Laboratory Products
Strong Clinical Performance
Jan 07 2011
Hologic, Inc is dedicated to serving the healthcare needs of women and announced the final results from an independent Trial that highlights the clinical effectiveness of Cervista® HPV HR.
The SHENCCAST II study is the first and only large-scale independent evaluation of clinical performance of Cervista® HPV HR compared to Hybrid Capture® 2 (hc2). Data from the completed study of over 8400 women were presented at the 26th International Papillomavirus Conference in Montreal.
The HPV positivity rate in women with normal cytology was 6.0% when tested with Cervista HPV HR, lower than the 7.9% positive rate with hc2; sensitivity for ‡ CIN2 was statistically equivalent for the Cervista HPV HR test, 92.9% (88.8-95.9) and hc2, 95.6% (92.0-97.9); Cervista HPV demonstrated a statistically significant improvement in specificity compared to hc2 with 91.1% (90.5-91.7) vs 88.6% (87.9-89.3) (p = <.05); and a statistical analysis of overall test accuracy that plots comparative sensitivity and specificity found the two methods were clinically equivalent.
In a large and demographically diverse prospective clinical trial, Cervista® HPV demonstrated clear clinical utility. The study’s clinical findings found: sensitivity of the Cervista HPV HR test for detection of ‡ CIN2 among women with ASC-US cytology was 92.8% (84.1-96.9) and the NPV was 99.1% (98.1-99.6); sensitivity for detection of ‡ CIN3 among women with ASC-US cytology was 100% (85.1-100) and the NPV was 100% (99.4-100); and 16/18 genotyping test sensitivity of ‡ CIN2 was 68.8 (56.6-78.8) and NPV was 96.0% (93.9-97.4).
16/18 genotyping test sensitivity of ‡ CIN3 was 77.3 (56.6-89.9) and NPV was 99.0% (97.7-99.6).
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