Aptima® HPV Assay


  1. Genital HPV Infection - CDC Fact Sheet. http://www.cdc.gov/std/hpv/hpv-factsheet-march-2014-press.pdf. Published 2014. Accessed August 24, 2015.
  2. Wright C, et al. The ATHENA human papillomavirus study: design, methods & baseline results. Am J Obstet Gynecol. 2012;206(1):46.e1-46.e11. (Study included cobas® HPV, Hybrid Capture® 2 assay)
  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):65-70.
  5. Doorbar J. Molecular biology of human papillomavirus infection and cervical cancer. Clin. Sci. (Lond). 2006 May;110(5):525-41.
  6. Aptima HPV Assay [package insert, AW-11141-001 Rev 003 (EN)], San Diego, CA; Hologic, Inc., 2015. Table#22.
  7. Szarewski A, et al. Comparison of predictors for highgrade cervical intraepithelial neoplasia in women with abnormal smears. Cancer Epidemiol Biomarkers Prev. 2008;17(11):3033-3042.
  8. 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.
  9. 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.
  10. 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.
  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 high-grade 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.
  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. 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.
  17. 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.
  18. 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; Nov 30-Dec 6, 2012; San Juan, PuertoRico.
  19. Cuzick J, et al. Comparing the performance of six human papillomavirus tests in a screening population. Br J Cancer. 2013;108:908-913.
  20. 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.
  21. M. J. Binnicker, et al. Comparative evaluation of three commercial systems for detection of high-risk Human Papillomavirus in Cervical and Vaginal ThinPrep PreservCyt Samples and Correlation with biopsy results. J Clin Microbiol. 2014; 2(10):3763.
  22. Iftner, 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; 53:2509 –2516.