This disclosure provides for methods and reagents for rapid multiplex RPA reactions and improved methods for detection of multiplex RPA reaction products. In addition, the disclosure provides new methods for eliminating carryover contamination between RPA processes.

The present invention provides a diagnostic kit for detecting the presence or quantity of one or more test analytes within a test sample taken from a body surface of a mammal, the diagnostic kit comprising: a separate insert for a lateral flow device (200, 411) comprising a membrane (201) fixed to a rigid support (202) and, the separate insert being configured to obtain the test sample; a lateral-flow assay device configured (300, 400) to accept the separate insert (200, 411); a securing member (210) configured to releasably attach (211) the separate insert to a body surface of a mammal (213); wherein the securing member (210) comprise an expandable layer (212) configured to apply pressure to the separate insert (200, 411) thereby pressing the separate insert (200, 411) against the body surface of the mammal (213).

A microfluidic device can comprise at least one swept region that is fluidically connected to unswept regions. The fluidic connections between the swept region and the unswept regions can enable diffusion but substantially no flow of media between the swept region and the unswept regions. The capability of biological micro-objects to produce an analyte of interest can be assayed in such a microfluidic device. Biological micro-objects in sample material loaded into a microfluidic device can be selected for particular characteristics and disposed into unswept regions. The sample material can then be flowed out of the swept region and an assay material flowed into the swept region. Flows of medium in the swept region do not substantially affect the biological micro-objects in the unswept regions, but any analyte of interest produced by a biological micro-object can diffuse from an unswept region into the swept region, where the analyte can react with the assay material to produce a localized detectable reaction. Any such detected reactions can be analyzed to determine which, if any, of the biological micro-objects are producers of the analyte of interest.

The object is to provide a lysis method, lysis treatment solution, detection method using an immunochromatographic device, and detection kit comprising an immunochromatographic device for detecting whether causative bacteria of mastitis are coliform bacteria or not by using milk of a livestock animal. There is provided a method for lysing coliform bacteria, which comprises the step of mixing a lysis agent containing a lytic enzyme, and at least one kind of anionic surfactant, and preferably further containing at least one kind of nonionic surfactant, with milk obtained form a livestock animal to lyse coliform bacteria existing in the milk. The lytic enzyme is preferably lysozyme.

The object is to provide a lysis method, lysis treatment solution, detection method using an immunochromatographic device, and detection kit comprising an immunochromatographic device for detecting whether causative bacteria of mastitis are coliform bacteria or not by using milk of a livestock animal. There is provided a method for lysing coliform bacteria, which comprises the step of mixing a lysis agent containing a lytic enzyme, and at least one kind of anionic surfactant, and preferably further containing at least one kind of nonionic surfactant, with milk obtained form a livestock animal to lyse coliform bacteria existing in the milk. The lytic enzyme is preferably lysozyme.

A method for collection and dissemination of biologic data, comprising collecting at least one biologic sample by a testing device including thereon an alignment target and including a plurality of immunoassay test strips, wherein the at least one biologic sample contacts a sample pad on at least one of the plurality of immunoassay test strips, assigning correlative values as test results, wherein each test performed on the biologic sample is assigned a different correlative value, receiving the test results at a server disposed on a network, wherein the server has configured thereon a database, assigning a unique identification to the biologic sample, storing the unique identification in the database, storing the test results in the database in association with the unique identification of the biologic sample, and providing access to the database to healthcare organizations for analysis of the test results.

A method for collection and dissemination of biologic data, comprising collecting at least one biologic sample by a testing device including thereon an alignment target and including a plurality of immunoassay test strips, wherein the at least one biologic sample contacts a sample pad on at least one of the plurality of immunoassay test strips, assigning correlative values as test results, wherein each test performed on the biologic sample is assigned a different correlative value, receiving the test results at a server disposed on a network, wherein the server has configured thereon a database, assigning a unique identification to the biologic sample, storing the unique identification in the database, storing the test results in the database in association with the unique identification of the biologic sample, and providing access to the database to healthcare organizations for analysis of the test results.

According to an immunochromatographic device for detecting a substance to be detected contained in a detection target in an analyte which is characterized in that a nitrous acid compound containing member having a part containing a nitrous acid compound; a labeling substance retaining member having a labeling substance containing part; an acid anhydride containing member having a part containing an acid anhydride having vapor pressure at 25° C. of 5×10.sup.−2 Pa or less; and a chromatography medium member having a detection part are arranged in a manner that a sample develops in the members in this order, the storage stability can be improved; detection with high sensitivity is possible; and the complexity of production can be reduced.

Disclosed herein are devices, systems, methods and kits for performing immunoassay tests on a sample. The immunoassay devices may be used in conjunction with diagnostic reader systems for obtaining a sensitive read-out of the immunoassay results. The immunoassay devices may be especially suited for the detection of at least a first analyte and a second analyte in a sample. The immunoassay devices and methods may utilize a competitive binding-like assay and a sandwich binding assay to detect analytes in a sample.

A test strip with selective white blood cell (WBC) lysis for release of WBC contents and the capture and holding of red blood cells (RBC), allowing for fast clearance and result interpretation and more accurate results at early time points due to the lack of red color interference caused by background red heme color of lysing of RBCs. The removal of the red color interference enhances both visual and digital interpretation of test strips, such as test strips of an immunoassay test. The test strip enhances the detection of both intracellular proteins of WBCs and extracellular proteins of RBCs simultaneously such as MxA and CRP, MxA and PCT, MxA and HNL, and MxA and IL-6, MxA and myeloid cells (sTREM-1), MxA and angiopoietin 2, MxA and vascular endothelial growth factor (VEGF) or its soluble vascular endothelial growth factor receptor-1 (sVEGFR1), MxA and heparin binding protein (HBP) or other combinations.