The landmark ATHENA clinical study helped shape our understanding of the role of high-risk HPV testing in cervical cancer screening
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Conclusion: Individual detection of HPV 16 in women with ASC-US cytology identifies those women who are at the highest risk of cervical precancer.2
Conclusion: Women with ASC-US cytology who are HPV 16+ could benefit from intensive follow-up in the case of an unsatisfactory colposcopy result.2
The performance of the cobas® HPV Test is comparable to that of the prior standard of testing for pooled high-risk HPV, while adding the benefit of providing genotyping results for the highest-risk genotypes, HPV 16 and 18.
*hc2 and Hybrid Capture 2 is a trademark of Qiagen.
|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 (1,056/1,498)||(68,73)||71.1 (1,056/1,485)||(69,73)|
|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
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1. American Society for Colposcopy and Cervical Pathology. HPV genotyping clinical update. http://www.asccp.org/Portals/9/docs/pdfs/Consensus%20Guidelines/clinical_update_20090408.pdf. Accessed August 9, 2011.
2. 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.
3. cobas® 4800 HPV Test US package insert. April 2011.
4. Wright TC Jr, Stoler MH, Sharma A, Zhang G, Behrens CM, Wright TL. Evaluation of HPV-16 and HPV-18 genotyping for the triage of women with high-risk HPV+ cytology-negative results. Am J Clin Pathol. 2011;136:578-586.