Comparative study of the cervista and hybrid capture 2 methods in detecting high‐risk human papillomavirus in cervical lesions

Abstract

High-risk human papillomavirus (HR HPV) testing is important for the follow-up of patients with cytological abnormalities. This study was undertaken to compare the clinical value of the Cervista and hybrid capture 2 (HC2) tests for detection of HR HPV in cervical lesions. Overall 439 cervical specimens with abnormal cytology and 22 normal cervical specimens were subjected to the Cervista and HC2 tests. HPV positivity and its predictive value for high-grade cervical lesions were assessed. The Cervista and HC2 tests showed comparable HR HPV detection rates in women with all cytological and histological diagnoses, with a positive and negative percent agreement of 90.8% and 64.5%, respectively. The two methods had a same sensitivity of 90% in detecting CIN II or greater cervical lesions, while the specificity for the Cervista test and HC2 assay was 47% and 43%, respectively. The positive rate for the Cervista assay probe set A9 increased with the histological severity, ranging from 25.0% in normal specimens to 69.5% in high-grade lesions. In conclusion, the clinical performance for the Cervista test is as excellent as the HC2 test in detecting HR HPV and predicting high-grade cervical lesions.