IP Library Patent Application 12298881
Patent Application
App. No. 12/298,881

HDL Cholesterol Sensor Using Selective Surfactant

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Patent No.
US None
App. No.
12/298,881
Abstract

A method for the determination of the amount of cholesterol in high density lipoproteins in a high density lipoprotein containing sample, said method comprising reacting the sample with a surfactant which preferentially reacts with high density lipoproteins in the sample, said surfactant being selected from hydroxyethyl glucamide derivatives and N-acyl-N-methyl glucamine derivatives, and measuring the amount of cholesterol in the high density lipoproteins, for example using an electrochemical technique.

Claims (109)

1 . A method for the determination of the amount of cholesterol in high density lipoproteins in a high density lipoprotein containing sample, said method comprising reacting the sample with (a) a surfactant which preferentially breaks down high density lipoproteins, said surfactant being selected from hydroxyethyl glucamide derivatives and N-acyl-N-methyl glucamine derivatives, and measuring the amount of cholesterol in the high density lipoproteins.

2 . A method according to claim 1 , wherein the surfactant is for improving the reproducibility of the determination of the amount of cholesterol in high density lipoproteins.

3 . A method according to claim 1 , wherein the surfactant (a) has a differentiation for HDL over LDL given by the equation (i) below of at least 50%:

Differentiation

(

%

)

=

G

HDL

-

G

LDL

G

HDL

×

100

wherein

G

HDL

is

measured

(

HDLcholesterol

)

known

[

HDLcholesterol

]

,

and

G

LDL

is

measured

(

LDLcholesterol

)

known

[

LDLcholesterol

]

.

(

i

)

wherein measured (HDL cholesterol) or measured (LDL cholesterol) is a measured value which relates to the concentration of HDL or LDL respectively.

4 . A method according to claim 1 , wherein the surfactant (a) is selected from HEGA-8, HEGA-9, HEGA-10, C-HEGA-9, C-HEGA-10, MEGA-8, MEGA-9, MEGA-10 and MEGA-12.

5 . A method according to claim 1 , wherein the method comprises repeating the measurement one or more times for a given sample to provide a data set of a plurality of measurements relating to the HDL concentration of the sample, and wherein R 2 for the data set is at least 0.6.

6 . A method according to claim 1 , wherein the amount of cholesterol in the high density lipoproteins is measured by reacting the sample with (b) a cholesterol ester hydrolysing reagent and (c) cholesterol oxidase or cholesterol dehydrogenase and determining the amount of cholesterol which has reacted with the cholesterol oxidase or cholesterol dehydrogenase.

7 . A method according to claim 1 , wherein the amount of cholesterol in the high density lipoproteins is measured by an electrochemical technique.

8 . A method according to claim 7 , wherein the method comprises reacting the sample with

(a) a surfactant which preferentially breaks down high density lipoproteins;

(b) a cholesterol ester hydrolysing reagent;

(c) cholesterol oxidase or cholesterol dehydrogenase;

(d) a coenzyme; and

(e) a redox agent capable of being oxidised or reduced to form a product;

and electrochemically detecting the amount of product formed.

9 . A method according to claim 8 , wherein the sample is additionally reacted with (f) a reductase.

10 . A method according to claim 1 , wherein the sample is reacted simultaneously with the surfactant (a), the cholesterol ester hydrolysing reagent (b) and the cholesterol oxidase or cholesterol dehydrogenase (c).

11 . A method according to claim 1 , wherein the high density lipoprotein containing sample is whole blood and wherein the method additionally comprises the step of filtering the sample to remove red blood cells.

12 . A method according to claim 1 , wherein the measurement of the amount of cholesterol in the high density lipoproteins is completed within a period of no more than 3 minutes from reaction of the sample with the surfactant.

13 . A reagent mixture for use in a method for the determination of the amount of cholesterol in high density lipoproteins in a high density lipoprotein containing sample, the reagent mixture comprising

(a) a surfactant which preferentially breaks down high density lipoproteins, said surfactant being selected from hydroxyethyl glucamide derivatives and N-acyl-N-methyl glucamine derivatives;

(b) a cholesterol ester hydrolysing reagent; and

(c) cholesterol oxidase or cholesterol dehydrogenase.

