Test Catalog

Test Id : ECUMP

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Eculizumab Monitoring Panel, Serum

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

Therapeutic drug monitoring of eculizumab

Profile Information
A profile is a group of laboratory tests that are ordered and performed together under a single Mayo Test ID. Profile information lists the test performed, inclusive of the test fee, when a profile is ordered and includes reporting names and individual availability.

Test Id Reporting Name Available Separately Always Performed
C5FX C5 Complement, Functional, S Yes Yes
C5AG2 C5 Complement, Antigen, S Yes, (Order C5AG) Yes
INT86 ECUMP Interpretation No Yes

Method Name
A short description of the method used to perform the test

C5AG2: Nephelometry

C5FX: Automated Liposome Lysis Assay

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Eculizumab Monitoring Panel, S

Specimen Type
Describes the specimen type validated for testing

Serum Red

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Patient Preparation: Fasting preferred

Supplies: Sarstedt 5 mL Aliquot Tube (T914)

Specimen Type: Serum

Collection Container/Tube: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 1.5 mL

Collection Instructions:

1. Recommended timeframe for the blood collection is a trough, or immediately prior to next intravenous infusion.

2. Immediately after specimen collection, place the tube on wet ice.

3. Centrifuge and aliquot serum into plastic vial.

4. Freeze specimen within 30 minutes.

Forms

If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:

-Renal Diagnostics Test Request (T830)

-Coagulation Test Request (T753)

-Therapeutics Test Request (T831)

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

1 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis OK
Gross lipemia Reject
Gross icterus OK

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Serum Red Frozen 14 days

Useful For
Suggests clinical disorders or settings where the test may be helpful

Therapeutic drug monitoring of eculizumab

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Eculizumab (Soliris, Alexion Pharmaceuticals) is a humanized hybrid monoclonal antibody (IgG2/IgG4) that blocks complement C5 cleavage, thereby preventing the activation of the proinflammatory effects of C5a and the cytolytic effects of the membrane attack complex (MAC) formed by C5b-C9. It is US Food and Drug Administration approved for atypical hemolytic uremic syndrome(1) and paroxysmal nocturnal hemoglobinuria,(2) and it is also prescribed for other conditions such as C3 glomerulopathies.(3) The dosing regimen for an average adult may vary from 300 to 1200 mg intravenously every 2 weeks during the maintenance stages, according to the condition for which the drug is prescribed. Therapy efficacy may be monitored by measuring efficiency of complement blockade.(4) Eculizumab will affect complement function assays that rely on the formation of the MAC to generate cell lysis. Although total complement and soluble MAC have been recommended for eculizumab monitoring, the measurement of C5 function and C5 antigen more specifically indicate the impact of eculizumab on the complement system blockage and may help guide the next dose of the drug.

 

This panel measures the pharmacodynamics effects of eculizumab on the complement system.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

C5 COMPLEMENT ANTIGEN

10.6-26.3 mg/dL

 

C5 COMPLEMENT FUNCTIONAL

29-53 U/mL

Interpretation
Provides information to assist in interpretation of the test results

The panel will measure the pharmacodynamic effects of eculizumab on the complement system. Total complement function, alternative pathway function, and C5 function assays will be decreased to a similar extent in the presence of eculizumab. The function of C5 may be completely absent when eculizumab is present at therapeutic concentrations. C5 antigen, on the other hand, will be normal or elevated. C5 complement function drops on average 30% with 25 mcg/mL of eculizumab, and 70% with 50 mcg/mL. In the presence of 100 mcg/mL of eculizumab in serum, there is on average 20% residual C5 function.

 

Decreased C5 function in the presence of normal or elevated C5 antigen concentrations suggests eculizumab is partially blocking C5 activity.

 

Absent C5 function in the presence of normal or elevated C5 antigen concentrations suggests eculizumab is completely blocking C5 activity.

 

Normal C5 function in the presence of normal or elevated C5 antigen concentrations suggests eculizumab concentration is not sufficient to block C5 activity.

 

If C5 function and C5 antigen concentrations are all decreased, it may be due to a secondary consumption process, poor hepatic synthesis of complement proteins or C5 deficiency. Clinical correlation recommended. If indicated, resubmit samples to confirm results.

Supportive Data

In a Mayo Clinic study with samples from individual subjects with normal complement activity defined by the total complement (CH50) assay and spiked with varying concentrations of eculizumab,(5) there was a significant decrease in CH50, alternative pathway function, and C5 functional results with eculizumab. Considering that the therapeutic target concentrations are expected to be above 50 mcg/mL, the results showed that eculizumab is partially blocking the complement cascade at 25 mcg/mL, with a complete blockage for C5 functional at 100 mcg/mL.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Wong EK, Goodship TH, Kavanagh D: Complement therapy in atypical haemolytic uraemic syndrome (aHUS). Mol Immunol. 2013;56:199-212

2. Rother RP, Rollins SA, Mojcik CF, Brodsky RA, Bell L: Discovery and development of the complement inhibitor eculizumab for the treatment of paroxysmal nocturnal hemoglobinuria. Nat Biotechnol. 2007;25:1256-1264

3. Zuber J, Le Quintrec M, Krid S, et al: Eculizumab for atypical hemolytic uremic syndrome recurrence in renal transplantation. Am J Transplant. 2012;12:3337-3354

4. Volokhina EB, van de Kar NC, Bergseth G, et al: Sensitive, reliable and easy-performed laboratory monitoring of eculizumab therapy in atypical hemolytic uremic syndrome. Clin Immunol. 2015;160(2):237-243

5. Andreguetto B, Murray D, Snyder M, et al: The impact of eculizumab in complement assays. Mol Immunol. 2015;67:119-120

6. Willrich MAV, Braun KMP, Moyer AM, Jeffrey DH, Frazer-Abel A. Complement testing in the clinical laboratory. Crit Rev Clin Lab Sci. 2021 Nov;58(7):447-478. doi: 10.1080/10408363.2021.1907297

Method Description
Describes how the test is performed and provides a method-specific reference

Functional C5 complement

C5 activity is measured by mixing patient serum with a C5-deficient serum. The lytic activity of the serum mixture is tested against sensitized, labeled liposomes. If lysis occurs, the patient serum must be the source of the C5. The target liposomes are a commercial reagent.(Unpublished Mayo method)

 

C5 antigen

Anti-C5 reagent is added to patient serum and quantitated on a Siemens BN II analyzer by fixed-time kinetic nephelometry.(Unpublished Mayo method)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Friday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

2 to 14 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

14 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

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 US Food and Drug Administration.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

86160

86161

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
ECUMP Eculizumab Monitoring Panel, S In Process
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
C5FX C5 Complement, Functional, S 60472-8
C5AG2 C5 Complement, Antigen, S 4505-4
INT86 ECUMP Interpretation 69048-7

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports