Human Papillomavirus (HPV), High Risk with 16 and 18 Genotype by Nucleic Acid Amplification (NAA), ThinPrep
FDA-approved test for routine cervical cancer screening in combination with cervical cytology (Pap smear) in individuals ≥30 years of age with a cervix. Follow-up test for abnormal cytology results in individuals ≥21 years of age with a cervix.
Qualitative Nucleic Acid Amplification
New York DOH Approval Status
Females should avoid high concentrations of antifungal cream or contraceptive jelly, and should not douche prior to time of collection.
Cervical, anal, or vaginal specimen with brush or spatula from ThinPrep kit and place in PreservCyt Media
Transport original ThinPrep or briefly vortex and transfer 1 mL to an Aptima Specimen Transfer Tube (ARUP supply #42711). Available online through eSupply using ARUP Connect™ or contact ARUP Client Services at (800) 522-2787. To reduce the potential for contamination, ThinPrep specimens should be poured off, using sterile technique, into the Aptima Specimen Transfer Tube prior to Cytology Testing.
Bloody or dark brown specimens. Specimens in any media other than indicated above.
Specimen source required.
Ambient: 1 month; Refrigerated: 105 days; Frozen: Unacceptable
This test detects high-risk HPV types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) and differentiates HPV 16 and 18 associated with cervical cancer and its precursor lesions. Sensitivity may be affected by specimen collection methods, stage of infection, and the presence of interfering substances. Results should be interpreted in conjunction with other available laboratory and clinical data. A negative high-risk HPV result does not exclude the presence of other high-risk HPV types.
HPV testing should not be used for screening or management of atypical squamous cells of undetermined significance (ASCUS) in women under age 21.
Depends on Specimen/Source/Method
For cervical sources, a negative high-risk HPV result does not exclude the possibility of future cytologic abnormalities, underlying CIN2-3, or cancer.
|Component Test Code*||Component Chart Name||LOINC|
|0060821||HPV Genotype 16||61372-9|
|0060823||HPV Genotype 18||61373-7|
|3003042||HPV High Risk||82675-0|
- HPV HR E6/E7 TMA
- HPV RNA
- Nucleic Acid Amplification Test (NAAT) HPV PCR, HPV TMA