Abstract: An analysis device having at least one sample addition zone, at least one sink, and at least one flow path connecting the at least one sample addition zone and the at least one sink. The at least one flow path includes projections substantially vertical to the surface of the substrate and having a height (H), diameter (D) and reciprocal spacing (t1, t2) such that lateral capillary flow of a liquid sample is achieved. The device includes at least two reaction zones in series, wherein each reaction zone is adapted to facilitating measurement of a response originating from one and the same analyte, and wherein the reaction zones are positioned to allow calculation of the concentration of at least one analyte. Advantages include that a more accurate value can be calculated, variations are reduced, and an estimation of the uncertainty of the response can be calculated.

Abstract: A conjugate, for use as a detection reagent in an immunoassay, is based on a hydrophilic monodisperse macromolecule, i.e. a macromolecule having a substantially uniform size and shape, the macromolecule forming a practically useful and manageable carrier, to which carrier at least one binding entity and at least one label are bound.

Abstract: A device for handling liquid samples, comprising a flow path with at least one zone for receiving the sample, and a transport or incubation zone, said zones connected by or comprising an area having projections substantially vertical to its surface, said device provided with a sink with a capacity of receiving said liquid sample, said sink comprising an area having projections substantially vertical to its surface, and said sink being adapted to respond to an external influence regulating its capacity to receive said liquid sample.

Abstract: The present invention provides an assay device for performing an assay on a liquid sample using a detection conjugate capable of binding to an antigen and containing a label, said device comprising a substrate having a substrate surface, wherein the surface comprises projections substantially perpendicular to said surface, said projections having a height, diameter and distance capable of generating lateral capillary flow of a fluid in said passage, said surface comprising a sample addition zone, a reaction zone and an absorbing zone, said zones being connected by at least one fluid passage, wherein said device has a first functionality verifying feature located between the sample addition zone and the reaction zone, and a second functionality verifying feature located within the absorbing zone, and both functionality verifying features being features capable of undergoing a detectable change when contacted by the sample, said assay device further comprising at least one alignment verification zone.

Abstract: There is provided a method for the analysis of circulating antibodies comprising the steps: a) providing an analysis device comprising a substrate, and provided on said substrate at least one sample addition zone, at least one retaining zone, at least one sink, and at least one flow path connecting the sample addition zone, the retaining zone and the sink, wherein the flow path is open and comprises projections substantially vertical to the surface of said substrate and having a height (H), diameter (D) and reciprocal spacing (t1, t2) such that lateral capillary flow of said sample is achieved and such that cells can flow through the projections, wherein said retaining zone comprises at least one affinity binding means to which cell structures are bound, b) adding at least one sample to a sample addition zone, and c) reading a result, wherein circulating antibodies directed against cell structures are determined.

Abstract: There is provided an assay device comprising a lid and a base, said base comprising, a sample addition zone, a reaction zone and an absorbing zone, said components being in fluid connection and being part of a fluid passage leading from the sample addition zone to the absorbing zone, wherein: (a) a sample addition well is integrated in the lid, (b) the absorbing zone consists of an area on an non-porous substrate, having substantially perpendicular projections, said projections defining a volume, which together with the volume of the fluid passage defines the sample volume subjected to the assay, and (c) at least one filter is between the sample addition well and the sample addition zone. There is further provided methods for handling samples.

Abstract: An optical reader for an optical assay arrangement including a polymeric sample substrate having a reaction-site surface provided with protruding microstructures and at least one reaction-site area; a light source for illuminating the reaction-site area; and a detector device for detecting light emitted from the reaction-site area. The light source is arranged to inject exciting light rays into the polymeric sample substrate with a controlled angle of incidence such that the protruding microstructures guide the exciting light rays in the direction of the reaction-site area, and the detector device detects light emitted from the at least one reaction-site area.

Abstract: A method for use in a flow matrix, which utilizes biospecific affinity reactions to detect an analyte in the sample, and which comprises allowing the sample comprising the analyte and an analytically detectable reactant (Reactant*) to migrate through flow channels in a flow matrix to a detection zone located in the matrix, in which there is a firmly anchored biospecific affinity reactant (Capturer), and capturing the Reactant* in the detection zone in an amount related to the amount of analyte in the sample. The Reactant* has labeled particles of an analytically detectable group, and the Capturer is anchored to the matrix by immobilized particles which exhibit hydrophilic groups on their surface. A test kit comprises a flow matrix having a detection zone in which there is a firmly anchored biospecific affinity reactant (Capturer), and an analytically detectable reactant (Reactant*).

Abstract: A device and method for the separation of a component in a liquid sample prior to the detection of an analyte in said sample, wherein a sample is added to a receiving zone on a substrate, said substrate further optionally comprising a reaction zone, a transport or incubation zone connecting the receiving and reaction zone, respectively, forming a flow path on a substrate, wherein said substrate is a non-porous substrate, and at least part of said flow path consists of areas of projections substantially vertical to said surface, and having a height (H), diameter (D) and reciprocal spacing (t1, t2) such, that lateral capillary flow of said liquid sample in said zone is achieved, and where means for separation are provided adjacent to the zone for receiving the sample. Said means for separation are chosen among filter means, optionally enhanced by affinity binding and/or aggregation; magnetic means, also optionally enhanced by affinity binding and/or aggregation; and acoustic means.

Abstract: A device and method for the separation of a component in a liquid sample prior to the detection of an analyte in said sample, wherein a sample is added to a receiving zone on a substrate, said substrate further optionally comprising a reaction zone, a transport or incubation zone connecting the receiving and reaction zone, respectively, forming a flow path on a substrate, wherein said substrate is a non-porous substrate, and at least part of said flow path consists of areas of projections substantially vertical to said surface, and having a height (H), diameter (D) and reciprocal spacing (t1, t2) such, that lateral capillary flow of said liquid sample in said zone is achieved, and where means for separation are provided adjacent to the zone for receiving the sample. Said means for separation are chosen among filter means, optionally enhanced by affinity binding and/or aggregation; magnetic means, also optionally enhanced by affinity binding and/or aggregation; and acoustic means.

