Human Papillomavirus (HPV) Genotypes 16 and 18/45, E6/E7 mRNA by Transcription-Mediated Amplification (TMA)
2007894
 
Ordering Recommendation
Acceptable test for triaging women >= 30 years with negative cervical cytology (NILM Pap smear) and known positive HPV.
Mnemonic
HPVGENOTMA
Methodology
Transcription-mediated Amplification
Performed
Tue, Thu
Reported
2-5 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 Pap Test 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, and 45 only. It is intended for use in women 21 years and older with ASC-US cervical cytology results and in women 30 years and older with positive high-risk HPV results. 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 not intended for use as a stand-alone test.

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.
Note
CPT Code(s)
87621 x 2
Components
Component Test Code*Component Chart Name
2005402HPVG Source
2007895HPV Genotype 16 by TMA
2007896HPV Genotype 18/45 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 16, 18/45 TMA
  • HPV E6/E7 genotyping
  • HPV geno
  • HPV genotype
  • HPV genotyping
  • Nucleic Acid Amplification Test (NAAT)