US3920580A - Liquid control solution - Google Patents

Liquid control solution Download PDF

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US3920580A
US3920580A US378687A US37868773A US3920580A US 3920580 A US3920580 A US 3920580A US 378687 A US378687 A US 378687A US 37868773 A US37868773 A US 37868773A US 3920580 A US3920580 A US 3920580A
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solution
glucose
control solution
antidiffusing
agent
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US378687A
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Raymond L Mast
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Bayer Corp
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Miles Laboratories Inc
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Priority to CA195,748A priority patent/CA1009934A/en
Priority to GB3040674A priority patent/GB1466682A/en
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    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/54—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving glucose or galactose
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S435/00—Chemistry: molecular biology and microbiology
    • Y10S435/803—Physical recovery methods, e.g. chromatography, grinding
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00—Chemistry: analytical and immunological testing
    • Y10T436/10—Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
    • Y10T436/104998—Glucose, ketone, nitrate standard or control
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00—Chemistry: analytical and immunological testing
    • Y10T436/10—Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
    • Y10T436/105831—Protein or peptide standard or control [e.g., hemoglobin, etc.]
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00—Chemistry: analytical and immunological testing
    • Y10T436/10—Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
    • Y10T436/108331—Preservative, buffer, anticoagulant or diluent

Definitions

  • ABSTRACT [51] Int. Cl. C09K 3/00; G01N 31/00
  • the control solution comprising water, an antidiffusing agent and glu- [56] References Cited cose.
  • the antidiffusing agent may be selected from UNITED STATES PATENTS materials such as polyvinylpyrrolidone, polyvinyl alco- 3,050,373 8/1962 Collins 252/408 Polyethylene glycol dfixtran and f serum 3,104,209 9/1963 252,408 bumln.
  • This invention relates to a stable liquid control solution for use in establishing the validity of dry reagent strips which strips are for determining whether or not glucose is present in blood or serum. More specifically, this invention relates to a stable control solution including a predetermined amount of glucose which solution emulates whole blood or blood serum when applied to a reagent strip for glucose.
  • reagent strips are widely used for detecting specific materials in solutions. Such strips have become popular because of the accuracy and convenience thereof and the rapid production of results thereby. It is also known that data generated by these strips are highly reproducible if the strips have been properly prepared, stored and handled.
  • An example of such a reagent strip for determining glucose in blood is sold under the trademark DEXTROSTIX by Ames Company Division, Miles Laboratories, Inc.
  • This invention is embodied in a stable liquid control solution including a predetermined amount of glucose for use with dry reagent glucose indicating strips.
  • the solution comprises water, an antidiffusing agent, and a predetermined quantity of glucose.
  • Another object of this invention is to provide a control solution for evaluating the technique of a user of such a strip.
  • a further object of this invention is to provide a control solution that is stable for an extended period of I 2 time at normal room temperatures which solution emulates the behavior of whole blood or serum when used with a dry reagent strip.
  • a control solution suitable for use with dry reagent glucose indicating strips with a high degree of reproducibility in test results may be formed by including in an aqueous solution of glucose an antidiffusing agent. With the incor poration of such an agent in this solution, results are obtained with reagent strips which are substantially identical to or proportional to the results observed when whole blood or serum having similar quantities of glucose is evaluated. Although the mechanism of action of this antidiffusing agent is not fully understood, it is believed that it modifies the viscosity and the osmotic pressure of the control solution so as to avoid the adverse effects previously mentioned for an aqueous glucose solution.
  • control solution includes between about 3 and 35% of antidiffusing agent and preferably between about 20 and 30% thereof.
  • the D-glucose included in the control solution is preferably a high grade glucose such that an accurate weight percent thereof in the control solution may be determined. It is understood in this application that D- glucose and dextrose are considered equivalent materials and may be substituted one for the other without altering the novel control solution of this invention. Although the amount of glucose in the solution is not considered critical, within the solubility limit of the solution, it is preferable to include between about 1-1000 mg (mg/ ml solution) therein.
  • control solution common salts such as, for example, alkali metal salts of halogens, a phosphate or a sulfate.
  • Preferred salts include sodium chloride, potassium chloride, potassium phosphate and the like. It is believed that such salts further adjust the osmotic pressure of this control solution so that it more closely emulates whole blood or serum. Satisfactory control solutions are obtainable with between about 0 and 25% salt therein, and preferably between about 1 and 4% salt is included in the solution.
  • a preservative so as to avoid microbial growth therein.
  • Such preservative may be selected from the numerous materials which are known to have this property. Representative compositions for this function include benzoic acid, sodium benzoate, dichlorophene, hexachlorophene, quaternary ammonium compounds, sorbic acid, phosphoric acid and esters of p-hydroxybenzoic acid.
  • the preservative may be included in an amount corresponding to accepted levels, such as, between about 0.01 and 0.3%.
  • the procedure of this example was substantially the 3 EXAMPLE 6 same as that of Example 1 except that the following ingredients were combined with the dextrose and the water to form the five dextrose solutions.
  • Material Weight 40 Polyvinylpyrrolidone 13.34 gm. Material Weight Bovine Serum albumin, fraction V 3.33 gm. Sodium Chloride 2.67 gm. Benzoic Acid 0.2 gm. Benzoic Acid 0.2 gm. Dextran 25 gm.
  • a stable liquid control solution including a predeweigh termined amount of glucose for use in determining the Benzoic Acid 0.2 gm. validity of a dry reagent strip capable of indicating Egg??? ifg f g Lake 8- amounts of glucose in blood or blood serum which so- FD&C Red Zn Aluminum Lake 1 gm: lution emulates whole blood or blood serum used with said strip, the solution comprising water, glucose, a preservative, and between about 3 and 35 percent by The solutions of this Example had a color appearance weight of an antidiffusing agent selected from the substantially the same as whole blood. When applied to group consisting of polyvinylpyrrolidone, polyvinyl al- DEXTROSTIX according to the procedure of Example cohol, polyethylene glycol, dextran and bovine serum 1, correct color changes were observed. albumin.

