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HelpTest ID 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.
Highlights
Monitoring complete complement blockade by eculizumab has allowed personalized therapy in specific settings.
Therapeutic drug monitoring of eculizumab is helpful when providers are considering personalized treatment decisions such as therapy discontinuation or extending dose intervals when patients are in remission states. In paroxysmal nocturnal hemoglobinuria, a minimum therapeutic concentration is expected to be above 35 mcg/mL, and in atypical hemolytic uremic syndrome, the therapeutic concentrations are expected to be above 50 to 100 mcg/mL of eculizumab. Complement blockage studies can aid in determining that a therapeutic concentration of the drug has blocked the complement function and subsequent production of sC5b-9. Here we offer a panel of eculizumab concentration plus alternative pathway function (AH50) to monitor eculizumab therapy efficacy.
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 |
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)
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 |
NY State Approved
YesForms
If not ordering electronically, complete, print, and send a Coagulation Test Request (T753) with the specimen.