{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T03:29:01Z","timestamp":1772162941629,"version":"3.50.1"},"reference-count":31,"publisher":"American Society for Microbiology","issue":"5","license":[{"start":{"date-parts":[[2025,5,14]],"date-time":"2025-05-14T00:00:00Z","timestamp":1747180800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2025,5,14]],"date-time":"2025-05-14T00:00:00Z","timestamp":1747180800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["J Clin Microbiol"],"published-print":{"date-parts":[[2025,5,14]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title\/>\n                    <jats:p>\n                      Cervical cancer screening is vital for achieving global elimination of this preventable disease. Vaginal self-sampling (VSS) for human papillomavirus (HPV) has the potential to increase screening uptake, particularly among individuals who may be underserved by clinician collection. Expanding self-sampling options with accurate, acceptable collection devices is essential. The Daye diagnostic tampon (DDT) offers an innovative approach, utilizing a tampon for HPV-based detection. This study assessed the diagnostic accuracy of DDT in detecting high-risk HPV infections, using vaginal clinician-collected swabs (CCS) as the reference standard. In this UK-based study, 260 participants provided CCS and VSS (with Copan FLOQSwabs) and DDT samples for HPV testing. Samples were analyzed using the Aptima HPV assay, which detects 14 high-risk HPV types. The sensitivity, specificity, positive predictive value, and negative predictive value of the DDT were evaluated against the CCS. Invalidity rates\u2014HPV-negative results with negative internal controls\u2014were compared across sampling methods. The DDT showed a sensitivity of 82.9% [95% confidence interval (CI): 72.4%\u201389.9%], specificity of 91.6% (CI: 86.4%\u201394.9%), and overall accuracy of 89.0% (CI: 84.4%\u201392.4%) relative to CCS. McNemar\u2019s test showed no significant difference between CCS and DDT results (\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      = 0.845). Valid result rates were highest for DDT (99.2%), followed by VSS (95.4%) and CCS (90.8%). The DDT demonstrates comparable accuracy to CCS for detecting high-risk HPV. This novel device shows promise as a self-sampling method. Furthermore, complementary research should focus on assessing DDT\u2019s clinical performance in detecting HPV associated with cervical disease endpoints.\n                    <\/jats:p>\n                    <jats:sec>\n                      <jats:title>IMPORTANCE<\/jats:title>\n                      <jats:p>Cervical cancer remains a leading preventable cause of cancer death globally, with persistent disparities in screening access. Self-sampling for HPV has emerged as a critical tool to improve screening uptake, particularly among underserved populations, yet device acceptability and diagnostic reliability remain barriers to equitable implementation. This study demonstrates that the Daye diagnostic tampon (DDT), a novel, tampon-based self-sampling method, achieves diagnostic accuracy comparable to clinician-collected swabs (sensitivity 82.9% and specificity 91.6%) while yielding fewer invalid results (0.8%) than conventional swabs. By aligning with a familiar menstrual product, the DDT addresses usability concerns that hinder confidence in existing self-sampling devices, as evidenced by 70.5% participant preference in focus groups. These findings advance progress toward World Health Organisation (WHO) cervical cancer elimination targets by validating a culturally resonant, high-performance alternative to clinic-based sampling. The DDT\u2019s potential to expand screening access, especially in low-resource settings or among individuals avoiding pelvic exams, could transform preventive care landscapes, reducing disparities in a disease rooted in healthcare inequity.