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,
J.K. Dunbar,
C.M. Lowndes,
S.T. Sadiq
Affiliations
E.M. Harding-Esch
Applied Diagnostic Research and Evaluation Unit, Institute for Infection and Immunity, St George's University of London, London SW17 0RE, UK
E.C. Cousins
Applied Diagnostic Research and Evaluation Unit, Institute for Infection and Immunity, St George's University of London, London SW17 0RE, UK
S.-L.C. Chow
Applied Diagnostic Research and Evaluation Unit, Institute for Infection and Immunity, St George's University of London, London SW17 0RE, UK
L.T. Phillips
Applied Diagnostic Research and Evaluation Unit, Institute for Infection and Immunity, St George's University of London, London SW17 0RE, UK
C.L. Hall
Applied Diagnostic Research and Evaluation Unit, Institute for Infection and Immunity, St George's University of London, London SW17 0RE, UK
N. Cooper
Public Health England, National Infection Service, HIV/STI Department, Colindale, London NW9 5EQ, UK
S.S. Fuller
Applied Diagnostic Research and Evaluation Unit, Institute for Infection and Immunity, St George's University of London, London SW17 0RE, UK
A.V. Nori
Applied Diagnostic Research and Evaluation Unit, Institute for Infection and Immunity, St George's University of London, London SW17 0RE, UK
R. Patel
Solent Sexual Health, University of Southampton, UK
S. Thomas-William
The Starling Clinic, Musgrove Park Hospital, Taunton and Somerset NHS Foundation Trust, UK
G. Whitlock
56 Dean Street, Chelsea & Westminster Hospital NHS Foundation Trust, London, UK
S.J.E. Edwards
Sexual Health Hertfordshire Chelsea and Westminster NHS Foundation Trust, London SW10 9NH, UK
M. Green
Atlas Genetics, Derby Court, Epsom Square, White Horse Business Park, Trowbridge, Wiltshire, BA14 0XG, UK
J. Clarkson
Atlas Genetics, Derby Court, Epsom Square, White Horse Business Park, Trowbridge, Wiltshire, BA14 0XG, UK
B. Arlett
Atlas Genetics, Derby Court, Epsom Square, White Horse Business Park, Trowbridge, Wiltshire, BA14 0XG, UK
J.K. Dunbar
Public Health England, National Infection Service, HIV/STI Department, Colindale, London NW9 5EQ, UK
C.M. Lowndes
Public Health England, National Infection Service, HIV/STI Department, Colindale, London NW9 5EQ, UK
S.T. Sadiq
Applied Diagnostic Research and Evaluation Unit, Institute for Infection and Immunity, St George's University of London, London SW17 0RE, UK
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.
