Orderable Name 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
Specimen 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)
Day(s) Performed
Varies
Report Available
3 to 12 daysCPT Code Information
80299
86161
Forms
If not ordering electronically, complete, print, and send a Coagulation Test Request (T753) with the specimen.