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HelpTest Code ECUMP Eculizumab Monitoring Panel, Serum
Useful For
Therapeutic drug monitoring of eculizumab
Profile Information
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| C5FX | C5 Complement, Functional, S | Yes | Yes |
| C5AG2 | C5 Complement, Antigen, S | Yes, (Order C5AG) | Yes |
| INT86 | ECUMP Interpretation | No | Yes |
Reporting Name
Eculizumab Monitoring Panel, SSpecimen Type
Serum RedSpecimen Required
Patient Preparation:
1. Fasting preferred
2. Recommended timeframe for the blood draw is a trough, or immediately prior to next intravenous infusion.
Specimen Type: Serum
Collection Container/Tube: Red top
Submission Container/Tube: Plastic vial
Specimen Volume: 1.5 mL
Collection Instructions:
1. Immediately after drawing the specimen, place the tube on wet ice.
2. Spin down and separate serum from clot.
3. Freeze specimen within 30 minutes.
Specimen Minimum Volume
1 mL
Specimen Stability Information
| Specimen Type | Temperature | Time |
|---|---|---|
| Serum Red | Frozen | 14 days |
Reject Due To
|
Hemolysis |
Mild OK; Gross reject |
|
Lipemia |
Mild OK; Gross reject |
|
Icterus |
NA |
|
Other |
Serum gel tube |
Clinical Information
Eculizumab (Soliris, Alexion Pharmaceuticals) is a humanized hybrid monoclonal antibody (IgG2/IgG4) that blocks complement C5 cleavage, thereby preventing the activation of the proinflammatory effects of C5a and the cytolytic effects of the membrane attack complex (MAC) formed by C5b-C9. It is FDA-approved for atypical hemolytic uremic syndrome,(1) and paroxysmal nocturnal hemoglobinuria,(2) and also prescribed for other conditions such as C3 glomerulopathies.(3) The dosing regimen for an average adult may vary from 300 to 1200 mg intravenously every 2 weeks during the maintenance stages, according to the condition for which the drug is prescribed. Therapy efficacy may be monitored by measuring efficiency of complement blockade.(4) Eculizumab will affect complement function assays that rely on the formation of the MAC to generate cell lysis. Although CH50 and sMAC have been recommended for eculizumab monitoring, the measurement of C5 function and C5 antigen will more specifically indicate the impact of eculizumab on the complement system blockage and may help guide the next dose of the drug.
This panel measures the pharmacodynamics effects of eculizumab on the complement system.
Reference Values
C5 COMPLEMENT ANTIGEN
10.6-26.3 mg/dL
C5 COMPLEMENT FUNCTIONAL
29-53 U/mL
Day(s) and Time(s) Performed
Varies
Analytic Time
2 daysPerforming Laboratory
Mayo Clinic Laboratories in Rochester
Test Classification
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the U.S. Food and Drug Administration.CPT Code Information
86160-Complement; antigen, each component
86161-Complement; functional activity, each component
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| ECUMP | Eculizumab Monitoring Panel, S | In Process |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| C5FX | C5 Complement, Functional, S | 60472-8 |
| C5AG2 | C5 Complement, Antigen, S | 4505-4 |
| INT86 | ECUMP Interpretation | In Process |