The University of Southampton
University of Southampton Institutional Repository

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

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

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.

Chlamydia trachomatis, Diagnostic accuracy, Neisseria gonorrhoeae, Nucleic acid amplification tests, Performance evaluation, Point of care
1198-743X
Harding-Esch, E.M.
85573746-9eaa-4f9b-a9c5-1f793f87014d
Fuller, S.S.
aaf3f09c-b3b5-48f4-bf49-c366b0da3c21
Chow, S.L.C.
f46a41de-1374-4257-b6d1-a6d8956f2646
Nori, A.V.
c8d88ddc-962f-4c35-9252-2e4103037e17
Harrison, M.A.
797cd095-c2d9-42ad-a318-194050f50a9d
Parker, M.
82cf45a9-d0f1-4c58-87fb-98713866e2ec
Piepenburg, O.
4154379a-1423-4a55-a787-fbe316b5e0e6
Forrest, M.S.
194468e8-582e-4f13-9d68-53d3c7928e87
Brooks, D.G.
44453484-cd7f-4813-916a-9c399d522a49
Patel, R.
e64684a5-911f-46cd-b1e3-04ed1593f290
Hay, P.E.
c5c26cd0-742d-4035-93d2-a43be55047e9
Fearnley, N.
ef0d1c58-99f5-4da3-bdb2-394486a0bc96
Pond, M.J.
ed37bb2b-e2b0-44cb-af06-49c2a69c5767
Dunbar, J.K.
75be7535-1822-4392-88f8-5dd4e187950c
Butcher, P.D.
be7957dc-5683-4013-87eb-1aaea2dfab95
Planche, T.
6f1bdbd4-3fc3-444d-b1c7-24babbaf9acb
Lowndes, C.M.
3b9345c8-bb87-4691-83c7-bde6ee8533a3
Sadiq, S.T.
8734140d-4de3-4800-bbcc-3e28aadb4341
Harding-Esch, E.M.
85573746-9eaa-4f9b-a9c5-1f793f87014d
Fuller, S.S.
aaf3f09c-b3b5-48f4-bf49-c366b0da3c21
Chow, S.L.C.
f46a41de-1374-4257-b6d1-a6d8956f2646
Nori, A.V.
c8d88ddc-962f-4c35-9252-2e4103037e17
Harrison, M.A.
797cd095-c2d9-42ad-a318-194050f50a9d
Parker, M.
82cf45a9-d0f1-4c58-87fb-98713866e2ec
Piepenburg, O.
4154379a-1423-4a55-a787-fbe316b5e0e6
Forrest, M.S.
194468e8-582e-4f13-9d68-53d3c7928e87
Brooks, D.G.
44453484-cd7f-4813-916a-9c399d522a49
Patel, R.
e64684a5-911f-46cd-b1e3-04ed1593f290
Hay, P.E.
c5c26cd0-742d-4035-93d2-a43be55047e9
Fearnley, N.
ef0d1c58-99f5-4da3-bdb2-394486a0bc96
Pond, M.J.
ed37bb2b-e2b0-44cb-af06-49c2a69c5767
Dunbar, J.K.
75be7535-1822-4392-88f8-5dd4e187950c
Butcher, P.D.
be7957dc-5683-4013-87eb-1aaea2dfab95
Planche, T.
6f1bdbd4-3fc3-444d-b1c7-24babbaf9acb
Lowndes, C.M.
3b9345c8-bb87-4691-83c7-bde6ee8533a3
Sadiq, S.T.
8734140d-4de3-4800-bbcc-3e28aadb4341

Harding-Esch, E.M., Fuller, S.S., Chow, S.L.C., Nori, A.V., Harrison, M.A., Parker, M., Piepenburg, O., Forrest, M.S., Brooks, D.G., Patel, R., Hay, P.E., Fearnley, N., Pond, M.J., Dunbar, J.K., Butcher, P.D., Planche, T., Lowndes, C.M. and Sadiq, S.T. (2018) Diagnostic accuracy of a prototype rapid chlamydia and gonorrhoea recombinase polymerase amplification assay: a multicentre cross-sectional preclinical evaluation. Clinical Microbiology and Infection. (doi:10.1016/j.cmi.2018.06.003).

Record type: Article

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.

Text
1-s2.0-S1198743X18304622-main - Version of Record
Available under License Creative Commons Attribution.
Download (850kB)

More information

Accepted/In Press date: 1 June 2018
e-pub ahead of print date: 12 June 2018
Keywords: Chlamydia trachomatis, Diagnostic accuracy, Neisseria gonorrhoeae, Nucleic acid amplification tests, Performance evaluation, Point of care

Identifiers

Local EPrints ID: 422602
URI: http://eprints.soton.ac.uk/id/eprint/422602
ISSN: 1198-743X
PURE UUID: baa8134e-abae-4fdd-b458-20d74ebd8e6c

Catalogue record

Date deposited: 26 Jul 2018 16:30
Last modified: 06 Oct 2020 21:43

Export record

Altmetrics

Contributors

Author: E.M. Harding-Esch
Author: S.S. Fuller
Author: S.L.C. Chow
Author: A.V. Nori
Author: M.A. Harrison
Author: M. Parker
Author: O. Piepenburg
Author: M.S. Forrest
Author: D.G. Brooks
Author: R. Patel
Author: P.E. Hay
Author: N. Fearnley
Author: M.J. Pond
Author: J.K. Dunbar
Author: P.D. Butcher
Author: T. Planche
Author: C.M. Lowndes
Author: S.T. Sadiq

University divisions

Download statistics

Downloads from ePrints over the past year. Other digital versions may also be available to download e.g. from the publisher's website.

View more statistics

Atom RSS 1.0 RSS 2.0

Contact ePrints Soton: eprints@soton.ac.uk

ePrints Soton supports OAI 2.0 with a base URL of http://eprints.soton.ac.uk/cgi/oai2

This repository has been built using EPrints software, developed at the University of Southampton, but available to everyone to use.

We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we will assume that you are happy to receive cookies on the University of Southampton website.

×