Evidence map›Paper›PMID 28152073›Full record

ArticlePloS one2017

Estimation of measurement error in plasma HIV-1 RNA assays near their limit of quantification.

Viviane D Lima, Lu Wang, Chanson Brumme, Lang Wu, Julio S G Montaner, P Richard Harrigan

Abstract readValidation Study
In one paragraph

Article in PloS one, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
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

7 citing papers in PubMed.

  1. Trial
  2. Observational
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
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

6 authors.

Viviane D LimaBritish Columbia Centre for Excellence in HIV/AIDS, Vancouver, British Columbia, Canada.ORCID http://orcid.org/0000-0003-4943-091X
Lu WangBritish Columbia Centre for Excellence in HIV/AIDS, Vancouver, British Columbia, Canada.
Chanson BrummeBritish Columbia Centre for Excellence in HIV/AIDS, Vancouver, British Columbia, Canada.
Lang WuStatistics Department, University of British Columbia, Vancouver, British Columbia, Canada.
Julio S G MontanerBritish Columbia Centre for Excellence in HIV/AIDS, Vancouver, British Columbia, Canada.
P Richard HarriganBritish Columbia Centre for Excellence in HIV/AIDS, Vancouver, British Columbia, Canada.

Funding

Seek and Treat for Optimal Prevention of HIV & AIDS (STOP HIV/AIDS) in BCR01DA036307 · NIDA · UNIVERSITY OF BRITISH COLUMBIA · PI MONTANER, JULIO SERGIO GONZALEZ · 2013 to 2017
$3.0M
NIDA NIH HHS R01 DA036307
6 · The paper itself

Abstract

backgroundPlasma HIV-1 RNA levels (pVLs), routinely used for clinical management, are influenced by measurement error (ME) due to physiologic and assay variation.

objectiveTo assess the ME of the COBAS HIV-1 Ampliprep AMPLICOR MONITOR ultrasensitive assay version 1.5 and the COBAS Ampliprep Taqman HIV-1 assay versions 1.0 and 2.0 close to their lower limit of detection. Secondly to examine whether there was any evidence that pVL measurements closest to the lower limit of quantification, where clinical decisions are made, were susceptible to a higher degree of random noise than the remaining range.

methodsWe analysed longitudinal pVL of treatment-naïve patients from British Columbia, Canada, during their first six months on treatment, for time periods when each assay was uniquely available: Period 1 (Amplicor): 08/03/2000-01/02/2008; Period 2 (Taqman v1.0): 07/01/2010-07/03/2012; Period 3 (Taqman v2.0): 08/03/2012-30/06/2014. ME was estimated via generalized additive mixed effects models, adjusting for several clinical and demographic variables and follow-up time.

resultsThe ME associated with each assay was approximately 0.5 log10 copies/mL. The number of pVL measurements, at a given pVL value, was not randomly distributed; values ≤250 copies/mL were strongly systematically overrepresented in all assays, with the prevalence decreasing monotonically as the pVL increased. Model residuals for pVL ≤250 copies/mL were approximately three times higher than that for the higher range, and pVL measurements in this range could not be modelled effectively due to considerable random noise of the data.

conclusionsAlthough the ME was stable across assays, there is substantial increase in random noise in measuring pVL close to the lower level of detection. These findings have important clinical significance, especially in the range where key clinical decisions are made. Thus, pVL values ≤250 copies/mL should not be taken as the "truth" and repeat pVL measurement is encouraged to confirm viral suppression.

Indexed as

AdultAnti-HIV AgentsCD4 Lymphocyte CountFemaleHIV-1HIV InfectionsHumansLimit of DetectionMaleMiddle AgedRNA, ViralViral LoadAnti-HIV AgentsRNA, Viral

Identifiers

PMID28152073
PMCPMC5289538

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.