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Human Papillomavirus (HPV) High Risk Screen by Transcription-Mediated Amplification (TMA), with Reflex to Genotypes 16 and 18/45, ThinPrep

HPV REFLEX
Example Reports
Detected HPV 16
Detected
Not Detected

Ordering Recommendation

FDA-approved test for routine cervical cancer screening in combination with cervical cytology (pap smear) in individuals 30 years or older with a cervix. Follow-up test for abnormal cytology results in individuals 21 years or older with a cervix. Genotyping is performed to assess the presence or absence of high-risk HPV genotypes 16, 18, and/or 45, only as a follow-up to an Aptima HPV assay positive result.

New York DOH Approval Status

This test is New York state approved.

Specimen Required

Patient Preparation

Patients 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

Methodology

Qualitative Nucleic Acid Amplification (NAA)

Performed

Sun-Sat

Reported

1-5 days

Reference Interval

Negative

Interpretive Data

This test detects E6/E7 viral messenger RNA of 14 high-risk HPV types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) associated with cervical cancer and its precursor lesions. This test does not discriminate between the 14 high-risk HPV types. 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.

If Human Papillomavirus (HPV), High Risk is positive, then HPV genotypes 16, 18/45 will be added. Additional charges apply.

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

View Hotline History

 

Hotline History

Date of Change
Test Name Change
Methodology
Performance/Reported Schedule
Specimen Requirements
Reference Interval
Interpretive Data
Note
CPT Code
Component Change
Other Interface Change
New Test
Inactive
10/11/2023
X
N/A

CPT Codes

87624; if reflexed, add 87625

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Components

Component Test Code* Component Chart Name LOINC
0060752 HPV Source 31208-2
2007891 HPV, High Risk by TMA 49896-4
* 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 high-risk screen with genotype
  • HPV HR E6/E7 TMA
  • HPV RNA
  • Nucleic Acid Amplification Test (NAAT) HPV PCR, HPV TMA
Human Papillomavirus (HPV) High Risk Screen by Transcription-Mediated Amplification (TMA), with Reflex to Genotypes 16 and 18/45, ThinPrep