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

doi:10.1016/j.ebiom.2017.12.029

Abstract

BackgroundRapid 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. MethodsProspective 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. ResultsCT 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. ConclusionsThe 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.

Highlights

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 objective of this study was to conduct a performance evaluation of the io® CT assay using genital samples collected from females attending UK Genito-Urinary Medicine (GUM)/Reproductive and Sexual Health (RSH) clinics
A total of 785 female participants were recruited from the different clinics (Fig. 1). 76 participants were excluded from the final analyses, conducted on 709 (90.3%) participants, for reasons including not fulfilling eligibility criteria, missing initial reference test data, and final invalid io® CT assay results

Summary

Introduction

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. Participant characteristics were collected to assess risk factors associated with CT infection. 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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