CN109406798A - Creatinine enzyme process detection kit - Google Patents

Creatinine enzyme process detection kit Download PDF

Info

Publication number
CN109406798A
CN109406798A CN201811266231.1A CN201811266231A CN109406798A CN 109406798 A CN109406798 A CN 109406798A CN 201811266231 A CN201811266231 A CN 201811266231A CN 109406798 A CN109406798 A CN 109406798A
Authority
CN
China
Prior art keywords
reagent
creatinine
enzyme process
detection kit
process detection
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN201811266231.1A
Other languages
Chinese (zh)
Inventor
邹炳德
邹继华
章玉胜
贾江花
汪屹
武强
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Meikang Biological Polytron Technologies Inc
Original Assignee
Meikang Biological Polytron Technologies Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Meikang Biological Polytron Technologies Inc filed Critical Meikang Biological Polytron Technologies Inc
Priority to CN201811266231.1A priority Critical patent/CN109406798A/en
Publication of CN109406798A publication Critical patent/CN109406798A/en
Pending legal-status Critical Current

Links

Classifications

    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/70Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving creatine or creatinine
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/52Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54393Improving reaction conditions or stability, e.g. by coating or irradiation of surface, by reduction of non-specific binding, by promotion of specific binding
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00Detection or diagnosis of diseases
    • G01N2800/34Genitourinary disorders
    • G01N2800/347Renal failures; Glomerular diseases; Tubulointerstitial diseases, e.g. nephritic syndrome, glomerulonephritis; Renovascular diseases, e.g. renal artery occlusion, nephropathy

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Chemical & Material Sciences (AREA)
  • Hematology (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Urology & Nephrology (AREA)
  • Cell Biology (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)

Abstract

A kind of creatinine enzyme process detection kit, the reagent include reagent R1 and reagent R2: reagent R1 group becomes buffer, kreatinase, sarcosine oxidase, ascorbic acid oxidase, bilirubin oxidase, TOOS, peroxidase, stabilizer, surfactant;Reagent R2 group becomes buffer, 4-AA, Creatininase, stabilizer, surfactant, antibiotic antiseptic 0.1-10g/L.Toxicity can be effectively reduced and reduce the pollution to environment, and it is not easy to cause the drug resistance of bacterium, does not will lead to the generation of superbacteria, reduce the risk of the health for the mankind, and the creatinine enzyme process detection kit that stability is good, the creatinine for chronic diseases management detect.

