Polymer Technology Systems, Inc.

Donnie Smith

Gary L Hughes

Brittney L Werner

Jie Chen

Christopher Dailey

Jonathan A Broadwell

Steven Zucker

A method includes lysing the red blood cells of a whole blood sample, oxidizing the free hemoglobin in the lysed sample, and cleaving FVH from the hemoglobin A1C to form an electrochemical test solution. A first portion of the electrochemical test solution is reacted with fructosyl peptide oxidase and a reduced ruthenium mediator to form a first reaction product. A first electrical property of the first reaction product is measured, the measurement being indicative of hemoglobin A1C in the blood sample. A second portion of the electrochemical test solution is reacted with ferrocyanide to form a second reaction product. A second electrical property of the second reaction product is measured, the measurement being indicative of total hemoglobin in the blood sample. Hemoglobin A1C, total hemoglobin, and % HbA1C are determined based on the first and second electrical properties. Also provided are systems and components useful in performing the disclosed methods.

Systems and methods for electrochemical point-of-care detection of hemoglobin

A method for determining analytes includes lysing the red blood cells of a whole blood sample, oxidizing the free hemoglobin in the lysed sample, and cleaving FVH from the hemoglobin A1C to form an electrochemical test solution. In one aspect, a first portion of the electrochemical test solution is reacted with fructosyl peptide oxidase and a reduced ruthenium mediator to form a first reaction product. A first electrical property of the first reaction product is measured, the measurement being indicative of hemoglobin A1C in the blood sample. In another aspect, a second portion of the electrochemical test solution is reacted with ferrocyanide to form a second reaction product. A second electrical property of the second reaction product is measured, the measurement being indicative of total hemoglobin in the blood sample. Hemoglobin A1C, total hemoglobin, and % HbA1C are determined based on the first and second electrical properties.

In one embodiment, a system for determining the proper positioning of a test strip includes a test strip having a first reading window and a strip holder. The system further includes a meter, the meter receiving and configured to receive the test strip, the meter having a first light source of a first color and a second light source of a second color and a first read window. The meter is configured to illuminate the first light source; detect a first reflectance with the meter through the first read window; and determine if the first reflectance is greater than a no-strip value.

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Indianapolis, IN, United States of America

Donnie Smith