The present invention provides systems, devices, and methods for point-of-care and/or distributed testing services. The methods and devices of the invention are directed toward automatic detection of analytes in a bodily fluid. The components of the device can be modified to allow for more flexible and robust use with the disclosed methods for a variety of medical, laboratory, and other applications. The systems, devices, and methods of the present invention can allow for effective use of samples by improved sample preparation and analysis.

The invention relates to a new method of determining in a sample the presence or absence of one or more analyte members of a group of two or more analytes. The invention therefore relates to a multiplex assay for determining the presence or absence of each analyte in a group of multiple analytes. The assay uses aptamers and transmembrane pores.

A biosensor molecule comprises: a protease amino acid sequence; at least one sensor comprising at least one sensor amino acid sequence which is responsive to at least one target molecule; and an inhibitor of the protease activity of said protease amino acid sequence; wherein the biosensor is switchable from a protease active to a protease inactive state, or from a protease inactive to a protease active state when said sensor responds to said target molecule. The biosensor protease may be a protease of a virus such as a Potyvirus or a Flavivirus wherein the inhibitor is an autoinhibitory peptide derived from the virus. The biosensor may respond to the target molecule allosterically or may be cleaved by a target protease molecule.

What is described is a kit for preparing a liquid thromboplastin reagent for a prothrombin time assay. The kit simplifies and minimizes reagent preparation time and is stable for 2-5 years.

Provided is a method for purifying α-thrombin and for quantifying α-thrombin and its degradation polypeptides in a liquid proteinatious solution. The method employs a one-step anion exchange chromatography method. The method allows purification and/or quantification of a homogenous post-translationally modified α-thrombin. The method can also be used for purification and/or quantification of β-thrombin.

The present invention provides systems, devices, and methods for point-of-care and/or distributed testing services. The methods and devices of the invention are directed toward automatic detection of analytes in a bodily fluid. The components of the device can be modified to allow for more flexible and robust use with the disclosed methods for a variety of medical, laboratory, and other applications. The systems, devices, and methods of the present invention can allow for effective use of samples by improved sample preparation and analysis.

The present invention relates to chemiluminescent substrates for blood clotting enzyme Factor Xa. The substrates are particularly useful for assaying coagulation factors and for quantifying an anticoagulant in a sample.

A diagnostic device which enables measurement of fibrinogen concentration in a blood sample. The device comprises; a wettable testing substrate including viewing indicators which allow determination of a status of a test. The substrate has a first end and second end and intermediate therebetween a flow receiving zone, a flow path zone and a reaction zone; the reaction zone pre charged with at least one reagent. A blood sample to be tested is deposited near or in either of said flow receiving zone or said reaction zone, the sample reacting with the reagents inducing clotting of the sample. Water added to a dye added to said reaction zone, advances a distance along said substrate. The distance travelled along the substrate by the dye and through the sample is indicative of a measure of concentration of fibrinogen in said blood sample under test.

The present invention relates to sample analysis cartridges comprising micro-environment sensors and methods for assaying coagulation in a fluid sample applied to the micro-environment sensors, and in particular, to performing coagulation assays using micro-environment sensors in a point of care sample analysis cartridge. For example, the present invention may be directed to a sample analysis cartridge including an inlet chamber configured to receive a biological sample, and a conduit fluidically connected to the inlet chamber and configured to receive the biological sample from the inlet chamber. The conduit may include a micro-environment prothrombin time (PT) sensor, and a micro-environment activated partial thromboplastin time (aPTT) sensor.

What is described is a kit for preparing a liquid thromboplastin reagent for a prothrombin time assay. The kit simplifies and minimizes reagent preparation time and is stable for 2-5 years.