Performance of HPV E6/E7 mRNA assay as primary screening test: Results from the NTCC2 trial.
Int J Cancer
; 151(7): 1047-1058, 2022 10 01.
Article
in En
| MEDLINE
| ID: mdl-35579975
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 Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Uterine Cervical Neoplasms
/
Papillomavirus Infections
Type of study:
Diagnostic_studies
/
Screening_studies
Limits:
Female
/
Humans
/
Pregnancy
Language:
En
Journal:
Int J Cancer
Year:
2022
Type:
Article
Affiliation country:
Italy