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 types. The assay has been validated with cervical specimens in ThinPrep Pap Test vials containing PreservCyt Solution or in specimens collected with the APTIMA Cervical Specimen Collection and Transport Kit.
The assay can be used with the Direct Tube Sampling (DTS) Systems, the TIGRIS DTS System or the PANTHER 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.
| Description | Quantity | Catalogue |
|---|---|---|
| APTIMA HPV Assay, Panther | 250 tests | 303093 |
| APTIMA HPV Assay, Panther | 100 tests | 302929 |
| APTIMA HPV Assay, DTS | 100 tests | 302610 |
| APTIMA HPV Assay, TIGRIS | 250 tests | 302611 |
| APTIMA Cervical Specimen Collection and Transport Kit | 50 | 302657 |
| APTIMA HPV Calibrators Kit |
302554 |
|
| APTIMA HPV Controls Kit | 302556 | |
| APTIMA HPV 16 18/45 Genotyping Assay, TIGRIS | 100 tests | 303184 |
| Cat # | Product | Kit Size | PI |
|---|---|---|---|
| 303093 | APTIMA HPV Assay, Panther | 250 tests | EN DE ES FR IT PT NL |
| 302929 | APTIMA HPV Assay, Panther | 100 tests | EN DE ES FR IT PT NL |
| 302610 | APTIMA HPV Assay, DTS | 100 tests | EN DE ES FR IT PT NL |
| 302611 | APTIMA HPV Assay, TIGRIS | 250 tests | EN DE ES FR IT PT NL |
| 302657 | APTIMA Cervical Specimen Collection and Transport Kit | 50 | EN CS DA DE ES FR IT PT RO SV |
| 302554 | APTIMA HPV Calibrators Kit | EN | |
| 302556 | APTIMA HPV Controls Kit | EN | |
| 303184 | APTIMA HPV 16 18/45 Genotyping Assay | 100 tests | EN DE ES IT PT FR NL |
| Cat # | Product | Kit Size | MSDS |
|---|---|---|---|
| 303093 | APTIMA HPV Assay, Panther | 250 tests | EN(UK) |
| 302929 | APTIMA HPV Assay, Panther | 100 tests | EN(UK) |
| 302610 | APTIMA HPV Assay, DTS | 100 tests | EN EN(UK) DE ES FR IT |
| 302611 | APTIMA HPV Assay, TIGRIS | 250 tests | EN EN(UK) DE ES FR IT |
| 302657 | APTIMA Cervical Specimen Collection and Transport Kit | 50 | EN EN(UK) EN(JP) CS DA DE EL ES FI FR HU IT NO PT SV |
| 302554 | APTIMA HPV Calibrators Kit | EN(UK) | |
| 302556 | APTIMA HPV Controls Kit | EN(UK) | |
| 303184 | APTIMA HPV 16 18/45 Genotyping Assay | 100 tests | EN(UK) |
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.
Clinical Performance of the APTIMA HPV Assay for Dectection of E6/E7 mRNA from High-Risk HPV Types in Liquid Based Cytology Specimens Hill; Hologic Gen-Probe Incorporated, San Diego, CA. Poster 2009 ISSTDR
Clinical Correlation of APTIMA HPV Assay in Comparison with Hybrid Capture 2 Test in Cervical Cancer Screening Ratnam; Public Health Laboratory, Canada. Poster 2009 ISSTDR
Analytical Performance of the APTIMA HPV Assay on the PANTHER Analyzer Worlock; Hologic Gen-Probe Incorporated, San Diego, CA. Poster 2009 ISSTDR
Performance of APTIMA HPV Assay in Referral Population Getman; Hologic Gen-Probe Incorporate, San Diego, California. Abstract 2009, 25th International Papillomavirus Conference and Clinical Workshop (IPV)
Evaluation of the APTIMA Cervical Specimen Collection and Transport Kit Nugent; Hologic Gen-Probe Incorporate, San Diego, CA. Abstract 2009, 25th International Papillomavirus Conference and Clinical Workshop (IPV)
Comparison of Three High-Risk HPV (HR-HPV) Tests on ASC Samples with Follow-up Schledemann: Odense University Hospital, Denmark. Abstract 2009, 25th International Papillomavirus Conference and Clinical Workshop (IPV)
Performance of HPV E6/E7 mRNA and DNA Tests for the Detection of CIN or Worse: Results from a Multicentre Canadian Study Ratnam; Public Health Laboratory, St. John's, Canada. Abstract 2009, 25th International Papillomavirus Conference and Clinical Workshop (IPV)
Results of the French APTIMA HPV Screening Evaluation (FASE Study) Monsonego; European Institute of the Cervix, Paris, France. Abstract 2009, 25th International Papillomavirus Conference and Clinical Workshop (IPV)
Detection of HPV mRNA in Cytology Specimens with the APTIMA HPV HPV Assay Clad; Universitaets-Frauenklinik, Freiburg, Germany. Abstract 2009, 25th International Papillomavirus Conference and Clinical Workshop (IPV)
Does RNA Testing Detect Clinically Significant HPV Infection? Cuschieri; Royal Infirmary of Edinburgh, Scotland. Abstract 2009, 25th International Papillomavirus Conference and Clinical Workshop (IPV)
HPV mRNA and p16INK4a as Triage Markers in Cervical Cytology Reuschenbach; University of Heidelberg, Heidelberg, Germany. Abstract 2009, 25th International Papillomavirus Conference and Clinical Workshop (IPV)
Detection of High-Risk HPV mRNA in Liquid Based Cytology (LBC) with the APTIMA HPV Assay Clad: University Hospital, Freiburg, Germany. Oral Presentation 2008 EUROGIN, Nice, France
Performance of the APTIMA HPV Assay for detection of high-risk HPV mRNA in Liquid-Based Cytology Specimens Dockter: Hologic Gen-Probe Incorporated, San Diego, CA. Oral Presentation 2008 EUROGIN, Nice, France
French APTIMA HPV Screening Evaluation (FASE) Interim Results Monsonego; EUROGIN, France. Oral Presentation 2008 EUROGIN, Nice, France
Relative Performance of HPV DNA and E6/E7 mRNA Tests in Cervical Cancer Screening: Preliminary Resutls from a Multicentre Canadian Study Ratnam; St. John's, Newfoundland,Canada. Oral Presentation 2008 EUROGIN, Nice, France
Performance of the APTIMA HPV Assay in ASCUS Specimens Smith; University of North Carolina, Chapel Hill, NC. Oral Presentation 2008 EUROGIN, Nice, France