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

Harding-Esch, EM; Fuller, SS; Chow, S-LC; Nori, AV; Harrison, MA; Parker, M; Piepenburg, O; Forrest, MS; Brooks, DG; Patel, R; et al. Harding-Esch, EM; Fuller, SS; Chow, S-LC; Nori, AV; Harrison, MA; Parker, M; Piepenburg, O; Forrest, MS; Brooks, DG; Patel, R; Hay, PE; Fearnley, N; Pond, MJ; Dunbar, JK; Butcher, PD; Planche, T; Lowndes, CM; Sadiq, ST (2019) Diagnostic accuracy of a prototype rapid chlamydia and gonorrhoea recombinase polymerase amplification assay: a multicentre cross-sectional preclinical evaluation. Clin Microbiol Infect, 25 (3). 380.e1-380.e7. ISSN 1469-0691 https://doi.org/10.1016/j.cmi.2018.06.003
SGUL Authors: Butcher, Philip David Sadiq, Syed Tariq Planche, Timothy David Fuller, Sebastian Suarez Harding-Esch, Emma Michele

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Abstract

Objectives 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). Methods 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. Results 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). Conclusions 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.

Item Type: Article
Additional Information: © 2018 The Authors. Published by Elsevier Ltd on behalf of European Society of Clinical Microbiology and Infectious Diseases. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
Keywords: Chlamydia trachomatis, Diagnostic accuracy, Neisseria gonorrhoeae, Nucleic acid amplification tests, Performance evaluation, Point of care, 1103 Clinical Sciences, Microbiology
SGUL Research Institute / Research Centre: Academic Structure > Infection and Immunity Research Institute (INII)
Journal or Publication Title: Clin Microbiol Infect
ISSN: 1469-0691
Language: eng
Dates:
DateEvent
March 2019Published
12 June 2018Published Online
1 June 2018Accepted
Publisher License: Creative Commons: Attribution 4.0
Projects:
Project IDFunderFunder ID
G0901608UK Clinical Research CollaborationUNSPECIFIED
PubMed ID: 29906594
Go to PubMed abstract
URI: https://openaccess.sgul.ac.uk/id/eprint/109869
Publisher's version: https://doi.org/10.1016/j.cmi.2018.06.003

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