CN103185798A - Turbidimetric rapid detection kit for myocardial infarction nano-immunoenhancement and use method thereof - Google Patents
Turbidimetric rapid detection kit for myocardial infarction nano-immunoenhancement and use method thereof Download PDFInfo
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Abstract
The invention provides a turbidimetric rapid detection kit for myocardial infarction nano-immunoenhancement. The turbidimetric rapid detection kit comprises a reaction-detection integrated device, and a detection kit arranged in the reaction device, wherein a reagent R1, a reagent R2 and a calibrator are contained in the detection kit; simultaneously, quantitative detection for five important myocardial infarction-related biomarkers in one sample can be realized, and the five important biomarkers include content of troponin-I, content of D-dimer, content of myoglobin, content of hypersensitive C-reactive protein (hs-CRP) and content of heart-type fatty acid binding protein (FABP); and the turbidimetric rapid detection kit has an important clinical significance in the aspects of early diagnosis and disease course monitoring for myocardial infarction, treatment monitoring for medicines, and the like. The turbidimetric rapid detection kit provided by the invention realizes the integration of the reagents and the reaction device, and is simple, rapid and accurate to operate, high in sensitivity, strong in specificity, and low in detection cost; and the turbidimetric rapid detection kit is a detection/reagent measurement integrated kit suitable for outpatient and emergency treatment/clinical detection, and wide in instrument application range.
Description
Technical field
The present invention relates to disease fast detecting field, be specifically related to a kind of miocardial infarction quick detection kit and using method.
Background technology
1,700 ten thousand people that have an appointment global every year die from angiocardiopathy, and the acute myocardial infarction AMI of dying from over half is wherein arranged.The whole world 1,000 ten thousand routine myocardial infarction patients of having an appointment every year, wherein about 3,000,000 examples are acute myocardial infarction AMIs that the ST section is raised.In the U.S., 900,000 people that have an appointment every year have acute myocardial infarction (AMI), and before wherein about 22.5 ten thousand people died from and are admitted to hospital, its most death were arrhythmia caused.There are to surpass 2400 people and die from heart stalk comprehensive also many than cancer, chronic respiratory disease, diabetes and traffic hazard every day.
Behind the myocardial cell injury, the integrality of film and permeability changes, intracellular macromolecular substances is overflowed, and can be detected in blood circulation at last.These macromolecular substances are called as the myocardial damage mark, are called for short myocardium mark.Troponin-i (Troponin-I), D-dimer (D-dimer), myoglobins (Myoglobin), super quick C-reactive protein (hs-CRP) and H-FABP (FABP) are at present most widely used general.The testing result of these 5 indexs in various degree rising and change the physiological change can represent the infraction different phase, have the important clinical meaning to the early diagnosis of miocardial infarction, course of disease monitoring and to the aspects such as treatment monitoring of medicine.
In recent years, set up the detection method that the multiple valuable heart obstructs various indexs, mainly comprised: latex agglutination, enzyme linked immunological absorption (ELISA) method, fluorescence antibody detection method, immune-gold labeled method and latex immunoturbidimetry etc.
Latex agglutination is easy and simple to handle, quick, be applicable to that emergency treatment detects, but it can only be used for qualitative or semiquantitative determination, and the Chang Zuowei examination is used.Enzyme linked immunological absorption (ELISA) method accurately, quantitatively has very high susceptibility, but operates strictly and time-consuming, is not suitable for the needs of the diagnosis in time of emergency treatment and clinical patient and treatment.The fluorescence antibody detection method is to combine with fluoroscopic examination on the ELISA basis, the susceptibility height with the ELISA method good consistance is arranged, but instrument is expensive, be difficult at middle and small hospital, particularly in community clinic etc. through the specialized primary care website popularization of training of not testing.Immune-gold labeled method has the simple to operate, quick of latex agglutination, has ELISA method characteristic of accurate again, but rheumatoid factor, heparin and blood fat, quantitatively inaccurate is its maximum shortcoming.That the latex immunoturbidimetry has is easy and simple to handle, quick, quantitatively accurately, advantage such as susceptibility is high, special, can satisfy needs such as an emergency treatment, in clinical research, use more and more widely.But the commercial kit overall sensitivity of this method preparation of existing commercially available usefulness is not high, the uncork rear stability is not good enough.