Description

Creatinine enzyme process detection kit
Technical field:
The present invention relates to technical field of medical examination, and in particular to a kind of creatinine detection reagent for chronic diseases management, more It is specifically a kind of stable creatinine enzyme process detection kit.
Background technique:
Creatinine (CR) is the product of human muscle's metabolism, mainly passes through the irreversible slow shape of non-enzymatic dehydration by creatine At, then be discharged into blood, with homaluria, do not influenced substantially by diet and movement etc., it can be by glomerular filtration, in renal tubule It is interior it is seldom can be absorbed again, creatinine includes serum creatinine and urine creatinine, and serum creatinine measures that renal function is more meaningful, and serum creatinine is dense Degree measurement is to evaluate the efficiency index of glomerular filtration rate, can effectively reflect the substantial damage degree of renal function, clinically Detection helps to judge that the state of an illness such as kidney are of great significance.
It is reported that urban and rural residents' epidemiological survey in 2013 is shown, the total prevalence rate of Chinese chronic kidney disease (CKD) is 10.8%, calculate that there is CKD patient nearly 1.2 hundred million in China.But the awareness of chronic kidney disease is only 12.5%, while chronic kidney disease The treatment method in later period is hard to work, and also by serious influence, seeking one kind can be in morning for patient's prognosis and life quality Phase can High sensitivity, specifically reflect that the Testing index of kidney function damage is always the target of current clinical unremitting pursuit. Measurement change of serum C R is direct one kind, early stage, the sensitive important indicator for assessing renal function, clinically has very long hair Open up history.
The most commonly used is picric acid methods and enzyme process for CR clinical detection, although picric acid method reagent is cheap, the range of linearity is narrow, easily By the interference of other substances such as pyruvic acid, there is detection error, while picric acid itself has explosivity, in actual production, fortune There are certain risks during defeated.The principle of enzyme process detection is that the CR in sample hydrolyzes generation creatine under the catalysis of Creatininase, Creatine creatine enzyme effect be lauched solution generate sarcosine, sarcosine aoxidize under the catalysis of sarcosine oxidase generation glycine, Formaldehyde and H2O2, finally it is coupled Trinder reaction, the concentration of colorimetric estimation CR.Enzyme process has specificity height, and the range of linearity is wide, surveys True advantage is fixed, is the mainstream detection method recommended currently on the market.
According to the gradually popularization of the classification diagnosis and treatment policy of country, chronic diseases management is mainly by basic hospital, such as community hospital, village The medical institutions such as health-center undertake, and advantageously reduce the testing process of patient, reduce patient's detection time and expense cost, effectively Improve slow sick detection management efficiency.CR generallys use various large automatic Biochemical Analyzer detections at present, but due to equipment valence Lattice are high, and complicated for operation, need just to can be used by the clinical examination personnel Jing Guo professional training, take up a large area, maintenance cost Height needs professional's time-based maintenance, therefore basic medical unit or household person are all bought and used without condition.In view of upper Problem is stated, the small-sized detecting instruments such as POCT is mainly promoted currently on the market for basic medical unit and detects creatinine, to realize Effective monitoring and prognosis management to chronic kidney disease people.SMART as Meikang biotech inc produces is small-sized Automatic biochemical analyzer.
But when the POCT instrument such as small-sized automatic biochemical analyzer detection creatinine, creatinine reagent used is single packing detection Reagent, and it is used for basic medical unit, the time is long during transport and storage, lacks effective cold chain condition, this is for examination The high requirement that the stability of agent proposes.This not only includes the stability of reagent Related Component, while also including reagent anti- Rotten and antibiosis stability.Antibiotic antiseptic currently used for diagnostic kit is mainly chemical classes preservative and antibiotic Class preservative, but chemical classes preservative the problems such as that there is toxicity is big, environmental pollution, antibiotics preservative easily causes carefully The drug resistance of bacterium will lead to the generation of superbacteria, have great risk for the health of the mankind.In consideration of it, exploitation is stablized Creatinine enzyme process reagent, for basic medical unit be used for chronic kidney disease management, be a problem to be solved.
