CN114544734A - Reagent matched with electrolyte module of Beckmann AU series analyzer - Google Patents
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- G—PHYSICS
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- G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
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- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
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- G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
- G01N1/38—Diluting, dispersing or mixing samples
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- G—PHYSICS
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- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
- G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
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- G01N27/4166—Systems measuring a particular property of an electrolyte
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Abstract
The invention belongs to the technical field of potassium, sodium and chlorine detection in serum of a full-automatic biochemical analyzer, and relates to a matching reagent of an electrolyte module of a Beckmann AU series biochemical analyzer, which comprises a median standard solution, a buffer solution and a reference solution, wherein the main components of the median standard solution comprise sodium chloride, potassium chloride, a buffering agent and an antibacterial agent, and the main components of the buffer solution comprise the buffering agent and the antibacterial agent; the reference solution mainly comprises potassium chloride and an antibacterial agent; the reagent has low cost, and the precision, accuracy, linear range and stability of the measurement result have good correlation with the original imported reagent, so that the reagent can completely replace the original imported reagent, and the biological preservative replaces formaldehyde in the original reagent, so that the reagent is safer and more environment-friendly to use, and has higher clinical application value and industrial prospect.
Description
Technical Field
The invention relates to the field of in-vitro diagnostic reagents for medical instruments, in particular to a reagent matched with an electrolyte module of a Beckmann AU series analyzer.
Background
The full-automatic biochemical analyzer is one of important analyzers frequently used in clinical examination at present, measures a certain specific component in body fluid through a matched reagent according to a photoelectric colorimetric principle, performs comprehensive analysis by combining other clinical information, can quickly diagnose diseases, has the characteristics of multiple detection items, small reagent consumption, high sensitivity, high accuracy, small background interference, wide linear range, high detection speed, high automation degree and the like, and is widely applied to hospitals and physical examination centers at all levels. The electrolyte determination also plays an important role in clinical medicine, timely and accurate analysis of various ion activities in body fluid is an important content in clinical chemical examination projects, the Beckmann AU biochemical analyzer is the most advanced, stable and accurate centralized embodiment of clinical biochemical detection technology at home and abroad, and the analyzer is widely applied to markets at home and abroad at present.
The existing Beckmann AU biochemical analyzer has high occupancy rate in the domestic market, most of the matched detection reagents thereof adopt original-package imported reagents, and the purchase cost is high, so that the clinical examination cost is increased.
Disclosure of Invention
The invention aims to provide a reagent matched with an electrolyte module of a Beckmann AU series analyzer, so as to solve the problems in the background technology.
In order to achieve the purpose, the invention provides the following technical scheme: a reagent matched with an electrolyte module of a Beckmann AU series analyzer comprises a median standard solution, a buffer solution and a reference solution. The medium standard solution is used for calibrating the drift of electrode parameters, the buffer solution is used for diluting a sample in the detection process and maintaining the stability of the pH value of the detection environment, and the reference solution and the reference electrode are used together to form a bridge electrolyte in the reference electrode. The median standard solution comprises the following components in percentage by weight: 0.1-1 g/L of sodium chloride, 0.02-0.2 g/L of potassium chloride, 5-20 g/L of buffering agent and 0.2-1 g/L of antibacterial agent; the pH value of the median standard solution at 25 ℃ is 7.60-8.00, and the conductivity is 2.80-3.30 ms/cm;
the buffer solution comprises the following content components: 5-20 g/L of buffering agent and 0.2-1 g/L of antibacterial agent; the pH value of the buffer solution at 25 ℃ is 7.60-8.00, and the conductivity is 2.80-3.30 ms/cm;
the reference solution comprises the following components in percentage by weight: 74.5g/L of potassium chloride and 0.2-1 g/L of antibacterial agent; the conductivity of the reference solution is 127-129 ms/cm at 25 ℃.
Preferably, the buffer in the median standard solution and the buffer solution is selected from one or more of Tris, CAPS, MOPS, TAPS, MOPSO, HEPES, PIPES, ethanolamine, diethanolamine, triethanolamine, phosphoric acid, citric acid, oxalic acid and succinic acid.
Preferably, the antibacterial agent in the median standard solution, the buffer solution and the reference solution is selected from one or more of Proclin series biological preservatives and KroVin series biological preservatives.
