Simultaneous identification of Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium, and Trichomonas vaginalis - Multicenter evaluation of the Alinity m STI assay

• Main Authors: Azzato, F. (Author), Dhein, J. (Author), Galan, J.-C (Author), Glass, A. (Author), Goldstein, E. (Author), Gunson, R. (Author), Joseph, A.M (Author), Krügel, M. (Author), Lucic, D. (Author), Maree, L. (Author), Marlowe, N. (Author), Martinez-García, L. (Author), Nelson, K.S (Author), Obermeier, M. (Author), Onelia, F. (Author), Pacenti, M. (Author), Palm, M.J (Author), Pfeifer, K. (Author), Reinhardt, B. (Author)
• Format: Article
• Language: English
• Published: Walter de Gruyter GmbH 2021
• Subjects: Article; bacterium detection; bacterium identification; Chlamydia trachomatis; chlamydiasis; clinical practice; coinfection; comparative effectiveness; controlled study; diagnostic accuracy; female; field study; gonorrhea; human; human tissue; major clinical study; male; molecular diagnosis; molecular diagnostics; multicenter study; multiplex real time polymerase chain reaction; Mycoplasma genitalium; mycoplasmosis; Neisseria gonorrhoeae; nonhuman; nucleic acid amplification test; parasite identification; reproducibility; screening; sexually transmitted infection; Trichomonas vaginalis; trichomoniasis
• Online Access: View Fulltext in Publisher

 Objectives: Accurate and rapid diagnosis of sexually transmitted infections (STIs) is essential for timely administration of appropriate treatment and reducing the spread of the disease. We examined the performance of the new Alinity m STI assay, a qualitative real-time multiplex PCR test for simultaneous identification of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Mycoplasma genitalium (MG), and Trichomonas vaginalis (TV) run on the fully automated Alinity m platform. Methods: This international, multicenter study evaluated the accuracy, reproducibility, and clinical performance of the Alinity m STI assay compared to commonly used STI assays in a large series of patient samples encountered in clinical practice. Results: The Alinity m STI assay identified accurately and precisely single and mixed pathogens from an analytical panel of specimens. The Alinity m STI assay demonstrated high overall agreement rates with comparator STI assays (99.6% for CT [n=2,127], 99.2% for NG [n=2,160], 97.1% for MG [n=491], and 99.4% for TV [n=313]). Conclusions: The newly developed Alinity m STI assay accurately detects the 4 sexually transmitted target pathogens in various collection devices across clinically relevant specimen types, regardless of single or mixed infection status. © 2021 Emily Goldstein et al., published by De Gruyter, Berlin/Boston.