CN112858690A - 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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- CN112858690A CN112858690A CN202110082182.1A CN202110082182A CN112858690A CN 112858690 A CN112858690 A CN 112858690A CN 202110082182 A CN202110082182 A CN 202110082182A CN 112858690 A CN112858690 A CN 112858690A
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- DDRJAANPRJIHGJ-UHFFFAOYSA-N creatinine Chemical compound CN1CC(=O)NC1=N DDRJAANPRJIHGJ-UHFFFAOYSA-N 0.000 title claims abstract description 90
- 210000002700 urine Anatomy 0.000 title claims abstract description 53
- 229940109239 creatinine Drugs 0.000 title claims abstract description 45
- 238000003908 quality control method Methods 0.000 title claims abstract description 41
- 102000009027 Albumins Human genes 0.000 title claims abstract description 34
- 108010088751 Albumins Proteins 0.000 title claims abstract description 34
- 239000002131 composite material Substances 0.000 title claims abstract description 26
- 238000002360 preparation method Methods 0.000 title abstract description 8
- 238000004519 manufacturing process Methods 0.000 title description 2
- IAZDPXIOMUYVGZ-UHFFFAOYSA-N Dimethylsulphoxide Chemical compound CS(C)=O IAZDPXIOMUYVGZ-UHFFFAOYSA-N 0.000 claims abstract description 24
- 239000007853 buffer solution Substances 0.000 claims abstract description 24
- 238000001514 detection method Methods 0.000 claims abstract description 17
- 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 12
- 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 12
- 229960004369 flufenamic acid Drugs 0.000 claims abstract description 12
- 102000008100 Human Serum Albumin Human genes 0.000 claims abstract description 10
- 108091006905 Human Serum Albumin Proteins 0.000 claims abstract description 10
- 239000002518 antifoaming agent Substances 0.000 claims abstract description 10
- 150000003839 salts Chemical class 0.000 claims abstract description 10
- 239000003755 preservative agent Substances 0.000 claims abstract description 9
- 230000002335 preservative effect Effects 0.000 claims abstract description 9
- 239000003638 chemical reducing agent Substances 0.000 claims abstract description 8
- 239000000243 solution Substances 0.000 claims description 20
- 230000002485 urinary effect Effects 0.000 claims description 19
- 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
- 238000001914 filtration Methods 0.000 claims description 8
- 239000012528 membrane Substances 0.000 claims description 8
- 239000008213 purified water Substances 0.000 claims description 8
- 238000003756 stirring Methods 0.000 claims description 8
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 8
- 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 6
- 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 6
- 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 6
- 229960000367 inositol Drugs 0.000 claims description 6
- 238000000034 method Methods 0.000 claims description 6
- CDAISMWEOUEBRE-UHFFFAOYSA-N scyllo-inosotol Natural products OC1C(O)C(O)C(O)C(O)C1O CDAISMWEOUEBRE-UHFFFAOYSA-N 0.000 claims description 6
- 239000011780 sodium chloride Substances 0.000 claims description 6
- ASVYXWZOBCRSFB-UHFFFAOYSA-N C(C)S(=O)(O)=S.OCCN1CCNCC1 Chemical compound C(C)S(=O)(O)=S.OCCN1CCNCC1 ASVYXWZOBCRSFB-UHFFFAOYSA-N 0.000 claims description 5
- 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
- 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
- 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
- -1 (hydroxymethyl) methylamine-2-hydroxypropanesulfonic acid Chemical compound 0.000 claims 1
- 239000007983 Tris buffer Substances 0.000 claims 1
- 239000003795 chemical substances by application Substances 0.000 claims 1
- 239000003973 paint Substances 0.000 claims 1
- 230000000694 effects Effects 0.000 abstract description 3
- 238000012123 point-of-care testing Methods 0.000 description 8
- 239000000463 material Substances 0.000 description 5
- 208000007342 Diabetic Nephropathies Diseases 0.000 description 2
- 210000004369 blood Anatomy 0.000 description 2
- 239000008280 blood Substances 0.000 description 2
