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HPV mRNA E6/E7
Test Code90887
CPT Codes
87624
Preferred Specimen
ThinPrep® vial with a minimum of 1.5 mL PreservCyt® fluid remaining after cytology is performed or transfer 1 mL of PreservCyt® fluid into an APTIMA® specimen transfer tube (green label) before or after liquid-based cytology testing is performed. Ship to Quest Diagnostics.
Minimum Volume
1.5 mL
Instructions
For clients performing their own cytology (pap testing), who choose to send HPV mRNA testing to Quest Diagnostics, the preferred specimen requirement steps should be adhered to.
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: Tues, Thurs; Report available: 3-6 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 physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management.
Performing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly, VA 20153