Aptima® HPV Assay

Identify the presence and activity of a high-risk HPV infection

While nearly all sexually active women and men who are not vaccinated will have an HPV infection at some point
in their lives, relatively few will go on to develop cancer. 1 Thus, an optimal screening strategy should identify cervical cancer precursors likely to progress to invasive cancers, while avoiding detection and unnecessary treatment of transient HPV infection and its associated noncancerous lesions.2 With the extension of recommended intervals between cervical cancer screenings, it has become all the more important to accurately identify at-risk patients.

Targeted test

The Aptima® HPV assay targets E6/E7 mRNA and identifies high-risk HPV infections that are present and active.3,4

  • Studies have shown mRNA identifies the presence and activity of a high-risk HPV infection.
  • HPV DNA tests only identify the presence of any of the 14 high-risk HPV types.
  • E6/E7 mRNA expression is indicative of the HPV infections most likely to lead to disease.

Maximizing the benefits

Studies show the Aptima® HPV assay targets mRNA and provides the exact same excellent sensitivity as DNA-based tests.5-26

Clinical sensitivity for >= CIN3

Fewer false-positive results10


While minimizing potential harms10

In the NILM arm of the CLEAR trial, our Aptima HPV test showed 24% fewer false-positive test results compared to a DNA-based test. By minimizing false positives, our test helps clinicians accurately identify patients who require colposcopy.

Designed for sensitive detection of HPV oncogenic activity

  • Aptima® HPV targets oncogenic activity of the HPV virus by detecting E6/E7 mRNA.10
  • Tests that target only the L1 gene are detecting an area that is not needed for disease progression and that can be deleted during integration.27
  • HPV DNA must linearize to integrate into human DNA.27
  • L1 region can be deleted.27
  • HPV assays that only target the L1 region are at risk for false negative results.27
E6/E7 is retained during HPV DNA integration10

L1-based DNA tests have been shown to miss up to 10%-15% of the most severe disease cases.28,29,30

