Test Details
Methodology
Fluorescence in situ hybridization (FISH) and plasma cell enrichment. SNP microarray analysis is performed using the Cytoscan® HD platform, which uses more than 743,000 SNP probes and 1,953,000 NPCN probes with a median spacing of 0.88 kb.
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
Fluorescence in situ hybridization (FISH) for multiple myeloma (MM); IgH-CCDN1; FGFR3/IgH; CMAF/IgH; SNP microarray (Reveal®)
Use
This test 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. The SNP assay will detect chromosomal imbalance that may be present in neoplastic disorders and clonal evolution. It provides detection of copy-neutral loss of heterozygosity of any chromosome, and the percent and location of homozygosity, that may be associated with cancer gene mutations.
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This test 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. The SNP assay will detect chromosomal imbalance that may be present in neoplastic disorders and clonal evolution. It provides detection of copy-neutral loss of heterozygosity of any chromosome, and the percent and location of homozygosity, that may be associated with cancer gene mutations. |
Special Instructions
Indicate pertinent clinical diagnosis and previous cytogenetics studies on the test request form.
Limitations
The SNP assay does not detect balanced rearrangements, low-level mosaicism (<10%), marker chromosomes that only contain heterochromatin or tetraploidy.
This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.
The SNP assay does not detect balanced rearrangements, low-level mosaicism (<10%), marker chromosomes that only contain heterochromatin or tetraploidy. This test was developed and its performance characteristics determined by Lab |
The SNP assay does not detect balanced rearrangements, low-level mosaicism (<10%), marker chromosomes that only contain heterochromatin or tetraploidy. 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
Bone marrow
Volume
1 to 3 mL bone marrow
Minimum Volume
1 mL bone marrow (Note: This volume may not allow for repeat testing.)
1 mL bone marrow |
1 mL bone marrow (Note: This volume may not allow for repeat testing.) |
Container
Green-top (sodium heparin) tube; pediatric Vacutainer® is optimal or lavender-top (EDTA) tube (suboptimal). For samples with shared karyotype (510999) and any FISH study in the same tube, EDTA is not recommended due to the growth inhibition in cell culture. Adjust tube size to sample volume to avoid heparin toxicity.
Green-top (sodium heparin) tube |
Green-top (sodium heparin) tube; pediatric Vacutainer® is optimal or lavender-top (EDTA) tube (suboptimal). For samples with shared karyotype (510999) and any FISH study in the same tube, EDTA is not recommended due to the growth inhibition in cell culture. Adjust tube size to sample volume to avoid heparin toxicity. |
Collection Instructions
Utilize sterile technique and Labcorp transport kits when possible.
Utilize sterile technique and Labcorp transport kits when possible. |
Storage Instructions
Maintain specimen at room temperature.
Causes for Rejection
Whole blood; broken tube; for SNP microarray, quantity not sufficient for analysis, gel-separator tubes, microtainer tubes, fixed cell pellets
Whole blood; broken tube |
Whole blood; broken tube; for SNP microarray, quantity not sufficient for analysis, gel-separator tubes, microtainer tubes, fixed cell pellets |
References
LOINC® Map
Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
---|---|---|---|---|---|---|
