Fumarate Hydratase by Immunohistochemistry

Also known as: FUMHYD IHC

Clinical Use

Use

Fumarate Hydratase by Immunohistochemistry (IHC) is performed to qualitatively assess the presence of fumarate hydratase protein in tissue samples. This test is primarily used to aid in the diagnosis of fumarate hydratase deficiency and possibly evaluate FH-deficient tumors. Fumarate hydratase deficiency is associated with hereditary leiomyomatosis and renal cell cancer (HLRCC). The presence or absence of fumarate hydratase protein may assist in the evaluation of certain tumor syndromes. It is intended for clinical purposes and performed in a CLIA certified laboratory.

Special Instructions

Not provided.

Limitations

This lab-developed test has not been cleared or approved by the FDA. As an immunohistochemistry-based test, potential limitations include pre-analytical variations such as tissue fixation, antigen retrieval methods, and the inherent subjectivity in IHC interpretation. Staining results may also be affected by the degradation of tissue antigenicity over time if not properly fixed or stored. Conditions submitted with non-representative tissue type or depleted specimens will be rejected, which further limits the applicability of testing certain sample types.

Test Details

New York Approved

Methodology

Immunoassay (IHC)

Biomarkers

Fumarate Hydratase

Protein

IHC

Expression • Categorical (e.g., Positive / Negative / Indeterminate)

Result Turnaround Time

1-3 days

Specimen

Tissue (FFPE)

Volume

Not provided

Minimum Volume

2 slides

Container

Paraffin block or 5 unstained positively charged slides

Collection Instructions

Formalin fix (10 percent neutral buffered formalin) and paraffin embed specimen. Protect paraffin block and/or slides from excessive heat. Transport tissue block or slides in a tissue transport kit. Do not oven bake precut slides.