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 daratumumab gel shift assay uses an anti-daratumumab antibody to allow for the migration of Daratumumab/anti-daratumumab complexes away from the γ globulin zone on IFE, toward the α1-globulin fraction, thus removing IgG κ interference in the γ globulin zone caused by Daratumumab 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.
Test Includes
The in-vitro removal of potential IgG Κ M-protein interference to the serum IFE assay due to the DARA® drug administration; Quantitation of immunoglobuilns IgA, IgG, and IgM; IFE interpretation of heavy- and light-chain patterns in the serum.
Use
Detect and identify monoclonal immunoglobulin gammopathies in the presence of therapeutic monoclonal antibody (mAbs) drug treatment with Daratumumab (Dara®), a human IgG1 κ mAb, which migrates in the electrophoretic γ globulin zone of the electrophoresis gel. In this laboratory procedure, the Dara® in vitro interference is removed using an anti-daratumumab antibody reagent. This procedure will characterize the specific light and heavy chain components of a monoclonal protein without Dara® interference.
Special Instructions
State patient's age and clinical diagnosis on the test request form.
Custom Additional Information
DARAZLEX® (daratumumab) is a human monoclonal IgG κ 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 daratumumab reagent allows the laboratory to distinguish daratumumab interference from endogenous M protein1 on Hydragel IF assay and therefore suggest a potential complete response (CR) or stringent complete response (sCR)2-4 if the Immunofixation with HYDRASHIFT 2/4 daratumumab confirms undetectable endogenous M proteins.
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 |
Freeze/thaw cycles | Stable x3 |
Reference Range
Normal pattern
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 |
|---|---|---|---|---|---|---|
| 123218 | IFE, Dara-Specific, Serum | 123219 | IFE, Serum | 14895-7 | ||
| 123218 | IFE, Dara-Specific, Serum | 001776 | Immunoglobulin G, Qn, Serum | mg/dL | 2465-3 | |
| 123218 | IFE, Dara-Specific, Serum | 001784 | Immunoglobulin A, Qn, Serum | mg/dL | 2458-8 | |
| 123218 | IFE, Dara-Specific, Serum | 001792 | Immunoglobulin M, Qn, Serum | mg/dL | 2472-9 | |
| Order Code | 123218 | |||||
| Order Code Name | IFE, Dara-Specific, Serum | |||||
| Order Loinc | ||||||
| Result Code | 123219 | |||||
| Result Code Name | IFE, Serum | |||||
| UofM | ||||||
| Result LOINC | 14895-7 | |||||
| Order Code | 123218 | |||||
| Order Code Name | IFE, Dara-Specific, Serum | |||||
| Order Loinc | ||||||
| Result Code | 001776 | |||||
| Result Code Name | Immunoglobulin G, Qn, Serum | |||||
| UofM | mg/dL | |||||
| Result LOINC | 2465-3 | |||||
| Order Code | 123218 | |||||
| Order Code Name | IFE, Dara-Specific, Serum | |||||
| Order Loinc | ||||||
| Result Code | 001784 | |||||
| Result Code Name | Immunoglobulin A, Qn, Serum | |||||
| UofM | mg/dL | |||||
| Result LOINC | 2458-8 | |||||
| Order Code | 123218 | |||||
| Order Code Name | IFE, Dara-Specific, Serum | |||||
| Order Loinc | ||||||
| Result Code | 001792 | |||||
| Result Code Name | Immunoglobulin M, Qn, Serum | |||||
| UofM | mg/dL | |||||
| Result LOINC | 2472-9 |