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Test ID SHPV Human Papillomavirus (HPV) DNA Detection with Genotyping, High-Risk Types by PCR, SurePath, Varies

Useful For

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

 

An aid in triaging women with abnormal Pap smear test results

 

Individual genotyping of human papillomavirus (HPV)-16 and/or HPV-18, if present

 

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

Method Name

Real-Time Polymerase Chain Reaction (PCR)

Reporting Name

HPV with Genotyping, PCR, Surepath

Specimen Type

Varies


Necessary Information


Specimen source, collection date, and patient identifiers are required.



Specimen Required


Supplies: Cobas PCR Media Tube w/Cap (T945)

Specimen Type: Cervical (endocervical or ectocervical) or vaginal

Specimen Volume: 3.0 mL

Collection Instructions:

1. Aliquot 3 mL SurePath specimen into Cobas PCR Media Tube w/Cap tube.

2. Bag specimens individually as they have a tendency to leak during transport.

3. Place labels on the vial and on the bag.


Specimen Minimum Volume

1 mL

Specimen Stability Information

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

Reference Values

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

Day(s) Performed

Monday through Saturday

Performing Laboratory

Mayo Clinic Laboratories in Rochester

CPT Code Information

87624

G0476 (if appropriate)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
SHPV HPV with Genotyping, PCR, Surepath 77378-8

 

Result ID Test Result Name Result LOINC Value
SS018 Specimen Source 31208-2
36003 HPV High Risk type 16, PCR 61372-9
36004 HPV High Risk type 18, PCR 61373-7
36005 HPV other High Risk types, PCR 77375-4

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.

Report Available

3 to 6 days

NY State Approved

Yes

Forms

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