Objective: To assess the value of combining high-risk human papillomavirus (HPV) DNA test and cytological test in detection of early cervical dysplasia.
Methods: During January 2003 to June 2004, a total of 5210 women were screened by combining high-risk HPV DNA test (hybrid capture II, HC-II) and cytological test (liquid-based ThinPrep cytology test), and the abnormal cytological or HPV DNA findings were further biopsied under the colposcope.
Results: The age of the patients was between 17 to 80, the average was 34 +/- 9. Final pathological diagnosis was HPV infection in 890 cases, cervical intraepithelial neoplasia (CIN) I in 83 cases, CIN II in 73 cases, CIN III in 80 cases, invasive cervical cancer in 54 cases, endometrial cancer in 5 cases, vaginal intraepithelial neoplasia in 1 case and cervical tuberculosis in 1 case. Based on the criteria of histology and pathology, the sensitivity, specificity, positive-predictive value and negative-predictive value of high-risk HPV DNA test for detecting all cases of CIN II, III were 92.22%, 74.71%, 5.19% and 99.84% respectively. In detecting all cases of CIN II, III by cytological test, for atypical squamous cell of undetermined signification (ASCUS), the sensitivity, specificity, positive-predictive value and negative-predictive value were 90.00%, 80.34%, 11.94% and 99.63% respectively; for low-grade squamous intraepithelial lesion (LSIL), the sensitivity, specificity, positive-predictive value and negative-predictive value were 70.13%, 91.58%, 11.11% and 99.51% respectively; for high-grade squamous intraepithelial lesion (HSIL), the sensitivity, specificity, positive-predictive value and negative-predictive value were 48.05%, 98.46%, 31.90% and 99.21% respectively. By the combination of high-risk HPV DNA test and cytological test, the sensitivity, specificity, positive-predictive value and negative-predictive value for detecting all cases of CIN II, III were 98.70%, 73.08%, 5.21% and 100.00% respectively. The infection rate of HPV in cervical cancer was 85.2% (46/54), in CIN III 92.5% (74/80), in CIN II 86.3% (63/73) and in CIN I 45.8% (38/83).
Conclusions: High-risk HPV DNA test has high sensitivity and negative-predictive value. The combination of high-risk HPV DNA test and cytological test increases the sensitivity and negative-predictive value, but it does not increase the specificity. The performance of biopsy under the colposcope can help the diagnosis of cervical dysplasia.