' s report Title : A population-based observational study comparing Cervista and Hybrid Capture 2 methods : Improved relative specificity of the Cervista assay by increasing its cut-off Version : 2 Date : 27 July 2014

The manuscript puts forth a very interesting question as to the precision of the company set cut off of a new generation HPV test, the Cervista HPV assay. Thereby the data reported represents a data driven evaluation of whether the FDA approved and CE-IVD marked Cervista assay in fact has the right distinction between true disease and more or less transient infection, in a non-US population. Moreover, the manuscript offers comparative data in a true split sample fashion between the former marked leading assay, HC2, and Cervista, mostly I assume as HC2 is outlined in the European Meijer Criteria as the comparator for any new HPV test with respect to clinical sensitivity and specificity of detection of CIN2+. However, the value of true split sample studies can in this respect not be emphasised enough.