ORIGINAL RESEARCH article
Front. Med. Technol.
Sec. Diagnostic and Therapeutic Devices
Volume 7 - 2025 | doi: 10.3389/fmedt.2025.1458857
Validation of an In-House HPV Cervisens Self-Sampling Kit: Comparison against Clinician-Collected and Self-Collected Samples
Provisionally accepted
- Other, Pune, India
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Introduction: Cervical cancer (CA cervix) ranks as the second most frequent cancer among women aged 15 to 44 and is a leading cause of cancer-related mortality. Screening for cervical cancer significantly reduces mortality rates. Given the strong causal relationship between highrisk human papillomavirus (hrHPV) and cervical cancer, HPV DNA tests have been developed for screening. HPV self-sampling kits have the potential to increase screening uptake, facilitate early detection, and reduce the global burden of cervical cancer. This study evaluates the efficacy of an in-house developed HPV cervisens Self Sampling Kit for Women in detecting hrHPV types.The study, approved by the Gupte Hospital Ethics Committee, included women aged 35 to 65 visiting Gupte Hospital in Pune, India. Participants self-collected vaginal samples using the in-house developed HPV cervisens kit, and trained healthcare practitioners collected conventional samples. HPV DNA was analyzed using the Cobas 4800 assay. Concordance between self-sampling and clinician-sampling was assessed using Cohen's Kappa statistic. The sensitivity and specificity of HPV detection in self-samples were calculated with cliniciancollected samples as the reference standard. Results: A total of 203 paired self-collected and clinician-collected samples were analyzed for HPV detection in this study. The median age was 44 years. Concordance for HPV detection Commented [91]: Reviewer 7 Comment 2between self-samples and clinician-collected samples was very good (Cohen's kappa κ: 0.88, 95% CI: κ ≥ 0.81). For HPV detection in self-samples, the sensitivity of the in-house HPV CerviSens self-sampling kit was 98.0% (95% CI: 89.4%-99.9%), and the specificity was 99.4% (95% CI: 96.3%-99.9%) when clinician-collected samples were used as the reference standard. These results demonstrate the high accuracy of the self-sampling method in identifying high-risk HPV infections.HPV self-sampling using the in-house developed HPV cervisens kit is a reliable and effective method for cervical cancer screening, with high concordance and accuracy in detecting HPV infections. Integrating self-sampling into screening programs can enhance early detection, improve patient outcomes, and significantly reduce the global burden of cervical cancer.
Keywords: Self-Sampling kit, Human papillomavirus, Ca Cervix, cervical cancer, high-risk HPV, Self-sampling, HPV Screening Reviewer 7 comment 11 16. Racey, C. S.
Received: 03 Jul 2024; Accepted: 17 Jul 2025.
Copyright: © 2025 Arora, Jawale, Gupte and Shah. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Preeti Arora, Other, Pune, India
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