Roche Diagnostics Operations, Inc.

Roche Diagnostics Gmbh

Boehringer Mannheim Gmbh

Roche Operations Ltd.

F. Hoffmann-la Roche Ag

Brian A Heald

Robert Kitchel Earl

David W Burke

Eric R Diebold

Nigel A Surridge

Jiaxiong Jason Ho

R Dale Delk

Abner D Joseph

Richard J Bodensteiner

Daniel R McMinn

William F Crismore

Brian S Hill

David J Ledden

David R Moorman

Joseph E Bateson

David D Webster

G John Pritchard

Scott E Hubbard

Abner David Joseph

Daniel R Mcminn

A test strip with a sample chamber is secured to a meter. The sample chamber in the portion of the test strip that extends out of the meter is illuminated by transmitting light from a light source inside the meter internally through the test strip towards the sample chamber. By way of analogy, the test strip acts in a fashion similar to a fiber optic cable or optical wave guide by transmitting the light from the meter to the remotely located sample chamber that extends outside the meter. The user is then able to easily see the sample chamber of the test strip in dark conditions so that the user is able to readily align the sample chamber with the drop of fluid on the skin as well as view the sample chamber in order to ensure proper filling. The light also illuminates a test strip slot into which the test strip is inserted.

Method and apparatus for lighted test strip

An electrochemical biosensor test strip with four new features. The test strip includes an indentation for tactile feel as to the location of the strips sample application port. The sample application port leads to a capillary test chamber, which includes a test reagent. The wet reagent includes from about 0.2% by weight to about 2% by weight polyethylene oxide from about 100 kilodaltons to about 900 kilodaltons mean molecular weight, which makes the dried reagent more hydrophilic and sturdier to strip processing steps, such as mechanical punching, and to mechanical manipulation by the test strip user. The roof of the capillary test chamber includes a transparent or translucent window which operates as a 'fill to here' line, thereby identifying when enough test sample (a liquid sample, such as blood) has been added to the test chamber to accurately perform a test. The test strip may further include a notch located at the sample application port. The notch reduces a phenomenon called 'dose hesitation'.

Electrochemical biosensor test strip

An electrochemical biosensor test strip with four new features. The test strip includes an indentation for tactile feel as to the location of the strips sample application port. The sample application port leads to a capillary test chamber, which includes a test reagent. The wet reagent includes from about 0.2% by weight to about 2% by weight polyethylene oxide from about 100 kilodaltons to about 900 kilodaltons mean molecular weight, which makes the dried reagent more hydrophilic and sturdier to strip processing steps, such as mechanical punching, and to mechanical manipulation by the test strip user. The roof of the capillary test chamber includes a transparent or translucent window which operates as a &ldquo;fill to here&rdquo; line, thereby identifying when enough test sample (a liquid sample, such as blood) has been added to the test chamber to accurately perform a test. The test strip may further include a notch located at the sample application port. The notch reduces a phenomenon called &ldquo;dose hesitation&rdquo;.

There is disclosed a method of selectively increasing the hydrophilicity of a web, such as a plastic glucose electrochemical test strip. The web is corona arc treated, and a film of water is selectively applied to the web where a reduction of the effect of the initial corona treatment is desired. The water is then removed by drying.

Method of selectively increasing the hydrophilicity of a web

An electrochemical biosensor test strip that has a minimum volume blood sample requirement of about 9 microliters. The test strip has working and counter electrodes that are substantially the same size and made of the same electrically conducting material placed on a first insulating substrate. Overlaying the electrodes is a second insulating substrate, which includes a cutout portion that forms a reagent well. The cutout portion exposes a smaller area of the counter electrode than the working electrode. A reagent for analysis of an analyte substantially covers the exposed areas of working and counter electrodes in the reagent well. Overlaying the reagent well and affixed to the second insulating substrate is a spreading mesh that is impregnated with a surfactant. The small cutout portion of 4 millimeters by 4.2 millimeters, small mesh of 6 millimeters by 5.8 millimeters, and small amount of reagent, 4 microliters before drying, allow the test strip to analyze a whole blood sample of about 9 microliters.

The invention is an apparatus useful in carrying out an analytical assay. The apparatus has a positive and negative control, as well as a site for determining the presence, amount, or lack of an analyte in a sample.

Analytical test apparatus with on board negative and positive control

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Fishers, IN, United States of America

Brian A Heald