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Research article
Mette Tranberg
Department of Public Health Programmes
Corresponding Author
ORCiD: https://orcid.org/0000-0002-6285-6694
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background: To reach non-participants, reluctant to undergo clinician-based cervical cancer screening and vaginal self-sampling, urine collection for high-risk human papillomavirus detection (hrHPV) may be valuable. Using two hrHPV DNA assays, we evaluated the concordance of hrHPV positivity in urine samples in comparison with vaginal self-samples and cervical cytology samples taken by the general practitioner (GP). We also studied women's acceptance of urine collection and preferences towards the different sampling procedures.
Methods: One hundred fifty paired self-collected urine and vaginal samples and GP-collected cervical cytology samples were obtained from 30 to 59-year-old women diagnosed with ASC-US within the Danish cervical cancer screening program. After undergoing cervical cytology at the GP, the women collected first-void urine and vaginal samples at home and completed a questionnaire. Each sample was hrHPV DNA tested by the GENOMICA CLART® and COBAS® 4800 assays. Concordance in hrHPV detection between sample types was determined using Kappa (k) statistics. Sensitivity and specificity of hrHPV detection in urine was calculated using cervical sampling as reference.
Results: With the COBAS assay, urine showed good concordance to the vaginal (k=0.66) self-samples and cervical samples (k =0.66) for hrHPV detection. The corresponding concordance was moderate (k=0.59 and k=0.47) using CLART. Compared to cervical sampling, urinary hrHPV detection had a sensitivity of 63.9% and a specificity of 96.5% using COBAS; compared with 51.6% and 92.4% for CLART. Invalid hrHPV test rates were 1.8% for COBAS and 26.9% for CLART. Urine collection was well-accepted and 42.3% of the women ranked it as the most preferred future screening procedure.
Conclusions: Urine collection provides a well-accepted screening option. With COBAS, higher concordance between urine and vaginal self-sampling and cervical sampling for hrHPV detection was found compared to CLART. Urinary hrHPV detection with COBAS is feasible, but its accuracy may need to be improved before urine collection at home can be offered to non-participants reluctant to both cervical sampling and vaginal self-sampling.
Keywords
Self-sampling, human papillomavirus testing, cervical cancer screening, urinary sample, acceptability
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CURRENT STATUS: Published
View the published article at BMC Infectious Diseases.
Version 2
Posted 04 Dec, 2020
No community comments so far
Editorial decision: Accept
On 23 Nov, 2020
Editor assigned
On 22 Nov, 2020
Submission checks complete
On 22 Nov, 2020
Editor invited
On 22 Nov, 2020
No comments provided
Review #2 received
Received 22 Oct, 2020
Editorial decision: Minor revision
On 22 Oct, 2020
Review #3 received
Received 10 Oct, 2020
Reviewer #3 agreed
On 05 Oct, 2020
Review #1 received
Received 26 Sep, 2020
Reviewer #2 agreed
On 05 Sep, 2020
Reviewer #1 agreed
On 08 Aug, 2020
Reviewers invited
Invitations sent on 07 Aug, 2020
Editor assigned
On 17 Jul, 2020
First submitted
On 16 Jul, 2020
Submission checks complete
On 16 Jul, 2020
Editor invited
On 16 Jul, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Infectious Diseases
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A new preprint design is coming!
We have improved readability, clarity, accessibility, and opportunities for engagement.
See the published version of this preprint at BMC Infectious Diseases.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research article
Mette Tranberg
Department of Public Health Programmes
Corresponding Author
ORCiD: https://orcid.org/0000-0002-6285-6694
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at BMC Infectious Diseases.
Version 2
Posted 04 Dec, 2020
No community comments so far
Editorial decision: Accept
On 23 Nov, 2020
Editor assigned
On 22 Nov, 2020
Submission checks complete
On 22 Nov, 2020
Editor invited
On 22 Nov, 2020
No comments provided
Review #2 received
Received 22 Oct, 2020
Editorial decision: Minor revision
On 22 Oct, 2020
Review #3 received
Received 10 Oct, 2020
Reviewer #3 agreed
On 05 Oct, 2020
Review #1 received
Received 26 Sep, 2020
Reviewer #2 agreed
On 05 Sep, 2020
Reviewer #1 agreed
On 08 Aug, 2020
Reviewers invited
Invitations sent on 07 Aug, 2020
Editor assigned
On 17 Jul, 2020
First submitted
On 16 Jul, 2020
Submission checks complete
On 16 Jul, 2020
Editor invited
On 16 Jul, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Infectious Diseases
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at BMC Infectious Diseases.
Background: To reach non-participants, reluctant to undergo clinician-based cervical cancer screening and vaginal self-sampling, urine collection for high-risk human papillomavirus detection (hrHPV) may be valuable. Using two hrHPV DNA assays, we evaluated the concordance of hrHPV positivity in urine samples in comparison with vaginal self-samples and cervical cytology samples taken by the general practitioner (GP). We also studied women's acceptance of urine collection and preferences towards the different sampling procedures.
Methods: One hundred fifty paired self-collected urine and vaginal samples and GP-collected cervical cytology samples were obtained from 30 to 59-year-old women diagnosed with ASC-US within the Danish cervical cancer screening program. After undergoing cervical cytology at the GP, the women collected first-void urine and vaginal samples at home and completed a questionnaire. Each sample was hrHPV DNA tested by the GENOMICA CLART® and COBAS® 4800 assays. Concordance in hrHPV detection between sample types was determined using Kappa (k) statistics. Sensitivity and specificity of hrHPV detection in urine was calculated using cervical sampling as reference.
Results: With the COBAS assay, urine showed good concordance to the vaginal (k=0.66) self-samples and cervical samples (k =0.66) for hrHPV detection. The corresponding concordance was moderate (k=0.59 and k=0.47) using CLART. Compared to cervical sampling, urinary hrHPV detection had a sensitivity of 63.9% and a specificity of 96.5% using COBAS; compared with 51.6% and 92.4% for CLART. Invalid hrHPV test rates were 1.8% for COBAS and 26.9% for CLART. Urine collection was well-accepted and 42.3% of the women ranked it as the most preferred future screening procedure.
Conclusions: Urine collection provides a well-accepted screening option. With COBAS, higher concordance between urine and vaginal self-sampling and cervical sampling for hrHPV detection was found compared to CLART. Urinary hrHPV detection with COBAS is feasible, but its accuracy may need to be improved before urine collection at home can be offered to non-participants reluctant to both cervical sampling and vaginal self-sampling.
Figure 1
This is a list of supplementary files associated with this preprint. Click to download.
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