Clinical performance and acceptability of self-collected vaginal and urine samples compared with clinician-taken cervical samples for HPV testing among women referred for colposcopy: A cross-sectional study

Dorthe Ørnskov*, Kirsten Jochumsen, Pernille Husted Steiner, Ivan Moulun Grunnet, Annemette Wildfang Lykkebo, Marianne Waldstrøm

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Abstrakt

Objectives To increase effectiveness of the cervical cancer screening program, self-sampling can be an option. Both self-collected vaginal samples (SCV) and urine samples may be useful alternatives to clinician-taken cervical samples (CS). Design Cross-sectional study. Setting Colposcopy clinic. Participants Women (n=305) referred to colposcopy after abnormal cervical screening result or conditions like postcoital bleeding. Intervention All women self-collected a urine and a vaginal sample prior to colposcopy, where a CS and biopsies were taken. All samples were tested for high-risk human papillomavirus (HPV) using the Cobas HPV assay. The gold standard was histology diagnoses (CIN2+/CIN3+) from biopsies obtained at the same examination. Primary outcome Absolute and relative sensitivity and specificity of HPV testing on SCV and urine to detect CIN2+/CIN3+ compared with the CS. Secondary outcome The acceptability by women of self-sampling. Results Both the vaginal and urine sample were comparable to the CS in identifying severe intraepithelial neoplasia (CIN2+/CIN3+). Absolute sensitivity ranged from 93% for urine samples to 96% for SCV for detecting CIN2+, which is comparable to the sensitivity of CS (overlapping 95% CI). The relative sensitivity for detecting CIN2+ was 1.00 (95% CI 0.96 to 1.04) for SCV and 0.96 (95% CI 0.91 to 1.03) for urine samples. At CIN3+, the relative sensitivity was 1.00 (95% CI 0.96 to 1.08) and 0.97 (95% CI 0.89 to 1.07) for SCV and urine samples, respectively. There were no statistical differences between the self-collected samples and the CS (McNemar's test >0.05). The relative specificity was also similar (1.03 (95% CI 0.95 to 1.12) for SCV and 0.98 (95% CI 0.89 to 1.09) for urine samples) (McNemar's test >0.05). The acceptability of self-sampling was evaluated by questionnaire. The women found the instructions on sample collection easy to understand and were positive about self-sampling with a preference for the urine sample. Conclusion Self-sampling by SCV and urine is a clinically safe alternative to CS with a high degree of acceptability.

OriginalsprogEngelsk
Artikelnummere041512
TidsskriftBMJ Open
Vol/bind11
Udgave nummer3
Antal sider8
ISSN2044-6055
DOI
StatusUdgivet - 5. mar. 2021

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Publisher Copyright:
© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.

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