Preferably, the median standard solution comprises the following components in percentage by weight: 0.2455g/L of sodium chloride, 0.0603g/L, Tris 9.6.6 g/L of potassium chloride and 2.2g/L, Proclin 3000.5g/L of boric acid; the pH value of the median standard solution is 7.83, and the conductivity is 3.25 ms/cm;
the buffer solution comprises the following content components: tris 9.6g/L, boric acid 2.2g/L, Proclin 3000.5 g/L; the pH value of the buffer solution is 7.86, and the conductivity is 3.05 ms/cm;
the reference solution comprises the following components in percentage by weight: 74.55g/L, Proclin 3000.5g/L potassium chloride; the conductivity was 127.5 ms/cm.
Preferably, the median standard solution comprises the following components in percentage by weight: 0.2423g/L of sodium chloride, 0.0594g/L, HEPES 8.7.7 g/L of potassium chloride, 2.6g/L of boric acid and 3000.5g/L of Proclin; the pH value of the median standard solution is 7.77, and the conductivity is 3.19 ms/cm;
the buffer solution comprises the following content components: HEPES 8.7g/L, boric acid 2.6g/L, Proclin 3000.5 g/L; the pH value of the buffer solution is 7.79, and the conductivity is 2.96 ms/cm;
the reference solution comprises the following components in percentage by weight: 74.55g/L, Proclin 3000.5g/L potassium chloride; the conductivity of the reference liquid was 127.6 ms/cm.
Preferably, the median standard solution comprises the following components in percentage by weight: 0.2477g/L of sodium chloride, 0.0628g/L of potassium chloride, 6.7g/L of ethanolamine and 2.8g/L, Proclin 3000.5g/L of boric acid; the pH value of the median standard solution is 7.89, and the conductivity is 3.20 ms/cm;
the buffer solution comprises the following content components: 6.7g/L of ethanolamine and 2.8g/L, Proclin 3000.5g/L of boric acid; the pH value of the buffer solution is 7.89, and the conductivity is 3.02 ms/cm;
the reference solution comprises the following components in percentage by weight: 74.55g/L, Proclin 3000.5g/L potassium chloride; the conductivity of the reference liquid was 127.5 ms/cm.
Compared with the prior art, the invention provides a reagent matched with an electrolyte module of a Beckmann AU series analyzer, which has the following beneficial effects:
the buffering agent in the reagent has the functions of maintaining the pH value of the detection environment and enhancing the stability of the detection result; the antibacterial agent adopts Proclin series and KroVin series biological preservatives, replaces formaldehyde in the original reagent, is good in chemical stability, can prolong the effective period of the antibacterial agent to 18 months, has no influence on the detection result, is far lower in toxicity than formaldehyde, and can avoid harm to human bodies and environment.
Detailed Description
Example 1: a matching reagent for an electrolyte module of a Beckmann AU series biochemical analyzer comprises the following components in percentage by weight: 0.2455g/L of sodium chloride, 0.0603g/L of potassium chloride, 9.6g/L of Tris, 2.2g/L of boric acid and 3000.5g/L of Proclin; the pH value is 7.83, and the conductivity is 3.25 ms/cm; the buffer solution comprises the following components in percentage by weight: 9.6g/L of Tris, 2.2g/L of boric acid and 3000.5g/L of Proclin; the pH value is 7.86, and the conductivity is 3.05 ms/cm; the reference solution comprises the following components in percentage by weight: 74.55g/L potassium chloride, 3000.5g/L Proclin; the conductivity was 127.5 ms/cm.
Example 2: a matching reagent of an electrolyte module of a Beckmann AU series biochemical analyzer comprises the following components in percentage by weight: 0.2423g/L of sodium chloride, 0.0594g/L of potassium chloride, 8.7g/L of HEPES, 2.6g/L of boric acid and 3000.5g/L of Proclin; the pH value is 7.77, and the conductivity is 3.19 ms/cm; the buffer solution comprises the following components in percentage by weight: HEPES 8.7g/L, boric acid 2.6g/L, Proclin 3000.5 g/L; the pH value is 7.79, and the conductivity is 2.96 ms/cm; the reference solution comprises the following components in percentage by weight: 74.55g/L potassium chloride, 3000.5g/L Proclin; the conductivity was 127.6 ms/cm.
