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Human Papillomavirus (HPV) Vaginal Detection with Genotyping for High-Risk Types by PCR

Important Note

This test is for Lab Use Only.

The results of this testing will be included in the Pap report.

Additional Codes

Orderable Codes:

Epic Code (not ord) Atlas Code (not ord) Mayo Test ID Order LOINC
LAB17593 N/A VHPV 77378-8

 


Necessary Information


Specimen source is required.



Specimen Required


Specimen Type: Vaginal

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.


Useful For

Detection of high-risk (HR) genotypes associated with the development of cervical cancer

 

Aids in triaging women with abnormal Pap smear 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 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)

Reporting Name

HPV Vaginal Detect / Genotyping PCR

Specimen Type

Vaginal

Specimen Minimum Volume

1 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Vaginal 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

Day(s) Performed

Monday through Saturday

Report Available

3 to 6 days

Specimen Retention Time

2 weeks

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test has been modified from the manufacturer's instructions. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information

87624

G0476 (if appropriate)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
VHPV HPV Vaginal Detect / Genotyping PCR 77378-8

 

Result ID Test Result Name Result LOINC Value
619403 HPV High Risk type 16, PCR 61372-9
619404 HPV High Risk type 18, PCR 61373-7
619405 HPV other High Risk types, PCR 77375-4

NY State Approved

Yes

Forms

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