A dry reagent composition that includes an active redox enzyme that oxidizes an analyte as a specific substrate to produce an inactive reduced form of the enzyme; and a salt of ferricyanide provides improved performance in electrochemical test strips such as those used for detection of glucose. The salt of ferricyanide consists of ferricyanide and positively-charged counter ions, and the positively charged counter ions are selected such that the salt of ferricyanide is soluble in water, and such that the salt of ferricyanide or the crystalline phase of the salt of ferricyanide has a solubility in water and/or a lower E.sup.0.sub.eff at a concentration of 100 mM than potassium ferricyanide. For example, the salt of ferricyanide may be tetramethylammonium ferricyanide.

A test meter for analyzing a body fluid sample applied to a test strip includes an outer housing having an opening, an actuator, and a cartridge positioned adjacent the outer housing. The cartridge further includes a dispensing member connected to the actuator, a plurality of stacked test strips biased toward the dispensing member, and a cartridge outer housing that is adjacent at least a portion of the dispensing member. Each time the actuator is actuated, the dispensing member is rotated to cause movement of one test strip from the plurality of stacked test strips through the opening, and another test strip is biased toward the dispensing member.

The present invention relates to methods and systems for testing for the presence of a material such as one or more analyte types within a sample and more particularly, for improved single enzyme-linked immunosorbent assay (sELISA) testing as well as other variants of single-enzyme linked molecular analysis (SELMA). The invention involves flow systems for digital counting of analytes with at least one opening (inlet/outlet). A support with hydrophilic and hydrophobic patches preferably harbours capture probes immobilised on the hydrophilic features. Nano-to-attoliter droplets are formed on the hydrophilic features. A gas phase (called gas phase seal) is applied to prevent/reduce evaporation from the droplets.

A coagulation test device for measuring clotting time and clot characteristics of a whole blood sample under different hemostatic conditions. Results of the test are used as an aid in management of patients with coagulopathy of unknown etiology in order to help the physician determine appropriate clinical action to arrest bleeding in a patient.

An article, a system, and a method for indication of treatment are provided. The article comprises a first body, a second body, and a treatment indicator. The first body comprises a first axis, a cavity, a first port, and a second port. The cavity is positioned within the first body and configured to receive the second body. The second body comprises a second axis, a chamber, a third port, and a fourth port. The article is configured to move between a first configuration and a second configuration. In the first configuration, the first port is aligned with the third port to form a fluid pathway to the chamber, and the second port is aligned with the fourth port to form a fluid pathway to the chamber. In the second configuration, the first port is misaligned with the third port, and the second port is misaligned with the fourth port.

A treatment indicator, a method for indicating a level of treatment in a treatment apparatus, and a method of preparing a treatment indicator are provided. The treatment indicator comprises a first body comprising a biological material, a fluid porous body in fluid communication with the first body in a fluid path, and a cleaning test soil disposed in at least a portion of interstitial spaces of the fluid porous body to inhibit traversal of a fluid through the fluid porous body to the first body via the fluid path.

A self-contained apparatus and methods for detecting the presence of any specified substance in any medium. A sample of the medium is placed in a capsule, along with a solvent and a sensor configured to test for a target analyte. The solvent comes into contact with the medium in the capsule, and the capsule is agitated to create a dispersion in the solvent of a portion of any target analyte present in the medium. A release mechanism configured to cause conduction of the dispersion to the sensor, so that the sensor produces an indication of presence of the target analyte if the target analyte is present in the medium. The apparatus uses a disposable capsule where the medium in question is placed and the disposable capsule is placed inside a reader and analyzed for presence of the harmful substance.

A system of detecting a blood analyte includes a lateral flow test strip and a test strip holder, the lateral flow test strip located in the test strip holder. The system further includes a meter for receiving the test strip holder.

In various embodiments single-step ATPS paper-based diagnostic assays are provided that exploit the concept of sequential resolubilization of ATPS components to give rise to the desired phase separation behavior within paper. In one illustrative embodiment, a wick is provided for concentrating an analyte within an aqueous two-phase extraction system in a paper, where the wick comprises a paper configured to receive a sample where the paper comprises a first region containing a first component of an aqueous two-phase system (ATPS) where the first component is in a dry form, and a second region containing a second component of an aqueous two-phase system (ATPS) where the second component is in a dry form; and where said first region and the second region are disposed so that when said wick is contacted with a fluid sample, the first component of said ATPS is hydrated before the second component. In certain embodiments the first and second component are disposed so they are hydrated substantially simultaneously.

Identification of autoantibodies associated with Crohn's disease useful in diagnosis and management using an innovative protein array technology, namely nucleic acid programmable protein arrays (NAPPA) and applications relating thereto. Overall, reactivity of IgG autoantibodies was stronger than that of IgA autoantibodies; however, IgA autoantibodies showed greater differential reactivity between cases and controls. Four IgA autoantibodies against SNRPB, PRPH, PTTG1 and SNAI1 were newly identified with sensitivities above 15% at 95% specificity, among which anti-SNRPB-IgA had the highest sensitivity of 24.0%. Autoantibodies associated with specific disease subtypes were also found.