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.

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.

CPT Codes

86334

LOINC Codes

NG