Evidence map›Paper›PMID 32522826›Full record

ArticleJournal of clinical microbiology2020

Diagnostic Accuracy of Pan-Degenerate Amplification and Adaptation Assay for HIV-1 Drug Resistance Mutation Analysis in Low- and Middle-Income Countries.

Vinie Kouamou, Justen Manasa, David Katzenstein, Alan M McGregor, Chiratidzo E Ndhlovu, Tariro Makadzange

Erratum issuedOpen access · greenAbstract read
In one paragraph

Article in Journal of clinical microbiology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.3field-weighted citation impact, top 32% 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

6 citing papers in PubMed, 13 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Review
  5. Article
  6. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 3 institutions in 2 countries.

Vinie KouamouDepartment of Medicine, College of Health Sciences, University of Zimbabwe, Harare, Zimbabwe kvinie2005@yahoo.fr.ORCID 0000-0003-3531-7780
Justen ManasaDepartment of Medical Microbiology, College of Health Sciences, University of Zimbabwe, Harare, Zimbabwe.
David KatzensteinDepartment of Molecular Biology, Biomedical Research and Training Institute, Harare, Zimbabwe.
Alan M McGregorDepartment of Medicine, College of Health Sciences, University of Zimbabwe, Harare, Zimbabwe.
Chiratidzo E NdhlovuDepartment of Medicine, College of Health Sciences, University of Zimbabwe, Harare, Zimbabwe.
Tariro MakadzangeDepartment of Medicine, College of Health Sciences, University of Zimbabwe, Harare, Zimbabwe.
University of Zimbabwe · ZWBiomedical Research and Training Institute · ZWHarvard University · US

Funding

Advanced Training in Community Based Research; training in Bio-informatics, Drug Resistance and PathogenesisD43TW011326 · FIC · BIOMEDICAL RESEARCH & TRAINING INSTITUTE · PI MUNYATI, SHUNGU · 2020 to 2024
$1.6M
Implementing objective measures of adherence and low cost genotyping to assess a community based intervention to strengthen virologic outcomes among youth failing ARTR21AI124402 · NIAID · COLLEGE OF HEALTH SCIS UNIV OF ZIMBABWE · PI NDHLOVU, CHIRATIDZO ELLEN · 2016 to 2017
$293k
FIC NIH HHS D43 TW011326NIAID NIH HHS R21 AI124402
6 · The paper itself

Abstract

HIV drug resistance (HIVDR) is a barrier to sustained virologic suppression in low- and middle-income countries (LMICs). Point mutation assays targeting priority drug resistance mutations (DRMs) are being evaluated to improve access to HIVDR testing. In a cross-sectional study (June 2018 to September 2019), we evaluated the diagnostic accuracy of a simple and rapid HIVDR assay (the pan-degenerate amplification and adaptation [PANDAA] assay targeting the mutations K65R, K103NS, M184VI, Y181C, and G190A) compared to Sanger sequencing and next-generation sequencing (NGS). Plasma samples from adolescents and young adults (aged 10 to 24 years) failing antiretroviral therapy (viral load, >1,000 copies/ml on 2 consecutive occasions 1 month apart) were analyzed. Sensitivity and specificity of the PANDAA assay were determined by a proprietary application designed by Aldatu Biosciences. Agreement between genotyping methods was evaluated using Cohen's kappa coefficient. One hundred fifty samples previously characterized by Sanger sequencing were evaluated using PANDAA. For all DRMs detected, PANDAA showed a sensitivity and specificity of 98% and 94%, respectively. For nucleotide reverse transcriptase inhibitor DRMs, sensitivity and specificity were 98% (95% confidence interval [CI], 92% to 100%) and 100% (94% to 100%), respectively. For non-nucleotide reverse transcriptase inhibitor DRMs, sensitivity and specificity were 100% (97% to 100%) and 76% (61% to 87%), respectively. PANDAA showed strong agreement with Sanger sequencing for K65R, K103NS, M184VI, and G190A (kappa > 0.85) and substantial agreement for Y181C (kappa = 0.720). Of the 21 false-positive samples genotyped by PANDAA, only 6 (29%) were identified as low-abundance variants by NGS. With the high sensitivity and specificity to detect major DRMs, PANDAA could represent a simple and rapid alternative HIVDR assay in LMICs.

Indexed as

Anti-HIV AgentsHIV-1HIV InfectionsAdolescentCross-Sectional StudiesDeveloping CountriesDrug Resistance, ViralGenotypeHumansMutationViral LoadYoung AdultAnti-HIV AgentsARTdiagnostic accuracygenotypinghuman immunodeficiency viruslow- and middle-income countriesmutationPANDAApoint mutation assays

Identifiers

PMID32522826
PMCPMC7448631
OpenAlexW3033756306

What OpenQuestion holds

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Registered trials

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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.