Ten Years of External Quality Assessment of Human Immunodeficiency Virus Type 1 RNA Quantification

Sénéchal, Brigitte; James, Vivienne L. A.

doi:10.1128/jcm.01221-12

Cited by 22 publications

(17 citation statements)

References 16 publications

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“…The higher CV for the results from the Roche Amplicor assay group than for the results for the automated assays could be explained by the manual handling of multiple steps of the testing procedure. Other studies have also observed that fully automated high-throughput assays, such as the Abbott and the Roche Cobas assays, show smaller variability than manual assays, such as the Roche Amplicor assay (18). Despite the small number of data points provided by participants using the Biocentric and NucliSens assays, the intra-assay variability was below 17%, which also demonstrated good reproducibility by these semiautomated assays (data not shown).…”

Section: Discussionmentioning

confidence: 72%

Monitoring the Quality of HIV-1 Viral Load Testing through a Proficiency Testing Program Using Dried Tube Specimens in Resource-Limited Settings

et al. 2015

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HIV-1 viral load (VL) levels are used for monitoring disease progression and antiretroviral therapy outcomes in HIV-infected patients. To assess the performance of laboratories conducting HIV-1 VL testing in resource-limited settings, the U.S. Centers for Disease Control and Prevention implemented a voluntary, free-of-charge, external quality assurance program using dried tube specimens (DTSs). Between 2010 and 2012, DTS proficiency testing (PT) panels consisting of 5 specimens were distributed at ambient temperature to participants. The results from the participants (n > 6) using the same assay were grouped, analyzed, and graded as acceptable within a group mean ؎ 3 standard deviations. Mean proficiency scores were calculated by dividing the combined PT scores by the number of testing cycles using a linear regression model. Between 2010 and 2012, the number of participants enrolled increased from 32 in 16 countries to 114 in 44 countries. A total of 78.2% of the participants reported results using 10 different VL assays. The rates of reporting of acceptable results by the participants were 96.6% for the Abbott assay, 96.3% for the Roche Cobas assay, 94.5% for the Roche Amplicor assay, 93.0% for the Biocentric assay, and 89.3% for the NucliSens assay. The overall mean proficiency scores improved over time (P ‫؍‬ 0.024). DTSs are a good alternative specimen type to plasma specimens for VL PT programs, as they do not require cold chain transportation and can be used on PCR-based assays. Our data suggest that the CDC HIV-1 VL PT program using DTSs positively impacts the testing performance of the participants, which might translate into better and more accurate VL testing services for patients.H igh-quality clinical laboratories are urgently needed to sustain global efforts to expand the number of individuals infected with human immunodeficiency virus (HIV) receiving antiretroviral therapy (ART) (1). At the end of 2012, over 35 million people were estimated to be living with HIV, with more than twothirds of new HIV infections occurring in sub-Saharan Africa (2). Worldwide, ART has been shown to effectively reduce the rates of morbidity and mortality associated with AIDS (3). Quantitation of HIV-1 viral loads (VLs) has become the standard of care for monitoring the response to ART in HIV-infected patients, understanding disease progression, and preventing HIV transmission (4, 5). On the basis of the World Health Organization (WHO) 2010 treatment guidelines, which recommended initiating ART at a CD4 count threshold of 350 cells/mm 3 , it was estimated that over 8 million people in low-and middle-income countries were receiving ART in 2011 (6). The number of patients eligible for ART is expected to rise as countries adopt the new 2013 WHO treatment guidelines, which recommend a CD4 count threshold of 500 cells/mm 3 for initiation of ART (1), and the Joint United Nations Programme on HIV/AIDS (UNAIDS) Treatment 2015 plan, which calls for starting 15 million people on ART by 2015 (2). The President's Emergency Plan for ...

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Section: Discussionmentioning

confidence: 72%

Monitoring the Quality of HIV-1 Viral Load Testing through a Proficiency Testing Program Using Dried Tube Specimens in Resource-Limited Settings

et al. 2015

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“…3B). Given that technical variability of Ͻ0.5 log 10 copies/ml is considered acceptable (17,18) and of low clinical relevance (19), our data suggest that both plasma and WB specimens are appropriate for BKVL determination. The statistical power of this analysis reached 90%.…”