Abstract

A stable liquid control solution useful with dry reagent strips which strips are for determining whether or not glucose is present in blood or serum. The control solution comprising water, an antidiffusing agent and glucose. The antidiffusing agent may be selected from materials such as polyvinylpyrrolidone, polyvinyl alcohol, polyethylene glycol, dextran and bovine serum albumin. The control solution may also include adjuvants such as preservatives, common salts, dyes, colored latex particles, etc.

Description

nlted States Patent 1191 [111 3,920,580
Mast Nov. 18, 1975 1 LIQUID CONTROL SOLUTION 3,753,863 8/1973 Speck 195/1035 c 3,753,925 8/1973 Louderback et a1 1. 252/408 [75] Inventor' Raymmd Mast Elkhart 3,814,668 6/1974 Blake et a1. 195/1035 c [73] Ass1gnee: ages Laboratories, Inc'., Elkhart, FOREIGN PATENTS OR APPLICATIONS I 867,192 5/1961 United Kingdom 252/408 [22] Flledi July 12, 1973 880,526 10/1961 United Kingdom 252/408 [21] Appl. No.: 378,687
Primary Examiner-Benjamin R. Padgett Assistant E.\'aminerT. S. Gron [52] US. Cl. 252/408; 23/230 B; 23/230 M; 23/253 TP; 195/1035 C; 424/2; 424/78;
424/80; 424/101 1571 ABSTRACT [51] Int. Cl. C09K 3/00; G01N 31/00 A stable liquid control solution useful with dry reagent 1 Field of Search 23/230 230 strips which strips are for determining whether or not 3/2 195/10 C; 0, 78 glucose is present in blood or serum. The control solution comprising water, an antidiffusing agent and glu- [56] References Cited cose. The antidiffusing agent may be selected from UNITED STATES PATENTS materials such as polyvinylpyrrolidone, polyvinyl alco- 3,050,373 8/1962 Collins 252/408 Polyethylene glycol dfixtran and f serum 3,104,209 9/1963 252,408 bumln. The control solutlon may also include ad u- 3,546,131 12/1970 Stern et a1. 252/408 vants Such as preservatlves, Common Salts, y ol- 3,558,522 l/1971 Louderback et a1....... 23/230 B ored latex particles, etc. 3,598,704 8/1971 Dahlqvist 23/230 B 3,630,958 12 197 7 Claims, No Drawings Free et a1 252/408 LIQUID CONTROL SOLUTION BACKGROUND OF THE INVENTION This invention relates to a stable liquid control solution for use in establishing the validity of dry reagent strips which strips are for determining whether or not glucose is present in blood or serum. More specifically, this invention relates to a stable control solution including a predetermined amount of glucose which solution emulates whole blood or blood serum when applied to a reagent strip for glucose.
It is recognized that reagent strips are widely used for detecting specific materials in solutions. Such strips have become popular because of the accuracy and convenience thereof and the rapid production of results thereby. It is also known that data generated by these strips are highly reproducible if the strips have been properly prepared, stored and handled. An example of such a reagent strip for determining glucose in blood is sold under the trademark DEXTROSTIX by Ames Company Division, Miles Laboratories, Inc.
Recently machines have been available that read such strips. Some of these machines are even capable of giving quantitative amounts of the unknown materialin the solution being tested. With such accuracy, it is important that the reagent strips function properly. Further, although these machines yield accurate determinations with properly prepared, stored and handled strips, they cannot readily detect faulty strips as can a human counterpart. One such machine is the Ames Reflectance Meter available from Ames Company Division, Miles Laboratories, Inc.
To insure the proper reactivity and to establish the validity of such test devices, it has been desirable to have available a control solution. Although the ideal control would be a whole blood solution for which these test devices are primarily designed, this material is unsuitable because of its instability when stored, glycolysis of glucose in the whole blood, the inherent variability of blood from one individual to another and the critical storage conditions required for this material. Accordingly, whole blood has not been found suitable for use as a control for this test.
It has also been suggested that a simple aqueous solution of glucose be employed as a control solution. In practice, however, such solutions have not produced results consistent with the amount of glucose therein. Also, a noticeable lack of reproducibility has been observed when such solutions are used with dry reagent strips.
SUMMARY OF THE INVENTION This invention is embodied in a stable liquid control solution including a predetermined amount of glucose for use with dry reagent glucose indicating strips. The solution comprises water, an antidiffusing agent, and a predetermined quantity of glucose.
Accordingly, it is an object of this invention to provide a stable control solution for confirming the validity of a dip-and-read dry reagent strip of the type for determining an unknown glucose concentration in a solution.
Another object of this invention is to provide a control solution for evaluating the technique of a user of such a strip.
A further object of this invention is to provide a control solution that is stable for an extended period of I 2 time at normal room temperatures which solution emulates the behavior of whole blood or serum when used with a dry reagent strip.
DESCRIPTION OF THE PREFERRED EMBODIMENTS It has unexpectedly been found that a control solution suitable for use with dry reagent glucose indicating strips with a high degree of reproducibility in test results may be formed by including in an aqueous solution of glucose an antidiffusing agent. With the incor poration of such an agent in this solution, results are obtained with reagent strips which are substantially identical to or proportional to the results observed when whole blood or serum having similar quantities of glucose is evaluated. Although the mechanism of action of this antidiffusing agent is not fully understood, it is believed that it modifies the viscosity and the osmotic pressure of the control solution so as to avoid the adverse effects previously mentioned for an aqueous glucose solution. Such materials are readily soluble in water and have a medium or high molecular weight. Examples of such antidiffusing agents, which may be used singly or in combination, include polyvinylpyrroliclone, polyvinyl alcohol, polyethylene glycol, dextran and bovine serum albumin. Beneficially, the control solution includes between about 3 and 35% of antidiffusing agent and preferably between about 20 and 30% thereof.
