Ordering Recommendation

FDA-approved test for triaging women ≥30 years to colposcopy who are cytology-negative (NILM) and HPV-positive.

Mnemonic
HPVGENOTMA
Methodology

Qualitative Transcription-Mediated Amplification

Performed

Wed, Fri

Reported

1-5 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 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, 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.

No compliance statements are in use for this test.

Note
Hotline History
N/A
CPT Codes

87625

Components
Component Test Code* Component Chart Name LOINC
2005402 HPVG Source 31208-2
2007895 HPV Genotype 16 by TMA 59263-4
2007896 HPV Genotype 18/45 by TMA 59264-2
* 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 16, 18/45 TMA
  • HPV E6/E7 genotyping
  • HPV geno
  • HPV genotype
  • HPV genotyping
  • Nucleic Acid Amplification Test (NAAT)
Human Papillomavirus (HPV) Genotypes 16 and 18/45 by Transcription-Mediated Amplification (TMA), ThinPrep