Summary of the invention
The objective of the invention is at the fast nearly clinical diagnosis (POCT) of heart stalk, provide a kind of and can quantitatively detect Troponin-I, D-dimer, Myoglobin, hs-CRP, FABP content, reagent, reaction unit are integrated, simple to operate, quick, accurate, susceptibility is high, high specificity, detection cost are low, is applicable to an emergency treatment/nearly clinical detection and the widely applicable detection/integrated kit of mensuration reagent and using method thereof of instrument.
For achieving the above object, technical scheme provided by the invention is, a kind of miocardial infarction nano immune strengthens than turbid quick detection kit, it is characterized in that, comprise reaction detection integrated device and the detection kit that places reaction unit, in described detection kit, comprise R1 reagent, R2 reagent and calibration object;
Described R1 reagent comprises stabilizing agent, damping fluid, set accelerator and antiseptic;
Described R2 reagent comprises the latex particle of mark of many strains specificity mouse-anti human troponin-I(Troponin-I) or latex particle or the latex particle of the super quick C-reactive protein of many strains specificity mouse-anti people (hs-CRP) mark or latex particle, stabilizing agent, damping fluid and the antiseptic of many strains specificity mouse-anti popular feeling flesh fatty acid binding protein (FABP) mark of D-dimer (D-dimer) monoclonal antibody latex particle or many strains specificity mouse-anti human muscle hemoglobin (Myoglobin) mark;
Described calibration object is made up of in conjunction with albumen (FABP), stabilizing agent, damping fluid, excipient and antiseptic the recombinant protein myoglobins (Myoglobin) of the recombinant protein troponin-i (tropoinI) of purifying or fibrin degradation product (FDP) D-dimer (D-dimer) or purifying or the recombinant protein c RP of purifying or the reorganization cardiac muscle fat of purifying.
Preferably, described stabilizing agent is one or more in protein, inorganic salts, metal chelating agent, surfactant, suspending agent and the antioxidant.
Preferably, described stabilizing agent is selected from protein and inorganic salts.
Preferably, described stabilizing agent is selected from inorganic salts.
Preferably, the protein in the described stabilizing agent is selected from bovine serum albumin(BSA) or gelatin.
Preferably, the inorganic salts in the described stabilizing agent are selected from a kind of in sodium chloride, potassium chloride, sodium sulphate and the glazier's salt.
Preferably, described stabilizing agent is sodium chloride.
Preferably, the quality concentration of volume percent of described sodium chloride stabilizing agent is 0.7% ~ 0.9%.
Preferably, the metal chelating agent in the described stabilizing agent is selected from one or more in glycocoll, serine, arginine and the ethylenediamine tetraacetic acid.
Preferably, the surfactant in the described stabilizing agent is selected from one or more in polysorbas20, the polysorbate40.
Preferably, the suspending agent in the described stabilizing agent is selected from one or more in ethylene glycol, glycerine, lactose and the maltose.
Preferably, described damping fluid is selected from 3-[N, two (2-hydroxyethyl) amino of N-]-in damping fluid, phosphate buffer, imidazole buffer, glycine buffer and the barbital-HCl damping fluid of 2-hydroxy-propanesulfonic acid-NaOH (DIPSO-NaOH) damping fluid, 4-(2-hydroxyethyl)-1-piperazine propane sulfonic acid-sodium hydrate buffer solution (HEPPS-NaOH), N-2-hydroxyethyl piperazine-N-N-ethyl sulfonic acid-NaOH (HEPES-NaOH) damping fluid, trishydroxymethylaminomethane-HCl(Tris-HCl) one or more.
