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HelpTest Code ECMP Eculizumab Monitoring Panel, Serum
Ordering Guidance
To measure only serum concentration of eculizumab, order ECULI / Eculizumab, Serum.
Specimen Required
Patient Preparation:
1. Fasting preferred.
2. Suggest discontinuing natalizumab at least 4 weeks prior to testing for eculizumab quantitation in serum. Patient should consult the healthcare provider who prescribed this drug to determine if discontinuation is an option. If not, ok to proceed with testing while taking natalizumab.
Supplies: Sarstedt Aliquot Tube, 5 mL (T914)
Collection Container/Tube: Red top (serum gel/SST are not acceptable)
Submission Container/Tube: 2 Plastic vials
Specimen Volume: 2 mL in 2 plastic vials, each vial containing 1 mL
Collection Instructions:
1. Draw blood immediately before next scheduled dose.
2. Immediately after specimen collection, place the tube on wet ice.
3. After sample has clotted on wet ice, centrifuge at 4° C and aliquot serum into two 5 mL plastic vials.
4. Freeze specimen within 30 minutes of centrifugation. Sample must be placed on dry ice if not frozen immediately.
Useful For
Monitoring of complement blockage by eculizumab
Assessing the response to eculizumab therapy
Assessing the need for dose escalation
Evaluating the potential for dose de-escalation or discontinuation of therapy in remission states
Monitoring patients who need to be above a certain eculizumab concentration to improve the odds of a clinical response for therapy optimization
This test is not useful as the sole basis for a diagnosis or treatment decisions.
Profile Information
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| ECULI | Eculizumab, S | Yes | Yes |
| EAH50 | Eculizumab Complement Blockage, S | No | Yes |
| ECUIN | Eculizumab Interpretation, S | No | Yes |
Method Name
EAH50: Enzyme-Linked Immunosorbent Assay (ELISA)
ECULI: Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS), High Resolution Accurate Mass
Reporting Name
Eculizumab Monitoring Panel, SSpecimen Type
SerumSerum Red
Specimen Minimum Volume
1 mL total in 2 plastic vials, each vial containing 0.5 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum | Frozen | 14 days | |
| Serum Red | Frozen | 14 days |
Reject Due To
| Gross hemolysis | Reject |
| Gross lipemia | Reject |
| Gross icterus | OK |
Reference Values
Eculizumab Complement Blockage:
≥46% normal
Eculizumab:
Lower limit of quantitation =5.0 mcg/mL
>35 Therapeutic concentration for paroxysmal nocturnal hemoglobinuria (PNH)
>50 Therapeutic concentration for atypical hemolytic uremic syndrome (aHUS)
Interpretation
Minimum trough therapeutic concentrations (immediately before next infusion) of eculizumab are expected to be above 35 mcg/mL for paroxysmal nocturnal hemoglobinuria and above 50 mcg/mL for atypical hemolytic uremic syndrome.
For the complement blockage monitoring of eculizumab:
-When eculizumab is present in serum at concentrations around 100 mcg/mL, the results are below the limit of quantitation of the assay (<10% of normal).
Day(s) Performed
Varies
Report Available
3 to 12 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. It has not been cleared or approved by the US Food and Drug Administration.CPT Code Information
80299
86161
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| ECMP | Eculizumab Monitoring Panel, S | 101922-3 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 65676 | Eculizumab, S | 90240-3 |
| 619951 | Eculizumab Interpretation | 59462-2 |
| 618697 | Eculizumab Complement Blockage, S | 74520-8 |
Forms
If not ordering electronically, complete, print, and send a Coagulation Test Request (T753) with the specimen.