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Test Code 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

Reporting Name

Eculizumab Monitoring Panel, S

Specimen Type

Serum
Serum 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 days

Performing 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

Forms

If not ordering electronically, complete, print, and send a Coagulation Test Request (T753) with the specimen.