Infliximab Level and Anti-Drug Antibody
INFLEV
Test Summary
Infliximab is a therapeutic monoclonal antibody with the ability to bind to tumor necrosis factor (TNF), an inflammatory cytokine, blocking its action. Infliximab is indicated for the treatment of Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, and juvenile idiopathic arthritis.
Aliases
- TNF inhibitor,Remsima™
- Anti-Remsima™ antibody
- Renflexis™
- Anti-Renflexis™ antibody
- Anti-Remicade® antibody
- Anti-infliximab antibody,Remicade®
- Inflectra™
- infliximab-dyyb
- Anti-TNF
- TNF blocker
Specimen Collection
Special Instructions
N/A
Preferred Specimen
0.8 mL serum
Minimum Volume
0.5 mL
Instructions
Collect immediately before next scheduled dose (trough specimen).
Patient Preparation
Dietary supplements containing biotin may interfere in assays and may skew results to be either falsely high or falsely low. For patients receiving the recommended daily doses of biotin, draw samples at least 8 hours following the last biotin supplementation. For patients on mega-doses of biotin supplements, draw samples at least 72 hours following the last biotin supplementation. Collect immediately before next scheduled dose (trough specimen).
Storage
Plastic screw-cap vial
Transport Temperature
Refrigerated (preferred)
Specimen Stability
Room Temperature: 48 hours Refrigerated: 7 days Frozen: -20 C: 28 days Frozen: -70 C: 70 days
Limitations
Trough concentrations of infliximab correlate with the likelihood of clinical remission, but the role of routine monitoring is not clear. Target concentrations may depend on indication, induction vs. maintenance, dosing schedules, drug clearance, and other factors
Other Acceptable Specimens
N/A
Unacceptable Specimens
Moderate and gross hemolysis
Order Code
INFLEV
EPIC (Premier) Code
Includes
Infliximab Level
Infliximab Antibody
CPT Code
82397
80230
Billing Code
671389
671390
CPT Statement
Methodology
Chemiluminescent Immunoassay
FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Physician Attestation of Informed Consent
N/A
Testing Laboratory
33608 Ortega Highway
San Juan Capistrano CA, 92675
Department
Reference Range
See Laboratory Report
Setup Schedule / Expected Turnaround Time
Monday, Tuesday, Thursday-Saturday; Report available: 3-5 days
Specimen Collection
Special Instructions
N/A
Preferred Specimen
0.8 mL serum
Minimum Volume
0.5 mL
Instructions
Collect immediately before next scheduled dose (trough specimen).
Patient Preparation
Dietary supplements containing biotin may interfere in assays and may skew results to be either falsely high or falsely low. For patients receiving the recommended daily doses of biotin, draw samples at least 8 hours following the last biotin supplementation. For patients on mega-doses of biotin supplements, draw samples at least 72 hours following the last biotin supplementation. Collect immediately before next scheduled dose (trough specimen).
Storage
Plastic screw-cap vial
Transport Temperature
Refrigerated (preferred)
Specimen Stability
Room Temperature: 48 hours Refrigerated: 7 days Frozen: -20 C: 28 days Frozen: -70 C: 70 days
Limitations
Trough concentrations of infliximab correlate with the likelihood of clinical remission, but the role of routine monitoring is not clear. Target concentrations may depend on indication, induction vs. maintenance, dosing schedules, drug clearance, and other factors
Other Acceptable Specimens
N/A
Unacceptable Specimens
Moderate and gross hemolysis
Result Information
Methodology
Chemiluminescent Immunoassay
Testing Laboratory
Reference Range
See Laboratory Report
Setup Schedule / Expected Turnaround Time
Monday, Tuesday, Thursday-Saturday; Report available: 3-5 days