OBJECTIVE: To determine the performance of HR-HPV E6/E7 massager RNA (mRNA) test for detecting high-grade cervical intraepithelial neoplasia in cervical cancer screening and compare the clinical performance of HR-HPV E6/E7 mRNA test with HC-2 and Cervista HPV DNA tests for cross-sectional positivity in women with and without cervical neoplasia. METHODS: A total of 172 women underwent cytology, HR-HPV DNA test, HR-HPV E6/7 mRNA test, colposcopy and biopsy. We compared the clinical performance of HR-HPV E6/E7 mRNA test with Hybrid Capture 2 DNA test (HC-2) and Cervista HR-HPV DNA test on the cervical brush specimens during colposcopy and routine screening. The samples were histologically confirmed high-grade cervical intraepithelial neoplasia (CIN II) or worse (CIN II+) as an endpoint. RESULTS: HR-HPV E6/E7 mRNA positive rate was 37.9% in NILM, 67.9% in ASCUS and LSIL, 88.5% in ASC-H+. HR-HPV E6/E7 mRNA positive rate was 38.6% in CIN I, 77.4% in CIN II-3 and 92.5% in SCC. HR-HPV E6/E7 mRNA test showed a higher specificity than HC-2 and Cervista HPV DNA tests for high-grade lesions (61.4%, 54.3%, 55.7%, respectively, P < 0.05) and also a higher positive predictive value (75.9%, 74.8%, 74.6% respectively). Among three tests, HR-HPV E6/E7 mRNA had the largest area of ROC curve and the best diagnostic value. CONCLUSION: HR-HPV E6/E7 mRNA test has a performance more specific for detecting CIN II+ with the same sensitivity as HC-2 and Cervista HPV DNA tests. And it may serve as a more specific test for predicting the risk of progression and offer a viable tool for triage during cervical cancer screening.
OBJECTIVE: To determine the performance of HR-HPV E6/E7 massager RNA (mRNA) test for detecting high-grade cervical intraepithelial neoplasia in cervical cancer screening and compare the clinical performance of HR-HPV E6/E7 mRNA test with HC-2 and Cervista HPV DNA tests for cross-sectional positivity in women with and without cervical neoplasia. METHODS: A total of 172 women underwent cytology, HR-HPV DNA test, HR-HPV E6/7 mRNA test, colposcopy and biopsy. We compared the clinical performance of HR-HPV E6/E7 mRNA test with Hybrid Capture 2 DNA test (HC-2) and Cervista HR-HPV DNA test on the cervical brush specimens during colposcopy and routine screening. The samples were histologically confirmed high-grade cervical intraepithelial neoplasia (CIN II) or worse (CIN II+) as an endpoint. RESULTS:HR-HPV E6/E7 mRNA positive rate was 37.9% in NILM, 67.9% in ASCUS and LSIL, 88.5% in ASC-H+. HR-HPV E6/E7 mRNA positive rate was 38.6% in CIN I, 77.4% in CIN II-3 and 92.5% in SCC. HR-HPV E6/E7 mRNA test showed a higher specificity than HC-2 and Cervista HPV DNA tests for high-grade lesions (61.4%, 54.3%, 55.7%, respectively, P < 0.05) and also a higher positive predictive value (75.9%, 74.8%, 74.6% respectively). Among three tests, HR-HPV E6/E7 mRNA had the largest area of ROC curve and the best diagnostic value. CONCLUSION:HR-HPV E6/E7 mRNA test has a performance more specific for detecting CIN II+ with the same sensitivity as HC-2 and Cervista HPV DNA tests. And it may serve as a more specific test for predicting the risk of progression and offer a viable tool for triage during cervical cancer screening.