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

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

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

23 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)120-127
Number of pages8
JournalEBioMedicine
Volume28
DOIs
Publication statusPublished - Feb 2018

Bibliographical note

Funding Information:
The Applied Diagnostic Research and Evaluation Unit acknowledges the support of the National Institute for Health Research Clinical Research Network (NIHR CRN).

Funding Information:
Authors declare: Support for the submitted work from UKCRC (grant number G0901608 ) and Atlas Genetics Ltd. for staff and consumable costs for the study (EC, EHE, S-LCC, LTP, CH, SSF, AVN, STS); Support for the submitted work from St George's, University of London for fully completed datasets for each CT positive participant (RP, STW, GW, SE); Employee of Atlas Genetics Ltd. (MG, JC, BA); No support from any organisation for the submitted work (NC, JKD, CML). Financial relationships that might have an interest in the submitted work in the previous three years from Atlas Genetics Ltd., Alere, Cepheid, SpeeDx, Sekisui, Innovate UK (grant number 971543 ) and NIHR (grant number II- LB-0214-20005 ) (EC, EHE, S-LCC, LTP, CH, SSF, AVN, STS) and Becton Dickinson (EHE, SSF and RP); Roche and Abbott (RP); Cepheid (GW); Employee of Atlas Genetics Ltd. (MG, JC, BA); no financial relationships (NC, STW, SE, JKD, CML). Patents and copyrights to io® system detection chemistry, instrument and cartridge and licensed decontamination chemistry (MG, JC, BA); All other authors declare no other relationships or activities that could appear to have influenced the submitted work.

Funding Information:
Authors declare: Support for the submitted work from UKCRC (grant number G0901608) and Atlas Genetics Ltd. for staff and consumable costs for the study (EC, EHE, S-LCC, LTP, CH, SSF, AVN, STS); Support for the submitted work from St George's, University of London for fully completed datasets for each CT positive participant (RP, STW, GW, SE); Employee of Atlas Genetics Ltd. (MG, JC, BA); No support from any organisation for the submitted work (NC, JKD, CML). Financial relationships that might have an interest in the submitted work in the previous three years from Atlas Genetics Ltd., Alere, Cepheid, SpeeDx, Sekisui, Innovate UK (grant number 971543) and NIHR (grant number II-LB-0214-20005) (EC, EHE, S-LCC, LTP, CH, SSF, AVN, STS) and Becton Dickinson (EHE, SSF and RP); Roche and Abbott (RP); Cepheid (GW); Employee of Atlas Genetics Ltd. (MG, JC, BA); no financial relationships (NC, STW, SE, JKD, CML). Patents and copyrights to io? system detection chemistry, instrument and cartridge and licensed decontamination chemistry (MG, JC, BA); All other authors declare no other relationships or activities that could appear to have influenced the submitted work.

Funding Information:
This study was funded by the UK Clinical Research Collaboration (Medical Research Council) Translation Infection Research Initiative Consortium (grant number G0901608) and by Atlas Genetics Ltd. This study was sponsored by St George's, University of London. The sponsor had no role in the study design; the collection, analysis, or interpretation of data; the writing of the article; or the decision to submit it for publication. The UKCRC had no role in the study design; in the collection, analysis, or interpretation of data; in the writing of the report; or in the decision to submit the article for publication. Atlas Genetics contributed to the conception of the study, reviewed the protocol for io® platform methodology, provided technical support during the study, and reviewed and commented on the final draft of the manuscript. Atlas Genetics did not have a role in data collection, analysis or interpretation.

Publisher Copyright:
© 2018 The Authors

Copyright:
Copyright 2018 Elsevier B.V., All rights reserved.

Keywords

  • Chlamydia trachomatis
  • Diagnostic accuracy
  • Performance evaluation
  • Point-of-care
  • Rapid test
  • Risk factor

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