WO1993021928A1 - Solution temoin de glucose liquide et procede de preparation - Google Patents

Solution temoin de glucose liquide et procede de preparation Download PDF

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Publication number
WO1993021928A1
WO1993021928A1 PCT/US1993/003799 US9303799W WO9321928A1 WO 1993021928 A1 WO1993021928 A1 WO 1993021928A1 US 9303799 W US9303799 W US 9303799W WO 9321928 A1 WO9321928 A1 WO 9321928A1
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WO
WIPO (PCT)
Prior art keywords
glucose
control solution
concentration
red blood
blood cells
Prior art date
Application number
PCT/US1993/003799
Other languages
English (en)
Inventor
Wayne L. Ryan
Original Assignee
Streck Laboratories, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Streck Laboratories, Inc. filed Critical Streck Laboratories, Inc.
Publication of WO1993021928A1 publication Critical patent/WO1993021928A1/fr

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Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/96—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood or serum control standard
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/66—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood sugars, e.g. galactose

Definitions

  • the present invention is directed generally to a glucose control solution for use in establishing the validity of dry reagent glucose test strips, and more particularly to a liquid glucose control suitable for use in glucose analyzer systems that give quantitative measures of glucose in blood or serum.
  • the control solution includes water, a reaction-rate regulator, a gel which does not change viscosity with temperature, and glucose.
  • the level of glucose in the blood is determined by the amount of carbohydrate ingested and by available insulin.
  • the diabetic may produce either excess insulin and have an abnormally low blood glucose level or, insufficient insulin which will result in an abnormally high level of blood glucose. Both circumstances lead to serious health problems for the diabetic. Monitoring the level of glucose in the blood is therefore important to the management of diabetes.
  • Dry reagent strips are widely used for detecting glucose in urine and blood.
  • test strips comprise plastic strips provided at one end thereof with an absorbent paper portion impregnated with a detector system, e.g., an enzyme system and a color indicator compound which changes color when oxidized.
  • the detector system is normally covered with a porous membrane filter.
  • the change in r 3» color can be measured by comparing the strip to a color chart calibrated to various glucose concentrations.
  • instruments have been developed to measure the color change in a reflectance photometer and thereby give quantitative results.
  • One such instrument is commercially available from Diagnostic Laboratory Systems Division, Boehringer Mannheim corporation and is marketed under the name Accu-Chek ® EasyTM. This instrument is designed for use by diabetics so that they can monitor their blood glucose level.
  • a primary object of the invention is to provide an improved liquid glucose control solution.
  • Another object of the invention to provide a control solution with reaction kinetics providing rapid accurate readings stable over ninety seconds when used with a dry reagent strip.
  • Another object of the invention is to provide a control solution that produces reproducible readings within a normal range of temperatures.
  • the liquid glucose control solution of the present invention includes a stable liquid control solution including water, a predetermined amount of glucose, phosphate as an anionic component, and xanthan as a soluble gel.
  • An alternative control solution may additionally include fixed red blood cells.
  • Other materials such as a disinfectant may be mixed with the above four required components.
  • Another aspect of the invention is a process of making the liquid glucose control solution by mixing the four required components together.
  • Figure 1 is a graph showing the effect of different phosphate concentrations on the reaction kinetics resulting from use of the present invention.
  • liquid glucose control solution of the present invention is designed to operate with an instrument called the Accu-Chek ® EasyTM, it will also operate with many other instruments.
  • the objectives of the control are to provide reaction kinetics comparable to blood; to defuse or chromatograph like blood, and to give responses that are not temperature dependent.
  • Any convenient method can be used to formulate the glucose reference control of the invention.
  • One preferred procedure involves first making up an aqueous glucose solution by adding glucose to distilled water followed by the addition of the essential phosphate and xanthan components and any optimal components such as a disinfectant.
  • Fixed red cells may also be added to the control as in Ryan, U.S. Patent No. 4,729,959.
  • the water is used to create a reagent solution.
  • predetermined means that, prior to formulation of the actual reagent, a concentration of glucose has been selected. This concentration may vary as will be recognized by those skilled in the art.
  • Ryan U.S. Patent No.4,729,959 discloses a range of from 2.22 mM/Lto 27.8 mM/L, but lower ranges to about 1.11 mM/L are possible. A typical range would be from about 3.33 mM/L to 16.7 mM/L. The units expressed are millimolar per liter.
