Ordering Recommendation

FDA-approved test for routine cervical cancer screening in combination with cervical cytology (Pap smear) in women ≥30 years; genotyping performed for triaging women to colposcopy who are cytology-negative (NILM) and HPV-positive.

Mnemonic
HPV TMA GR
Methodology

Qualitative Transcription-Mediated Amplification

Performed

Sun-Sat

Reported

2-7 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 specimen with the ThinPrep Pap Test Collection kit.

Specimen Preparation

Vortex ThinPrep PreservCyt solution and transfer 1 mL to an APTIMA Specimen Transfer Tube (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 media other than indicated above.

Remarks

Specimen source required.

Stability

ThinPrep PreservCyt solution: Ambient: 1 month; Refrigerated: 1 month; Frozen: 2 years
APTIMA Specimen Transfer Tube: 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.

No compliance statements are in use for this test.

Note
Hotline History
N/A
CPT Codes

87624; if reflexed, add 87625

Components
Component Test Code* Component Chart Name LOINC
0060752 HPV Source 31208-2
2007891 HPV, High Risk by TMA 49896-4
* 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
  • HPV HR E6/E7 reflex to 16 and 18/45
  • HPV HR reflex to genotyping
  • HPV mRNA reflex
  • Nucleic Acid Amplification Test (NAAT)
Human Papillomavirus (HPV), High Risk by Transcription-Mediated Amplification (TMA) with Reflex to HPV Genotypes 16 and 18/45 by TMA, ThinPrep