<\/jats:p>\n                    <\/jats:sec>\n                  <\/jats:sec>","DOI":"10.1128\/jcm.01852-24","type":"journal-article","created":{"date-parts":[[2025,4,11]],"date-time":"2025-04-11T09:00:56Z","timestamp":1744362056000},"update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":1,"title":["Diagnostic accuracy of the Daye diagnostic tampon compared to clinician-collected and self-collected vaginal swabs for detecting HPV: a comparative study"],"prefix":"10.1128","volume":"63","author":[{"given":"Valentina","family":"Milanova","sequence":"first","affiliation":[{"name":"Daye","place":["London, United Kingdom"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0004-5362-229X","authenticated-orcid":true,"given":"Michelle","family":"Gomes","sequence":"additional","affiliation":[{"name":"Daye","place":["London, United Kingdom"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kalina","family":"Mihaylova","sequence":"additional","affiliation":[{"name":"Daye","place":["London, United Kingdom"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John Luke","family":"Twelves","sequence":"additional","affiliation":[{"name":"Lindus Health","place":["London, United Kingdom"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jan","family":"Multmeier","sequence":"additional","affiliation":[{"name":"TotaEffects GmH","place":["Oranienburg, Germany"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hana","family":"McMahon","sequence":"additional","affiliation":[{"name":"Center for Reproductive Health, University of Edinburgh","place":["Edinburgh, United Kingdom"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5006-967X","authenticated-orcid":true,"given":"Hannah","family":"McCulloch","sequence":"additional","affiliation":[{"name":"Independent consultant","place":["London, United Kingdom"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2604-3928","authenticated-orcid":false,"given":"Kate","family":"Cuschieri","sequence":"additional","affiliation":[{"name":"Center for Reproductive Health, University of Edinburgh","place":["Edinburgh, United Kingdom"]}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"235","reference":[{"key":"e_1_3_5_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/S2214-109X(19)30482-6"},{"key":"e_1_3_5_3_2","doi-asserted-by":"publisher","DOI":"10.3390\/cancers15061669"},{"key":"e_1_3_5_4_2","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2022-068940"},{"key":"e_1_3_5_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ypmed.2019.105953"},{"key":"e_1_3_5_6_2","doi-asserted-by":"publisher","DOI":"10.1186\/s12885-020-07085-9"},{"key":"e_1_3_5_7_2","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.k4823"},{"key":"e_1_3_5_8_2","doi-asserted-by":"publisher","DOI":"10.1136\/bmjgh-2020-003743"},{"key":"e_1_3_5_9_2","doi-asserted-by":"publisher","DOI":"10.1177\/09691413231205965"},{"key":"e_1_3_5_10_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41416-022-02094-w"},{"key":"e_1_3_5_11_2","doi-asserted-by":"publisher","unstructured":"Milanova V Mihaylova K Lazarova I Gomes M Kiosseva L Dobreva D Dechev A. 2024. Efficacy of self-collected diagnostic tampon as a novel tool for vaginal sample collection towards the detection of genital infections. 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Cervical screening: helping you decide. Available from: https:\/\/www.gov.uk\/government\/publications\/cervical-screening-description-in-brief\/cervical-screening-helping-you-decide--2#:~:text=Cervical%20screening%20is%20for%20women months%20before%20people%20turn%2025. Retrieved 15 Nov 2024."},{"key":"e_1_3_5_32_2","doi-asserted-by":"publisher","DOI":"10.1093\/jnci\/djn019"}],"container-title":["Journal of Clinical Microbiology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/jcm.01852-24","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/jcm.01852-24","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,5,14]],"date-time":"2025-05-14T09:01:30Z","timestamp":1747213290000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.asm.org\/doi\/10.1128\/jcm.01852-24"}},"subtitle":[],"editor":[{"given":"Elitza S.","family":"Theel","sequence":"additional","affiliation":[],"role":[{"role":"editor","vocabulary":"crossref"}]}],"short-title":[],"issued":{"date-parts":[[2025,5,14]]},"references-count":31,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2025,5,14]]}},"alternative-id":["10.1128\/jcm.01852-24"],"URL":"https:\/\/doi.org\/10.1128\/jcm.01852-24","relation":{"has-preprint":[{"id-type":"doi","id":"10.1101\/2024.12.02.24318200","asserted-by":"object"}]},"ISSN":["0095-1137","1098-660X"],"issn-type":[{"value":"0095-1137","type":"print"},{"value":"1098-660X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,5,14]]},"assertion":[{"value":"2024-11-26","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-03-14","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-04-11","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e01852-24"}}