CN110726842B - Glucose quality control liquid - Google Patents

Glucose quality control liquid Download PDF

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Publication number
CN110726842B
CN110726842B CN201810786597.5A CN201810786597A CN110726842B CN 110726842 B CN110726842 B CN 110726842B CN 201810786597 A CN201810786597 A CN 201810786597A CN 110726842 B CN110726842 B CN 110726842B
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quality control
solution
addition amount
control liquid
glucose
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CN110726842A (en
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刘峻
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Shanghai Hanlian Diagnostic Technology Co ltd
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Shanghai Hanlian Diagnostic Technology Co ltd
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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/66Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood sugars, e.g. galactose

Abstract

The glucose quality control liquid provided by the invention comprises the following components: potassium dihydrogen phosphate, disodium hydrogen phosphate dihydrate, potassium chloride, sodium nitrate, disodium edentate dihydrate, triton x-100, parmetol k40, and distilled or purified water as solvents. The glucose quality control liquid provided by the invention can be used for quality control of POCT blood glucose meters of various brands, can meet the requirements of clinical indoor and indoor quality control application, and simultaneously saves the use cost of the total reagent.

Description

Glucose quality control liquid
Technical Field
The invention relates to the field of medical instrument in-vitro diagnostic reagents.
Background
The main components of the glucose quality control liquid are phosphate diluent and beta-D (+) anhydrous glucose. Among them, phosphates are one of the most widely used buffers in biochemical studies, and since they are secondary dissociations, have two pKa values, buffers formulated with them have the widest pH range. beta-D (+) anhydrous dextrose is a purified, crystallized D-glucose anhydrous or contains a molecule of water of crystallization. White odorless crystalline particles or crystalline powder. Is easily soluble in water, very easily soluble in boiling water and slightly soluble in ethanol. The storage condition is 2-8 ℃. D-glucose changes its optical rotation with time when dissolved in water, gradually approaching +57.2°. This is because the solution at this time forms a stable system containing 1/3 of alpha-D-glucose and 2/3 of beta-D-glucose.
The glucose quality control liquid of the commercial glucometer generally adopts a solvent as water for injection, the pH value of the water for injection is 5.0-7.0, the conductivity is 1.3us/cm, the quality control liquid produced by the method has more adverse reactions clinically and poor stability due to the larger conductivity, the technical index pH value of water quality used by the quality control liquid prepared by us is 6.0-7.0, the water quality is more neutral, the conductivity is 0.65us/cm, and the quality of the quality control liquid is prevented from being influenced by microorganisms. Meanwhile, after the commercial quality control product is opened, the commercial quality control product can be stored at a certain temperature for 8 hours or 7 days, wherein the Langdao quality control product can be stored for a long time when being frozen at the temperature of minus 20 ℃, but the use of the commercial quality control product is more complicated for users. The diluent used in the quality control liquid prepared by the method contains Parmetol K40, so that the long-term stability of the quality control liquid is ensured, the quality control liquid is stored in a sealed manner at 2-8 ℃ for 9 months, the quality control liquid can be stored for one month after being used for bottle opening at 2-8 ℃, the quality control liquid is longer than the bottle opening valid period of the common quality control liquid, and the blood test result on an instrument is quite optimistic.
The technical indexes of the glucose quality control liquid used as an in-vitro diagnostic reagent mainly relate to accuracy and precision, and according to the related technology, the quality control liquid with the accuracy within the range of +/-11 wt% and the precision CV less than or equal to 8.00wt% is found to be suitable for POCT blood glucose analyzers of various styles on the market, and the test effect is superior to that of the reagents matched with some blood glucose meters.
