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Test Code LAB10004 High Risk HPV DNA Detection with Genotyping

Performing Laboratory

Barnes-Jewish Hospital Molecular Infectious Disease Laboratory

Methodology

Polymerase Chain Reaction (PCR) performed on the cobas® 6800 platform using the cobas® HPV Assay (Roche Molecular Systems, Inc.).  This test detects the high-risk HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 66, and 68.

 

Note: HPV molecular testing is indicated for use for routine cervical cancer screening per professional medical guidelines, including triage as ASC-US cytology, co-testing (or adjunctive screen) with cytology, and HPV molecular primary screening of women to assess the risk for cervical precancer and cancer.  See below for ordering options that include HPV testing:

Specimen Type

Epic Test Name

Testing Strategy

Patient-Collected Vaginal Specimens

(Copan FLOQ swab or Evalyn brush) in ThinPrep

High Risk HPV and Genotyping

High risk molecular only (primary screening)*

Provider-collected

Endocervical/cervical ThinPrep

High Risk HPV and Genotyping

High risk molecular only (primary screening)**

Co-testing (Pap&HPV)

Cytology and high risk molecular

If ASCUS (Reflex HPV)

Cytology with reflex to High Risk HPV and Genotyping

Pap Only (No HPV)

Cytology alone

* If high risk molecular testing is positive and cytology is not previously ordered cytology will automatically be performed

**If high risk molecular testing is positive this specimen cannot be utilized for cytology (Pap).

Specimen Requirements

Acceptable Specimens:

Cervical or endocervical specimens collected in ThinPrep® PreservCyt® solution.

Patient self-collected vaginal specimens collected with Evalyn brush OR Copan FLOQ swab, rinsed in ThinPrep® PreservCyt® solution.

Note: Providers should dispose of the swab/brush following the rinse step and send only the ThinPrep vial to the lab.

Provider collected vaginal collection for HPV testing to be forwarded to Mayo Clinical Laboratories. See Mayo testing information here.

 

Collection Procedure: 

ThinPrep - Provider Collection Guide

HPV self-collection guide - Copan FLOQ swab

HPV self-collection guide - Evalyn brush

 

Day(s) Test Set Up

Monday through Friday

 

Turnaround Time:

STAT: not available

Routine: 1-2 days; Final report available the day of testing

Test Classification and CPT Coding

Test Classification:

This assay is FDA cleared for qualitative Human Papillomavirus (HPV) testing on cervical/endocervical specimens and patient self-collected vaginal specimens and its performance has been evaluated by Barnes-Jewish Hospital Molecular Infectious Disease Laboratory.

 

Limitations:

  1. cobas® HPV has only been validated for use with cervical specimens collected by a clinician using an endocervical brush/spatula or a cervical broom and placed in the ThinPrep® PreservCyt® Solution and vaginal specimens collected by the patient using an Evalyn brush or Copan FLOQ swab and placed in the ThinPrep® PreservCyt® solution. Assay performance has not been validated for use with other collection media and/or specimen types.
  2. Products containing carbomer(s), including vaginal lubricants, creams and gels may interfere with the test and should not be used during or prior to collecting cervical specimens.
  3. Use of over-the-counter products Replens™, RepHresh™ Vaginal Gel and RepHresh™ Clean Balance™ Kit has been associated with false-negative results.
  4. Use of Metronidazole Vaginal Gel has been associated with false-negative results.
  5. cobas® HPV detects DNA of the high-risk types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. This test does not detect DNA of HPV low-risk types (e.g. 6, 11, 42, 43, 44) since there is no clinical utility for testing of low-risk HPV types.

 

CPT Code:

87624

Reference Values

Negative

Specimen Transport Temperature

Room temperature

Additional Information

For BJH Laboratory Use Only

 

Minimum Volume:

1 20mL ThinPrep® PreservCyt® solution vial