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  • Man and woman laboratorians

    cobas® HPV Test

    Risk matters. Deliver 3 results in 1 test for accuracy that your clinical partners expect and that patients deserve      

  The cobas® HPV Test identifies women with the highest risk of cervical cancer

 

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.

 

 

ATHENA-CIN2-risk-ASC-US.png

Clinically proven performance that clinical partners expect and patients deserve

 

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

Scroll Right
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

  • Acronyms:

References:

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.