Test Overview
Clinical Utility
Eculizumab is an anti-C5 monoclonal antibody that blocks the terminal complement activation pathway. This medication is mainly used to treat diseases related to overactivation of the alternative complement pathway, such as paroxysmal nocturnal hemoglobinuria, membranoproliferative glomerulonephritis and atypical hemolytic uremic syndrome. The Eculizumab assay makes it possible to determine the concentration of free plasma Eculizumab by ELISA method.
Method
Enzyme-linked immunosorbent assay (ELISA)
Result Included
Eculizumab
Specimen
Specimen Type
PlasmaContainers
Collection Containers
Blue top (3.2% buffered citrate)
Volume
Sample Volume
2.0 mL
Collection & Handling
Collection Instructions
Collect trough specimen prior to dose.
Handling Information
Prepare double-spun plasma within 2 hours of collection and transfer to polypropylene transfer vial. Store and send frozen.
Stability
| Refrigerated | Frozen |
|---|---|
| 4 hours | 7 days |
90 days at - 70 ºC
Performance & Interpretation
Turnaround Time
25 days
Results
Name
Units
Reference Range
Conversion
-
Eculizumab levelμg/mL> 99 at trough level (atypical hemolytic-uremic syndrome , aHUS)
> 35 μg/mL at trough level (Paroxystic nocturnal haemoglobinuria , PNH)
Referral Location
Canada
Test Version
Last Updated
2025-09-09