HPV Primary Screen by PCR With Reflex to Cytology
Also known as: HPV PRMRY
Use
The HPV Primary Screen by PCR With Reflex to Cytology is an FDA-approved test for routine cervical cancer screening in individuals aged 25 years and older with a cervix. This test detects DNA from high-risk HPV types, including HPV16, HPV18, and 12 other types associated with cervical cancer and its precursor lesions. Positive results for high-risk HPV types prompt reflex testing with cytology, and positive cases for HPV 16 or 18 should be managed according to current clinical guidelines, specifically the ASCCP guidelines from 2019.
Special Instructions
It is critical to use the correct collection kits: ARUP supply #41785 ThinPrep (Vial and Broom) or #51369 ThinPrep (Vial, Brush, and Spatula), which can be obtained from ARUP Client Services. Proper specimen collection and handling instructions must be followed as per ARUP's guidelines, including placing the collection device in the ThinPrep media vial and storing the specimen at refrigerated temperatures to maintain validity.
Limitations
The test's sensitivity can vary based on the specimen collection methods, the stage of infection, and the presence of interfering substances. Specimens that are bloody, dark brown, or not within the prescribed media will be rejected. The test is not FDA-approved for specimens from individuals outside the age criterion of 25 years and older, and it is not New York state approved.
FDA Approved
Methodology
PCR-based (PCR)
Biomarkers
LOINC Codes
- 31208-2
- 77399-4
- 77400-0
- 82675-0
Result Turnaround Time
1-5 days
Related Documents
For more information, please review the documents below
Specimen
Tissue
Volume
Not provided
Minimum Volume
Not provided
Container
ThinPrep media
Collection Instructions
Collect cervical or endocervical specimen with brush or spatula from ThinPrep kit collection kit. Place collection device in corresponding ThinPrep media vial.
Storage Instructions
Refrigerated
Causes for Rejection
Bloody or dark brown specimens. Specimens in any media other than indicated above.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 6 months |
| Refrigerated | 6 months |
| Frozen | Unacceptable |