Amira Medical

Mercury Diagnostics, Inc.

Polymer Technology International Corp.

Roche Diagnostics Operations, Inc.

John M Gleisner

Joel Sterling Douglas

John H Priest

David A Hasker

Ryszard Radwanski

Brent G Duchon

Jeffrey N Roe

John Cuevas Ramirez

Charles C Raney

Karen R Drexler

John E Priest

A method of making strip for testing for the presence of an analyte generally comprises providing a support member which includes a spreading layer and a reagent layer, and a capillary in communication with the support layer and spreading layer for transporting a sample of body fluid thereto.

Device for determination of an analyte in a body fluid

A multi-use assay system accurately docks a removable test strip supporting a reagent-analyte reaction with an optics system including an LED, photodetector, and lenses or light pipes for directing light to and from the test strip. Docking is achieved using alignment fixturing, whereby an optics block holder is relied upon to align the test strip and test pad with the various optical components. Signals from the photodetector indicative of test strip reaction progress are provided to a processor for measuring the analyte.

Optics alignment and calibration system

A strip for testing for the presence of an analyte generally comprises a support member which contains a spreading layer and a reagent layer, and a capillary tube in communication with the support layer and spreading layer for transporting a sample of body fluid thereto. A method of testing a fluid for the presence or concentration of an analyte is also provided which generally includes providing a test strip with a support member, a spreading layer, and a reagent layer on the spreading layer. A capillary tube is provided on the support member whereby a fluid containing an analyte to be tested is introduced into the tube and flows through the tube to the spreading layer and contacts the reagent layer.

A dry chemistry reagent matrix composition is provided containing a matrix material and a reagent composition containing 3-methyl-6(sulfonate salt)-benzothiazolinone-(2)-hydrazone (MBTH-S), N-ethyl-N-(3-sulfopropyl)aniline, and an oxidase enzyme or a peroxidase enzyme or a mixture thereof. The dry chemistry reagent matrix composition is useful in reagent test strips for determining the presence or concentration of an analyte in a fluid sample, such as blood.

Diagnostic compositions and devices utilizing same

This invention provides methods and apparatus for applying a reagent to an analytical test device. The methods and apparatus employ a nozzle and a flexible restrictor to accurate control the amount of reagent applied to the test device. The analytical test devices prepared by the methods of this invention are used to determine the presence or the quantity of an analyte in a liquid sample, such as whole blood.

Methods for applying a reagent to an analytical test device

Test strip device

A method for making a test strip is described. The test strip is generally a substrate, a layer disposed on the substrate and located near the distal end of the substrate. The layer typically contains a chemical reagent detection system capable of detecting the presence of a predetermined analyte in a sample of biological fluid, wherein the reagent detection system produces a detectable change in the layer in the presence of the analyte. In the method, a length of substrate is provided having a width substantially the dimension of the final length of the test strip being made; on the substrate near one edge thereof is provided a layer of material permeable to biological fluids, the layer having a width sufficient to place thereon a drop of biological fluid for treating; to the layer of permeable material is continuously applied an aqueous solution containing reagent detection chemicals capable of providing a detectable change in the presence of a predetermined analyte, the solution being applied in an amount to substantially saturate the permeable material; the layer of permeable material is dried to contain the reagent detection chemicals within the layer; and the web is cut into predetermined shorter lengths containing a preset number of test strips for further processing.

Method for continuous manufacture of diagnostic test strips

A test strip for the detection of a predetermined substance in a fluid is described. This test strip is stable to storage and accelerated keeping test conditions and comprises a support having thereof a reagent layer wherein the reagent layer contains a dialyzed latex polymer and a reagent detection system which reacts with the substance to provide a detectable change.

Method of making a test strip having a dialyzed polymer layer

A method for the detection of a predetermined substance in a fluid is described. The method uses a test strip that is stable to storage and accelerated keeping test conditions. A sample of a fluid containing an unknown quantity of a predetermined substance is contacted with a support having thereon a reagent layer wherein the reagent layer contains a dialyzed latex polymer and a reagent detection system which reacts with the substance to provide a detectable change. The detectable change can be determined qualitatively or quantitatively to determine the presence or the amount of the predetermined substance.

Method of detection using a test strip having a non particulate dialyzed

A diagnostic test strip for the detection of a analyte in a test fluid. The test strip has a reagent layer on a support layer. The reagent layer contains an analyte detection system in a non-particulate dialyzed latex polymer.

Growing community of inventors

Lynnwood, WA, United States of America

John M Gleisner