HPV mRNA E6/E7, SurePath™ Vial with Reflex to HPV Genotype 16, 18/45

Test Code

92211

CPT Codes
87624

Includes

If HPV mRNA E6/E7, SurePath™ Vial is Detected, then HPV Genotypes 16,18/45, SurePath™ Vial will be performed at an additional charge (CPT code(s): 87625).

Preferred Specimen

10 mL SurePath™ Collection Vial, or Aptima® Transfer Tube with 0.5 mL SurePath™ Fluid

Minimum Volume

10 mL

Instructions

Transfer 0.5 mL of SurePath® fluid into an Aptima® Transfer Tube (containing 2.9 mL STM) within 7 days of collection.
Client labs performing cytology and testing departments: transfer 0.5 mL of SurePath® solution into Aptima® Specimen Transfer Tube (green label).

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: 7 days
Refrigerated: 7 days
Frozen: Unacceptable

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 the FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule

Set up: Mon, Wed, Fri; Report available: 2 days

Reference Range

Not detected

Clinical Significance

This assay detects E6/E7 viral messenger RNA (mRNA) from 14 high-risk HPV types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68).

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.