Results from the ATHENA trial validated the importance of detecting HPV 16 individually. Trial results demonstrated that women with ASC-US who were HPV 16 positive were more than twice as likely to have ≥CIN2 than those who were pooled hrHPV positive.1 In fact, the absolute risk of ≥CIN2 was 31.5% among women who were HPV 16 positive.1 The cobas® HPV test provides individual HPV 16 results to help identify those women with ASC-US who are at the highest risk and may need more intensive post colposcopic follow-up.
The performance of the cobas® HPV Test is comparable to that of the prior standard of testing for pooled hrHPV, while adding the benefit of providing genotyping results for the highest-risk genotypes, HPV 16 and 18.
cobas® HPV Test and Hybrid Capture 2 (hc2)* in the ASC-US population for detection of ≥CIN22
|Result (%)||cobas® HPV Test||hc2 Test|
|Point estimate||(95% CI)||Point estimate||(95% CI)|
|Sensitivity||90.0 (72/80)||(82,95)||87.2 (68/78)||(78,93)|
|Specificity||70.5 (1,056/1,064)||(68,73)||71.1 (1,056/1,485)||(69,73)|
|PPV||14.0 (72/514)||(13,15)||13.7 (68/497)||(12,15)|
|NPV||99.2 (1,056/1,064)||(98.6,99.6)||99.1 (1,056/1,066)||(99.9,99.5)|
PPV = positive predictive value; NPV = negative predictive value
*hc2 and Hybrid Capture 2 is a trademark of Qiagen
1. Stoler MH, Wright TC, Sharma A, et al. High-risk human papillomavirus testing in women with ASC-US cytology: results from the ATHENA HPV study. Am J Clin Pathol. 2011;135(3):468-475.
2. cobas® 4800 HPV Test US package insert. April 2016.