CN108048525A - The kit of bleeding risk after a kind of detection thrombolysis - Google Patents

The kit of bleeding risk after a kind of detection thrombolysis Download PDF

Info

Publication number
CN108048525A
CN108048525A CN201711378493.2A CN201711378493A CN108048525A CN 108048525 A CN108048525 A CN 108048525A CN 201711378493 A CN201711378493 A CN 201711378493A CN 108048525 A CN108048525 A CN 108048525A
Authority
CN
China
Prior art keywords
thrombolysis
detection
kit
reagent
bleeding risk
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
CN201711378493.2A
Other languages
Chinese (zh)
Inventor
唐熠达
田间
王文尧
尤世杰
尤宏钊
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.)
Fuwai Hospital of CAMS and PUMC
Original Assignee
Fuwai Hospital of CAMS and PUMC
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 Fuwai Hospital of CAMS and PUMC filed Critical Fuwai Hospital of CAMS and PUMC
Priority to CN201711378493.2A priority Critical patent/CN108048525A/en
Publication of CN108048525A publication Critical patent/CN108048525A/en
Pending legal-status Critical Current

Links

Classifications

    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12QMEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/26Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving oxidoreductase
    • C12Q1/28Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving oxidoreductase involving peroxidase
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12QMEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/02Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving viable microorganisms
    • C12Q1/04Determining presence or kind of microorganism; Use of selective media for testing antibiotics or bacteriocides; Compositions containing a chemical indicator therefor
    • C12Q1/06Quantitative determination
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12QMEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/26Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving oxidoreductase
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12QMEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/34Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving hydrolase
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12QMEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/48Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving transferase
    • C12Q1/50Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving transferase involving creatine phosphokinase
    • 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
    • G01N33/5005Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells
    • G01N33/5008Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for testing or evaluating the effect of chemical or biological compounds, e.g. drugs, cosmetics
    • G01N33/5044Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for testing or evaluating the effect of chemical or biological compounds, e.g. drugs, cosmetics involving specific cell types
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/90Enzymes; Proenzymes
    • G01N2333/902Oxidoreductases (1.)
    • G01N2333/906Oxidoreductases (1.) acting on nitrogen containing compounds as donors (1.4, 1.5, 1.7)
    • G01N2333/9065Oxidoreductases (1.) acting on nitrogen containing compounds as donors (1.4, 1.5, 1.7) acting on CH-NH groups of donors (1.5)
    • G01N2333/90672Oxidoreductases (1.) acting on nitrogen containing compounds as donors (1.4, 1.5, 1.7) acting on CH-NH groups of donors (1.5) with oxygen as acceptor (1.5.3) in general
    • G01N2333/90677Oxidoreductases (1.) acting on nitrogen containing compounds as donors (1.4, 1.5, 1.7) acting on CH-NH groups of donors (1.5) with oxygen as acceptor (1.5.3) in general with a definite EC number (1.5.3.-)
    • G01N2333/90683Sarcosine oxidase (1.5.3.1)
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/90Enzymes; Proenzymes
    • G01N2333/914Hydrolases (3)
    • G01N2333/978Hydrolases (3) acting on carbon to nitrogen bonds other than peptide bonds (3.5)
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00Detection or diagnosis of diseases
    • G01N2800/22Haematology

Landscapes

  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Zoology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Wood Science & Technology (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • General Health & Medical Sciences (AREA)
  • Microbiology (AREA)
  • Analytical Chemistry (AREA)
  • Biotechnology (AREA)
  • Physics & Mathematics (AREA)
  • Biochemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Engineering & Computer Science (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Biomedical Technology (AREA)
  • Cell Biology (AREA)
  • Toxicology (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

The present invention relates to area of medical diagnostics, in particular to a kind of kit of bleeding risk after detection thrombolysis.The kit includes serum creatinine detection reagent and white blood cell count(WBC) reagent.The kit can quickly and accurately detect bleeding risk after thrombolysis, easy to operate, relatively low to the requirement of operating personnel's technology, and the reagent composition in kit is readily available, thus easily fabricated and popularization.

Description

The kit of bleeding risk after a kind of detection thrombolysis
Technical field
The present invention relates to area of medical diagnostics, in particular to a kind of kit of bleeding risk after detection thrombolysis.
