Simultaneous identification of Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium, and Trichomonas vaginalis ‒ multicenter evaluation of the Alinity m STI assay
| Autor: | Laura Martínez-García, Birgit Reinhardt, Francesca Azzato, Kevin S. Nelson, Jens Dhein, Michael J. Palm, Natalia Marlowe, Leana Maree, Monia Pacenti, Ajith M. Joseph, Francesco Onelia, Allison Glass, Rory Gunson, Martin Obermeier, Juan-C. Galan, Maria Krügel, Danijela Lucic, Karin Pfeifer, Emily Goldstein |
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| Rok vydání: | 2021 |
| Předmět: |
biology
nucleic acid amplification test business.industry screening Biochemistry (medical) Clinical Biochemistry urologic and male genital diseases medicine.disease_cause biology.organism_classification Molecular diagnostics Virology female genital diseases and pregnancy complications molecular diagnostics Chlamydia trachomatis+Neisseria gonorrhoeae Medical technology Discrete Mathematics and Combinatorics Medicine Identification (biology) Trichomonas vaginalis sexually transmitted infection R855-855.5 business Mycoplasma genitalium |
| Zdroj: | Journal of Laboratory Medicine, Vol 45, Iss 4-5, Pp 213-223 (2021) |
| ISSN: | 2567-9449 2567-9430 |
| DOI: | 10.1515/labmed-2020-0136 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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