Age-Stratified Performance of the Cervista HPV 16/18 Genotyping Test in Women with ASC-US Cytology

作者：Einstein Mark H^*; Garcia Francisco A R; Mitchell Amy L; Day Stephen P

来源：Cancer Epidemiology Biomarkers & Prevention, 2011, 20(6): 1185-1189.

DOI：10.1158/1055-9965.EPI-11-0116

Background: The objective of this study was to evaluate the clinical performance of the Cervista HPV 16/18 genotyping test for detection of human papilloma virus (HPV) 16 and 18 in cervical cytology specimens in women stratified by age.
Methods: In a multicenter, prospective clinical study, ThinPrep specimens were tested for the presence of HPV 16 and 18 using the HPV 16/18 genotyping test. Genotyping results from women with atypical squamous cells of undetermined significance or greater cytology were compared with local colposcopy and/or histology results. Sensitivity, specificity, and negative and positive predictive values (NPV and PPV) were determined.
Results: The prevalence of cervical intraepithelial neoplasia (CIN) 2(+) in subjects positive for HPV 16/18 was 6.6% and 4.1% for women <30 and >= 30 years of age, respectively. The sensitivity of the test was 70.0% (95% CI: 54.6-81.9) and 66.7% (95% CI: 46.7-82.0) in women <30 and >= 30 years, respectively. The NPV was 95.5% (95% CI: 93.4-97.6) in women <30 years and 96.6% (95% CI: 94.8-98.5) in women >= 30 years. Specificity was higher in women >= 30 years (79.9%; 95% CI: 74.9-84.2) than women <30 years (61.9%; 95% CI: 57.1-66.4). The PPV was 15.2% (95% CI: 12.7-19.1) in women <30 years and 21.9% (95% CI: 17.0-30.7) in women >= 30 years.
Conclusions: The performance of the Cervista HPV 16/18 genotyping test for predicting >= CIN 2 is what would be expected across the key >= CIN 2 age strata.
Impact: HPV 16/18 genotyping may help further stratify women with a greater potential to develop cervical cancer. Cancer Epidemiol Biomarkers Prev; 20(6); 1185-9.

• 出版日期2011-6