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Test Code HPV Human Papillomavirus (HPV) DNA Detection with Genotyping, High-Risk Types by PCR, ThinPrep, Varies

Reporting Name

HPV with Genotyping, PCR, ThinPrep

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 testing is intended for use in clinical monitoring and management of patients. It is not intended for use in medical-legal applications.

 

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)

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Specimen Type

Varies


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 Minimum Volume

1 mL

Reject Due To

Specimen containing CytoRich Red preservative fluid Reject
 

Specimen Stability Information

Specimen Type Temperature Time Special Container
Varies Ambient (preferred) 42 days
  Refrigerated  42 days

Reference Values

Negative for human papillomavirus (HPV) genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68

Day(s) Performed

Monday through Saturday

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

Report Available

3 to 6 days

Test 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.

Forms

If not ordering electronically, complete, print, and send Microbiology Test Request (T244) with the specimen.