test version 2.0 by Roche (CAP/CTM v2.0), the BioMérieux NucliSens Version 2.0 Easy Q/Easy Mag (NucliSens v2.0) and the Roche COBAS Amplicor HIV-1 Monitor Test Version 1.5 (Amplicor v1.5). Strong linear correlation was observed and Bland-Altman analyses showed overall good agreement between the assays with mean viral load differences of 0.078 log cp/ml (NucliSens v2.0 – Amplicor v1.5), 0.260 log cp/ml (CAP/CTM v2.0 – Amplicor v1.5) and 0.164 log cp/ml (CAP/CTM v2.0 – NucliSens v2.0), indicating lower mean viral load results for the Amplicor v1.5 and higher mean readings for the CAP/CTM v2.0. Consistent with observations following previous comparisons of CAP/CTM v2.0 versus Amplicor v1.5, the CAP/CTM v2.0 assay detected low-level viremia (median 65 cp/ml) in more than one-third of those in whom viremia had been undetectable (<20 cp/ml) in assays using the NucliSens platform. These levels of viremia are of uncertain clinical significance but may be of importance in early detection of ART resistance in those on treatment. Overall the three assays showed good comparability of results but with consistent, albeit relatively small, discrepancies for HIV-1 clade-C samples, especially in the low-viremic range that should be taken into account when interpreting viral load data.

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“…The CAP/CTM v2.0 measured consistently higher than the Amplicor v1.5 with a bias of m = 0.2603 log cp/ml which is consistent with other studies [18], [19].…”

Section: Discussionsupporting

confidence: 91%

Evaluation of the NucliSens EasyQ v2.0 Assay in Comparison with the Roche Amplicor v1.5 and the Roche CAP/CTM HIV-1 Test v2.0 in Quantification of C-Clade HIV-1 in Plasma

Muenchhoff

Madurai²,

Hempenstall

et al. 2014

PLoS ONE

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“…All differences in the Cq values of the heating procedure and the reproducibility were below the 0.5-log 10 difference. A difference above this value is considered to be clinically relevant (16,17). We therefore conclude that our methodology of DNA isolation of the strains by using heat-killed bacilli, the even distribution of MTC, and the reproducibility was appropriate.…”

Section: Discussionmentioning

confidence: 99%

Comparison of 14 Molecular Assays for Detection of Mycobacterium tuberculosis Complex in Bronchoalveolar Lavage Fluid

Akkerman

Werf

Boer³

et al. 2013

J Clin Microbiol

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g We compared 14 molecular assays for their ability to detect the Mycobacterium tuberculosis complex in bronchoalveolar lavage fluid samples. Three approaches were followed. First, by using DNA from Mycobacterium bovis BCG, we determined the detection limits of the assays using routine molecular methods. Second, in order to determine the analytical sensitivities of the assays, we added one of four M. tuberculosis isolates with various numbers of the insertion sequence IS6110 to N-acetyl-L-cysteine (NALC)-NaOH-treated bronchoalveolar lavage fluid samples in dilutions of 1:10 to 1:10,000,000. Third, intertest variabilities were measured and defined by the standard deviations for the quantitation cycle (Cq) values of three positive test results per dilution per assay. The 14 assays tested had similar analytical sensitivities, except for GeneXpert, which had an analytical sensitivity that was 10-to 100-fold lower than that of the other assays. The MP MTB/NTM test and the in-house TaqMan-10 revealed the best performances for the detection limit and had the highest analytical sensitivities. Most of the tests performed well regarding detection limit and analytical sensitivity for the detection of the M. tuberculosis complex in serial dilutions, and the differences were small. The MP MTB/NTM and the in-house TaqMan-10 assays revealed the best, and GeneXpert the worst, overall performances. I n 2011, 6.2 million patients were diagnosed with tuberculosis (TB) worldwide and reported this to the national tuberculosis control programs (NTP) (1). Control of this high-burden disease heavily depends on improved rapid diagnosis and optimal treatment. Real-time (RT)-PCR is the standard DNA amplification technique currently used in TB laboratories. In a short time span, a substantial number of commercial nucleic acid amplification tests for Mycobacterium tuberculosis complex (MTC) infections have become available. However, these assays have not been compared in a systematic manner. The clinical sensitivity of a part of the assays has been reported in only a few studies, using culture positivity and/or clinical diagnosis as the "gold standard" (2-6).The insertion sequence IS6110 has long been appreciated as a target in the molecular detection of the M. tuberculosis complex in clinical material, and it is the most abundant IS element in the genome of M. tuberculosis. However, among clinical isolates worldwide, the number of IS6110 copies in the genome of M. tuberculosis varies from 0 to 25, potentially influencing the detection limits of related assays (7-10).In this study, we compared the analytical performances of 14 assays for the molecular detection of MTC in three different approaches. We hypothesized that not all assays would have equally good analytical sensitivities and that the analytical sensitivity of assays targeting IS6110 would depend on the number of target copies in the genomes of M. tuberculosis strains studied. We therefore compared IS6110-targeting tests with those not targeting this element or that explored unkno...

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“…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

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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.

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

Cited by 18 publications

References 31 publications

Evaluation of the NucliSens EasyQ v2.0 Assay in Comparison with the Roche Amplicor v1.5 and the Roche CAP/CTM HIV-1 Test v2.0 in Quantification of C-Clade HIV-1 in Plasma

Evaluation of the NucliSens EasyQ v2.0 Assay in Comparison with the Roche Amplicor v1.5 and the Roche CAP/CTM HIV-1 Test v2.0 in Quantification of C-Clade HIV-1 in Plasma

Comparison of 14 Molecular Assays for Detection of Mycobacterium tuberculosis Complex in Bronchoalveolar Lavage Fluid

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

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