Clinical validation of high risk HPV DNA testing versus ThinPrep cytology for primary cervical cancer screening

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Abstract

Objective(s): To compare the validity of the high risk HPV DNA testing using the hybrid capture II technique (HC-II) to ThinPrep cytology for primary cervical cancer screening. Design: Cross sectional pilot study. Setting: Department of Obstetrics and Gynecology, Taiba Hospital, Sabah Al Salem, Kuwait. Methods: Consecutive 1923 cervical smear samples were taken for ThinPrep cytological screening and hr-HPV DNA testing using HC-II assay. Histological diagnoses were obtained from a total of 426 women who had positive results on screening and a group of women with negative screening and suspicious cervix underwent colposcopy and directed biopsies, and those with cervical precancerous lesions or cancer received appropriate treatment. Main outcome measures: Sensitivity, specificity, positive predictive value and negative predictive value of screening methods. Results: HPV was found positive in 15.5% of cases. 19/22 cases (86.4.1%) with a biopsy diagnosis of CIN2+ had a HC-II positive test. For CIN3, HC-II was positive in all cases (100%). Assuming a similar specificity level, the relative sensitivity of the HC-II test was higher when histologically confirmed high grade lesions (CIN2+ or CIN3+) were observed. HC-II test had the best sensitivity when defining cases as CIN2+ or CIN3+ (98.7% and 100%, respectively). When using the ASCUS+ cytological cutoff, the differences in CIN2+ and CIN3+ sensitivity between HC-II test and ThinPrep cytology were statistically not significant. Specificity of the ThinPrep cytology for any low and high grade histological lesions was clearly >95% when cytological diagnosis LSIL+ cutoff was used and nearly 100% when HSIL+ cutoff was used. All these specificity estimates were high compared with HC-II test. The specificity of the ThinPrep cytology decreased with about 10% when ASCUS+ was the cutoff. At cutoff ASCUS+, specificity of HC-II was comparable or only slightly lower than with ThinPrep ASCUS+ cytology with no statistically significant differences. Conclusions: ThinPrep smears and hr-HPV DNA detection by HC-II performed very well with regard to identifying high grade lesions. HPV DNA testing is a promising new technology for cervical cancer prevention and can be used for primary screening in conjunction with cervical cytology for women aged 30 years and older. © 2013 Middle East Fertility Society.Production and hosting by Elsevier B. V. All rights reserved.

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Aboul-Fotouh, M. E. M., & Hana, I. T. (2013). Clinical validation of high risk HPV DNA testing versus ThinPrep cytology for primary cervical cancer screening. Middle East Fertility Society Journal, 18(2), 102–109. https://doi.org/10.1016/j.mefs.2012.12.001

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