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Test Code LAB52198 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

 

Endocervial/cervical ThinPrep

High Risk HPV and Genotyping with reflex to Pap

High risk molecular only (primary screening)*

Pap Only

Cytology alone

Pap with reflex to High Risk HPV and Genotyping

Cytology with reflex to high risk molecular if ASCUS

Pap and High Risk Genotyping

Cytology and high risk molecular (co-testing)

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

 

Specimen Requirements

Acceptable Specimens:

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

 

Vaginal collection for HPV testing to be forwarded to Mayo Clinical Laboratories. See Mayo testing information here.

 

Collection Procedure: 

ThinPrep Collection Guide

 

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 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. Assay performance has not been validated for use with other collection media and/or specimen types. Use of other collection media and/or specimen types may lead to false positive, false negative or invalid results.
  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