Comprise damping fluid in the R1 reagent of Troponin-I, Myoglobin, hs-CRP, D-dimer, FABP, requiring this damping fluid is that surge capability is to regulate the pH scope 7. 0 ~ 9. between 0.Under this requires, can select above-mentioned any damping fluid, two property ion damping fluids such as preferred DIPSO-NaOH, HEPPS-NaOH, HEPES-NaOH.Compare with other damping fluid, two property ion damping fluids have that surge capability is strong, solubleness is high, good biological fitness and reactionlessness, and pH changes very little advantage with temperature and dilution variation.Wherein the DIPSO-NaOH damping fluid is a kind of hydrogen ion buffering agent, can the long period the constant pH scope of control, therefore more preferably DIPSO-NaOH damping fluid.
Preferably, described 3-[N, two (2-hydroxyethyl) amino of N-]-2-hydroxy-propanesulfonic acid-sodium hydrate buffer solution final concentration is 10mmol/L ~ 70mmol/L, pH value scope is 7. 0 ~ 9. 0.
Preferably, described 3-[N, two (2-hydroxyethyl) amino of N-]-the best final concentration of 2-hydroxy-propanesulfonic acid-sodium hydrate buffer solution is 50mmol/L, pH value optimum range is 7.5 ~ 8.0.
Preferably, the set accelerator in the described R1 reagent is Macrogol 6000 or polyglycol 8000.
Preferably, the set accelerator in the described R1 reagent is polyglycol 8000, and its quality percent by volume final concentration is 2% ~ 6%.
Preferably, the set accelerator in the described R1 reagent is polyglycol 8000, and its quality percent by volume final concentration is 2%.
Preferably, described 5 kinds of detection reagent Troponin-I, D-dimer, Myoglobin, hs-CRP, FABP pass through chemical crosslink technique sensitization by mouse-anti people corresponding monoclonal antibody specific and Carboxylated Polystyrene latex particle in phosphate buffer, again through centrifugal, the washing after, at the 3-[N that contains stabilizing agent and antiseptic, two (2-hydroxyethyl) amino of N-]-disperse to form in 2-hydroxy-propanesulfonic acid-sodium hydrate buffer solution.
Preferably, described 3-[N, two (2-hydroxyethyl) amino of N-]-2-hydroxy-propanesulfonic acid-sodium hydrate buffer solution final concentration is 20 mmol/L ~ 40mmol/L, and pH value scope is 7. 0 ~ 9. 0, and the antibody latex particle final concentration of its sensitization is 1 mg/ml ~ 5mg/ml.
Preferably, described 3-[N, two (2-hydroxyethyl) amino of N-]-2-hydroxy-propanesulfonic acid-sodium hydrate buffer solution in contained stabilizer element and concentration be: ethylenediamine tetraacetic acid, the quality concentration of volume percent that the quality concentration of volume percent is 0.7% ~ 0.9% sodium chloride, concentration is 5 mmol/L ~ 20mmol/L is that 0.1% ~ 0.5% bovine serum albumin(BSA), concentration of volume percent are 0.1% ~ 0.6% polysorbas20, concentration of volume percent is 1% ~ 10% glycerine, the quality concentration of volume percent be 0.01% 2, the 6-BHT.
Preferably, described 3-[N, two (2-hydroxyethyl) amino of N-]-in 2-hydroxy-propanesulfonic acid-sodium hydrate buffer solution in the contained stabilizing agent, the quality percent by volume of sodium chloride the best is 0.8%.
Preferably, described 3-[N, two (2-hydroxyethyl) amino of N-]-in 2-hydroxy-propanesulfonic acid-sodium hydrate buffer solution in the contained stabilizing agent, the ethylenediamine tetraacetic acid optium concentration is 10 mmol/L.
Preferably, described 3-[N, two (2-hydroxyethyl) amino of N-]-in 2-hydroxy-propanesulfonic acid-sodium hydrate buffer solution in the contained stabilizing agent, the best in quality concentration of volume percent of bovine serum albumin(BSA) is 0.3%.
Preferably, described 3-[N, two (2-hydroxyethyl) amino of N-]-in 2-hydroxy-propanesulfonic acid-sodium hydrate buffer solution in the contained stabilizing agent, the optimal volume percent concentration of polysorbas20 is 0.2%.
Preferably, described 3-[N, two (2-hydroxyethyl) amino of N-]-in 2-hydroxy-propanesulfonic acid-sodium hydrate buffer solution in the contained stabilizing agent, the optimal volume percent concentration of glycerine is 5%.