510904 | MM Enrich CMA + MM Trans FISH | 511435 | Specimen Type | 31208-2 | ||
510904 | MM Enrich CMA + MM Trans FISH | 510189 | # of Genotyping Targets | N/A | ||
510904 | MM Enrich CMA + MM Trans FISH | 510190 | Diagnosis | 62357-9 | ||
510904 | MM Enrich CMA + MM Trans FISH | 510191 | Interpretation | 62365-2 | ||
510904 | MM Enrich CMA + MM Trans FISH | 510192 | Director Review: | 48672-0 | ||
510904 | MM Enrich CMA + MM Trans FISH | 512123 | 11502-2 | |||
510904 | MM Enrich CMA + MM Trans FISH | 510816 | Specimen Type | 31208-2 | ||
510904 | MM Enrich CMA + MM Trans FISH | 510817 | Cells Counted | 62361-1 | ||
510904 | MM Enrich CMA + MM Trans FISH | 510818 | Cells Analyzed | 62360-3 | ||
510904 | MM Enrich CMA + MM Trans FISH | 510819 | FISH Result | 62357-9 | ||
510904 | MM Enrich CMA + MM Trans FISH | 510964 | Interpretation | 62365-2 | ||
510904 | MM Enrich CMA + MM Trans FISH | 510973 | Director Review: | 48672-0 | ||
Order Code | 510904 | |||||
Order Code Name | MM Enrich CMA + MM Trans FISH | |||||
Order Loinc | ||||||
Result Code | 511435 | |||||
Result Code Name | Specimen Type | |||||
UofM | ||||||
Result LOINC | 31208-2 | |||||
Order Code | 510904 | |||||
Order Code Name | MM Enrich CMA + MM Trans FISH | |||||
Order Loinc | ||||||
Result Code | 510189 | |||||
Result Code Name | # of Genotyping Targets | |||||
UofM | ||||||
Result LOINC | N/A | |||||
Order Code | 510904 | |||||
Order Code Name | MM Enrich CMA + MM Trans FISH | |||||
Order Loinc | ||||||
Result Code | 510190 | |||||
Result Code Name | Diagnosis | |||||
UofM | ||||||
Result LOINC | 62357-9 | |||||
Order Code | 510904 | |||||
Order Code Name | MM Enrich CMA + MM Trans FISH | |||||
Order Loinc | ||||||
Result Code | 510191 | |||||
Result Code Name | Interpretation | |||||
UofM | ||||||
Result LOINC | 62365-2 | |||||
Order Code | 510904 | |||||
Order Code Name | MM Enrich CMA + MM Trans FISH | |||||
Order Loinc | ||||||
Result Code | 510192 | |||||
Result Code Name | Director Review: | |||||
UofM | ||||||
Result LOINC | 48672-0 | |||||
Order Code | 510904 | |||||
Order Code Name | MM Enrich CMA + MM Trans FISH | |||||
Order Loinc | ||||||
Result Code | 512123 | |||||
Result Code Name | ||||||
UofM | ||||||
Result LOINC | 11502-2 | |||||
Order Code | 510904 | |||||
Order Code Name | MM Enrich CMA + MM Trans FISH | |||||
Order Loinc | ||||||
Result Code | 510816 | |||||
Result Code Name | Specimen Type | |||||
UofM | ||||||
Result LOINC | 31208-2 | |||||
Order Code | 510904 | |||||
Order Code Name | MM Enrich CMA + MM Trans FISH | |||||
Order Loinc | ||||||
Result Code | 510817 | |||||
Result Code Name | Cells Counted | |||||
UofM | ||||||
Result LOINC | 62361-1 | |||||
Order Code | 510904 | |||||
Order Code Name | MM Enrich CMA + MM Trans FISH | |||||
Order Loinc | ||||||
Result Code | 510818 | |||||
Result Code Name | Cells Analyzed | |||||
UofM | ||||||
Result LOINC | 62360-3 | |||||
Order Code | 510904 | |||||
Order Code Name | MM Enrich CMA + MM Trans FISH | |||||
Order Loinc | ||||||
Result Code | 510819 | |||||
Result Code Name | FISH Result | |||||
UofM | ||||||
Result LOINC | 62357-9 | |||||
Order Code | 510904 | |||||
Order Code Name | MM Enrich CMA + MM Trans FISH | |||||
Order Loinc | ||||||
Result Code | 510964 | |||||
Result Code Name | Interpretation | |||||
UofM | ||||||
Result LOINC | 62365-2 | |||||
Order Code | 510904 | |||||
Order Code Name | MM Enrich CMA + MM Trans FISH | |||||
Order Loinc | ||||||
Result Code | 510973 | |||||
Result Code Name | Director Review: | |||||
UofM | ||||||
Result LOINC | 48672-0 |