Additional Information:
T Cell Clonality Analysis
Epic Order Code: LAB5639
CPT Code(s):
- 81342
- 88381 (FFPE)
Specimen Requirements:
Acceptable sample type: The samples should be specifically chosen by a pathologist to include at least 5 % tumor cells without significant necrosis or inflammation. The following types of samples are accepted:
a. FFPE (formalin fixed, paraffin embedded) block
b. Unstained slides (USS) from FFPE
c. Bone marrow aspirate
d. Peripheral blood
Formalin Fixed Parafin Embedded (FFPE) specimens or Unstained Slides (USS) prepared from FFPE specimens must be accompanied by 1 corresponding H&E from the same block with the tumor circled by a qualified pathologist AND the estimated percentage of tumor cells in the circled area(s). For Peripheral Blood (PB) or Bone Marrow Aspirate (BMA), only the estimated percent of tumor cells is required.
Bone marrow aspirate or Peripheral blood:
Container/Tube: Lavender top (EDTA)
Specimen Volume: 3mL
Collection Instructions:
1. Invert several times to mix blood.
2. Send whole blood specimen in original tube. Do not aliquot. Do not freeze or centrifuge.
Specimen Stability Information: Ambient 24 Hours/ Refrigerated 1 Week/ Frozen Unacceptable
Transport to the laboratory as soon as possible for testing.
Unacceptable conditions:
Clotted or frozen blood.
Specimens received beyond recommended stability.
Less than the minimum volume requirements for blood collection.
Failure to indicate tumor and/or percent tumor will result in delayed specimen processing or specimen rejection.
Tumor percent cannot be zero (0) or unknown.
A percent tumor of less than 5 will be reviewed on a case by case basis by the director of molecular pathology.
Use:
T-cell receptor (TCRG) Gene Rearrangement Analysis is a qualitative assay used to detect clonal rearrangements in a T-cell population from genomic DNA.
Methodology:
PCR and Fragment Analysis
Reported:
5 – 10 business days
Reference Values:
Normal: Polyclonal
Abnormal: Monoclonal/Clonal/Oligoclonal
Test Classification:
Laboratory Developed Test