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ThinPrep® Imaging Pap reflex HPV mRNA E6/E7, C. trachomatis,N. gonorrhoeae
Test Code91912
CPT Codes
88175, 87491, 87591<br><strong>This test is not available for California patient testing.</strong>
Includes
ThinPrep® Imaging Pap reflex HPV mRNA E6/E7
Chlamydia/Neisseria gonorrhoeae RNA, TMA, Urogenital
If ThinPrep® Pap result is ASCUS, then HPV mRNA E6/E7 will be performed at an additional charge (CPT Code(s): 87624)
Chlamydia/Neisseria gonorrhoeae RNA, TMA, Urogenital
If ThinPrep® Pap result is ASCUS, then HPV mRNA E6/E7 will be performed at an additional charge (CPT Code(s): 87624)
Preferred Specimen
Pap sample collected in PreservCyt® (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. 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® PreservCyt® Solution Vials: 1 mL of PreservCyt® 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?)
Cervical swabs in Digene® HC cervical sampler • Digene® vials • Swabs • SurePath™ vials
Methodology
CYTYC Imaging System • Dual Kinetic Assay (DKA) • Target Capture • Transcription-Mediated Amplification (TMA)
Setup Schedule
Set up: Mon-Sat; Report available: 10 days
Reference Range
See Laboratory Report
Clinical Significance
Early detection of cervical cancer by pap screening performed by ThinPrep® Imager; testing for HPV mRNA; and Chlamydia trachomatis, and Neisseria gonorrhoeae.