Disclosure of Invention
The glucose quality control liquid provided by the invention comprises the following components: the addition amount of potassium dihydrogen phosphate is 0.055wt%, the addition amount of disodium hydrogen phosphate dihydrate is 0.237-0.238 wt%, the addition amount of potassium chloride is 0.15wt%, the addition amount of sodium nitrate is 0.019-0.020 wt%, the addition amount of disodium edentate dihydrate is 0.038-0.040 wt%, the addition amount of TritonX-100 is 0.005-0.0055 wt%, and the addition amount of Parmetol K40 is 0.05-0.06 wt%, and distilled water is used as a solvent.
The phosphate diluent not only dilutes glucose to prepare the quality control liquid, but also dilutes blood through a large number of experiments, and the quality control liquid has optimal efficacy and blood dilutability under the concentration ratio.
The glucose quality control liquid provided by the invention can be used for quality control of POCT blood glucose meters of various brands, can meet the requirements of clinical indoor and indoor quality control application, and simultaneously saves the use cost of the total reagent.
Detailed Description
The technical scheme of the invention is further described by the following specific embodiments. It is to be understood that the specific embodiments described herein are merely illustrative of the invention and are not limiting thereof.
Preparation example
The stage object of the invention is as follows:
the first stage designs a phosphate diluent technical formula containing Parmetol K40 bactericide;
preparing a glucose quality control liquid level 1 (13.6 mmol/L glucose quality control liquid level 2) of 5.80mmol/L in the second stage;
the third stage establishes a mature process flow according to the formula;
and in the fourth stage, the accuracy test, the precision test, the repeated test and the clinical calibration consistency test are carried out by utilizing the blood glucose meter and other instruments, and the blood glucose meter is formally put into production.
The final purpose is as follows: a method for preparing a glucose control solution level 1 (13.6 mmol/L glucose control solution level 2) of 5.80mmol/L for blood glucose sample detection.
1. Additional conditions required for the solutions studied in the present invention are as follows:
1.1 analytical balance (0.0001 g)
1.2 magnetic stirrer;
1.3 digital temperature controller;
1.4pH meter;
1.5 conductivity meter;
1.6 beaker;
1.7 the pH and conductivity of the formulated phosphate diluent were measured as follows:
1.7.1 taking small amounts of phosphate diluent in a small 100ml beaker;
1.7.2 inserting the electrodes of the calibrated pH meter and conductivity meter into the solution sequentially;
1.7.3 pressing the "read" buttons of the pH meter and conductivity meter, respectively;
1.7.4 wait for 1min-2min, record the reading on the pH meter and the reading on the conductivity;
2. key technical key points are as follows:
2.1 the volume of solvent for dissolving the raw materials should be 60wt% of the target volume, so that the generation of foam can be avoided;
2.2 for the organic matters Parmetol K40 and TritonX-100, one is to play a role in sterilization and disinfection, and the other is to disperse cells in discrete blood samples, so that the device is convenient to detect, and simultaneously, the surface tension of the diluent is reduced so as to reduce the generation of bubbles, eliminate the interference of the bubbles on measurement, and the substance also has the function of sheath fluid; the adding sequence is adding TritonX-100 and then adding Parmetol K40;
2.3 preparing the quality control liquid, namely preparing a concentrated solution with a certain concentration, and then diluting to ensure the uniformity of the solution;
2.4, standing the prepared glucose quality control liquid;
2.5 the invention adopts a low-rotation-speed stirring dissolution method, and stirring is required to be carried out for 30min after preparation.
2.6Parmetol K40 content should be 0.05wt% -0.06 wt%, the stability of the prepared calibration solution is better, and the test result is more accurate;
2.7 the water quality is preferably three-stage distilled water or purified water and meets certain standards.
3. Glucose control level 1 (glucose control level 2) specific preparation method:
3.1 preparing a volume of phosphate diluent, wherein the phosphate diluent comprises: the addition amount of potassium dihydrogen phosphate is 0.055wt%, the addition amount of disodium hydrogen phosphate dihydrate is 0.237-0.238 wt%, the addition amount of potassium chloride is 0.15wt%, the addition amount of sodium nitrate is 0.019-0.020 wt%, the addition amount of disodium edentate dihydrate is 0.038-0.040 wt%, the addition amount of Triton X-100 is 0.005-0.0055 wt%, the addition amount of Parmetol K40 is 0.05-0.06 wt%, and distilled water meeting a certain standard is used as a solvent;
3.2 placing 3000ml of phosphate diluent in a 5000ml beaker, placing the beaker on a magnetic stirrer, and enabling a stirring rotor to rotate at a constant speed;
3.3 then slowly adding 52.3g of beta-D (+) anhydrous glucose into a 5000ml beaker, and placing the mixture on a magnetic stirrer to continuously stir for 30min;
3.4, after the chemicals such as the water and the like are completely dissolved, adding a phosphate diluent into a 5L beaker to fix the volume to 5L;
3.5 transferring 500ml of the mixed solution into another 5L beaker, then fixing the volume to 5L by using a phosphate diluent, placing the mixed solution on a magnetic stirrer, continuously stirring for 30min, and standing for 30min;
3.6, after being uniformly dissolved, obtaining a solution before filling, putting a cellulose acetate filter membrane of 0.22um soaked in triple distilled water into a filter, and filtering for three times, thus obtaining the required glucose quality control liquid level 1 of 5.80 mmol/L;
3.7, if the solution is clear and transparent, sampling and detecting, continuously making three batches, starting to test the accuracy, and if the solution has precipitation and turbidity phenomena, removing and re-preparing;
3.8, after the test is qualified, performing an on-machine verification test by using the glucose quality control liquid level 1 with the concentration of 5.80mmol/L
Citation: YYT 0456.1-2014 reagent for blood analyzer part 1: cleaning liquid; YYT 0456.3-2014 reagent for blood analyzer part 3: a diluent; ISO18113-2 part 2: in vitro diagnostic reagent for professional use; GBT 26124-2011 clinical chemistry in vitro diagnostic kit standard (GB) YYT 0701-2008 calibrator for blood cell analyzer GBT1.1-2009 standard working guide section 1: standard construction and writing (abstract)
Effect examples
Description of the content of each substance component
Inorganic salts outside the standard range of conductivity were added to comparative example 1, and the conductivity was 40.23ms/cm, outside the standard range of conductivity of 5.00 to 6.00 ms/cm.
In comparative example 2, an excessive amount of Triton X-100 was added, and the resulting foam was extremely difficult to eliminate and required to stand for more than 30 minutes.
The addition of excess Parmetol K40 in comparative example 3 resulted in poor solution stability and failure to achieve the expected shelf life.
The materials were added in the proportions described in example 1, with a conductivity of 5.3ms/cm, and the foam produced was very easy to eliminate within the specified conductivity standards. Example 2 also has excellent electrical conductivity.
Effect example 2
In comparative example 1, disodium hydrogen phosphate dihydrate was replaced with sodium hydroxide, wherein sodium hydroxide was widely used for pH adjustment of a solution, but the sodium hydroxide was exothermic when dissolved in the solution, and the ionization balance in the solution was easily broken, so that the pH did not reach the expected range.
In comparative example 2, potassium chloride was replaced with sodium chloride, wherein the physical properties and chemical properties of potassium chloride are similar to those of sodium chloride, but the solubility of potassium chloride is higher than that of sodium chloride, so that the potassium chloride is more suitable for industrial production, and the conductivity of the potassium chloride is lower than 5.00ms/cm.
The present invention is capable of other and further embodiments and its several details are capable of modification and variation in light of the present invention, as will be apparent to those skilled in the art, without departing from the spirit and scope of the invention as defined in the appended claims.
The foregoing is only illustrative of the present invention and is not to be construed as limiting thereof, but rather as various modifications, equivalent arrangements, improvements, etc., within the spirit and principles of the present invention.

