Study Validates Clinical Performance of Cervista HPV Test

30 March 2010 (Last Updated March 30th, 2010 18:30)

Cervista HPV HR is a validated diagnostic test for the detection of 14 high-risk human papillomavirus (HPV) types, according to an interim data study. The SHENCCAST II study, presented at the 4th Biennial Meeting of AOGIN (Asia-Oceanic Research Organization in Genital Infection and Neo

Cervista HPV HR is a validated diagnostic test for the detection of 14 high-risk human papillomavirus (HPV) types, according to an interim data study.

The SHENCCAST II study, presented at the 4th Biennial Meeting of AOGIN (Asia-Oceanic Research Organization in Genital Infection and Neoplasia) in New Delhi, India, compared Cervista HPV HR to Hybrid Capture 2 (hc2).

The study was conducted on more than 10,000 women in China to evaluate the performance of HPV assays, among other endpoints.

Overall HPV positivity was 12.2% for the Cervista HPV HR test and 14.6% with the hc2 test, according to a preliminary analysis of data from 5,043 patients.

The Cervista HPV HR test proved improved specificity and the hc2 test yielded higher sensitivity, and the overall test confirmed that the two methods were clinically equivalent.

The Cervista HPV HR test offers clinicians and labs specific advantages in HPV testing including an internal control to guard against false negatives, a lower required sample size and various workflow advantages for labs.