CN112858690B - Urine albumin/urine creatinine composite quality control product and preparation method thereof - Google Patents
Urine albumin/urine creatinine composite quality control product and preparation method thereof Download PDFInfo
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- DDRJAANPRJIHGJ-UHFFFAOYSA-N creatinine Chemical compound CN1CC(=O)NC1=N DDRJAANPRJIHGJ-UHFFFAOYSA-N 0.000 title claims abstract description 86
- 229940109239 creatinine Drugs 0.000 title claims abstract description 44
- 238000003908 quality control method Methods 0.000 title claims abstract description 40
- 210000002700 urine Anatomy 0.000 title claims abstract description 37
- 102000009027 Albumins Human genes 0.000 title claims abstract description 32
- 108010088751 Albumins Proteins 0.000 title claims abstract description 32
- 239000002131 composite material Substances 0.000 title claims abstract description 25
- 238000002360 preparation method Methods 0.000 title claims abstract description 9
- 238000004519 manufacturing process Methods 0.000 title description 2
- 230000002485 urinary effect Effects 0.000 claims abstract description 31
- IAZDPXIOMUYVGZ-UHFFFAOYSA-N Dimethylsulphoxide Chemical compound CS(C)=O IAZDPXIOMUYVGZ-UHFFFAOYSA-N 0.000 claims abstract description 20
- 239000007853 buffer solution Substances 0.000 claims abstract description 20
- 238000001514 detection method Methods 0.000 claims abstract description 18
- 239000003153 chemical reaction reagent Substances 0.000 claims abstract description 13
- 229920002307 Dextran Polymers 0.000 claims abstract description 12
- 238000005516 engineering process Methods 0.000 claims abstract description 11
- 102000008100 Human Serum Albumin Human genes 0.000 claims abstract description 10
- 108091006905 Human Serum Albumin Proteins 0.000 claims abstract description 10
- LPEPZBJOKDYZAD-UHFFFAOYSA-N flufenamic acid Chemical compound OC(=O)C1=CC=CC=C1NC1=CC=CC(C(F)(F)F)=C1 LPEPZBJOKDYZAD-UHFFFAOYSA-N 0.000 claims abstract description 10
- 229960004369 flufenamic acid Drugs 0.000 claims abstract description 10
- 239000002518 antifoaming agent Substances 0.000 claims abstract description 8
- 239000003638 chemical reducing agent Substances 0.000 claims abstract description 8
- 150000003839 salts Chemical class 0.000 claims abstract description 8
- 239000003755 preservative agent Substances 0.000 claims abstract description 7
- 230000002335 preservative effect Effects 0.000 claims abstract description 7
- 239000000243 solution Substances 0.000 claims description 17
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 12
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 12
- 239000008213 purified water Substances 0.000 claims description 9
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 9
- HATKUFQZJPLPGN-UHFFFAOYSA-N 2-phosphanylethane-1,1,1-tricarboxylic acid Chemical compound OC(=O)C(CP)(C(O)=O)C(O)=O HATKUFQZJPLPGN-UHFFFAOYSA-N 0.000 claims description 8
- SQUHHTBVTRBESD-UHFFFAOYSA-N Hexa-Ac-myo-Inositol Natural products CC(=O)OC1C(OC(C)=O)C(OC(C)=O)C(OC(C)=O)C(OC(C)=O)C1OC(C)=O SQUHHTBVTRBESD-UHFFFAOYSA-N 0.000 claims description 8
- 238000001914 filtration Methods 0.000 claims description 8
- CDAISMWEOUEBRE-GPIVLXJGSA-N inositol Chemical compound O[C@H]1[C@H](O)[C@@H](O)[C@H](O)[C@H](O)[C@@H]1O CDAISMWEOUEBRE-GPIVLXJGSA-N 0.000 claims description 8
- 229960000367 inositol Drugs 0.000 claims description 8
- 239000012528 membrane Substances 0.000 claims description 8
- CDAISMWEOUEBRE-UHFFFAOYSA-N scyllo-inosotol Natural products OC1C(O)C(O)C(O)C(O)C1O CDAISMWEOUEBRE-UHFFFAOYSA-N 0.000 claims description 8
- 238000003756 stirring Methods 0.000 claims description 8
- 239000011780 sodium chloride Substances 0.000 claims description 6
- FTOAOBMCPZCFFF-UHFFFAOYSA-N 5,5-diethylbarbituric acid Chemical compound CCC1(CC)C(=O)NC(=O)NC1=O FTOAOBMCPZCFFF-UHFFFAOYSA-N 0.000 claims description 4
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims description 4
- TWRXJAOTZQYOKJ-UHFFFAOYSA-L Magnesium chloride Chemical compound [Mg+2].[Cl-].[Cl-] TWRXJAOTZQYOKJ-UHFFFAOYSA-L 0.000 claims description 4