Background technology
On bleeding risk quickly detects after thrombolysis at present, Serologic markers detection reagent or method can be used, such as Publication No. CN103901214A, publication date disclose a kind of acute for predicting for the Chinese patent application on July 2nd, 2014 The reagent of micro- bleeding occurs for Patients with Cerebral Infarction, and the reagent is by detection adiponectin, E-Selectin, S100B and soluble evening The reagent of any one or more composition in phase glycosylated end-product receptor sRAGE, is detected in Patients with Cerebral Infarction venous blood Adiponectin, E-Selectin, the content of S100B and soluble Advanced Glycation End Product Receptors, so as to which carly fruit drop patient is It is no that micro- bleeding may occur;Alternatively, such as Publication No. CN105203749 A, publication date is the China on December 30th, 2015 Patent application disclose it is a kind of assess the serum markers of risk of intracerebral hemorrhage and its application after thrombolysis, provide a kind of reagent Box, for detecting the Occludin albumen in human serum, rise and cerebral hemorrhage after thrombolysis are in just to the albumen in level in serum Risk of intracerebral hemorrhage is higher after correlation, the i.e. higher thrombolysis of the protein level;Alternatively, such as Publication No. CN106093412A, open Day discloses a kind of micro- bleeding after diagnosis acute cerebral infarction is prepared of peptide molecule for the Chinese patent application of 2016.11.09 Application in kit, the polypeptide answering in the kit of micro- bleeding after diagnosis acute cerebral infarction is prepared as detection target With negatively correlated with the incidence of micro- bleeding after patients acuity cerebral infarction, i.e., the peptide molecule is fewer, and Patients with Cerebral Infarction is more held Micro- bleeding easily occurs.
But the detection reagent or method there are the problem of be its more concern risk of intracerebral hemorrhage, go out for removing brain The bleeding of other vitals is without apparent Clinical significance of detecting outside blood, and such as hemorrhage of digestive tract severe haemorrhage also may be used after thromboembolism treatment Patient's prognosis mala can be caused, it is necessary to the positive remedy measures such as transfuse blood, in some instances it may even be possible to which there are life dangers;In addition, the above method It is complicated, it is necessary to special reagent/tool and method, it is more difficult to underdeveloped or with interventional treatment qualification hospital relative rarity Central and west regions or I and II medical institutions use.
Quickly to detect bleeding risk after thrombolysis, also assessed or simply according to patient age, property using clinical experience Not, weight carries out finding that the age increases bleeding risk increase after 10 years old thrombolysis in bleeding risk detection, such as GUSTO I researchs 1.3 times, bleeding risk is reduced to 80% after weight gain 10kg thrombolysis, and bleeding risk increases by 1.42 times after female patient thrombolysis. This detection method there are the problem of include:Each department medical level differs greatly, the related training that different stage doctor receives Difference is big, first, being difficult to bleeding after specification detection thrombolysis, with the subsequent treatment of control, causing can be with the patient of thrombolysis because worry goes out Blood risk and not all right treatment, at the same the high-risk patient of bleeding receive thrombolysis after there is even more serious complication;Second is that simple root Bleeding risk is carried out according to the simple layering at age, gender, weight to be assessed, although providing for clinical manipulation to a certain extent Reference, but still can not the detection patient of individuation receive the bleeding risk of thromboembolism treatment, and will clinically not increasingly Valued hematology label includes the scope of risk supervision.
In view of this, it is special to propose the present invention.
The content of the invention
It is an object of the invention to provide a kind of kit of bleeding risk after detection thrombolysis, to solve the above problems.
The present invention relates to a kind of kit of bleeding risk after detection thrombolysis, including serum creatinine detection reagent and leucocyte Count reagent.
The kit can rapidly and accurately detect bleeding risk after thrombolysis, easy to operate, to operating personnel's technology It is required that it is relatively low, and the reagent composition in kit is readily available, thus easily fabricated and popularization.
According to an aspect of the present invention, the invention further relates to serum creatinine detection reagents and white blood cell count(WBC) reagent to prepare Application after detection thrombolysis in the kit of bleeding risk.
