BÜHLMANN Quantum Blue® Adalimumab is an in vitro diagnostic lateral flow immunoassay for the quantitative determination of trough levels of adalimumab in serum samples.
The assay serves as an aid to therapeutic drug monitoring in patients with inflammatory bowel disease (IBD) under adalimumab therapy, in conjunction with other clinical and laboratory findings.
Quantum Blue Adalimumab is combined with the Quantum Blue Reader.
The test is designed for the selective measurement of adalimumab by a sandwich immunoassay.
Recombinant tumor necrosis factor alpha (TNFα) is conjugated to gold colloids. On the test cassette the gold conjugate is released from a pad into the reaction system as the sample is applied. Adalimumab present in the sample will bind to the gold conjugate. A monoclonal antibody, highly specific for adalimumab, is immobilised on the analytical membrane and will capture the complex of gold conjugate and the adalimumab analyte, resulting in a colouring of the Test Line (T). The remaining free TNFα-gold conjugate will bind to the Control Line (C). The signal intensities of the Test Line (T) and the Control Line (C) are measured quantitatively by the Quantum Blue Reader.
Specimen collection and storage: Collect blood into plain venipuncture tubes without any additives avoiding haemolysis and let the serum clot at room temperature for at least 20 and for up to 60 minutes. Centrifuge at room temperature at ~2000 x g for 15 minutes. Decant the serum. Serum samples can be stored refrigerated at 2-8 C for up to 14 days. For longer storage, keep serum samples at ≤-20 C. These samples are stable for at least 3 months at ≤-20 C.
Interpretation of Results: The determination of adalimumab trough levels in patient serum samples can support therapy monitoring of IBD patients. Generally, trough levels in serum that reach a value of 5 µg/mL and above, during therapy maintenance, correlate well with clinical remission, low CRP values, as well as endoscopic healing of the gut mucosa. A plateau for endoscopic remission was demonstrated for adalimumab trough levels above 12 µg/mL. Values below 5 μg/mL Sub-therapeutic adalimumab levels in serum suggest pharmacokinetic failure. Therapy adjustment, taking into account available clinical and laboratory findings, should be considered. Values between 5-12 µg/mL Therapeutic adalimumab trough levels may serve as an indication for continuing therapy with the current dosage, in patients in IBD disease remission. Values above 12 µg/mL Supra-therapeutic adalimumab trough levels may serve as an indication for dose reduction in conjunction with the clinical picture, in patients in IBD disease remission.
The reagents supplied with this kit are optimised tomeasure trough levels of adalimumab in diluted serum samples.
Samples from patients switching from certolizumab (Cimzia®) therapy should not be tested directly with Quantum Blue Adalimumab, as cross-reactivity may occur. Allow certolizumab (Cimzia®) trough levels to fall at least below 2.9 μg/mL.The BÜHLMANN Quantum Blue®