14 . A reagent mixture according to claim 13 , which additionally comprises (d)

a coenzyme, (e) a redox agent capable of being oxidised or reduced to form a product; and optionally (f) a reductase.

15 . A kit for the determination of the amount of cholesterol in high density lipoproteins in a high density lipoprotein containing sample, the kit comprising (a) a surfactant which preferentially breaks down high density lipoproteins, said surfactant being selected from hydroxyethyl glucamide derivatives and N-acyl-N-methyl glucamine derivatives, (b) a cholesterol ester hydrolysing reagent, and (c) cholesterol oxidase or cholesterol dehydrogenase, and optionally one or more of (d) a coenzyme, (e) a redox agent capable of being oxidised or reduced to form a product, and (f) a reductase, and means for measuring the amount of cholesterol which reacts with the cholesterol oxidase or cholesterol dehydrogenase.

16 . A kit according to claim 15 wherein the means for measuring the amount of cholesterol which reacts with the cholesterol oxidase or cholesterol dehydrogenase comprises

an electrochemical cell having a working electrode, a reference or pseudo reference electrode and optionally a separate counter electrode;

a power supply for applying a potential across the cell; and

a measuring instrument for measuring the resulting electrochemical response.

17 . A kit according to claim 15 , wherein the reagents (a), (b) and (c) and optionally one or more of (d), (e) and (f) are present in the form of a single reagent mixture.

18 . A kit according to claim 17 , wherein the reagent mixture is in dried form.

19 . A method of operating a kit for the determination of the amount of cholesterol in high density lipoproteins in a high density lipoprotein containing sample, the kit comprising:

(a) a surfactant which preferentially breaks down high density lipoproteins, said surfactant being selected from hydroxyethyl glucamide derivatives and N-acyl-N-methyl glucamine derivatives, (b) a cholesterol ester hydrolysing reagent, and (c) cholesterol oxidase or cholesterol dehydrogenase, and optionally one or more of (d) a coenzyme, (e) a redox agent capable of being oxidised or reduced to form a product and (f) a reductase;

and means for measuring the amount of cholesterol which reacts with the cholesterol oxidase or cholesterol dehydrogenase comprising

an electrochemical cell having a working electrode, a reference or pseudo reference electrode and optionally a separate counter electrode;

a power supply for applying a potential across the cell; and

a measuring instrument for measuring the resulting electrochemical response; said method comprising

(i) contacting (1) the reagents (a), (b) and (c), and optionally one or more of (d), (e) and (f), and (2) a high density lipoprotein containing sample, with each other and with the electrodes;

(ii) applying a potential across the electrochemical cell; and

(iii) electrochemically detecting the amount of product formed by measuring the resulting electrochemical response.

20 . A method according to claim 19 , wherein step (iii) is completed within a period of up to 3 minutes from the time at which the sample is contacted with the reagents (a), (b) and (c).

21 . A method of improving the reproducibility of a determination of the amount of cholesterol in high density lipoproteins, comprising reacting a high density lipoprotein containing sample with a surfactant selected from hydroxyethyl glucamide derivatives and N-acyl-N-methyl glucamine derivatives.

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 23, 2015
From: ROCHE DIAGNOSTICS OPERATIONS, INC.
To: ROCHE DIABETES CARE, INC.
Reel/Frame 036008/0670 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 1, 2011
From: F. HOFFMANN-LA ROCHE AG A/K/A F. HOFFMAN-LA ROCHE LTD; F. HOFFMANN-LA ROCHE LTD
To: ROCHE DIAGNOSTICS OPERATIONS, INC.
Reel/Frame 026110/0749 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 16, 2011
From: OXFORD BIOSENSORS LIMITED
To: F. HOFFMAN-LA ROCHE LTD A/K/A F. HOFFMANN-LA ROCHE AG AND HOFFMANN-LA ROCHE LTD
Reel/Frame 025993/0549 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 3, 2008
From: MURPHY, LINDY; BURROWS, CARLA; BAYLY, SIMON; WILKINSON, KATHERINE; ASKEW, HERBERT FRANK; ORMAN, HOWARD
To: OXFORD BIOSENSORS LIMITED
Reel/Frame 021778/0770 →