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HPV mRNA E6/E7 with Reflex to HPV Genotypes 16, 18/45
Test Code90942
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.
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
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).
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).
Performing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly, VA 20153