Human Papillomavirus (HPV) Genotypes 16 and 18/45, by Transcription-Mediated Amplification (TMA), ThinPrep
Also known as: HPVGENO
Use
The test is FDA-approved and designed to assess the presence or absence of high-risk HPV genotypes 16, 18, and/or 45. It is used as a follow-up to an Aptima HPV assay positive result in individuals 21 years and older with ASC-US and in individuals 30 years and older in conjunction with cervical cytology test results. The test should be used in conjunction with other laboratory and clinical data for comprehensive patient evaluation.
Special Instructions
Not provided.
Limitations
Sensitivity of the test may be influenced by specimen collection methods, stage of infection, and the presence of interfering substances. The test is not intended to be used as a stand-alone test nor for screening or management of atypical squamous cells of undetermined significance (ASC-US) in women under age 21.
FDA ApprovedNew York Approved
Methodology
PCR-based (RT-PCR)
Biomarkers
HPV
MicroorganismHPV
Microorganism
LOINC Codes
- 31208-2
- 59263-4
- 59264-2
Result Turnaround Time
1-5 days
Related Documents
For more information, please review the documents below
Specimen
Other
Volume
1 mL
Minimum Volume
Not provided
Container
PreservCyt Media
Collection Instructions
Collect cervical, anal, or vaginal specimen with brush or spatula from ThinPrep kit and place in PreservCyt Media. Transport original ThinPrep or briefly vortex and transfer 1 mL to an Aptima Specimen Transfer Tube.
Patient Preparation
Patient should avoid high concentrations of antifungal cream or contraceptive jelly, and should not douche before collection.
Causes for Rejection
Bloody or dark brown specimens. Specimens in any media other than indicated above.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 1 month |
| Refrigerated | 105 days |
| Frozen | Unacceptable |
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