Human Papillomavirus (HPV), Biopsy in situ Hybridization Low- and High-risk Subtypes

Test ID: 

705770

CPT code:

87624

Synonyms:

Human Papillomavirus (HPV) High- and Low-risk DNA Detection
HPV Detection and Typing
HPV DNA Probe
Hybrid Capture®

Clinical 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 18 different human papillomavirus types in cervical specimens. The HPV test distinguishes between two HPV DNA groups without differentiation of the individual type:
• Low-risk HPV types: 6, 11, 42, 43, 44
• High-risk types: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68

Specimen Type:

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

Requested Volume: 

One brush or tissue biopsy

Container Type: 

Digene DNA collection kit; 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 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 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 rotate 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. may require five days for processing.

Stability Requirements:

Rejection Criteria

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 patien