Abstract: A micro-liter liquid sample, particularly a biological sample, is analyzed in a device employing centrifugal and capillary forces. The sample is moved through one or more sample wells arrayed within a small flat chip via interconnecting capillary passageways. The passageways may be either hydrophobic or hydrophilic and may include hydrophobic or hydrophilic capillary stops.

Abstract: The invention relates to methods for determining the activity of a proteolytic coagulation factor of the blood coagulation cascade in a body fluid such as whole blood or plasma. A combination is provided in a reaction mixture. The combination comprises the sample and an activation agent for activating a proteolytic coagulation factor of the blood coagulation cascade or for activating the blood coagulation cascade. The effect of the activating on a reagent system comprising a cleavable moiety is evaluated. The cleavable moiety is or becomes bound to a chemiluminescent agent or a sensitizer agent or both. The chemiluminescent agent and the sensitizer agent are related in that, when in close proximity, energization of the sensitizer agent results in energization of the chemiluminescent agent. The effect of the activating is related to the activity of a proteolytic coagulation factor of the blood coagulation cascade wherein the effect is the extent of cleavage of the cleavable moiety.

Abstract: Assays in which samples of biological fluids are dispensed onto reagent-containing porous substrates are improved in the accuracy and repeatability by dispensing the biological fluids in two or more fractions thereof, separated by intervals in which the biological fluid is not dispensed. Reagents and other fluids may be dispensed during the intervals when the biological fluid is not dispensed. Alternatively, reagents and other fluids may be dispensed in a similar manner onto substrates already containing biological fluids.

Abstract: Biological fluid samples are deposited by methods that produce a uniform layer of the sample over a reagent-containing surface. In one embodiment, a nozzle having multiple openings is used to deposit a sample over the reagent-containing surface simultaneously. In an alternative embodiment, single droplets of the sample are deposited in a pattern on the surface, preferably in a sequence of parallel lines. The reaction between the biological sample and the reagents is read from a spectrographic image of the reagent-containing surface obtained by optical methods.

Abstract: This invention is directed to a lateral flow assay for detecting the presence of an analyte in a liquid test sample. The lateral flow assay represents an improvement in the ability to accurately and with high fidelity to detect the presence or absence of a target analyte in a liquid sample, in part, by encompassing a reference region of immobilized, non-diffusible analyte that allows for detection of any factors that interfere with the interaction and binding of the analyte to the labeled capture reagent. Any influences on the interaction and binding of the analyte that is free in solution in the liquid test sample to its complementary labeled reagent will be encountered in parallel in the binding between the immobilized analyte in reference region to the labeled reagent as it diffuses through the reference region. In one embodiment, the lateral flow assay of the invention is a urine-based human Chorionic Gonadotropin (hCG) assay.

Abstract: An improved agglutination immunoassay is characterized by reacting a sample fluid which may contain an analyte with a generic antibody conjugated to latex particles and then adding an antibody specific to the analyte to be determined. Agglutination resulting from adding the antibody specific to the analyte is measured and correlated with the amount of analyte in the sample.

Abstract: Certain monoclonal antibodies are able to detect urinary trypsin inhibitors (UTIs) that are characteristic of disease in humans. In particular, the UTIs include AMBK, Bikunin, Uristatin, Uristatin-1, Uristatin-2, as defined herein, also including the fragments and aggregates thereof.

Abstract: Apparatus and methods are disclosed for verifying one or more operational conditions of an optical inspection machine. A row of grooves (1-5) that simulate a reagent pad containing a specific type of analytes at known concentrations can be used for verification of the operation of the machine. Apparatus can include a row of grooves (1-5), each with different geometry, configured on an insertable device (20). The insertable device (20) can be positioned so that the row of grooves (1-5) can be illuminated by the readhead of the machine. If the optical inspection machine provides results corresponding to the known type(s) and concentrations of analyte(s), proper operation of the optical inspection machine is indicated. If the simulated type and concentration of specified reagen is not indicated, improper operation is indicated. Measurement error due to non-machine error is indicated when the known type and concentration of the analyte simulated by the rows (1-5) is indicated.

Abstract: Certain monoclonal antibodies are able to detect urinary trypsin inhibitors (UTIs) that are characteristic of disease in humans. In particular, the UTIs include AMBK, Bikunin, Uristatin, Uristatin-1, Uristatin-2, as defined herein, also including the fragments and aggregates thereof.