Sensitivity and specificity of the Cobas Liat CT/NG/MG nucleic acid test in a clinical laboratory setting and point-of-care location

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Abstract
Sexually transmitted infections, e.g., Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Mycoplasma genitalium (MG), present with similar signs/symptoms and are often treated empirically due to delays in receiving diagnostic test results. This study evaluated the clinical performance of the Cobas Liat CT/NG/MG nucleic acid amplification test (NAAT) in detecting these pathogens in a point-of-care (POC) setting. This non-interventional, multicenter study recruited symptomatic/asymptomatic participants from 13 geographically diverse POC sites across the USA. Prospective clinician- and self-collected specimens (urine/vaginal swabs) were used to determine the sensitivity and specificity of the Cobas Liat CT/NG/MG test relative to the composite reference standard (CRS), determined using a combination of results from three FDA-approved NAATs and one laboratory-developed test. Among 4,800 evaluable participants, 40.4% ( n = 1,941) were symptomatic, and 51.9% ( n = 2,489) were female at birth. The Cobas Liat CT/NG/MG test demonstrated good clinical performance across all specimen types regardless of symptom status, with specificity >97% for each analyte, and sensitivity ≥92%, except female urine (≥CT 87%, NG ≥ 83%, MG ≥ 77%). The test was considered easy to use, and no statistically significant difference in performance results was observed between trained/untrained users. The Cobas Liat CT/NG/MG test demonstrated good clinical performance, with high sensitivity and specificity for CT/NG/MG detection, regardless of symptom status. The assay provides a short turn-around time (approximately 20 min) with centralized testing laboratory accuracy at the POC for self- and clinician-collected samples. POC testing can facilitate rapid pathogen identification and accurate treatment, thereby mitigating the need for empiric treatment. IMPORTANCE: Nucleic acid amplification tests are the preferred method for diagnosing CT and NG infections and are the only reliable tests for MG; however, delays in receiving results can lead to empiric treatment, potentially causing misdiagnosis and overtreatment of STIs. Point-of-care testing could mitigate these issues by enabling rapid pathogen identification and treatment, but no rapid POC tests are currently available for the detection of CT, NG, and MG despite the similarity of symptoms, and these three pathogens being responsible for the majority of symptomatic STIs in some settings. Our findings suggest that the Cobas Liat CT/NG/MG assay may help to reduce reliance on empiric treatment of symptoms and minimize resulting return visits for unresolved infections. Use of the Cobas Liat CT/NG/MG assay may also result in improved patient outcomes, help realize population benefits by reducing the duration of infection and potentially transmission, and reduce healthcare costs.
Funding Information
  • Roche Molecular Systems (N/A)

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