Abstract: Methods for harmonization of test results from a biological sample in a multiplexed biochemical assay, wherein presence and/or concentration of multiple biomarkers are determined at the same time in the same sample, making test results obtained in different laboratories comparable comprise: quantifying a presence or concentration of at least two different biomarkers in a biological sample and in a harmonization standard sample, independently in each sample, by means of a defined multiplexed biochemical assay implemented in a defined type of analytical instrument; receiving the test results from the samples into a computer-based decision engine for harmonization of test results from biological samples; and transforming the test results received from the biological sample, which includes transforming the test results from the harmonization standard sample into generalized units and adjusting the test results of the biological sample into the generalized units, GE.

Abstract: A multiplex assay system for detection of a molecule of interest, such as (a) an immunoglobulin or (b) a peptide/protein biomarker present in a biological sample, comprises: —a reaction vessel, a plurality of capturing agents immobilised on a solid phase, a detection molecule, such as (a) an anti-immunoglobulin detection molecule or (b) a detection molecule binding to a peptide/protein biomarker, a calibration reagent, —a reaction buffer medium, characterised in that the calibration reagent comprises at least two different binding molecules, wherein each binding molecule has a capacity to bind specifically to a capturing agent immobilised on the solid phase and a capacity to bind to the detection molecule, and wherein at least two of the binding molecules are present at different concentrations in the calibration reagent.

Abstract: The present invention relates to a method for calibrating a multiplex assay, comprising: adding a calibration reagent to a solid phase on which a plurality of capturing agents are immobilized, adding a detection molecule which has a capacity to bind to the calibration reagent, detecting bound detection molecule, thereby creating a calibration curve, wherein the calibration reagent comprises at least two different binding molecules, wherein each binding molecule has a capacity to bind specifically to a capturing agent immobilized on the solid phase and a capacity to bind to a detection molecule. Further provided is a multiplex assay system comprising such a calibration reagent.

Abstract: A two step lateral flow assay method for identifying IgE antibodies in a sample comprises applying a sample to a sample port of a device, wherein the device is adapted to deliver the sample to a lateral flow matrix having a plurality of IgE antigen species immobilized at respective positions at a first location; allowing the sample to travel along the lateral flow matrix through the immobilized plurality of IgE antigen species to a second location downstream of the first location; and, after a predetermined period of time, applying liquid buffer to the lateral flow matrix to mobilize labeled reagent which is adapted to bind anti-IgE antibody and which is dried on the lateral flow matrix at a location upstream of the sample port delivery of the sample to the lateral flow matrix, and allowing labeled reagent mobilized by the liquid buffer to travel along the lateral flow matrix through the immobilized plurality of IgE antigen species and bind with any IgE antibody bound to the immobilized IgE antigen species, a

Abstract: The present invention relates to a method for calibrating a multiplex assay, comprising: adding a calibration reagent to a solid phase on which a plurality of capturing agents are immobilised, adding a detection molecule which has a capacity to bind to the calibration reagent, detecting bound detection molecule, thereby creating a calibration curve, wherein the calibration reagent comprises at least two different binding molecules, wherein each binding molecule has a capacity to bind specifically to a capturing agent immobilised on the solid phase and a capacity to bind to a detection molecule. Further provided is a multiplex assay system comprising such a calibration reagent.

Abstract: A method of providing a clinical decision support in allergy diagnosis comprises the steps of: a) providing a body fluid sample from a patient, b) selecting a plurality of allergens to be tested for in the sample, c) determining for each allergen the concentration in the sample of at least one immunoglobulin directed against the allergen, d) transforming each determined immunoglobulin concentration to a clinical effect value on a normalized scale common to allergens in general, e) assigning to each allergen tested for, based on known cross-reactivity information for the allergen, an allergen specificity value, representing the degree of cross-reactivity for the allergen, and f) presenting determined clinical effect and allergen specificity values for each allergen, or a group or groups of the allergens. A computer-implemented method, a computer program product, and a patient information carrier device containing a diagnosis result are also disclosed.

Abstract: A two step lateral flow assay method for identifying IgE antibodies in a sample comprises applying a sample to a sample port of a device, wherein the device is adapted to deliver the sample to a lateral flow matrix having a plurality of IgE antigen species immobilized at respective positions at a first location; allowing the sample to travel along the lateral flow matrix through the immobilized plurality of IgE antigen species to a second location downstream of the first location; and, after a predetermined period of time, applying liquid buffer to the lateral flow matrix to mobilize labeled reagent which is adapted to bind anti-IgE antibody and which is dried on the lateral flow matrix at a location upstream of the sample port delivery of the sample to the lateral flow matrix, and allowing labeled reagent mobilized by the liquid buffer to travel along the lateral flow matrix through the immobilized plurality of IgE antigen species and bind with any IgE antibody bound to the immobilized IgE antigen species, a

Abstract: Lateral flow assay devices and methods for detecting an analyte in a sample which comprises a plurality of nonspecific binding pair members are adapted for two step determinations.

Abstract: Lateral flow assay devices and methods for detecting a first member of a specific binding pair in a sample which comprises a plurality of nonspecific binding pair members are adapted for two step determinations.

Abstract: The invention provides a reagent supply system including a reagent rack for retaining a plurality of vials. The rack has a base and first and second walls extend upwardly from the base. The first wall includes an abutment extending toward the second wall and adapted to engage a first recess on one of the vials, while the second wall includes a flexible clip having a shoulder thereon, the shoulder being biased toward a position adapted to engage a second recess on the vial. The invention also provides a method of handling reagents which includes providing a variable reagent rack adapted to retain a plurality of vials and a common reagent pack containing a plurality of predetermined common reagents adapted to coact with reagents in the vials. A patient fluid is provided and a plurality of assays to be performed on that fluid are determined. Vials are then selected, each vial containing a different assay-specific reagent necessary for one of the assays, and the selected vials are loaded onto the rack.