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-Esch¹, E C Cousins², S-L C Chow³, L T Phillips⁴, C L Hall⁵, N Cooper⁶, S S Fuller⁷, A V Nori⁸, R Patel⁹, S Thomas-William¹⁰, G Whitlock¹¹, S J E Edwards¹², M Green¹³, J Clarkson¹⁴, B Arlett¹⁵, J K Dunbar¹⁶, C M Lowndes¹⁷, S T Sadiq¹⁸

Affiliations

¹ Applied Diagnostic Research and Evaluation Unit, Institute for Infection and Immunity, St George's University of London, London SW17 0RE, UK; Public Health England, National Infection Service, HIV/STI Department, Colindale, London NW9 5EQ, UK. Electronic address: eharding@sgul.ac.uk.
² Applied Diagnostic Research and Evaluation Unit, Institute for Infection and Immunity, St George's University of London, London SW17 0RE, UK. Electronic address: E.Cousins@soton.ac.uk.
³ Applied Diagnostic Research and Evaluation Unit, Institute for Infection and Immunity, St George's University of London, London SW17 0RE, UK. Electronic address: christine.chow@imperial.ac.uk.
⁴ Applied Diagnostic Research and Evaluation Unit, Institute for Infection and Immunity, St George's University of London, London SW17 0RE, UK. Electronic address: lphillip@sgul.ac.uk.
⁵ Applied Diagnostic Research and Evaluation Unit, Institute for Infection and Immunity, St George's University of London, London SW17 0RE, UK. Electronic address: Catherine.Hall@lshtm.ac.uk.
⁶ Public Health England, National Infection Service, HIV/STI Department, Colindale, London NW9 5EQ, UK. Electronic address: Nicholas.Cooper@phe.gov.uk.
⁷ Applied Diagnostic Research and Evaluation Unit, Institute for Infection and Immunity, St George's University of London, London SW17 0RE, UK. Electronic address: sfuller@sgul.ac.uk.
⁸ Applied Diagnostic Research and Evaluation Unit, Institute for Infection and Immunity, St George's University of London, London SW17 0RE, UK. Electronic address: achyuta.nori@nhs.net.
⁹ Solent Sexual Health, University of Southampton, UK. Electronic address: prj467@gmail.com.
¹⁰ The Starling Clinic, Musgrove Park Hospital, Taunton and Somerset NHS Foundation Trust, UK. Electronic address: Sathish.Thomas-William@tst.nhs.uk.
¹¹ 56 Dean Street, Chelsea & Westminster Hospital NHS Foundation Trust, London, UK. Electronic address: gary.whitlock@chelwest.nhs.uk.
¹² Sexual Health Hertfordshire Chelsea and Westminster NHS Foundation Trust, London SW10 9NH, UK; Central London Community Healthcare NHS Trust, London SW1E 6QP, UK. Electronic address: sarah.edwards17@nhs.net.
¹³ Atlas Genetics, Derby Court, Epsom Square, White Horse Business Park, Trowbridge, Wiltshire, BA14 0XG, UK. Electronic address: Marc.Green@atlasgenetics.com.
¹⁴ Atlas Genetics, Derby Court, Epsom Square, White Horse Business Park, Trowbridge, Wiltshire, BA14 0XG, UK. Electronic address: John.Clarkson@atlasgenetics.com.
¹⁵ Atlas Genetics, Derby Court, Epsom Square, White Horse Business Park, Trowbridge, Wiltshire, BA14 0XG, UK. Electronic address: Ben.Arlett@atlasgenetics.com.
¹⁶ Public Health England, National Infection Service, HIV/STI Department, Colindale, London NW9 5EQ, UK. Electronic address: kevin.dunbar@phe.gov.uk.
¹⁷ Public Health England, National Infection Service, HIV/STI Department, Colindale, London NW9 5EQ, UK. Electronic address: cmlowndes@googlemail.com.
¹⁸ Applied Diagnostic Research and Evaluation Unit, Institute for Infection and Immunity, St George's University of London, London SW17 0RE, UK; Public Health England, National Infection Service, HIV/STI Department, Colindale, London NW9 5EQ, UK; Courtyard Clinic, St George's University Hospitals NHS Foundation Trust, London, UK, SW17 0QT, UK. Electronic address: ssadiq@sgul.ac.uk.

PMID: 29396306
PMCID: PMC5897918
DOI: 10.1016/j.ebiom.2017.12.029

Multicenter Study

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 et al. EBioMedicine. 2018 Feb.

. 2018 Feb:28:120-127.

doi: 10.1016/j.ebiom.2017.12.029. Epub 2018 Jan 10.