According to an aspect of the present invention, the invention further relates to bleeding wind after a kind of ST sections of elevation thrombolysis in myocardial infarction of prediction The method of danger, including:
For meeting the patient of thromboembolism treatment indication, obtained using kit measurement as described above in patient's measuring samples Serum creatinine is horizontal and white blood cell count(WBC) data, transfer patient and symptom occur to consultation time, systolic pressure value and diabetes Above-mentioned all data are distinguished assignment and calculate gross score by the data that history whether there is, and the gross score is total with pre-establishing The correspondence of bleeding risk is compared to obtain bleeding risk knot after thrombolysis after-ST sections of elevation thrombolysis in myocardial infarction of fraction Fruit.
Description of the drawings
It, below will be to specific in order to illustrate more clearly of the specific embodiment of the invention or technical solution of the prior art Embodiment or attached drawing needed to be used in the description of the prior art are briefly described, it should be apparent that, in describing below Attached drawing is some embodiments of the present invention, for those of ordinary skill in the art, before not making the creative labor It puts, can also be obtained according to these attached drawings other attached drawings.
Fig. 1 be one embodiment of the present of invention provided in thrombolysis after bleeding risk forecasting system schematic diagram;
Fig. 2 be one embodiment of the present of invention provided in thrombolysis after bleeding risk forecasting system client typing Information interface schematic diagram;
Fig. 3 is the serum creatinine detection reagent operating process schematic diagram employed in one embodiment of the present of invention;
Fig. 4 is the Kurt theory of electrical impedance signal of the white blood cell count(WBC) reagent employed in one embodiment of the present of invention Figure;
Fig. 5 is leucocyte in the corresponding testing result of white blood cell count(WBC) reagent employed in one embodiment of the present of invention Volume distributed median histogram.
Specific embodiment
Embodiment of the present invention is described in detail in conjunction with the embodiments, it will be appreciated by those skilled in the art that The following example is merely to illustrate the present invention, and is not construed as limiting the scope of the invention.Actual conditions is not specified in embodiment Person, the condition suggested according to normal condition or manufacturer carry out.Reagents or instruments used without specified manufacturer, being can be with Conventional products that are commercially available.
The present invention relates to a kind of kit of bleeding risk after detection thrombolysis, including serum creatinine detection reagent and leucocyte Count reagent.
According to an aspect of the present invention, the invention further relates to serum creatinine detection reagents and white blood cell count(WBC) reagent to prepare Application after detection thrombolysis in the kit of bleeding risk.
Preferably, as described above to apply, bleeding is bleeding after ST sections of elevation thrombolysis in myocardial infarction after the thrombolysis.
Current main creatinine assay method have chemical assay (alkaline picrate method), enzyme process, high performance liquid chromatography (HPLC), Raman scattering method, isotope dilution mass spectrometry, capillary electrophoresis and electrode method etc..Isotope dilution mass spectrometry, Raman scattering Method, high performance liquid chromatography (HPLC) are not suitable for the analysis of high-volume clinical samples, generally only as the reference method of creatinine assay, institute Generally this method is not used to measure with clinical;Although capillary electrophoresis setting-out line scope is wide, operation is relatively simple, needs to use Special installation and the pretreatment for carrying out serum specimen, routine clinical use are more difficult;Alkaline picrate method and enzymatic assays creatinine By clinical institute's extensive use.Alkaline picrate method has carried out alkaline picrate method various due to the interference of false creatinine, people It improves, to improve the authenticity of measurement result, and realizes automated analysis, become clinically used detection method, but its line Property scope and antijamming capability are still not as good as enzyme process.Enzyme process kit interference resistance is stronger than picric acid method, and sample dosage is few, pollution It is few, suitable for automatic clinical chemistry analyzer.Thus preferred, the serum creatinine detection reagent is enzyme process serum creatinine detection reagent. Zymetology method is in the thrombolysis bleeding detection of the present invention, is had the characteristics that relatively stable and easily operated.
Preferably, the kit of bleeding risk or application, the serum creatinine detection reagent after detection thrombolysis as described above Including creatine kinase, kreatinase, sarcosine oxidase and peroxidase.
By screening, the present invention measures creatinine level using zymetology method.Creatinine generates flesh under sarcosine oxidase effect Propylhomoserin, sarcosine generate hydrogen peroxide under sarcosine oxidase effect, and the latter pacifies under hydrogen peroxide enzyme effect with 4- amino For than woods, ESPAS reaction generation colour generation product aubergine quinone imines, at 545nm absorbance is caused to increase, pass through monitoring The concentration for rising to measure creatinine of absorbance at 545nm.
