Human Papillomavirus (HPV) Detection, High Risk with Genotyping

CPT Code(s):

87624

Specimen Requirements:

Specimens in ThinPrep® Cytyc PreservCyt® Solution:There must be at least 1 mL of PreservCyt® solution remaining for the result.

Remarks:Vaginal specimens are not preferred.

Unacceptable Conditions:

  • Frozen specimens
  • Swabs or samples in any other transport media
Stability (collection to initiation of testing):

  • Ambient:
    • Thin Prep® or PreservCyt®: Three weeks at 15° – 30° C

Use:

  • Detecting the presence of high-risk HPV DNA and determining the specific genotype (HPV 16, HPV 18 or other high-risk HPV (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68)
  • This test helps fulfill the new ACS, ASCCP and ASCP screening guidelines for Pap tests.

Methodology:


The Aptima HPV assay is a transcription-based nucleic acid amplification method with detection by the Hybridization Protection Assay (HPA) using the Panther System.

Reported:


4 days from receipt of the specimen

Reference Values:

Negative (interpretative report provided)

Interpretation Data:

Results

HPV High-Risk Result
The Aptima HPV assay is an in vitro nucleic acid amplification test for the qualitative detection of E6/E7 viral messenger RNA (mRNA) from 14 high-risk types of human papillomavirus (HPV) in cervical specimens. The high-risk HPV types detected by the assay include: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68.

with Genotyping:

  • HPV 16 : Result
  • HPV 18/45 : Result
Result Interpretation
Positive (detected) Corresponding HPV
was detected.
Negative (not detected) Corresponding HPV
was not detected.
Invalid A valid result
was not obtained.

A specimen will be reported as quantity not sufficient for testing (QNS) if there is less than 1 mL of specimen in the submitted liquid Pap test vial.