Human Papillomavirus (HPV), High Risk by Hybrid Capture, SurePath
0060744
Ordering Recommendation
Adjunct to cytology (Pap smear) for cervical cancer screening and monitoring.
Mnemonic
SP HPV-HI
Methodology
Qualitative Nucleic Acid Probe
Performed
Sun-Sat
Reported
1-5 days  
New York DOH Approval Status
This test is New York DOH approved.
Submit With Order
Specimen Required
Patient Preparation
Females should avoid high concentrations of antifungal cream, contraceptive jelly, or douche at time of collection.  
Collect
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
Refrigerated.  
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).  
Remarks
Specimen source required.  
Stability
Ambient: 2 weeks; Refrigerated: 4 weeks; Frozen: Unacceptable  
Reference Interval
   
Interpretive Data
Test Information:
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
Statement B: This test was developed and its performance characteristics determined by ARUP Laboratories. The U.S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.
 
Note
 
CPT Code(s)
87621
Components
Component Test Code*Component Chart NameLOINC
0060745HPV High Risk, Hybrid Capture, SurePath30167-1
0060752HPV Source31208-2
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.
Aliases
  • HPV HR SurePath