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Human Papillomavirus (HPV) Genotypes 16 and 18/45, by Transcription-Mediated Amplification (TMA), ThinPrep

HPVGENO
Example Reports
Detected
Not Detected

Ordering Recommendation

FDA-approved test 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 in individuals 21 years and older with ASC-US and in individuals 30 years and older in conjunction with cervical cytology test results.

New York DOH Approval Status

This test is New York state approved.

Specimen Required

Patient Preparation

Patient 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

Wed, Sat

Reported

1-5 days

Reference Interval

Negative

Interpretive Data

This test detects E6/E7 viral messenger RNA of the high-risk HPV types 16, 18, and 45 only. It is intended for use in women 21 years and older with ASC-US cervical cytology results and in women 30 years and older as a follow-up to a positive high-risk HPV screen. 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. This test is not intended for use as a stand-alone test.

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

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

87625

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Components

Component Test Code* Component Chart Name LOINC
2005402 HPVG Source 31208-2
2007895 HPV Genotype 16 by TMA 59263-4
2007896 HPV Genotype 18/45 by TMA 59264-2
* 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 16 genotype, HPV 18 genotype
  • HPV HR E6/E7 TMA
  • HPV RNA
  • Nucleic Acid Amplification Test (NAAT) HPV PCR, HPV genotype, HPV genotyping
Human Papillomavirus (HPV) Genotypes 16 and 18/45, by Transcription-Mediated Amplification (TMA), ThinPrep