CN113267395A - Reagent for urine visible component analyzer and preparation method thereof - Google Patents
Reagent for urine visible component analyzer and preparation method thereof Download PDFInfo
- Publication number
- CN113267395A CN113267395A CN202110755651.1A CN202110755651A CN113267395A CN 113267395 A CN113267395 A CN 113267395A CN 202110755651 A CN202110755651 A CN 202110755651A CN 113267395 A CN113267395 A CN 113267395A
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- China
- Prior art keywords
- reagent
- visible component
- component analyzer
- urine
- ethylene glycol
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- 239000003153 chemical reaction reagent Substances 0.000 title claims abstract description 40
- 210000002700 urine Anatomy 0.000 title claims abstract description 31
- 238000002360 preparation method Methods 0.000 title claims abstract description 8
- 239000003085 diluting agent Substances 0.000 claims abstract description 11
- 239000012192 staining solution Substances 0.000 claims abstract description 6
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 claims description 22
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 16
- 238000004043 dyeing Methods 0.000 claims description 14
- QCDWFXQBSFUVSP-UHFFFAOYSA-N 2-phenoxyethanol Chemical compound OCCOC1=CC=CC=C1 QCDWFXQBSFUVSP-UHFFFAOYSA-N 0.000 claims description 8
- KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical compound OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 claims description 8
- 150000003242 quaternary ammonium salts Chemical class 0.000 claims description 8
- 239000011780 sodium chloride Substances 0.000 claims description 8
- 239000000243 solution Substances 0.000 claims description 8
- 238000001914 filtration Methods 0.000 claims description 6
- 239000012528 membrane Substances 0.000 claims description 6
- 239000007788 liquid Substances 0.000 claims description 5
- 239000003109 Disodium ethylene diamine tetraacetate Substances 0.000 claims description 3
- 235000019301 disodium ethylene diamine tetraacetate Nutrition 0.000 claims description 3
- 229960001484 edetic acid Drugs 0.000 claims description 3
- 230000002209 hydrophobic effect Effects 0.000 claims description 3
- 238000003756 stirring Methods 0.000 claims description 3
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 3
- WGCNASOHLSPBMP-UHFFFAOYSA-N hydroxyacetaldehyde Natural products OCC=O WGCNASOHLSPBMP-UHFFFAOYSA-N 0.000 claims description 2
- 238000007865 diluting Methods 0.000 claims 2
- 238000004519 manufacturing process Methods 0.000 claims 1
- 230000002485 urinary effect Effects 0.000 claims 1
- 238000001514 detection method Methods 0.000 abstract description 10
- 230000002349 favourable effect Effects 0.000 abstract 1
- 238000012360 testing method Methods 0.000 description 3
- 241000894006 Bacteria Species 0.000 description 2
- 238000002835 absorbance Methods 0.000 description 2
- 210000004027 cell Anatomy 0.000 description 2
- 238000009535 clinical urine test Methods 0.000 description 2
- 230000007547 defect Effects 0.000 description 2
- 238000011161 development Methods 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 210000003743 erythrocyte Anatomy 0.000 description 2
- 238000002474 experimental method Methods 0.000 description 2
- 210000000265 leukocyte Anatomy 0.000 description 2
- 150000007523 nucleic acids Chemical class 0.000 description 2
- 102000039446 nucleic acids Human genes 0.000 description 2
- 108020004707 nucleic acids Proteins 0.000 description 2
- 238000004445 quantitative analysis Methods 0.000 description 2
- 238000004458 analytical method Methods 0.000 description 1
- 238000000149 argon plasma sintering Methods 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 210000003855 cell nucleus Anatomy 0.000 description 1
- 230000000052 comparative effect Effects 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 230000008676 import Effects 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 238000001556 precipitation Methods 0.000 description 1
- 238000003908 quality control method Methods 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 238000009666 routine test Methods 0.000 description 1
- 238000010186 staining Methods 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
- G01N1/30—Staining; Impregnating ; Fixation; Dehydration; Multistep processes for preparing samples of tissue, cell or nucleic acid material and the like for analysis
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- 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
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
- G01N1/30—Staining; Impregnating ; Fixation; Dehydration; Multistep processes for preparing samples of tissue, cell or nucleic acid material and the like for analysis
- G01N2001/302—Stain compositions
Abstract
The invention belongs to a reagent for a medical diagnostic instrument, and particularly relates to a reagent for a urine visible component analyzer and a preparation method thereof. The reagent for the urine visible component analyzer comprises a diluent and a staining solution. The reagent for the urine visible component analyzer has wide application range, is suitable for domestic and imported models, has stable detection result, accurate detection result and low cost, and is favorable for popularization and application of the reagent for the urine visible component analyzer.
Description
Technical Field
The invention belongs to a reagent for a medical diagnostic instrument, and particularly relates to a reagent for a urine visible component analyzer.
Background
The traditional detection is mostly carried out by observation under a microscope after centrifugal precipitation, but the traditional detection has long time consumption, is easy to be interfered by human factors, has large error and poor repeatability, cannot carry out quantitative analysis, and the existence of the defects seriously influences the accuracy of clinical detection. At present, with the development of medical science and technology and medical equipment, a full-automatic urine analyzer is widely used in clinic gradually due to its advantages of high detection speed, good result repeatability, easy quality control, and capability of performing quantitative analysis on various visible components such as red blood cells, white blood cells, casts, bacteria, and the like.
The main stream urine visible component analyzer principle mainly comprises a flow type laser dyeing combined detection method, an image type detection method and the like, wherein the reagent used in the cell dyeing method mainly comprises a diluent and a dyeing solution, the dyeing solution mainly comprises a nucleic acid dyeing solution and a chemical dyeing solution, and the main stream urine visible component analyzer principle mainly relates to a nucleic acid dyeing technology. Since the degree of staining with a dye varies among red blood cells, white blood cells, bacteria, casts, and the like, and the intensity of light scattering varies among the cell nucleus morphology specific to each cell and the structure of the particle, a specific absorbance and scattered light intensity are generated, and thus the result of each visible component can be detected on the basis of the difference between the absorbance and scattered light intensity in the scattergram.
At present, Sysmex UF series urine visible component analyzers produced by Sysmex corporation of east Asia of Japan are the most common, however, the use of the analyzer usually needs a matched reagent, and the cost of clinical detection is increased and the economic burden of patients is increased due to the unique formula and the need of massive import, so that the development of an analysis reagent which has simple formula and low cost and can replace the original reagent used on a computer is necessary to reduce the dependence on foreign imported products.
Disclosure of Invention
The invention aims to overcome the defects of high cost and long supply period of original reagents of a urine visible component analyzer in the prior art, and aims to independently develop a reagent which is low in cost and excellent in reagent performance and is suitable for the urine visible component analyzer.
The reagent for the urine visible component analyzer comprises diluent, and is characterized in that the diluent comprises the following components in percentage by weight: 0.5-1g/L of quaternary ammonium salt, 3-7g/L of ethylene diamine tetraacetic acid disodium salt, 5-10g/L of sodium chloride and 1-5g/L of ethylene glycol phenyl ether.
Further, the preparation method of the diluent comprises the steps of dissolving the quaternary ammonium salt, the disodium ethylene diamine tetraacetate, the sodium chloride and the ethylene glycol phenyl ether by pure water to a constant volume, and filtering by a 0.2um hydrophilic microporous filter membrane.
The reagent for the urine visible component analyzer comprises a staining solution, and is characterized in that the staining solution comprises the following components in percentage by weight: 0.02-0.04g/L of polymethine dye and 1000g/L of glycol.
Further, the preparation method of the dyeing solution comprises the steps of stirring and dissolving the polymethine dye and ethylene glycol, and filtering by using a 0.2um hydrophobic microporous filter membrane.
The reagent for a urine visible component analyzer according to the present invention has a preferable formulation as follows:
the diluent comprises the following components in percentage by weight: 0.8g/L of quaternary ammonium salt, 5g/L of ethylene diamine tetraacetic acid, 9.5g/L of sodium chloride and 3.5g/L of ethylene glycol phenyl ether;
the dyeing liquid comprises the following components in percentage by weight: 0.02-0.04g/L of polymethine dye and 999.9g/L of ethylene glycol.
