Evidence map›Paper›PMID 26292298›Full record

ArticleJournal of clinical microbiology2015

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.

Orna Mor, Yael Gozlan, Marina Wax, Fernando Mileguir, Avia Rakovsky, Bina Noy, Ella Mendelson, Itzchak Levy

Open access · bronzeAbstract readComparative StudyEvaluation Study
In one paragraph

Article in Journal of clinical microbiology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 4 pooled it
4.4field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 4 syntheses or guidelines pooled it, 51 citations in OpenAlex.

  1. Pooled it
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  8. Determinants of Direct Costs of HIV-1 Outpatient Care in Israel.International journal of environmental research and public health · 2022
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  12. Performance evaluation of the Aptima HIV-1 RNA Quant assay on the Panther system using the standard and dilution protocols.Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2020
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 1 country.

Orna MorNational HIV Reference Laboratory, Central Virology Laboratory, Ministry of Health, Sheba Medical Center, Ramat-Gan, Israel orna.mor@sheba.health.gov.il.
Yael GozlanNational HIV Reference Laboratory, Central Virology Laboratory, Ministry of Health, Sheba Medical Center, Ramat-Gan, Israel.
Marina WaxNational HIV Reference Laboratory, Central Virology Laboratory, Ministry of Health, Sheba Medical Center, Ramat-Gan, Israel.
Fernando MileguirNational HIV Reference Laboratory, Central Virology Laboratory, Ministry of Health, Sheba Medical Center, Ramat-Gan, Israel.
Avia RakovskyNational HIV Reference Laboratory, Central Virology Laboratory, Ministry of Health, Sheba Medical Center, Ramat-Gan, Israel.
Bina NoyIlex Medical, Petach Tikva, Israel.
Ella MendelsonNational HIV Reference Laboratory, Central Virology Laboratory, Ministry of Health, Sheba Medical Center, Ramat-Gan, Israel School of Public Health, Tel Aviv University, Tel Aviv, Israel.
Itzchak LevyInfectious Diseases Unit, Sheba Medical Center, Ramat-Gan, Israel.
Sheba Medical Center · ILIsrael Ministry of Health · IL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

HIV-1 RNA monitoring, both before and during antiretroviral therapy, is an integral part of HIV management worldwide. Measurements of HIV-1 viral loads are expected to assess the copy numbers of all common HIV-1 subtypes accurately and to be equally sensitive at different viral loads. In this study, we compared for the first time the performance of the NucliSens v2.0, RealTime HIV-1, Aptima HIV-1 Quant Dx, and Xpert HIV-1 viral load assays. Plasma samples (n = 404) were selected on the basis of their NucliSens v2.0 viral load results and HIV-1 subtypes. Concordance, linear regression, and Bland-Altman plots were assessed, and mixed-model analysis was utilized to compare the analytical performance of the assays for different HIV-1 subtypes and for low and high HIV-1 copy numbers. Overall, high concordance (>83.89%), high correlation values (Pearson r values of >0.89), 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.

Indexed as

Biological AssayHIV-1HIV InfectionsHumansMolecular Diagnostic TechniquesReagent Kits, DiagnosticRNA, ViralSensitivity and SpecificityViral LoadReagent Kits, DiagnosticRNA, Viral

Identifiers

PMID26292298
PMCPMC4609691
OpenAlexW2265505420

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.