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ThinPrep®, HPV mRNA E6/E7 with Reflex to HPV 16,18/45
Test Code94927
CPT Codes
87624, 88142<br><strong>Limited Access Code</strong><br><strong>This test is not available for California patient testing.</strong>
Includes
the Pap is normal and the HPV mRNA E6/E7 is detected, HPV Genotypes 16, 18/45 will be performed at an additional charge (CPT code: 87625).
Preferred Specimen
Pap sample collected in 1 ThinPrep® pap vial
Minimum Volume
1 ThinPrep pap vial
Instructions
Pap sample collected in ThinPrep® vial, alcohol-based solution that serves as preservative, transport and antibacterial medium for gynecologic samples. For Invitro Use Only. (Minimum): Gynecologic sample collected in routine manner (i.e. following NCLS guideline) and rinsed in PreservCyt® following recommended technique.
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® 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.
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® 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
Room temperature: 30 days
Refrigerated: 30 days
Frozen: Unacceptable
Refrigerated: 30 days
Frozen: Unacceptable
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Swabs • Cervical swabs in Digene® HC cervical sampler • Digene® vials • SurePath™ vials • Received frozen • Leakage of fluid during transport
Methodology
Thinprep processing • CYTYC Imaging System
Setup Schedule
Set up: Mon-Sat; Report available: 10 days
Reference Range
See Laboratory Report
Clinical Significance
Liquid-based pap testing is intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all other cytologic categories as defined by the Bethesda system for reporting results of cervical cytology. Pap screening is not reliable for the detection of endometrial cancer.