Example 3: a matching reagent of an electrolyte module of a Beckmann AU series biochemical analyzer comprises the following components in percentage by weight: 0.2477g/L of sodium chloride, 0.0628g/L of potassium chloride, 6.7g/L of ethanolamine, 2.8g/L of boric acid and 3000.5g/L of Proclin; the pH value is 7.89, and the conductivity is 3.20 ms/cm; the buffer solution comprises the following components in percentage by weight: ethanolamine 6.7g/L, boric acid 2.8g/L and Proclin 3000.5 g/L; the pH value is 7.89, and the conductivity is 3.02 ms/cm; the reference solution comprises the following components in percentage by weight: 74.55g/L potassium chloride, 3000.5g/L Proclin; the conductivity was 127.5 ms/cm.
The above components were mixed, stirred, dissolved and fixed to volume to obtain the reagent kit for the electrolyte module of the beckmann AU series biochemical analyzer prepared in examples 1 to 3.
Compared with the performance test of the original Beckmann AU series electrolyte module reagent, the invention has the following advantages:
firstly, accuracy verification:
1. placing the median standard solution, the buffer solution and the reference solution prepared in the example 1 on corresponding positions of a Beckmann AU5800 biochemical analyzer for verification test, taking 30 patient sera for test, and comparing the correlation with the determination result of the original assembly kit reagent;
the results show that the detection results of the median standard solution, the buffer solution and the reference solution in the self-prepared example 1 have good correlation with the performance of the original reagent.
2. Placing the median standard solution, the buffer solution and the reference solution prepared in the example 2 on corresponding positions of a Beckmann AU5800 biochemical analyzer for verification test, taking 30 patient sera for test, and comparing the correlation with the determination result of the original assembly kit reagent;
| example 2 | Linear correlation equation | Coefficient of linear correlation r |
| Sodium ion | y＝1.0035x-1.3667 | 0.9988 |
| Potassium ion | y＝0.9996x+0.0954 | 0.9994 |
| Chloride ion | y＝0.9988x+1.1267 | 0.9985 |
The results show that the detection results of the median standard solution, the buffer solution and the reference solution in the self-prepared example 2 have good correlation with the performance of the original reagent.
3. Placing the median standard solution, the buffer solution and the reference solution prepared in the example 3 on corresponding positions of a Beckmann AU5800 biochemical analyzer for verification test, taking 30 patient sera for test, and comparing the correlation with the determination result of the original assembly kit reagent;
| example 3 | Linear correlation equation | Coefficient of linear correlation r |
| Sodium ion | y＝0.9995x-1.1221 | 0.9991 |
| Potassium ion | y＝1.0021x+0.0927 | 0.9990 |
| Chloride ion | y＝1.0124x+1.2387 | 0.9994 |
The results show that the detection results of the median standard solution, the buffer solution and the reference solution in the self-prepared example 3 have good correlation with the performance of the original reagent.
In summary, the electrolyte module kit reagents of examples 1 to 3 have good correlation with the original reagent detection results, which indicates that the self-prepared reagents can still complete the electrolyte determination on the beckmann AU series full-automatic biochemical analyzer based on the change of the formula, and the results are accurate.
Secondly, precision verification:
1. taking 1 part of normal serum, respectively using the self-prepared example 1 and the original matched reagent to repeatedly determine for 11 times, and comparing the precision of the determination result with the original matched reagent;
the results show that the precision of the median standard, buffer and reference solutions from the dispensing example 1 correlates well with the performance of the original reagent.
2. Taking 1 part of normal serum, respectively using the self-prepared example 2 and the original matched reagent to repeatedly determine for 11 times, and comparing the precision of the determination result with the original matched reagent;
the results show that the precision of the median standard, buffer and reference solutions from dispensing example 2 correlates well with the performance of the original reagent.
3. Taking 1 part of normal serum, respectively using the self-prepared example 3 and the original matched reagent to repeatedly determine for 11 times, and comparing the precision of the determination result with the original matched reagent;
the results show that the precision of the median standard, buffer and reference solutions from dispensing example 3 correlates well with the performance of the original reagent.
In summary, the precision of the reagent kit of the electrolyte module in examples 1 to 3 has a good correlation with the detection result of the original reagent, which indicates that the reagent kit of the electrolyte module can still complete the electrolyte determination on the beckmann AU series full-automatic biochemical analyzer with good precision on the basis of changing the formula.
