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Test ID FCZAC Certolizumab and Anti-Certolizumab Antibody, DoseASSURE CTZ


Specimen Required


Specimen Type: Serum

Container/Tube: Red or SST

Specimen Volume: 2 mL

Collection Instructions: Draw blood in a plain red-top tube(s), serum gel tube(s) is acceptable. Spin down and send 2 mL of serum frozen in a plastic vial.

To avoid delays in turnaround time when requesting multiple tests, please submit separate frozen specimens for each test requested.


Useful For

Provides certolizumab drug concentration and anti-certolizumab antibodies in order to optimize treatment and facilitate clinical decision-making.

 

This assay may be helpful in any patient on certolizumab therapy for Crohn's disease, psoriasis, or other autoimmune condition.

Method Name

Electrochemiluminescence immunoassay (ECLIA); Surface Plasmon Resonance

Reporting Name

Certolizumab and Anti-Certo Ab

Specimen Type

Serum

Specimen Minimum Volume

0.60 mL (Note: This volume does not allow for repeat testing.)

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Frozen (preferred) 14 days
  Refrigerated  14 days

Reference Values

Certolizumab:

Quantitation Limit: <1.0 ug/mL

 

Results of 1 ug/mL or higher indicate detection of certolizumab

 

Anti-Certolizumab Antibody:

Quantitation Limit: <40 ng/mL

 

Results of 40 ng/mL or higher indicate detection of anti-certolizumab pegol antibodies.

Performing Laboratory

Esoterix Endocrinology

Test Classification

These tests were developed and their performance characteristics determined by LabCorp. They have not been cleared or approved by the Food and Drug Administration.

CPT Code Information

80299

82397

LOINC Code Information

Test ID Test Order Name Order LOINC Value
FCZAC Certolizumab and Anti-Certo Ab Not Provided

 

Result ID Test Result Name Result LOINC Value
Z5637 Certolizumab 87404-0
Z5638 Anti-Certolizumab Antibody 87405-7

NY State Approved

Yes

Day(s) Performed

Tuesday

Report Available

10-21 days