HPV Genotypes 16, 18/45, SurePath™ Vial
Also known as: E6/E7 Genotype, Genotype, HPV
Use
This assay detects human papillomavirus (HPV) genotypes 16, 18/45 from cervical SurePath™ fluid, facilitating identification of high-risk HPV strains associated with cervical cancer risk. It aids in triaging women with abnormal cytology or positive HPV results by distinguishing the highest-risk genotypes. It is intended for clinical use under CLIA validation.
Special Instructions
Preferred specimen: 0.5 mL SurePath™ fluid collected in an Aptima® transfer tube; acceptable: SurePath™ fluid in SurePath™ collection vial. Specimens must be cervical in origin; if a vaginal source is from a patient post-hysterectomy, contact the laboratory. Transfer instructions and transport conditions apply.
Limitations
Modifications have not been cleared or approved by the FDA; performance was determined by Quest Diagnostics under CLIA regulations. Frozen specimen stability is not established. The test only genotypes 16 and 18/45 and does not distinguish among other high-risk HPV types.
Methodology
Other
Biomarkers
Result Turnaround Time
1-3 days
Related Documents
For more information, please review the documents below
Specimen
Other
Volume
0.5 mL (0.5 mL minimum)
Minimum Volume
0.5 mL
Container
Aptima® transfer tube containing 2.9 mL STM
Collection Instructions
Transfer 0.5 mL of SurePath™ fluid into an Aptima® transfer tube within 7 days of collection
Causes for Rejection
Non‑cervical specimen or specimen from hysterectomy without cervix (contact lab)
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 7 days |
| Refrigerated | 7 days |
| Frozen | Not established |