Diagnostic accuracy of a prototype rapid chlamydia and gonorrhoea recombinase polymerase amplification assay: a multicentre cross-sectional preclinical evaluation.
Adolescent
Adult
Aged
Ambulatory Care Facilities
Chlamydia trachomatis
/ isolation & purification
Cross-Sectional Studies
Female
Humans
Male
Middle Aged
Neisseria gonorrhoeae
/ isolation & purification
Nucleic Acid Amplification Techniques
/ standards
Point-of-Care Testing
Prospective Studies
Sensitivity and Specificity
Sexually Transmitted Diseases
/ diagnosis
Specimen Handling
Young Adult
Chlamydia trachomatis
Diagnostic accuracy
Neisseria gonorrhoeae
Nucleic acid amplification tests
Performance evaluation
Point of care
Journal
Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases
ISSN: 1469-0691
Titre abrégé: Clin Microbiol Infect
Pays: England
ID NLM: 9516420
Informations de publication
Date de publication:
Mar 2019
Mar 2019
Historique:
received:
14
03
2018
revised:
31
05
2018
accepted:
01
06
2018
pubmed:
16
6
2018
medline:
20
9
2019
entrez:
16
6
2018
Statut:
ppublish
Résumé
Rapid 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). Prospective, 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. Both 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). This 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.
Identifiants
pubmed: 29906594
pii: S1198-743X(18)30462-2
doi: 10.1016/j.cmi.2018.06.003
pmc: PMC6420679
pii:
doi:
Types de publication
Evaluation Study
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
380.e1-380.e7Subventions
Organisme : Medical Research Council
ID : G0901608
Pays : United Kingdom
Informations de copyright
Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.
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