Summary of the invention:
The present invention be directed to the prior art above-mentioned deficiency, provide it is a kind of can effectively reduce toxicity and reduce to environment Pollution, and be not easy to cause the drug resistance of bacterium, not will lead to the generation of superbacteria, reduce the health for the mankind Risk, and the creatinine enzyme process detection kit that stability is good, the creatinine for chronic diseases management detect.
In order to solve the above technical problems, the technical solution adopted by the present invention are as follows: a kind of enzyme process creatinine detection reagent, the reagent Including
Reagent R1 and reagent R2:
Reagent R1 composition are as follows:
Buffer: 10-100mmol/L,
Kreatinase: 1-100KU/L,
Sarcosine oxidase: 1-200KU/L,
Ascorbic acid oxidase: 1-100KU/L,
Bilirubin oxidase: 1-100KU/L,
TOOS (N- ethyl-N- (2-Hydroxy-3-sulfopropyl)-3-methylaniline sodium salt) 0.1-10mmol/L,
Peroxidase 1-100KU/L,
Stabilizer 1-50g/L,
Surfactant 0.1-1g/L,
Antibiotic antiseptic 0.1-10g/L;
Reagent R2 composition are as follows:
Buffer: 10-100mmol/L,
4-AA 0.1-10mmol/L,
Creatininase 1-1000KU/L,
Stabilizer 1-50g/L,
Surfactant 0.1-1.0g/L,
Antibiotic antiseptic 0.1-10g/L.
Buffer described in reagent R1 and reagent R2 be kaliumphosphate buffer, Tris buffer, HEPES buffer solution, It is several or a kind of in PIPES buffer and MOPS, and pH range is 7.0~8.8;That is delay described in reagent R1 and reagent R2 Fliud flushing can select to use from above-mentioned buffer type, and the pH of buffer range in two kinds of reagents is 7.0~8.8.
Surfactant described in reagent R1 and reagent R2 is nonionic surfactant, such as TWEEN Series, SPAN Series, it is several or a kind of in specific surfactant in TRITON series, and concentration range is 0.1-1.0g/L.
Stabilizer described in reagent R1 and reagent R2 is glycitols and protein matter, specially sucrose, trehalose, cream Sugar, fructose, glycerol, mannitol, sorbierite, BSA (bovine serum albumin(BSA)) it is several or a kind of, and concentration range be 1-50g/L.
Antibiotic antiseptic described in reagent R1 and reagent R2 is Allopelagic sterilizing peptide, anti-for horseshoe crab class antibacterial peptide, shellfish It is several or a kind of in bacterium peptide, shrimp antimicrobial peptide, fish antibacterial peptide and crab class antibacterial peptide, and concentration range is 0.1-10g/L.
The preparation method of the reagent is to be added after distilled water to mix according to formula rate by the agent formulations to stir evenly i.e. Can, it is industry conventional practices.
The technical principle that the present invention uses are as follows:
This reagent uses two-step reaction method, and when sample is added in reagent R1, kreatinase and sarcosine oxidase can be effective The interference of the endogenous creatine of serum is removed, bilirubin oxidase removes bilirubin interference, and ascorbic acid oxidase removes ascorbic acid Interference;After instrument mixes automatically, and reagent R2 is added, the CR in sample is hydrolyzed under the catalysis of Creatininase generates creatine, creatine Solution is lauched in creatine enzyme effect and generates sarcosine, and sarcosine aoxidizes under the catalysis of sarcosine oxidase generates glycine, formaldehyde And H2O2, it is finally coupled Trinder reaction, by colorimetric, and by measuring CR concentration compared with calibration object.
The test condition that CR measures reagent is as follows: temperature: 37 DEG C;Detect dominant wavelength: 546nm, commplementary wave length 700nm, sample Additional amount: 10 μ l.
The Allopelagic sterilizing peptide that heretofore described antibiotic antiseptic uses.It is reported that antibacterial peptide is due to its uniqueness Antibacterial mechanisms, with molecular weight is small, good water solubility, heat resistance are strong, non-immunogenicity, wide spectrum bactericidal effect, efficient anti- The advantages that bacterium is active, it is considered to be antibiotic antiseptic of new generation, and external diagnosis reagent and the Antimicrobial preservative performance for reagent It is required that it is high, so antibacterial peptide is suitable as the Antimicrobial preservative preparation of a new generation for external diagnosis reagent case.
The advantages of the present invention:
1. reagent of the invention is had good anti-as antibiotic antiseptic in conjunction with the use of stabilizer using antibacterial peptide Bacterium anti-corrosion and resistance heat damage effect, reagent is on the basis of high sensitivity, accuracy height, strong antijamming capability, stability pole It is good, it is suitable for the creatinine detection of chronic diseases management.