Preferably, described chemical crosslinking in phosphate buffer is under the catalysis of carbodiimides (EDC), the amino on the antibody is linked on the carboxyl of polystyrene latex particle surface.
Preferably, described excipient is selected from one or more in sucrose, trehalose, sweet mellow wine, lactose, glucose and the maltose.
Preferably, the antiseptic in the described R1 reagent is selected from Sodium azide, 2-methyl-4-isothiazoline-3-ketone, one or more in 5-chloro-2-methyl-4-isothiazoline-3-ketone, thimerosal, phenol and the ethyl mercury sodium thiosulfate.
Preferably, described antiseptic is Sodium azide.
Preferably, described antiseptic is that concentration is 0. 1% Sodium azide.
Preferably, the reactant liquor 1(R1 of described 5 kinds of detection kit) be contained in reactant liquor 1(R1 separately respectively in advance) in the storage/colorimetric one cup.
Preferably, the reactant liquor of described 5 kinds of detection kit (R2) reagent is contained in reactant liquor 2(R2 separately respectively in advance) in the apotheca.
The present invention also provides a kind of using method of the kit for the fast detecting miocardial infarction, it is characterized in that described method step is as follows:
Step 3 is used than turbid instrument and is analyzed and report numerical value to gained solution in the step 2.
The invention has the beneficial effects as follows that reagent storage bottle and detection system unite two into one, and need not special training, need not uncork, need not to wait for, with to doing, do not waste reagent, really accomplished nearly clinical fast detecting.The early diagnosis of miocardial infarction, the aspects such as treatment monitoring that course of disease monitoring reaches medicine had the important clinical meaning.
Description of drawings
Fig. 1 is the structure of reactor synoptic diagram.
1:R1 storage/colorimetric one cup; The 11:R1 apotheca;
The 2:R2 cup; The 21:R2 apotheca;
3: the filling push rod.
Embodiment
Below in conjunction with specific embodiment, further set forth the present invention.Should be understood that these embodiment only to be used for explanation the present invention and be not used in and limit the scope of the invention.Should be understood that in addition after having read content of the present invention, those skilled in the art can make various changes or modifications the present invention, these equivalent form of values fall within the attached claims restricted portion of the application equally.
Be that 0.7% sodium chloride is as stabilizing agent by the quality concentration of volume percent, 3-[N, two (2-hydroxyethyl) amino of N-]-2-hydroxy-propanesulfonic acid-sodium hydrate buffer solution final concentration is 10mmol/L, set accelerator is polyglycol 8000, its quality percent by volume final concentration is 2%, antiseptic is that concentration is 0. 1% Sodium azide, is mixed with R1 reagent.
By the latex particle of mark of many strains specificity mouse-anti human troponin-I(Troponin-I), the quality concentration of volume percent is that 0.7% sodium chloride is as stabilizing agent, final concentration is the 3-[N of 10mmol/L, two (2-hydroxyethyl) amino of N-]-2-hydroxy-propanesulfonic acid-NaOH is damping fluid, antiseptic is that concentration is 0. 1% Sodium azide, is mixed with R2 reagent.
By the natural of purifying or recombinant protein troponin-i (Troponin-I), the quality concentration of volume percent is that 0.7% sodium chloride is as stabilizing agent, final concentration is the 3-[N of 10mmol/L, two (2-hydroxyethyl) amino of N-]-2-hydroxy-propanesulfonic acid-NaOH is damping fluid, antiseptic is that concentration is 0. 1% Sodium azide, sucrose is mixed with troponin-i (Troponin-I) examination criteria product as excipient.
During experiment, the R2 cup 2 in the Troponin-I reaction unit is extracted, add a certain amount of serum to be detected or blood plasma and with R1 reagent mixing in R1 apotheca 11; Then R2 cup 2 is docked again with R1 reaction cup 1; Filling push rod 3 by the R2 solution in its R2 apotheca 21 thoroughly is pressed in the R1 apotheca 11, and is made itself and the thorough mixing of R1; It is small-sized than in the turbid instrument to react 1 insertion of colorimetric one cup, reads and report numerical value automatically than turbid instrument.
