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Etanercept Concentration and Anti-Etanercept Antibody Levels (Serial Monitor)
Therapeutic monitoring of etanercept and antidrug antibody development for individuals with Crohn's disease, inflammatory bowel disease, ulcerative colitis, rheumatoid arthritis, or other autoimmune conditions. This test provides etanercept drug concentration as well as the level of anti-etanercept antibodies.
Failure of etanercept therapy may not always be due to the presence of anti-etanercept antibodies. Conversely, the absence of anti-etanercept antibodies does not guarantee response to treatment.
Electrochemiluminescence immunoassay (ECLIA); enzyme-linked immunosorbent assay (ELISA)
Etanercept drug level: Limit of quantitation: <0.2 μg/mL; a result of 0.2 μg/mL or higher indicates detection of etanercept. In the presence of anti-etanercept antibodies, the etanercept drug level reflects the antibody-unbound fraction of serum etanercept concentration.
Anti-etanercept antibody: Limit of quantitation: <75 ng/mL; a result of 75 ng/mL or higher indicates detection of anti-etanercept antibodies.
Serum (preferred) or plasma
1 mL (Note: This volume does not allow for repeat testing.)
Serum/plasma must be separated from cells within 45 minutes of venipuncture. Submit serum/plasma 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.
Refrigerate; stable for 14 days. Stable at room temperature or frozen for 14 days. Freeze/thaw cycles: stable x6.
Causes for Rejection
Gross hemolysis; gross lipemia
This test is pending NY state approval.