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HelpTest Code LAB3875 Eculizumab, Serum
Additional Codes
Eculiz LC/MS
Ordering Guidance
Therapeutic drug monitoring of eculizumab may be useful when providers are considering personalized treatment decisions, such as therapy discontinuation of extended dose intervals when patients are in remission states.
Specimen Required
Patient Preparation: 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.
Collection Container/Tube:
Preferred: Red top
Acceptable: Serum gel
Submission Container/Tube: Plastic vial
Specimen Volume: 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 specimen has clotted on wet ice, centrifuge at 4° C and aliquot serum into 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
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
Method Name
Liquid Chromatography Tandem Mass Spectrometry, High-Resolution Accurate Mass (LC-MS/MS HRAM)
Reporting Name
Eculizumab, SSCH Clinical System Name: Eculizumab Level by LC/MS
Specimen Type
SerumSpecimen Minimum Volume
0.5 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum | Frozen (preferred) | 30 days | |
| Refrigerated | 28 days | ||
| Ambient | 4 days |
Reject Due To
| Gross hemolysis | Reject |
| Gross lipemia | Reject |
| Gross icterus | OK |
Reference Values
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)
Method Description
Eculizumab is extracted from serum and measured by liquid chromatography high-resolution accurate-mass mass spectrometry.(Unpublished Mayo method)
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)
Aliases: Alexion; Soliris