TY - JOUR
T1 - Determinants of viral oncogene E6-E7 mRNA overexpression in a population- based large sample of women infected by high-risk human papillomavirus types
AU - Rossi, Paolo Giorgi
AU - Bisanzi, Simonetta
AU - Allia, Elena
AU - Mongia, Alessandra
AU - Carozzi, Francesca
AU - Gillio-Tos, Anna
AU - De Marco, Laura
AU - Ronco, Guglielmo
AU - Gustinucci, Daniela
AU - Del Mistro, Annarosa
AU - Frayle, Helena
AU - Iossa, Anna
AU - Fantacci, Giulia
AU - Pompeo, Giampaolo
AU - Cesarini, Elena
AU - Bulletti, Simonetta
AU - Passamonti, Basilio
AU - Rizzi, Martina
AU - Penon, Maria Gabriella
AU - Barca, Alessandra
AU - Benevolo, Maria
PY - 2017/4/1
Y1 - 2017/4/1
N2 - Cervical cancer screening by human papillomavirus (HPV) DNA testing with cytology triage is more effective than cytology testing. Compared to cytology, the HPV DNA test's higher sensitivity, which allows better protection with longer intervals, makes it necessary to triage the women with a positive result to compensate its lower specificity. We are conducting a large randomized clinical trial (New Technologies for Cervical Cancer 2 [NTCC2]) within organized population-based screening programs in Italy using HPV DNA as the primary screening test to evaluate, by the Aptima HPV assay (Hologic), the use of HPV E6-E7 mRNA in a triage test in comparison to cytology. By the end of June 2016, data were available for 35,877 of 38,535 enrolled women, 2,651 (7.4%) of whom were HPV DNA positive. Among the samples obtained, 2,453 samples were tested also by Aptima, and 1,649 (67.2%) gave a positive result. The proportion of mRNA positivity was slightly higher among samples tested for HPV DNA by the Cobas 4800 HPV assay (Roche) than by the Hybrid Capture 2 (HC2) assay (Qiagen). In our setting, the observed E6-E7 mRNA positivity rate, if used as a triage test, would bring a rate of immediate referral to colposcopy of about 4 to 5%. This value is higher than that observed with cytology triage for both immediate and delayed referrals to colposcopy. By showing only a very high sensitivity and thus allowing a longer interval for HPV DNA-positive/HPV mRNA-negative women, a triage by this test might be more efficient than by cytology.
AB - Cervical cancer screening by human papillomavirus (HPV) DNA testing with cytology triage is more effective than cytology testing. Compared to cytology, the HPV DNA test's higher sensitivity, which allows better protection with longer intervals, makes it necessary to triage the women with a positive result to compensate its lower specificity. We are conducting a large randomized clinical trial (New Technologies for Cervical Cancer 2 [NTCC2]) within organized population-based screening programs in Italy using HPV DNA as the primary screening test to evaluate, by the Aptima HPV assay (Hologic), the use of HPV E6-E7 mRNA in a triage test in comparison to cytology. By the end of June 2016, data were available for 35,877 of 38,535 enrolled women, 2,651 (7.4%) of whom were HPV DNA positive. Among the samples obtained, 2,453 samples were tested also by Aptima, and 1,649 (67.2%) gave a positive result. The proportion of mRNA positivity was slightly higher among samples tested for HPV DNA by the Cobas 4800 HPV assay (Roche) than by the Hybrid Capture 2 (HC2) assay (Qiagen). In our setting, the observed E6-E7 mRNA positivity rate, if used as a triage test, would bring a rate of immediate referral to colposcopy of about 4 to 5%. This value is higher than that observed with cytology triage for both immediate and delayed referrals to colposcopy. By showing only a very high sensitivity and thus allowing a longer interval for HPV DNA-positive/HPV mRNA-negative women, a triage by this test might be more efficient than by cytology.
KW - Biomarkers
KW - Cervical cancer screening
KW - HPV E6-E7 oncogene mRNA
KW - Human papillomavirus
U2 - 10.1128/JCM.01794-16
DO - 10.1128/JCM.01794-16
M3 - Article
VL - 55
SP - 1056
EP - 1065
JO - Journal of Clinical Microbiology
JF - Journal of Clinical Microbiology
SN - 0095-1137
IS - 4
ER -