- Patient Preparation
- Females should avoid high concentrations of antifungal cream, contraceptive jelly, or douche at time of collection.
- Cervical Brush in SurePath™ liquid-based Pap test media.
- Specimen Preparation
- Place each specimen in an individually sealed bag. (Min: 2 mL)
- Storage/Transport Temperature
- Unacceptable Conditions
- Specimens in any transport media other than indicated above. For specimens in ThinPrep transport media, refer to Human Papillomavirus (HPV), High Risk by Hybrid Capture, ThinPrep (ARUP test code 2008404). For cervical brush specimens in Digene transport media, refer to Human Papillomavirus (HPV), High Risk by Hybrid Capture, Cervical Brush (ARUP test code 0065999).
- Specimen source required.
- Ambient: 2 weeks; Refrigerated: 4 weeks; Frozen: Unacceptable
The performance characteristics of HPV testing using the SurePath sample medium were determined by ARUP Laboratories in a validation study. The FDA has not approved the SurePath sample medium for HPV testing. Specimens collected in SurePath sample medium may produce false-negative results under certain conditions, e.g., when specimens exceed stability requirements. For HPV results using an FDA-approved test, laboratories should collect and transport specimens according to the instructions of FDA-approved kits (e.g., ThinPrep medium or HPV Digene collection kits).
This test detects high-risk HPV genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68 associated with cervical cancer and its precursor lesions. However, cross-reactions with other genotypes may occur. Results should be correlated with cytologic and histologic findings. Sensitivity may be affected by specimen cellularity.
This test is intended for medical purposes only and is not valid for the evaluation of suspected sexual abuse or for other forensic purposes.
HPV testing should not be used for screening or management of atypical squamous cells of undetermined significance (ASCUS) in women under age 21.
See Compliance Statement B: www.aruplab.com/CS
|Component Test Code*||Component Chart Name|
|0060745||HPV High Risk, Hybrid Capture, SurePath|
- Genital Warts (Human Papillomavirus (HPV) DNA Probe, High Risk Surepath® (AutoCyte))