  • Phosphate is included as a reaction rate regulator. It is desirable for the reaction to proceed rapidly and then plateau to a constant value. This pattern produces a result that is less time dependent. Thus, the meter can be read for example in 10 seconds or 60 seconds and the result will be the same.
  • Figure 1 shows the reflectance values obtained at different times and the effect of phosphate ions on the process. As the phosphate is increased, lower initial reflectance values (more color) are attained. However, when 40 mM/LP0 4 is used, there is a decoloration that occurs with time. - 5 -
  • the ideal concentration is the 20 mM/LP0 4 where the reflectance is constant with time.
  • the sample with no P0 4 produces such a slow reaction, that equilibrium is not reached until 70 seconds have passed.
  • a phosphate concentration of about 5 to 35 mM/L may be used with about 10 to 30 being more preferred and about 20 mM/L being most preferred. These concentrations of phosphate are best for glucose concentrations of 2.8 mM/L - 13.9 mM/L. At higher concentrations of glucose, more phosphate is required and less at lower concentrations.
  • the glucose containing solution must move to the analysis system in a similar manner as blood.
  • a thickening agent or gel be used.
  • These agents include polyvinylpyrrolidone, polyvinyl alcohol, polyethylene glycol, dextran and bovine serum albumin. None of these agents provide any special characteristics except to make the solution viscous.
  • polystyrene sulphonate is claimed as a viscosity agent. As in the above, this agent simply increases viscosity.
  • the gel that is used in the present invention is xanthan, a polysaccharide. This provides special characteristics to the product.
  • Xanthan unlike other gels, does not change viscosity with temperature.
  • the viscosity of the solution containing xanthan gum experiences almost no change with temperatures upto93°C (200 ,, F).
  • a change in viscosity produces erratic values and variation in results with temperature.
  • this gel produces uniform chromatography or diffusion of the control. This provides greater precision as shown by the data of the following Table I.
  • Table I shows that both the standard deviation and coefficient of variation were about tenfold less in the series of tests with xanthan as compared to the series of tests using the control solution without xanthan.
  • Xanthan may be used in concentrations of about 1 to 5 g/1, more preferably 2 to 4 g/1 and optimally about 3 g/1.
  • a control for the Accu-Chek ® EasyTM is prepared by dissolving per liter
  • a control for the Accu-Chek ® EasyTM is prepared by dissolving per liter:
  • Example II describes the addition of fixed red blood cells.
  • Fixed red blood cells can be obtained by using conventional red blood cell fixing agents known in the art as, for example, aldehydes such as formaldehyde and glutaraldehyde, and imidinating agent such as dimethylsuberimidate or other chemical fixative agents. Any animal red blood cells can be utilized, but human and bovine red blood cells are preferred.
  • Fixing of the red blood cells is readily accomplished by treating a suspension of the red blood cells with a sufficient concentration of the fixing agent.
  • the amount of fixing agent added to the suspension of red blood cells will vary depending upon the number of cells in suspension being treated and the fixing agent employed. In the case of aldehyde and imidinating fixing agents, the concentration will usually vary from 0.004 to 1.0% by weight per 0.1xl0 1 /dL of red blood cells. A preferred concentration of redblood cells is about 0.1 to 0.3xl0 12 /dL.
  • the reaction of the fixing agent with the red blood cells is allowed to proceed until their ability to metabolize glucose is completely inhibited. The fixing period necessary to achieve this result ordinarily takes about 24 to 48 hours.
  • Figure 1 shows the reflectance values obtained at different time points and the effect of phosphate ions on the process at a constant glucose concentration. As the phosphate is increased, equilibrium is attained much quicker, resulting in higher reflectance values (less color) .

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Molecular Biology (AREA)
  • Urology & Nephrology (AREA)
  • Biomedical Technology (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Food Science & Technology (AREA)
  • Microbiology (AREA)
  • Cell Biology (AREA)
  • Biotechnology (AREA)
  • Medicinal Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Diabetes (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

Une solution témoin de glucose liquide comprend de l'eau, une quantité prédéterminée de glucose, du phosphate en tant que régulateur de la vitesse de réaction et du xanthane en tant que gel soluble. Une autre solution témoin peut comprendre, en outre, des globules rouges fixés. On peut ajouter à la solution d'autres matériaux, tels qu'un désinfectant. L'invention se rapporte également à un procédé de préparation de la solution témoin de glucose liquide par mélange des constituants nécessaires.
PCT/US1993/003799 1992-04-24 1993-04-21 Solution temoin de glucose liquide et procede de preparation WO1993021928A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US87429992A 1992-04-24 1992-04-24
US07/874,299 1992-04-24

