Vaginal and urine self-sampling compared to cervical sampling for HPV-testing with the cobas 4800 HPV test

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Abstract

Background/Aim: To compare human papillomavirus (HPV) DNA detection in self-collected vaginal and urine samples with clinician-taken cervical samples in relation to histology. Materials and Methods: Self-collected vaginal, urine and clinician-taken cervical samples were analyzed from 218 women with the Cobas 4800 HPV test (Roche Molecular Diagnostics). Results: The sensitivity for detection of HPV in the vaginal self-sampling test was 96.4% and in urine was 83.9% relative to detection by clinician-taken cervical sample. The vaginal self-sampling and the clinician-taken HPV tests had the same sensitivity of 92.8% (95% confidence interval=86.3-96.8%) and specificity for detection of high-grade squamous intraepithelial lesion (HSIL) and adenocarcinoma in situ (AIS). Detection in urine samples had a sensitivity of 76.3% (95% confidence interval=67.9-84.2%) for HSIL/AIS. Conclusion: The Cobas 4800 HPV test detects high-grade pre-cancerous cervical lesions in self-collected vaginal samples with the same high sensitivity as in clinician-taken cervical samples.

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Asciutto, K. C., Henningsson, A. J., Borgfeldt, H., Darlin, L., & Borgfeldt, C. (2017). Vaginal and urine self-sampling compared to cervical sampling for HPV-testing with the cobas 4800 HPV test. Anticancer Research, 37(8), 4183–4187. https://doi.org/10.21873/anticanres.11807

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