Harding-Esch, E.M., Cousins, E.C., Chow, S.L.C., Phillips, L.T., Hall, C.L., Cooper, N., Fuller, S.S., Nori, A.V., Patel, R., Thomas-William, S., Whitlock, G., Edwards, S.J.E., Green, M., Clarkson, J., Arlett, B., Dunbar, J.K., Lowndes, C.M. and Sadiq, S.T. (2018) 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. EBioMedicine. (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 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.
More information
Identifiers
Catalogue record
Export record
Altmetrics
Contributors
Download statistics
Downloads from ePrints over the past year. Other digital versions may also be available to download e.g. from the publisher's website.