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HPV, HIGH-RISK
Message"Specimen must be submitted using HPV collection kit (supplied by LabCorp) or liquid-based cytology preservative. If ThinPrep® vials are QNS for the hybrid capture assay, then a test requiring a lower input volume will be automatically performed if there is sufficient volume to perform that assay.
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Test Code
507301
Alias/See Also
"HPV DNA Probe, High Risk
Hybrid Capture®
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Hybrid Capture®
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CPT Codes
87621
Includes
"Detection of high-risk type HPV DNA sequences in exfoliated cells or tissue biopsies
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Preferred Specimen
"Cervical brush sample in Digene DNA collection kit or liquid-based cytology preservative; cervical biopsy
One brush or tissue biopsy
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One brush or tissue biopsy
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Minimum Volume
"For cells collected in liquid-based cytology preservative, at least 4 mL of preservative must be submitted for ThinPrep® specimens. For SurePath™ specimens that have been processed for a Pap, add 2 mL CytoRich™ fixative to the 0.8 mL cellular concentrate
Instructions
"Specimen must be submitted using the Digene DNA collection kit (supplied by LabCorp) or liquid-based cytology fixative.
Digene DNA collection kit: Remove excess mucus from the cervical os and surrounding ectocervix using a cotton or polyester swab. Discard this swab. To obtain specimen, insert the Digene cervical sampling brush 1.0 to 1.5 cm into the cervical os until the largest bristles touch the ectocervix. Do not insert the brush completely into the cervical canal. Rotate brush three full turns in a counterclockwise direction and remove from the canal. Insert the brush into the transport tube. Snap off shaft at scored line, leaving brush end inside tube, and recap securely by snapping in place.
ThinPrep® Vial - using a cervical broom: Obtain a sample from the cervix using a broom-like device by inserting the brush portion into the cervical os and rotating the brush five times. Rinse the collection device in the PreservCyt® 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. Tighten the cap on the ThinPrep® vial until the cap passes the torque line on the vial.
SurePath™ Vial - using a cervical broom: Insert the broom into the cervical os and rotate five times. Place the broom head into the CytoRich™ preservative fluid in the SurePath™ collection vial. Tightly cap the vial.
Tissue: Submit tissue biopsy (frozen) in an HPV collection tube. Biopsies must be shipped frozen at -20°C.
To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate frozen specimens for each test requested.
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Digene DNA collection kit: Remove excess mucus from the cervical os and surrounding ectocervix using a cotton or polyester swab. Discard this swab. To obtain specimen, insert the Digene cervical sampling brush 1.0 to 1.5 cm into the cervical os until the largest bristles touch the ectocervix. Do not insert the brush completely into the cervical canal. Rotate brush three full turns in a counterclockwise direction and remove from the canal. Insert the brush into the transport tube. Snap off shaft at scored line, leaving brush end inside tube, and recap securely by snapping in place.
ThinPrep® Vial - using a cervical broom: Obtain a sample from the cervix using a broom-like device by inserting the brush portion into the cervical os and rotating the brush five times. Rinse the collection device in the PreservCyt® 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. Tighten the cap on the ThinPrep® vial until the cap passes the torque line on the vial.
SurePath™ Vial - using a cervical broom: Insert the broom into the cervical os and rotate five times. Place the broom head into the CytoRich™ preservative fluid in the SurePath™ collection vial. Tightly cap the vial.
Tissue: Submit tissue biopsy (frozen) in an HPV collection tube. Biopsies must be shipped frozen at -20°C.
To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate frozen specimens for each test requested.
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Transport Container
"Digene DNA collection kit (contact the LabCorp local branch for collection kits); or liquid-based cytology preservative (ie, ThinPrep® vial with PreservCyt® solution or SurePath™ vial with CytoRich™ fixative)
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Transport Temperature
"Maintain liquid-based cytology specimens at room temperature. Maintain Digene HPV collection kit at room temperature for up to two weeks or refrigerated for up to three weeks. Freeze biopsy. Cervical specimens collected using the Digene DNA collection ki
Specimen Stability
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Room temperature
3 months
Refrigerated
Unstable
Frozen
Biopsy only
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Room temperature
3 months
Refrigerated
Unstable
Frozen
Biopsy only
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Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
"Improper collection or inadequate specimen; improper labeling; specimen more than 21 days old in digene DNA collection kit or SurePath™ liquid-based preservative; specimen more than three months old in PreservCyt® solution; specimen leaked in transit; qu
Methodology
"Nucleic acid amplification (NAA) "
Limitations
"A negative result does not exclude the possibility of an HPV infection since very low levels of infection or sampling error may cause a false-negative result
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Clinical Significance
"This assay aids in the diagnosis of sexually-transmitted HPV infection and is used for the triage of patients with an ASC-US Pap test result. The test provides a qualitative molecular detection of 13 different human papillomavirus high-risk types: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68 without differentiation of the individual type.
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