The D-glucose included in the control solution is preferably a high grade glucose such that an accurate weight percent thereof in the control solution may be determined. It is understood in this application that D- glucose and dextrose are considered equivalent materials and may be substituted one for the other without altering the novel control solution of this invention. Although the amount of glucose in the solution is not considered critical, within the solubility limit of the solution, it is preferable to include between about 1-1000 mg (mg/ ml solution) therein.
It has been found advantageous, although not essential, to include in this control solution common salts such as, for example, alkali metal salts of halogens, a phosphate or a sulfate. Preferred salts include sodium chloride, potassium chloride, potassium phosphate and the like. It is believed that such salts further adjust the osmotic pressure of this control solution so that it more closely emulates whole blood or serum. Satisfactory control solutions are obtainable with between about 0 and 25% salt therein, and preferably between about 1 and 4% salt is included in the solution.
It is benefical to include in the novel control solution of this invention a preservative so as to avoid microbial growth therein. Such preservative may be selected from the numerous materials which are known to have this property. Representative compositions for this function include benzoic acid, sodium benzoate, dichlorophene, hexachlorophene, quaternary ammonium compounds, sorbic acid, phosphoric acid and esters of p-hydroxybenzoic acid. The preservative may be included in an amount corresponding to accepted levels, such as, between about 0.01 and 0.3%.
Further adjuvants may be added to the solution to obtain a particular color or physical appearance. A red blood color may be obtained by incorporating therewith a red, water insoluble lake dye. Other water insoluble or water soluble dyes producing desired colors may be included therein. Further, a blood appearance ma be enhanced b the addition of inert colored latex particles thereto. y EXAMPLE 4 The novel liquid control solution of this invention The procedure of this example was substantially the and the preparation thereof will be further described in same as that of Example 1 except that the following inthe following examples which set forth specific embodi- 5 gredients were combined with the dextrose and the ments of this invention which are only representative water to form the five dextrose solutions. thereof and do not limit the scope or use of this invention in any way.
Material Weight EXAMPLE 1 Benzo ic Acid 0.2 gm. Astable liquid control solution was prepared by disgg fisg ifgl g z Lake 8 :2: solving in 88 ml. of water at a temperature of about FDSLC Red No 40 Aluminum Lake (H75 gm 100C. 0.2 gm. benzoic acid, 30 gm. of polyvinylpyrrol- Sodium Chloride 2.25 idone and 45 mg. of anhydrousdextrose. Upon dissolution of these ingredients in the warm water, water was added to bring the solution to a volume of 100 ml. This These Solutions had ntially the me pp rprocedure was further used to prepare four more soluance and reactivity as the) SOhItiOnS f Ex mpl tziggs having glucose concentration of 90, 130, 175 and EXAMPLE 5 mg. Upon cooling, these solutlons had a clear appearance and were free of reci it nt The procedure of this example was substantially the With clean eye droppers, a large drop of each msame as that of Example 1 except that the following intion was applied to separate reagent areas respectively g ed e s Were omb ned t the dextrose nd the of glucose indicating reagent strips (DEXTROSTIX). Water to form the five dextrose Solutions- After 60 seconds, each drop was washed from the surface of the reagent strip with water and the amount of glucose therein determined by comparing the color of the reagent strip with a color block calibrated therefor. Benzoic Acid 0.2 gm. it was observed that the colors of the reagent strips inffafifg'x i gfzi dicated 45, 90, 130, 175 and 250 mgs. glucose per 100 ml. blood respectively corresponding to the amount of glucose incorporated in each control solution.
Material Weight These solutions had substantially the same appear- EXAMPLE 2 ance and reactivity as the solutions of Example 1.
The procedure of this example was substantially the 3 EXAMPLE 6 same as that of Example 1 except that the following ingredients were combined with the dextrose and the water to form the five dextrose solutions.
The procedure of this example was substantially the same as that of Example 1 except that the following ingredients were combined with the dextrose and the water to form the five dextrose solutions.
Material Weight 40 Polyvinylpyrrolidone 13.34 gm. Material Weight Bovine Serum albumin, fraction V 3.33 gm. Sodium Chloride 2.67 gm. Benzoic Acid 0.2 gm. Benzoic Acid 0.2 gm. Dextran 25 gm.
These solutions had an appearance substantially the These solutions had substantially the same appearsame as the solutions prepared in Example 1 and were ance and reactivity as the solutions of Example 1. observed to develop a proper color change when ap- Based on accelerated stability evaluations, it has plied to DEXTROSTIX. been concluded that the unique liquid control solution of this invention is stable for at least 5 years at about EXAMPLE 3 room temperature if properly stored in a closed con- The procedure of this Example was substantially the tainer. With such stability and reproducible results with same as that of Example 1 except that the following inreagent strips, a stable liquid control solution is progredients were combined with the dextrose and the vided which meets the criteria desired for such a conwater to form the five dextrose solutions. trol solution but which were previously unobtainable.
What is claimed is: 1. A stable liquid control solution including a predeweigh termined amount of glucose for use in determining the Benzoic Acid 0.2 gm. validity of a dry reagent strip capable of indicating Egg??? ifg f g Lake 8- amounts of glucose in blood or blood serum which so- FD&C Red Zn Aluminum Lake 1 gm: lution emulates whole blood or blood serum used with said strip, the solution comprising water, glucose, a preservative, and between about 3 and 35 percent by The solutions of this Example had a color appearance weight of an antidiffusing agent selected from the substantially the same as whole blood. When applied to group consisting of polyvinylpyrrolidone, polyvinyl al- DEXTROSTIX according to the procedure of Example cohol, polyethylene glycol, dextran and bovine serum 1, correct color changes were observed. albumin.
is present in an amountbetween about 0.01 and 0.3
percent by weight.
6. The solution of claim 1 which additionally includes a common salt.
7. The solution according to claim 6 in which said common salt is sodium chloride.

