Test Overview
Test Methodology

Polymerase Chain Reaction (Cobas HPV Test)

Test Usage

The Cobas HPV is a qualitative in vitro test for the detection of Human Papillomavirus in clinician-collected cervical specimens using an endocervical brush/spatula or broom and placed in the ThinPrep® Pap Test™ PreservCyt® Solution. This test detects the high-risk HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. Rectal/anal specimens are also acceptable.

Reference Range *

Negative for HPV High Risk Profile DNA; Type 16: not detected; Type 18: not detected; Other High Risk Types: not detected.

* Reference ranges may change over time. Please refer to the original patient report when evaluating results.

Test Limitations

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. Use of over-the-counter products Replens™, RepHresh™ Vaginal Gel and RepHresh™ Clean Balance™ Kit has been associated with false-negative results. Use of Metronidazole Vaginal Gel has been associated with false-negative results.
A negative high-risk HPV result does not exclude the possibility of future cytologic HSIL or underlying CIN2-3 or cancer.
The assay does not test for all HPV types known to infect anogenital tissue or for low risk types. Result should be interpreted in conjunction with clinical conditions.

Test Details
Days Set Up
Monday - Friday
Analytic Time

8 hours

Soft Order Code
HPVD
MiChart Code
Human Papillomavirus (HPV) DNA Profile
Synonyms
  • Condyloma
  • Genital Warts
  • HPV DNA High Risk Assay
  • HPV Hybrid Capture
  • HPV High Risk
  • Human Papillomavirus (HPV) Hybrid Capture
  • Human Papillomavirus (HPV)
  • Papilloma
  • Papillomavirus
  • HPVDNA
  • HPV HYBRID CAPTURE II
  • HPVH
  • HPVL
  • HPVT
  • HPVT
Laboratory
Microbiology
Section
Microbiology
Specimen Requirements
Collection

Collect cervical specimen and place into ThinPrep/PreservCyt vial. Store and transport at room temperature.

Normal Volume
3 mL PreservCyt liquid
Additional Information

The results of this assay should be used in conjunction with clinical information derived from other diagnostic and screening tests, physical exam, and full medical history, and should not be used as the sole basis for clinical assessment and treatment of patients.

Billing
CPT Code
87624
Fee Code
32368
LOINC
77378-8