Test Details
Disease
Hematologic malignancies
Technology
Methodology
The Labcorp TP53 NGS assay utilizes capture-based next generation sequencing of whole genomic DNA libraries to identify gene alterations in TP53 that have diagnostic, prognostic and therapeutic significance in hematologic malignancies. Somatic mutations in the TP53 gene include single nucleotide variants (SNVs), insertions and deletions (indels), whole gene copy number variants (CNVs) and sub-gene (exon level) CNVs genes.
Result Turnaround Time
10 - 14 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Test Includes
This test includes the following gene: TP53.
Use
This test is used to identify alterations in TP53 to aid diagnosis, prognostic risk assessment and therapeutic selection in myeloid and lymphoid malignancies.
Special Instructions
Please provide a clinical indication or related ICD-10 code on the requisition. Test will be delayed if the clinical indication is not received. Please direct any questions regarding this test to customer service at 800-345-4363.
Limitations
The analytical sensitivity of this assay is 3% Variant Allele Fraction (VAF) for Single Nucleotide Variants (SNV), 5% for insertions/deletions (indels) <25 base pairs (bp) and 15% for indels ≥25 bp. Sensitivity for CNVs with size ≥ two contiguous exons (subset) to whole gene at a copy number ≤0.85 for deletions and ≥1.15 for gains.
Insertions and deletions of any length are detected when at least one breakpoint is contained within a sequence read. Insertions up to 27 bp and deletions up to 34 bp have been detected in clinical specimens. Mutations outside the targeted regions and gene rearrangements will not be detected.
Variants are categorized into tiers based on their clinical impact, following a joint consensus recommendation from the AMP, ASCO and CAP. Clinical and experimental evidence grouped in to four levels (A-D) based on significance in clinical decision making (therapeutic, diagnosis, prognosis) is assigned to variants to determine their clinical significance: Tier 1, Variants with Strong Clinical Significance (level A and B evidence); Tier 2, Variants with Potential Clinical Significance (level C or D evidence); Tier 3, Variants of Unknown Clinical Significance and Tier 4, Benign or Likely Benign. Somatic variant tiers may be reclassified as the knowledge base evolves.
The tier classifications in this report reflect the status at the time of testing. Hematologic malignancies can undergo clonal evolution, and patients may exhibit multiple clones or chimeric cell populations due to age or at various treatment stages, including bone marrow transplant. This assay cannot distinguish whether detected variants arise from individual clones or from chimeric cell mixture. Results should be interpreted in conjunction with clinical and other laboratory findings for the most accurate interpretation.
This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.
Specimen Requirements
Specimen
Whole blood, bone marrow, cell pellets from whole blood or cell suspension
Volume
3-5 mL (blood), 1-2 mL (bone marrow)
Minimum Volume
3 mL (blood), 1 mL (bone marrow)
Container
Lavender-top (EDTA) tube; green-top (sodium heparin) tube; cells left over from flow cytometry analysis, either fresh cell suspension or fresh/frozen cell pellet spun down from suspension.
Cell suspension should be shipped on ice.
Collection Instructions
Submit at room temperature. Specimens should arrive in the laboratory within 48 hours of collection. Indicate date and time of collection on test request form.
Storage Instructions
Submit at room temperature. If specimen has to be stored more than 48 hours, refrigerate at 2°C to 8°C.
