Adalimumab and Anti-Adalimumab Antibody, DoseASSURE™ ADL

Serum

2 mL

1 mL (Note: This volume does not allow for repeat testing.)

Red-top tube or gel-barrier tube

Monitor antiadalimumab therapy for individuals with Crohn's disease, inflammatory bowel disease, ulcerative colitis, rheumatoid arthritis, or other autoimmune conditions. This test provides adalimumab drug concentration levels as well as the level of antiadalimumab antibodies.

Electrochemiluminescence immunoassay (ECLIA)

• Adalimumab drug level:

− Quantitation limit: <0.6 μg/mL

− Results ≥0.6 μg/mL indicate detection of adalimumab.

In the presence of antiadalimumab antibody, the adalimumab drug level reflects the antibody-unbound fraction of adalimumab concentration in serum.

• Antiadalimumab antibody:

− Quantitation limit: <25 ng/mL

− Results ≥25 ng/mL indicate detection of adalimumab antibody.

In the absence of antiadalimumab antibodies, the adalimumab drug level typically reflects the total adalimumab concentration in serum. In the presence of antiadalimumab antibodies, the adalimumab level typically reflects the antibody-unbound fraction of adalimumab concentration in serum.

This assay provides clinically valid antibody results at drug levels well above treatment targets (>30 μg/mL). Failure of adalimumab therapy may not always be due to the presence of antiadalimumab antibodies. In addition, the absence of antiadalimumab antibodies does not guarantee positive response to treatment.