APTIMA HPV Assays
Cervical cancer is one of the most common female cancers in the world. Human papillomavirus (HPV) is the etiological agent responsible for more than 99% of all cervical cancers.1-3
The APTIMA HPV assay accurately detects the HPV types likely to progress to cancer.4 In numerous clinical studies involving approximately 45,000 women worldwide, the APTIMA HPV assay has consistently shown similar sensitivity and better specificity than the most frequently used DNA-based test.
Confidently deliver results with fewer false positives
Based on a clinical evaluation of more than 10,000 US women with normal cytology results, the APTIMA HPV assay had 24% fewer false positives than an FDA-approved DNA test.5 With the APTIMA HPV assay, labs can now confidently deliver results to physicians with fewer false positives, helping avoid the complaints that arise from the performance of unnecessary colposcopies and costly medical procedures.4
The APTIMA HPV assay is an in vitro nucleic acid amplification test for the qualitative detection of E6/E7 viral messenger RNA (mRNA) from 14 high-risk types of HPV in cervical specimens. The high-risk HPV types detected by the assay include: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. The APTIMA HPV Assay provides clear positive, negative, or invalid results for the cumulative 14 high-risk genotypes. The assay has been validated with cervical specimens in ThinPrep Pap Test vials containing PreservCyt Solution and collected with broom-type or cytobrush/spatula collection devices.
The APTIMA HPV Assay is the latest addition to Hologic Gen-Probe’s menu of women’s health test options, and expands the test offerings that labs can run on the fully automated TIGRIS system.
1 Doorbar, J. 2006. Molecular biology of human papillomavirus infection and cervical cancer. Clin Sci (Lond). 110(5):525-41.
2 Monsonego J., F.X. Bosch, P. Coursaget, J.T. Cox, E. Franco, I. Frazer, R. Sankaranarayanan, J. Schiller, A. Singer, T.C. Wright Jr, W. Kinney, C.J. Meijer, J. Linder, E. McGoogan, and C. Meijer. 2004. Cervical cancer control, priorities and new directions. Int J Cancer. 108(3):329-33. Erratum in: Int J Cancer. 108(6):945.
3 Walboomers, J. M., M.V. Jacobs, M.M. Manos, F.X. Bosch, J.A. Kummer, K.V. Shah, P.J. Snijders, J. Peto, C. J. Meijer, N. Muñoz.1999. Human papillomavirus is a necessary cause of invasive cervical cancer worldwide. J Pathol. 189:12-19.
4 Clad A, et al. J Clin Microbiol. 2011 Mar;49(3):1071-6.
5 APTIMA HPV Assay (package insert), San Diego, CA: Hologic Gen-Probe Incorporated, 2011. Calculated based on the specificity difference between the APTIMA HPV assay and the FDA -approved DNA test (95.2% vs. 93.7%), as reported in Table 13 of the package insert: NILM ≥ 30 Years Population: Performance of the APTIMA HPV Assay and an FDA -approved HPV DNA Test for Detection of ≥CIN2 and ≥CIN3 (Verification-Bias Adjusted Estimates). Three-year clinical follow-up study for the NILM population is ongoing.
|APTIMA HPV Assay, TIGRIS||250 tests||303012|
|APTIMA HPV Calibrators Kit||-||303010|
|APTIMA HPV Controls Kit||-||303011|
|Cat #||Product||Kit Size||PI|
|303012||APTIMA HPV Assay, TIGRIS||250 tests||PI|
|303010||APTIMA HPV Calibrators Kit||PI|
|303011||APTIMA HPV Controls Kit||PI|
|303234||APTIMA HPV 16 18/45 Genotype Assay, TIGRIS||100 tests||PI|
|303235||APTIMA HPV 16 18/45 Genotype Calibrators Kit||PI|
|Cat #||Product||Kit Size||MSDS|
|303012||APTIMA HPV Assay, TIGRIS||250 tests||MSDS|
|303010||APTIMA HPV Calibrators Kit||MSDS|
|303011||APTIMA HPV Controls Kit||MSDS|
|303234||APTIMA HPV 16 18/45 Genotype Assay, TIGRIS||100 tests||MSDS|
|303235||APTIMA HPV 16 18/45 Genotype Calibrators Kit||MSDS|
The APTIMA HPV assay is FDA approved for IVD use in the U.S. The APTIMA HPV assay was CE-marked May 9, 2008.
For additional availability in other countries please contact your local sales rep or distributor.
Burger EA, Kornør H, Klemp M, Lauvrak V, Kristiansen IS. “HPV mRNA tests for the detection of cervical intraepithelial neoplasia: a systematic review.” Gynecol Oncology 2011, 120(3):430-438.
Castle PE, Dockter J, Giachetti C, Garcia FA, McCormick MK, Mitchell AL, Holladay EB, Kolk DP. “A cross-sectional study of a prototype carcinogenic human papillomavirus E6/E7 messenger RNA assay for detection of cervical precancer and cancer.” Clin Cancer Res 2007, 13(9):2599-2605.
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.
Cushieri K, Wentzensen N. “Human papillomavirus mRNA and p16 detection as biomarkers for the improved diagnosis of cervical neoplasia.” Cancer Epidemiol Biomarkers Prev 2008, 17(10):2536-2545.
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:S55-S61.
Getman D, Aiyer A, Dockter J, Giachetti C, Zhang F, Ginocchio CC. “Efficiency of the APTIMA HPV Assay for detection of HPV RNA and DNA targets.” J Clin Virol 2009, 45:S49-S54.
Monsonego J, Hudgens MG, Zerat L, Zerat JC, Syrjänen K, Halfon P, Ruiz F, Smith JS. “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.
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.” Gynecologic Oncology 2011, 123(2):278-283.
Ratnum S, Coutlee F, Fontaine D, Bentley J, Escott N, Ghatage P, Gadag V, Holloway G, Bartellas E, Kum N, Giede C, Lear A. “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.
Reuschenbach M, Clad A, von Knebel Doeberitz C, Wentzensen N, Rahmsdorf J, Schaffrath F, Griesser H, Freudenberg N, von Knebel Doeberitz M. “Performance of p16INK4a-cytology, HPV mRNA, and HPV DNA testing to identify high grade cervical dysplasia in women with abnormal screening results.” Gynecol Oncology 2010, 119(1):98-105.
Szarewski A, Ambroisine L, Cadman L, Austin J, Ho L, Terry G, Liddle S, Dina R, McCarthy J, Buckley H, Bergeron C, Soutter P, Lyons D, Cuzick J. “Comparison of predictors for high-grade cervical Intraepithelial neoplasia in women with abnormal smears.” Cancer Epidemiol Biomarkers Prev 2008, 17(11):3033-3042.
Waldstrøm M, Ornskov D. “Clinical performance of a human papillomavirus messenger RNA test (APTIMA HPV Assay) on residual material from archived 3-year-old PreservCyt samples with low-grade squamous intraepithelial lesion.” Arch Pathol Lab Med 2011, 135(8):1052-1056.
Waldstrøm M, Ornskov D. “Comparison of the clinical performance of an HPV mRNA test and an HPV DNA test in triage of atypical squamous cells of undetermined significance (ASC-US).” Cytopathology 2011, Epub ahead of print.
Wu R, Belinson SE, Du H, Na W, Qu X, Wu R, Liu Y, Wang C, Zhou Y, Zhang L, Belinson JL. “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.