Evidence map›Paper›PMID 27535684›Full record

ArticleJournal of clinical microbiology2016

Evaluation of the Aptima HIV-1 Quant Dx Assay Using Plasma and Dried Blood Spots.

Malaya K Sahoo, Vici Varghese, Elizabeth White, Meg Winslow, David A Katzenstein, Robert W Shafer, Benjamin A Pinsky

Abstract readComparative StudyEvaluation Study
In one paragraph

Article in Journal of clinical microbiology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
–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

8 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Nucleic acid amplification testing using dried blood spots to confirm the diagnosis of HIV-1 in adults.Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2024
    Article
  3. Article
  4. Article
  5. 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
    Article
  6. Article
  7. Article
  8. 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

7 authors.

Malaya K SahooDepartment of Pathology, Stanford University School of Medicine, Stanford, California, USA.
Vici VargheseDepartment of Medicine, Division of Infectious Diseases and Geographic Medicine, Stanford University School of Medicine, Stanford, California, USA.
Elizabeth WhiteDepartment of Medicine, Division of Infectious Diseases and Geographic Medicine, Stanford University School of Medicine, Stanford, California, USA.
Meg WinslowDepartment of Medicine, Division of Infectious Diseases and Geographic Medicine, Stanford University School of Medicine, Stanford, California, USA.
David A KatzensteinDepartment of Medicine, Division of Infectious Diseases and Geographic Medicine, Stanford University School of Medicine, Stanford, California, USA.
Robert W ShaferDepartment of Medicine, Division of Infectious Diseases and Geographic Medicine, Stanford University School of Medicine, Stanford, California, USA.
Benjamin A PinskyDepartment of Pathology, Stanford University School of Medicine, Stanford, California, USA Department of Medicine, Division of Infectious Diseases and Geographic Medicine, Stanford University School of Medicine, Stanford, California, USA bpinsky@stanford.edu.ORCID 0000-0001-8751-4810

Funding

PUBLIC HIV DRUG RESISTANCE DATABASER01AI068581 · NIAID · STANFORD UNIVERSITY · PI SHAFER, ROBERT WILLIAM · 2006 to 2017
$6.2M
NIAID NIH HHS R01 AI068581
6 · The paper itself

Abstract

HIV-1 RNA quantitation in plasma, or virus load testing, is the primary method by which the response to antiretroviral therapy is monitored. Here we describe evaluation of the Aptima HIV-1 Quant Dx assay (Aptima) performed on the automated Panther system. The clinical performance of Aptima was compared to that of the Cobas AmpliPrep/Cobas TaqMan HIV-1 Test v2.0 (CAP/CTM) using 162 EDTA plasma samples collected from patients undergoing HIV-1 monitoring. Overall agreement was 84.0% (136/162), with a kappa statistic of 0.723 (standard error, 0.047; 95% confidence interval [CI], 0.630 to 0.815), indicating substantial agreement. Using the 86 clinical samples quantifiable by both methods, Passing-Bablok regression revealed a regression line of Y = (1.069 × X) - 0.346 (95% CI of the slope [1.003 to 1.139] and intercept [-0.666 to -0.074]), and Bland-Altman analysis demonstrated a mean difference (Aptima-CAP/CTM) of -0.075 log10 copies/ml (95% limits of agreement of -0.624 to 0.475), consistent with negative bias. Comparison of Aptima results for paired dried blood spot (DBS) and plasma specimens archived from participants in the Peninsula AIDS Research Cohort Study (PARC) demonstrated an overall agreement of 94.7% (90/95) when 1,000 copies/ml was used as the threshold. In conclusion, the Aptima HIV-1 Quant Dx assay provides a suitable alternative for HIV-1 monitoring in plasma and DBS.

Indexed as

BloodDrug MonitoringHIV-1HIV InfectionsHumansMolecular Diagnostic TechniquesRNA, ViralViral LoadRNA, Viral

Identifiers

PMID27535684
PMCPMC5035416

What OpenQuestion holds

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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.