Performance of HPV E6/E7 mRNA assay as primary screening test: Results from the NTCC2 trial

As the primary screening test, E6/E7 mRNA has shown similar sensitivity for CIN3+ and lower positivity rate than the HPV DNA test. Nevertheless, the overall mRNA positivity is too high for immediate colposcopy, making a triage test necessary. The aim was to estimate the mRNA performance as a primary test with different triage strategies. All HPV DNA‐positives were tested for mRNA, cytology and p16/ki67. A sample of HPV DNA‐negatives was also tested for mRNA to estimate test specificity. We included all CIN3+ histologically diagnosed within 24 months since recruitment. Of the 41 127 participants, 7.7% were HPV DNA‐positive, of which 66.4% were mRNA‐positive. Among the HPV DNA‐negatives, 10/1108 (0.9%) were mRNA‐positive. Overall, 97 CIN3+ were found. If mRNA was used as the primary test, it would miss about 3% of all CIN3+ with a 22% reduction of positivity compared with HPV DNA. The weighted specificity estimate for

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