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 claims description 4
- PXIPVTKHYLBLMZ-UHFFFAOYSA-N Sodium azide Chemical compound [Na+].[N-]=[N+]=[N-] PXIPVTKHYLBLMZ-UHFFFAOYSA-N 0.000 claims description 4
- YEIKGFFXYDKWAJ-UHFFFAOYSA-N ethyl hydrogen sulfate;2-piperazin-1-ylethanol Chemical compound CCOS(O)(=O)=O.OCCN1CCNCC1 YEIKGFFXYDKWAJ-UHFFFAOYSA-N 0.000 claims description 4
- RWSXRVCMGQZWBV-WDSKDSINSA-N glutathione Chemical compound OC(=O)[C@@H](N)CCC(=O)N[C@@H](CS)C(=O)NCC(O)=O RWSXRVCMGQZWBV-WDSKDSINSA-N 0.000 claims description 4
- 239000000203 mixture Substances 0.000 claims description 3
- CHHHXKFHOYLYRE-UHFFFAOYSA-M 2,4-Hexadienoic acid, potassium salt (1:1), (2E,4E)- Chemical compound [K+].CC=CC=CC([O-])=O CHHHXKFHOYLYRE-UHFFFAOYSA-M 0.000 claims description 2
- QKNYBSVHEMOAJP-UHFFFAOYSA-N 2-amino-2-(hydroxymethyl)propane-1,3-diol;hydron;chloride Chemical compound Cl.OCC(N)(CO)CO QKNYBSVHEMOAJP-UHFFFAOYSA-N 0.000 claims description 2
- ZYVIIEFODRWQGD-UHFFFAOYSA-N 2-piperazin-1-ylethanol;propane-1-sulfonic acid Chemical compound CCCS(O)(=O)=O.OCCN1CCNCC1 ZYVIIEFODRWQGD-UHFFFAOYSA-N 0.000 claims description 2
- 108010024636 Glutathione Proteins 0.000 claims description 2
- 229920001213 Polysorbate 20 Polymers 0.000 claims description 2
- HVUMOYIDDBPOLL-XWVZOOPGSA-N Sorbitan monostearate Chemical compound CCCCCCCCCCCCCCCCCC(=O)OC[C@@H](O)[C@H]1OC[C@H](O)[C@H]1O HVUMOYIDDBPOLL-XWVZOOPGSA-N 0.000 claims description 2
- 239000013504 Triton X-100 Substances 0.000 claims description 2
- 229920004890 Triton X-100 Polymers 0.000 claims description 2
- 229960002319 barbital Drugs 0.000 claims description 2
- VHJLVAABSRFDPM-QWWZWVQMSA-N dithiothreitol Chemical compound SC[C@@H](O)[C@H](O)CS VHJLVAABSRFDPM-QWWZWVQMSA-N 0.000 claims description 2
- 229960003180 glutathione Drugs 0.000 claims description 2
- 229910001629 magnesium chloride Inorganic materials 0.000 claims description 2
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims description 2
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims description 2
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims description 2
- 229920000053 polysorbate 80 Polymers 0.000 claims description 2
- 239000001103 potassium chloride Substances 0.000 claims description 2
- 235000011164 potassium chloride Nutrition 0.000 claims description 2
- 239000004302 potassium sorbate Substances 0.000 claims description 2
- 235000010241 potassium sorbate Nutrition 0.000 claims description 2
- 229940069338 potassium sorbate Drugs 0.000 claims description 2
- WXMKPNITSTVMEF-UHFFFAOYSA-M sodium benzoate Chemical compound [Na+].[O-]C(=O)C1=CC=CC=C1 WXMKPNITSTVMEF-UHFFFAOYSA-M 0.000 claims description 2
- 235000010234 sodium benzoate Nutrition 0.000 claims description 2
- 239000004299 sodium benzoate Substances 0.000 claims description 2
- OTNVGWMVOULBFZ-UHFFFAOYSA-N sodium;hydrochloride Chemical compound [Na].Cl OTNVGWMVOULBFZ-UHFFFAOYSA-N 0.000 claims description 2
- 239000003795 chemical substances by application Substances 0.000 claims 1
- 230000000694 effects Effects 0.000 abstract description 3
- 238000012123 point-of-care testing Methods 0.000 description 8
- QAOWNCQODCNURD-UHFFFAOYSA-N Sulfuric acid Chemical compound OS(O)(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-N 0.000 description 4
- 238000000034 method Methods 0.000 description 4
- WFCSWCVEJLETKA-UHFFFAOYSA-N 2-piperazin-1-ylethanol Chemical compound OCCN1CCNCC1 WFCSWCVEJLETKA-UHFFFAOYSA-N 0.000 description 2
- 208000007342 Diabetic Nephropathies Diseases 0.000 description 2
- 206010027525 Microalbuminuria Diseases 0.000 description 2
- 210000004369 blood Anatomy 0.000 description 2
- 239000008280 blood Substances 0.000 description 2
- 239000000872 buffer Substances 0.000 description 2
- 230000007547 defect Effects 0.000 description 2
- 208000033679 diabetic kidney disease Diseases 0.000 description 2
- 238000003745 diagnosis Methods 0.000 description 2
- 230000029142 excretion Effects 0.000 description 2
