Test Details
Methodology
Electrophoresis followed by immunodiffusion against mono-specific antisera to immunoglobulin and individual heavy and light chains (IFE); turbidimetric quantitation of IgA, IgG, IgM.
The HYDRASHIFT 2/4 isatuximab gel shift assay uses an anti-isatuximab antibody to allow for the migration of isatuximab/anti-Isatuximab complexes away from the gamma globulin zone on IFE, toward the alpha-1-globulin fraction, thus removing IgG kappa interference in the gamma globulin zone caused by isatuximab in the patient's serum.
Result Turnaround Time
4 - 8 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.
Use
Detect and identify monoclonal immunoglobulin gammopathies in the presence of therapeutic monoclonal antibody (mAbs) drug treatment with isatuximab (SARCLISA®), a human IgG1 kappa mAb, which migrates in the electrophoretic gamma globulin zone of the electrophoresis gel. In this laboratory procedure, the isatuximab in vitro interference is removed using an anti-isatuximab antibody reagent. This procedure will characterize the specific light and heavy chain components of a monoclonal protein without isatuximab interference.
Special Instructions
State patient's age and clinical diagnosis on the test request form.
Custom Additional Information
SARCLISA® (isatuximab) is a human monoclonal IgG Kappa antibody targeting CD38 that has been shown to provide clinical benefit as monotherapy in heavily pre-treated multiple myeloma patients and when combined with standard of care regimens for the treatment of MM in patients with the earlier disease.
The HYDRASHIFT 2/4 isatuximab reagent allows the laboratory to distinguish isatuximab interference from endogenous M protein1 on Hydragel IF assay.
A negative immunofixation result with HYDRASHIFT 2/4 isatuximab may suggest a complete response (CR) or stringent complete response (sCR) to therapy along with other clinical assessment for patients receiving isatuximab.2
Specimen Requirements
Specimen
Serum
Volume
2 mL
Minimum Volume
1 mL
Container
Red-top tube or gel-barrier tube
Collection Instructions
Separate serum from red cells.
Stability Requirements
Temperature | Period |
|---|---|
Room temperature | 14 days |
Refrigerated | 14 days |
Frozen | 14 days |
Storage Instructions
Room temperature
Patient Preparation
Overnight fasting is preferred but not required.
Causes for Rejection
Plasma sample
Footnotes
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 123062 | IFE,Isatuximab-Specific, Serum | 123063 | IFE, Serum | 14895-7 | ||
| 123062 | IFE,Isatuximab-Specific, Serum | 001776 | Immunoglobulin G, Qn, Serum | mg/dL | 2465-3 | |
| 123062 | IFE,Isatuximab-Specific, Serum | 001784 | Immunoglobulin A, Qn, Serum | mg/dL | 2458-8 | |
| 123062 | IFE,Isatuximab-Specific, Serum | 001792 | Immunoglobulin M, Qn, Serum | mg/dL | 2472-9 | |
| Order Code | 123062 | |||||
| Order Code Name | IFE,Isatuximab-Specific, Serum | |||||
| Order Loinc | ||||||
| Result Code | 123063 | |||||
| Result Code Name | IFE, Serum | |||||
| UofM | ||||||
| Result LOINC | 14895-7 | |||||
| Order Code | 123062 | |||||
| Order Code Name | IFE,Isatuximab-Specific, Serum | |||||
| Order Loinc | ||||||
| Result Code | 001776 | |||||
| Result Code Name | Immunoglobulin G, Qn, Serum | |||||
| UofM | mg/dL | |||||
| Result LOINC | 2465-3 | |||||
| Order Code | 123062 | |||||
| Order Code Name | IFE,Isatuximab-Specific, Serum | |||||
| Order Loinc | ||||||
| Result Code | 001784 | |||||
| Result Code Name | Immunoglobulin A, Qn, Serum | |||||
| UofM | mg/dL | |||||
| Result LOINC | 2458-8 | |||||
| Order Code | 123062 | |||||
| Order Code Name | IFE,Isatuximab-Specific, Serum | |||||
| Order Loinc | ||||||
| Result Code | 001792 | |||||
| Result Code Name | Immunoglobulin M, Qn, Serum | |||||
| UofM | mg/dL | |||||
| Result LOINC | 2472-9 |