Abstract: The present invention provides a method of making an assay device for conducting an assay to detect a concentration of an analyte in a sample fluid. The assay devices would typically have a substantially planar surface having a series of site specific immobilized calibration spot arrays containing pre-determined quantities of the analyte printed thereon. In addition, a series of site specific immobilized test spot arrays, including capture antibody for binding the analyte protein is printed on the assay device. The method involves first modifying the planar surface to provide hydrophobic binding sites, hydrophilic linking and covalent bonding sites. Then the method requires printing the series of site specific immobilized test spot arrays and the series of site specific immobilized calibration spot arrays on the substantially planar surface.

Abstract: An analyte reading system which includes a reader unit for rapidly detecting and evaluating the outcome of an assay to measure the presence of analytes in a sample. Quantitative and qualitative measurements of analyte concentration in a sample may be rapidly obtained using the reader device with algorithms which ascertain the nature of the assay and perform a comparison against a calibration sample. The reader device scans preset areas of an assay device in order to provide focal points for the reader device and evaluate the volume of the test sample in the assay device. The reading portion of the assay slide has at least one test dot for detecting the presence of the analyte and the signal intensity of the labelled analyte, and processes the detected signal using an algorithm which provides an accurate output measurement indicating the quantity of the analyte in the test sample.

Abstract: A method of determining an amount of analyte in a sample solution is provided. The method involves the use of an assay device that has a substantially planar assay surface. The surface has a plurality of calibration dots a test dot printed thereon. The calibration dots contain pre-determined quantities of the analyte while the test dot includes a capture antibody for binding to the analyte. The analyte is mixed into a solution having a sample antibody for the analyte, where the antibody is labeled with a detectable marker. The sample solution is introduced into the loading portion of the assay device for delivery to said reading portion. The next step is to measure the intensity of detectable marker in the calibration dots. With the data obtained, one then prepares a calibration curve correlating the amount of analyte in said calibration dots to said intensity of detectable marker.

Abstract: The present invention provides a method and device for rapidly detecting the presence of analytes in a sample. Quantitative and qualitative measurements of analyte concentration in a sample may be rapidly obtained. A sample including the analyte and analyte metabolites produced by the analyte are introduced into a vessel that contains a reagent or reagents that have a detectable marker and rapidly bind to the analyte and to the metabolite. The sample is then introduced to an assay device that has a loading area, a separation and a reading area. The sample is introduced into the loading area of the assay device and moves to the reading area preferably by capillary action. The methodology permits for the detection of analytes and metabolites using means for the detecting the detectable marker. The sample may be subjected to a force application means for the controlled progressive fragmentation of any analyte, which is preferably a pathogen present in the sample, into a plurality of fragments.

Abstract: Assay devices are disclosed comprising a base defining a cavity and an insert received in the cavity. The cavity has major surface and at least one sidewall, preferably surrounding the major surface. The insert comprises a first surface with a portion opposing the major surface of the cavity. A space is provided between the portion of the first surface and the major surface for the receipt of a fluid sample. The space has an entrance defined by the first surface of the insert and the major surface. The insert also comprises a second surface opposing the first surface and having an input portion for the application of a fluid sample. The input portion is in fluid communication with the entrance to the space, such that a fluid sample applied to the input portion passes to the entrance to the space and into the space. At least one or more passages is preferably defined through the insert, for passage of the fluid sample through the insert, to the entrance to the space.

Abstract: A device and method for separating a fluid component from a non-fluid component of a sample comprises a plurality of microspheres disposed in abutting relation and forming therebetween a plurality of capillary channels, whereby when the microspheres are disposed in fluid communication with a sample the fluid component is separated from the non-fluid component by capillary flow of the fluid component through the capillary channels formed by the interstitial spacing between abutting microspheres.