Mercury Diagnostics, Inc.

Amira Medical

Roche Diagnostics Operations, Inc.

F. Hoffmann-la Roche Ag

Karen R Drexler

Joel Sterling Douglas

Jeffrey N Roe

James N Wilson

John H Priest

John M Gleisner

An analyte detection system is provided with calibration information uniquely specific to the set of test strips to which the sample is to be applied. The calibration information may be stored in permanent memory of the testing device, such that the device is discarded after use of all the test strips in a kit, or it may be stored in a calibration chip accompanying the set of test strips and distributed therewith, thereby enabling re-use of the testing device with a different set of test strips and associated calibration chip.

Synchronized analyte testing system

Devices and methods for utilizing dry chemistry dye indicator systems for body fluid analysis such as glucose level in whole blood are provided by incorporating a porous membrane with a skin side which enables separation of whole blood and visually reading the indicator without removing the red blood cell portion of the blood from the membrane. The devices also enable visual reading of the indicator by use of a membrane or matrix which provides separation of whole blood in a lateral flow of the blood through the matrix from the input area to a test area of the matrix. The devices also provide for microtitration of fluid samples in fixed volumetric openings containing indicator reagent. Another aspect of the device provides a determination of hematocrit level in whole blood in combination with indicator indication of analyte concentration which can be compensated for the hematocrit level. The devices provided are low cost.

Devices for testing for the presence and/or concentration of an analyte in a body fluid

A dry chemistry dye indicator composition provides improved shelf life, stable color indication end point and capability for a system at near normal pH. The novel dry chemistry dye indication system comprises 3-Methyl-6-(sodium sulfonate)-benzothiazolinone-(2)-hydrazone (MBTH-S). A preferred dye systems are based on the dye couple (MBTH-S) and 8-anilino-1-naphthalenesulfonate (ANS), and the dye couple MBTH-S and N-(3-sulfopropyl)analine. These dye indicator systems are used in conventional blood chemistry test strips and are particularly preferred for indication of glucose in blood.

Diagnostic compositions and devices utilizing same

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.

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.

Devices and methods for utilizing dry chemistry dye indicator systems for body fluid analysis such as glucose level in whole blood are provided by incorporating a porous membrane with a skin side which enables separation of whole blood and visually reading the indicator without removing the red blood cell portion of the blood from the membrane. The devices also enable visual reading of the indicator by use of a cellulose fiber glass composite matrix which provides separation of whole blood in a lateral flow of the blood through the matrix from the input area to a test area of the matrix. Another aspect of the device provides a determination of hematocrit level in whole blood by measuring flow rate through a restricted passageway in the device.

Growing community of inventors

Los Altos Hills, CA, United States of America

Karen R Drexler