2. the antibacterial peptide that the present invention uses is to pass through DNA recombinant expression, separation and purification of protein using marine resources as raw material Etc. technologies development have efficiently, the novel antimicrobial peptide of broad-spectrum antiseptic characteristic, and the stability for kit, sensitivity and Reagent blank is without influence;It is nontoxic, damage will not be generated to human body and environment, do not make yet it is bacterial resistance occurred, in liquid reagent In have a good dissolubility and stability, therefore kit of the present invention addition antibacterial peptide can effectively dissolve, at low concentrations both Play the role of anti-corrosive antibacterial to reagent, there is good stabilization for reagent.But antibacterial peptide itself is micromolecule polypeptide, is lacked Weary complete protein colloid structure, stability itself is poor, influences that denaturation occurs vulnerable to factors such as high temperature, oscillations, resists There is also decline phenomenons along with denaturation for bacterium antiseptic property.And stabilizer is as glycitols or protein matter, for small Molecular polypeptide has protective effect, and the heat-resisting of polypeptide can be improved, resist the denaturation of oscillation, to effectively improve antibacterial peptide The stability of itself promotes it to play long-acting Antimicrobial preservative performance;Stabilizer plays the albumen such as enzyme in reagent simultaneously Effect is effectively protected, can effectively improve reagent for the resistivity of heat damage.In addition, antibacterial peptide is as small molecule egg It is white, it interacts with macromolecule proteins ingredients such as enzymes, also effectively further improves the storage stability of antibacterial peptide and reagent. In conclusion antibiotic antiseptic proposed by the present invention and stability are applied in combination, the heat for effectively increasing antibiotic antiseptic is steady It is qualitative, promote it and play long-acting bacteriostasis, while also improving kit high temperature resistant equistability, promotees it and be effective against hot break Bad effect.The two synergistic effect, efficiently solves creatinine reagent instability problem.The application novelty proposes antibacterial peptide As antibiotic antiseptic, the use of combinative stability agent, and the specific kit formulation feature and its requirement of Creatininase are combined, completely Ground proposes the Recipe of kit, solves the long-standing stability problem of creatinine reagent box.
Detailed description of the invention
Fig. 1: SMART IV figure compared with the CR end value that automatic clinical chemistry analyzer measures, wherein X-axis represents full-automatic 7180 measurement result of Biochemical Analyzer Hitachi, Y-axis represent measurement result on SMARTIV analyzer.
Fig. 2: to add the linear result figure that the CR of various concentration is detected in standard serum samples.
Case is embodied:
The present invention by following embodiment and verification test to stable creatinine enzyme process detection kit of the invention make into The explanation of one step.
Embodiment 1:
The creatinine enzyme process detection kit of the present embodiment, is made of reagent R1 and reagent R2, in which:
Reagent R1 composition are as follows: Tris buffer: 20mmol/L, pH7.50;Kreatinase: 20KU/L;Sarcosine oxidase: 15.2KU/L;Ascorbic acid oxidase: 18KU/L;Bilirubin oxidase: 80KU/L;TOOS 2mmol/L;Peroxidase 40KU/L;BSA 20g/L;Trehalose 10g/L;Tween20 0.3g/L;TgHb 1-5 0.5g/L.
Reagent R2 composition are as follows: Tris buffer: 30mmol/L, pH7.80;4-AA 3mmol/L;Creatininase 400KU/L;BSA 5g/L;Tween80 0.3g/L;TgHb 1-5 0.4g/L.
Embodiment 2:
The creatinine enzyme process detection kit of the present embodiment, is made of reagent R1 and reagent R2, in which:
Reagent R1 composition are as follows: HEPES buffer solution: 50mmol/L, pH8.0;Kreatinase: 40KU/L;Sarcosine oxidase: 29KU/L;Ascorbic acid oxidase: 50KU/L;Bilirubin oxidase: 40KU/L;TOOS 5mmol/L;Peroxidase 60KU/ L;Sucrose 10g/L;TritonX-100 0.2g/L;Aurelin 0.2g/L.
Reagent R2 composition are as follows: PIPES buffer: 50mmol/L, pH8.2;4-AA 5mmol/L;Creatininase 600KU/L;Fructose 15g/L;TritonX-100 0.5g/L;Aurelin 0.8g/L.
Embodiment 3:
The creatinine enzyme process detection kit of the present embodiment, is made of reagent R1 and reagent R2, in which:
Reagent R1 composition are as follows: MOPS buffer: 30mmol/L, pH8.5;Kreatinase: 62KU/L;Sarcosine oxidase: 35KU/L;Ascorbic acid oxidase: 80KU/L;Bilirubin oxidase: 15KU/L;TOOS 6mmol/L;Peroxidase 45KU/ L;Glycerol 20g/L;SPAN20 0.1g/L;MCdef:0.6g/L.
Reagent R2 composition are as follows: MPOS buffer: 50mmol/L, pH8.4;4-AA 6mmol/L;Creatininase: 700KU/L;Mannitol: 10g/L;Glycerol: 10g/l;SPAN20 0.21g/L;MCdef:0.4g/L.
TgHb 1-5 is mud blood clam antibacterial peptide (shellfish) in the present invention, according to Chinese patent application CN2017104041998 system Standby and obtain, Aurelin is jellyfish antibacterial peptide, is prepared according to Chinese patent application CN2017104041983;MCdef is flower Clam antibacterial peptide is prepared according to Chinese patent application CN2017104041964;Or TgHb 1-5 is anti-for mud blood clam in the present invention Bacterium peptide (shellfish), Aurelin are jellyfish antibacterial peptide, and MCdef is " the mud blood clam that flower clam antibacterial peptide can be delivered according to Wang Sufang etc. respectively The preparation of hemoglobin and its antibacterial activity research " (" ocean journal " 12 phases in 2014), what TV Ovchinnikova etc. was delivered 《Aurelin,a novel antimicrobial peptide from jellyfish Aurelia aurita with structural features of defensins and channel-blocking toxins》(《Biochem Biophys Res Commun ", 2 phases of volume 348 in 2006), " the Cloning and localization that M Adhya etc. is delivered of MCdef,a defensin from Manila clams(Ruditapes philippinarum)》(《Comp Biochem Physiol B Biochem Mol Biol " 1 phases of volume 161 in 2012) it prepares.
