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HelpTest Code HPV Human Papillomavirus (HPV) DNA Detection with Genotyping, High-Risk Types by PCR, ThinPrep, Varies
Reporting Name
HPV with Genotyping, PCR, ThinPrepPerforming Laboratory
Mayo Clinic Laboratories in Rochester
Useful For
Detecting high-risk (HR) genotypes associated with the development of cervical cancer
Aiding in triaging women with abnormal Pap smear test results
Individual genotyping of human papillomavirus (HPV)-16 and/or HPV-18 if present
Results of HPV-16 and HPV-18 genotyping can aid in triaging women with positive HR-HPV but negative Pap smear results
This test is not intended for use in determining the need for treatment (ie, excisional or ablative treatment of the cervix) in the absence of high-grade cervical dysplasia. Patients who are HPV16/18 positive should be monitored carefully for the development of high-grade cervical dysplasia according to current practice guidelines.
This test is not intended for women who have undergone hysterectomy.
This test is not intended for use with samples other than those collected by a clinician using an endocervical brush or spatula and placed in the ThinPrep Pap test PreservCyt solution.
Method Name
Real-Time Polymerase Chain Reaction (PCR)
Ordering Guidance
For vaginal specimens, order VHPV / Human Papillomavirus (HPV) Vaginal Detection with Genotyping for High-Risk Types by PCR.
Necessary Information
Specimen source is required, collection date, and patient identifiers are required.
Specimen Required
Specimen Type: Cervical (endocervical or ectocervical)
Container/Tube: ThinPrep/PreservCyt solution vial
Specimen Volume: 3 mL of solution in ThinPrep/PreservCyt vial
Collection Instructions:
1. Bag ThinPrep specimens individually as they have a tendency to leak during transport.
2. Place labels on the vial and on the bag.
Specimen Type
VariesSpecimen Minimum Volume
1 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Varies | Ambient (preferred) | 42 days | |
| Refrigerated | 42 days |
Reject Due To
| Specimen containing CytoRich Red preservative fluid | Reject |
Reference Values
Negative for human papillomavirus (HPV) genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68
Interpretation
A positive result indicates the presence of human papillomavirus (HPV) DNA from one or more of the following genotypes: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68.
A negative result indicates the absence of HPV DNA of the targeted genotypes.
For patients with atypical squamous cells of undetermined significance Pap smear result and who are positive for high-risk (HR) HPV, consider referral for colposcopy, if clinically indicated.
For women 25 years and older with a negative Pap smear result but who are positive for HPV-16 and/or HPV-18, consider referral for colposcopy, if clinically indicated.
For women 25 years and older with a negative Pap smear, positive-HR-HPV test result, but who are negative for HPV-16 and HPV-18, consider repeat testing by both cytology and a HR-HPV test in 12 months.
Day(s) Performed
Monday through Saturday
Report Available
3 to 6 daysTest Classification
This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.CPT Code Information
87624
G0476 (if appropriate)
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| HPV | HPV with Genotyping, PCR, ThinPrep | 71432-9 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| SS017 | Specimen Source | 31208-2 |
| 35924 | HPV High Risk type 16, PCR | 77399-4 |
| 35925 | HPV High Risk type 18, PCR | 77400-0 |
| 35926 | HPV other High Risk types, PCR | 71431-1 |
Forms
If not ordering electronically, complete, print, and send Microbiology Test Request (T244) with the specimen.