Test Details
Methodology
Fluorescence in situ hybridization (FISH) and plasma cell enrichment
Result Turnaround Time
5 - 7 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
Fluorescence in situ hybridization (FISH) for multiple myeloma (MM), targeting 13q14, IGH/CCND1, TP53, FGFR1/IGH, cMAF/IGH, amplification of 1p/1q, on plasma enriched cells.
Use
This is a diagnostic test for multiple myeloma. Plasma cell enrichment diagnosis increased as much as 50% to 100%. The FISH results on the enriched assay should not be used as a quantitative assay, since the abnormal cells do not represent the percentage of abnormal cells in the aspirate.
Special Instructions
Indicate pertinent clinical diagnosis and previous cytogenetics studies on the test request form. If insufficient plasma cells are available, the following probe priority will be followed: Previous abnormality, p53, FGFR3/IGH, MAF/IGH, 1p/1q, 13q14, CCND1/IGH, 7/9/15 aneuploidy probes. If a chromosome study (510999) is ordered concurrently and sample is not sufficient for both tests, FISH will be prioritized.
Limitations
Molecular mutations below the resolution of FISH will not be detected. This test also will not detect regions not targeted by FISH probes.
This test was developed, and its performance characteristics determined, by LabCorp. It has not been cleared or approved by the US Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary.
References
Specimen Requirements
Specimen
Bone marrow
Volume
1 to 3 mL bone marrow
Minimum Volume
1 mL bone marrow
Container
Green-top (sodium heparin) tube with bone marrow aspirate
Collection Instructions
Transport to the testing lab at room temperature; use a cool pack or LabCorp transport kit. Do not allow sample to freeze. Sample must arrive in the laboratory within 72 hours of collection.
Storage Instructions
Maintain specimen at room temperature.
Causes for Rejection
Whole blood; broken Vacutainer®; specimen received at testing facility 72 hours after collection
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 510325 | Multiple Myeloma FISH Panel | 510768 | Specimen Type | 31208-2 | ||
| 510325 | Multiple Myeloma FISH Panel | 510695 | Cells Counted | 62361-1 | ||
| 510325 | Multiple Myeloma FISH Panel | 510696 | Cells Analyzed | 62360-3 | ||
| 510325 | Multiple Myeloma FISH Panel | 510769 | FISH Result | 62357-9 | ||
| 510325 | Multiple Myeloma FISH Panel | 510318 | Interpretation | 62365-2 | ||
| 510325 | Multiple Myeloma FISH Panel | 510319 | Director Review: | 48672-0 | ||
| 510325 | Multiple Myeloma FISH Panel | 512123 | 11502-2 | |||
| Order Code | 510325 | |||||
| Order Code Name | Multiple Myeloma FISH Panel | |||||
| Order Loinc | ||||||
| Result Code | 510768 | |||||
| Result Code Name | Specimen Type | |||||
| UofM | ||||||
| Result LOINC | 31208-2 | |||||
| Order Code | 510325 | |||||
| Order Code Name | Multiple Myeloma FISH Panel | |||||
| Order Loinc | ||||||
| Result Code | 510695 | |||||
| Result Code Name | Cells Counted | |||||
| UofM | ||||||
| Result LOINC | 62361-1 | |||||
| Order Code | 510325 | |||||
| Order Code Name | Multiple Myeloma FISH Panel | |||||
| Order Loinc | ||||||
| Result Code | 510696 | |||||
| Result Code Name | Cells Analyzed | |||||
| UofM | ||||||
| Result LOINC | 62360-3 | |||||
| Order Code | 510325 | |||||
| Order Code Name | Multiple Myeloma FISH Panel | |||||
| Order Loinc | ||||||
| Result Code | 510769 | |||||
| Result Code Name | FISH Result | |||||
| UofM | ||||||
| Result LOINC | 62357-9 | |||||
| Order Code | 510325 | |||||
| Order Code Name | Multiple Myeloma FISH Panel | |||||
| Order Loinc | ||||||
| Result Code | 510318 | |||||
| Result Code Name | Interpretation | |||||
| UofM | ||||||
| Result LOINC | 62365-2 | |||||
| Order Code | 510325 | |||||
| Order Code Name | Multiple Myeloma FISH Panel | |||||
| Order Loinc | ||||||
| Result Code | 510319 | |||||
| Result Code Name | Director Review: | |||||
| UofM | ||||||
| Result LOINC | 48672-0 | |||||
| Order Code | 510325 | |||||
| Order Code Name | Multiple Myeloma FISH Panel | |||||
| Order Loinc | ||||||
| Result Code | 512123 | |||||
| Result Code Name | ||||||
| UofM | ||||||
| Result LOINC | 11502-2 |