Description of test is carried out to the performance of the gained detection reagent in inventive embodiments 1 below.
1, accuracy:
Continuously 40 parts of samples of monitoring carry out the CR end value measured in pattern detection result and automatic clinical chemistry analyzer Compare, as a result such as Fig. 1, wherein X-axis represents determination data on automatic clinical chemistry analyzer, and Y-axis is represented for chronic diseases management Determination data on SMARTIV (being produced by Meikang biotech inc).According to Fig. 1 it is found that fit equation are as follows:
Y=1.0088X+0.7249, coefficient R2It is 0.9994, shows that the two correlation is good, the measurement of SMART reagent Result precision is good.
2, precision:
20 measurements are carried out continuously to certain two sample, measurement result is subjected to precision assessment, the results are shown in Table 1:
Table 1: precision experiment result
Sample Average value (μm ol/L) SD(μmol/L) CV
1 47.2 2.2 4.66%
2 77.2 3.0 3.89%
3, the range of linearity:
It is detected with adding the analyte of various concentration outside standard serum samples, testing result such as Fig. 2, wherein X-axis generation 7180 measurement result of table automatic clinical chemistry analyzer Hitachi, Y-axis represent measurement result on SMARTIV analyzer;According to Fig. 2 it is found that Fit equation are as follows: Y=0.9835X+11.6, linearly dependent coefficient R2Up to 0.9996, show SMART reagent in 0-2000 μ It is linear good within the scope of mol/L.
4, storage stability:
Reagent is placed at 4 DEG C, respectively at the 3rd, 6,9,12,15,18,21,24 month, measures quality-control product, and will survey Determine result to be compared with 0 month measurement result, the results are shown in Table 2:
At 2:4 DEG C of table, reagent detects stability result
Month 0 3 6 9 12 15 18 21 24
Quality-control product 1 (μm ol/L) 49.6 49.2 48.2 47.2 49.5 46.9 47.8 48.0 47.2
Deviation (%) -0.81 -2.82 -4.84 -0.20 -5.44 -3.63 -3.23 -4.84
Quality-control product 2 (μm ol/L) 97.0 95.8 95.4 94.9 95.2 94.3 95.0 93.8 93.2
Deviation (%) -1.24 -1.65 -2.16 -1.86 -2.78 -2.06 -3.30 -3.92
Reagent is placed at 25 DEG C, respectively at the 7th, 14,21,28,35,49,63,77 day, measures quality-control product, and will survey Determine result to be compared with 0 day measurement result.It the results are shown in Table 3:
At 3:25 DEG C of table, reagent detects stability result
From above-mentioned experimental result it is found that reagent of the present invention have good accuracy, precision, the good range of linearity, It can stablize 24 months under 4 DEG C of storages, 77 days, i.e., 11 weeks can be stablized under 25 DEG C of storages, be fully able to meet slow disease pipe The creatinine testing requirements of reason.
5, Antimicrobial preservative performance:
The present invention is special in order to further verify invented kit for the resistance and Antimicrobial preservative performance of heat damage It is not to transport and store the Antimicrobial preservative performance after being influenced by heat in reagent, has done following experiment: having taken reagent, be directly added into respectively Certain density Escherichia coli, staphylococcus aureus and bacillus subtilis, at 37 DEG C, with 20rpm (oscillation amplitude 30mm) after slow oscillation 7d, certain density Escherichia coli (Escherichia coli), staphylococcus aureus are added It is anti-after by heat damage to detect it for (Staphylococcus aureus) and bacillus subtilis (Bacillus subtilis) Bacterium performance, and be compared in creatinine detection reagent box common in the market.It the results are shown in Table 4:
Table 4: reagent anti-microbial property result after by heat damage
From above-mentioned test result it is found that reagent of the present invention is with good stability, can not only resist a degree of Heat damage, for common contaminating microorganisms, all has good anti-microbial property, sufficiently shows especially after heat damage Reagent of the present invention on the basis of the range of linearity is wide, has good resistance heat damage and Antimicrobial preservative performance in accuracy height.
Case study on implementation described above, separate embodiment only of the invention.It should be pointed out that for the common of the art For technical staff, under the premise of not departing from core of the invention technology, improvements and modifications can also be made, these improve and Retouching also should belong to scope of patent protection of the invention.With it is any in the comparable meaning and scope of claims of the present invention Change, is all considered as being included within the scope of the claims.

