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
Performance of HPV E6/E7 mRNA assay as primary screening test: Results from the NTCC2 trial / Giorgi Rossi, P.; Ronco, G.; Mancuso, P.; Carozzi, F.; Allia, E.; Bisanzi, S.; Gillio-Tos, A.; De Marco, L.; Rizzolo, R.; Gustinucci, D.; Del Mistro, A.; Frayle, H.; Confortini, M.; Iossa, A.; Cesarini, E.; Bulletti, S.; Passamonti, B.; Gori, S.; Toniolo, L.; Barca, A.; Bonvicini, L.; Venturelli, F.; Benevolo, M.. - In: INTERNATIONAL JOURNAL OF CANCER. - ISSN 0020-7136. - 151:7(2022), pp. 1047-1058. [10.1002/ijc.34120]
Performance of HPV E6/E7 mRNA assay as primary screening test: Results from the NTCC2 trial
Venturelli F.;
2022
Abstract
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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