Janet D Wilson1, Harriet E Wallace1, Michelle Loftus-Keeling1, Helen Ward2, Bethan Davies3, Armando Vargas-Palacios4, Claire Hulme4, Mark H Wilcox5. 1. Leeds Sexual Health, Leeds Teaching Hospitals NHS Trust, Leeds, UK. 2. Department of Infectious Disease Epidemiology, Imperial College, London, UK. 3. Department of Epidemiology and Biostatistics, Imperial College, London, UK. 4. Academic Unit of Health Economics, University of Leeds, Leeds, UK. 5. Department of Clinical Microbiology, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
Abstract
BACKGROUND: Sexual history does not accurately identify those with extragenital Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) so universal extragenital sampling is recommended. Nucleic acid amplification tests (NAATs) are expensive. If urogenital, plus rectal and pharyngeal, samples are analysed the diagnostic cost is trebled. Pooling samples into one NAAT container would cost the same as urogenital samples alone. We compared clinician triple samples analysed individually with self-taken pooled 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, rectum, plus first catch urine (FCU) in MSM and vulvovaginal swabs (VVS) in females, for NG and CT detection. RESULTS: Of 1793 participants (1284 females, 509 MSM), 116 had NG detected (75 urogenital, 83 rectum, 72 pharynx). 276 had CT detected (217 urogenital, 249 rectum, 63 pharynx).There was no difference in sensitivities between clinician triple samples and self-pooled specimens for NG (99.1%, 98.3%) but clinician samples analysed individually identified 3% more chlamydia infections than pooled (99.3%, 96.0%; p=0.027). However, pooled specimens identified more infections than VVS/FCU alone. Pooled specimens missed 2 NG and 11 CT infections, whereas VVS/FCU missed 41 NG and 58 CT infections. Self-taken pooled specimens were the most cost-effective. CONCLUSIONS: Just FCU/VVS testing missed many infections. Self-taken pooled samples were as sensitive as clinician triple samples for identifying NG, but clinician samples analysed individually identified 3% more CT infections than pooled. The extragenital sampling was achievable at no additional diagnostic cost to the FCU/VVS. TRIAL REGISTRATION: ClinicalTrials.gov NCT02371109.
BACKGROUND: Sexual history does not accurately identify those with extragenital Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) so universal extragenital sampling is recommended. Nucleic acid amplification tests (NAATs) are expensive. If urogenital, plus rectal and pharyngeal, samples are analysed the diagnostic cost is trebled. Pooling samples into one NAAT container would cost the same as urogenital samples alone. We compared clinician triple samples analysed individually with self-taken pooled 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, rectum, plus first catch urine (FCU) in MSM and vulvovaginal swabs (VVS) in females, for NG and CT detection. RESULTS: Of 1793 participants (1284 females, 509 MSM), 116 had NG detected (75 urogenital, 83 rectum, 72 pharynx). 276 had CT detected (217 urogenital, 249 rectum, 63 pharynx).There was no difference in sensitivities between clinician triple samples and self-pooled specimens for NG (99.1%, 98.3%) but clinician samples analysed individually identified 3% more chlamydia infections than pooled (99.3%, 96.0%; p=0.027). However, pooled specimens identified more infections than VVS/FCU alone. Pooled specimens missed 2 NG and 11 CTinfections, whereas VVS/FCU missed 41 NG and 58 CTinfections. Self-taken pooled specimens were the most cost-effective. CONCLUSIONS: Just FCU/VVS testing missed many infections. Self-taken pooled samples were as sensitive as clinician triple samples for identifying NG, but clinician samples analysed individually identified 3% more CTinfections than pooled. The extragenital sampling was achievable at no additional diagnostic cost to the FCU/VVS. TRIAL REGISTRATION: ClinicalTrials.gov NCT02371109.
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