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1. WO2020113129 - SYSTEMS AND METHODS FOR ELECTROCHEMICAL POINT-OF-CARE DETECTION OF HEMOGLOBIN

Publication Number WO/2020/113129
Publication Date 04.06.2020
International Application No. PCT/US2019/063789
International Filing Date 27.11.2019
IPC
C07K 16/18 2006.01
CCHEMISTRY; METALLURGY
07ORGANIC CHEMISTRY
KPEPTIDES
16Immunoglobulins, e.g. monoclonal or polyclonal antibodies
18against material from animals or humans
G01N 33/48 2006.01
GPHYSICS
01MEASURING; TESTING
NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
33Investigating or analysing materials by specific methods not covered by groups G01N1/-G01N31/131
48Biological material, e.g. blood, urine; Haemocytometers
CPC
C12N 9/50
CCHEMISTRY; METALLURGY
12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
9Enzymes; Proenzymes; Compositions thereof
14Hydrolases (3)
48acting on peptide bonds (3.4)
50Proteinases ; , e.g. Endopeptidases (3.4.21-3.4.25)
G01N 27/3272
GPHYSICS
01MEASURING; TESTING
NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
27Investigating or analysing materials by the use of electric, electro-chemical, or magnetic means
26by investigating electrochemical variables; by using electrolysis or electrophoresis
28Electrolytic cell components
30Electrodes, e.g. test electrodes; Half-cells
327Biochemical electrodes ; electrical and mechanical details of in vitro measurements
3271Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood
3272Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels
G01N 33/721
GPHYSICS
01MEASURING; TESTING
NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
33Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
48Biological material, e.g. blood, urine
50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
72involving blood pigments, e.g. haemoglobin, bilirubin ; or other porphyrins; involving occult blood
721Haemoglobin
Applicants
  • POLYMER TECHNOLOGY SYSTEMS, INC. [US]/[US]
Inventors
  • SMITH, Donnie
  • WERNER, Brittney L.
  • HUGHES, Gary L.
  • CHEN, Jie
Agents
  • HAYNES AND BOONE, LLP
  • ZIEMIAN, Robert P.
Priority Data
62/772,78929.11.2018US
Publication Language English (EN)
Filing Language English (EN)
Designated States
Title
(EN) SYSTEMS AND METHODS FOR ELECTROCHEMICAL POINT-OF-CARE DETECTION OF HEMOGLOBIN
(FR) SYSTÈMES ET MÉTHODES DE DÉTECTION DE POINT D'INTERVENTION ÉLECTROCHIMIQUE D'HÉMOGLOBINE
Abstract
(EN)
A method of determining Hemoglobin A1C, total hemoglobin, and %HbA1C includes lysing the red blood cells of a whole blood sample, oxidizing the free hemoglobin, 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. The %HbA1C is calculated. Also provided are systems and components useful in performing the disclosed methods.
(FR)
L'invention concerne une méthode de détermination de l'hémoglobine A1C, de l'hémoglobine totale et du % de HbA1C faisant appel à la lyse des globules rouges d'un échantillon de sang total, à l'oxydation de l'hémoglobine libre, et au clivage de FVH par rapport à l'hémoglobine A1C pour former une solution de test électrochimique. Selon un aspect, une première partie de la solution de test électrochimique est mise à réagir avec une fructosyle peptide oxydase et avec un médiateur de ruthénium réduit pour former un premier produit de réaction. Une première propriété électrique du premier produit de réaction est mesurée, la mesure indiquant l'hémoglobine A1C dans l'échantillon de sang. Selon un autre aspect, une seconde partie de la solution de test électrochimique est mise à réagir avec du ferrocyanure pour former un second produit de réaction. Une seconde propriété électrique du second produit de réaction est mesurée, la mesure indiquant l'hémoglobine totale dans l'échantillon de sang. Le % de HbA1C est calculé. L'invention concerne également des systèmes et des composants qui trouvent leur utilisation dans la mise en œuvre desdites méthodes.
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