Preferably, the kit of bleeding risk or application, the serum creatinine detection reagent after detection thrombolysis as described above Further include the one or more in reaction buffer, color developing agent, cleaning agent, preservative:
Preferably, the reaction buffer is trihydroxy methyl amino buffer solution, Goods buffer solutions, glycine-NaOH are buffered Liquid, N-2- hydroxyethyl piperazine-N'-2- ethanesulfonic acid buffers, N- tri- (methylol) methylamino -2- hydroxy-propanesulfonic acids buffer solution, N- Three (methylol) methyl-2-amino ethanesulfonic acid buffers, double (2- hydroxyethanesulfonic acids) buffer solutions of piperazine-N, N-, 3- morpholine -2s- Hydroxypropionate sodium buffer solution, 3- (N- morpholines) ethanesulfonic acid sodium buffer solution, 4- (2- ethoxys) piperazine -1-2- hydroxy-propanesulfonic acids Double (2- ethoxys) amino -2- hydroxy-propanesulfonic acids bufferings of buffer solution, N- (2- ethoxys) piperazine-N'-4- fourths sulfonate buffer, 3- Liquid, 3- (ring amine) -2- hydroxyl -1- propane sulfonic acid buffer solution, 4- (2- ethoxys) -1- piperazine propane sulfonic acid buffer solution, (ring is by 3- Amine) -1- propane sulfonic acid buffer solution, 3- N-morpholinyls buffer solution, the one of N- tri- (methylol) methyl-3-aminopropanesulfonicacid acid buffer solution Kind is several;
Preferably, the color developing agent is N- ethyls-N- (hydroxyl -3- sulfopropyls) meta-aminotoluene, potassium ferrocyanide and 4- Amino-antipyrine;
Preferably, the preservative is potassium sorbate, in sodium benzoate, sodium nitrite, Proclin series preservatives A kind of a kind of specific substance in specific substance or paraben esters;
It is furthermore preferred that the Proclin series preservative is Proclin300;
It is furthermore preferred that the paraben esters are methyl p-hydroxybenzoate, ethyl-para-hydroxybenzoate, para hydroxybenzene first One kind in propyl propionate, butyl p-hydroxybenzoate, p-Hydroxybenzoic acid isopropyl ester, p-Hydroxybenzoic acid isobutyl ester.
Preferably, serum creatinine detection reagent of the present invention is divided into the first reagent and the second reagent;
First reagent includes creatine kinase, kreatinase;
Second reagent includes sarcosine oxidase, peroxidase, N- ethyls-N- (hydroxyl -3- sulfopropyls) meta-aminotoluene (TOOS), 4-AA (PAP).
The detection sample that the serum creatinine detection reagent is detected can be serum or heparin blood plasma.
The stability of serum, blood plasma:4~25 DEG C of preservations can stablize 3 days.
Wherein, assay method principle is:
Absorption of the orchil of generation in 545nm is directly proportional to creatine concentration in sample.
Analysis type:End-point method deducts reagent blank;
Incubation time:5 minutes;
Reaction time:5 minutes;
The ratio of reagents of first reagent/sample/second:1800/60/600.Specifically used method is as shown in figure 3, absorbance becomes The calculation formula of change is:
Δ A=[(A2-A1) calibrates quality control or sample cell]-[(A2-A1) blank tubes].
The computational methods of concentration are:
C samples=(Δ A samples/Δ A calibrations) × C calibrations;
C samples:For the concentration of specimens of measure;
C standards:For the concentration of calibration object.
In addition, to further improve the accuracy of detection, one or more detection reagents or instrument can be combined for examining The diagnosis of bleeding risk after thought-read vascular diseases, especially thrombolysis.
Current white blood cell count(WBC) is detected can be divided into capacitive, photoelectric type, laser class and electrical impedance according to principle difference Type.Electrical impedance method detection leucocyte is Kurt (W.H.Coulter) invention by the U.S. earliest, is improved by decades, should Testing principle is verified repeatedly in clinical practice.
