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Human Papillomavirus (HPV) High-risk DNA Detection

CPT: 87624
Updated on 01/29/2020
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Synonyms

  • HPV DNA Probe, High Risk
  • Hybrid Capture®

Test Includes

Detection of high-risk type HPV DNA sequences in exfoliated cells or tissue biopsies

Detection of high-risk type HPV DNA sequences in exfoliated cells or tissue biopsies


Special Instructions

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.


Expected Turnaround Time

2 - 4 days


Related Information


Related Documents

For more information, please view the literature below.

Microbiology Specimen Collection and Transport Guide


Specimen Requirements


Specimen

Cervical brush sample in Digene DNA collection kit or liquid-based cytology preservative; cervical biopsy


Volume

One brush or tissue biopsy


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 fraction. Minimum 2 mm biopsy specimen.


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)


Collection

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.


Storage Instructions

Maintain liquid-based cytology specimens at room temperature. Digene HPV collection kit can be kept at room temperature for two weeks or refrigerated for three weeks. Freeze biopsy. Cervical specimens collected using the Digene DNA collection kit or SurePath™ vial must be processed for testing within 21 days of collection. Specimens in ThinPrep® vials must be processed for testing within three months of collection. LabCorp may require up to five days for processing.


Stability Requirements

Temperature

Period

Room temperature

3 months

Refrigerated

Unstable

Frozen

Biopsy only


Causes for Rejection

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; quantity not sufficient for analysis; biopsies less than 2 mm in diameter; name discrepancies; specimens submitted on male patients


Test Details


Use

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.


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.


Methodology

Nucleic acid amplification (NAA)


References

Ferris DG, Wright TC, Litaker MS, et al. Triage of women with ASCUS and LSIL Pap smear reports: Management by repeat Pap smear, HPV DNA testing, or colposcopy. J Fam Pract. 1998 Feb; 46(2):125-134. 9487318
Manos MM, Kinney WK, Hurley LB, et al. Identifying women with cervical neoplasia: Using human papillomavirus DNA testing for equivocal Papanicolaou results. JAMA. 1999 May 5; 281(17):1605-1610. 10235153
Schiffman M, Herrero R, Hildesheim A, et al. HPV DNA testing cervical cancer screening: Results from women in a high-risk province in Costa Rica. JAMA. 2000 Jan 5, 283(1):87-93.10632285

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
507301 HPV, high-risk 30167-1 507303 HPV, high-risk 30167-1
Reflex Table for HPV, high-risk
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 507405 HPV, low volume rfx 507405 HPV, low volume rfx 59420-0

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