Evidence map›Paper›PMID 29396306›Full record

ArticleEBioMedicine2018

A 30-Min Nucleic Acid Amplification Point-of-Care Test for Genital Chlamydia trachomatis Infection in Women: A Prospective, Multi-center Study of Diagnostic Accuracy.

E M Harding-Esch, E C Cousins, S-L C Chow, L T Phillips, C L Hall, N Cooper, S S Fuller, A V Nori, R Patel, S Thomas-William and 8 more

Abstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in EBioMedicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing 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

16 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Review
  5. Review
  6. Diagnosis of Chlamydia trachomatis genital infections in the era of genomic medicine.Brazilian journal of microbiology : [publication of the Brazilian Society for Microbiology] · 2021
    Review
  7. A profile of the binx healthExpert review of molecular diagnostics · 2021
    Review
  8. Article
  9. Article
  10. Review
  11. Article
  12. Review
  13. Article
  14. Article
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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

18 authors.

E M Harding-EschApplied Diagnostic Research and Evaluation Unit, Institute for Infection and Immunity, St George's University of London, London SW17 0RE, UK; Public Health England, National Infection Service, HIV/STI Department, Colindale, London NW9 5EQ, UK. Electronic address: eharding@sgul.ac.uk.
E C CousinsApplied Diagnostic Research and Evaluation Unit, Institute for Infection and Immunity, St George's University of London, London SW17 0RE, UK. Electronic address: E.Cousins@soton.ac.uk.
S-L C ChowApplied Diagnostic Research and Evaluation Unit, Institute for Infection and Immunity, St George's University of London, London SW17 0RE, UK. Electronic address: christine.chow@imperial.ac.uk.
L T PhillipsApplied Diagnostic Research and Evaluation Unit, Institute for Infection and Immunity, St George's University of London, London SW17 0RE, UK. Electronic address: lphillip@sgul.ac.uk.
C L HallApplied Diagnostic Research and Evaluation Unit, Institute for Infection and Immunity, St George's University of London, London SW17 0RE, UK. Electronic address: Catherine.Hall@lshtm.ac.uk.
N CooperPublic Health England, National Infection Service, HIV/STI Department, Colindale, London NW9 5EQ, UK. Electronic address: Nicholas.Cooper@phe.gov.uk.
S S FullerApplied Diagnostic Research and Evaluation Unit, Institute for Infection and Immunity, St George's University of London, London SW17 0RE, UK. Electronic address: sfuller@sgul.ac.uk.
A V NoriApplied Diagnostic Research and Evaluation Unit, Institute for Infection and Immunity, St George's University of London, London SW17 0RE, UK. Electronic address: achyuta.nori@nhs.net.
R PatelSolent Sexual Health, University of Southampton, UK. Electronic address: prj467@gmail.com.
S Thomas-WilliamThe Starling Clinic, Musgrove Park Hospital, Taunton and Somerset NHS Foundation Trust, UK. Electronic address: Sathish.Thomas-William@tst.nhs.uk.
G Whitlock56 Dean Street, Chelsea & Westminster Hospital NHS Foundation Trust, London, UK. Electronic address: gary.whitlock@chelwest.nhs.uk.
S J E EdwardsSexual Health Hertfordshire Chelsea and Westminster NHS Foundation Trust, London SW10 9NH, UK; Central London Community Healthcare NHS Trust, London SW1E 6QP, UK. Electronic address: sarah.edwards17@nhs.net.
M GreenAtlas Genetics, Derby Court, Epsom Square, White Horse Business Park, Trowbridge, Wiltshire, BA14 0XG, UK. Electronic address: Marc.Green@atlasgenetics.com.
J ClarksonAtlas Genetics, Derby Court, Epsom Square, White Horse Business Park, Trowbridge, Wiltshire, BA14 0XG, UK. Electronic address: John.Clarkson@atlasgenetics.com.
B ArlettAtlas Genetics, Derby Court, Epsom Square, White Horse Business Park, Trowbridge, Wiltshire, BA14 0XG, UK. Electronic address: Ben.Arlett@atlasgenetics.com.
J K DunbarPublic Health England, National Infection Service, HIV/STI Department, Colindale, London NW9 5EQ, UK. Electronic address: kevin.dunbar@phe.gov.uk.
C M LowndesPublic Health England, National Infection Service, HIV/STI Department, Colindale, London NW9 5EQ, UK. Electronic address: cmlowndes@googlemail.com.
S T SadiqApplied Diagnostic Research and Evaluation Unit, Institute for Infection and Immunity, St George's University of London, London SW17 0RE, UK; Public Health England, National Infection Service, HIV/STI Department, Colindale, London NW9 5EQ, UK; Courtyard Clinic, St George's University Hospitals NHS Foundation Trust, London, UK, SW17 0QT, UK. Electronic address: ssadiq@sgul.ac.uk.

Funding

Medical Research Council G0901608
6 · The paper itself

Abstract

backgroundRapid Point-Of-Care Tests for Chlamydia trachomatis (CT) may reduce onward transmission and reproductive sexual health (RSH) sequelae by reducing turnaround times between diagnosis and treatment. The io® single module system (Atlas Genetics Ltd.) runs clinical samples through a nucleic acid amplification test (NAAT)-based CT cartridge, delivering results in 30min.

methodsProspective diagnostic accuracy study of the io® CT-assay in four UK Genito-Urinary Medicine (GUM)/RSH clinics on additional-to-routine self-collected vulvovaginal swabs. Samples were tested "fresh" within 10days of collection, or "frozen" at -80°C for later testing. Participant characteristics were collected to assess risk factors associated with CT infection.

resultsCT prevalence was 7.2% (51/709) overall. Sensitivity, specificity, positive and negative predictive values of the io® CT assay were, respectively, 96.1% (95% Confidence Interval (CI): 86.5-99.5), 97.7% (95%CI: 96.3-98.7), 76.6% (95%CI: 64.3-86.2) and 99.7% (95%CI: 98.9-100). The only risk factor associated with CT infection was being a sexual contact of an individual with CT.

conclusionsThe io® CT-assay is a 30-min, fully automated, high-performing NAAT currently CE-marked for CT diagnosis in women, making it a highly promising diagnostic to enable specific treatment, initiation of partner notification and appropriately intensive health promotion at the point of care.

Indexed as

Point-of-Care SystemsChlamydia InfectionsChlamydia trachomatisFemaleGenitaliaHumansNucleic Acid Amplification TechniquesProspective StudiesReference StandardsRisk FactorsChlamydia trachomatisDiagnostic accuracyPerformance evaluationPoint-of-careRapid testRisk factor

Identifiers

PMID29396306
PMCPMC5897918

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.