Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021
Swab-yourself Trial With Economic Monitoring and Testing for Infections Collectively (SYSTEMATIC): Part 1. A Diagnostic Accuracy and Cost-effectiveness Study Comparing Clinician-taken vs Self-taken Rectal and Pharyngeal Samples for the Diagnosis of Gonorrhea and Chlamydia.
СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Wilson Janet D, Wallace Harriet E, Loftus-Keeling Michelle, Ward Helen, Davies Bethan, Vargas-Palacios Armando, Hulme Claire, Wilcox Mark H
Аннотация
BACKGROUND: Urogenital testing misses extragenital Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT). Extragenital self-sampling is frequently undertaken despite no robust randomized, controlled trial evidence of efficacy. We compared clinician-taken rectal and pharyngeal samples with self-taken samples for diagnostic accuracy and cost in men who have sex with men (MSM) and in females.
METHODS: This was a prospective convenience sample from a UK sexual health clinic. We randomized the order of clinician- and self-taken samples from the pharynx and rectum, plus first catch urine (MSM) and vulvovaginal swabs (females), for NG/CT detection.
RESULTS: Of 1793 participants (1284 females, 509 MSM), 116 had NG detected (75 urogenital, 83 rectum, 72 pharynx); 9.4% infected females and 67.3% MSM were urogenital-negative. A total of 276 had CT detected (217 urogenital, 249 rectum, 63 pharynx); 13.1% infected females and 71.8% MSM were urogenital-negative. Sexual history did not identify those with rectal infections. There was no difference in diagnostic accuracy between clinician- and self-taken samples from the rectum or pharynx. Clinicians took swabs more quickly than participants, so costs were lower. However, in asymptomatic people, nonqualified clinicians would oversee self-swabbing making these costs lower.
CONCLUSIONS: There was no difference in the diagnostic accuracy of clinician-taken compared with self-taken extragenital samples. Sexual history did not identify those with rectal infections, so individuals should have extragenital clinician- or self-taken samples. Clinician-taken swabs cost less than self-taken swabs; however, in asymptomatic people or those who perform home testing, the costs would be lower than for clinician-taken swabs.
CLINICAL TRIALS REGISTRATION: NCT02371109.
METHODS: This was a prospective convenience sample from a UK sexual health clinic. We randomized the order of clinician- and self-taken samples from the pharynx and rectum, plus first catch urine (MSM) and vulvovaginal swabs (females), for NG/CT detection.
RESULTS: Of 1793 participants (1284 females, 509 MSM), 116 had NG detected (75 urogenital, 83 rectum, 72 pharynx); 9.4% infected females and 67.3% MSM were urogenital-negative. A total of 276 had CT detected (217 urogenital, 249 rectum, 63 pharynx); 13.1% infected females and 71.8% MSM were urogenital-negative. Sexual history did not identify those with rectal infections. There was no difference in diagnostic accuracy between clinician- and self-taken samples from the rectum or pharynx. Clinicians took swabs more quickly than participants, so costs were lower. However, in asymptomatic people, nonqualified clinicians would oversee self-swabbing making these costs lower.
CONCLUSIONS: There was no difference in the diagnostic accuracy of clinician-taken compared with self-taken extragenital samples. Sexual history did not identify those with rectal infections, so individuals should have extragenital clinician- or self-taken samples. Clinician-taken swabs cost less than self-taken swabs; however, in asymptomatic people or those who perform home testing, the costs would be lower than for clinician-taken swabs.
CLINICAL TRIALS REGISTRATION: NCT02371109.