Section: Resultsmentioning

confidence: 99%

Toward Standardization of BK Virus Monitoring: Evaluation of the BK Virus R-gene Kit for Quantification of BK Viral Load in Urine, Whole-Blood, and Plasma Specimens

et al. 2014

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Screening of BK virus (BKV) replication is recommended to identify patients at increased risk of BKV-associated diseases. However, the heterogeneity of molecular techniques hinders the establishment of universal guidelines for BKV monitoring. Here we aimed to compare the performance of the CE-marked BK virus R-gene kit (R-gene) to the performance of our in-house assay for quantification of BKV DNA loads (BKVL). A 12-specimen panel from the Quality Control for Molecular Diagnostics (QCMD) organization, 163 urine samples, and 88 paired specimens of plasma and whole blood (WB) from transplant recipients were tested. Both the R-gene and in-house assays showed a good correlation within the QCMD panel (r ‫؍‬ 0.995 and r ‫؍‬ 0.989, respectively). BKVL were highly correlated between assays, although positive biases were observed with the in-house assay in analysis of urine (0.72 ؎ 0.83 log 10 copies/ml), plasma (1.17 ؎ 0.63 log 10 copies/ml), and WB (1.28 ؎ 0.37 log 10 copies/ml). Recalibration with a common calibrator significantly reduced the bias in comparisons between assays. In contrast, BKVL was underestimated with the in-house PCR in eight samples containing BKV genotype II, presenting point mutations at primer-annealing sites. Using the R-gene assay, plasma and WB specimens were found to be equally suitable for quantification of BKVL, as indicated by the high correlation coefficient (r ‫؍‬ 0.965, P < 0.0001). In conclusion, the R-gene assay demonstrated reliable performance and higher accuracy than the in-house assay for quantification of BKVL in urine and blood specimens. Screening of BKV replication by a well-validated commercial kit may enable clinical laboratories to assess viral loads with greater reproducibility and precision.

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“…To evaluate viral load assays, several parameters must be addressed. Interassay reproducibility is important to ensure effective treatment of HIV-1-infected persons, especially when switching from one assay to another (4). The accuracies of such assays are expected to remain identical in different ranges of HIV-1 viral loads.…”

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confidence: 99%

“…Viral loads exceeding 50 copies/ml trigger further investigation, and Ͼ1,000 copies/ml (Ͼ3 log copies/ml) is considered to be the threshold for resistance testing (2,3). Decreases or increases in HIV-1 RNA concentrations of 0.5 log copies/ml are considered significant changes that cannot be attributed to testing or normal biological variations and may reflect treatment success or failure (4). In Israel, HIV-1 patients are primarily infected with group M viruses, mainly subtype A1/CRF01_AE (referred to here as subtype A1), subtype B, subtype C, subtypes CRF02_AG and G (collectively referred to here as subtype CRF02_AG/G), and rarer subtypes (5,6).…”

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confidence: 99%

Evaluation of the RealTime HIV-1, Xpert HIV-1, and Aptima HIV-1 Quant Dx Assays in Comparison to the NucliSens EasyQ HIV-1 v2.0 Assay for Quantification of HIV-1 Viral Load

et al. 2015

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, and good agreement were observed among all assays, although the Xpert and Aptima assays, which provided the most similar outputs (estimated mean viral loads of 2.67 log copies/ml [95% confidence interval [CI], 2.50 to 2.84 log copies/ml] and 2.68 log copies/ml [95% CI, 2.49 to 2.86 log copies/ml], respectively), correlated best with the RealTime assay (89.8% concordance, with Pearson r values of 0.97 to 0.98). These three assays exhibited greater precision than the NucliSens v2.0 assay. All assays were equally sensitive for subtype B and AG/G samples and for samples with viral loads of 1.60 to 3.00 log copies/ml. The NucliSens v2.0 assay underestimated A1 samples and those with viral loads of >3.00 log copies/ml. The RealTime assay tended to underquantify subtype C (compared to the Xpert and Aptima assays) and subtype A1 samples. The Xpert and Aptima assays were equally efficient for detection of all subtypes and viral loads, which renders these new assays most suitable for clinical HIV laboratories.

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Ten Years of External Quality Assessment of Human Immunodeficiency Virus Type 1 RNA Quantification

Cited by 22 publications

References 16 publications

Monitoring the Quality of HIV-1 Viral Load Testing through a Proficiency Testing Program Using Dried Tube Specimens in Resource-Limited Settings

Monitoring the Quality of HIV-1 Viral Load Testing through a Proficiency Testing Program Using Dried Tube Specimens in Resource-Limited Settings

Toward Standardization of BK Virus Monitoring: Evaluation of the BK Virus R-gene Kit for Quantification of BK Viral Load in Urine, Whole-Blood, and Plasma Specimens

Evaluation of the RealTime HIV-1, Xpert HIV-1, and Aptima HIV-1 Quant Dx Assays in Comparison to the NucliSens EasyQ HIV-1 v2.0 Assay for Quantification of HIV-1 Viral Load

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