Quality, acceptability and usability of self-sampling kits used by non-healthcare professionals for STI diagnosis in Spain: a single-blind study.

Autor:	Gómez-Castellá J; Division for Control of HIV, STIs, Viral Hepatitis and Tuberculosis, Government of Spain Ministry of Health, Madrid, Spain jgomezc@sanidad.gob.es.; University of Alcalá de Henares, Madrid, Spain., Cobos Briz M; Division for Control of HIV, STIs, Viral Hepatitis and Tuberculosis, Government of Spain Ministry of Health, Madrid, Spain., Nuño N; Division for Control of HIV, STIs, Viral Hepatitis and Tuberculosis, Government of Spain Ministry of Health, Madrid, Spain., Diaz A; National Centre for Epidemiology, CIBERINFEC, Institute of Health Carlos III (ISCIII), Madrid, Spain., Bru-Gorraiz FJ; STI/Dermatology Department-Centro de Diagnóstico Médico, Madrid City Council, Madrid, Spain., Martín-Gorgojo A; STI/Dermatology Department-Centro de Diagnóstico Médico, Madrid City Council, Madrid, Spain., Almonacid-Garrido MC; Clinic Laboratory Department-Centro de Diagnóstico Médico, Madrid City Council, Madrid, Spain., Mir A; Technical, RA, Quality & Environment Director, Deltalab Group, Barcelona, Spain., Muñoz M; Strategy & Business Development Director, Deltalab Group, Barcelona, Spain., Del Amo J; Division for Control of HIV, STIs, Viral Hepatitis and Tuberculosis, Government of Spain Ministry of Health, Madrid, Spain.
Jazyk:	angličtina
Zdroj:	Sexually transmitted infections [Sex Transm Infect] 2024 Oct 17; Vol. 100 (7), pp. 405-410. Date of Electronic Publication: 2024 Oct 17.
DOI:	10.1136/sextrans-2024-056124
Abstrakt:	Objectives: Sexually transmitted infections (STIs) have markedly increased over the last decade in Spain, calling for prevention and control innovative approaches. While there is evidence indicating the effectiveness of self-sampling for STI diagnosis, no kits for this purpose have been authorised in Spain. Methods: A prospective single-blind cross-sectional study carried out between November and December 2022 in an STI clinic in Madrid, Spain, to determine the validity, feasibility and acceptability of self-sampling kits used by non-healthcare professionals from vagina, pharynx, rectum and urethra to diagnose Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG). Self-samples were compared with samples collected by healthcare professional (HC samples) and analysed by PCR. Frequency of CT and NG diagnosis by sample type was compared using McNemar's test for paired data. Sensitivity and specificity of self-samples for CT and NG diagnosis were also calculated. Results: 306 self-samples from 51 participants were analysed. 80% were men with median age of 33 (IQR: 28-38) years. Self-samples and HC samples showed no significant statistical differences in CT and NG diagnosis. Self-samples had a sensitivity of 81% for CT and 93% for NG, with a specificity of 97% for CT and 95% for NG. More than 90% of participants had no difficulty understanding the kit instructions and 71% expressed high levels of satisfaction with the self-sampling kit. Conclusion: Self-sampling kits for CT and NG diagnosis can be safely and effectively used by non-healthcare professionals in Spain. National strategies for STI prevention and control should prioritise self-sampling strategies. Competing Interests: Competing interests: This study is the result of an agreement between the Spanish Ministry of Health of Spain, the City Council of Madrid and Deltalab Group. Deltalab Group was responsible for the development and provision of the self-sampling kits used in this study. (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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