We want you to know the facts.
Here are answers to questions you may have.
Given the common nature of HPV17, it is likely that patients who have ever been sexually active have been infected with cervical HPV. Because most HPV infections are asymptomatic and clear within 1-2 years of acquisition, knowing a patient’s HPV status is of limited clinical value.
No FDA-approved HPV test is designed to detect all HPV infections. All FDA-approved HPV tests have a cut-off, and are designed to detect HPV infections that are clinically relevant and properly identify women at risk of developing cervical disease. Rest assured that the Aptima HPV test has shown no statistical difference in sensitivity when compared to DNA-based HPV tests.
The Aptima HPV test indications are the same as those for DNA based tests, and align with current guidelines.
The Aptima HPV 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.
ACOG has acknowledged that the RNA based test is acceptable, and has not indicated that it should be used any differently than DNA based tests.
The ACOG Practice Bulletin Committee acknowledges that the RNA test is acceptable for use with cervical cancer screening but was not included in the 2012 Practice Bulletin #131 because, “At the time the Practice Bulletin was being developed, only DNA based tests were available. The Committee acknowledged that the RNA test is also acceptable.”
The Aptima HPV 16, 18/45 genotype assay is the first FDA‐approved HPV genotype test to include type 45. Recent data suggests that although cervical cancer incidence has decreased since the 1970s, the prevalence of adenocarcinoma cases has risen approximately 32% in the same time frame.14 Detection of these HPV types as part of reflex testing may help clinicians identify up to 94% of all cervical adenocarcinomas.13
Although HPV genotype 45 is fairly uncommon, identified in only 0.4% of women with normal cytology, data indicates that it is the third most common HPV genotype in invasive cancer. The addition of HPV genotype 45 is designed to help identify more women at risk for adenocarcinoma, with minimal impact to colposcopy rates.
Yes, the Aptima HPV test has an internal control that controls for inhibition and instrument error.
The Aptima HPV test can detect a clinically relevant infection with a lower number of cells per milliliter (mL) compared to other HPV tests. The guiding bodies, such as the FDA, CDC, CAP, and others, recommend an internal control be used either through a house-keeping gene or a spiked in control. Aptima HPV has a spiked in control that meets this criteria.
Aptima HPV only requires 1 mL of specimen from a ThinPrep pap vial, compared to 4 mL for the HC2 assay. A decreased specimen requirement may result in few Quantity Not Sufficient (QNS) results for you and your patients.
In the context of cervical cancer screening, clinical sensitivity refers to the ability of the HPV test to detect a cervical lesion that is likely a precursor to cervical cancer. The definition of a true positive is the positive HPV result, in a patient with underlying cervical disease (CIN2+ lesion).
A recently published meta-analysis of clinical data for Aptima HPV as compared to digene Hybrid Capture (HC2) determined that the pooled sensitivity for Aptima among ASC-US patients was high (see table below).16 The authors further determined that, “Aptima is as sensitive as other currently used HPV DNA test systems for the detection of CIN2 or greater.”16
The NPV of an assay is a function of a number of factors, particularly its sensitivity and the prevalence of disease in the patient population under study. In the CLEAR trial, Aptima HPV was found to have a high NPV. The NPV of Aptima HPV was also found to be statistically similar to the NPV of digene HC2 HPV DNA assay.2 A high NPV provides confidence that the Aptima HPV assay will detect HPV infections that are putting patients at risk for developing cervical disease.
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.
- 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;129:691-701.
- Aptima HPV Assay (package insert), San Diego, CA: Gen-Probe Incorporated; 2011.
- Dockter J, Schroder A, Hill C, et al. Clinical performance of the Aptima HPV Assay for the detection of high-risk HPV and high-grade cervical lesions. J Clin Virol. 2009;45(S1):S55-S61.
- 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.
- 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 Micro. 2012;50(6):1867-1873.
- 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.
- Clad A, Reuschenbach M, Weinschenk J, 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 Micro. 2011;49(3):1071-1076.
- 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 Micro. 2011;49(2):557-564.
- 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.
- Cuzick J, et al. International Papillomavirus Conference; 2011. Data on file.
- Iftner T, et al. International Papillomavirus Conference; 2012. Data on file.
- 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.
- de Sanjose S, Quint WG, Alemany L, et al. Human papillomavirus genotype attribution in invasive cervical cancer: a retrospective cross-sectional worldwide study. Lancet Oncol. 2010;11(11):1045-1056.
- Adegoke O, Kulasingam S, Virnig B. Cervical cancer trends in the United States: a 35-year population-based analysis. J Woman’s Health. 2012;21(10):1031-1037.
- Guan P, Howell-Jones R, Li N, et al. Human papillomavirus types in 115,789 HPV-positive women: a meta-analysis from cervical infection to cancer. Int J Cancer. 2012;131(10):2349-2359.
- Arbyn M, Roelens J, Cuschieri K, et al. The Aptima HPV assay versus the Hybrid Capture 2 test in triage of women with ASC-US or LSIL cervical cytology: a meta-analysis of the diagnostic accuracy. Int J Cancer. 2013;132(1):101-108.
- Moscicki AB, Schiffman M, Kjaer S, Villa LL. Chapter 5: Updating the natural history of HPV and anogenital cancer. Vaccine. 2006;24(S3):42–51.