The detection of troponin-i (Troponin-I)
Be that 0.9% sodium chloride is as stabilizing agent by the quality concentration of volume percent, 3-[N, two (2-hydroxyethyl) amino of N-]-2-hydroxy-propanesulfonic acid-sodium hydrate buffer solution final concentration is 70mmol/L, set accelerator is polyglycol 8000, its quality percent by volume final concentration is 6%, antiseptic is that concentration is 0. 1% Sodium azide, is mixed with R1 reagent.
By the latex particle of mark of many strains specificity mouse-anti human troponin-I(TroponinI), the quality concentration of volume percent is that 0.9% sodium chloride is as stabilizing agent, final concentration is the 3-[N of 70mmol/L, two (2-hydroxyethyl) amino of N-]-2-hydroxy-propanesulfonic acid-NaOH is damping fluid, antiseptic is that concentration is 0. 1% Sodium azide, is mixed with R2 reagent.
By the natural of purifying or recombinant protein troponin-i (Troponin-I), the quality concentration of volume percent is that 0.9% sodium chloride is as stabilizing agent, final concentration is the 3-[N of 70mmol/L, two (2-hydroxyethyl) amino of N-]-2-hydroxy-propanesulfonic acid-NaOH is damping fluid, antiseptic is that concentration is 0. 1% Sodium azide, trehalose is mixed with troponin-i (Troponin-I) examination criteria product as excipient.
Embodiment 3, the detection of troponin-i (Troponin-I)
Be that 0.8% sodium chloride is as stabilizing agent by the quality concentration of volume percent, 3-[N, two (2-hydroxyethyl) amino of N-]-2-hydroxy-propanesulfonic acid-sodium hydrate buffer solution final concentration is 50mmol/L, set accelerator is polyglycol 8000, its quality percent by volume final concentration is 4%, antiseptic is that concentration is 0. 1% Sodium azide, is mixed with R1 reagent.
By the latex particle of mark of many strains specificity mouse-anti human troponin-I(Troponin-I), the quality concentration of volume percent is that 0.8% sodium chloride is as stabilizing agent, final concentration is the 3-[N of 50mmol/L, two (2-hydroxyethyl) amino of N-]-2-hydroxy-propanesulfonic acid-NaOH is damping fluid, antiseptic is that concentration is 0. 1% Sodium azide, is mixed with R2 reagent.
By the natural of purifying or recombinant protein troponin-i (TroponinI), the quality concentration of volume percent is that 0.8% sodium chloride is as stabilizing agent, final concentration is the 3-[N of 50mmol/L, two (2-hydroxyethyl) amino of N-]-2-hydroxy-propanesulfonic acid-NaOH is damping fluid, antiseptic is that concentration is 0. 1% Sodium azide, glucose is mixed with troponin-i (Troponin-I) examination criteria product as excipient.
Embodiment 4, the detection of D-dimer (D-dimer)
Be that 0.7% sodium chloride is as stabilizing agent by the quality concentration of volume percent, 3-[N, two (2-hydroxyethyl) amino of N-]-2-hydroxy-propanesulfonic acid-sodium hydrate buffer solution final concentration is 20mmol/L, set accelerator is polyglycol 8000, its quality percent by volume final concentration is 3%, antiseptic is that concentration is 0. 1% Sodium azide, is mixed with R1 reagent.
By D-dimer (D-dimer) monoclonal antibody latex particle, the quality concentration of volume percent is that 0.7% sodium chloride is as stabilizing agent, final concentration is the 3-[N of 20mmol/L, two (2-hydroxyethyl) amino of N-]-2-hydroxy-propanesulfonic acid-NaOH is damping fluid, antiseptic is that concentration is 0. 1% Sodium azide, is mixed with R2 reagent.
D-dimer (D-dimer) by purifying, the quality concentration of volume percent is that 0.7% sodium chloride is as stabilizing agent, final concentration is the 3-[N of 20mmol/L, two (2-hydroxyethyl) amino of N-]-2-hydroxy-propanesulfonic acid-NaOH is damping fluid, antiseptic is that concentration is 0.1% Sodium azide, glucose is mixed with D-dimer (D-dimer) examination criteria product as excipient.
