Given the common nature of HPV,1 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, just 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. The Aptima HPV test has shown no statistical difference in sensitivity when compared to DNA-based HPV tests.
Get the facts about Aptima HPV testing
The Aptima HPV test is indicated to screen women greater than 21 years of age with ASCUS cytology to determine the need for colposcopy, and to screen women ages 30 to 65 with Pap in conjunction with HPV as part of co-testing.
ACOG acknowledges that the HPV mRNA test is acceptable for use with cervical cancer screening.
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 housekeeping 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 fewer 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).2 The authors further determined that, "Aptima is as sensitive as other currently used HPV DNA test systems for the detection of CIN2 or greater."2
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.3 A high NPV provides confidence that the Aptima HPV assay will detect HPV infections that are putting patients at risk for developing cervical disease.
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.
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
- 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.
- 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.
- Aptima HPV assay (package insert): Gen-Probe Incorporated; 2011.
Co-testing solutions for
cervical cancer
Co-testing solutions for
cervical cancer
Learn more about how Pap and HPV mRNA
testing work together to provide early
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