Thirdly, verifying a linear range:
1. according to the linear range in the original reagent use instruction, low-value and high-value serum samples of 3 items of potassium ions, sodium ions and chloride ions are respectively taken, the low-value content is as low as possible, the high-value content reaches the upper limit of the linear range in the instruction, a group of mixed systems with the concentration from low to high are prepared in a combined mode, the determination is carried out by using the self-prepared example 1, each concentration is determined for 3 times, the average value of the results of 3 times is taken, and a linear regression equation and a correlation coefficient are calculated;
the results show that the linear ranges and correlation numbers of the median standard, buffer and reference solutions from the preparation example 1 meet the assay requirements.
2. According to the linear range in the original reagent use instruction, low-value and high-value serum samples of 3 items of potassium ions, sodium ions and chloride ions are respectively taken, the low-value content is as low as possible, the high-value content reaches the upper limit of the linear range in the instruction, a group of mixed systems with the concentration from low to high are prepared in a combined mode, the determination is carried out by using the self-prepared example 2, each concentration is determined for 3 times, the average value of the results of 3 times is taken, and a linear regression equation and a correlation coefficient are calculated;
the results show that the linear ranges and correlation numbers of the median standard, buffer and reference solutions from the preparation example 2 meet the assay requirements.
3. According to the linear range in the original reagent use instruction, low-value and high-value serum samples of 3 items of potassium ions, sodium ions and chloride ions are respectively taken, the low-value content is as low as possible, the high-value content reaches the upper limit of the linear range in the instruction, a group of mixed systems with the concentration from low to high are prepared in a combined mode, the self-prepared example 3 is used for determination, each concentration is determined for 3 times, the average value of the results of 3 times is taken, and a linear regression equation and a correlation coefficient are calculated;
the results show that the linear ranges and correlation numbers of the median standard, buffer and reference solutions from the preparation example 3 meet the assay requirements.
In summary, the linear range of the reagent matched with the electrolyte module in examples 1 to 3 has good correlation with the detection result of the original reagent, which indicates that the self-prepared reagent can still complete the electrolyte determination on the Beckmann AU series full-automatic biochemical analyzer with good linear range on the basis of changing the formula.
Fourthly, stability verification:
1. the pH value and the conductivity of the self-prepared examples 1 to 3 were measured at 25.0 ℃. + -. 0.1 ℃ after 18 months of storage at room temperature in a closed environment, and compared with those of the newly prepared examples 1 to 3, the results were as follows:
the median standard solution stability test result is as follows:
results of buffer stability test:
reference solution stability test results:
the results show that after the median standard solution, the buffer solution and the reference solution of the self-prepared examples 1-3 are stored in a temperature-sealed manner for 18 months, the pH value and the conductivity are not obviously changed, and no precipitation and turbidity are caused by visual inspection of the appearance.
2. After the self-prepared examples 1-3 are stored for 18 months under the sealing condition at room temperature, the accuracy, precision and linear range of the self-prepared examples are further determined, and the comparison results are as follows:
1) accuracy:
accuracy results of self-prepared example 1:
self-prepared example 2 accuracy results:
self-prepared example 3 accuracy results:
the results show that the correlation coefficient of the accuracy and the original reagent meets the determination requirements after the median standard solution, the buffer solution and the reference solution in the self-prepared example 1 are stored for 18 months in a sealing way at room temperature.
2) Precision:
precision results from formulation example 1:
precision results from formulation example 2:
precision results from formulation example 3:
the results show that the precision correlates well with the performance of the original reagent after 18 months of storage at room temperature in a closed environment from the median standard, buffer and reference of examples 1-3.
3) Linear range:
self-prepared example 1 linear range results:
self-prepared example 2 linear range results:
self-prepared example 3 linear range results:
the results show that the linear range correlates well with the performance of the original reagent after 18 months of storage at room temperature in a closed environment from the median standard, buffer and reference of examples 1-3.
To sum up: after the medium standard solution, the buffer solution and the reference solution in the embodiments 1 to 3 are prepared, and are stored in a closed manner at room temperature for 18 months, the pH value, the conductivity, the property, the accuracy, the precision and the linear range are not obviously changed, and the stability is good.
In the description of the present invention, the terms "first", "second", "another", and "yet" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implying any number of technical features indicated. Thus, features defined as "first" and "second" may explicitly or implicitly include one or more features. In the description of the embodiments of the present invention, "a plurality" means two or more unless specifically limited otherwise.
In the description of the present invention, it is to be noted that, unless otherwise explicitly specified or limited, the terms "connected" and "connected" are to be interpreted broadly, e.g., as being either fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; may be directly connected or indirectly connected through an intermediate. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art. In addition, in the description of the present invention, "a plurality" means two or more unless otherwise specified.