Claims (9)

1. a kind of creatinine enzyme process detection kit, it is characterised in that: the kit includes reagent R1 and reagent R2:
Reagent R1 composition are as follows:
Buffer: 10-100mmol/L,
Kreatinase: 1-100KU/L,
Sarcosine oxidase: 1-200KU/L,
Ascorbic acid oxidase: 1-100KU/L,
Bilirubin oxidase: 1-100KU/L,
TOOS (N- ethyl-N- (2-Hydroxy-3-sulfopropyl)-3-methylaniline sodium salt) 0.1-10mmol/L,
Peroxidase 1-100KU/L,
Stabilizer 1-50g/L,
Surfactant 0.1-1g/L,
Antibiotic antiseptic 0.1-10g/L;
Reagent R2 composition are as follows:
Buffer: 10-100mmol/L,
4-AA 0.1-10mmol/L,
Creatininase 1-1000KU/L,
Stabilizer 1-50g/L,
Surfactant 0.1-1.0g/L,
Antibiotic antiseptic 0.1-10g/L.
2. creatinine enzyme process detection kit according to claim 1, it is characterised in that: described in reagent R1 and reagent R2 Buffer be kaliumphosphate buffer, Tris buffer, HEPES buffer solution, PIPES buffer and MOPS in it is several or a kind of, And pH range is 7.0~8.8.
3. creatinine enzyme process detection kit according to claim 1, it is characterised in that: described in reagent R1 and reagent R2 Surfactant is nonionic surfactant.
4. creatinine enzyme process detection kit according to claim 3, it is characterised in that: described in reagent R1 and reagent R2 Surfactant is TWEEN Series, SPAN is serial, several or a kind of in specific surfactant in TRITON series, and concentration Range is 0.1-1.0g/L.
5. creatinine enzyme process detection kit according to claim 1, it is characterised in that: described in reagent R1 and reagent R2 Stabilizer is glycitols or protein matter.
6. creatinine enzyme process detection kit according to claim 5, it is characterised in that: the glycitols include sucrose, Trehalose, lactose, fructose, glycerol, mannitol, sorbierite it is several or a kind of, the protein matter is specially BSA.
7. enzyme process creatinine detection reagent according to claim 1, it is characterised in that: resist described in reagent R1 and reagent R2 Bacterium preservative is Allopelagic sterilizing peptide.
8. creatinine enzyme process detection kit according to claim 7, it is characterised in that: the Allopelagic sterilizing peptide is It is several or a kind of in horseshoe crab class antibacterial peptide, shellfish antibacterial peptide, shrimp antimicrobial peptide, fish antibacterial peptide and crab class antibacterial peptide, and concentration Range is 0.1-10g/L.
9. creatinine enzyme process detection kit according to claim 1, it is characterised in that: the reagent can be used for chronic diseases management Creatinine detection field.
CN201811266231.1A 2018-10-29 2018-10-29 Creatinine enzyme process detection kit Pending CN109406798A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201811266231.1A CN109406798A (en) 2018-10-29 2018-10-29 Creatinine enzyme process detection kit

