HPV Genotypes 16, 18/45

Test Code
91826


CPT Codes
87625

Preferred Specimen
1 mL Liquid Cytology (PreservCyt®) Preservative (ThinPrep®) in Aptima® Specimen Transfer Tube (green label), or Multitest Collection Kit (orange label)


Minimum Volume
1 mL


Other Acceptable Specimens
PreservCyt® solution in Aptima® Unisex Swab Collection Kit (white label)


Instructions
Labs performing cytology: Aliquot PreservCyt® solution before or after performance of liquid based cytology testing.

PreservCyt®: Transfer 1 mL of PreservCyt® solution into Aptima® Vaginal Collection tube or Multi-test Collection Tube (orange label), or Aptima® Specimen Transfer tube (green label). Ship to lab.

Note: Cervical sources are required for HPV testing. If a vaginal source from a patient who has had a total hysterectomy with removal of cervix was submitted, please contact the testing laboratory for alternative testing options.


Transport Temperature
Room temperature


Specimen Stability
Room temperature: 60 days
Refrigerated: 60 days
Frozen: 2 years


Methodology
Transcription-Mediated Amplification (TMA)

FDA Status
The analytical performance characteristics of this assay have been determined by Quest Diagnostics. The modifications have not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule
A.M. Sets up 3 days a week.


Clinical Significance
Assay is used in combination with cervical cytology to assess the presence or absence of high-risk HPV genotypes 16, 18, and/or 45. This information, together with physician's assessment of cytology history, other risk factors, and professional guidlines, may be used to guide patient management.




The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.