Reviewer’ s report
Title: HPV testing for cervical cancer screening: technical improvement of laboratory logistics
and good clinical performance of the cobas 6800 in comparison to the 4800 system.
Version: 0Date: 26 Jul 2018
Reviewer: Collette Bromhead
Reviewer's report:
Whilst this paper details an adequate comparative study between two molecular assays for HPVon
liquid based cytology samples, the design of the trial and the samples tested are not sufficient tolead to the conclusion given that the 6800 cobas HPV assay is suitable for use in large centralisedlaboratories i operating in population based cervical cancer screening programs, particularly not inthis setting of HPV Primary screening. There is no mention of comparison to the Meijer criteria.There is no consideration for prediction of clinical disease, ie CIN2, CIN3. And there is noexamination of the difference in viral load assessed between the two assays, which some of yourdiscordant results suggest may be considerable. I agree your results show promise and that theutility of the new automated system in the clinical laboratory is a big advantage over the cobas4800 system which is highly manual by comparison. A higher quality study would have made thispaper of considerable significance to laboratory users around the world who are facing thetransition to HPV Primary screening and the increasing workload that entails. Unfortunately itseems the 6800 assay is quite different to the 4800 HPV test that achieved FDA approval for HPVPrimary Screening off the back of the large Athena Trial in the USA. More work is needed tovalidate this new assay.
Are the methods appropriate and well described?
If not, please specify what is required in your comments to the authors.
NoDoes the work include the necessary controls?
If not, please specify which controls are required in your comments to the authors.
NoAre the conclusions drawn adequately supported by the data shown?
If not, please explain in your comments to the authors.
NoAre you able to assess any statistics in the manuscript or would you recommend an
additional statistical review?If an additional statistical review is recommended, please specify what aspects require further
assessment in your comments to the editors.
I recommend additional statistical review
Quality of written English
Please indicate the quality of language in the manuscript:
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