Eculizumab Level - LG6572


Sunquest Code:LSMISC  
Epic Code:LAB4909Epic Name:Send Outs Misc Test
Methodology:Enzyme linked immunosorbent assay (ELISA)
CPT Code:80299
Turnaround Time:Specimens are sent to the reference laboratory M on-Fri; results are reported within 3 days.
Special Instructions:A completed requisition must accompany each sample. See Associated Links.
Associated Links:

Thrombotic Microangiopathy Test Requisition



Collection Instructions

Specimen:Blood
Optimal Volume:6 mL
Minimum\Peds Volume:1.2 mL
Patient Preparation:For trough level, please collect sample 30 minutes prior to next dose.
Causes for Rejection:Thawed specimen


Processing and Shipping

Specimen Processing:Centrifuge and aliquot 2 mL, 0.5 mL minimum. Store in freezer.
Test Performed at or Referral Lab Lab Sendouts  (Cincinnati Children's Hospital Medical Center)
Referral Lab number:7453356


Interpretive

Reference Range:Eculizumab is considered to be present i a therapeutic level in aHUS if the trough serum concentration is >99 µg/mL (Legendre CM et al, NEJM 2013) and in PNH if the serum concentration is >35 µg/mL (Hillmen P et all, NEJM 2004).
Use:The Eculizumab level (free anti-C5) is a measurement of the serum level of Eculizumab (Soliris, Alexion Pharmaceuticals), a humanized IgG4 monoclonal antibody directed against the complement protein C5. By binding to C5, Eculizumab prevents cleavage of C5 to its active fragments C5a and C5b, thereby preventing formation of C5b-9 and halting the process of complement-mediated cell destruction. Adequate dosage and dosing interval of Eculizumab results in a complete blockade of activation of the terminal complement pathway. If a patient is not being adequately dosed with Eculizumab, breakthrough activation of the complement system and subsequently disease reactivation may occur. Along with clinical markers of disease activity and other laboratory measures of other complement pathway activity (such as CH50, C5a and sC5b-9), the Eculizumab level may be used to guide therapeutic decision making as to adequate dosage and dosing interval.


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