title: Accuracy of human papillomavirus testing in primary screening of cervical neoplasia: results from a multicenter study in India.
abstract: The knowledge that cervical neoplasia are caused by human papillomavirus (HPV) infection has led to the evaluation of its role in screening. We evaluated the accuracy of HPV testing by Hybrid capture II (HC II) method in detecting cervical intraepithelial neoplasia grade 2 and 3 (CIN 2 and 3) lesions in 4 cross-sectional studies with common protocol and questionnaire in 3 different locations (Kolkata, Mumbai and Trivandrum) in India. These studies involved 18,085 women aged 25-65 years. The reference standard for final diagnosis was a combination of colposcopy/biopsy. All women were investigated with colposcopy and 3,116 received directed biopsy. The sensitivity of HPV testing for detecting CIN 2-3 lesions varied from 45.7% to 80.9% across the study sites; the specificity varied from 91.7% to 94.6% and the positive predictive value from 6.7% to 13.7%. Retesting of 298 randomly chosen denatured samples in France revealed an agreement rate of 85.9% and a kappa-value of 0.72. Although HPV testing seems to be a promising approach for cervical cancer prevention, a large range in sensitivity was observed in our study, possibly due to variations in the quality of specimen collection and reference standards. A higher sensitivity was associated with the center performing the test well. Further developments in terms of more reproducible, less expensive and less sophisticated testing are essential to make the test feasible and effective in low-resource settings.
authors.affiliation: International Agency for Research on Cancer, Lyon, France. sankar@iarc.fr
authors.forename: Rengaswamy
authors.initials: R
authors.lastname: Sankaranarayanan
authors.forename: Ramdas
authors.initials: R
authors.lastname: Chatterji
authors.forename: Surendra S
authors.initials: SS
authors.lastname: Shastri
authors.forename: Ramani S
authors.initials: RS
authors.lastname: Wesley
authors.forename: Partha
authors.initials: P
authors.lastname: Basu
authors.forename: Cédric
authors.initials: C
authors.lastname: Mahe
authors.forename: Richard
authors.initials: R
authors.lastname: Muwonge
authors.forename: Daniel
authors.initials: D
authors.lastname: Seigneurin
authors.forename: Thara
authors.initials: T
authors.lastname: Somanathan
authors.forename: Chinmoy
authors.initials: C
authors.lastname: Roy
authors.forename: Rohini
authors.initials: R
authors.lastname: Kelkar
authors.forename: Roshini
authors.initials: R
authors.lastname: Chinoy
authors.forename: Ketayun
authors.initials: K
authors.lastname: Dinshaw
authors.forename: Ranajit
authors.initials: R
authors.lastname: Mandal
authors.forename: Geethanjali
authors.initials: G
authors.lastname: Amin
authors.forename: Smriti
authors.initials: S
authors.lastname: Goswami
authors.forename: Smarajit
authors.initials: S
authors.lastname: Pal
authors.forename: Sharmila
authors.initials: S
authors.lastname: Patil
authors.forename: Namrata
authors.initials: N
authors.lastname: Dhakad
authors.forename: Lucien
authors.initials: L
authors.lastname: Frappart
authors.forename: Bernard
authors.initials: B
authors.lastname: Fontaniere
mesh_terms: D000328:Adult; D000368:Aged; D001706:Biopsy; D003127:Colposcopy; D003430:Cross-Sectional Studies; D004279:DNA, Viral / Q000032:analysis*; D005260:Female; D006801:Humans; D017403:In Situ Hybridization; D007194:India; D008403:Mass Screening / Q000592:standards*; D008875:Middle Aged; D030361:Papillomavirus Infections / Q000175:diagnosis*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000821:virology*; D014626:Vaginal Smears
chemical_list: D004279:DNA, Viral