Abstract: A method of quantitatively determining an analyte in a fluid sample by an immunoassay comprises binding of the analyte to a ligand capable of specifically binding to the analyte, wherein at least part of the analyte is present as an analyte complex is disclosed. The method comprises the steps of: a) subjecting the sample to a first acidic pH to at least substantially dissociate any analyte complex present and provide substantially all analyte in free form, b) raising the first acidic pH to a second acidic pH where re-formation of complexes is prevented but where binding of analyte to the ligand is permitted, and c) determining the binding of analyte to the ligand to quantitatively determine the analyte in the sample.

Abstract: The present invention relates to an in vitro method for the detection of an anti-drug antibody (ADA) against a therapeutic drug antibody (TDA) in a biological sample. The in vitro method comprises detecting and capturing said ADA using affinity moieties obtained from an intact therapeutic drug antibody, or a Fab fragment thereof, in a certain manner. Avoiding using only intact therapeutic drug antibodies or only Fab fragments thereof as reagents in such a method has been proven as an efficient way of increasing sensitivity, decreasing unspecific binding and the formation of large protein complexes. Such a method has great utility in therapeutic drug development or in the evaluation of a particular treatment of a patient.

Abstract: A method of quantitatively determining an analyte in a fluid sample by an immunoassay comprises binding of the analyte to a ligand capable of specifically binding to the analyte, wherein at least part of the analyte is present as an analyte complex is disclosed. The method comprises the steps of: a) subjecting the sample to a first acidic pH to at least substantially dissociate any analyte complex present and provide substantially all analyte in free form, b) raising the first acidic pH to a second acidic pH where re-formation of complexes is prevented but where binding of analyte to the ligand is permitted, and c) determining the binding of analyte to the ligand to quantitatively determine the analyte in the sample.

Abstract: A microfluidic device that comprises a microchannel structure in which there are one, two or more flow paths (101;201a,b;301a,a?,b) all of which comprises a porous bed I (104,204,304) that is common for all of the flow paths and exposes an immobilized reactant R that is capable of interacting with a solute S that passes through the bed. The characteristics are that at least one of the flow paths comprises/comprise a second porous bed II (105,205,305) that is placed upstream of porous bed I (104,204,304) and is dummy with respect to interaction with solute S but capable of interacting with a substance DS that is present in a liquid aliquot together with solute S and is capable of disturbing the result of the interaction between solute S and said immobilized reactant R. There is also disclosed a method utilizing the device and variant of the device in which the immobilized R is replaced with a generic affinity ligand LI and/or porous bed II exposes a generic ligand LII that may be different from LI.

Abstract: A collection of one or more microfluidic devices which together carry a plurality of microchannel structures each of which comprises a reaction microcavity in which there is a solid phase with an immobilized affinity ligand L, characterized in that (i) the plurality is divided into sets of microchannel structures, and (ii) the affinity ligand L is directed to the same counterpart (binder, B) independent of set, and (iii) the sets differ in a) the capacity per reaction microcavity and/or the capacity/unit volume of the solid phase in a reaction microcavity for binder B, and/or b) the base matrix of the solid phase between the sets but are equal within each set.

Abstract: A collection of one or more microfluidic devices which together carry a plurality of microchannel structures each of which comprises a reaction microcavity (104a-h) in which there is a solid phase with an immobilized affinity ligand L, characterized in that (i) the plurality is divided into sets of microchannel structures, and (ii) the affinity ligand L is directed to the same counterpart (binder, B) independent of set, and (iii) the sets differ in a) the capacity per reaction microcavity and/or the capacity/unit volume of the solid phase in a reaction microcavity for binder B, and/or b) the base matrix of the solid phase between the sets but are equal within each set.

Abstract: The present invention relates to a method, a system, a neural network and a computer program product for determining the quality of an analytical process, preferably the confidence value. The analytical process is performed in a microchannel structure of a microfluidic device, from which data information of the analytic process is acquired by scanning at least one search area of the microchannel structure for signal data. The search area comprises the result of the analytical process and the acquired data information is stored as an image, one image for each scanned search area.