1. A 30-min nucleic acid amplification point-of-care test for genital chlamydia trachomatis infection in women: A prospective, multi-center study of diagnostic accuracyi-center Study of Diagnostic Accuracy
- Author
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Harding-Esch, EM, Cousins, EC, Chow, S-LC, Phillips, LT, Hall, CL, Cooper, N, Fuller, SS, Nori, AV, Patel, R, Thomas-William, S, Whitlock, G, Edwards, SJE, Green, M, Clarkson, J, Arlett, B, Dunbar, JK, Lowndes, CM, and Sadiq, ST
- 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.
- Published
- 2021
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