Evidence map›Paper›PMID 29057945›Full record

ArticleScientific reports2017

A pilot evaluation of whole blood finger-prick sampling for point-of-care HIV viral load measurement: the UNICORN study.

Sarah Fidler, Heather Lewis, Jodi Meyerowitz, Kristin Kuldanek, John Thornhill, David Muir, Alice Bonnissent, Georgina Timson, John Frater

Registry-linked trialOpen access · goldAbstract readEvaluation Study
In one paragraph

Article in Scientific reports, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05690607 (Small Volume Blood Testing Validity and Acceptability for HIV-1 and Hepatitis B), which is not on this map. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
1.3field-weighted citation impact, top 22% 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.

NCT05690607 unknown statusnot on this mapstarted 2023, after this paper: background citation

Small Volume Blood Testing Validity and Acceptability for HIV-1 and Hepatitis B

TypeobservationalSponsorCentral and North West London NHS Foundation TrustRan2023 to 2024Enrolled300ConditionsHIV Infections, Hepatitis BArmsDoctors Laboratory TINIES small volume blood testing kit
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 2 syntheses or guidelines pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. Article
  6. Low-cost, point-of-care biomarker quantification.Current opinion in biotechnology · 2022
    Review
  7. Article
  8. Article
  9. 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
  10. Review
  11. Review
  12. Article
  13. Propelling the Pediatric HIV Therapeutic Agenda With Science, Innovation, and Collaboration.Journal of acquired immune deficiency syndromes (1999) · 2018
    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

9 authors at 4 institutions in 1 country.

Sarah FidlerDivision of Medicine, Wright Fleming Institute, Imperial College, London, UK.
Heather LewisDivision of Medicine, Wright Fleming Institute, Imperial College, London, UK.
Jodi MeyerowitzPeter Medawar Building for Pathogen Research, Nuffield Department of Medicine, University of Oxford UK; Oxford NIHR BRC, Oxford, UK; Oxford Martin School, Oxford, UK.
Kristin KuldanekDivision of Medicine, Wright Fleming Institute, Imperial College, London, UK.
John ThornhillDivision of Medicine, Wright Fleming Institute, Imperial College, London, UK.
David MuirImperial College Healthcare Trust, London, UK.
Alice BonnissentCepheid Inc., Sunnyvale, California, USA.
Georgina TimsonCepheid Inc., Sunnyvale, California, USA.
John FraterPeter Medawar Building for Pathogen Research, Nuffield Department of Medicine, University of Oxford UK; Oxford NIHR BRC, Oxford, UK; Oxford Martin School, Oxford, UK. john.frater@ndm.ox.ac.uk.
Imperial College London · GBImperial College Healthcare NHS Trust · GBOxford Spires Academy · GBUniversity of Oxford · GB

Funding

Medical Research Council MR/L00528X/1Medical Research Council MR/L006588/1Medical Research Council MR/N001265/1
6 · The paper itself

Abstract

There is a global need for HIV viral load point-of-care (PoC) assays to monitor patients receiving antiretroviral therapy. UNICORN was the first study of an off-label protocol using whole blood finger-prick samples tested with and without a simple three minute spin using a clinic-room microcentrifuge. Two PoC assays were evaluated in 40 HIV-positive participants, 20 with detectable and 20 with undetectable plasma viral load (pVL) (<20 copies/ml). Using 100 µl finger-prick blood samples, the Cepheid Xpert HIV-1 Viral Load and HIV-1 Qual cartridges were compared with laboratory pVL assessment (TaqMan, Roche). For participants with undetectable viraemia by TaqMan, there was poor concordance without centrifugation with the TaqMan platform with only 40% 'undetectable' using Xpert VL and 25% 'not detected' using the Qual assay. After a 3 minute spin, 100% of samples were undetectable using either assay, showing full concordance with the TaqMan assay. Defining a lower limit of detection of 1000 copies/ml when including a spin, there was 100% concordance with the TaqMan platform with strong correlation (rho 0.95 and 0.94; p < 0.0001 for both assays). When including a simple microcentrifugation step, finger-prick PoC testing was a quick and accurate approach for assessing HIV viraemia, with excellent concordance with validated laboratory approaches.

Indexed as

Blood Specimen CollectionHIV-1Point-of-Care TestingViral LoadAdolescentAdultAgedCentrifugationFemaleHIV InfectionsHumansMaleMiddle AgedPilot ProjectsYoung Adult

Identifiers

PMID29057945
PMCPMC5651802
OpenAlexW2766066209

What OpenQuestion holds

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Registered trials

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.