Publications (1)

Publication Number Publication Date
WO1993021928A1 true WO1993021928A1 (fr) 1993-11-11

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PCT/US1993/003799 WO1993021928A1 (fr) 1992-04-24 1993-04-21 Solution temoin de glucose liquide et procede de preparation

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Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0730735A1 (fr) * 1993-11-12 1996-09-11 Boehringer Mannheim Corporation Preparation d'etalonnage et de controle pour bandelettes d'essai pour la determination du glucose
US5858699A (en) * 1994-04-05 1999-01-12 Northern General Hospital Nhs Trust Method to stabilize cell suspensions using aged heavy metal solution and paraformaldehyde
US6197540B1 (en) 1993-07-05 2001-03-06 Northern General Hospital N.H.S. Trust Preparation and stabilization of cells using aged transition metal solutions
WO2006061607A1 (fr) * 2004-12-07 2006-06-15 Honeywell Analytics Ag Procede et systeme de detection de gaz
EP2002841A1 (fr) * 2006-03-23 2008-12-17 Senju Pharmaceutical Co., Ltd. Composition ophtalmique comprenant de la gomme de xanthane et du glucose
US7504020B2 (en) 2002-10-31 2009-03-17 Panasonic Corporation Determination method for automatically identifying analyte liquid and standard solution for biosensor
EP2267150A1 (fr) 2005-04-08 2010-12-29 Bayer Healthcare LLC Composé oxydable servant de référence interne d'une solution de contrôle pour biocapteurs
US8102517B2 (en) 2004-12-13 2012-01-24 Bayer Healthcare, Llc Method of differentiating between blood and control solutions containing a common analyte
US8337691B2 (en) 2007-12-10 2012-12-25 Bayer Healthcare Llc Control markers for auto-detection of control solution and method of use
US8696880B2 (en) 2004-02-06 2014-04-15 Bayer Healthcare Llc Oxidizable species as an internal reference for biosensors and method of use
EP3483598A1 (fr) 2005-09-30 2019-05-15 Ascensia Diabetes Care Holdings AG Voltampérométrie commandée

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3920580A (en) * 1973-07-12 1975-11-18 Miles Lab Liquid control solution
US4572899A (en) * 1982-07-07 1986-02-25 Biotest-Serum-Institut Gmbh Aqueous solution for suspending and storing cells, especially erthrocytes
US4729959A (en) * 1986-02-24 1988-03-08 Streck Laboratories, Inc. Glucose reference control for glucose test strips
US5028542A (en) * 1990-02-07 1991-07-02 Boehringer Mannheim Corporation Glucose measurement control reagent and method of making the same

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3920580A (en) * 1973-07-12 1975-11-18 Miles Lab Liquid control solution
US4572899A (en) * 1982-07-07 1986-02-25 Biotest-Serum-Institut Gmbh Aqueous solution for suspending and storing cells, especially erthrocytes
US4729959A (en) * 1986-02-24 1988-03-08 Streck Laboratories, Inc. Glucose reference control for glucose test strips
US5028542A (en) * 1990-02-07 1991-07-02 Boehringer Mannheim Corporation Glucose measurement control reagent and method of making the same

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
CHEMICAL ABSTRACTS, Vol. 113, issued 1990, HARADA et al., "Electron Microscopic Studies on Molecular Association in Gels of Curdlan and Other Polysaccharides in Food", see page 592, Abstract No. 189906r; & KOBE JOSHI DAIGAKU KIYO, 23(2):137-153. *
G.O. PHILLIPS et al., "Gums and Stabilisers for the Food Industry 4", published 1987, by IRL PRESS (WASH. D.C.), pages 363-369. *

