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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.


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

Specimen Retention Time

14 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

CPT Code Information

80299

86161