Lifescan Corporation

Roche Molecular Systems, Inc.

Roche Diagnostics Gmbh

F. Hoffmann-La Roche Ag

Manoj Sharma

Paul G Hayter

David Horwitz

Diego Ariel Rey

Kirk Harmon

Timothy J Ohara

Darwin R Poulos

Nick Reinig

Erik Otto

Ramanan Gopalan

Sharbel E Noujaim

Jon Michael Messamer

Maria Aquino

Paul Hayter

Joseph Marhoul

Harmon Kirk

Accurate measurements of the presence or absence of an analyte (e.g., MRSA) in a sample are provided. For example, the sample can be subjected to an activation reagent (potentially after an initial reagent has already been added), which can cause a flash signal that increases and then decreases over time. Signal data points can be measured from the flash signal using a detector. A quadratic regression function that fits the signal data points can be determined. An accuracy of the quadratic fit can be determined, as well as a signal-to-background ratio. A difference between a signal-to-background term and an accuracy term can be used as a score that is compared to a threshold to determine whether the analyte is present in the sample.

Detecting an analyte in a flash and glow reaction

The present invention is directed to a method of reducing false readings in a hypoglycemic detector that includes establishing a predetermined hypoglycemic threshold, a predetermined critical threshold, a predetermined rate of change in glucose concentration where the predetermined critical threshold is below the predetermined hypoglycemic threshold. A first sampling rate is then calculated based upon said predetermined hypoglycemic threshold, said predetermined critical threshold, and said predetermined rate of change in glucose concentration.

Systems and methods for detecting hypoglycemic events having a reduced incidence of false alarms

The present invention relates to methods and systems for monitoring the effectiveness of diabetes treatment. Methods and systems in accordance with the present invention provide information relating to variability of glucose levels and hypoglycemia and hyperglycemia. Such information is based on time-stamped blood glucose data obtained from a meter or the like and actual measurements of HbA1c levels are not required.

Diabetes management methods and systems

A method for selectively combining multiple membranes for assembly into test strips (such as visual blood glucose test strips with side-by-side membranes). The method includes first measuring a plurality of color parameters (e.g., L*, a* and b*color parameters) associated with membrane samples from at least two membrane lots. Next, response characteristics (e.g., blood glucose response levels) are simulated for a speculative test strip that includes, for purposes of the simulation, combined multiple membranes tentatively selected from the at least two membrane lots. The simulated response characteristics are based on the measured plurality of color parameters of the tentative selection of combined multiple membranes. Optionally, the simulated response characteristics can also be based on simulated color parameters of the tentative selection of combined multiple membranes. Subsequently, assembly of the at least two membrane lots into a test strip with combined membranes is contingent on acceptable simulated response characteristics. Any suitable color parameters can be employed. The method can be used to selectively combine two or more membranes based on any number of color parameters. The assembled test strips can be used to measure glucose, cholesterol, proteins, ketones, phenylalanine or enzymes in blood, urine, saliva or other biological fluid, as well as sample fluid characteristics (e.g., pH and alkalinity).

Method for selectively combining multiple membranes for assembly into test strips

A diagnostic kit for measuring a characteristic of a fluid sample includes a test strip (e.g., a disposable blood glucose test strip) and device (e.g., a hand-held meter) for measuring a property (e.g., an optical or electrochemical property) of the test strip. The device also calculates, based on the measured property of the test strip, a characteristic (e.g., blood glucose concentration or INR) of a fluid sample applied to the test strip. Stored in a memory of the device are test strip calibration codes that represent geometric regions (e.g., polygonal or hexagonal geometric regions) of a multi-dimensional calibration parameter space. The test strip calibration codes and geometric regions are distributed across the multi-dimensional calibration parameter space such that a quantization error of assigning one of test strip calibration codes to the test strip is optimally reduced. Also, a method for optimally associating test strip calibration codes to calibration parameters for use in such a diagnostic kit that includes first optimally distributing a plurality of test strip calibration codes and geometric regions represented thereby across a multi-dimensional calibration parameter space. The distribution is conducted such that a quantization error of assigning one of the test strip calibration codes to the test strip of the diagnostic kit is optimally reduced. The method also includes storing the distributed test strip calibration codes in a memory of the diagnostic kit.

Diagnostic kit with a memory storing test strip calibration codes and related methods

Growing community of inventors

Milpitas, CA, United States of America

Manoj Sharma