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Test Name: HPV, high-risk
Test Code: 507301
Other Names: N/A
Test Includes: HPV, high-risk
Specimen Requirements: Cervical brush sample in Digene DNA collection kit or liquid-based cytology preservative, cervical biopsy, One brush or tissue biopsy
Container: Digene DNA collection kit (contact the local LabCorp branch for collection kits); or liquid-based cytology preservative (ThinPrep(R) vial with PreservCyt(R) solution or SurePath(R) vial with CytoRich(R) fixative).
Collection Instructions: Specimen must be submitted using the Digene DNA collection kit (supplied by LabCorp) or liquid-based cytology fixative. Digene DNA collection kit: 1. First remove excess mucus from the cervical os and surrounding ectocervix using a cotton or polyester swab. Discard this swab. 2. To obtain specimen, insert the Digene Cervical Sampling Brush 1.0-1.5 centimeters into the cervical os until the largest bristles touch the ectocervix. Do not insert brush completely into the cervical canal. Rotate brush 3 full turns in a counterclockwise direction, remove from the canal. 3. Insert brush into the transport tube. Snap off shaft at scored line, leaving brush end inside tube, and recap securely by snapping in place. ThinPrep(R) vial-use a cervical broom: 1. Obtain a sample from the cervix using a broom-like device by inserting the brush portion into the cervical os and rotate the brush 5 times. 2. Rinse the collection device in the PreservCyt(R) solution by pushing the brush into the bottom of the vial 10 times, forcing the bristles to bend apart to release the cervical material. As a final step, twirl the brush between the thumb and forefinger vigorously to further release cellular material. Discard the collection device. 3. Tighten the cap on the ThinPrep(R) vial until the cap passes the torque line on the vial. SurePath(R) vial-use a cervical broom: 1. Insert the broom into the cervical os and rotate 5 times. 2. Place the broom head into the CytoRich(R) preservative fluid in the SurePath(R) collection vial. 3. Tightly cap the vial. Tissue: Submit tissue biopsy (frozen) in an HPV collection tube. Biopsies must be shipped frozen at -20(degrees)C.
Stability: Maintain liquid-based cytology specimens at room temperature. Maintain Digene HPV collection kit at room temperature for up to 2 weeks, and refrigerated for up to 3 weeks. Freeze biopsy. Cervical specimens collected using the Digene DNA collection kit or
Rejection Criteria / Special Instructions: Specimen must be submitted using HPV collection kit (supplied by LabCorp), or liquid based cytology preservative. If ThinPrep(R) vials are QNS for the hybrid capture assay, then a test requiring a lower input volume will be automatically performed if ther
Methodology: Nucleic acid amplification (NAA)