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

Reporting Name

HPV with Genotyping, PCR, Surepath

Performing Laboratory

Mayo Clinic Laboratories in Rochester

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)


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 Type

Varies

Specimen Minimum Volume

1 mL

Specimen Stability Information

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

Reject Due To

SurePath enriched cell pellet Reject

Reference Values

Negative for 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.

 

For patients with atypical squamous cells of undetermined significance Pap smear test result and who are positive for high-risk (HR) HPV, consider referral for colposcopy, if clinically indicated.

A negative result indicates the absence of HPV DNA of the targeted genotypes.

 

For women aged 30 years and older with a negative Pap smear test result but who are positive for HPV-16 and/or HPV-18, consider referral for colposcopy, if clinically indicated.

 

For women aged 30 years and older with a negative Pap smear test result, 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 days

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

87626

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

Forms

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