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


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.


Secondary ID

619401

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)

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

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 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.

Method Description

The cobas human papillomavirus (HPV) test is a qualitative real-time polymerase chain reaction (PCR) test that detects 14 high-risk HPV genotypes. The test uses primers to define a sequence of approximately 200 nucleotides within the polymorphic L1 region of the HPV genome. A pool of HPV primers present in the Master Mix is designed to amplify HPV DNA from 14 high-risk types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68). An additional primer pair targets the human beta-globin gene (330 base pair amplicon) as an internal control to monitor the entire sample preparation and PCR amplification process. Fluorescent oligonucleotide probes bind to polymorphic regions within the sequence defined by these primers. The test utilizes a low titer positive and a negative control.(Package insert: cobas HPV: Qualitative nucleic acid test for the cobas 6800/8800 Systems. Roche Diagnostics, Inc; Rev. 2.0, 03/2021)

Day(s) Performed

Monday through Saturday

Report Available

3 to 6 days

Specimen Retention Time

2 weeks

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
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

Forms

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