Human Papillomavirus (HPV) Detection, High Risk

Additional Information:


CPT Code(s):


87621

Collection Procedure:


Specimen Requirements:

  • Cervical Brushes: Specimens must be collected prior to the application of acetic acid or iodine if colposcopic examination is being performed. The samples should be collected by using a Digene cervical brush and stored in Digene STM solution.
  • Cervical Biopsies: Specimens must be freshly collected, 2 – 5 mm in cross section. The biopsy specimen must be placed immediately into 1.0 mL of STM and stored frozen.
  • Specimens in ThinPrep® Cytyc PreservCyt® Solution: There must be at least 4 mL of PreservCyt® solution remaining for the HPV DNA test.
  • Specimen in SurePath™ (AutoCyte) Solution: There are must be 2 mL of SurePath™ solution remaining for the HPV DNA test.

Remarks: Vaginal specimens are not preferred.

Handling: Cervical-brush specimens may be shipped without refrigeration to a testing laboratory; however, fresh specimens should be shipped in an insulated container using either an overnight or second-day delivery vendor.

Cervical biopsy specimens may be shipped at 2° – 30° C for overnight delivery to the testing laboratory.

Unacceptable Conditions:
  • Frozen specimens
  • Swabs or samples in any other transport media
Stability (collection to initiation of testing):
  • Ambient: SurePath™; 4 weeks at 15° – 30° C.
  • Ambient: Thin Prep® or PreservCyt®; 3 weeks at 15° – 30° C.

Use:

The HPV DNA, high-risk test is used in conjunction with liquid-based cytology screenings to detect cervical cancer.

Methodology:


Nucleic acid probe

Reported:


4 days

Reference Values:


Negative (interpretative report provided)

Interpretation Data:

HPV DNA was detected by using the FDA-approved testing kit, Hybrid Capture 2. The test detects HPV high-risk genotypes: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68.

Diagnosis Interpretation Text
Detected High-risk HPV DNA was detected in
this patient sample.
Not Detected High-risk HPV DNA was not detected
in this patient sample.
QNS Due to inadequate specimens,
resubmission of samples is suggested.