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN201811266231.1A CN109406798A (en) 2018-10-29 2018-10-29 Creatinine enzyme process detection kit

Publications (1)

Publication Number Publication Date
CN109406798A true CN109406798A (en) 2019-03-01

Family

ID=65470127

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201811266231.1A Pending CN109406798A (en) 2018-10-29 2018-10-29 Creatinine enzyme process detection kit

Country Status (1)

Country Link
CN (1) CN109406798A (en)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111057744A (en) * 2019-12-31 2020-04-24 扬中酵诚生物技术研究有限公司 Creatinine kit and manufacturing process thereof
CN111272991A (en) * 2020-01-21 2020-06-12 苏州德沃生物技术有限公司 Antigen stabilizing agent
CN113075142A (en) * 2021-03-31 2021-07-06 长沙中生众捷生物技术有限公司 Creatinine test strip and application thereof
CN113514451A (en) * 2021-04-19 2021-10-19 深圳市锦瑞生物科技有限公司 Blood creatinine detection reagent ball and blood creatinine detection chip

Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101038289A (en) * 2006-03-15 2007-09-19 中国农业科学院上海家畜寄生虫病研究所 Test paper for rapid diagnosing livestocks schistosomiasis japonica
CN101042401A (en) * 2007-04-24 2007-09-26 艾博(武汉)生物技术有限公司 Dog anti rabies virus antibody colloidal gold immunochromatography assay detection reagent plate and preparation method thereof
CN101055274A (en) * 2007-06-08 2007-10-17 中国人民解放军军事医学科学院军事兽医研究所 Animal brucella antigen colloidal gold test paper film detection reagent kit
CN101988038A (en) * 2009-07-31 2011-03-23 广东中大南海海洋生物技术工程中心有限公司 Hippocampus antibiotic peptide pichia pastoris engineering strain and use thereof in breeding
CN102363784A (en) * 2011-10-14 2012-02-29 中国科学院烟台海岸带研究所 Ruditapes philippinarum Defensin B gene, its recombinant protein and application
US20120064083A1 (en) * 2003-05-08 2012-03-15 Abbott Biotherapeutics Corp. Therapeutic use of anti-cs1 antibodies
CN103278468A (en) * 2013-05-24 2013-09-04 宁波美康生物科技股份有限公司 Creatinine detection reagent
CN104198408A (en) * 2014-08-14 2014-12-10 上海睿康生物科技有限公司 Detection kit for determining content of creatinine in serum by enzymic method
CN104459164A (en) * 2014-11-28 2015-03-25 山东博科生物产业有限公司 Serum creatinine detecting reagent
CN107505470A (en) * 2017-08-10 2017-12-22 威特曼生物科技(南京)有限公司 Stable creatinine detection reagent box and its application method

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120064083A1 (en) * 2003-05-08 2012-03-15 Abbott Biotherapeutics Corp. Therapeutic use of anti-cs1 antibodies
CN101038289A (en) * 2006-03-15 2007-09-19 中国农业科学院上海家畜寄生虫病研究所 Test paper for rapid diagnosing livestocks schistosomiasis japonica
CN101042401A (en) * 2007-04-24 2007-09-26 艾博(武汉)生物技术有限公司 Dog anti rabies virus antibody colloidal gold immunochromatography assay detection reagent plate and preparation method thereof
CN101055274A (en) * 2007-06-08 2007-10-17 中国人民解放军军事医学科学院军事兽医研究所 Animal brucella antigen colloidal gold test paper film detection reagent kit
CN101988038A (en) * 2009-07-31 2011-03-23 广东中大南海海洋生物技术工程中心有限公司 Hippocampus antibiotic peptide pichia pastoris engineering strain and use thereof in breeding
CN102363784A (en) * 2011-10-14 2012-02-29 中国科学院烟台海岸带研究所 Ruditapes philippinarum Defensin B gene, its recombinant protein and application
CN103278468A (en) * 2013-05-24 2013-09-04 宁波美康生物科技股份有限公司 Creatinine detection reagent
CN104198408A (en) * 2014-08-14 2014-12-10 上海睿康生物科技有限公司 Detection kit for determining content of creatinine in serum by enzymic method
CN104459164A (en) * 2014-11-28 2015-03-25 山东博科生物产业有限公司 Serum creatinine detecting reagent
CN107505470A (en) * 2017-08-10 2017-12-22 威特曼生物科技(南京)有限公司 Stable creatinine detection reagent box and its application method

