Rapid and precise detection of Chlamydia trachomatis —the leading global cause of sexually transmitted infections (STI)—at the point-of-care (POC) is required for treatment decisions to prevent transmission and sequelae including pelvic inflammatory disease, ectopic pregnancy, tubal-factor infertility and preterm birth. We developed a rapid POC test (POCT), termed LH-POCT, which uses Loop-mediated AMPlification (LAMP) of nucleic acids, and performed a head-to-head comparison with the Cepheid Xpert® CT/NG assay using clinician-collected de-identified paired vaginal samples from a parent study that consecutively enrolled symptomatic and asymptomatic females over age 18 years from the Ministry of Health and Medical Services Health Centers in Fiji. Samples were processed by the Xpert® CT/NG assay and LH-POCT, blinded to the comparator. Discrepant samples were resolved by qPCR. De-identified clinical data and tests for Trichomonas vaginalis , Candida and bacterial vaginosis (BV) were provided. There were a total of 353 samples from 327 females. C. trachomatis positivity was 16.7% (59/353) while the prevalence was 16.82% (55/327) after discrepant resolution. Seven discrepant samples resolved to: four false negatives, two false positives and one true positive for the LH-POCT. The sensitivity of the LH-POCT was 93.65% (95% CI: 84.53% to 98.24%) and specificity 99.31% (95% CI: 97.53% to 99.92%). Discrepant samples clustered among women with vaginal discharge and/or BV. The prototype LH-POCT workflow has excellent performance, meeting many World Health Organization ASSURED criteria for POC tests, including a sample-to-result time of 35 minutes. Our LH-POCT holds promise for improving clinical practice to prevent and control C. trachomatis STIs in diverse health care settings globally.
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