Human Papillomavirus (HPV), High Risk with 16 and 18 Genotype by PCR, SurePath
Also known as: SP HPV1618
Use
This test is intended for use in routine cervical cancer screening for individuals ≥25 years of age with a cervix and as a follow-up test for abnormal cytology results in individuals ≥21 years of age with a cervix. It detects DNA from HPV16, HPV18, and 12 other high-risk HPV types associated with cervical cancer and its precursor lesions, helping guide patient management decisions. The test is not recommended for individuals under 21 years of age.
Special Instructions
Not provided.
Limitations
The test's sensitivity may be affected by specimen collection methods, stage of infection, and the presence of interfering substances. It should not be used for screening or management of atypical squamous cells of undetermined significance (ASCUS) in women under age 21. A negative result does not exclude the presence of other high-risk HPV types or the possibility of future cytologic abnormalities.
New York Approved
Methodology
PCR-based (PCR)
Biomarkers
HPV16
MicroorganismHPV18
Microorganism
LOINC Codes
- 31208-2
- 77400-0
- 77399-4
- 82675-0
Result Turnaround Time
1-5 days
Related Documents
For more information, please review the documents below
Specimen
Other
Volume
3 mL
Minimum Volume
1.5 mL
Container
SurePath media
Collection Instructions
Use SurePath collection kit and place in SurePath media.
Storage Instructions
Refrigerate specimens for transport.
Causes for Rejection
Bloody or dark brown specimens, specimens in media other than indicated.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 1 month |
| Refrigerated | 6 months |
| Frozen | Unacceptable |
Other tests from different labs that may be relevant