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Human Papillomavirus (HPV), High Risk with 16 and 18 Genotype by Nucleic Acid Amplification (NAA), ThinPrep

HPVNAA
Example Reports
Detected HPV 16
Detected HPV 18
Detected
Not Detected

Ordering Recommendation

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.

Methodology

Qualitative Nucleic Acid Amplification (NAA)

Performed

Sun-Sat

Reported

1-5 days

New York DOH Approval Status

This test is New York DOH approved.

Specimen Required

Patient Preparation

Females should avoid high concentrations of antifungal cream or contraceptive jelly, and should not douche prior to time of collection.

Collect

Cervical, anal, or vaginal specimen with brush or spatula from ThinPrep kit and place in PreservCyt Media

Specimen Preparation

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.

Storage/Transport Temperature

Refrigerated

Unacceptable Conditions

Bloody or dark brown specimens. Specimens in any media other than indicated above.

Remarks

Specimen source required.

Stability

Ambient: 1 month; Refrigerated: 105 days; Frozen: Unacceptable

Reference Interval

Negative

Interpretive Data

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.

Compliance Category

Depends on Specimen/Source/Method

Note

For cervical sources, a negative high-risk HPV result does not exclude the possibility of future cytologic abnormalities, underlying CIN2-3, or cancer.

Hotline History

N/A

CPT Codes

87624

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Components

Component Test Code* Component Chart Name LOINC
0060752 HPV Source 31208-2
0060821 HPV Genotype 16 61372-9
0060823 HPV Genotype 18 61373-7
3003042 HPV High Risk 82675-0
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.

Aliases

  • HPV HR E6/E7 TMA
  • HPV RNA
  • Nucleic Acid Amplification Test (NAAT) HPV PCR, HPV TMA
Human Papillomavirus (HPV), High Risk with 16 and 18 Genotype by Nucleic Acid Amplification (NAA), ThinPrep