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Brain Biopsy Testing

Fixed Brain Biopsy
CPT Code 88307 & 88342
Ordering Recommendation

This test can aid in determining the type of prion disease. Different types of prion disease have different distribution patterns of the abnormal protein.

Please note: cortical brain biopsies do not rule out the possibility of Fatal Insomnia (FI). 
Methodology

Histological Analysis: 

  • Immunohistochemistry staining (IHC): Detection of PrPSc with 3F4 monoclonal antibody to diagnose Prion Disease and its subtype.
  • Hematoxylin & Eosin staining (H&E): To view cellular and tissue structure detail.
Available STAT No. 
Analytic Timei 5 business days.
Submit With Order

NPDPSC Test Request Form. Please fill out the insurance information if the center is to bill the patient directly.

 

Specimen Requirements
Patient Preparation Patients under 12 years of age will require documentation of medical necessity and testing will be approved by NPDPSC Director. 
Specimen Type Brain Tissue (gray matter only).
Preferred Container 10% buffered formalin.
Other Accepted Forms
  • Unstained Slides.
  • Cassettes.
  • Paraffin Embedded (P&E) Blocks.
Specimen Preparation

Place at least 0.5g of gray matter tissue in 10% buffered formalin for at least 24 hours.

Storage/Transport

- Unstained Slides: Should be placed in plastic slide holders, then placed in a sealed primary bag and mailed in a FedEx Clinical Pack envelope.

- Cassettes/Blocks: Should be placed in a sealed primary bag and mailed in a bubble wrap envelope.

- Fixed Tissue: Should be shipped in a pre-filled 10% neutral buffered formalin container. Place the labeled specimen in a leak-proof plastic bag, and place the bag in a Styrofoam carton with absorbent material.

Please note: Please call the laboratory at
216-368-0587 to notify the staff of the incoming biopsy. Shipments are not received on weekends and/or holidays. Ship only Monday through Thursday (priority overnight).
Unacceptable Conditions

White matter, tumor, mass, or dura are not acceptable for prion diagnosis and subtyping. Additionally, specimen quality could affect the ability to rule out prion disease.

Avoid freezing of fixed tissue, which may cause artifact.
Remarks Complete the required test request forms linked above. 
Stability

Up to 7 days at room temperature (in formalin). 
No refrigeration or freezing.

 

Specimen Reporting
Reference Range Negative.
Critical Results None.
Histopathology Results Negative or Positive.

 

References

i. Expected turnaround-time (business days) for results, beginning when the center receives the specimen.
 

Frozen Brain Biopsy
CPT Code 88372
Ordering Recommendation

This test can aid in determining the type of prion disease. Different types of prion disease have different distribution patterns of the abnormal protein.

Please note: cortical brain biopsies do not rule out the possibility of Fatal Insomnia (FI).  
Methodology Western Blot : Digestion of brain tissue containing the pathogenic prion protein yields a 21kD peptide (Type 1) or a 19kD peptide (Type 2), both of which are detected. The resulting peptides are separated on the basis of molecular size by electrophoresis.
Available STAT No. 
Analytic Timei 5 business days.
Submit With Order

NPDPSC Test Request Form. Please fill out the insurance information if the center is to bill the patient directly.

 

Specimen Requirements
Patient Preparation Patients under 12 years of age will require documentation of medical necessity and testing will be approved by NPDPSC Director. 
Specimen Type Brain Tissue (gray matter only).
Preferred Container Sterile specimen cup.
Storage/Transport
  1. Place at least 0.5g of gray matter tissue into a sterile specimen cup, label the cup with the patient's name and date of birth, and store in freezer (at least -20°C) until shipped. 
  2. When shipping, place the sterile cup with the brain tissue inside a primary bag and seal. Prepare a larger secondary bag by filling the bag with absorbent material, and place the primary bag inside the secondary bag.
  3. Place the complete secondary bag into a Styrofoam box filled with sufficient dry ice (5lb for 24 hours).
  4. Place the Styrofoam box into a UN3373 approved cardboard box, seal and ship to NPDPSC.

Please note: Always send frozen specimens separately from fixed specimens to avoid freezing of fixed tissue, which may cause artifact. 

Please call the laboratory at
216-368-0587 to notify the staff of the incoming biopsy. Shipments are not received on weekends and/or holidays. Ship only Monday through Thursday (priority overnight).
Unacceptable Conditions

White matter, tumor, mass or dura are not acceptable for prion diagnosis and subtyping. Additionally, specimen quality could affect the ability to rule out prion disease.
Remarks Complete the required test request forms linked above. 
Stability

Up to 7 days at least -20°C.
No room temperature or refrigeration.

 

Specimen Reporting
Reference Range Negative.
Critical Results None.
Histopathology Results Negative or Positive.

 

References

i. Expected turnaround-time (business days) for results, beginning when the center receives the specimen.