- FZWBNHMXJMCXLU-BLAUPYHCSA-N isomaltotriose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1OC[C@@H]1[C@@H](O)[C@H](O)[C@@H](O)[C@@H](OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C=O)O1 FZWBNHMXJMCXLU-BLAUPYHCSA-N 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- 238000000926 separation method Methods 0.000 description 2
- 210000002966 serum Anatomy 0.000 description 2
- 208000017667 Chronic Disease Diseases 0.000 description 1
- 239000002318 adhesion promoter Substances 0.000 description 1
- 238000004458 analytical method Methods 0.000 description 1
- 210000002469 basement membrane Anatomy 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 210000000601 blood cell Anatomy 0.000 description 1
- 239000000337 buffer salt Substances 0.000 description 1
- 230000015556 catabolic process Effects 0.000 description 1
- 238000004113 cell culture Methods 0.000 description 1
- 238000005119 centrifugation Methods 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 238000012937 correction Methods 0.000 description 1
- 238000005336 cracking Methods 0.000 description 1
- 238000006731 degradation reaction Methods 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 206010012601 diabetes mellitus Diseases 0.000 description 1
- 238000010790 dilution Methods 0.000 description 1
- 239000012895 dilution Substances 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 238000000338 in vitro Methods 0.000 description 1
- 210000003734 kidney Anatomy 0.000 description 1
- 230000003902 lesion Effects 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 238000004321 preservation Methods 0.000 description 1
- 238000012797 qualification Methods 0.000 description 1
- 238000011002 quantification Methods 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 238000005070 sampling Methods 0.000 description 1
- 238000012216 screening Methods 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 230000001360 synchronised effect Effects 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
Classifications
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- 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
- G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
- G01N33/6803—General methods of protein analysis not limited to specific proteins or families of proteins
- G01N33/6827—Total protein determination, e.g. albumin in urine
-
- 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
- G01N33/70—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving creatine or creatinine
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- Life Sciences & Earth Sciences (AREA)
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
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- Urology & Nephrology (AREA)
- Biomedical Technology (AREA)
- Hematology (AREA)
- Immunology (AREA)
- Chemical & Material Sciences (AREA)
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- General Physics & Mathematics (AREA)
- Pathology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Bioinformatics & Computational Biology (AREA)
- Biophysics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Investigating Or Analysing Biological Materials (AREA)
Abstract
The invention provides a urinary albumin/urinary creatinine composite quality control product and a preparation method thereof, wherein the urinary albumin/urinary creatinine composite quality control product comprises the following components: buffer solution: 50-100 mmol/L; salts: 5-15 g/L; flufenamic acid: 5-15 g/L; dimethyl sulfoxide: 5-15 g/L; reducing agent: 5-15 g/L; dextran: 5-15 g/L; defoaming agent: 5-15 g/L; tackifier: 0.5-1g/L; human serum albumin: 100-200 mg/L; creatinine: 10-20 mmol/L; preservative: 1g/L; the PH of the quality control product is 7.2-7.4. The invention can be used for evaluating the accuracy of the urine albumin/urine creatinine detection reagent based on the microfluidic technology, and has an important effect on ensuring the quality of laboratory detection results of the urine albumin/urine creatinine detection reagent and reducing errors.