Abstract: Fluorescence reader (10) for an optical assay arrangement comprising a polymeric sample substrate (1) having a reaction site-surface and a substrate surface (3), the fluorescence reader comprising a light source (5) arranged to illuminate the reaction site-surface through the substrate surface, and a detector device (6) arranged to detect fluorescent light emitted from said reaction site-surface and transmitted through the substrate surface, the substrate surface provided with total-internal-reflection suppressing means (15).

Abstract: Optical reader (33, 43, 53, 63, 73, 83) for an optical assay arrangement comprising a polymeric sample substrate (1) having a reaction site-area (5) provided with protruding microstructures (2), the optical reader comprising a light source (6, 11) for illuminating the reaction site-area (5), and a detector device (7, 12) for detecting light emitted from said reaction site-area.

Abstract: An absorbing zone for establishing and/or maintaining fluid transport through or along said at least one fluid passage is manufactured on the basis of a non-porous substrate, having projections substantially perpendicular to said surface, and said projections having a height, diameter and a distance or distances between the projections such, that lateral capillary flow of said fluid in said zone is achieved.

Abstract: A device for handling liquid samples, comprising a flow path with at least one zone for receiving the sample, and a transport or incubation zone, said zones connected by or comprising an area having projections substantially vertical to its surface, said device provided with a sink with a capacity of receiving said liquid sample, said sink comprising an area having projections substantially vertical to its surface, and said sink being adapted to respond to an external influence regulating its capacity to receive said liquid sample.

Abstract: An assay device for determining an analyte in an aqueous sample comprises: (i) an elongate flow matrix (6) allowing lateral transport of fluid therethrough by capillary action, wherein the matrix comprises a liquid application zone (3) and downstream thereof, a detection zone (8) having an immobilized capture agent capable of directly or indirectly binding to said analyte, (ii) a wicking member (13) placed at the downstream end of the flow matrix and having an upstream end and a downstream end, and (iii) a time indicator (14) placed downstream of the detection zone (8) for indicating when liquid applied to the liquid application zone has reached the time indicator. The time indicator comprises an indicator substance or substance combination which is capable of exhibiting a visible color change when hydrated by the aqueous sample.

Abstract: A lateral flow method for the determination of an analyte in a sample utilizes biospecific affinity reactions. The method comprises forming a complex comprising Reactant I - - - Analyte? - - - Reactant* wherein Reactant* and Reactant I exhibit biospecific affinity to the analyte, Reactant* is analytically detectable, and Analyte? is the analyte or an analyte-related reactant, determining a detectable signal from Reactant* in the complex (sample value), and obtaining the amount of analyte in a sample by comparing the sample value with one or more calibrator values, each of which corresponds to a standard amount of analyte. Before determination of the calibrator value, either calibrator or a binder for the calibrator has been bound to a matrix and is released at the determination of calibrator value.

Abstract: The invention relates to a micro fluidic system comprising a substrate, and, provided on said substrate, at least one flow path interconnecting with functional means in which liquid samples can be treated by desired procedures. The flow paths are laid out to form a pattern for the transport of liquid samples to and from said functional means. These flow paths comprise a plurality of micro posts protruding upwards from said substrate, the spacing between the micro posts being small enough to induce a capillary action in a liquid sample applied anywhere within any of said flow paths, so as to force said liquid to move from where said liquid sample was applied.

Abstract: A test device and a kit for conducting an assay for the determination of an analyte in a sample comprises (i) a housing (1,2), and within said housing, (ii) a flow matrix (6) allowing liquid to be transported by capillary action and having at least one zone with immobilized capturing agent capable of directly or indirectly binding to the analyte, (iii) a liquid container (13) for sample liquid, and (iv) at least one liquid container for liquid other than sample liquid. The device further comprises (v) separation means (5) between the flow matrix (6) and the liquid containers (13), wherein said separation means (5) are mounted in movable relationship with the liquid containers to in a first position prevent liquid contact of the flow matrix (6) with the liquid containers (13), and in a second position permit liquid receiving contact of the flow matrix (6) with the liquid containers (13).

Abstract: The invention relates to a method of determining an analyte in a sample, especially a high concentration analyte, comprises the steps of: a) contacting the sample with a specified amount of a receptor which binds specifically to the analyte to form an analyte/receptor complex, said specified amount of receptor being in excess of that required to bind all analyte in the sample, b) isolating on a solid phase a specified fraction of the amount of receptor contacted with the analyte, including analyte/receptor complex and unreacted receptor, c) detecting the amount of analyte/receptor complex in said isolated specified fraction, and d) from the detected amount analyte/receptor complex, determining the concentration of analyte in the sample. The invention also relates to test kits for carrying out the method.

Abstract: The present invention relates to a solid phase assay device comprising a multi-spot detection zone, and to use thereof in immunochromatographic assays. More precisely, the invention relates to a device for determining analytes in an aqueous sample comprising: an elongate flow matrix (6) allowing lateral transport of fluid therethrough, wherein said matrix comprises a sample application zone (3) and downstream thereof, a detection zone (8) having immobilised capture agents capable of directly or indirectly binding to said analytes, wherein said analytes are detected by allowing a labelled second binding agent to bind directly or indirectly to the analytes. The device is characterised in that the immobilised capture agents are distributed in the detection zone (8) as a plurality of small spots, thereby permitting multi-analyte and/or multi-specificity detection.