Embodiment 5, the detection of D-dimer (D-dimer)
Be that 0.75% sodium chloride is as stabilizing agent by the quality concentration of volume percent, 3-[N, two (2-hydroxyethyl) amino of N-]-2-hydroxy-propanesulfonic acid-sodium hydrate buffer solution final concentration is 30mmol/L, set accelerator is polyglycol 8000, its quality percent by volume final concentration is 4%, antiseptic is that concentration is 0. 1% Sodium azide, is mixed with R1 reagent.
By D-dimer (D-dimer) monoclonal antibody latex particle, the quality concentration of volume percent is that 0.75% sodium chloride is as stabilizing agent, final concentration is the 3-[N of 30mmol/L, two (2-hydroxyethyl) amino of N-]-2-hydroxy-propanesulfonic acid-NaOH is damping fluid, antiseptic is that concentration is 0.1% Sodium azide, is mixed with R2 reagent.
D-dimer (D-dimer) by purifying, the quality concentration of volume percent is that 0.7% sodium chloride is as stabilizing agent, final concentration is the 3-[N of 30mmol/L, two (2-hydroxyethyl) amino of N-]-2-hydroxy-propanesulfonic acid-NaOH is damping fluid, antiseptic is that concentration is 0.1% Sodium azide, glucose is mixed with D-dimer (D-dimer) examination criteria product as excipient.
Embodiment 6, the detection of D-dimer (D-dimer)
Be that 0.85% sodium chloride is as stabilizing agent by the quality concentration of volume percent, 3-[N, two (2-hydroxyethyl) amino of N-]-2-hydroxy-propanesulfonic acid-sodium hydrate buffer solution final concentration is 60mmol/L, set accelerator is polyglycol 8000, its quality percent by volume final concentration is 5%, antiseptic is that concentration is 0.1% Sodium azide, is mixed with R1 reagent.
By D-dimer (D-dimer) monoclonal antibody latex particle, the quality concentration of volume percent is that 0.85% sodium chloride is as stabilizing agent, final concentration is the 3-[N of 60mmol/L, two (2-hydroxyethyl) amino of N-]-2-hydroxy-propanesulfonic acid-NaOH is damping fluid, antiseptic is that concentration is 0.1% Sodium azide, is mixed with R2 reagent.
D-dimer (D-dimer) by purifying, the quality concentration of volume percent is that 0.7% sodium chloride is as stabilizing agent, final concentration is the 3-[N of 60mmol/L, two (2-hydroxyethyl) amino of N-]-2-hydroxy-propanesulfonic acid-NaOH is damping fluid, antiseptic is that concentration is 0.1% Sodium azide, maltose is mixed with D-dimer (D-dimer) examination criteria product as excipient.
Above-described only is cited preferred implementation of the present invention of coming out, and remaining preparation all according to said method changes in the concentration selectable range.
The invention has the beneficial effects as follows that reagent storage bottle and detection system unite two into one, and need not special training, need not uncork, need not to wait for, with to doing, do not waste reagent, really accomplished nearly clinical fast detecting.The early diagnosis of miocardial infarction, the aspects such as treatment monitoring that course of disease monitoring reaches medicine had the important clinical meaning.
More than be the description to the embodiment of the invention, by the above-mentioned explanation to the disclosed embodiments, make this area professional and technical personnel can realize or use the present invention.Multiple modification to these embodiment will be apparent concerning those skilled in the art, and defined General Principle can realize under the situation that does not break away from the spirit or scope of the present invention in other embodiments herein.Therefore, the present invention will can not be restricted to these embodiment shown in this article, but will meet the wideest scope consistent with principle disclosed herein and features of novelty.