Claims (1)

1. The preparation method of the glucose quality control liquid is characterized by comprising the following steps:
1) Preparing a volume of phosphate diluent, wherein the phosphate diluent comprises: the addition amount of potassium dihydrogen phosphate is 0.055wt%, the addition amount of disodium hydrogen phosphate dihydrate is 0.237wt% to 0.238wt%, the addition amount of potassium chloride is 0.15wt%, the addition amount of sodium nitrate is 0.019wt% to 0.020wt%, the addition amount of disodium edentate dihydrate is 0.038wt% to 0.040wt%, the addition amount of TritonX-100 is 0.005wt% to 0.0055wt%, the addition amount of Parmetol K40 is 0.05wt% to 0.06wt%, and distilled water is used as a solvent;
2) Placing 3000ml of phosphate diluent in a 5000ml beaker, placing the beaker on a magnetic stirrer, and enabling a stirring rotor to rotate at a constant speed;
3) Then, 52.3g of beta-D (+) anhydrous glucose is slowly added into a 5000ml beaker, and the mixture is placed on a magnetic stirrer to be continuously stirred for 30min;
4) After the chemicals are completely dissolved, adding a phosphate diluent into a 5L beaker to fix the volume to 5L;
5) Transferring 500ml of the mixed solution into another 5L beaker, then fixing the volume to 5L by using a phosphate diluent, putting the mixed solution on a magnetic stirrer, continuously stirring for 30min, and standing for 30min;
6) After being dissolved uniformly, the solution before filling is obtained, a cellulose acetate filter membrane of 0.22um soaked in triple distilled water is put into a filter, and the solution is filtered for three times, namely the required glucose quality control liquid level 1 of 5.80 mmol/L;
7) If the solution is clear and transparent, sampling and detecting, continuously making three batches, starting to test the accuracy of the solution, and if the solution has precipitation and turbidity phenomena, removing the solution and preparing the solution again;
8) And after the test is qualified, performing an on-machine verification test by using the glucose quality control liquid level 1 with the concentration of 5.80 mmol/L.
CN201810786597.5A 2018-07-17 2018-07-17 Glucose quality control liquid Active CN110726842B (en)

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IN163297B (en) * 1981-12-23 1988-09-03 John Richard Baker
JP2000262299A (en) * 1999-03-17 2000-09-26 Kainosu:Kk Determination of glucose with glucose dehydrogenase and reagent for determining glucose
CN1329250A (en) * 2001-08-03 2002-01-02 长春市迪瑞检验制品有限责任公司 Quality control liquor for analysis of urine and its preparation method
CN204631039U (en) * 2015-04-27 2015-09-09 江西恒盛晶微技术有限公司 A kind of glucose monitoring biochip
CN106771112A (en) * 2016-12-27 2017-05-31 长春迪瑞医疗科技股份有限公司 A kind of multinomial compound quality control liquor for analysis of urine
CN108196058A (en) * 2018-01-02 2018-06-22 深圳市双平泰医疗科技有限公司 Blood glucose meter Quality Control detection method and system
CN109307769A (en) * 2017-07-28 2019-02-05 上海瀚联医疗技术股份有限公司 A kind of blood glucose solution allocation method for 12mmol/L

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IN163297B (en) * 1981-12-23 1988-09-03 John Richard Baker
JP2000262299A (en) * 1999-03-17 2000-09-26 Kainosu:Kk Determination of glucose with glucose dehydrogenase and reagent for determining glucose
CN1329250A (en) * 2001-08-03 2002-01-02 长春市迪瑞检验制品有限责任公司 Quality control liquor for analysis of urine and its preparation method
CN204631039U (en) * 2015-04-27 2015-09-09 江西恒盛晶微技术有限公司 A kind of glucose monitoring biochip
CN106771112A (en) * 2016-12-27 2017-05-31 长春迪瑞医疗科技股份有限公司 A kind of multinomial compound quality control liquor for analysis of urine
CN109307769A (en) * 2017-07-28 2019-02-05 上海瀚联医疗技术股份有限公司 A kind of blood glucose solution allocation method for 12mmol/L
CN108196058A (en) * 2018-01-02 2018-06-22 深圳市双平泰医疗科技有限公司 Blood glucose meter Quality Control detection method and system

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
3种便携式血糖检测仪的分析性能评价;纪昕;王鑫;岳晓乐;赵丹丹;张艳华;;检验医学与临床(第07期);全文 *
Evaluation of a glucose meter against analytical quality specifications for hospital use.;Singh Dhatt G;Agarwal M;Bishawi B;Clinica Chimica Acta;第343卷(第1/2期);全文 *
五种即时检验血糖仪的主要分析性能评价;郑松柏;张秀明;林莲英;孙蕾;马艳;罗燕玲;;检验医学(第05期);全文 *

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