Causes for Rejection
Specimen does not meet criteria for sample type, container, minimum volume, collection and storage; frozen whole blood or marrow; leaking tube; clotted blood or marrow; grossly hemolyzed specimen or otherwise visibly degraded; contaminated specimen; contains suspicious foreign material
References
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LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 452423 | TP53 Mutation NGS | 99961-5 | 452424 | Genes | 36908-2 | |
| 452423 | TP53 Mutation NGS | 99961-5 | 452425 | Specimen Type | 31208-2 | |
| 452423 | TP53 Mutation NGS | 99961-5 | 452426 | Referring Physician | 8251-1 | |
| 452423 | TP53 Mutation NGS | 99961-5 | 452427 | Clinical Indication | 42349-1 | |
| 452423 | TP53 Mutation NGS | 99961-5 | 452428 | Result | 99961-5 | |
| 452423 | TP53 Mutation NGS | 99961-5 | 452429 | Comments | 8251-1 | |
| 452423 | TP53 Mutation NGS | 99961-5 | 452430 | Interpretation | 53039-4 | |
| 452423 | TP53 Mutation NGS | 99961-5 | 452431 | Method/Limitations | 49549-9 | |
| 452423 | TP53 Mutation NGS | 99961-5 | 452432 | References | 75608-0 | |
| 452423 | TP53 Mutation NGS | 99961-5 | 452433 | Released By | 72486-4 | |
| 452423 | TP53 Mutation NGS | 99961-5 | 452434 | Appendix-Clinical Trials | 8251-1 | |
| 452423 | TP53 Mutation NGS | 99961-5 | 452435 | Image | 51969-4 | |
| Order Code | 452423 | |||||
| Order Code Name | TP53 Mutation NGS | |||||
| Order Loinc | 99961-5 | |||||
| Result Code | 452424 | |||||
| Result Code Name | Genes | |||||
| UofM | ||||||
| Result LOINC | 36908-2 | |||||
| Order Code | 452423 | |||||
| Order Code Name | TP53 Mutation NGS | |||||
| Order Loinc | 99961-5 | |||||
| Result Code | 452425 | |||||
| Result Code Name | Specimen Type | |||||
| UofM | ||||||
| Result LOINC | 31208-2 | |||||
| Order Code | 452423 | |||||
| Order Code Name | TP53 Mutation NGS | |||||
| Order Loinc | 99961-5 | |||||
| Result Code | 452426 | |||||
| Result Code Name | Referring Physician | |||||
| UofM | ||||||
| Result LOINC | 8251-1 | |||||
| Order Code | 452423 | |||||
| Order Code Name | TP53 Mutation NGS | |||||
| Order Loinc | 99961-5 | |||||
| Result Code | 452427 | |||||
| Result Code Name | Clinical Indication | |||||
| UofM | ||||||
| Result LOINC | 42349-1 | |||||
| Order Code | 452423 | |||||
| Order Code Name | TP53 Mutation NGS | |||||
| Order Loinc | 99961-5 | |||||
| Result Code | 452428 | |||||
| Result Code Name | Result | |||||
| UofM | ||||||
| Result LOINC | 99961-5 | |||||
| Order Code | 452423 | |||||
| Order Code Name | TP53 Mutation NGS | |||||
| Order Loinc | 99961-5 | |||||
| Result Code | 452429 | |||||
| Result Code Name | Comments | |||||
| UofM | ||||||
| Result LOINC | 8251-1 | |||||
| Order Code | 452423 | |||||
| Order Code Name | TP53 Mutation NGS | |||||
| Order Loinc | 99961-5 | |||||
| Result Code | 452430 | |||||
| Result Code Name | Interpretation | |||||
| UofM | ||||||
| Result LOINC | 53039-4 | |||||
| Order Code | 452423 | |||||
| Order Code Name | TP53 Mutation NGS | |||||
| Order Loinc | 99961-5 | |||||
| Result Code | 452431 | |||||
| Result Code Name | Method/Limitations | |||||
| UofM | ||||||
| Result LOINC | 49549-9 | |||||
| Order Code | 452423 | |||||
| Order Code Name | TP53 Mutation NGS | |||||
| Order Loinc | 99961-5 | |||||
| Result Code | 452432 | |||||
| Result Code Name | References | |||||
| UofM | ||||||
| Result LOINC | 75608-0 | |||||
| Order Code | 452423 | |||||
| Order Code Name | TP53 Mutation NGS | |||||
| Order Loinc | 99961-5 | |||||
| Result Code | 452433 | |||||
| Result Code Name | Released By | |||||
| UofM | ||||||
| Result LOINC | 72486-4 | |||||
| Order Code | 452423 | |||||
| Order Code Name | TP53 Mutation NGS | |||||
| Order Loinc | 99961-5 | |||||
| Result Code | 452434 | |||||
| Result Code Name | Appendix-Clinical Trials | |||||
| UofM | ||||||
| Result LOINC | 8251-1 | |||||
| Order Code | 452423 | |||||
| Order Code Name | TP53 Mutation NGS | |||||
| Order Loinc | 99961-5 | |||||
| Result Code | 452435 | |||||
| Result Code Name | Image | |||||
| UofM | ||||||
| Result LOINC | 51969-4 |