
Cervical

Know the Facts
APTIMAforherhealth
Aptima HPV mRNA Assay
Offers same excellent sensitivity as DNA-based HPV tests
Provide increased specificity compared to DNA-based HPV tests
FDA-approved and HSA-approved for use with ThinPrep®
Aligns with current WHO cervical cancer screening guidelines and Singapore guidelines*
Same coverage as DNA-based HPV tests

Aptima HPV
HPV is responsible for more than 99% of all cervical cancers (1-3)
The Aptima HPV assay:
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targets E6/E7 mRNA to identify the presence and activity of a high-risk HPV infection (4,5).
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allows clinicians to maximize the benefits of screening while minimizing potential harm.
Diagnostic support you can count on.
Because we know every woman counts on you.
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 ≥25 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.
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
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Doorbar, J. Clin Sci (Lond). 2006; 110(5):525-41.
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Monsonego J., et al. Int J Cancer. 2004; 108(3):329-33. Erratum in: Int J Cancer. 108(6):945.
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Walboomers, J. M. J Pathol. 1999; 189:12-19.
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Tinelli A, et al. Curr Pharm Biotechnol. 2009 Dec;10(8):767-71
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Cuschieri K, et al. J Med Virol. 2004 May;73(1):65-70
* The Singapore Guidelines (2019) recommends that all women who ever had sexual intercourse to have their first cervical cytology test from the age of 25.
From age 25 to 29 years, a Pap smear is recommended every 3 years
From age 30 to 69 years, HPV test alone every 5 years for a negative HPV test
What is the clinical sensitivity of Aptima HPV mRNA?
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 (9)). The authors further determined that "Aptima is as sensitive as other currently used HPV DNA test systems for the detection of CIN2 or greater (9)."​