- 208000033679 diabetic kidney disease Diseases 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
- 238000000926 separation method Methods 0.000 description 2
- 210000002966 serum Anatomy 0.000 description 2
- 238000003860 storage Methods 0.000 description 2
- 230000001360 synchronised effect Effects 0.000 description 2
- 238000012360 testing method Methods 0.000 description 2
- WFCSWCVEJLETKA-UHFFFAOYSA-N 2-piperazin-1-ylethanol Chemical compound OCCN1CCNCC1 WFCSWCVEJLETKA-UHFFFAOYSA-N 0.000 description 1
- 208000017667 Chronic Disease Diseases 0.000 description 1
- 206010027525 Microalbuminuria Diseases 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
- 238000006243 chemical reaction Methods 0.000 description 1
- 238000012937 correction Methods 0.000 description 1
- 230000009089 cytolysis Effects 0.000 description 1
- 230000007547 defect Effects 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
- 238000003745 diagnosis Methods 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
- 238000011156 evaluation Methods 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
- 230000007774 longterm Effects 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 238000012797 qualification Methods 0.000 description 1
- 238000011002 quantification Methods 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
- 239000007858 starting material Substances 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
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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)
- Molecular Biology (AREA)
- Urology & Nephrology (AREA)
- Biomedical Technology (AREA)
- Hematology (AREA)
- Immunology (AREA)
- Chemical & Material Sciences (AREA)
- Physics & Mathematics (AREA)
- Food Science & Technology (AREA)
- General Health & Medical Sciences (AREA)
- Cell Biology (AREA)
- Medicinal Chemistry (AREA)
- Biotechnology (AREA)
- Analytical Chemistry (AREA)
- Biochemistry (AREA)
- Microbiology (AREA)
- 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 urine albumin/urine creatinine composite quality control product and a preparation method thereof, wherein the urine albumin/urine 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: 0.5-1 g/L; human serum albumin: 100-200 mg/L; creatinine: 10-20 mmol/L; preservative: 1 g/L; the pH value 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 important effects 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, and particularly relates 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 determine the excretion rate of microalbumin in urine in 24 hours. However, the method is troublesome and time-consuming in specimen collection, poor in patient compliance, and poor in repeatability and accuracy of detection results, so that the clinical application of the method is limited to a certain extent. Urinary creatinine has an excellent correlation with urine concentration and is not affected by the changes in the renal basement membrane, and therefore, the correction with urinary creatinine eliminates the effects of sampling pattern and urine concentration on urinary albumin excretion, so KDOQI guidelines for diabetic nephropathy and the american Association of Diabetes (ADA) recommend the urinary albumin/urinary creatinine ratio (ACR) as the preferred method for screening microalbuminuria.
Point-of-care testing (POCT) is an emerging technology field, and is mainly characterized by rapid result, simple operation, easy use and miniaturization. With the progress of diagnostic and auxiliary techniques, and the increased level of understanding and treatment of diseases, POCT is receiving attention. In fact, POCT has gradually become an important research project in the field of in vitro diagnostic reagents and instruments in the market of europe and america, and many products are put into the market, but such POCT instruments have an important defect at present, namely, analyzers and reagent consumables are extremely expensive, and for countries such as china with huge basic medical systems and very large reagent consumption, the instruments and the matched reagent consumables developed in europe and america at present are obviously challenged.
