ArticleFrontiers in medical technology2025
Validation of an in-house HPV CerviSens self-sampling kit: comparison against clinician-collected and self-collected samples.
Article in Frontiers in medical technology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Introduction: Cervical cancer (CA cervix) ranks as the second most common cancer among women aged 15-44 and remains a leading cause of cancer-related mortality. Regular screening for cervical cancer significantly reduces mortality rates. Due to the strong causal relationship between high-risk human papillomavirus (hrHPV) and cervical cancer, HPV DNA testing has been developed as a screening method. 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. Methodology: The study, approved by the Gupte Hospital Ethics Committee, included women aged 35-65 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 analysis was performed using the Cobas 4800 assay. Concordance between self-sampling and clinician sampling was assessed using Cohen's Results: A total of 203 paired self-collected and clinician-collected samples were analyzed for HPV detection. The median age of participants was 44 years. Concordance for HPV detection between self-samples and clinician-collected samples was very good (Cohen's Conclusion: 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.
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