By screening, present invention preferably employs electrical impedance method white blood cell count(WBC) reagents, have for Kurt theory of electrical impedance Detect white blood cell count(WBC).According to Fig. 4, after quantitative blood is drawn and is diluted by quantitative conducting solution, just It is sent to sensing chamber.In each sensing chamber there are one small opening, it is called detection aperture.Have in the both sides of detection aperture logical There is the positive and negative electrode of constant current direct current.When diluted haemocyte by constant negative pressure act through detection aperture when, electricity D.C. resistance between pole will change.This resistance can form a kind of proportional pulse of same blood cell volume size and become Change.The distribution of particles that these data on pulse change being collected into can be used for one reflection size of blood cells of picture is bent Line.
Detector is distributed according to its volume size and is stored in corresponding when carrying out cell analysis, by the pulse of each cell Volume channel in, the data that each passage is collected are counted relative number, are represented in Y-axis, volume data is with ascend to heaven (fl) For unit, represent in X-axis.Leucocyte volume can be divided from 30~450fl for 256 passages, each passage 1.64fl, foundation Volume size is placed it in respectively in different passages, obtains the volume distributing histogram of leukocyte (as shown in Figure 5).
Preferably, the kit of bleeding risk or application, the white blood cell count(WBC) reagent after detection thrombolysis as described above Ingredient include potassium dihydrogen phosphate, disodium hydrogen phosphate, cetyl trimethylammonium bromide, disodium ethylene diamine tetraacetate, ammonium oxalate And glacial acetic acid.
It is furthermore preferred that the formula of the white blood cell count(WBC) reagent is:
Potassium dihydrogen phosphate:0.256~0.296g/L, disodium hydrogen phosphate:9.05~9.45g/L, disodium ethylene diamine tetraacetate: 15~25g/L, cetyl trimethylammonium bromide:7~8g/L, ammonium oxalate:15~25g/L, glacial acetic acid:20~30ml/L, it is molten Agent is water.
Preferably, the kit of bleeding risk or application, the white blood cell count(WBC) reagent after detection thrombolysis as described above Further include anti-coagulants;
Preferably, the anti-coagulants includes edta salt, heparinate, citrate, oxalates, hirudin, potassium fluoride, fluorination One or more in sodium;
It is furthermore preferred that the edta salt is specially the potassium, sodium or lithium salts of EDTA;
It is furthermore preferred that the heparinate is specially the sodium, lithium or ammonium salt of heparin;
It is furthermore preferred that the citrate is specially the sodium or sylvite of citric acid;
It is furthermore preferred that the oxalates is specially the sodium or sylvite of oxalic acid.
In some embodiments, white blood cell count(WBC) can carry out in the following way:
1) reagent.Reagent includes diluent ingredient and hemolytic agent ingredient, collocation method:First match somebody with somebody buffer solution, in a graduated cylinder, Claim 4.6 grams of potassium dihydrogen phosphate, add 500 milliliters of distilled water, pH value 5.5, take 30 milliliters it is spare.In another graduated cylinder, claim phosphoric acid hydrogen 9.5 grams of disodium adds 1000 milliliters of distilled water, after dissolving, takes out 30 milliliters and does not have to, pH value is controlled 8.5, by two graduated cylinder solution Mixing, pH value 8.5 claim 7.5 grams of cetyl trimethylammonium bromide, 20 grams of disodium ethylene diamine tetraacetate, 20 grams of ammonium oxalate, will be upper It states buffer solution and adds to 1000 milliliters, 25 milliliters of ice acetic acid again after heating for dissolving are filtered, filtrate pH value 5.5 to 5.8 with filter paper Between.The reagent of pre-configuration can be used for diluted blood cell, prevents blood cell aggregation and adhesion, for haemolysis red blood cell, beats Broken red blood cell, in favor of white blood cell count(WBC).
2) sample requirement:Venous blood collection uses EDTA-K2 anti-freezings.Capillary blood sampling should wipe First Blood, so as not to it is mixed Entering tissue fluid influences result.Collection of specimens is completed to measure after placing 5-10 minutes.
3) operating procedure:
A. small test tube 1 adds pre-configured leucocyte dilution+hemolytic agent 0.38ml.
B. 20 μ l of peripheral blood are accurately drawn with micropipet, wipe outside tip more than blood, will suction pipe be inserted into it is dilute in small test tube The bottom of liquid is released, gently releases blood, and draws supernatant liquor, cleaning suction pipe is secondary, mixing.