The beneficial technical effects of the invention are as follows:
compared with the prior art, the reagent for the urine visible component analyzer has the following advantages:
1) the reagent for the urine visible component analyzer has wide application range and multiple applicable machine types, and is particularly suitable for Japanese Sysmex UF series urine visible component analyzers;
2) the reagent for the urine visible component analyzer has the advantages of rich raw materials, low cost and simple formula.
Detailed Description
The present invention is further illustrated by the following specific examples, but it should be understood by those skilled in the art that the specific examples of the present invention are not intended to limit the present invention in any way, and any equivalents based on the present invention are within the scope of the present invention.
Examples
1. Laboratory apparatus and reagent
1.1 Experimental apparatus: sysmex UF-4000i full-automatic urine analyzer (manufactured by Schissemcon Japan)
1.2 comparison reagents: original Sysmex UF-4000i analytical reagent
1.3 reagent for urine visible component analyzer of the present invention
(1) Prescription of the diluent: 0.8g/L of quaternary ammonium salt, 5g/L of ethylene diamine tetraacetic acid, 9.5g/L of sodium chloride and 3.5g/L of ethylene glycol phenyl ether;
dissolving quaternary ammonium salt, disodium ethylene diamine tetraacetate, sodium chloride and ethylene glycol phenyl ether by pure water according to the above prescription amount to a constant volume, and filtering by a 0.2um hydrophilic microporous filter membrane to obtain a diluent.
(2) Dyeing liquid prescription: 0.02-0.04g/L of polymethine dye and 999.9g/L of ethylene glycol;
and stirring and dissolving the polymethine dye and the ethylene glycol according to the prescription amount, and filtering a 0.2um hydrophobic microporous filter membrane to obtain a dyeing solution.
2. Clinical comparative test
2.1 correlation experiments: 20 parts of urine samples reserved in 3 hours of the current day of the clinical laboratory of Haimen people hospital in Nantong city are randomly selected, the reagent (A) and the reagent (B) of Sysmex original factory are respectively used for urine specimen determination, and the correlation of two groups of test results is calculated, and the results are shown in Table 1.
Table 1: the reagent (A) and the Sysmex original factory reagent (B) of the invention analyze and determine urine samples
As can be seen from Table 1, the results of the sample measurement using the reagent of the present invention have high correlation and consistency with those of the Sysmex original factory reagent, and can meet the requirements of clinical urine routine tests.
2.2 repeatability experiments: randomly selecting 10 parts of urine sample high value and 10 parts of median value reserved in 3 hours of the clinical laboratory of Haimen people hospital in Nantong City, measuring the urine sample by using the reagent, and calculating the repeatability of two groups of test results.
TABLE 2 high value urine test results
Table 3 median urine test results
The result shows that the difference between the detection results of the original reagent and the reagent of the invention is not large, which shows that the reagent of the invention can effectively replace the original reagent to detect the visible components in urine.
Claims (3)
1. A reagent for a urine visible component analyzer, comprising a diluting solution and a staining solution,
the diluent comprises the following components in percentage by weight: 0.5-1g/L of quaternary ammonium salt, 3-7g/L of ethylene diamine tetraacetic acid disodium salt, 5-10g/L of sodium chloride and 1-5g/L of ethylene glycol phenyl ether;
the dyeing liquid comprises the following components in percentage by weight: 0.01-0.06g/L of polymethine dye and 1000g/L of ethylene glycol 800-.
2. A method for producing a reagent for a urine visible component analyzer according to claim 1,
the preparation method of the diluent comprises the following steps: dissolving the quaternary ammonium salt, the disodium ethylene diamine tetraacetate, the sodium chloride and the ethylene glycol phenyl ether by using pure water to a constant volume, and filtering by using a 0.2um hydrophilic microporous filter membrane.
The preparation method of the staining solution comprises the following steps: the preparation method of the dyeing liquid comprises the steps of stirring and dissolving the polymethine dye and the glycol, and filtering by using a 0.2um hydrophobic microporous filter membrane.
