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


Specimen Required


Patient Preparation: High serum biotin concentrations in patients taking biotin supplements may cause an interference in this assay. Patients may be advised to stop biotin consumption at least 72 hours prior to sample collection.

Collection Container/Tube:

Preferred: Red top

Acceptable: Serum gel

Submission Container/Tube: Plastic vial

Specimen Volume: 2 mL Serum

Collection Instructions:

1. Allow a minimum clotting time of 30 to 60 minutes.

2. Within 2 hours of collection, centrifuge and aliquot serum into a plastic vial.

3. Send frozen.

 

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


Method Name

Electrochemiluminescence immunoassay (ECLIA); Surface Plasmon Resonance

Reporting Name

Certolizumab and Anti-Certo Ab

Specimen Type

Serum

Specimen Minimum Volume

Serum: 0.6 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

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.

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

Day(s) Performed

Tuesday

Report Available

10 to 21 days

Clinical Information

Refer to www.labcorp.com/test-menu

Mayo Clinic Laboratories | Gastroenterology Catalog Additional Information:

mml-gi-ibd, mml-gi-ibd-tdm