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111057744A (en) * 2019-12-31 2020-04-24 扬中酵诚生物技术研究有限公司 Creatinine kit and manufacturing process thereof
CN111272991A (en) * 2020-01-21 2020-06-12 苏州德沃生物技术有限公司 Antigen stabilizing agent
CN113075142A (en) * 2021-03-31 2021-07-06 长沙中生众捷生物技术有限公司 Creatinine test strip and application thereof
CN113075142B (en) * 2021-03-31 2023-10-03 复星诊断科技(长沙)有限公司 Creatinine test strip and application thereof
CN113514451A (en) * 2021-04-19 2021-10-19 深圳市锦瑞生物科技有限公司 Blood creatinine detection reagent ball and blood creatinine detection chip
CN113514451B (en) * 2021-04-19 2023-12-22 深圳市锦瑞生物科技股份有限公司 Blood creatinine detection reagent ball and blood creatinine detection chip

Similar Documents

Publication Publication Date Title
CN109406798A (en) Creatinine enzyme process detection kit
US11808776B2 (en) Method of analyzing diluted biological sample component
CN103278468B (en) A kind of creatinine detection reagent
CN102023158A (en) Method for enzymatically determining creatinine in serum by two steps
Amamcharla et al. Development of a rapid method for the measurement of lactose in milk using a blood glucose biosensor
CN107870170B (en) A kind of kit of luminol chemiluminescence analysis measurement glycated albumin
Atkins et al. Use of a portable point-of-care (Vetscan VS2) biochemical analyzer for measuring plasma biochemical levels in free-living loggerhead sea turtles (Caretta caretta)
CN101135688A (en) Method for measuring fructosamine NBT in blood serum
CN112029817B (en) Creatinine detection kit and application method thereof
CN104388530B (en) The lactate detection reagent that a kind of stability is strong
CN112710853B (en) Anti-interference and stable serum direct bilirubin (enzyme method) determination kit and preparation method and application thereof
Misdraji et al. Urinalysis: when—and when not—to order
CN106404686A (en) Antiheparin serum total bilirubin (vanadate oxidation method) detection kit
CN106443014B (en) Detection kit of ischemia modified albumin IMA and preparation method thereof
CN105223192B (en) A kind of glycated serum protein detection reagent and its application
Nielsen et al. An automated plasma D-lactate assay with a new sample preparation method to prevent interference from L-lactate and L-lactate dehydrogenase
CN103397076B (en) The application in the biochemical reagents of negative value or null value is there is in chlorate in preparation elimination measurement result
CN112710854B (en) Anti-interference and stable serum total bilirubin (enzyme method) determination kit and preparation method and application thereof
Noraddin et al. Measurement of Urinary Cystatin C with a Particle‐Enhanced Turbidimetric Immunoassay on Architect C i8200
JP3713901B2 (en) Method for measuring osteoclast-derived acid phosphatase
Kasidas Plasma and urine measurements for monitoring of treatment in the primary hyperoxaluric patient
khudhur Mohammad et al. Studies on bacteriological and biochemical tests of urinary tract infections in some Iraqi patients undergoing hemodialysis due to renal failure and chronic kidney diseases
CN103290097A (en) Gamma-glutamoyl transferase detection reagent
CN107817233A (en) A kind of method for detecting biotin enzyme enzymatic activity
Kayukov et al. Creatinin in the modern evaluation of the kidneys functional condition (literature review and own data)

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination
RJ01 Rejection of invention patent application after publication

Application publication date: 20190301

RJ01 Rejection of invention patent application after publication