Infliximab and Anti-Infliximab Antibody, DoseASSURE IFX

Test Code
LAB00109


Alias/See Also
LAB00109
LabCorp TC: 503870

Anti-TNF-alpha Drug
IFD
Remicade


CPT Codes
80230, 82397

Includes
Infliximab Drug Level Infliximab (IFX) Conc+IFX Ab
Anti-Infliximab Antibody


Preferred Specimen
2 mL Serum
(Marble, Gold, Red)


Minimum Volume
1 mL


Instructions
Serum must be separated from cells within 45 minutes of venipuncture. Send serum in a plastic transport tube. To avoid delays in turnaround time when requesting multiple test on frozen samples, please submit separate frozen specimens for each test requested. 


Transport Temperature
FROZEN


Specimen Stability
Frozen: 359 days


Methodology
Electrochemiluminescence Immunoassay (ECLIA)

Report Available
5-10 days


Limitations
Failure of infliximab therapy may not always be due to the presence of anti-infliximab antibodies. In addition, the absence of anti-infliximab antibodies does not guarante positive response to treatment.


Clinical Significance
Provides infliximab drug concentration levels as well as levels of anti-infliximab antibodies.
In the absence of anti-infliximab antibodies, the infliximabdrug level typically reflects the total infliximab concentration in serum. In the presence of anti-infliximab antibodies, the infliximab drug level typically reflects theantibody-unbound fraction of infliximab concentration in serum. The presence of infliximab drug, even at concentrations well above target treatment levels (>50 ug/mL), does not interfere with the anti-infliximab antibody detection. This assay may be helpful for any patients on infliximab therapy for diseases such as Crohn's disease, inflammatory bowel disease, ulcerative colitis, rhematoid arthritis, or other autoimmune conditions. This test includes long-term serial monitoring of results.


Performing Laboratory
LabCorp



The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.