Evidence map›Paper›PMID 29906594›Full record

ArticleClinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases2019

Diagnostic accuracy of a prototype rapid chlamydia and gonorrhoea recombinase polymerase amplification assay: a multicentre cross-sectional preclinical evaluation.

E M Harding-Esch, S S Fuller, S-L C Chow, A V Nori, M A Harrison, M Parker, O Piepenburg, M S Forrest, D G Brooks, R Patel and 8 more

Open access · hybridAbstract readEvaluation StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 2 pooled it
1.7field-weighted citation impact, top 18% 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

14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 20 citations in OpenAlex.

  1. German evidence- and consensus-based guideline on the management of penile urethritis.Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG · 2025
    Guideline
  2. Pooled it
  3. Therapeutic Options forAntibiotics (Basel, Switzerland) · 2022
    Review
  4. Diagnostics (Basel, Switzerland) · 2022
    Review
  5. Article
  6. Review
  7. Article
  8. Article
  9. Article
  10. Current and Future Trends in the Laboratory Diagnosis of Sexually Transmitted Infections.International journal of environmental research and public health · 2021
    Review
  11. Review
  12. Article
  13. Point-by-Point Progress: Gonorrhea Point of Care Tests.Expert review of molecular diagnostics · 2020
    Article
  14. The Laboratory Diagnosis ofPathogens (Basel, Switzerland) · 2020
    Review
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 at 6 institutions in 1 country.

E M Harding-EschApplied Diagnostic Research & Evaluation Unit (ADREU), Institute for Infection & Immunity, St George's University of London, London, UK; HIV/STI Department, National Infection Service, Public Health England, London, UK.
S S FullerApplied Diagnostic Research & Evaluation Unit (ADREU), Institute for Infection & Immunity, St George's University of London, London, UK; HIV/STI Department, National Infection Service, Public Health England, London, UK.
S-L C ChowApplied Diagnostic Research & Evaluation Unit (ADREU), Institute for Infection & Immunity, St George's University of London, London, UK.
A V NoriApplied Diagnostic Research & Evaluation Unit (ADREU), Institute for Infection & Immunity, St George's University of London, London, UK; HIV/STI Department, National Infection Service, Public Health England, London, UK; St George's University Hospitals NHS Foundation Trust, London, UK.
M A HarrisonApplied Diagnostic Research & Evaluation Unit (ADREU), Institute for Infection & Immunity, St George's University of London, London, UK.
M ParkerTwistDx Limited, Cambridge, UK.
O PiepenburgTwistDx Limited, Cambridge, UK.
M S ForrestTwistDx Limited, Cambridge, UK.
D G BrooksTwistDx Limited, Cambridge, UK.
R PatelDepartment of Sexual Health, University of Southampton, Southampton, UK.
P E HaySt George's University Hospitals NHS Foundation Trust, London, UK.
N FearnleyBradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.
M J PondApplied Diagnostic Research & Evaluation Unit (ADREU), Institute for Infection & Immunity, St George's University of London, London, UK.
J K DunbarHIV/STI Department, National Infection Service, Public Health England, London, UK.
P D ButcherApplied Diagnostic Research & Evaluation Unit (ADREU), Institute for Infection & Immunity, St George's University of London, London, UK.
T PlancheApplied Diagnostic Research & Evaluation Unit (ADREU), Institute for Infection & Immunity, St George's University of London, London, UK; St George's University Hospitals NHS Foundation Trust, London, UK.
C M LowndesApplied Diagnostic Research & Evaluation Unit (ADREU), Institute for Infection & Immunity, St George's University of London, London, UK; HIV/STI Department, National Infection Service, Public Health England, London, UK.
S T SadiqApplied Diagnostic Research & Evaluation Unit (ADREU), Institute for Infection & Immunity, St George's University of London, London, UK; HIV/STI Department, National Infection Service, Public Health England, London, UK; St George's University Hospitals NHS Foundation Trust, London, UK. Electronic address: ssadiq@sgul.ac.uk.
St George's, University of London · GBTwistDx (United Kingdom) · GBBradford Teaching Hospitals NHS Foundation Trust · GBPublic Health England · GBSt George’s University Hospitals NHS Foundation Trust · GBUniversity of Southampton · GB

Funding

Medical Research Council G0901608
6 · The paper itself

Abstract

objectivesRapid and accurate sexually transmitted infection diagnosis can reduce onward transmission and improve treatment efficacy. We evaluated the accuracy of a 15-minute run-time recombinase polymerase amplification-based prototype point-of-care test (TwistDx) for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG).

methodsProspective, multicentre study of symptomatic and asymptomatic patients attending three English sexual health clinics. Research samples provided were additional self-collected vulvovaginal swab (SCVS) (female participants) and first-catch urine (FCU) aliquot (female and male participants). Samples were processed blind to the comparator (routine clinic CT/NG nucleic acid amplification test (NAAT)) results. Discrepancies were resolved using Cepheid CT/NG GeneXpert.

resultsBoth recombinase polymerase amplification and routine clinic NAAT results were available for 392 male and 395 female participants. CT positivity was 8.9% (35/392) (male FCU), 7.3% (29/395) (female FCU) and 7.1% (28/395) (SCVS). Corresponding NG positivity was 3.1% (12/392), 0.8% (3/395) and 0.8% (3/395). Specificity and positive predictive values were 100% for all sample types and both organisms, except male CT FCU (99.7% specificity (95% confidence interval (CI) 98.4-100.0; 356/357), 97.1% positive predictive value (95% CI 84.7-99.9; 33/34)). For CT, sensitivity was ≥94.3% for FCU and SCVS. CT sensitivity for female FCU was higher (100%; 95% CI, 88.1-100; 29/29) than for SCVS (96.4%; 95% CI, 81.7-99.9; 27/28). NG sensitivity and negative predictive values were 100% in FCU (male and female).

conclusionsThis prototype test has excellent performance characteristics, comparable to currently used NAATs, and fulfils several World Health Organization ASSURED criteria. Its rapidity without loss of performance suggests that once further developed and commercialized, this test could positively affect clinical practice and public health.

Indexed as

Point-of-Care TestingAdolescentAdultAgedAmbulatory Care FacilitiesChlamydia trachomatisCross-Sectional StudiesFemaleHumansMaleMiddle AgedNeisseria gonorrhoeaeNucleic Acid Amplification TechniquesProspective StudiesSensitivity and SpecificitySexually Transmitted DiseasesChlamydia trachomatisDiagnostic accuracyNeisseria gonorrhoeaeNucleic acid amplification testsPerformance evaluationPoint of care

Identifiers

PMID29906594
PMCPMC6420679
OpenAlexW2807732095

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.