Adalimumab (Humira) is a recombinant human IgG1 monoclonal antibody specific for Tumor Necrosis Factor-Alpha (TNF-) and is used to treat rheumatic arthritis, intestinal disorders, dermatological diseases and cancer. Adalimumab specifically binds to TNF alpha and blocks its interaction with p55 and p75 cell surface TNF receptors and reduces the inflammation and subsequently improves the patients health. Drug level quantification can be important to adapt patient prescription or to switch to an alternative TNF inhibitor drug. The DeQuanto Adalimumab (Humira) PK ELISA kit is an ELISA based immunoassay. The Adalimumab present in the sample binds to pre coated TNF- on polystyrene microtiter plate. Non bound or the excess substances are removed by washing. Horseradish Peroxidase (HRP) labeled antibody is added to the wells which binds to the TNF/Adalimumab complex in the wells. Following a wash to remove any unbound antibody-enzyme reagent, substrate solution is added to the wells. A color product is formed in proportion to the amount of Adalimumab present in the sample or standards. The color development is stopped by addition of a stop solution. The absorbance is measured at 450 nm in a microtiter plate reader. The concentration of Adalimumab in a sample can be interpolated from the standard curve.

ACCURACY AND PRECISION: Inter and intra assay precision %RE 20%

SELECTIVITY: Tested in Human Plasma Matrices

SENSITIVITY: LLOQ is 5.2 ng/ml MRD: 1/200

DILUTION LINEARITY: Tested and passes with %RE 20%

ASSAY RANGE: 300 ng/ml to 2.31 ng/ml

ASSAY TIME: 3-4 Hours