3. The reagent for urinary visible component analyzer according to claim 1, comprising a diluting solution and a staining solution,
the diluent comprises the following components in percentage by weight: 0.8g/L of quaternary ammonium salt, 5g/L of ethylene diamine tetraacetic acid, 9.5g/L of sodium chloride and 3.5g/L of ethylene glycol phenyl ether;
the dyeing liquid comprises the following components in percentage by weight: 0.02-0.04g/L of polymethine dye and 999.9g/L of ethylene glycol.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110755651.1A CN113267395A (en) | 2021-07-05 | 2021-07-05 | Reagent for urine visible component analyzer and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110755651.1A CN113267395A (en) | 2021-07-05 | 2021-07-05 | Reagent for urine visible component analyzer and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN113267395A true CN113267395A (en) | 2021-08-17 |
Family
ID=77236434
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202110755651.1A Pending CN113267395A (en) | 2021-07-05 | 2021-07-05 | Reagent for urine visible component analyzer and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN113267395A (en) |
Citations (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH09329596A (en) * | 1996-05-23 | 1997-12-22 | Toa Medical Electronics Co Ltd | Method and reagent for analysis of component having shape in urine |
| CN1238455A (en) * | 1998-06-04 | 1999-12-15 | 梁建华 | Diluent and cleaning liquid for blood analysis counter |
| CN101819199A (en) * | 2010-05-08 | 2010-09-01 | 桂林市朗道诊断用品有限公司 | Reagent for hemocyte analyzers |
| CN103575579A (en) * | 2012-08-07 | 2014-02-12 | 上海睿康生物科技有限公司 | Diluent formula for bacterium channel of urine visible component analyzer |
| CN104698157A (en) * | 2015-02-13 | 2015-06-10 | 中山市创艺生化工程有限公司 | Agent for blood cell analyzer |
| CN107976354A (en) * | 2017-11-22 | 2018-05-01 | 中山市创艺生化工程有限公司 | A kind of reagent for hemocyte analyzers |
| CN108169468A (en) * | 2017-12-12 | 2018-06-15 | 山东兰桥医学科技有限公司 | A kind of dilution and its configuration method suitable for a variety of blood analysers |
| CN111521834A (en) * | 2020-03-20 | 2020-08-11 | 佛山市顺德区德维医疗器械有限公司 | Reagent for XN series full-automatic modular blood body fluid analyzer |
| CN112985966A (en) * | 2021-02-08 | 2021-06-18 | 桂林优利特医疗电子有限公司 | Diluent for analyzing urine visible components and preparation method thereof |
-
2021
- 2021-07-05 CN CN202110755651.1A patent/CN113267395A/en active Pending
Patent Citations (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH09329596A (en) * | 1996-05-23 | 1997-12-22 | Toa Medical Electronics Co Ltd | Method and reagent for analysis of component having shape in urine |
| CN1238455A (en) * | 1998-06-04 | 1999-12-15 | 梁建华 | Diluent and cleaning liquid for blood analysis counter |
| CN101819199A (en) * | 2010-05-08 | 2010-09-01 | 桂林市朗道诊断用品有限公司 | Reagent for hemocyte analyzers |
| CN103575579A (en) * | 2012-08-07 | 2014-02-12 | 上海睿康生物科技有限公司 | Diluent formula for bacterium channel of urine visible component analyzer |
| CN104698157A (en) * | 2015-02-13 | 2015-06-10 | 中山市创艺生化工程有限公司 | Agent for blood cell analyzer |
| CN107976354A (en) * | 2017-11-22 | 2018-05-01 | 中山市创艺生化工程有限公司 | A kind of reagent for hemocyte analyzers |
| CN108169468A (en) * | 2017-12-12 | 2018-06-15 | 山东兰桥医学科技有限公司 | A kind of dilution and its configuration method suitable for a variety of blood analysers |
| CN111521834A (en) * | 2020-03-20 | 2020-08-11 | 佛山市顺德区德维医疗器械有限公司 | Reagent for XN series full-automatic modular blood body fluid analyzer |
| CN112985966A (en) * | 2021-02-08 | 2021-06-18 | 桂林优利特医疗电子有限公司 | Diluent for analyzing urine visible components and preparation method thereof |
Non-Patent Citations (2)
| Title |
|---|
| 吴永国 等: "Sysmex UF-1000i 全自动尿液分析仪试剂的研制与应用评价", 《现代医学》 * |
| 滕飞鹏 等: "UF-100全自动尿沉渣分析仪稀释液的研制和应用", 《检验医学与临床》 * |
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