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33336 - TA-TMA Eculizumab Monitoring

Test Code: 33336

TA TMA Transplant-Associated Thrombotic Microangiopathy

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Clinical and Procedure
Clinical Utility

The Eculizumab is an ELISA test used as an analytical tool for quantitative determination of Eculizumab in human serum.

About Test

Eurofins Viracor has validated an assay to measure eculizumab levels in serum. Eculizumab is monoclonal antibody targeting complement component 5 (C5) and is used to treat complement-mediated diseases including transplant associate thrombotic microangiopathy (TA-TMA). Patients treated with eculizumab exhibit highly variable serum levels and therefore accurate monitoring is required for dosing decisions and to achieve target eculizumab trough levels (e.g. > 100 mcg/mL). Two additional assays available at Eurofins Viracor with rapid turnaround time, CH50 and sC5b-9, also support management of patients with TA-TMA.

Specificity

Inclusive to Lipemic, Icteric, Hemolyzed

Turnaround Time

Same day (within 24 of hours of receipt of specimen), Tuesday through Saturday.

Specimen Information
Specimen Type Test Code CPT Code NY Approved Volume Assay Range Special Instructions
serum 33336 80299 Yes

1 mL optimal (0.5 mL minimum)

  • Collection container: Red top no additive no gel.

  • Sample should clot for a minimum of 60 minutes and centrifuged for >1000g for 15 minutes.

  • Serum should immediately be aliquoted into a sterile aliquot and frozen at -80°C or below. Samples may be stored at -80°C for 36 days.

Shipping

Ship Monday through Friday. Friday shipments must be labeled for Saturday delivery.

Causes for Rejection

Specimens received outside of stated stability.

Disclaimer

Specimens are approved for testing in New York only when indicated in the Specimen Information field above. The CPT codes provided are based on Eurofins Viracor’s interpretation of the American Medical Association's Current Procedural Terminology (CPT) codes and are provided for informational purposes only. CPT coding is the sole responsibility of the billing party. Questions regarding coding should be addressed to your local Medicare carrier. Eurofins Viracor assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.

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