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.

Journal article

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.

Authors: Harding-Esch, EM; Cousins, EC; Chow, S-LC; Phillips, LT; Hall, CL

• Publication status: Published
• Peer review status: Peer reviewed
• Publisher: Elsevier
• Journal: EBioMedicine
• Volume: 28
• Pages: 120-127
• Publication date: 2018-01-09
• Acceptance date: 2017-12-22
• DOI: 10.1016/j.ebiom.2017.12.029
• EISSN: 2352-3964
• Pmid: 29396306
• Language: English
• Keywords: point-of-care; reference standards; prospective studies; genitalia; diagnostic accuracy; Chlamydia trachomatis; nucleic acid amplification techniques; performance evaluation; risk factors; FFR