Multicenter Comparison of Nucleic Acid Amplification Tests for the Diagnosis of Rectal and Oropharyngeal Chlamydia trachomatis and Neisseria gonorrhoeae Infections
| Autor: | Van Der Pol, Barbara, Chernesky, Max, Gaydos, Charlotte A, Hook, Edward W, Joseph, Ajith M, Christensen, Katherine, Arcenas, Rodney, Boutwell, Alexander, Wiesenfeld, Harold C, Taylor, Stephanie N, Mayer, Kenneth H, Golden, Matthew R, Moncada, Jeanne, Jang, Dan, Schachter, Julius, ExGen Study Group Kristal Aaron University of Alabama at Birmingham, Paula Dixon University of Alabama at Birmingham, Karen Eckert Becton, Dickinson and Company, BD Life Sciences – Integrated Diagnostic Solutions, Shiaolan Y. Ho Abbott, Medical Affairs, Michael Lewinski Roche Diagnostic Solutions, Kevin Luk Roche Diagnostic Solutions, Carl McGill Abbott, Medical Affairs, Shiv Parmar Becton, Dickinson and Company, BD Life Sciences – Integrated Diagnostic Solutions, James Price Becton, Dickinson and Company, BD Life Sciences – Integrated Diagnostic Solutions, Charles Rivers University of Alabama at Birmingham |
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| Přispěvatelé: | Munson, Erik |
| Rok vydání: | 2022 |
| Předmět: |
Medical Affairs
Male rectal infection Carl McGill Abbott Chlamydia trachomatis molecular methods Sensitivity and Specificity Medical and Health Sciences Microbiology James Price Becton molecular diagnostics Gonorrhea Charles Rivers University of Alabama at Birmingham oropharyngeal infection Clinical Research Humans Kevin Luk Roche Diagnostic Solutions Michael Lewinski Roche Diagnostic Solutions sexually transmitted infections ExGen Study Group Kristal Aaron University of Alabama at Birmingham Agricultural and Veterinary Sciences Shiaolan Y. Ho Abbott Karen Eckert Becton Chlamydia Infections Biological Sciences Neisseria gonorrhoeae Shiv Parmar Becton Infectious Diseases Good Health and Well Being BD Life Sciences – Integrated Diagnostic Solutions extragenital extragenital STI Sexually Transmitted Infections HIV/AIDS Dickinson and Company Female Paula Dixon University of Alabama at Birmingham Digestive Diseases Infection Nucleic Acid Amplification Techniques |
| Zdroj: | Journal of clinical microbiology, vol 60, iss 1 |
| Popis: | Research using nucleic acid amplification tests (NAATs) have repeatedly found rectal and oropharyngeal infections with Chlamydia trachomatis and Neisseria gonorrhoeae to be common and potentially more difficult to treat than genital infections. Unfortunately, public health and patient care efforts have been hampered by the lack of FDA-cleared NAATs with claims for anorectal or oropharyngeal samples. At the time of the initiation of this study, no commercially available assays had these claims. We formed a novel partnership among academic institutions and diagnostic manufacturers to address this public health need. From May 2018 through August 2019, we recruited 1108 women, 1256 men, and 26 transgender persons each of whom provided 3 anal and 3 oropharyngeal swab specimens. The 3 anal swabs were pooled into a single transport tube as were the 3 oropharyngeal swabs. The performance of each of three study assays was estimated by comparison to the composite result and relative to one another. Percent positivity for chlamydia was 5.9 and 1.2% from anal and oropharyngeal specimens, respectively, compared to 4.2 and 4.1% for gonorrhea. Sensitivity for chlamydia detection ranged from 81.0 to 95.1% and 82.8 to 100% for anal and oropharyngeal specimens, respectively. Gonorrhea sensitivity ranged from 85.9 to 99.0% and 74.0 to 100% for anal and oropharyngeal samples, respectively. Specificity estimates were ≥ 98.9% for all assays, organisms, and sample types. Although there was heterogeneity between sensitivity estimates, these assays offer better ability to detect extragenital infections than culture and potential solutions for providing appropriate sexual health care for populations in which these infections are of concern. |
| Databáze: | OpenAIRE |
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