C. pond is filled, 2~3min is stood, treats that leucocyte passes through respective aperture.
D. white blood cell count(WBC) is carried out with Counting software.
4) calculate:It is quantified using the time, by the liquid volume in the unit interval is also constant when negative pressure is constant , deviation that may be present is corrected using the counting for being carried out continuously same time twice, by the result that this is counted twice compared to pair, It is quoted within the acceptable range as a result, carrying out third time counting if beyond normal acceptable scope.Utilize software pair Histogram is analyzed to judge.
According to an aspect of the present invention, the invention further relates to bleeding wind after a kind of ST sections of elevation thrombolysis in myocardial infarction of prediction The method of danger, including:
For meeting the patient of thromboembolism treatment indication, obtained using kit measurement as described above in patient's measuring samples Serum creatinine is horizontal and white blood cell count(WBC) data, transfer patient and symptom occur to consultation time, systolic pressure value and diabetes Above-mentioned all data are distinguished assignment and calculate gross score by the data that history whether there is, and the gross score is total with pre-establishing The correspondence of bleeding risk is compared to obtain bleeding risk knot after thrombolysis after-ST sections of elevation thrombolysis in myocardial infarction of fraction Fruit.
Preferably, the measuring samples include whole blood, serum or blood plasma.
Preferably, the method that above-mentioned all data distinguish assignment is by method as described above:
The following institute of correspondence of bleeding risk after-ST sections of elevation thrombolysis in myocardial infarction of the gross score pre-established Show:
According to an aspect of the present invention, the invention further relates to a kind of forecasting system of bleeding risk after thrombolysis, such as Fig. 1 institutes Show, the system comprises:
Admission controller, serum creatinine detection part, the first assignment module, white blood cell count(WBC) component, the second assignment module, sample This information receiving module, the 3rd assignment module and Risk Calculation module and reporting system main interface;
The admission controller is for assessing whether detected object meets thromboembolism treatment indication, will be by inspection pair if meeting The sample to be checked of elephant is passed to serum creatinine detection part and the white blood cell count(WBC) component, and starts the sample information and receive work( It can module;
The serum creatinine that the serum creatinine detection part is used to detect in the sample to be checked is horizontal, and serum creatinine is detected and is tied Fruit is passed to the first assignment module and carries out assignment;
The white blood cell count(WBC) component is for will carry out white blood cell count(WBC) in the sample to be checked, and by white blood cell count(WBC) knot Fruit is passed to the second assignment module and carries out assignment;
The sample information receiving module for receive detected object information and be passed to the 3rd assignment module into Row assignment;
The Risk Calculation module receives the first assignment module, the second assignment module and the 3rd assignment The assignment of module, and be calculated bleeding risk after thrombolysis according to the total score of each assignment;
The reporting system main interface is used to receive the sample information receiving module and/or the Risk Calculation mould The information of block, and bleeding risk assessment result after thrombolysis is exported.
Wherein, thromboembolism treatment indication can be judged according to standard well known in the art, such as:Heart of Europe disease in 2017 Learn to provide in the ST-Elevation Acute Myocardial Infarction practice guidelines formulated:If in diagnosis ST-Elevation Acute Myocardial Infarction Afterwards 2 it is small when it is interior cannot row emergency PCI in time, it is proposed that the patient of no clear and definite contraindication is after symptom appearance 12 interior carry out thromboembolism treatments when small.
The serum creatinine detection part can be that serum creatinine detection reagent as described above and this field routine serum creatinine are examined Survey pertinent instruments (particularly enzyme process serum creatinine detection pertinent instruments).
The white blood cell count(WBC) component can be white blood cell count(WBC) reagent as described above and this field conventional white cytometer Number pertinent instruments (particularly electrical impedance method white blood cell count(WBC) pertinent instruments).
The system when in use, only can be only shown in client for serum creatinine detection part described in typing, described white The interface of the output result of cell count component, and the interface also supports that being manually entered sample information receiving module is connect The information (as shown in Figure 2) of receipts, and other component and/or module are hidden in backstage.After information is inputted, click on " vertical Calculate " button, you can it enters information into the Risk Calculation module, the main boundary of reporting system is then directly displayed at client Face.
