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Test ID ECULI Eculizumab, Serum


Advisory Information


Therapeutic drug monitoring of eculizumab may be useful when assessing response to therapy is difficult or patients need to be above a certain therapeutic monoclonal antibody (mAb) concentration in order to improve the odds of a clinical response for therapy optimization, including potential dose de-escalation or discontinuation of therapy in remission states. Pharmacodynamic studies of complement blockage are also common, see ECUMP / Eculizumab Monitoring Panel, Serum for more information on related testing.



Specimen Required


Patient Preparation: Pembrolizumab/Keytruda must be discontinued at least 4 weeks prior to testing for eculizumab quantitation in serum.

Container/Tube:

Preferred: Red top

Acceptable: Serum gel

Specimen Volume: 1 mL

Collection Instructions:

1. Draw blood immediately before next scheduled dose.

2. Spin down within 2 hours of draw.


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 (LC-MS/MS)

Reporting Name

Eculizumab, S

Specimen Type

Serum

Specimen Minimum Volume

0.5 mL

Specimen Stability Information

Specimen Type Temperature Time
Serum Refrigerated (preferred) 28 days
  Frozen  30 days
  Ambient  4 days

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)

Day(s) and Time(s) Performed

Wednesday

Performing Laboratory

Mayo Medical Laboratories in Rochester

Test Classification

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the U.S. Food and Drug Administration.

CPT Code Information

80299

LOINC Code Information

Test ID Test Order Name Order LOINC Value
ECULI Eculizumab, S In Process

 

Result ID Test Result Name Result LOINC Value
65676 Eculizumab, S In Process