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Analysis of the role of the human papillomavirus 16/18 E7 protein assay in screening for cervical intraepithelial neoplasia: a case control study
Honghui Shi
Peking Union Medical College Hospital
Corresponding Author
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at BMC Cancer.
Background: Cervical cancer is the second-most common gynecological cancer, early screening plays a key role in the diagnosis and treatment of cervical intraepithelial neoplasia (CIN). Sustained E7 protein expression is the pathological basis for CIN and cervical cancer.
Methods: We collected the cervical cell samples of women who visited the gynecological clinic of Peking Union Medical College Hospital between September 2018 and September 2019 and submitted them to the high-risk human papillomavirus (Hr-HPV) test. We performed a magnetic particle–based chemiluminescence enzyme immunoassay to analyze the HPV16/18 E7 protein level in CIN of different severities and compared the results with those of cervical pathology (gold standard) and the HPV test.
Results: The positive rate of HPV16/18 E7 protein increased with the severity of CIN: 26.6% in normal tissue, 58.3% in CIN1, and 70.6% in CIN2 or higher (CIN2+). For CIN2+, the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the E7 protein were 70.6%, 67.9%, 52.2%, and 82.3%, respectively. These values of the HPV test were 86.8%, 44.5%, 43.7%, and 87.1%, respectively. With the combination of the E7 protein assay and HPV test, the specificity for diagnosing CIN2+ was 78.1%, which was significantly higher than that of the HPV test alone.
Conclusions: HPV16/18 E7 protein level is correlated with the severity of CIN and has a high concordance rate with the pathological result. For cervical cancer screening, the combination of HPV16/18 E7 protein assay and HPV test improves the CIN diagnostic specificity, detection rate, and detection accuracy.
Keywords
cervical intraepithelial neoplasia (CIN); E7 oncoprotein; high-risk human papillomavirus (Hr-HPV)
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CURRENT STATUS: Published
Version 2
Posted 18 Sep, 2020
Published
On 14 Oct, 2020
Published
On 14 Oct, 2020
No community comments so far
Editorial decision: Accept
On 01 Oct, 2020
Reviewer #1 agreed
On 21 Sep, 2020
Review #1 received
Received 21 Sep, 2020
Reviewers invited
Invitations sent on 20 Sep, 2020
Editor assigned
On 15 Sep, 2020
Submission checks complete
On 14 Sep, 2020
Editor invited
On 14 Sep, 2020
No comments provided
Editorial decision: Major revision
On 17 Aug, 2020
Review #2 received
Received 09 Aug, 2020
Reviewer #3 agreed
On 23 Jul, 2020
Review #1 received
Received 20 Jul, 2020
Reviewers invited
Invitations sent on 14 Jul, 2020
Reviewer #1 agreed
On 14 Jul, 2020
Reviewer #2 agreed
On 14 Jul, 2020
First submitted
On 01 Jul, 2020
Editor assigned
On 01 Jul, 2020
Submission checks complete
On 30 Jun, 2020
Editor invited
On 30 Jun, 2020
Metrics
Comments: 0
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This preprint is under consideration at BMC 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
Analysis of the role of the human papillomavirus 16/18 E7 protein assay in screening for cervical intraepithelial neoplasia: a case control study
Honghui Shi
Peking Union Medical College Hospital
Corresponding Author
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 18 Sep, 2020
Published
On 14 Oct, 2020
Published
On 14 Oct, 2020
No community comments so far
Editorial decision: Accept
On 01 Oct, 2020
Reviewer #1 agreed
On 21 Sep, 2020
Review #1 received
Received 21 Sep, 2020
Reviewers invited
Invitations sent on 20 Sep, 2020
Editor assigned
On 15 Sep, 2020
Submission checks complete
On 14 Sep, 2020
Editor invited
On 14 Sep, 2020
No comments provided
Editorial decision: Major revision
On 17 Aug, 2020
Review #2 received
Received 09 Aug, 2020
Reviewer #3 agreed
On 23 Jul, 2020
Review #1 received
Received 20 Jul, 2020
Reviewers invited
Invitations sent on 14 Jul, 2020
Reviewer #1 agreed
On 14 Jul, 2020
Reviewer #2 agreed
On 14 Jul, 2020
First submitted
On 01 Jul, 2020
Editor assigned
On 01 Jul, 2020
Submission checks complete
On 30 Jun, 2020
Editor invited
On 30 Jun, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at BMC Cancer.
Background: Cervical cancer is the second-most common gynecological cancer, early screening plays a key role in the diagnosis and treatment of cervical intraepithelial neoplasia (CIN). Sustained E7 protein expression is the pathological basis for CIN and cervical cancer.
Methods: We collected the cervical cell samples of women who visited the gynecological clinic of Peking Union Medical College Hospital between September 2018 and September 2019 and submitted them to the high-risk human papillomavirus (Hr-HPV) test. We performed a magnetic particle–based chemiluminescence enzyme immunoassay to analyze the HPV16/18 E7 protein level in CIN of different severities and compared the results with those of cervical pathology (gold standard) and the HPV test.
Results: The positive rate of HPV16/18 E7 protein increased with the severity of CIN: 26.6% in normal tissue, 58.3% in CIN1, and 70.6% in CIN2 or higher (CIN2+). For CIN2+, the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the E7 protein were 70.6%, 67.9%, 52.2%, and 82.3%, respectively. These values of the HPV test were 86.8%, 44.5%, 43.7%, and 87.1%, respectively. With the combination of the E7 protein assay and HPV test, the specificity for diagnosing CIN2+ was 78.1%, which was significantly higher than that of the HPV test alone.
Conclusions: HPV16/18 E7 protein level is correlated with the severity of CIN and has a high concordance rate with the pathological result. For cervical cancer screening, the combination of HPV16/18 E7 protein assay and HPV test improves the CIN diagnostic specificity, detection rate, and detection accuracy.
Figure 1
Figure 2
Figure 3
Figure 4