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LAB COMMUNICATIONS 

 

COLLECTION & HANDLING

 

SPECIMEN TRANSPORTATION

Please call 616.774.7721 for specimen pick up

 

GENERAL INFORMATION

 

GENERAL TEST INFORMATION

 

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Mayo Clinic Laboratories

Epic Code LAB1231853 Self Collect HPV High Risk Screen with HPV Genotype Reflex

Important Note

Self-Collect devices are NOT acceptable for STI or PAP testing.  If PAP, Chlamydia, Gonococcus, or Trichomonas testing is desired in conjunction with HPV testing, a provider-collected specimen must be submitted.

Test Name Alias

Human Papilloma Virus | Primary HPV

Interface Order Alias

1231853

Quick Collect

+A

Clinical Information

Detection of 14 HR HPV genotypes:

  • HPV Genotype 16
  • HPV Genotype 18
  • Other HR HPV - includes 31,33,35,39,45,51,52,56,58,59,66,68

Collection Instructions

Specimen Type: Self Collect Vaginal
Container/Tube: ThinPrep Pap Test vials containing PreservCyt Solution
Volume: 4.0 mL
Minimum volume: 1.0 mL

 

Acceptable Source: Patient Self-collected vaginal

Collection Device: Rovers® Evalyn® Brush ITM-1303902

Collection Instructions:

  1. Patients must use the Evalyn Brush in a healthcare setting (i.e. physician office or clinic) to self-collect a vaginal specimen following the Evalyn Brush collection instructions. (Spanish instructions) 
  2. A trained healthcare staff member must immediately suspend the Evalyn Brush into a vial of ThinPrep PreservCyt solution following transport instructions. The ThinPrep PreservCyt vial can then be transported to the lab at 2 to 30°C.  
  3. This may not be collected at home or in an outpatient draw site. 

Specimen Transport Temperature

Ambient

Specimen Stability

Ambient: 30 days

Refrigerated: 105 days

Frozen: 6 months

Laboratory Retention: 30 days

Test Frequency

Available Monday through Friday, usual TAT 7 - 10 business days.

Reference Range

Qualitative detection of fourteen high-risk HPV types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) associated with the development or progression of invasive cervical carcinoma. This test provides genotype-specific reporting at no additional cost as follows: HPV genotype 16, HPV genotype 18 and Other HPV High Risk.

This test includes an internal control (human β-globin) to ensure adequate specimen cellularity. Samples lacking detectable internal control will be reported inadequate. A negative result does not exclude the possibility of HPV infection. Very low levels of infection may cause a false-negative result. Bloody specimens may give false-negative results. 

Performing Department

Molecular

Performing Department Laboratory Location

Corewell Health Royal Oak Laboratory

Methodology

Nucleic Acid Amplification (FDA Approved). Roche Cobas HPV Test.

CPT

87624

CDM Code

3068762402

Epic Test ID

n/a

LOINC

HPV Genotype 16, 61372-9, HPV Genotype 18, 61373-7 

Reviewed Date

Under Review