TCRG (T-cell) Clonality, fragment analysis

Intended Use: This assay is intended for the identification of clonal T-cell populations, which is highly suggestive of T-cell malignancies.

Specimen Required: Whole blood or Bone marrow in lavender (EDTA), FFPE Tissue.

Patient Preparation

• Sample Collection: 2 Tubes / EDTA Blood / 2 mL per tube or Bone marrow in lavender (EDTA) or FFPE.
• Specimen Preparation

     Whole Blood: Transport 5 mL whole blood. (Min: 3 mL)

     Bone Marrow: Transport 3 mL bone marrow. (Min: 1 mL)

     FFPE Tissue: Formalin-fixed (10 percent neutral buffered formalin) and paraffin-embedded tissue. Protect from excessive heat.

• Storage/Transport Temperature:

     Whole Blood and Bone Marrow: CRITICAL REFRIGERATED. Separate specimens must be submitted when multiple tests are ordered.

     FFPE Tumor Tissue: Room temperature. Also acceptable: Refrigerated. Ship in cooled container during summer months.

• Unacceptable Conditions

     Serum, plasma, extracted DNA, CSF, ambient whole blood, or frozen whole blood or bone marrow.

     Specimens collected in anticoagulants other than EDTA. Severely haemolyzed or clotted specimens.

     FFPE Tissue: Specimens fixed in any fixative other than 10 percent neutral buffered formalin.

     Bone specimens submitted in non-EDTA decalcifier.

• Remarks:

If multiple specimens (blocks or slides) are sent to CMDL, they must be accompanied by one of the following: an order comment indicating that the CMDL pathologist should choose the specimen most appropriate for testing (e.g., “Choose best block”), or individual orders for each sample submitted. If multiple specimens are sent to CMDL without a request for pathologist block/slide selection or individual orders, they will be held until clarification is provided.

• Stability

     Whole Blood or Bone Marrow: Refrigerated: 7 days; Frozen: Unacceptable

     FFPE Tissue: Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable

Methodology: The test employs a single multiplex PCR reaction that targets the conserved variable (V) and joining (J) regions of the T-cell receptor gamma (TCRG) gene locus.

Sample Received to Report Turnaround Time (TAT): Twice in a week (Scheduled Test)

Interpretive Data: Refer to the report.