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Test Code 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
Serum Frozen (preferred) 14 days
  Refrigerated  14 days

Reject Due To

Gross hemolysis Gross reject; Mild OK
Gross lipemia Reject
Gross icterus NA
Other/Tissue/Swab Specimens other than indicated

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

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

Day(s) Performed

Tuesday

Report Available

10-21 days