Description
Technical Field
The invention relates to the field of analysis and detection, in particular to a urine albumin/urine creatinine composite quality control product and a preparation method thereof.
Background
Diabetic nephropathy is one of the most common chronic diseases in China, and the gold standard for diagnosis is to measure the excretion rate of microalbuminuria in 24 hours. However, the method has the defects of troublesome sample collection, time consumption, poor patient compliance, poor repeatability and accuracy of detection results, and limited clinical application. Urinary creatinine has excellent correlation with urinary concentration and is not affected by kidney basement membrane lesions, so that correction with urinary creatinine eliminates the effects of sampling mode and urine concentration on urinary albumin excretion, and thus both the guidelines for KDOQI diabetic nephropathy and the American society for diabetes (ADA) recommend urinary albumin-to-create-creatinine ratio (ACR) as a preferred method for screening microalbuminuria.
Point-of-care testing (POCT) is an emerging technical field, and is mainly characterized by fast result, simple operation, easy use and miniaturization. POCT is receiving attention as diagnosis and auxiliary technologies advance, and people's knowledge of diseases and demands for increased therapeutic levels. In fact, POCT has gradually become an important research project in the fields of in vitro diagnostic reagents and instruments in the european and american market, and a lot of products have been put into the market, but such POCT instruments have an important defect at present that analyzers and reagent consumables are particularly expensive, so that for countries with huge basic medical systems like china and extremely large reagent usage, instruments and matched reagent consumables currently developed in the european and american industry obviously face challenges.
Microfluidic chip technology is one of the most important leading edge technologies in the 21 st century world, integrates basic operation units of sample preparation, reaction, separation, detection, cell culture, sorting, cracking and the like, which are related to the fields of biology, chemistry and the like, on a chip of tens of square centimeters (even smaller), forms a network by micro channels, penetrates the whole system with controllable fluid, and is a technology for replacing various functions of a conventional biological or chemical laboratory. The microfluidic chip technology is introduced into POCT equipment, a new situation of POCT development is created, and the steps of whole blood quantification, blood cell and serum separation, serum dilution, synchronous measurement and the like which are complicated in the laboratory in the past can be completed in the on-line automatic operation of the chip, so that the aim of synchronously detecting various marks is fulfilled. The POCT analyzer combined with the micro-fluidic chip technology has the advantages of high accuracy, low blood demand, simple operation, less detection reagent consumption, low cost and the like, and is very suitable for China with huge basic medical systems and extremely large reagent consumption. Therefore, the urine albumin/urine creatinine composite quality control product which can be used for the centrifugal microfluidic chip has an important effect on ensuring the quality of laboratory detection results of urine albumin/urine creatinine detection reagents based on microfluidic technology, reducing errors and enabling results among different laboratories to have better comparability.
Disclosure of Invention
The invention aims to provide a urine albumin/urine creatinine composite quality control product which can be used for a centrifugal microfluidic chip, so as to ensure the quality of laboratory detection results of urine albumin/urine creatinine detection reagents based on a microfluidic technology and reduce errors.
The invention provides the following technical scheme:
a urine albumin/urine creatinine composite quality control product consists of the following components:
buffer solution: 50-100 mmol/L;
salts: 5-15 g/L;
flufenamic acid: 5-15 g/L;
dimethyl sulfoxide: 5-15 g/L;
reducing agent: 5-15 g/L;
dextran: 5-15 g/L;
defoaming agent: 5-15 g/L;
tackifier: 0.5-1g/L;
human serum albumin: 100-200 mg/L;
creatinine: 10-20 mmol/L;
preservative: 1g/L;
the PH of the quality control product is 7.2-7.4;
preferably, the buffer solution is one of a hydroxyethyl piperazine ethyl sulfuric acid buffer solution, a 4-hydroxyethyl piperazine propane sulfonic acid buffer solution, a tris hydrochloride buffer solution, a 3-tris-2-hydroxy propane sulfonic acid buffer solution and a barbital sodium-hydrochloric acid buffer solution.
Preferably, the salt is one or more of sodium chloride, potassium chloride and magnesium chloride.
Preferably, the reducing agent is one of tricarboxyethyl phosphine, glutathione and dithiothreitol.
Preferably, the defoaming agent is one of inositol and triton X-100.
Preferably, the tackifier is one or more of Emulgen B66, tween-20, tween-80 and span 60.
