Cytology / High Risk HPV
The Pap smear is a screening procedure to aid in the detection of cancer and its precursors and should not be used as the sole means to detect cervical cancer. The FDA-approved Aptima® HPV assay is an in vitronucleic acid amplification test that detects several high-risk HPV types. The FDA-approved Aptima Combo 2® assay detects the presence of Chlamydia trachomatis and Neisseria gonorrhoeae.
Indication
Indicated for cervical cancer screening for women between the ages of 24 and 65.
SAMPLE METHODS
Clinical Utility
ThinPrep Results
The source, specimen adequacy, descriptions, and additional findings are noted, along with recommended follow-up steps.
Aptima® HPV Assay
Positive results indicate qualitative detection of E6/E7 viral messenger RNA (mRNA) of any one or more of the high-risk types of HPV in the cervical specimen. Negative results indicate HPV E6/E7 mRNA was not detected.
High-risk HPV types detected include 16, 18, 31, 33, 35, 39, 45, 58, 59, and 68.
Aptima Combo 2® Assay
Positive results diagnose chlamydia and/or gonococcal urogenital disease.
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