Development and evaluation of dried urine strip for genital chlamydia and gonorrhea testing
Rattachement africain : ca, Afrique du Sud. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
ABSTRACT Here, we developed and evaluated a filter-paper urine collection method for chlamydia and gonorrhea testing. Dried urine strips (DUS) were developed to fit into the sample collection tube used for high throughput Hologic Aptima Combo 2 assay, minimizing processing post-sample collection. Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) bacterial stock dilutions were used to assess DUS performance and long-term stability at different temperature conditions. DUS diagnostic performance was evaluated against urine samples with Aptima Combo 2 Assay and an in-house RT-PCR method for CT and NG detection utilizing residual diagnostic urine specimens ( n = 60 CT and NG negative, n = 50 CT-positive and n = 55 NG-positive, including 5 CT/NG dual-positive). Replacing the overnight strip drying step with use of additional desiccants was evaluated in order to reduce barriers to self-sample collection. We observed a high degree of diagnostic accuracy (>91% sensitivity and >98% specificity), compared to traditional urine samples across all evaluated DUS preparation and storage methods. DUS samples demonstrated high stability for prolonged periods at tested temperature storage conditions with some loss in sensitivity at lower bacterial loads. While drying of the sample was crucial to preserve sample integrity and improve recovery post-elution, placing the DUS directly into the sample storage bag with additional desiccants did not negatively impact diagnostic performance. DUS specimens were shown suitable for downstream CT genotyping and NG sequence typing. The developed DUS represents an accurate and stable sample collection method for CT and NG diagnostic testing and downstream pathogen characterization. IMPORTANCE Innovative sampling methods that are convenient, accurate, and user-friendly are crucial to increase sexually transmitted infection (STI) testing uptake. This study establishes a novel dried urine strip sample collection method for chlamydia and gonorrhea testing and downstream molecular characterization. Results show no inferiority of dried urine strips compared to urine, with regard to diagnostic performance, when analyzed using molecular in-house and commercial assays for chlamydia and gonorrhea detection. A dried urine strip sample collection method for chlamydia and gonorrhea testing offers significant advantages in resource-limited or stigmatized settings; it enables self-collection, mail-in return, and long-term storage at ambient temperatures, making it ideal for reaching underserved populations. The broader public health impact is the expansion of STI screening access and reduction in STI transmission by offering a discreet, scalable alternative to traditional specimen collection.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Development and evaluation of dried urine strip for genital chlamydia and gonorrhea testing
- Date Crossref
- 13/05/2026
- Éditeur
- American Society for Microbiology
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Public Health Agency of Canada pays non établi dans la noticeOrganisme public
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University of Manitoba pays non établi dans la noticeUniversité ou école supérieure
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BC Centre for Disease Control pays non établi dans la noticeÉtablissement de santé
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HQ Toronto pays non établi dans la noticeÉtablissement de santé
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McMaster University Department of Medicine pays non établi dans la noticeUniversité ou école supérieure
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Centre for the AIDS Programme of Research in South Africa Afrique du Sud (code pays fourni par la source)Institution
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University of KwaZulu-Natal Department Medical Microbiology University of KwaZulu-Natal, Afrique du Sud (code pays fourni par la source)Université ou école supérieure
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National Microbiology Laboratory Branch pays non établi dans la noticeStructure de recherche
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Faculty of Health Sciences Department of Medical Microbiology and Infectious Diseases pays non établi dans la noticeUniversité ou école supérieure
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BCCDC Public Health Laboratory pays non établi dans la noticeStructure de recherche
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Centre for the AIDS Programme of Reserach in South Africa (CAPRISA) Afrique du Sud (pays nommé en fin d’affiliation)Institution
Public Health Agency of Canada, University of Manitoba et BC Centre for Disease Control, avec 8 autres affiliations. Pays d’affiliation : Afrique du Sud.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.