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HelpTest Code ECULI Eculizumab, Serum
Ordering Guidance
Therapeutic drug monitoring of eculizumab may be useful when healthcare professionals are considering personalized treatment decisions, such as therapy discontinuation of extended dose intervals when patients are in remission states.
For a panel that includes both eculizumab concentration and eculizumab complement blockage testing; order ECMP / Eculizumab Monitoring Panel, Serum.
Specimen Required
Patient Preparation: Suggest discontinuing natalizumab at least 4 weeks prior to testing for eculizumab quantitation in serum. Patient should consult the healthcare professional 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:
Preferred: Red top
Acceptable: Serum gel
Submission Container/Tube: Plastic vial
Specimen Volume: 1 mL Serum
Collection Instructions:
1. Draw blood immediately before next scheduled dose.
2. Immediately after specimen collection, place the tube on wet ice.
3. After specimen has clotted on wet ice, centrifuge at 4° C and aliquot serum into a plastic vial.
4. Freeze specimen within 30 minutes of centrifugation. Specimen must be placed on dry ice if not frozen immediately.
Useful For
Assessing the response to eculizumab therapy when measured at trough, immediately before the next scheduled infusion
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 in order to improve the odds of a clinical response for therapy optimization
This assay does not differentiate between the originator and biosimilar products.
Method Name
Liquid Chromatography Tandem Mass Spectrometry, High-Resolution Accurate Mass (LC-MS/MS HRAM)
Reporting Name
Eculizumab, SSpecimen Type
SerumSpecimen Minimum Volume
Serum: 0.5 mL
Specimen Stability Information
| Specimen Type | Temperature | Time |
|---|---|---|
| Serum | Frozen (preferred) | 28 days |
| Ambient | 28 days | |
| Refrigerated | 28 days |
Reference Values
Lower limit of quantitation =5.0 mcg/mL
>35 mcg/mL: Therapeutic concentration for paroxysmal nocturnal hemoglobinuria
>50 mcg/mL: Therapeutic concentration for atypical hemolytic uremic syndrome
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 to 100 mcg/mL for atypical hemolytic uremic syndrome.
Clinical Reference
1.Soliris (eculizumab). Package insert. Prescribing information. Alexion Pharmaceuticals. Revised 02/2025
2. Legendre CM, Licht C, Muus P, et al. Terminal complement inhibitor eculizumab in atypical hemolytic-uremic syndrome.N Engl J Med. 2013;368(23):2169-218
3. Weitz M, Amon O, Bassler D, Koenigsrainer A, Nadalin S. Prophylactic eculizumab prior to kidney transplantation for atypical hemolytic uremic syndrome. Pediatr Nephrol. 2011;26(8):1325-1329
4. Krid S, Roumenina LT, Beury D, et al. Renal transplantation under prophylactic eculizumab in atypical hemolytic uremic syndrome with CFH/CFHR1 hybrid protein. Am J Transplant. 2012;12(7):1938-1944
5. Nester C, Stewart Z, Myers D, et al. Pre-emptive eculizumab and plasmapheresis for renal transplant in atypical hemolytic uremic syndrome. Clin J Am Soc Nephrol. 2011;6(6):1488-1494
6. Zimmerhackl LB, Hofer J, Cortina G, et al. Prophylactic eculizumab after renal transplantation in atypical hemolytic-uremic syndrome. N Engl J Med. 2010;362(18):1746-1748
7. Zuber J, Le Quintrec M, Krid S, et al. Eculizumab for atypical hemolytic uremic syndrome recurrence in renal transplantation. Am J Transplant. 2012;12(12):3337-3354
8. Noris M, Galbusera M, Gastoldi S, et al. Dynamics of complement activation in aHUS and how to monitor eculizumab therapy. Blood. 2014;124(11):1715-1726
9. Peffault de Latour R, Fremeaux-Bacchi V, Porcher R, et al. Assessing complement blockade in patients with paroxysmal nocturnal hemoglobinuria receiving eculizumab. Blood. 2015;125(5):775-783
10. Willrich MAV, Andreguetto BD, Sridharan M, et al. The impact of eculizumab on routine complement assays. J Immunol Methods. 2018;460:63-71. doi:10.1016/j.jim.2018.06.010
11. Ladwig PM, Barnidge DR, Willrich MA. Quantification of the IgG2/4 kappa monoclonal therapeutic eculizumab from serum using isotype specific affinity purification and microflow LC-ESI-Q-TOF mass spectrometry. J Am Soc Mass Spectrom. 2017;28(5):811-817
12. Ladwig PM, Barnidge DR, Willrich MA. Mass spectrometry approaches for identification and quantitation of therapeutic monoclonal antibodies in the clinical laboratory. Clin Vaccine Immunol. 2017;24(5):e00545-164
13. Noris M, Remuzzi G. Every Fifteen Days Forever?. Kidney Int Rep. 2022;8(1):4-7.doi:10.1016/j.ekir.2022.11.006
14. Sridharan M, Go RS, Willrich MAV. Clinical utility and potential cost savings of pharmacologic monitoring of eculizumab for complement-mediated thrombotic microangiopathy. Mayo Clin Proc Innov Qual Outcomes. 2022;6(5):458-46. doi:10.1016/j.mayocpiqo.2022.03.005
Day(s) Performed
Wednesday
Report Available
3 to 9 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
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| ECULI | Eculizumab, S | 90240-3 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 65676 | Eculizumab, S | 90240-3 |
Forms
If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:
-Renal Diagnostics Test Request (T830)
-Coagulation Test Request (T753)
-Therapeutics Test Request (T831)