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Epic Test Code LAB31135 Human Papillomavirus (HPV) DNA Detection with reflex to Genotyping, High-Risk Types by PCR, ThinPrep

Important Note

Ordered on PAP samples for female patients age >21 years old .

Specimen Type

Varies

Volume Required

1 mL

Storage Requirements

 

Specimen Type Temperature Time
Varies Ambient (preferred) 30 days
  Refrigerated  60 days

 

Transportation Needs

 

Specimen Type Temperature Time
Varies Ambient (preferred) 30 days
  Refrigerated  60 days

 

Causes for Rejection

  • Specimen in anything other than Thin prep preservative (PreservCyt)
  • Mislabeled or unlabeled specimen

Days of Analysis

M, W, F

Methodology

PANTHER (NAAT) Nucleic Acid Amplification

Transcription mediated Amplification

CPT Code

87624

Last Updated

02-Feb-2016

Reflexive Testing

Positive HPV results triggers HPV 16 18/45 genotyping (CPT87625), HPV 16 18/45 genotyping are non-orderable test.

Reporting Name

HPV In-house Screen

Specimen Required

Specimen source is required. 

 

Submit only 1 of the following specimens:

 

Specimen Type: Cervical (endocervical or ectocervical)

Container/Tube: ThinPrep/PreservCyt solution vial

Specimen Volume: 3 mL of solution in ThinPrep/PreservCyt vial

Collection Instructions:

1. Bag ThinPrep specimens individually as they have a tendency to leak during transport.

2. Place labels on the vial and on the bag. 

 

Specimen Type: Vaginal

Container/Tube: ThinPrep/PreservCyt solution vial

Specimen Volume: 3 mL of solution in ThinPrep/PreservCyt vial

Collection Instructions:

1. Bag ThinPrep specimens individually as they have a tendency to leak during transport.

2. Place labels on the vial and on the bag.

 

Analytic Time

HPV 3-8 days

Reference Values

HPV Screen

  •  Negative. The following high risk genotypes were not detected: 16, 18,31,33,35,39,45,51,52,56,58,59,66,68. Negative results are not intended to prevent women from proceeding to colposcopy.  

Minimum Volume

1 mL

Limitations

  • Test is not validated for HPV vaccinated individuals or suspected abuse        
  • Results may be affected by improper specimen collection, storage or processing
  • Personal lubricants that contain Polyquaternium 15 may interfere
  • A negative result does not exclude the possibility of cytologic abnormalities or of future or underlying CIN2, CIN3 or cancer