HPV mRNA E6/E7 with Reflex to HPV Genotypes 16, 18/45

Test Code

90942

CPT Codes
87624

Includes

If HPV mRNA E6/E7 is detected, then HPV Genotypes 16, 18/45 will be performed at an additional charge (CPT Code(s): 87625).

Preferred Specimen

5 mL liquid cytology (PreservCyt®) preservative (ThinPrep®) collected in an APTIMA® transport tube (green label)

Minimum Volume

1 mL

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 transfer tube (green label). Ship to lab.
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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: 30 days
Refrigerated: 90 days
Frozen: Unacceptable

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Cervical swabs in Digene® HC cervical sampler • Digene® vials • Swabs • SurePath™ vials • Received frozen

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: 2-5 days

Reference Range

Not detected

Clinical Significance

The presence of E6/E7 messenger RNA from 14 high risk HPV types indicates incorporation of HPV DNA into the host cells. Proteins expressed from E6-E7 polycistronic mRNA alter cellular p53 and retinoblastoma protein functions, leading to disruption of cell-cycle check points and cell genome instability. This information, together with the physicians assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management.
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.