Analyte detection devices and methods with hematocrit/volume correction and feedback control

Abstract

Disclosed are devices, arrangements and methods for quantifying the concentration of an analyte present in bodily fluid, including: an assay pad having at least one chemical reagent capable of producing a detectable signal in the form of a reaction spot upon reaction with the analyte; a light source; a detector array; a processor; and a memory in communication with the processor, the memory comprising: (a) at least one value indicative of one or more of: (i) the level of hematocrit contained in the sample; (ii) the volume of the sample applied to the assay pad; or (iii) imperfections present in the reaction spot; and (b) at least one algorithm for calculating the concentration of the analyte contained in the sample.

Description

[0001] The present application claims priority pursuant to 35 U.S.C. §119(e) to provisional application Ser. No. 60 / 689,546 filed Jun. 13, 2005, the entire content of which is incorporated herein by reference. FIELD OF THE INVENTION [0002] The present invention is directed to techniques and devices for detection of the presence and / or concentration of an analyte. BACKGROUND OF THE INVENTION [0003] In the following discussion certain articles and methods will be described for background and introductory purposes. Nothing contained herein is to be construed as an “admission” of prior art. Applicant expressly reserves the right to demonstrate, where appropriate, that the articles and methods referenced herein do not constitute prior art under the applicable statutory provisions. [0004] According to the American Diabetes Association, diabetes is the fifth-deadliest disease in the United States and kills more than 213,000 people a year, the total economic cost of diabetes in 2002 was est...

AI Technical Summary

Benefits of technology

[0016] According to the present invention, the state of the art has been advanced through the provision of arrangements, devices and techniques such as those described further herein, for accurately, efficiently, and economically determining the presence and / or concentration of an analyte. According to the present invention, the state of the art has been advanced, especially, but not exclusively, within the context of personal glucose monitoring devices and techniques. Additionally, or alternatively, according to the present invention arrangements, devices and techniques are provided which may overcome one or more of the abovementioned shortcomings associated with conventional systems and methods.

[0017] Devices and methods are contemplated that may employ a detector comprising an array of detector elements or pixels to detect color change or intensity of reflected light associated with a photometric chemical reaction between the analyte and reagent chemistry. Optionally, the detector elements comprise CMOS-based detector elements. In particular, the CMOS detector elements help correct for differences in hematocrit levels and / or volumes associated with samples under analysis. An additional aspect of the present invention provides for CMOS-based detector elements that can provide feedback control for a connected device that performs automated whole blood sampling and detection of an analyte. In yet another aspect of the present invention, feedback from CMOS detection elements is used to compensate for non-ideal reaction spot characteristics.

Problems solved by technology

Glucose monitoring technology that relies on the photometric method of quantifying the glucose concentration in whole blood may be subject to errors associated with variations in hematocrit level, or concentration of red blood cells within the blood sample.

This presents a challenge for the development of accurate glucose monitoring.

If the user has not supplied a sufficient amount, then the meter generally displays an error code and the user must test again.

Further, a user may supply more than the typical amount of blood to the test strip, which may lead to an inaccurate result if the calibration of the strip is volume sensitive.

For others, this pre-programmed catalyst may produce either an insufficient or excessive amount of blood, as well as other undesired outcomes, such as excessive bruising (for those with fragile capillary networks), an unnecessary delay in obtaining results (for fast bleeding individuals), as well as excessive residual blood left on the skin.

For a variety of reasons, the quality of a spot developed as a result of an analyte reacting with the reagent membrane may not be ideal as described above.

Most devices on the market cannot detect or correct for low quality spots.

Their sensors, typically one or more photodiodes, do not have the ability to discretely analyze the flaws within a reagent spot.

Thus, there exists a risk that these systems may not provide an accurate reading in circumstances of a non-ideal spot.

Images