Daratumumab is an anti-CD38 IgGk monoclonal antibody currently in clinical development for multiple myeloma (MM) treatment. In MM, malignant cells secrete high levels of monoclonal immunoglobulin (M-protein) that is commonly detectable by serum immunofixation electrophoresis (IFE). As immunoglobulin, daratumumab also can be detected in IFE and may co-migrate with M-protein in a subset of patients (~50% of MM patient produce IgGk M protein). Addition of anti-idiotypic antibodies raised against daratumumab to patient serum containing daratumumab alters banding pattern as assessed to IFE (daratumumab shift) by forming a Daratumumab and anti-Daratumumab complex, helping to distinguish between therapeutic monoclonal antibody and M-protein present in the serum.
Patient Preparation
Overnight fasting is preferred.
Sample Type
Serum
Collect
Gold top or red top
Amount to Collect
4 mL blood
Preferred Volume
2 mL serum
Minimum Volume
1 mL serum
Stability (from collection to initiation)
Room temperature: 14 days Refrigerated: 14 days Frozen: 14 days
Rejection Criteria
Specimens other than serum
Test Code
MOLT
Sendout
Yes
Performing Lab
LabCorp (via ARUP)
Specimen Preparation
Aliquot on freeze serum. Send sample to CB frozen.
Preferred Volume
2 mL serum
Minimum Volume
1 mL serum
Rejection Criteria
Specimens other than serum
Stability (from collection to initiation)
Room temperature: 14 days Refrigerated: 14 days Frozen: 14 days
Additional Information
Daratumumab is an anti-CD38 IgGk monoclonal antibody currently in clinical development for multiple myeloma (MM) treatment. In MM, malignant cells secrete high levels of monoclonal immunoglobulin (M-protein) that is commonly detectable by serum immunofixation electrophoresis (IFE). As immunoglobulin, daratumumab also can be detected in IFE and may co-migrate with M-protein in a subset of patients (~50% of MM patient produce IgGk M protein). Addition of anti-idiotypic antibodies raised against daratumumab to patient serum containing daratumumab alters banding pattern as assessed to IFE (daratumumab shift) by forming a Daratumumab and anti-Daratumumab complex, helping to distinguish between therapeutic monoclonal antibody and M-protein present in the serum.
CPT Codes
86334
LOINC Codes
NG
Available Stat
No
Test Code
MOLT
Performing Lab
LabCorp (via ARUP)
Sendout
Yes
Methodology
Immunofixation
Patient Preparation
Overnight fasting is preferred.
Collect
Gold top or red top
Amount to Collect
4 mL blood
Sample Type
Serum
Preferred Volume
2 mL serum
Minimum Volume
1 mL serum
Rejection Criteria
Specimens other than serum
Specimen Preparation
Aliquot on freeze serum. Send sample to CB frozen.
Stability (from collection to initiation)
Room temperature: 14 days Refrigerated: 14 days Frozen: 14 days
Reported
4-6 days
Additional Information
Daratumumab is an anti-CD38 IgGk monoclonal antibody currently in clinical development for multiple myeloma (MM) treatment. In MM, malignant cells secrete high levels of monoclonal immunoglobulin (M-protein) that is commonly detectable by serum immunofixation electrophoresis (IFE). As immunoglobulin, daratumumab also can be detected in IFE and may co-migrate with M-protein in a subset of patients (~50% of MM patient produce IgGk M protein). Addition of anti-idiotypic antibodies raised against daratumumab to patient serum containing daratumumab alters banding pattern as assessed to IFE (daratumumab shift) by forming a Daratumumab and anti-Daratumumab complex, helping to distinguish between therapeutic monoclonal antibody and M-protein present in the serum.
CPT Codes
86334
LOINC Codes
NG
Ordering
Available Stat
No
Performing Lab
LabCorp (via ARUP)
Methodology
Immunofixation
Reported
4-6 days
Additional Information
Daratumumab is an anti-CD38 IgGk monoclonal antibody currently in clinical development for multiple myeloma (MM) treatment. In MM, malignant cells secrete high levels of monoclonal immunoglobulin (M-protein) that is commonly detectable by serum immunofixation electrophoresis (IFE). As immunoglobulin, daratumumab also can be detected in IFE and may co-migrate with M-protein in a subset of patients (~50% of MM patient produce IgGk M protein). Addition of anti-idiotypic antibodies raised against daratumumab to patient serum containing daratumumab alters banding pattern as assessed to IFE (daratumumab shift) by forming a Daratumumab and anti-Daratumumab complex, helping to distinguish between therapeutic monoclonal antibody and M-protein present in the serum.
Collection
Patient Preparation
Overnight fasting is preferred.
Sample Type
Serum
Collect
Gold top or red top
Amount to Collect
4 mL blood
Preferred Volume
2 mL serum
Minimum Volume
1 mL serum
Stability (from collection to initiation)
Room temperature: 14 days Refrigerated: 14 days Frozen: 14 days
Rejection Criteria
Specimens other than serum
Processing
Test Code
MOLT
Sendout
Yes
Performing Lab
LabCorp (via ARUP)
Specimen Preparation
Aliquot on freeze serum. Send sample to CB frozen.
Preferred Volume
2 mL serum
Minimum Volume
1 mL serum
Rejection Criteria
Specimens other than serum
Stability (from collection to initiation)
Room temperature: 14 days Refrigerated: 14 days Frozen: 14 days
Result Interpretation
Additional Information
Daratumumab is an anti-CD38 IgGk monoclonal antibody currently in clinical development for multiple myeloma (MM) treatment. In MM, malignant cells secrete high levels of monoclonal immunoglobulin (M-protein) that is commonly detectable by serum immunofixation electrophoresis (IFE). As immunoglobulin, daratumumab also can be detected in IFE and may co-migrate with M-protein in a subset of patients (~50% of MM patient produce IgGk M protein). Addition of anti-idiotypic antibodies raised against daratumumab to patient serum containing daratumumab alters banding pattern as assessed to IFE (daratumumab shift) by forming a Daratumumab and anti-Daratumumab complex, helping to distinguish between therapeutic monoclonal antibody and M-protein present in the serum.
Administrative
CPT Codes
86334
LOINC Codes
NG
Complete View
Available Stat
No
Test Code
MOLT
Performing Lab
LabCorp (via ARUP)
Sendout
Yes
Methodology
Immunofixation
Patient Preparation
Overnight fasting is preferred.
Collect
Gold top or red top
Amount to Collect
4 mL blood
Sample Type
Serum
Preferred Volume
2 mL serum
Minimum Volume
1 mL serum
Rejection Criteria
Specimens other than serum
Specimen Preparation
Aliquot on freeze serum. Send sample to CB frozen.
Stability (from collection to initiation)
Room temperature: 14 days Refrigerated: 14 days Frozen: 14 days
Reported
4-6 days
Additional Information
Daratumumab is an anti-CD38 IgGk monoclonal antibody currently in clinical development for multiple myeloma (MM) treatment. In MM, malignant cells secrete high levels of monoclonal immunoglobulin (M-protein) that is commonly detectable by serum immunofixation electrophoresis (IFE). As immunoglobulin, daratumumab also can be detected in IFE and may co-migrate with M-protein in a subset of patients (~50% of MM patient produce IgGk M protein). Addition of anti-idiotypic antibodies raised against daratumumab to patient serum containing daratumumab alters banding pattern as assessed to IFE (daratumumab shift) by forming a Daratumumab and anti-Daratumumab complex, helping to distinguish between therapeutic monoclonal antibody and M-protein present in the serum.