HPV High Risk
Molecular · Women's Health
This assay is a nucleic acid amplification test for the qualitative detection of E6/E7 viral messenger RNA (mRNA) from 14 high-risk types of human papilloma virus (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. This assay does not discriminate between the types. Studies show that targeting E6/E7 mRNA identifies the presence and activity of a high-risk HPV infection. Testing is available with reflex to HPV Genotyping when positive.
Table of Contents
Assay Description
This assay is a nucleic acid amplification test for the qualitative detection of E6/E7 viral messenger RNA (mRNA) from 14 high-risk types of human papilloma virus (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. This assay does not discriminate between the types. Studies show that targeting E6/E7 mRNA identifies the presence and activity of a high-risk HPV infection. Testing is available with reflex to HPV Genotyping when positive.
Specimen Requirements
Cervical Specimens. Acceptable specimen collection/transport containers are:
•ThinPrep® Pap Vial
Storage and Transport
Specimens can be shipped and stored at 2 - 30°C. If shipping temperatures exceeding 30°C are anticipated, use cool pack. Viability after transfer to collection/transport tube is:
•ThinPrep® Pap Vial: 30 days •APTIMA® Specimen Transfer Tube: 30 days containing ThinPrep® aliquot
Specimen Rejection Criteria
All specimens must be submitted according to the test directory instructions. Before submitting specimen, please carefully review specimen requirements.
Listed below are possible causes for delays in specimen processing or possible specimen rejections or cancellations:
- No patient identification on requisition form
- No patient identification on specimen container or slides
- No referring provider
- No account information provided
- No test ordered on requisition
- No specimen source provided
- Inappropriate specimen type
- Insufficient volume for analysis
- Inappropriate specimen container
- Improper specimen transport
- Specimen leaked in transport
- Specimen submitted in incorrect or expired transport media
- Slides broken beyond repair on receipt
- Conflict between patient name on specimen and requisition form
- Specimen not properly preserved
- Sample containing a needle
A representative from Client Services will attempt to contact your office to resolve specimen problems. Additional documentation may be requested from your office to be returned by fax. In the event that resolution is not possible, the specimen may be returned to your office.
Turn Around Time (TAT)
2-4 Days.
CPT Codes*
87624