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Human Papillomavirus (HPV) 16 and 18 Genotype by PCR, SurePath
2011937
Ordering Recommendation

Use of FDA-cleared sample preservative (ie, ThinPrep) is recommended. Refer to Human Papillomavirus (HPV), High Risk with 16 and 18 Genotype by PCR, ThinPrep (2011940).

Mnemonic
SP HPVGENO
Methodology
Qualitative Polymerase Chain Reaction
Performed
Mon, Wed, Fri
Reported
1-5 days
New York DOH Approval Status
Specimens from New York clients will be sent out to a New York DOH approved laboratory, if possible.
Submit With Order
ARUP Consult®
Disease Topics
Specimen Required
Patient Preparation
 
Collect
Cervical specimen with SurePath collection kit and place in SurePath media. 
Specimen Preparation
Transfer 3 mL to an ARUP Standard Transport Tube. (Min 1.5 mL) 
Storage/Transport Temperature
Refrigerated. 
Unacceptable Conditions
Bloody or dark brown specimens. Specimens in any media other than indicated above. 
Remarks
Specimen source required. 
Stability
Ambient: 3 months; Refrigerated: 3 month; Frozen: Unacceptable 
Reference Interval
Negative
Interpretive Data
This test amplifies DNA of HPV16 and HPV18. Laboratories should collect and transport specimens according to the instructions of FDA-approved kits (ThinPrep medium).

Sensitivity may be affected by specimen collection methods, stage of infection, and the presence of interfering substances. Results should be interpreted in conjunction with other available laboratory and clinical data. A negative HPV16 and/or HPV18 result does not exclude the presence of other high-risk HPV types, the possibility of future cytologic abnormalities, or underlying CIN2-3 or cancer.

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.

Compliance 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)
87625
Components
Component Test Code*Component Chart NameLOINC
0060752HPV Source31208-2
2011935HPV Genotype 16 by PCR61372-9
2011938HPV Genotype 18 by PCR, SurePath61373-7
* 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 Genotype SurePath
  • HPV Typing
  • Human papilloma virus