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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

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
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

Background: Rapid 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 30. min. Methods: Prospective 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 10. days of collection, or "frozen" at -80. °C for later testing. Participant characteristics were collected to assess risk factors associated with CT infection. Results: CT 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. Conclusions: The 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.

Chlamydia trachomatis, Diagnostic accuracy, Performance evaluation, Point-of-care, Rapid test, Risk factor
Harding-Esch, E.M.
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Cousins, E.C.
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Chow, S.L.C.
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Phillips, L.T.
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Hall, C.L.
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Cooper, N.
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Fuller, S.S.
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Nori, A.V.
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Patel, R.
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Thomas-William, S.
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Whitlock, G.
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Edwards, S.J.E.
77fe38e5-ebfd-4a82-904f-010aa9c99b49
Green, M.
a30ffef3-cb40-4322-9caf-27b941af0502
Clarkson, J.
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Arlett, B.
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Dunbar, J.K.
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Lowndes, C.M.
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Sadiq, S.T.
8734140d-4de3-4800-bbcc-3e28aadb4341
Harding-Esch, E.M.
85573746-9eaa-4f9b-a9c5-1f793f87014d
Cousins, E.C.
6c252521-4654-4189-8564-59cdf631b380
Chow, S.L.C.
f46a41de-1374-4257-b6d1-a6d8956f2646
Phillips, L.T.
41db2864-d2fb-4f32-9d78-246cfc727cc3
Hall, C.L.
f0a6211b-27df-4c96-b82d-c037efddbe7c
Cooper, N.
b9dc9948-2c25-49ff-9c0c-73bfb0249887
Fuller, S.S.
aaf3f09c-b3b5-48f4-bf49-c366b0da3c21
Nori, A.V.
c8d88ddc-962f-4c35-9252-2e4103037e17
Patel, R.
04b7e57d-ef05-4d6f-ab9c-aaec3a788203
Thomas-William, S.
45a14f28-263e-4b73-aba3-b88a7a59599a
Whitlock, G.
d45317bc-ec33-475c-9aee-e454382026b6
Edwards, S.J.E.
77fe38e5-ebfd-4a82-904f-010aa9c99b49
Green, M.
a30ffef3-cb40-4322-9caf-27b941af0502
Clarkson, J.
8f23f202-2dd5-43bf-8027-0a17affdff61
Arlett, B.
a32cf3a1-375c-4e0c-ac92-044f9fb5fce4
Dunbar, J.K.
a4848a59-e1ea-48fa-be2c-26b85cb9b448
Lowndes, C.M.
3b9345c8-bb87-4691-83c7-bde6ee8533a3
Sadiq, S.T.
8734140d-4de3-4800-bbcc-3e28aadb4341

Harding-Esch, E.M., Cousins, E.C., Chow, S.L.C., Phillips, L.T., Hall, C.L., Cooper, N., Fuller, S.S., Nori, A.V., Patel, R., Thomas-William, S., Whitlock, G., Edwards, S.J.E., Green, M., Clarkson, J., Arlett, B., Dunbar, J.K., Lowndes, C.M. and Sadiq, S.T. (2018) 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 EBioMedicine (doi:10.1016/j.ebiom.2017.12.029).

Record type: Article

Abstract

Background: Rapid 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 30. min. Methods: Prospective 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 10. days of collection, or "frozen" at -80. °C for later testing. Participant characteristics were collected to assess risk factors associated with CT infection. Results: CT 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. Conclusions: The 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.

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Accepted/In Press date: 22 December 2017
e-pub ahead of print date: 10 January 2018
Keywords: Chlamydia trachomatis, Diagnostic accuracy, Performance evaluation, Point-of-care, Rapid test, Risk factor

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Local EPrints ID: 417421
URI: https://eprints.soton.ac.uk/id/eprint/417421
PURE UUID: 806a4495-8a13-4c5d-a013-e6c1751d68ac

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Date deposited: 31 Jan 2018 17:30
Last modified: 14 Feb 2018 17:31

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Contributors

Author: E.M. Harding-Esch
Author: E.C. Cousins
Author: S.L.C. Chow
Author: L.T. Phillips
Author: C.L. Hall
Author: N. Cooper
Author: S.S. Fuller
Author: A.V. Nori
Author: R. Patel
Author: S. Thomas-William
Author: G. Whitlock
Author: S.J.E. Edwards
Author: M. Green
Author: J. Clarkson
Author: B. Arlett
Author: J.K. Dunbar
Author: C.M. Lowndes
Author: S.T. Sadiq

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