T-Cell Clonality Screening by PCR

0055567
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Additional Technical Information
Ordering Recommendation

Aid in the diagnosis of T-cell lymphoproliferative disorders.

Mnemonic
T CELL-F
Methodology

Polymerase Chain Reaction/Capillary Electrophoresis

Performed

DNA Isolation: Sun-Sat
Assay: Mon, Wed-Fri

Reported

5-7 days

New York DOH Approval Status
This test is New York DOH approved.
Specimen Required
Patient Preparation
Collect

Lavender (EDTA), bone marrow (EDTA), or tissue. Also acceptable: DNA extracted by CLIA certified lab.

Specimen Preparation

Whole Blood: Do not freeze. Transport 5 mL. (Min: 1 mL)
Bone marrow: Do not freeze. Transport 3 mL. (Min: 1 mL)
Fresh Tissue: Freeze immediately. Transport 100 mg or 0.5-2.0 cm3 tissue
FFPE Tumor Tissue: Formalin fix (10 percent neutral buffered formalin) and paraffin embed tissue. Protect from excessive heat. Tissue block will be returned after testing. Transport tissue block or four 10-micron shavings in a tissue transport kit (ARUP Supply #47808) available online through eSupply using ARUP Connect™ or contact ARUP Client Services at (800) 522-2787.
Extracted DNA: Transport 40uL DNA with at least 50 ng/uL concentration. Transport DNA in a tissue transport kit (ARUP Supply #47808) available online through eSupply using ARUP Connect™ or contact ARUP Client Services at (800) 522-2787.

Storage/Transport Temperature

Whole Blood, Bone Marrow or Extracted DNA: Refrigerated.
Fresh Tissue: Frozen on dry ice.
FFPE Tumor Tissue: Room temperature. Also acceptable: Refrigerated. Ship in cooled container during summer months.

Unacceptable Conditions

Whole Blood, Bone Marrow or Extracted DNA: Plasma, serum, or DNA extracted by a non-CLIA lab. Specimens collected in anticoagulants other than EDTA or sodium heparin. Clotted or grossly hemolyzed specimens.
Tissue: Specimens fixed/processed in alternative fixatives, heavy metal fixatives (B-4 or B-5), or tissue sections on slides. Decalcified specimens.

Remarks
Stability

Whole Blood or Bone Marrow: Ambient: 24 hours; Refrigerated: 5 days; Frozen: Unacceptable
Fresh Tissue: Ambient: Unacceptable; Refrigerated: 2 hours; Frozen: 1 year
FFPE Tumor Tissue: Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable
Extracted DNA: Ambient: 1 month; Refrigerate: Indefinitely; Frozen: Indefinitely

Reference Interval
Interpretive Data

Refer to report.

Compliance Statement B: For laboratory developed tests not using a RUO kit, and for FDA approved, cleared or 510(k) exempt assays with alterations. This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.

Note
Hotline History

View Hotline History

 

Hotline History

Date of Change
Test Name Change
Methodology
Performance/Reported Schedule
Specimen Requirements
Reference Interval
Interpretive Data
Note
CPT Code
Component Change
Other Interface Change
New Test
Inactive
08/19/2019
X
N/A
CPT Codes

81342

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Components
Component Test Code* Component Chart Name LOINC
0055567 T-Cell Clonality by PCR 21753-9
2006285 T-Cell Clonality Source
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.
Aliases
  • T Cell Gamma
  • T Cell Gene Rearrangement
  • T-cell receptor gamma rearrangment
  • T-Cell Receptor Gene Rearrangement
  • TCRG
T-Cell Clonality Screening by PCR