While embodiments of the invention have been shown and described, it will be understood by those skilled in the art that: various changes, modifications, substitutions and alterations can be made to the embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the claims and their equivalents.
Claims (6)
1. A reagent matched with an electrolyte module of a Beckmann AU series analyzer comprises a median standard solution, a buffer solution and a reference solution, and is characterized in that the median standard solution comprises the following components in percentage by weight: 0.1-1 g/L of sodium chloride, 0.02-0.2 g/L of potassium chloride, 5-20 g/L of buffering agent and 0.2-1 g/L of antibacterial agent; the pH value of the median standard solution at 25 ℃ is 7.60-8.00, and the conductivity is 2.80-3.30 ms/cm;
the buffer solution comprises the following content components: 5-20 g/L of buffering agent and 0.2-1 g/L of antibacterial agent; the pH value of the buffer solution at 25 ℃ is 7.60-8.00, and the conductivity is 2.80-3.30 ms/cm;
the reference solution comprises the following components in percentage by weight: 74.5g/L of potassium chloride and 0.2-1 g/L of antibacterial agent; the conductivity of the reference solution is 127-129 ms/cm at 25 ℃.
2. The reagent matched with the electrolyte module of the Beckman AU series analyzer according to claim 1, wherein the buffer in the median standard solution and the buffer solution is selected from one or more of Tris, CAPS, MOPS, TAPS, MOPSO, HEPES, PIPES, ethanolamine, diethanolamine, triethanolamine, phosphoric acid, citric acid, oxalic acid and succinic acid.
3. The reagent matched with the electrolyte module of the Beckmann AU series analyzer in claim 2, wherein the antibacterial agent in the median standard solution, the buffer solution and the reference solution is one or more of Proclin series biological preservatives and KroVin series biological preservatives.
4. The reagent matched with the electrolyte module of the Beckmann AU series analyzer in claim 3, wherein the median standard solution comprises the following components in percentage by weight: 0.2455g/L of sodium chloride, 0.0603g/L, Tris 9.6.6 g/L of potassium chloride and 2.2g/L, Proclin 3000.5g/L of boric acid; the pH value of the median standard solution is 7.83, and the conductivity is 3.25 ms/cm;
the buffer solution comprises the following content components: tris 9.6g/L, boric acid 2.2g/L, Proclin 3000.5 g/L; the pH value of the buffer solution is 7.86, and the conductivity is 3.05 ms/cm;
the reference solution comprises the following components in percentage by weight: 74.55g/L, Proclin 3000.5g/L potassium chloride; the conductivity was 127.5 ms/cm.
5. The reagent matched with the electrolyte module of the Beckmann AU series analyzer in claim 3, wherein the median standard solution comprises the following components in percentage by weight: 0.2423g/L of sodium chloride, 0.0594g/L, HEPES 8.7.7 g/L of potassium chloride, 2.6g/L of boric acid and 3000.5g/L of Proclin; the pH value of the median standard solution is 7.77, and the conductivity is 3.19 ms/cm;
the buffer solution comprises the following content components: HEPES 8.7g/L, boric acid 2.6g/L, Proclin 3000.5 g/L; the pH value of the buffer solution is 7.79, and the conductivity is 2.96 ms/cm;
the reference solution comprises the following components in percentage by weight: 74.55g/L, Proclin 3000.5g/L potassium chloride; the conductivity of the reference solution was 127.6 ms/cm.
6. The reagent matched with the electrolyte module of the Beckmann AU series analyzer according to claim 3, wherein the median standard solution comprises the following components in percentage by weight: 0.2477g/L of sodium chloride, 0.0628g/L of potassium chloride, 6.7g/L of ethanolamine and 2.8g/L, Proclin 3000.5g/L of boric acid; the pH value of the median standard solution is 7.89, and the conductivity is 3.20 ms/cm;
the buffer solution comprises the following content components: 6.7g/L of ethanolamine and 2.8g/L, Proclin 3000.5g/L of boric acid; the pH value of the buffer solution is 7.89, and the conductivity is 3.02 ms/cm;
the reference solution comprises the following components in percentage by weight: 74.55g/L, Proclin 3000.5g/L potassium chloride; the conductivity of the reference solution was 127.5 ms/cm.
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115165986A (en) * | 2022-06-02 | 2022-10-11 | 山东博科生物产业有限公司 | High-stability electrolyte analyzer matching reagent |
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