The microfluidic chip technology is one of the most important leading technologies in the world of the 21 st century, and integrates basic operation units of sample preparation, reaction, separation, detection, cell culture, sorting, lysis and the like in the fields of biology, chemistry and the like on a chip of dozens of square centimeters (even smaller), and a network is formed by microchannels, so that a controllable fluid penetrates through the whole system, and the microfluidic chip technology is a technology for replacing various functions of a conventional biological or chemical laboratory. The micro-fluidic chip technology is introduced into POCT equipment, a new situation of POCT development is created, the complicated steps of whole blood quantification, blood cell serum separation, serum dilution, synchronous determination and the like in a laboratory can be realized, the on-line automatic operation of the chip is completed, and the aim of synchronous detection of various marks is fulfilled. The POCT analyzer combined with the microfluidic 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 provided urine albumin/urine creatinine composite quality control product for the centrifugal microfluidic chip has important effects on ensuring the quality of laboratory detection results of the urine albumin/urine creatinine detection reagent based on the microfluidic technology, reducing errors and ensuring that the results in different laboratories 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 micro-fluidic chip so as to ensure the quality of laboratory detection results of a urine albumin/urine creatinine detection reagent based on a micro-fluidic technology and reduce errors.
The invention provides the following technical scheme:
a urine albumin/urine 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: 0.5-1 g/L;
human serum albumin: 100-200 mg/L;
creatinine: 10-20 mmol/L;
preservative: 1 g/L;
the PH value of the quality control product is 7.2-7.4;
preferably, the buffer solution is one of a hydroxyethyl piperazine ethanesulfoacid buffer solution, a 4-hydroxyethyl piperazine propanesulfonic acid buffer solution, a tris hydrochloride buffer solution, a 3-tris-2-hydroxypropanesulfonic 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 tricarboxyethylphosphine, 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 urine albumin/urine creatinine composite quality control product is applied to the evaluation of the accuracy of a urine albumin/urine creatinine detection reagent based on a microfluidic technology.
A preparation method of a urine albumin/urine creatinine composite quality control product for a centrifugal microfluidic chip comprises the following steps:
s1, adding purified water into the container, then sequentially adding buffer solution, salt, flufenamic acid and dimethyl sulfoxide into the purified water, stirring until the buffer solution, the salt, the flufenamic acid and the dimethyl sulfoxide 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 dextran, the defoaming agent, the tackifier and the preservative are completely dissolved;
s5, adding human serum albumin, and filtering once by using a 0.22mm filter membrane; obtaining 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, thereby reducing the degradation of creatinine in the solution during long-term storage;
2. the reducing agent and the dextran are matched for use, so that the human serum albumin can be prevented from being oxidized and precipitated;
3. the defoaming agent can prevent bubbles from being generated in the centrifuging and uniformly mixing processes and influence the accuracy of the detection result;
4. the tackifier with proper concentration can ensure that the quality control product can smoothly pass through the microfluidic channel and can promote the stability of the quality control product.
Detailed Description
Example 1:
a urine albumin/urine creatinine composite quality control product comprises the following components:
hydroxyethyl piperazine ethanethiosulfonic acid buffer: 50 mmol/L; sodium chloride: 5 g/L; flufenamic acid: 5 g/L; dimethyl sulfoxide: 5 g/L; tricarboxyethyl phosphine: 5 g/L; dextran: 5 g/L; inositol: 5 g/L; emulgen B66: 0.5 g/L; human serum albumin: 120 mg/L; creatinine: 18 mmol/L; proclin 300: 1 g/L; the pH of the quality control product was 7.2.
The preparation method comprises the following steps: s1, adding purified water into the container, then sequentially adding hydroxyethyl piperazine ethanethiosulfonic acid buffer solution, sodium chloride, flufenamic acid and dimethyl sulfoxide into the purified water, and stirring until the materials 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 tricarboxyethylphosphine, dextran, inositol, Emulgen B66 and Proclin 300 into the obtained solution, and stirring until the materials are completely dissolved; s5, adding human serum albumin, and filtering once by using a 0.22mm filter membrane; obtaining the urine albumin/urine creatinine composite quality control product.
Example 2
A urine albumin/urine creatinine composite quality control product comprises the following components:
hydroxyethyl piperazine ethanethiosulfonic acid buffer: 50 mmol/L; sodium chloride: 5 g/L; flufenamic acid: 5 g/L; dimethyl sulfoxide: 5 g/L; tricarboxyethyl phosphine: 5 g/L; dextran: 5 g/L; inositol: 5 g/L; emulgen B66: 0.5 g/L; human serum albumin: 180 mg/L; creatinine: 10 mmol/L; proclin 300: 1 g/L; the pH of the quality control product was 7.2.