Preferably, the preservative is one or more of potassium sorbate, sodium benzoate, sodium azide and Proclin 300.
Preferably, the urinary albumin/urinary creatinine composite quality control is applied to evaluating the accuracy of a urinary albumin/urinary creatinine detection reagent based on a microfluidic technology.
The preparation method of the urinary albumin/urinary creatinine composite quality control product for the centrifugal microfluidic chip comprises the following steps:
s1, adding purified water into a container, then sequentially adding buffer solution, salts, flufenamic acid and dimethyl sulfoxide into the purified water, stirring until the components are completely dissolved,
s2, adding creatinine, and filtering once by using a 0.22mm filter membrane;
s3, adjusting the PH value to 7.2-7.4 by using a dilute hydrochloric acid solution or a 0.1% sodium hydroxide solution at the temperature of 25+/-0.5 ℃;
s4, adding a reducing agent, dextran, a defoaming agent, a tackifier and a preservative into the obtained solution, and stirring until the mixture is completely dissolved;
s5, adding human serum albumin, and filtering once by using a 0.22mm filter membrane; to obtain the urine albumin/urine creatinine composite quality control product.
The invention has the beneficial effects that:
1. the invention selects proper buffer solution and salt concentration, and the flufenamic acid and the dimethyl sulfoxide are added, so that the degradation of creatinine in the long-term preservation process in the solution is reduced;
2. the cooperation of the reducer and the dextran can prevent the human serum albumin from being oxidized and precipitated;
3. the defoaming agent can prevent bubbles from being generated in the centrifugation and uniform mixing processes, and the accuracy of the detection result is affected;
4. the adhesion promoter with proper concentration can make the quality control product pass through the micro-fluidic channel smoothly and promote the stability of the quality control product.
Detailed Description
Example 1:
a urine albumin/urine creatinine composite quality control product consists of the following components:
hydroxyethyl piperazine b sulfuric acid buffer: 50mmol/L; sodium chloride: 5g/L; flufenamic acid: 5g/L; dimethyl sulfoxide: 5g/L; tricarboxyethyl phosphine: 5g/L; dextran: 5g/L; inositol: 5g/L; emulgen B66:0.5g/L; human serum albumin: 120mg/L; creatinine: 18mmol/L; proclin 300:1g/L; the pH of the quality control product is 7.2.
The preparation method comprises the following steps: s1, adding purified water into a container, then sequentially adding a hydroxyethyl piperazine ethyl sulfuric acid buffer solution, sodium chloride, flufenamic acid and dimethyl sulfoxide into the purified water, and stirring until the components are completely dissolved; s2, adding creatinine, and filtering once by using a 0.22mm filter membrane; s3, adjusting the pH value to 7.2 by using a dilute hydrochloric acid solution or a 0.1% sodium hydroxide solution at the temperature of 25 ℃; s4, adding tricarboxyethyl phosphine, dextran, inositol, emulgen B66 and Proclin 300 into the obtained solution, and stirring until the tricarboxyethyl phosphine, the dextran, the inositol, the Emulgen B66 and the Proclin 300 are completely dissolved; s5, adding human serum albumin, and filtering once by using a 0.22mm filter membrane; to obtain the urine albumin/urine creatinine composite quality control product.
Example 2
A urine albumin/urine creatinine composite quality control product consists of the following components:
hydroxyethyl piperazine b sulfuric acid buffer: 50mmol/L; sodium chloride: 5g/L; flufenamic acid: 5g/L; dimethyl sulfoxide: 5g/L; tricarboxyethyl phosphine: 5g/L; dextran: 5g/L; inositol: 5g/L; emulgen B66:0.5g/L; human serum albumin: 180mg/L; creatinine: 10mmol/L; proclin 300:1g/L; the pH of the quality control product is 7.2.
The preparation method comprises the following steps: s1, adding purified water into a container, then sequentially adding a hydroxyethyl piperazine ethyl sulfuric acid buffer solution, sodium chloride, flufenamic acid and dimethyl sulfoxide into the purified water, and stirring until the components are completely dissolved; s2, adding creatinine, and filtering once by using a 0.22mm filter membrane; s3, adjusting the pH value to 7.2 by using a dilute hydrochloric acid solution or a 0.1% sodium hydroxide solution at the temperature of 25 ℃; s4, adding tricarboxyethyl phosphine, dextran, inositol, emulgen B66 and Proclin 300 into the obtained solution, and stirring until the tricarboxyethyl phosphine, the dextran, the inositol, the Emulgen B66 and the Proclin 300 are completely dissolved; s5, adding human serum albumin, and filtering once by using a 0.22mm filter membrane; to obtain the urine albumin/urine creatinine composite quality control product.
