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- Sean P Wilson, Taher Vohra, Jared Goldberg, Christopher Price, Sean Calo, Meredith Mahan, and Joseph Miller.
- Department of Emergency Medicine, Kaiser Permanente, Anaheim, California.
- J Emerg Med. 2017 Dec 1; 53 (6): 890-895.
BackgroundChlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are common sexually transmitted infections seen in the emergency department (ED). Due to an inability to reliably make accurate diagnosis by physical examination, concern for unreliable follow-up, and current delays in diagnostic nucleic acid amplification testing (NAAT), presumptive treatment active against CT and NG, as described by Centers for Disease Control clinical practice guidelines, is often performed.ObjectivesThe purpose of this study was to determine whether a rapid, urine NAAT performed in the ED is noninferior in its diagnostic sensitivity compared with a traditional, swab NAAT assay.MethodsWe performed a prospective, noninferiority study comparing two U.S. Food and Drug Administration-approved NAAT assays for CT and NG: a 90-min rapid assay, the Xpert CT/NG Assay (Cepheid, Sunnyvale, CA) using a urine sample vs. a traditional assay, the Aptima Combo 2 Assay (Gen-Probe Incorporated, San Diego, CA) using a swab sample. This study was registered on Clinicaltrials.gov (NCT02386514).ResultsA total of 1162 patient samples were included in the primary analysis. We observed excellent kappa agreement between assays: NG for men, 1.00 (95% confidence interval [CI] 1.00-1.00); NG for women, 0.87 (95% CI 0.79-0.94); CT for men, 0.81 (95% CI 0.59-1.00); and CT for women: 0.85 (95% CI 0.80-0.90), as well as excellent negative and positive predictive values for the rapid assay.ConclusionAlthough the rapid Xpert CT/NG assay's diagnostic sensitivity did not meet our prespecified threshold for noninferiority, the diagnostic characteristics are robust enough to fit into a management pathway that may reduce unnecessary antibiotic use. There may be an opportunity to utilize the rapid Xpert CT/NG assay to improve accuracy of treatment in the ED.Copyright © 2017 Elsevier Inc. All rights reserved.
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