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


Necessary Information


Specimen source, collection date and patient identifiers are required.



Specimen Required


Patient Preparation: For 24 hours prior to specimen collection, patients should not use carbomer-containing feminine hygiene products (eg, KY Jelly [Physician Formula], Vagisil creme regular strength). For additional information about carbomer-containing feminine hygiene products, including additional examples, see Cautions.

Specimen Type: Vaginal

Container/Tube: ThinPrep/PreservCyt solution vial

Specimen Volume: 3 mL of solution in ThinPrep/PreservCyt vial

Collection Instructions:

1. Obtain an adequate sampling from vagina using a sterile brush, broom, or spatula.

2. Rinse the collection device as quickly as possible into the PreservCyt Solution vial.

3. DISCARD THE COLLECTION DEVICE.

4. Place ThinPrep specimens in individual bags, as they tend to leak during transport.

5. 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 Papanicolaou test (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

 

Clinical monitoring and management of patients

 

This test 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.

Reporting Name

HPV Vaginal Detect / Genotyping PCR

Specimen Type

Vaginal

Specimen Minimum Volume

1 mL

Specimen Stability Information

Specimen Type Temperature Time
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

Method Description

The cobas HPV (human papillomavirus) 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 5800/6800/8800 Systems. Roche Diagnostics; Rev. 2.0, 09/2024)

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

87626

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.