Claims (7)

1. A STABLE LIQUID CONTROL SOLUTION INCLUDING A PREDETERMINED AMOUNT OF GLUCOSE FOR USE IN DETERMINING THE VALIDITY OF A DRY REAGENT STRIP CAPABLE OF INDICATING AMOUNTS OF GLUCOSE IN BLOOD OR BLOOD SERUM WHICH SOLUTION EMULATES WHOLE BODY OR BLOOD SERUM USED WITH SAID STRIP, THE SOLUTION COMPRISING WATER, GLUCOSE, A PRESERVATIVE AND BETWEEN ABOUT 3 AND 35 PERCENT BY WEIGHT OF AN ANTIDIFFUSING AGENT SELECTED FROM THE GROUP CONSISTING OF POLYVINYLPYRROLIDONE, POLYVINYL ALCOHOL, POLYETHYLENE GLYCOL DEXTRAN AND BOVINE SERUM ALBUMIN.
2. The solution of claim 1 in which said antidiffusing agent is polyvinylpyrrolidone.
3. The solution of claim 1 in which said antidiffusing agent is polyethylene glycol.
4. The solution of claim 1 in which said antidiffusing agent is dextran.
5. The solution of claim 1 in which said preservative is present in an amount between about 0.01 and 0.3 percent by weight.
6. The solution of claim 1 which additionally includes a common salt.
7. The solution according to claim 6 in which said common salt is sodium chloride.
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