Preferably, after thrombolysis as described above bleeding risk forecasting system, controlled if the detected object does not meet thrombolysis Indication is treated, then information is directly exported the reporting system main interface and generates suggestion intervention or drug is controlled by the admission controller The report for the treatment of, while the system is closed by the admission controller.
Preferably, after thrombolysis as described above bleeding risk forecasting system, the first assignment module passes through with lower section Formula carries out assignment:
If 0 μm of ol/L≤88.4 μm of serum creatinine < ol/L, is scored at 0;
If 88.4 μm of ol/L≤176.8 μm of serum creatinine < ol/L, are scored at 5;
If serum creatinine >=176.8 are scored at 9.
Preferably, after thrombolysis as described above bleeding risk forecasting system, the second assignment module passes through with lower section Formula carries out assignment:
If white blood cell count(WBC)≤10 × 109, then it is scored at 0;
If white blood cell count(WBC)>10×109, then it is scored at 4.
Preferably, after thrombolysis as described above bleeding risk forecasting system, the detected object information, which further includes, to be examined , weight, nationality, eating habit, life style, medication history, history of disease, there is symptom to medical at gender in the photo of object, age One in time, household heredity factors, religious belief, heart condition, the Smoking And Drinking frequency, type of sports and the frequency, systolic pressure It is or multinomial;Preferably, the history of disease is diabetic history;
Preferably, the detected object information includes at least systolic pressure, diabetic history and symptom occurs to consultation time.
Wherein, in the present invention, systolic pressure, diabetic history and occur symptom to consultation time definition be art technology Well known to personnel, such as:
1) blood pressure measurement:A. patient takes clinostatism or seat, 5-10 minutes tranquil, and bilateral ancon is placed in heart level;B. it is Patient's turn-up cuff dew arm (ancon stretches, and palmar is upward);C. sphygmomanometer is placed, is made at mercury " 0 " scale with arteria brachialis, at heart In same level position, mercury cell switch is opened, drives residual air in sphygmomanometer girding to the greatest extent;D. twine cuff is smooth in upper arm Portion, lower edge are advisable away from fossa cubitalis 2-3CM, elastic referred to insertion one;E. arteria brachialis is touched, wears stethoscope, stethoscope head is put in the upper arm At arteriopalmus;F. valve screw-cap is closed, homogenous charge to auscultation brachial dance disappears, then raises 20-30mmHg.Slowly put Gas, speed 4mmHg/s, looks squarely reading, and it is systolic pressure to hear the beating of the first sound, and beating is changed voice/disappeared as diastolic pressure.
2) diabetes medical history confirms:Diabetes of previously clarifying a diagnosis or the person that receives diabetes drug treatment;After being admitted to hospital on an empty stomach Blood glucose >=7.0mmol/L (126mg/dl) or random plasma glucose >=11.1mmol/L (200mg/dl).
3) there is symptom to consultation time to confirm:There is symptom and be defined as before being this time admitted to hospital last breaking-out pectoralgia, uncomfortable in chest, dizzy It faints, consultation time is defined as the assessment time started, and chronomere is accurate to hour.
Preferably, after thrombolysis as described above bleeding risk forecasting system, the 3rd assignment module passes through with lower section Formula carries out assignment:
If systolic pressure < 90mmHg, are scored at 0;
If 90mmHg≤systolic pressure < 140mmHg, is scored at 3;
If 140mmHg≤systolic pressure < 180mmHg, is scored at 6;
If aglycosuria medical history, is scored at 0;
If there is diabetic history, 4 are scored at;
If 0h≤consultation time < 3h, is scored at 0;
If 3h≤consultation time < 6h, is scored at 2;
If consultation time >=6h, is scored at 4.
Preferably, after thrombolysis as described above bleeding risk forecasting system, the Risk Calculation module is according to each assignment Total score when be calculated bleeding risk after thrombolysis, the total score and the correspondence of bleeding risk after the thrombolysis For:
Preferably, after thrombolysis as described above bleeding risk forecasting system, the system also includes system personnel permissions Control module, control content include:
A) access right of each functional components of and/or module controls;
B) typings, examination & verification, printing, the personnel's permission differentiation for cancelling examination & verification;
C) defines artificial screen locking or locks screen automatically function without operation.
