Polymer Technology Systems, Inc.

Polymer Technology System, Inc.

Gary L Hughes

Aniruddha Patwardhan

Brittney L Werner

Ryan D Jesswein

Jie Chen

Keith Moskowitz

Donnie Smith

Robert Huffstodt

William Benedict

Christopher Dailey

Aniruddha P Patwardhan

A system for determining a level of hematocrit includes a test strip configured to receive a sample; a meter configured to receive the test strip; and further including circuitry and a microprocessor, the circuitry and microprocessor configured to apply electrical energy to the test strip and the sample and determine an electrical property of the sample, either the impedance phase angle or the impendence magnitude of the test strip and the sample and, based on the electrical property, calculate the level of hematocrit in the sample.

Systems and methods for electrochemical hematocrit determination by alternate current impedance phase angle determinations

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

In one embodiment, a system for detecting an analyte in a bodily fluid sample includes an electrochemical biosensor, the electrochemical biosensor configured to receive the bodily fluid sample, test for the analyte, and produce an analyte level for the analyte. The system further includes a mediator, the mediator configured to provide for the testing of the analyte by facilitating electron exchange between the analyte and the biosensor. The system further includes an oxygen tension reducing agent, the oxygen tension reducing agent reducing interference of oxygen with the operation of the mediator.

Systems and methods for reduction of oxygen tension in electrochemical biosensors

An electrochemical test for total cholesterol includes a test strip for an electrochemical testing testing of a blood analyte which includes a first receiving port, the first receiving port for receiving a blood sample, the first receiving port at a first end of the test strip. The test strip further includes a first electrode and a second electrode, the first and second electrodes proximate to the first receiving port. The test strip further includes a first contact and a second contact, the first and second contacts at a second end of the test strip, the first and second contacts interconnected with the first and second electrodes, respectively. The test strip further includes cholesterol oxidase, located proximate to the first and the second electrode. The test strip further includes a mediator, located proximate to the first and the second electrode, wherein the cholesterol oxidase and the mediator interact with the blood sample and the first and second electrode to generate a measurable electrical event.

Systems and methods for an electrochemical total cholesterol test

A system for determining a concentration of hemoglobin A1C includes a first electrochemical test strip, the first electrochemical test strip providing for an HbA1C concentration; and a second electrochemical test strip, the second electrochemical test strip providing for the total amount of hemoglobin.

Systems and methods for enzymatic A1C detection and quantification

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.

A system for determining a level of hematocrit includes a test strip configured to receive a sample; a meter configured to receive the test strip; and further including circuitry and a microprocessor, the circuitry and microprocessor configured to apply electrical energy to the test strip and the sample and determine an electrical property of the sample, either the impedance phase angle or the impedance magnitude of the test strip and the sample and, based on the electrical property, calculate the level of hematocrit in the sample.

A system for preparing a sample containing hemoglobin HbA1c for measurement by an electrochemical sensor includes a lysing formulary, the lysing formulary including a zwitterionic surfactant. The system further includes a oxidizing formulary, the oxidizing formulary including a cationic surfactant and a isothiazoline derivative and a protease formulary, the protease formulary including a molecule including an azole.

Systems and methods for sample preparation for enzymatic A1C detection and quantification

A test strip for electrochemical testing of a blood analyte includes a plurality of test sites for the electrochemical testing of analytes on a single test strip. Each test site includes a first receiving port, the first receiving port for receiving a blood sample, the first receiving port at a first end of the test strip. The test site further includes a first electrode and a second electrode, the first and second electrodes proximate to the first receiving port. Each test site further includes a first contact and a second contact, the first and second contacts at a second end of the test strip, the first and second contacts interconnected with the first and second electrodes, respectively.

Systems and methods for a versatile electrochemical test strip that may include one or more assays for different analytes in the same test strip

A system for the electrochemical detection of triglyceride levels includes a test strip including an electrode and a counter electrode, the electrode and counter electrode located proximate to a sample reception area; and a coating on one of the electrode and counter electrode, the coating including a reagent coating for triglycerides.

Systems and methods for electrochemical triglycerides assays

A linearity standard includes a plurality of calibration solutions, each calibration solution having a different level of a reactant having a known response in a test strip and meter combination, and an electronic storage medium for storing calibration instructions and known responses for each solution of the plurality of calibration solutions.

Systems and methods for artificial test strip controls

A system for the electrochemical detection of ketone levels includes a test strip including an electrode and a counter electrode, the electrode and counter electrode located in a sample reception area. The system further includes a coating on one of the electrode and counter electrode, the coating including a mediator for ketones. Optionally, the mediator is ferricyanide.

Systems and methods for electrochemical ketone detection and measurement

A system for preserving a blood sample and removing hematocrit includes a casing, the casing having a sample port and a lateral flow strip in the casing, the lateral flow strip receiving a sample through the sample port, and flowing the sample down a length of the lateral flow strip.

Systems and methods for blood sample preservation and hematocrit separation

A system for electrochemically detecting AST and ALT includes a first sampler for producing pyruvate from ALT and a second sampler for producing pyruvate from AST. The system further includes an electrochemical test strip for receiving processed samples from the first and second samplers, the processed samples containing pyruvate. The system further includes a meter for reading the electrochemical test strip and indicating an amount of AST and ALT in the sample.

Systems and methods for electrochemical aspartate transaminase (AST) and alanine transaminase (ALT) detection and quantification

An extended range test strip includes a simple system where the end user can determine the concentration of the analyte at high concentration with a single drop of whole blood. A single drop of blood spreads across a spreading layer and into multiple reagent stacks. Multiple reagent stacks of the test strip may be configured to test for different ranges by adding a peroxide modulator. Readings from multiple reagent stacks producing a colorimetric response may be tested simultaneously. Working from the lowest range to the highest range of reagent stacks, the first reagent stack to be less than its maximum range is considered to be the reagent stack that is producing a colorimetric response related to the actual amount of analyte in the sample.

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Camby, IN, United States of America

Gary L Hughes