Claims (14)
1. a miocardial infarction nano immune strengthens than turbid quick detection kit, it is characterized in that, comprises reaction detection integrated device and the detection kit that places reaction unit, comprises R1 reagent, R2 reagent and calibration object in described detection kit;
Described R1 reagent comprises stabilizing agent, damping fluid, set accelerator and antiseptic;
Described R2 reagent comprises the latex particle of mark of many strains specificity mouse-anti human troponin-I(troponin-I) or latex particle or the latex particle of the super quick C-reactive protein of many strains specificity mouse-anti people (hs-CRP) mark or the latex particle of many strains specificity mouse-anti popular feeling flesh fatty acid binding protein (FABP) mark of D-dimer (D-dimer) monoclonal antibody latex particle or many strains specificity mouse-anti human muscle hemoglobin (Myoglobin) mark, and stabilizing agent, damping fluid and antiseptic;
Described calibration object is by the natural or reorganization H-FABP (FABP) of natural or recombinant protein c RP or the purifying of natural or recombinant protein myoglobins (Myoglobin) or the purifying of the fibrin degradation product (FDP) D-dimer (D-dimer) of the natural of the purifying corresponding with R2 reagent or recombinant protein troponin-i (troponin-I) or purifying or purifying, and stabilizing agent, damping fluid, excipient and antiseptic are formed.
2. miocardial infarction nano immune as claimed in claim 1 strengthens than turbid quick detection kit, it is characterized in that described stabilizing agent is one or more in protein, inorganic salts, metal chelating agent, surfactant, suspending agent and the antioxidant.
3. strengthen than turbid quick detection kit as the arbitrary described miocardial infarction nano immune of claim 2, it is characterized in that, the inorganic salts in the described stabilizing agent are selected from a kind of in sodium chloride, potassium chloride, sodium sulphate and the glazier's salt.
4. miocardial infarction nano immune as claimed in claim 3 strengthens than turbid quick detection kit, it is characterized in that the quality concentration of volume percent of described sodium chloride stabilizing agent is 0.7% ~ 0.9%.
5. miocardial infarction nano immune as claimed in claim 2 strengthens than turbid quick detection kit, it is characterized in that the metal chelating agent in the described stabilizing agent is selected from one or more in glycocoll, serine, arginine and the ethylenediamine tetraacetic acid.
6. miocardial infarction nano immune as claimed in claim 2 strengthens than turbid quick detection kit, it is characterized in that the surfactant in the described stabilizing agent is selected from one or more in polysorbas20, the polysorbate40.
7. miocardial infarction nano immune as claimed in claim 1 strengthens than turbid quick detection kit, it is characterized in that, described damping fluid is selected from 3-[N, two (2-hydroxyethyl) amino of N-]-in 2-hydroxy-propanesulfonic acid-sodium hydrate buffer solution, 4-(2-hydroxyethyl)-1-piperazine propane sulfonic acid-sodium hydrate buffer solution, N-2-hydroxyethyl piperazine-N-N-ethyl sulfonic acid-sodium hydrate buffer solution, trishydroxymethylaminomethane-HCl damping fluid, phosphate buffer, imidazole buffer, glycine buffer and the barbital-HCl damping fluid one or more.
8. miocardial infarction nano immune as claimed in claim 7 strengthens than turbid quick detection kit, it is characterized in that, described 3-[N, two (2-hydroxyethyl) amino of N-]-2-hydroxy-propanesulfonic acid-sodium hydrate buffer solution final concentration is 10mmol/L ~ 70mmol/L, pH value scope is 7. 0 ~ 9. 0.
9. miocardial infarction nano immune as claimed in claim 1 strengthens than turbid quick detection kit, it is characterized in that described set accelerator is Macrogol 6000 or polyglycol 8000, and its quality percent by volume final concentration is 2% ~ 6%.
10. miocardial infarction nano immune as claimed in claim 1 strengthens than turbid quick detection kit, it is characterized in that, described 5 kinds of detection reagent Troponin-I, D-dimer, Myoglobin, hs-CRP, FABP pass through chemical crosslink technique sensitization by mouse-anti people corresponding monoclonal antibody specific and shuttle polystyrene latex particle in phosphate buffer, again through centrifugal, the washing after, at the 3-[N that contains stabilizing agent and antiseptic, two (2-hydroxyethyl) amino of N-]-disperse to form in 2-hydroxy-propanesulfonic acid-sodium hydrate buffer solution.
