Reviewer ’s report  
 
Title: Performance of OncoE6 Cervical Test with collection methods enabling self -sampling  
 
Version: 0 Date: 25 Feb 2018  
 
Reviewer: Paolo Giorgi Rossi  
 
Reviewer's report:  
 
The paper is well written and the results are correctly presented. Nevertheless, the study design 
has several limits thus the relevance of the results is only for a technical check not fo r accuracy:  
1. The population is only of cancers, that are not the real target of screening. Cervical  
screening aims at preventing cancer identifying and treating CIN2 and 3. Thus this 
population does not give a measure of the test sensitivity of E6 as s creening test. 
Furthermore, having only cancer obviously does not give any idea of the specificity, but for 
a screening test, especially for self sampling on lavage, specificity showed to be a major 
issue (see the systematic review by Arbyn et al on lancet  oncol).  
 
2. The self sampler has been used by a physician. Actually the use of the sampler is very easy, 
but it is not completely free of problems, for example women are concerned about quantity 
of media recollected after lavage.  
 
3. The decision to exclude  the case with a mutation on E6 is questionable. This is part of the 
mechanisms reducing analytical and clinical sensitivity. If we rely on random sampling to 
represent universe, we cannot exclude rare cases that casually entered in the sample. The 
discuss ion presents very well the problem and the conclusion that this is probably not a real 
problem for the general population is correct, but if the data will be included in a large 
systematic review, excluding this case is completely incorrect.  
 
Abstract  
Results: I suggest to report more detailed results and not excluding the case with mutation, but 
describe the reasons for  the two failures.  
Conclusions are correct and justified by the results, even if the absence of any insight on 
specificity can limit also  the conclusion on adequacy of samples.  
 
  
Discussion  
Pag 12/13 these considerations about sensitivity are cannot be drown from these results: we are 
looking only at cancers, the numbers are very small and definitely results do not suggest a low 
sensitivity . These considerations are reasonable in the light of literature results.  
Are the methods appropriate and well described?  
If not, please specify what is required in your comments to the authors.  
 
Yes 
 
Does the work include the necessary controls?  
If not, please specify which controls are required in your comments to the autho rs. 
 
No 
 
Are the conclusions drawn adequately supported by the data shown?  
If not, please explain in your comments to the authors.  
 
Yes 
 
Are you able to assess any statistics in the manuscript or would you recommend an  
additional statistical review?  
If an addi tional statistical review is recommended, please specify what aspects require further  
assessment in your comments to the editors.  
 
I am able to assess the statistics  
 
Quality of written English  
Please indicate the quality of language in the manuscript:  
 
Accep table  
 
Declaration of competing interests  
Please complete a declaration of competing interests, considering the following questions:  
 
1. Have you in the past five years received reimbursements, fees, funding, or salary from an  
organisation that may in any wa y gain or lose financially from the publication of this  
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2. Do you hold any stocks or shares in an organisation that may in any way gain or lose  
financially from the publication of this manuscript, either now or in the future?  
 
3. Do you hold or are you currently applying for any patents relating to the content of the  
manuscript?  
 
4. Have you received reimbursements, fees, funding, or salary from an organization that 
holds  or has applied for patents relating to the content of the manuscript?  
 
5. Do you have any other financial competing interests?  
 
6. Do you have any non -financial competing interests in relation to this paper?  
 
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below.  If your reply is yes to any, please give details below.  
 
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