Swab-yourself trial with economic monitoring and testing for infections collectively (SYSTEMATIC): Part 1. A diagnostic accuracy, and cost-effectiveness, study comparing clinician-taken versus self-taken rectal and pharyngeal samples for the diagnosis of gonorrhoea and chlamydia
File(s)SYSTEMATIC Part 1_Accepted version.docx (86.13 KB)
Accepted version
Author(s)
Type
Journal Article
Abstract
Background
Urogenital testing misses extragenital Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT). Extragenital self-sampling is frequently undertaken despite no robust RCT evidence of efficacy. We compared clinician-taken rectal and pharyngeal samples with self-taken samples for diagnostic accuracy and cost in MSM and females.
Methods
Prospective, convenience, sample in UK sexual health clinic. Randomised order of clinician and self-samples from 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 site, 83 rectum, 72 pharynx); 9.4% infected females and 67.3% MSM were urogenital negative. 276 had CT detected (217 urogenital site, 249 rectum, 63 pharynx); 13.1% infected females and 71.8% MSM were urogenital negative. Sexual history did not identify those with rectal infections. Clinician-rectal and self-rectal positive percent agreements (PPA) for NG detection were 92.8% and 97.6%; clinician-rectal, and self-rectal PPA for CT detection were 95.6% and 97.2%. There was no difference in diagnostic accuracy between clinician and self-taken samples.
Clinicians performed swabs quicker than participants so costs were lower. However, in asymptomatic people, non-qualified clinicians would oversee self-swabbing and these costs would be lower than clinician’s.
Conclusions
There was no difference in diagnostic accuracy of clinician 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 swabs cost less than self-swabs but in asymptomatic people, or doing home testing, their costs would be lower than clinician swabs.
Urogenital testing misses extragenital Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT). Extragenital self-sampling is frequently undertaken despite no robust RCT evidence of efficacy. We compared clinician-taken rectal and pharyngeal samples with self-taken samples for diagnostic accuracy and cost in MSM and females.
Methods
Prospective, convenience, sample in UK sexual health clinic. Randomised order of clinician and self-samples from 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 site, 83 rectum, 72 pharynx); 9.4% infected females and 67.3% MSM were urogenital negative. 276 had CT detected (217 urogenital site, 249 rectum, 63 pharynx); 13.1% infected females and 71.8% MSM were urogenital negative. Sexual history did not identify those with rectal infections. Clinician-rectal and self-rectal positive percent agreements (PPA) for NG detection were 92.8% and 97.6%; clinician-rectal, and self-rectal PPA for CT detection were 95.6% and 97.2%. There was no difference in diagnostic accuracy between clinician and self-taken samples.
Clinicians performed swabs quicker than participants so costs were lower. However, in asymptomatic people, non-qualified clinicians would oversee self-swabbing and these costs would be lower than clinician’s.
Conclusions
There was no difference in diagnostic accuracy of clinician 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 swabs cost less than self-swabs but in asymptomatic people, or doing home testing, their costs would be lower than clinician swabs.
Date Issued
2021-11-01
Date Acceptance
2020-07-30
Citation
Clinical Infectious Diseases, 2021, 73 (9), pp.e3172-e3180
ISSN
1058-4838
Publisher
Oxford University Press (OUP)
Start Page
e3172
End Page
e3180
Journal / Book Title
Clinical Infectious Diseases
Volume
73
Issue
9
Copyright Statement
© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com. This is a pre-copy-editing, author-produced version of an article accepted for publication in Clinical Infectious Diseases following peer review. The definitive publisher-authenticated version [insert complete citation information here] is available online at: https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaa1266/5900625
Subjects
Chlamydia trachomatis
Neisseria gonorrhoeae
cost-effectiveness
diagnostic techniques and procedures
positive percent agreement
Chlamydia Infections
Chlamydia trachomatis
Cost-Benefit Analysis
Female
Gonorrhea
Homosexuality, Male
Humans
Male
Neisseria gonorrhoeae
Pharynx
Prospective Studies
Rectum
Sexual and Gender Minorities
Microbiology
06 Biological Sciences
11 Medical and Health Sciences
Publication Status
Published
Date Publish Online
2020-09-02