The performance of the quality control product prepared in the examples of the present invention is described below with reference to the table.
1. Storage stability at 2-8deg.C
The quality control product prepared by the embodiment of the invention has the detection results stored in an environment of 2-8 ℃ as shown in the following table:
from the detection data in the table, the quality control product can be stored for at least 12 months.
2. Microchannel passage rate
Placing the microfluidic reagent disk on a detection platform horizontally, sucking 2 mu L of the quality control product prepared by the embodiment of the invention by using a pipetting gun, slowly adding the quality control product into the top end of a chip sample hole flow channel, and observing whether the flow channel can be smoothly paved; the qualification standard is that the tested sample can be paved on the whole flow channel. And detecting the micro-channel passing rate of the quality control product at the 0 th month, the 3 rd month, the 6 th month, the 9 th month and the 12 th month respectively.
From the detection data in the table, the pass rate of the micro-channel of the quality control products in the 0 th, 3 rd, 6 th, 9 th and 12 th months is 100%, which indicates that the quality control products can pass through the micro-channel smoothly.
The raw materials used in the examples are commercial industrial products unless otherwise specified
The above is only a preferred embodiment of the present invention, and the present invention is not limited thereto, but it is to be understood that the present invention is described in detail with reference to the foregoing embodiments, and modifications and equivalents of some of the technical features described in the foregoing embodiments may be made by those skilled in the art. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (8)
1. A urine albumin/urine creatinine composite quality control product is characterized in that:
the composition comprises the following components:
buffer solution: 50-100 mmol/L;
salts: 5-15 g/L;
flufenamic acid: 5-15 g/L;
dimethyl sulfoxide: 5-15 g/L;
reducing agent: 5-15 g/L;
dextran: 5-15 g/L;
defoaming agent: 5-15 g/L;
tackifier: 0.5-1g/L;
human serum albumin: 100-200 mg/L;
creatinine: 10-20 mmol/L;
preservative: 1g/L;
the PH of the quality control product is 7.2-7.4;
the reducing agent is one of tricarboxyethyl phosphine, glutathione and dithiothreitol.
2. The urinary albumin/urinary creatinine composite quality control of claim 1, wherein: the buffer solution is one of a hydroxyethyl piperazine ethyl sulfuric acid buffer solution, a 4-hydroxyethyl piperazine propane sulfonic acid buffer solution, a tris hydrochloride buffer solution, a 3-tris-2-hydroxy propane sulfonic acid buffer solution and a barbital sodium-hydrochloric acid buffer solution.
3. The urinary albumin/urinary creatinine composite quality control of claim 1, wherein: the salt is one or more of sodium chloride, potassium chloride and magnesium chloride.
4. The urinary albumin/urinary creatinine composite quality control of claim 1, wherein said anti-foaming agent is one of inositol, triton X-100.
5. The urinary albumin/urinary creatinine composite quality control of claim 1, wherein said viscosity increasing agent is one or more of Emulgen B66, tween-20, tween-80, span 60.
6. The urinary albumin/urinary creatinine composite quality control of claim 1, wherein the preservative is one or more of potassium sorbate, sodium benzoate, sodium azide, and Proclin 300.
7. The urinary albumin/urinary creatinine composite quality control of claim 1, wherein the urinary albumin/urinary creatinine composite quality control is used for evaluating the accuracy of a urinary albumin/urinary creatinine detection reagent based on microfluidic technology.
8. The preparation method of the urine albumin/urine creatinine composite quality control product according to claim 1, wherein S1, adding purified water into a container, then sequentially adding buffer solution, salts, flufenamic acid and dimethyl sulfoxide into the purified water, and stirring until the purified water is completely dissolved;
s2, adding creatinine, and filtering once by using a 0.22mm filter membrane;
s3, adjusting the PH value to 7.2-7.4 by using a dilute hydrochloric acid solution or a 0.1% sodium hydroxide solution at the temperature of 25+/-0.5 ℃;
s4, adding a reducing agent, dextran, a defoaming agent, a tackifier and a preservative into the obtained solution, and stirring until the mixture is completely dissolved;
s5, adding human serum albumin, and filtering once by using a 0.22mm filter membrane; to obtain the urine albumin/urine creatinine composite quality control product.
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