11. miocardial infarction nano immune as claimed in claim 10 strengthens than turbid quick detection kit, it is characterized in that, described 3-[N, two (2-hydroxyethyl) amino of N-]-2-hydroxy-propanesulfonic acid-sodium hydrate buffer solution final concentration is 20 mmol/L ~ 40mmol/L, pH value scope is 7. 0 ~ 9. 0, and the antibody latex particle final concentration of its sensitization is 1 mg/ml ~ 5mg/ml.
12. miocardial infarction nano immune as claimed in claim 10 strengthens than turbid quick detection kit, it is characterized in that, described 3-[N, two (2-hydroxyethyl) amino of N-]-2-hydroxy-propanesulfonic acid-sodium hydrate buffer solution in contained stabilizer element and concentration be: the quality concentration of volume percent is 0.7% ~ 0.9% sodium chloride, concentration is the ethylenediamine tetraacetic acid of 5 mmol/L ~ 20mmol/L, the quality concentration of volume percent is 0.1% ~ 0.5% bovine serum albumin(BSA), concentration of volume percent is 0.1% ~ 0.6% polysorbas20, concentration of volume percent is 1% ~ 10% glycerine, the quality concentration of volume percent be 0.01% 2, the 6-BHT.
13. miocardial infarction nano immune as claimed in claim 1 strengthens than turbid quick detection kit, it is characterized in that, the reactant liquor 1(R1 of described 5 kinds of detection kit) be contained in separately reactant liquor 1(R1 respectively in advance) in the storage/colorimetric one cup, the reactant liquor of described 5 kinds of detection kit (R2) reagent is contained in reactant liquor 2(R2 separately respectively in advance) in the apotheca.
14. a using method that is used for the kit of fast detecting miocardial infarction is characterized in that described method step is as follows:
Step 1 is a certain amount of serum to be detected or blood plasma and R1 reagent mixing;
Step 2 is with gained solution in the step 1 and R2 reagent mix;
Step 3 is used than turbid instrument and is analyzed and report numerical value to gained solution in the step 2.
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Cited By (17)
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| CN109254153A (en) * | 2018-08-27 | 2019-01-22 | 广东菲鹏生物有限公司 | The antioxidant of myoglobins and its application |
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| CN103389385A (en) * | 2013-08-07 | 2013-11-13 | 上海睿康生物科技有限公司 | Latex-coated troponin detection kit |
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| CN104597250A (en) * | 2015-01-21 | 2015-05-06 | 南京吉瑞康生物科技有限公司 | Latex enhanced immune turbidimetric kit for detecting content of human replication protein variants |
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| CN107389944A (en) * | 2017-07-31 | 2017-11-24 | 青岛辰达生物科技有限公司 | A kind of detection reagent for being used to detect myoglobins |
| CN107543931A (en) * | 2017-09-12 | 2018-01-05 | 四川新健康成生物股份有限公司 | Kit based on latex enhancing immune turbidimetry detection TnI and preparation method thereof |
| CN107543931B (en) * | 2017-09-12 | 2020-02-21 | 四川新健康成生物股份有限公司 | Kit for detecting TnI based on latex enhanced immunoturbidimetry and preparation method thereof |
| CN108459162A (en) * | 2018-02-07 | 2018-08-28 | 深圳赛斯鹏芯生物技术有限公司 | Detect the method and its kit of inflammation biomarker |
| CN109212199A (en) * | 2018-08-11 | 2019-01-15 | 金华市强盛生物科技有限公司 | A kind of Troponin I detection kit |
| CN109254153A (en) * | 2018-08-27 | 2019-01-22 | 广东菲鹏生物有限公司 | The antioxidant of myoglobins and its application |
| CN110286080A (en) * | 2018-10-25 | 2019-09-27 | 中国科学院苏州生物医学工程技术研究所 | Ejaculated sperm cells rapid typing detection reagent box and detection method |
| CN114761561A (en) * | 2019-11-29 | 2022-07-15 | 东洋纺株式会社 | Recombinant C-reactive protein |
| CN114761561B (en) * | 2019-11-29 | 2024-04-30 | 东洋纺株式会社 | Recombinant C-reactive protein |
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