Human Papilloma Virus (HPV) High Risk DNA
Label Mnemonic: HPVPCR
Epic Lab Code: LAB7624
Downtime Form: A-1a Clinical Microbiology Laboratory Requisition
Microbiology/Molecular Infectious Disease
BT 6004
356-2591
Specimen(s):
Cervical or Anal Brush from SurePath Liquid-Based Pap Test Media or Tissue
Specimen Instructions:
Collect cytology sample using either a broom-like device or combination brush/spatula with detachable heads. Drop the detachable head in to the BD SurePath vial. Place the cap on the vial and tighten. Transport each specimen vial in an individual sealed bag.
Collection Medium:
SurePathTM collection devices
Rejection Criteria:
Vaginal specimens are not recommended because of limited clinical correlative data.

Samples other than cervical are not acceptable for children under age 12.
Testing Schedule:
Batch testing two to three times per week.
Turn Around Time:
8 working days
Reference Range:
Negative
Interpretive Data:
The HPV PCR test detects high risk HPV genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68 from cytology specimens collected in SurePath and from tissue specimens. HPV16 and HPV18 types are identified separately within the HPV PCR test and are reported at no additional charge for women ages 30-65 years old with a normal cytology or Pap test who have a positive high risk HPV PCR result. • The American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology recommend HPV16 and HPV18 genotype testing for women 30-65 years of age with normal cytology and who have a positive HPV high risk result (Saslo D, Journal of Lower Genital Tract Disease, Mar. 2012). • HPV16 or HPV18 in these particular specimens is further indication for examination of the patient with colposcopy. If the results are negative for HPV16 and HPV18, the recommendation is to repeat cytology and HPV high risk DNA testing in one year. • Following these guidelines, the lab will report HPV types 16 and 18 genotype results for women ages 30-65 years old with a normal cytology or Pap test who have a positive high risk HPV PCR result. Cross-reaction with other non-high risk HPV genotypes may occur and results should be correlated with cytologic and histologic findings. Sensitivity may be affected by the cellularity of specimen. Performance characteristics were determined by the University of Iowa Molecular Pathology Laboratory.
Comments:
Specimen must be transported in SurePath Liquid-Based Pap Test: HPV specimen transport medium.

The performance characteristics of this test were determined by the University of Iowa Microbiology and Molecular Pathology Laboratory. It has not been cleared or approved by the U.S. Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary. This test is for clinical purposes. It should not be regarded as investigational or for research. The laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high complexity clinical laboratory testing.
Methodology:
PCR amplification; Cobas HPV Test (Roche Diagnostics, Inc.)
CPT Code:
87624