The ThinPrep Difference
FDA-Approved/Cleared and Chosen by Physicians
The ThinPrep Pap Test is the most comprehensive, FDA-approved, liquid-based pap test available. It offers increased HSIL detection,1 and is the only pap test approved/cleared by the FDA for HPV, Chlamydia/Gonorrhea and Trichomonas testing "out of the vial". Additionally, it is the only pap test for which the FDA has approved labeling supported by multiple peer-reviewed publications2-7 reporting improved glandular disease detection.
The significance of FDA aprrovals/clearance
To obtain FDA approval/clearance, manufacturers must meet rigorous testing criteria demonstrating that their product is safe and effective.8 The criteria require valid scientific evidence to ensure consistent and reproducible product performance, such that the particular requirements for the specific intended use can be fulfilled consistently. The ThinPrep Pap Test met these criteria so that physicians, lab personnel, and patients can be confident using the ThinPrep Pap Test specimen for such tests. In fact, governing bodies such as the American Society for Colposcopy and Cervical Pathology noted that:
"The appropriate use of [ASCCP] guidelines require that laboratories utilize only HPV tests that have been analytically and clinically validated with proven, acceptable reproducibility, clinical sensitivity, specificity, and positive and negative predictive values for cervical cancer and verified precancer (CIN 2,3) as documented by the Food and Drug Administration (FDA) approval and/or publication in peer-reviewed scientific literature."
— American Journal of Obstetrics and Gynecology, October 2007
FDA-approved/cleared out of the vial tests
The ThinPrep Pap Test is the only pap test to secure FDA approvals/clearance for ancillary testing including:
FDA Approved Tests:
- Cervista® HPV HR
- Cervista® HPV 16/18
- APTIMA® HPV Assay
- APTIMA® HPV 16, 18/45 Genotype Assay
- Roche cobas® HPV Test
- Roche cobas® AMPLICOR CT/NG
- Digene® hc2®
FDA Cleared Tests:
- APTIMA® Combo 2 Assay
- APTIMA® Trichomonas Assay
- BD ProbeTec™ Chlamydia trachomatis (CT)
- BD ProbeTec™ Neisseria gonorrhoeae (GC)
The ThinPrep Pap Test is also the only pap test supported by multiple peer reviewed studies2-7 to meet the FDA standards for improved glandular disease detection.
*Hybrid Capture® 2 (hc2) and Digene® HPV Test are registered trademarks of QIAGEN Group. COBAS AMPLICOR™ is a trademark of Roche Diagnostics Corporation and ProbeTec™ is a trademark of Becton Dickinson.
Learn more about clinical guidelines for pap testing
1. Versus the Conventional Pap Smear, Hologic, Inc. The ThinPrep Pap Test package insert results based on a multi-site prospective, historically-controlled, direct-to-vial study of routine screening and referral patient populations at 10 leading academic institutions resulting in a 59.7% increase in detection of HSIL+ lesions for ThinPrep specimens.
2. Bai H, Sung CJ, Steinhoff MM. ThinPrep Pap Test promotes detection of glandular lesions of the endocervix. Diagn Cytopathol. 2000;23:19-22.
3. Carpenter AB, Davey DD. ThinPrep Pap Test: performance biopsy follow-up in a university hospital. Cancer. 1999;87:105-12.
4. Guidos BJ, Selvaggi SM. Detection of endometrial adenocarcinoma with the ThinPrep Pap Test. Diagn Cytopathol. 2000;23:260-5.
5. Schorge JO, Hossein Saborian M, Hynan L, et al. ThinPrep detection of endometrial adenocarcinoma: a retrospective cohort study. Cancer Cytopathol. 2002;96:338-43.
6. Wang N, Emancipator SN, Rose P, et al. Histologic follow-up of atypical endocervical cells. Liquid-based, thin-layer preparation vs. conventional pap smear. Acta Cytol. 2002;46:453-7.
7. Ashfaq R, Gibbons D, Vela C, Saboorian MH, Iliya F. ThinPrep Pap Test accuracy for glandular disease. Acta Cytol. 1999;43:81-5.
8. U.S. Food and Drug Administration. FDA Heart Health Online. Available at: http://www.fda.gov/hearthealth/faqs/faqs.html. Accessed 4/30/08.