Comparison of detection strategies

Comparison of HPV tests

Years of long-term results

Studies show the mRNA-based Aptima HPV assay has up to 7 years of continuous follow-up in cervical cancer screening.33,34
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1. Genital HPV Infection –CDC Fact Sheet. Published July 2017. Accessed September 2, 2020. https://www.cdc.gov/std/hpv/HPV-FS-July-2017.pdf. 2. Saslow D, et al. American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology Screening Guidelines for the Prevention and Early Detection of Cervical Cancer. Am J Clin Pathol. 2012;137:516-542. 3. Tinelli A, et al. HPV viral activity by mRNA HPV molecular analysis to screen the transforming infections in precancer cervical lesions. Curr Pharm Biotechnol. 2009;10(8):767-771. 4. Cuschieri K, et al. Human Papillomavirus Type Specific DNA and RNA Persistence–Implications for Cervical Disease Progression and Monitoring. J Med Virol. 2004;73(1):6570.doi:10.1002/jmv.20062 5. Szarewski A, et al. Comparison of predictors for high grade cervical intraepithelial neoplasia in women with abnormal smears. Cancer Epidemiol Biomarkers Prev. 2008;17(11):3033-3042.6. Dockter J, et al. Clinical performance of the APTIMA HPV Assay for the detection of high-risk HPV and high-grade cervical lesions. J Clin Virol. 2009;45(S1):S55-S61. 7. Reuschenbach M, et al. Performance of p16INK4a-cytology, HPV mRNA, and HPV DNA testing to identify high grade cervical dysplasia in women with abnormal screening results. Gynecol Oncol. 2010;119(1):98-105. 8. Clad A, et al. Performance of the Aptima high-risk human papillomavirus mRNA assay in a referral population in comparison with Hybrid Capture 2 and cytology. J Clin Microbiol. 2011;49(3):1071-1076. 9. Ratnam S, et al. Aptima HPV E6/E7 mRNA test is as sensitive as Hybrid Capture 2 assay but more specific at detecting cervical precancer and cancer. J Clin Microbiol. 2011;49(2):557-564.10. Aptima HPV Assay [package insert]. AW-12820, Rev.004. San Diego, CA; Hologic, Inc., 2017.11. Ovestad IT, et al. Comparison of different commercial methods for HPV detection in follow-up cytology after ASCUS/LSIL, prediction of CIN2-3 in follow up biopsies and spontaneous regression of CIN2-3. Gynecol Oncol. 2011;123(2):278-283.12. Szarewski A, et al. Comparison of seven tests for highgrade cervical intraepithelial neoplasia in women with abnormal smears: the Predictors 2 study. J Clin Microbiol. 2012; 50(6):1867-1873.13. Eaton, et al. Comparison of the Aptima HPV assay and the cobas HPV test in an ASC-US population [abstract]. Paper presented at: 28th International Papillomavirus Conference. November 30-December 6, 2017. San Juan, Puerto Rico.14. Cuschieri K, et al. Clinical performance of RNA and DNA based HPV testing in a colposcopy setting: Influence of assay target, cut off and age. J Clin Virol. 2014;59(2):104-108.15. Cubie HA, et al. Evaluation of commercial HPV assays in the context of post-treatment follow-up: Scottish Test of Cure Study (STOCS-H). J Clin Pathol. 2014;67(6):458-463.16. Binniker M, et al. Comparative evaluation of three commercial systems for the detection of high-risk human papillomavirus in cervical and vaginal ThinPrep PreservCyt samples with biopsy correlation. J Clin Microbiol. 2014;52(10):3763-8.17. Castle P, et al. Comparison of human papillomavirus detection by Aptima HPV and cobas HPV Tests in a population of women referred for colposcopy following detection of atypical squamous cells of undetermined significance by pap cytology. J Clin Microbiol. 2015;53(4):1277-1281.18. Cuzick J, et al. A comparison of different human papillomavirus tests in PreservCyt versus SurePath in a referral population—PREDICTORS 4. J Clin Virology. 2016;82:145-151.19.Virtanen E, et al. Performance of mRNA-and DNA-based high-risk human papillomavirus assays in detection of high-grade cervical lesions. Acta Obstetricia et Gynecologica Scandinavica. 2017; 96(1):61-68.20. Wu R, et al. Human papillomavirus messenger RNA assay for cervical cancer screening: the Shenzhen Cervical Cancer Screening Trial I. Intl J Gynecol Cancer. 2010;20(8):1411-1414. 21. Monsonego J, et al. Evaluation of oncogenic human papillomavirus RNA and DNA tests with liquid-based cytology in primary cervical cancer screening: the FASE study. Intl J Cancer. 2011;129(3):691-701. 22. Iftner, et al. Comparison of Aptima and HC2 in a routine screening trial in Germany with follow up [abstract]. Paper presented at: 28th International Papillomavirus Conference; November 30-December 6, 2012; San Juan, Puerto Rico. 23. Cuzick J, et al. Comparing the performance of six human papillomavirus tests in a screening population. Br J Cancer. 2013;108:908-913. 24. Nieves L, et al. Primary cervical cancer screening and triage using an mRNA human papillomavirus assay and visual inspection.Int J Gynecol Cancer.2013;23(3):513-518. 25. Iftner T, et al. Head-to-Head Comparison of the RNA-Based Aptima Human Papillomavirus (HPV) Assay and the DNA-Based Hybrid Capture 2 HPV Test in a Routine Screening Population of Women Aged 30 to 60 Years in Germany. J Clin Microbiol. 2015;53(8):2509-2516. 26. American Society for Colposcopy and Cervical Pathology. 2012 Updated Consensus Guidelines for the Management of Abnormal Cervical Cancer Screening Tests and CancerPrecursors.J Low Genit Tract Dis.2013;17(5):S1-S27. 27. Morris BJ. Clin Chem Lab Med. 2005;43(11):1171-7. doi:10.1515/ CCLM.2005.203.28. De Sanjose et al.Lancet Oncol.2010;11(11):1048-56. doi: 10.1016/S1470-2045(10)70230-8. 29. Wheeler CM, et al. J Natl Cancer Inst.2009;101(7):475-87. doi:10.1093/jnci/djn510. 30. Coutlée F, et al. J MedVirol. 2011;83(6):1034-41. doi:10.1002/jmv.22081. 31. Hybrid Capture 2 [package insert]. #L00665. QIAGEN, Inc. 32.Cobas c4800 [package insert]. #05641268001-0N. Roche Molecular Systems, Inc. 33. Iftner T, et al. The longitudinal clinical performance of the RNA-based AHPV Human Papillomavirus (HPV) Assay in comparison to the DNA-based Hybrid Capture 2 HPV Test in 2 consecutive screening rounds with a 6-year interval inGermany. J Clin Microbiol. 2018. doi:10.1128/JCM.01177-18 (GAST) 34. Forslund O, et al. HPV-mRNA and HPV-DNA detection in samples taken up to seven years before dysplasia of cervix uteri. Int J Cancer. 2018; doi: 10.1002/ijc.31819