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HelpTest Code CSP53 TP53 Gene Somatic Mutation Pre-Analysis Cell Sorting, Varies
Specimen Required
Only orderable as a reflex. For more information see P53CA / Hematologic Neoplasms, TP53 Somatic Mutation, DNA Sequencing Exons 4-9, Varies.
Specimen Type: Blood
Container/Tube: Lavender top (EDTA) or yellow top (ACD solution B)
Specimen Volume: 3 mL
Collection Instructions:
1. Invert several times to mix blood.
2. Send whole blood specimen in original tube. Do not aliquot.
3. Label specimen as blood.
Specimen Stability Information: Ambient/Refrigerate <10 days
Useful For
Determination of B-cell content and confirmation the presence of a clonal B-cell population evaluating chronic lymphocytic leukemia patients prior to TP53 variant analysis
Method Name
Only orderable as a reflex. For more information see P53CA / Hematologic Neoplasms, TP53 Somatic Mutation, DNA Sequencing Exons 4-9, Varies.
Flow Cytometric Cell Selection
Reporting Name
TP53 Pre-Analysis Cell Sorting, VSpecimen Type
VariesSpecimen Minimum Volume
1 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Varies | Ambient (preferred) | 10 days | |
| Refrigerated | 10 days |
Reject Due To
| Gross hemolysis | Reject |
| Fully clotted | Reject |
Clinical Information
Patients with chronic lymphocytic leukemia (CLL) have variable disease course influenced by a series of tumor biologic factors. The presence of chromosomal 17p- or TP53 gene variation confers a very poor prognosis to a subset of CLL patients, both at time of initial diagnosis as well as at disease progression, or in the setting of therapeutic resistance. TP53 gene variant status in CLL has emerged as the single most predictive tumor genetic abnormality associated with adverse outcome and poor response to standard immunochemotherapy; however, patients can be managed with alternative therapeutic options.
Reference Values
Only orderable as a reflex. For more information see P53CA / Hematologic Neoplasms, TP53 Somatic Mutation, DNA Sequencing Exons 4-9, Varies.
Interpretation
Correlation with clinical, histopathologic and additional laboratory findings is required for final interpretation of these results. The final interpretation of results for clinical management of the patient is the responsibility of the managing physician.
Cautions
No significant cautionary statements
Method Description
Peripheral blood specimens from chronic lymphocytic leukemia patients are analyzed by fluorescent activated cell sorting and enrichment to determine B-cell content and confirm the presence of a clonal B-cell population.(Instruction manual: BD FACSMelody Cell Sorter User's Guide. Revision 3. BD Biosciences; 03/2020)
Day(s) Performed
Specimens processed: Monday through Sunday
Results reported: Monday through Friday
Report Available
7 daysSpecimen Retention Time
DNA: 3 monthsPerforming 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
88184-Flow cytometry, first cell surface, cytoplasmic or nuclear marker
88185 x 4-Each additional marker
LOINC Code Information
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 607678 | TP53 Pre-Analysis Cell Sort | No LOINC Needed |
| 607687 | Final Diagnosis | 22637-3 |