Test Overview
Test Methodology

Polymerase Chain Reaction (Cobas HPV Test)

Test Usage

The Cobas HPV Test is a qualitative in vitro test for the detection of Human Papillomavirus in patient specimens. The test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk (HR) HPV types in a single analysis. The test specifically identifies types HPV16 and HPV18 while concurrently detecting the rest of the high risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68).

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

A negative result does not exclude the possibility of HPV infection; very low levels of infection or bloody specimens may give a false-negative result. 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

6 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 presence of human papillomavirus in the female genital tract is associated with a number of disease states, including genital condyloma acuminata, condyloma plana, Bowenoid papulosis, and cervical, vaginal, and vulvar intraepithelial neoplasia and carcinoma. It is generally accepted that these viruses are sexually transmitted. 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
NY State Approved
No
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