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, Maximilian; Madurai, Savathee; Hempenstall, Allison; Adland, Emily; Carlqvist, Anna; Moonsamy, Angeline; Jaggernath, Manjeetha; Mlotshwa, Busisiwe C.; Siboto, Emma; Ndung’u, Thumbi; Goulder, Philip

doi:10.1371/journal.pone.0103983

Cited by 12 publications

(9 citation statements)

References 22 publications

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“…Moreover, group 1 is prone to inherent precision issues, especially since the limits of quantification for the four assays are different. In the group of samples with viral loads of Ͼ3.00 log copies/ml (group 4), which includes either virological failures or untreated cases, the NucliSens v2.0 assay was less sensitive and tended to underestimate viral loads, as reported by others (23). Taken together, the data suggest that the NucliSens v2.0 assay has lower viral load readings and inferior precision and accuracy.…”

Section: Discussionsupporting

confidence: 50%

“…Our data indicate that the four assays could successfully quantify the main subtypes, albeit with different degrees of efficiency. Discrepancies between different testing platforms (including the NucliSens v2.0 assay) have been predominantly reported for HIV-1 clade C samples, especially in the low-viremic range (23). In a different study that compared the NucliSens v2.0 assay and six other assays, including the RealTime assay, large quantitative differences, which exceeded 0.5 log IU/ml for approximately 50% of the tested samples, were identified for subtype AE and BC samples, although very similar mean viral load values were observed across the assays for subtype B samples (8).…”

Section: Discussionmentioning

confidence: 99%

“…Smaller sample volumes may be advantageous in certain settings, especially when the initial blood volume is small. However, small volumes can reduce assay sensitivity (23). On the other hand, the ability to utilize the remains of the separate nucleic acids extracted with the easyMAG extractor in the first step of the NucliSens assay may be particularly beneficial for resistance testing.…”

Section: Discussionmentioning

confidence: 99%

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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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Section: Discussionsupporting

confidence: 50%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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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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“…However, higher variations were observed at low viral loads, ie; at 200 copies/ml (%CV 3.34, 1.97) respectively which was found to be less than the Abbott assay. Thus, variation observed at low viral load results agrees with previously reported study by Swenson et al, in 2014 where comparisons were based on 4221 paired samples [37], These variations could be attributed to the discrepancies in different testing platforms in quantifying subtype C samples as reported earlier [38]. Apart from variations observed while using such platforms, the parameters like type of sample and its integrity were assessed in one of the study wherein good precision as well as accuracy was reported for another POC (Liat HIV Quant (IQuum) platform) in comparison with other platforms (Roche CAP/CTMv2 and Abbott RealTime HIV-1) [39].…”

Section: Discussionsupporting

confidence: 90%

GeneXpert HIV-1 quant assay, a new tool for scale up of viral load monitoring in the success of ART programme in India

et al. 2017

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BackgroundRecent WHO guidelines identify virologic monitoring for diagnosing and confirming ART failure. In view of this, validation and scale up of point of care viral load technologies is essential in resource limited settings.MethodsA systematic validation of the GeneXpert® HIV-1 Quant assay (a point-of-care technology) in view of scaling up HIV-1 viral load in India to monitor the success of national ART programme was carried out. Two hundred nineteen plasma specimens falling in nine viral load ranges (<40 to >5 L copies/ml) were tested by the Abbott m2000rt Real Time and GeneXpert HIV-1 Quant assays. Additionally, 20 seronegative; 16 stored specimens and 10 spiked controls were also tested. Statistical analysis was done using Stata/IC and sensitivity, specificity, PPV, NPV and %misclassification rates were calculated as per DHSs/AISs, WHO, NACO cut-offs for virological failure.ResultsThe GeneXpert assay compared well with the Abbott assay with a higher sensitivity (97%), specificity (97-100%) and concordance (91.32%). The correlation between two assays (r = 0.886) was statistically significant (p < 0.01), the linear regression showed a moderate fit (R2 = 0.784) and differences were within limits of agreement. Reproducibility showed an average variation of 4.15 and 3.52% while Lower limit of detection (LLD) and Upper limit of detection (ULD) were 42 and 1,740,000 copies/ml respectively. The misclassification rates for three viral load cut offs were not statistically different (p = 0.736). All seronegative samples were negative and viral loads of the stored samples showed a good fit (R2 = 0.896 to 0.982).ConclusionThe viral load results of GeneXpert HIV-1 Quant assay compared well with Abbott HIV-1 m2000 Real Time PCR; suggesting its use as a Point of care assay for viral load estimation in resource limited settings. Its ease of performance and rapidity will aid in timely diagnosis of ART failures, integrated HIV-TB management and will facilitate the UNAIDS 90-90-90 target.

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“…Diagnostic accuracy studies are relatively simple, and many laboratories in sub-Saharan Africa perform in-house and/or community based evaluations of new assays, but few publish the results [ 24 , 25 ]. Diagnostic accuracy studies are good introductions to laboratory and clinical research.…”

Section: Discussionmentioning

confidence: 99%

Diagnostic Accuracy of the HemoCue Hb 301, STAT-Site MHgb and URIT-12 Point-of-Care Hemoglobin Meters in a Central Laboratory and a Community Based Clinic in Durban, South Africa

Jaggernath

Naicker²,

Madurai³

et al. 2016

PLoS ONE

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In South Africa, various point-of-care hemoglobin meters are used. However, the regulatory framework for approval, implementation and oversight of use of point-of-care hemoglobin meters is suboptimal. We assessed the diagnostic accuracy of the HemoCue Hb 301, STAT-Site MHgb and URIT-12 point-of-care hemoglobin meters, compared to a central laboratory based reference assay, in a central laboratory and a community based clinic in Durban, South Africa. Differences in performance of the point-of-care assays, compared to the reference assay, were more pronounced in the community based clinic. Results were reasonable for the HemoCue Hb 301, but poor for the STAT-Site MHgb and the URIT-12. Poor test performance of point-of-care hemoglobin meters, and inadequate evaluations and oversight in South Africa, leads to suboptimal clinical care and clinical research, and increased costs. There is a need for proper evaluation and quality assurance of point-of-care tests, the results of which should be made widely available to key stakeholders.

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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

Cited by 12 publications

References 22 publications

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

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

GeneXpert HIV-1 quant assay, a new tool for scale up of viral load monitoring in the success of ART programme in India

Diagnostic Accuracy of the HemoCue Hb 301, STAT-Site MHgb and URIT-12 Point-of-Care Hemoglobin Meters in a Central Laboratory and a Community Based Clinic in Durban, South Africa

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