The preparation method comprises the following steps: s1, adding purified water into the container, then sequentially adding hydroxyethyl piperazine ethanethiosulfonic acid buffer solution, sodium chloride, flufenamic acid and dimethyl sulfoxide into the purified water, and stirring until the materials 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 tricarboxyethylphosphine, dextran, inositol, Emulgen B66 and Proclin 300 into the obtained solution, and stirring until the materials are completely dissolved; s5, adding human serum albumin, and filtering once by using a 0.22mm filter membrane; obtaining the urine albumin/urine creatinine composite quality control product.
The properties of the quality control materials prepared in the examples of the present invention are described below with reference to tables.
1. Storage stability at 2-8 deg.C
The detection results of the quality control product prepared in the above embodiment of the present invention stored in an environment of 2-8 ℃ are shown in the following table:
as can be seen from the above table of test data, the quality control product of the present invention can be stored for at least 12 months.
2. Micro channel throughput rate
Flatly placing the microfluidic reagent disk on a detection platform, sucking 2 mu L of the quality control product prepared by the embodiment of the invention by using a pipette, slowly adding the quality control product to the top end of a chip sample hole flow channel, and observing whether the flow channel can be smoothly paved; the qualified standard is that the tested sample can be paved on the whole flow passage. And detecting the micro-channel passing rate of the quality control product at 0, 3, 6, 9 and 12 months respectively.
From the above table of test data, the qualification rates of the micro-channel passing rates of the quality control products of months 0, 3, 6, 9 and 12 are all 100%, which shows that the quality control products of the present invention can pass through the micro-channel smoothly.
The starting materials used in the examples are, unless otherwise indicated, commercially available industrial products
Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art will understand that various changes, modifications and substitutions can be made without departing from the spirit and scope of the invention as defined by the appended claims. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (9)
1. A urine albumin/urine creatinine composite quality control product is characterized in that:
the paint 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: 0.5-1 g/L;
human serum albumin: 100-200 mg/L;
creatinine: 10-20 mmol/L;
preservative: 1 g/L;
the pH value of the quality control product is 7.2-7.4.
2. The urinary albumin/urinary creatinine composite quality control product according to claim 1, wherein: the buffer solution is one of hydroxyethyl piperazine ethanethiosulfonic acid buffer solution, 4-hydroxyethyl piperazine propanesulfonic acid buffer solution, tris (hydroxymethyl) aminomethane hydrochloride buffer solution, 3-tris (hydroxymethyl) methylamine-2-hydroxypropanesulfonic acid buffer solution and barbital sodium-hydrochloric acid buffer solution.
3. The urinary albumin/urinary creatinine composite quality control product according to 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 product according to claim 1, wherein: the reducing agent is one of tricarboxyethyl phosphine, glutathione and dithiothreitol.
5. The urinary albumin/urinary creatinine composite quality control product according to claim 1, wherein said antifoaming agent is one of inositol and triton X-100.
6. The urinary albumin/urinary creatinine composite quality control product according to claim 1, wherein said viscosity-increasing agent is one or more of Emulgen B66, Tween-20, Tween-80 and span 60.
7. The urinary albumin/urinary creatinine composite quality control product according to claim 1, wherein said preservative is one or more of potassium sorbate, sodium benzoate, sodium azide and Proclin 300.
8. The urine albumin/urine creatinine composite quality control product according to claim 1, wherein the urine albumin/urine creatinine composite quality control product is used for evaluating the accuracy of a urine albumin/urine creatinine detection reagent based on a microfluidic technology.
9. The method for preparing the urinary albumin/urinary 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 buffer solution, the salts, the flufenamic acid and the dimethyl sulfoxide 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 dextran, the defoaming agent, the tackifier and the preservative are completely dissolved;
s5, adding human serum albumin, and filtering once by using a 0.22mm filter membrane; obtaining the urine albumin/urine creatinine composite quality control product.
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