公开(公告)号：US20230305026A1

公开(公告)日：2023-09-28

申请号：US18328942

申请日：2023-06-05

申请人： POLYMER TECHNOLOGY SYSTEMS, INC.

发明人： Donnie Smith ,  Brittney L. Werner ,  Gary L. Hughes ,  Jie Chen

IPC分类号： G01N33/72 ,  C12N9/50 ,  G01N27/327

CPC分类号： G01N33/721 ,  C12N9/50 ,  G01N27/3272 ,  G01N33/723

摘要： A method is disclosed comprising 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. Also provided are systems and components useful in performing the disclosed methods.

公开(公告)号：US20200174024A1

公开(公告)日：2020-06-04

申请号：US16698872

申请日：2019-11-27

申请人： POLYMER TECHNOLOGY SYSTEMS, INC.

发明人： Donnie Smith ,  Brittney L. Werner ,  Gary L. Hughes ,  Jie Chen

IPC分类号： G01N33/72 ,  G01N27/327 ,  C12N9/50

摘要： A method is disclosed comprising 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. Also provided are systems and components useful in performing the disclosed methods.

公开(公告)号：US11143502B2

公开(公告)日：2021-10-12

申请号：US16830779

申请日：2020-03-26

申请人： POLYMER TECHNOLOGY SYSTEMS, INC.

发明人： Steven Zucker ,  Donnie Smith ,  Christopher Dailey ,  Jonathan Broadwell

IPC分类号： G01B11/14 ,  B01L9/00 ,  G01V8/12

摘要： 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.

公开(公告)号：US11693016B2

公开(公告)日：2023-07-04

申请号：US16698872

申请日：2019-11-27

申请人： POLYMER TECHNOLOGY SYSTEMS, INC.

发明人： Donnie Smith ,  Brittney L. Werner ,  Gary L. Hughes ,  Jie Chen

IPC分类号： G01N33/72 ,  G01N27/327 ,  C12N9/50

CPC分类号： G01N33/721 ,  C12N9/50 ,  G01N27/3272 ,  G01N33/723

摘要： 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.

公开(公告)号：US20200309511A1

公开(公告)日：2020-10-01

申请号：US16830779

申请日：2020-03-26

申请人： POLYMER TECHNOLOGY SYSTEMS, INC.

发明人： Steven Zucker ,  Donnie Smith ,  Christopher Dailey ,  Jonathan Broadwell

IPC分类号： G01B11/14 ,  B01L9/00 ,  G01V8/12

摘要： 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.