Authors

Affiliations

¹ Applied Diagnostic Research and Evaluation Unit, Institute for Infection and Immunity, St George's University of London, London SW17 0RE, UK; Public Health England, National Infection Service, HIV/STI Department, Colindale, London NW9 5EQ, UK. Electronic address: eharding@sgul.ac.uk.
² Applied Diagnostic Research and Evaluation Unit, Institute for Infection and Immunity, St George's University of London, London SW17 0RE, UK. Electronic address: E.Cousins@soton.ac.uk.
³ Applied Diagnostic Research and Evaluation Unit, Institute for Infection and Immunity, St George's University of London, London SW17 0RE, UK. Electronic address: christine.chow@imperial.ac.uk.
⁴ Applied Diagnostic Research and Evaluation Unit, Institute for Infection and Immunity, St George's University of London, London SW17 0RE, UK. Electronic address: lphillip@sgul.ac.uk.
⁵ Applied Diagnostic Research and Evaluation Unit, Institute for Infection and Immunity, St George's University of London, London SW17 0RE, UK. Electronic address: Catherine.Hall@lshtm.ac.uk.
⁶ Public Health England, National Infection Service, HIV/STI Department, Colindale, London NW9 5EQ, UK. Electronic address: Nicholas.Cooper@phe.gov.uk.
⁷ Applied Diagnostic Research and Evaluation Unit, Institute for Infection and Immunity, St George's University of London, London SW17 0RE, UK. Electronic address: sfuller@sgul.ac.uk.
⁸ Applied Diagnostic Research and Evaluation Unit, Institute for Infection and Immunity, St George's University of London, London SW17 0RE, UK. Electronic address: achyuta.nori@nhs.net.
⁹ Solent Sexual Health, University of Southampton, UK. Electronic address: prj467@gmail.com.
¹⁰ The Starling Clinic, Musgrove Park Hospital, Taunton and Somerset NHS Foundation Trust, UK. Electronic address: Sathish.Thomas-William@tst.nhs.uk.
¹¹ 56 Dean Street, Chelsea & Westminster Hospital NHS Foundation Trust, London, UK. Electronic address: gary.whitlock@chelwest.nhs.uk.
¹² Sexual Health Hertfordshire Chelsea and Westminster NHS Foundation Trust, London SW10 9NH, UK; Central London Community Healthcare NHS Trust, London SW1E 6QP, UK. Electronic address: sarah.edwards17@nhs.net.
¹³ Atlas Genetics, Derby Court, Epsom Square, White Horse Business Park, Trowbridge, Wiltshire, BA14 0XG, UK. Electronic address: Marc.Green@atlasgenetics.com.
¹⁴ Atlas Genetics, Derby Court, Epsom Square, White Horse Business Park, Trowbridge, Wiltshire, BA14 0XG, UK. Electronic address: John.Clarkson@atlasgenetics.com.
¹⁵ Atlas Genetics, Derby Court, Epsom Square, White Horse Business Park, Trowbridge, Wiltshire, BA14 0XG, UK. Electronic address: Ben.Arlett@atlasgenetics.com.
¹⁶ Public Health England, National Infection Service, HIV/STI Department, Colindale, London NW9 5EQ, UK. Electronic address: kevin.dunbar@phe.gov.uk.
¹⁷ Public Health England, National Infection Service, HIV/STI Department, Colindale, London NW9 5EQ, UK. Electronic address: cmlowndes@googlemail.com.
¹⁸ Applied Diagnostic Research and Evaluation Unit, Institute for Infection and Immunity, St George's University of London, London SW17 0RE, UK; Public Health England, National Infection Service, HIV/STI Department, Colindale, London NW9 5EQ, UK; Courtyard Clinic, St George's University Hospitals NHS Foundation Trust, London, UK, SW17 0QT, UK. Electronic address: ssadiq@sgul.ac.uk.

PMID: 29396306
PMCID: PMC5897918
DOI: 10.1016/j.ebiom.2017.12.029

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 30min.

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 10days 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.

Keywords: Chlamydia trachomatis; Diagnostic accuracy; Performance evaluation; Point-of-care; Rapid test; Risk factor.

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Figures

**Fig. 1**
Flow chart summarizing patient recruitment and sample collection results availability. CT, *Chlamydia trachomatis*; NAAT, Nucleic Acid Amplification Test. Flow diagram showing total number of eligible participants who consented to the study, ending with the total number of participants included in the final analyses. Samples were excluded where the participant did not meet the study eligibility criteria (n = 18); that did not have a clinic NAAT result available (n = 18), that were not tested on the io® CT assay (n = 16); or that had a final invalid result by the io® CT assay (n = 24).

See this image and copyright information in PMC

References

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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

Affiliations

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

Authors

Affiliations

Abstract

Figures

References

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical