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ThinPrep® Automated Pap Reflex HPV(if ASCUS,ASC-H,LSIL,HSIL,AGUS)Refl Genot
Test Code38419
CPT Codes
88175<br><strong>This test is not available for California patient testing.</strong>
Includes
If ThinPrep Automated Pap result is ASC-U or ASC-H or LSIL or HSIL or AGUS, then HPV mRNA E6/E7 will be performed at an additional charge (CPT Code(s): 87624)
If HPV mRNA E6/E7 is detected, then HPV Genotypes 16, 18/45 will be performed at an additional charge (CPT Code(s): 87625).
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
ThinPrep® pap in PreservCyt® Solution (See Instructions)
Instructions
Collect cervical specimens in ThinPrep® Pap Test vials containing PreservCyt® Solution with broom-type or cytobrush/spatula collection devices according to the manufacturer?s instructions.
If the ThinPrep® Aliquot Removal procedure will be used prior to cytology processing, refer to the ThinPrep System instructions for use on aliquot removal. Transfer 1 mL of the removed aliquot into an APTIMA® Specimen Transfer tube according to the instructions in the APTIMA® Specimen Transfer Kit package insert.
If testing the specimen after cytology processing using the ThinPrep System, process the ThinPrep® liquid cytology specimen in accordance with the ThinPrep System instructions for use and the APTIMA® Specimen Transfer Kit package insert. Transfer 1 mL of the fluid remaining in the ThinPrep® Pap test vial into an APTIMA® Specimen Transfer tube according to the instructions in the APTIMA® Specimen Transfer Kit package insert.
Specimens should be transferred to an APTIMA® Specimen Transfer tube within 30 days of collection if stored at room temperature (see section 3.2).
ThinPrep PreservCyt® Solution Vials: 1 mL of PreservCyt® Solution specimen must be transferred into 2.9 mL of APTIMA® specimen transport media.
If the ThinPrep® Aliquot Removal procedure will be used prior to cytology processing, refer to the ThinPrep System instructions for use on aliquot removal. Transfer 1 mL of the removed aliquot into an APTIMA® Specimen Transfer tube according to the instructions in the APTIMA® Specimen Transfer Kit package insert.
If testing the specimen after cytology processing using the ThinPrep System, process the ThinPrep® liquid cytology specimen in accordance with the ThinPrep System instructions for use and the APTIMA® Specimen Transfer Kit package insert. Transfer 1 mL of the fluid remaining in the ThinPrep® Pap test vial into an APTIMA® Specimen Transfer tube according to the instructions in the APTIMA® Specimen Transfer Kit package insert.
Specimens should be transferred to an APTIMA® Specimen Transfer tube within 30 days of collection if stored at room temperature (see section 3.2).
ThinPrep PreservCyt® Solution Vials: 1 mL of PreservCyt® Solution specimen must be transferred into 2.9 mL of APTIMA® specimen transport media.
Transport Temperature
Room temperature
Specimen Stability
Room temperature: 30 days
Refrigerated: 30 days
Frozen: Unacceptable
Refrigerated: 30 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
CYTYC Imaging System • Thinprep processing • Dual Kinetic Assay • Transcription Mediated-Amplification
Setup Schedule
Set up: Mon-Sat; Report available: 5 days
Reference Range
HPV mRNA E6/E7: Not detected
HPV 16 RNA: Not detected
HPV 16 RNA: Not detected
Clinical Significance
Early detection of cervical cancer by pap screening performed by ThinPrep Imager; testing for HPV mRNA
