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Better specificity

Reduce false positives that can cause unnecessary alarm

HPV mRNA testing provides better specificity than HPV DNA testing

Aptima® HPV mRNA has been shown to reduce false positives by 37% vs Roche cobas® HPV1

EXCELLENT SENSITIVITY

Aptima, along with Pap testing, has a combined sensitivity of over 99% for detecting cancer and high-grade cervical disease.22
Sensitivity
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HPV mRNA GENOTYPING

Identifies high-risk HPV types of most concern, including 16, 18/45, most often associated with squamous cell carcinoma and adenocarcinoma.22
Genotyping
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For more information

To set up testing, contact your sales representative or call 1.866.MYQUEST (1.866.697.8378).

You can also learn more about Aptima in our Test Directory.

Test Directory

The Aptima HPV assay detects E6/E7 viral mRNA from 14 high-risk types of human papillomavirus in cervical specimens (in ThinPrep® Pap Test vials containing PreservCyt® Solution and collected with broomtype or cytobrush/spatula devices). The test is indicated to screen women ≥21 years with ASCUS cytology to determine the need for colposcopy, and to screen women ≥30 years for high-risk HPV types. This information with cytology history, other risk factors, and guidelines may be used to manage patients. See www.genprobe.com for more details.
 

The assay is not a substitute for regular cervical cytology screening. The results of this test are not intended to prevent women from proceeding to colposcopy. The assay has not been evaluated for managing HPV vaccinated women, women with prior ablative or excisional therapy, hysterectomy, who are pregnant, or have other risk factors. Aptima and other associated logos are registered trademarks of Hologic, Inc., and/or its subsidiaries in the United States, and/or other countries.
 

References
 

  1. Cuzick J, Cadman L, Mesher D, et al. Comparing the performance of six human papillomavirus tests in a screening population. Br J Cancer. 2013;108(4):908-913. doi: 10.1038/bjc.2013.22
  2. Stoler MH, Wright TC Jr, Parvu V, et al. The Onclarity Human Papillomavirus Trial: design, methods, and baseline results. Gynecol Oncol. 2018;149(3):498-505. doi: 10.1016/j.ygyno.2018.04.007
  3. Szarewski A, Ambroisine L, Cadman L, 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. doi: 10.1158/1055-9965.EPI-08-0508
  4. Dockter J, Schroder A, Hill C, Guzenski L, Monsonego J, Giachetti C. Clinical performance of the Aptima HPV Assay for the detection of high-risk HPV and high-grade cervical lesions. J Clin Virol. 2009;45(Suppl 1):S55-S61. doi: 10.1016/S1386-6532(09)70009-5
  5. Reuschenbach M, Clad A, von Knebel Doeberitz C, 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. doi: 10.1016/j.ygyno.2010.06.011
  6. Clad A, Reuschenbach M, Weinschenk J, Grote R, Rahmsdorf J, Freudenberg N. 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. doi: 10.1128/JCM.01674-10
  7. Ratnam S, Coutlee F, Fontaine D, 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. doi: 10.1128/JCM.02147-10
  8. Aptima HPV Assay (package insert) AW-10958 Rev., 002, 2015-02. Hologic, Inc.; 2017.
  9. Ovestad IT, Vennestrøm U, Andersen L, 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. doi: 10.1016/j.ygyno.2011.07.024
  10. Szarewski A, Mesher D, Cadman L, 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. doi: 10.1128/JCM.00181-12
  11. Castle PE, Eaton B, Reid J, Getman D, Dockter J. 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. doi: 10.1128/JCM.03558-14
  12. Cuschieri K, Cubie H, Graham C, 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. doi: 10.1016/j.jcv.2013.12.001
  13. Cubie HA, Canham M, Moore C, Pedraza J, Graham C, Cuschieri K. 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. doi: 10.1136/jclinpath-2013-202014
  14. Binnicker MJ, Pritt BS, Duresko BJ, 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 and correlation with biopsy results. J Clin Microbiol. 2014;52(10):3763-3768. doi: 10.1128/JCM.01928-14
  15. Castle PE, Eaton B, Reid J, Getman D, Dockter J. 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. doi: 10.1128/JCM.03558-14
  16. Wu R, Belinson SE, Du H, et al. Human papillomavirus messenger RNA assay for cervical cancer screening: the Shenzhen Cervical Cancer Screening Trial I. Int J Gynecol Cancer. 2010;20(8):1411-1414. doi: 10.1111/IGC.0b013e3181f29547
  17. Monsonego J, Hudgens MG, Zerat L, et al. Evaluation of oncogenic human papillomavirus RNA and DNA tests with liquid-based cytology in primary cervical cancer screening: the FASE study. Int J Cancer. 2011;129(3):691-701. doi:10.1002/ijc.25726
  18. Iftner T, Becker S, Sasieni P, et al. Comparison of Aptima and HC2 in a routine screening trial in Germany with follow up. Abstract presented at the 28th International Papillomavirus Conference, November 30 - December 6, 2012; San Juan, Puerto Rico.
  19. Cuzick J, Cadman L, Mesher D, et al. Comparing the performance of six human papillomavirus tests in a screening population. Br J Cancer. 2013;108(4):908-913. doi: 10.1038/bjc.2013.22
  20. Nieves L, Enerson CL, Belinson S, 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. doi: 10.1097/IGC.0b013e318280f3bc
  21. Iftner T, Becker S, Neis KJ, 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. doi: 10.1128/JCM.01013-15
  22. Aptima HPV assay [package insert].

Co-testing solutions for

cervical cancer

Learn more about how Pap and HPV mRNA

testing work together to provide early

detection of cervical cancer.

Download Brochure

Aptima HPV RNA assay

Resources

The importance of screening for STIs

Clinical view on diagnostic strategies from AAFP for sexually transmitted infections: a 3-part webinar series

ReproSource: Quest Diagnostics Center of Excellence for fertility testing

Testing by trimester

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