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Mayo Test ID BRAFV BRAF V600E Immunostain, Technical Component Only


Ordering Guidance


This test includes only technical performance of the stain (no pathologist interpretation is performed). If diagnostic consultation by a pathologist is required order PATHC / Pathology Consultation.



Shipping Instructions


Attach the green pathology address label and the pink Immunostain Technical Only label included in the kit to the outside of the transport container.



Specimen Required


Specimen Type: Tissue

Supplies: Immunostain Technical Only Envelope (T693)

Container/Tube: Immunostain Technical Only Envelope

Preferred:

-Formalin-fixed, paraffin-embedded tissue block

OR

-2 Unstained, positively charged glass slides (25- x 75- x 1-mm) per test ordered; sections 4-microns thick

Acceptable: None


Useful For

Identification of BRAF V600E-mutated protein

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
IHTOA IHC Additional, Tech Only No, (Bill Only) No
IHTOI IHC Initial, Tech Only No, (Bill Only) No

Method Name

Immunohistochemistry (IHC)

Reporting Name

BRAF V600E IHC, Tech Only

Specimen Type

TECHONLY

Specimen Stability Information

Specimen Type Temperature Time Special Container
TECHONLY Ambient (preferred)
  Refrigerated 

Reject Due To

Wet/frozen tissue
Cytology smears
Nonformalin fixed tissue
Nonparaffin embedded tissue
Noncharged slides
ProbeOn slides
Snowcoat slides
Reject

Clinical Information

BRAF is a serine/threonine protein kinase and a member of the Raf family. The BRAF V600E alteration leads to constitutive activation of the mitogen activated protein kinase pathway, which plays a role in cell proliferation and tumorigenesis. This genetic alteration has been detected in a variety of tumors such as melanoma, colorectal cancer, papillary thyroid carcinoma, hairy cell leukemia, Langerhans cell histiocytosis, and pleomorphic xanthoastrocytomas.

Interpretation

This test does not include pathologist interpretation, only technical performance of the stain. If interpretation is required, order PATHC / Pathology Consultation for a full diagnostic evaluation or second opinion of the case.

 

The positive and negative controls are verified as showing appropriate immunoreactivity. If a control tissue is not included on the slide, a scanned image of the relevant quality control tissue is available upon request; call 855-516-8404.

 

Interpretation of this test should be performed in the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.

Cautions

Age of a cut paraffin section can affect immunoreactivity. Stability thresholds vary widely among published literature and are antigen dependent. Best practice is for paraffin sections to be cut within 6 weeks.

 

The charge of glass slides can be affected by environmental factors and subsequently may alter slide staining. Sending unsuitable glass slides can result in inconsistent staining due to poor slide surface chemistry.

 

Best practices for storage of positively charged slides:

-Minimize time slides are stored after being unpackaged

-Limit exposure to high humidity and heat

-Minimize exposure to plastics

Clinical Reference

1. Ida C, Vrana JA, Rodriguez FJ, et al. Immunohistochemistry is highly sensitive and specific for detection of BRAF V600E mutation in pleomorphic xanthoastrocytoma. Acta Neuopath communications. 2013;1:20

2. Capper D, Berghoff AS, Magerle M, et al. Immunohistochemical testing of BRAF V600E status in 1,120 tumor tissue samples of patients with brain metastases. Acta Neuropathol. 2012;123(2):223-233

3. Andrulis M, Penzel R, Weichert W, von Deimling A, Capper D. Application of a BRAF V600E Mutation-specific Antibody for the Diagnosis of Hairy Cell Leukemia. Am J Surg Pathol. 2012;36(12):1796-1800

4. Koperek O, Kornauth C, Capper D, et al. Immunohistochemical detection of the BRAF V600E-mutated protein in papillary thyroid carcinoma. Am J Surg Pathol. 2012;36(6):844-850

5. Skorokhod A, Capper D, von Deimling A, Enk A, Helmbold P. Detection of BRAF V600E mutations in skin metastases of malignant melanoma by monoclonal antibody VE1. J Am Acad skin metastases of malignant melanoma by monoclonal antibody VE1. J Am Acad Dermatol. 2012;67(3):488-491

6. Magaki S, Hojat SA, Wei B, So A, Yong WH. An introduction to the performance of immunohistochemistry. Methods Mol Biol. 2019;1897:289-298. doi:10.1007/978-1-4939-8935-5_25

Method Description

Immunohistochemistry on sections of paraffin-embedded tissue.(Unpublished Mayo method)

Day(s) Performed

Monday through Friday

Report Available

1 to 3 days

Specimen Retention Time

Until staining is complete.

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information

88342-TC, primary

88341-TC, if additional IHC

LOINC Code Information

Test ID Test Order Name Order LOINC Value
BRAFV BRAF V600E IHC, Tech Only Order only;no result

 

Result ID Test Result Name Result LOINC Value
70680 BRAF V600E IHC, Tech Only Bill only; no result

Testing Algorithm

For the initial technical component only immunohistochemical (IHC) stain performed, the appropriate bill-only test ID will be reflexed and charged (IHTOI). For each additional technical component only IHC stain performed, an additional bill-only test ID will be reflexed and charged (IHTOA).