Cited By (30)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6197540B1 (en) 1993-07-05 2001-03-06 Northern General Hospital N.H.S. Trust Preparation and stabilization of cells using aged transition metal solutions
US6197539B1 (en) * 1993-07-05 2001-03-06 Northern General Hospital N.H.S. Trust Method for preparing a stabilized blood cell preparation using aged transition metal ion solution
EP0730735A4 (fr) * 1993-11-12 2001-02-07 Roche Diagnostics Corp Preparation d'etalonnage et de controle pour bandelettes d'essai pour la determination du glucose
EP0730735A1 (fr) * 1993-11-12 1996-09-11 Boehringer Mannheim Corporation Preparation d'etalonnage et de controle pour bandelettes d'essai pour la determination du glucose
US5858699A (en) * 1994-04-05 1999-01-12 Northern General Hospital Nhs Trust Method to stabilize cell suspensions using aged heavy metal solution and paraformaldehyde
US7504020B2 (en) 2002-10-31 2009-03-17 Panasonic Corporation Determination method for automatically identifying analyte liquid and standard solution for biosensor
US10067082B2 (en) 2004-02-06 2018-09-04 Ascensia Diabetes Care Holdings Ag Biosensor for determining an analyte concentration
US9410917B2 (en) 2004-02-06 2016-08-09 Ascensia Diabetes Care Holdings Ag Method of using a biosensor
US8696880B2 (en) 2004-02-06 2014-04-15 Bayer Healthcare Llc Oxidizable species as an internal reference for biosensors and method of use
US7981364B2 (en) 2004-12-07 2011-07-19 Honeywell Analytics Ag Gas detection method and system
WO2006061607A1 (fr) * 2004-12-07 2006-06-15 Honeywell Analytics Ag Procede et systeme de detection de gaz
US8102517B2 (en) 2004-12-13 2012-01-24 Bayer Healthcare, Llc Method of differentiating between blood and control solutions containing a common analyte
US8416398B2 (en) 2004-12-13 2013-04-09 Bayer Healthcare, Llc Method of differentiating between blood and control solutions containing a common analyte
US8681324B2 (en) 2004-12-13 2014-03-25 Bayer Healthcare, Llc Method of differentiating between blood and control solutions containing a common analyte
US8702926B2 (en) 2005-04-08 2014-04-22 Bayer Healthcare Llc Oxidizable species as an internal reference in control solutions for biosensors
US9244078B2 (en) 2005-04-08 2016-01-26 Bayer Healthcare Llc Oxidizable species as an internal reference in control solutions for biosensors
US9766198B2 (en) 2005-04-08 2017-09-19 Ascensia Diabetes Care Holdings Ag Oxidizable species as an internal reference in control solutions for biosensors
US8002965B2 (en) 2005-04-08 2011-08-23 Bayer Healthcare Llc Oxidizable species as an internal reference in control solutions for biosensors
EP2267150A1 (fr) 2005-04-08 2010-12-29 Bayer Healthcare LLC Composé oxydable servant de référence interne d'une solution de contrôle pour biocapteurs
EP3483598A1 (fr) 2005-09-30 2019-05-15 Ascensia Diabetes Care Holdings AG Voltampérométrie commandée
EP2002841A4 (fr) * 2006-03-23 2009-04-15 Senju Pharma Co Composition ophtalmique comprenant de la gomme de xanthane et du glucose
CN101405009B (zh) * 2006-03-23 2011-04-13 千寿制药株式会社 包含黄原胶和葡萄糖的眼科组合物
JP5244584B2 (ja) * 2006-03-23 2013-07-24 千寿製薬株式会社 キサンタンガムおよびブドウ糖を含有する眼科用組成物
EP2002841A1 (fr) * 2006-03-23 2008-12-17 Senju Pharmaceutical Co., Ltd. Composition ophtalmique comprenant de la gomme de xanthane et du glucose
US7875271B2 (en) 2006-03-23 2011-01-25 Senju Pharmaceutical Co., Ltd. Ophthalmic composition comprising xanthan gum and glucose
US8716024B2 (en) 2007-12-10 2014-05-06 Bayer Healthcare Llc Control solution for use in testing an electrochemical system
US8871517B2 (en) 2007-12-10 2014-10-28 Bayer Healthcare Llc Method of using a control solution and preparing for testing using the same
US8337691B2 (en) 2007-12-10 2012-12-25 Bayer Healthcare Llc Control markers for auto-detection of control solution and method of use
US9933385B2 (en) 2007-12-10 2018-04-03 Ascensia Diabetes Care Holdings Ag Method of using an electrochemical test sensor
US10690614B2 (en) 2007-12-10 2020-06-23 Ascensia Diabetes Care Holdings Ag Method of using an electrochemical test sensor

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