1. Comparison of CINtec PLUS cytology and cobas HPV test for triaging Canadian patients with LSIL cytology referred to colposcopy: A two-year prospective study
- Author
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Laura, Gilbert, Sam, Ratnam, Dan, Jang, Reza, Alaghehbandan, Miranda, Schell, Rob, Needle, Anne, Ecobichon-Morris, Arnav, Wadhawan, Dustin, Costescu, Laurie, Elit, Peter, Wang, George, Zahariadis, and Max, Chernesky
- Subjects
Adult ,Canada ,Cancer Research ,Papillomavirus Infections ,Uterine Cervical Neoplasms ,General Medicine ,Middle Aged ,Uterine Cervical Dysplasia ,Sensitivity and Specificity ,female genital diseases and pregnancy complications ,Young Adult ,Ki-67 Antigen ,Oncology ,Colposcopy ,Pregnancy ,Genetics ,Humans ,Female ,Prospective Studies ,Papillomaviridae ,Referral and Consultation ,Cyclin-Dependent Kinase Inhibitor p16 ,Early Detection of Cancer ,Aged - Abstract
OBJECTIVES & METHODS: CINtec PLUS and cobas HPV tests were compared for triaging patients referred to colposcopy with a history of LSIL cytology in a 2-year prospective study. Cervical specimens were tested once at enrollment, and test positivity rates determined. Test performance was ascertained with cervical intraepithelial neoplasia grade 2 or worse (CIN2+) and CIN3 or worse (CIN3+) serving as clinical endpoints. RESULTS: In all ages, (19–76 years, n= 598), 44.3% tested CINtec PLUS positive vs. 55.4% HPV positive (p< 0.001). To detect CIN2+ (n= 99), CINtec PLUS was 81.8% sensitive vs. 93.9% for HPV testing (p= 0.009); genotype 16/18-specific sensitivity was 46.5%. Specificity was 52.9% vs. 36.6%, respectively (p< 0.001). In all ages, to detect CIN3+ (n= 44), sensitivity was 93.2% for both tests; genotype 16/18-specific sensitivity was 52.3%. Specificity was 48.4% for CINtec PLUS vs. 31.1% for HPV testing (p< 0.001). In patients < 30 years, CINtec was 91.7% sensitive vs 95.8% for HPV testing (p= 0.549). CONCLUSIONS: CINtec PLUS or cobas HPV test could serve as a predictor of CIN3+ with high sensitivity in patients referred to colposcopy with a history of LSIL regardless of age while significantly reducing the number of LSIL referral patients requiring further investigations and follow-up in colposcopy clinics.
- Published
- 2022
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