Human Papillomavirus (HPV), High Risk, E6/E7 mRNA by Transcription-Mediated Amplification (TMA) with Reflex to Genotypes 16 and 18/45
2007890
 
Ordering Recommendation
Use in conjunction with cytology for cervical cancer screening in women >=30. May be used in triaging women to colposcopy who are cytology-negative (NILM) and HPV-positive.
Mnemonic
HPV TMA GR
Methodology
Transcription-mediated Amplification
Performed
Sun-Sat
Reported
3-7 days
New York DOH Approval Status
This test is New York DOH approved.
Specimen Required
Patient Preparation
Females should avoid high concentrations of antifungal cream or contraceptive jelly, and should not douche prior to time of collection.  
Collect
Cervical brush in ThinPrep transport media or APTIMA transport media.  
Specimen Preparation
Vortex Pap Test media and transfer a 1 mL aliquot to APTIMA Combo 2 transport media (ARUP supply #42711) available online through eSupply using ARUP Connect™ or contact ARUP Client Services at (800) 522-2787.  
Storage/Transport Temperature
Refrigerated.  
Unacceptable Conditions
Specimens in any transport media other than indicated above.  
Remarks
Specimen source required.  
Stability
ThinPrep media: Ambient: 1 month; Refrigerated: 1 month; Frozen: 2 years
APTIMA media: Ambient: 2 months; Refrigerated: 2 months; Frozen: 2 years  
Reference Interval
Negative
Interpretive Data
This test detects E6/E7 viral messenger RNA of the high-risk HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68 associated with cervical cancer and its precursor lesions. Cross-reactivity with low-risk HPV genotypes 26, 67, 70, and 82 may occur. 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.

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.

If Human Papillomavirus (HPV), High Risk is positive, then HPV genotypes 16, 18/45 will be added. Additional charges apply.
Note
CPT Code(s)
87621; if reflexed add 87621 x2
Components
Component Test Code*Component Chart Name
0060752HPV Source
2007891HPV, High Risk by TMA
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, contact interface support at interface.support@aruplab.com.
Cross References
  • HPV genotype
  • HPV HR E6/E7 reflex to 16 and 18/45
  • HPV HR reflex to genotyping
  • HPV mRNA reflex
  • Nucleic Acid Amplification Test (NAAT)