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Novel concepts in cervical cancer screening. A comparison of VIA, HPV DNA test and p16INK4a/Ki-67 dual stain cytology in Western Kenya.
Hermann Bussmann
UniversitatsKlinikum Heidelberg
Corresponding Author
ORCiD: https://orcid.org/0000-0003-0528-5941
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at Infectious Agents and Cancer.
Background: Screening of unvaccinated women remains essential to mitigate the high morbidity/mortality of cervical cancer. Here, we compared visual inspection with acetic acid (VIA), recommended by WHO as the most cost-effective screening approach in LMICs, with HPV-based screening, and usage of p16INK4a/Ki-67 dual stain cytology.
Methods: We prospectively enrolled women participating in a VIA-based cervical cancer screening program in two peri-urban health centers of Kenya. Consenting women had a VIA examination preceded by collection of a liquid-based cytology sample from the cervix stored in PreservCyt medium (Hologic®). Analysis of all samples included a hrHPV DNA test and evaluation of a p16INK4a /Ki-67 (CINtecPLUS®) dual stained slide that was prepared using the ThinPrep® 2000 Processor and evaluated by a pathologist trained in the methodology.
Results: In 701 of a total of 800 women aged 18-64 years, all three investigations were performed and data could be analyzed. The HPV, VIA and dual stain cytology positivity were 33%, 7%, and 2% respectively. The HPV positivity rate of VIA positive cases was 32%. The five most common HPV types were HPV16, 52, 68, 58 and 35. The OR among HIV infected women of an HPV infection, VIA positivity and positive dual stain cytology were 2.6 (95%CI 1.5-4.3), 1.9 (95%CI 0.89-4.4) and 3.4 (95%CI 1.07-10.9) respectively. The sensitivity of VIA to detect a p16INK4a/Ki-67 positive transforming infection was 13% (95%CI 2-38).
Conclusions: Primary HPV testing appears feasible and should be considered as a primary screening test also in LMICs. The poor sensitivity of VIA renders it unsuitable as a triage test for HPV positive women. The utility of p16INK4a/Ki-67 dual stain cytology as a triage test for HPV positive women in LMICs should be further studied.
Keywords
Cervical cancer screening, VIA, HPV, p16INK4a/Ki-67, LMICs, dual staining, HPV genotype, HIV
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CURRENT STATUS: Published
Version 2
Posted 17 Sep, 2020
Published
On 02 Oct, 2020
No community comments so far
Editorial decision: Accept
On 18 Sep, 2020
Editor assigned
On 17 Sep, 2020
Submission checks complete
On 16 Sep, 2020
Editor invited
On 16 Sep, 2020
No comments provided
Editorial decision: Minor revision
On 27 Aug, 2020
Review #2 received
Received 26 Aug, 2020
Reviewer #2 agreed
On 24 Aug, 2020
Reviewer #1 agreed
On 23 Aug, 2020
Review #1 received
Received 23 Aug, 2020
Reviewers invited
Invitations sent on 14 Jul, 2020
Editor assigned
On 05 Jul, 2020
Submission checks complete
On 04 Jul, 2020
Editor invited
On 04 Jul, 2020
First submitted
On 03 Jul, 2020
Metrics
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PDF Downloads: ...
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Subject Areas
Cancer Biology
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This preprint is under consideration at Infectious Agents and Cancer. A preprint is 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
Novel concepts in cervical cancer screening. A comparison of VIA, HPV DNA test and p16INK4a/Ki-67 dual stain cytology in Western Kenya.
Hermann Bussmann
UniversitatsKlinikum Heidelberg
Corresponding Author
ORCiD: https://orcid.org/0000-0003-0528-5941
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
Version 2
Posted 17 Sep, 2020
Published
On 02 Oct, 2020
No community comments so far
Editorial decision: Accept
On 18 Sep, 2020
Editor assigned
On 17 Sep, 2020
Submission checks complete
On 16 Sep, 2020
Editor invited
On 16 Sep, 2020
No comments provided
Editorial decision: Minor revision
On 27 Aug, 2020
Review #2 received
Received 26 Aug, 2020
Reviewer #2 agreed
On 24 Aug, 2020
Reviewer #1 agreed
On 23 Aug, 2020
Review #1 received
Received 23 Aug, 2020
Reviewers invited
Invitations sent on 14 Jul, 2020
Editor assigned
On 05 Jul, 2020
Submission checks complete
On 04 Jul, 2020
Editor invited
On 04 Jul, 2020
First submitted
On 03 Jul, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Cancer Biology
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at Infectious Agents and Cancer.
Background: Screening of unvaccinated women remains essential to mitigate the high morbidity/mortality of cervical cancer. Here, we compared visual inspection with acetic acid (VIA), recommended by WHO as the most cost-effective screening approach in LMICs, with HPV-based screening, and usage of p16INK4a/Ki-67 dual stain cytology.
Methods: We prospectively enrolled women participating in a VIA-based cervical cancer screening program in two peri-urban health centers of Kenya. Consenting women had a VIA examination preceded by collection of a liquid-based cytology sample from the cervix stored in PreservCyt medium (Hologic®). Analysis of all samples included a hrHPV DNA test and evaluation of a p16INK4a /Ki-67 (CINtecPLUS®) dual stained slide that was prepared using the ThinPrep® 2000 Processor and evaluated by a pathologist trained in the methodology.
Results: In 701 of a total of 800 women aged 18-64 years, all three investigations were performed and data could be analyzed. The HPV, VIA and dual stain cytology positivity were 33%, 7%, and 2% respectively. The HPV positivity rate of VIA positive cases was 32%. The five most common HPV types were HPV16, 52, 68, 58 and 35. The OR among HIV infected women of an HPV infection, VIA positivity and positive dual stain cytology were 2.6 (95%CI 1.5-4.3), 1.9 (95%CI 0.89-4.4) and 3.4 (95%CI 1.07-10.9) respectively. The sensitivity of VIA to detect a p16INK4a/Ki-67 positive transforming infection was 13% (95%CI 2-38).
Conclusions: Primary HPV testing appears feasible and should be considered as a primary screening test also in LMICs. The poor sensitivity of VIA renders it unsuitable as a triage test for HPV positive women. The utility of p16INK4a/Ki-67 dual stain cytology as a triage test for HPV positive women in LMICs should be further studied.
Figure 1
Figure 2
Figure 3