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ThinPrep® Pap with Reflex to HPV mRNA E6/E7
Test Code94928
CPT Codes
88142<br>Limited Access Code<br><strong>This test is not available for California patient testing.</strong>
Includes
If ASCUS or atypical cells are found, 90887 HPV RNA, High Risk, E6/E7, TMA will be added for an additional charge (CPT code: 87624).
Preferred Specimen
Pap sample collected in 1 ThinPrep® vial
Minimum Volume
1 ThinPrep pap vial
Instructions
Collect cervical specimens in ThinPrep® Pap Test vials containing 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® Solution Vials: 1 mL of Solution specimen must be transferred into 2.9 mL of APTIMA® specimen transport media. Transfer into APTIMA® transport media tubes contained in Specimen Transfer kits, Vaginal Swab collection kits, or Unisex Swab collection kits.
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® Solution Vials: 1 mL of Solution specimen must be transferred into 2.9 mL of APTIMA® specimen transport media. Transfer into APTIMA® transport media tubes contained in Specimen Transfer kits, Vaginal Swab collection kits, or Unisex Swab collection kits.
Transport Temperature
Room temperature
Specimen Stability
Pap
Room temperature: 6 weeks
Refrigerated: Unacceptable
Frozen: Unacceptable
HPV - ThinPrep pap vial
Room temperature: 30 days
Refrigerated: 105 days
Frozen: Unacceptable
ThinPrep in Aptima transfer tube
Room temperature: 60 days
Refrigerated: 60 days
Frozen: 2 years
Refer to local service area for specimen retention
Room temperature: 6 weeks
Refrigerated: Unacceptable
Frozen: Unacceptable
HPV - ThinPrep pap vial
Room temperature: 30 days
Refrigerated: 105 days
Frozen: Unacceptable
ThinPrep in Aptima transfer tube
Room temperature: 60 days
Refrigerated: 60 days
Frozen: 2 years
Refer to local service area for specimen retention
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Cervical swabs in Digene® HC cervical sampler
Methodology
Hologic ThinPrep System • Transcription Mediated-Amplification
Setup Schedule
Set up: Mon-Sat; Report available: 10 days
Reference Range
See Laboratory Report
Clinical Significance
HPV mRNA E6/E7 is used in conjunction with the Pap cytology findings to asses the risk of progression to cervical cancer and to guide patient management.