Preferably, after thrombolysis as described above bleeding risk forecasting system, the letter that the reporting system main interface is shown Breath include one in following content, it is multinomial or whole:
1) calls the detected object information in the specimen information receiving module and is shown;
2) record of date informations and modification function;
The date information includes:Sampling time, sample presentation time, instrument detection date, user information date of entry, reception Instrumental results date, audit report date, printed report date and send reporting day interim one or more.
3) calls bleeding risk evaluation word template displaying after thrombolysis, and provides modification authority;
4) printing and establish self-defined report template that is reported;Custom item includes detected object number, report Head, detected value, reference value, report picture, Health & Fitness Tip, auditor, printing people.
Preferably, after thrombolysis as described above bleeding risk forecasting system, bleeding risk is specially ST after the thrombolysis Bleeding risk after section elevation thrombolysis in myocardial infarction.
Finally it should be noted that:The above embodiments are only used to illustrate the technical solution of the present invention., rather than its limitations;To the greatest extent Pipe is described in detail the present invention with reference to foregoing embodiments, but it will be understood by those of ordinary skill in the art that:Its It can still modify to the technical solution recorded in foregoing embodiments either to which part or all technical characteristic Carry out equivalent substitution;And these modifications or replacement, the essence of appropriate technical solution is not made to depart from various embodiments of the present invention skill The scope of art scheme.

Claims (10)

1. the kit of bleeding risk after a kind of detection thrombolysis, which is characterized in that including serum creatinine detection reagent and leucocyte Count reagent.
2. the kit of bleeding risk after detection thrombolysis according to claim 1, which is characterized in that the serum creatinine detection Reagent is enzyme process serum creatinine detection reagent.
3. the kit of bleeding risk after detection thrombolysis according to claim 2, which is characterized in that the serum creatinine detection Reagent includes creatine kinase, kreatinase, sarcosine oxidase and peroxidase.
4. the kit of bleeding risk after detection thrombolysis according to claim 3, which is characterized in that the serum creatinine detection Reagent further includes the one or more in reaction buffer, color developing agent, cleaning agent, preservative:
Preferably, the reaction buffer for trihydroxy methyl amino buffer solution, Goods buffer solutions, glycine-NaOH buffer, N-2- hydroxyethyl piperazine-N'-2- ethanesulfonic acid buffers, N- tri- (methylol) methylamino -2- hydroxy-propanesulfonic acids buffer solution, N- tri- (methylol) methyl-2-amino ethanesulfonic acid buffer, piperazine-N, N- double (2- hydroxyethanesulfonic acids) buffer solution, 3- morpholine -2s-hydroxyl Base propanesulfonate buffer solution, 3- (N- morpholines) ethanesulfonic acid sodium buffer solution, 4- (2- ethoxys) piperazine -1-2- hydroxy-propanesulfonic acids delay Double (2- ethoxys) amino -2- hydroxy-propanesulfonic acids bufferings of fliud flushing, N- (2- ethoxys) piperazine-N'-4- fourths sulfonate buffer, 3- Liquid, 3- (ring amine) -2- hydroxyl -1- propane sulfonic acid buffer solution, 4- (2- ethoxys) -1- piperazine propane sulfonic acid buffer solution, (ring is by 3- Amine) -1- propane sulfonic acid buffer solution, 3- N-morpholinyls buffer solution, the one of N- tri- (methylol) methyl-3-aminopropanesulfonicacid acid buffer solution Kind is several;
Preferably, the color developing agent is N- ethyls-N- (hydroxyl -3- sulfopropyls) meta-aminotoluene, potassium ferrocyanide and 4- amino Antipyrine;
Preferably, the preservative is one kind in potassium sorbate, sodium benzoate, sodium nitrite, Proclin series preservatives A kind of specific substance in specific substance or paraben esters;
It is furthermore preferred that the Proclin series preservative is Proclin300;
It is furthermore preferred that the paraben esters are methyl p-hydroxybenzoate, ethyl-para-hydroxybenzoate, P-hydroxybenzoic acid third One kind in ester, butyl p-hydroxybenzoate, p-Hydroxybenzoic acid isopropyl ester, p-Hydroxybenzoic acid isobutyl ester.
5. the kit of bleeding risk after detection thrombolysis according to claim 1, which is characterized in that the white blood cell count(WBC) Reagent is electrical impedance method white blood cell count(WBC) reagent.
6. the kit of bleeding risk after detection thrombolysis according to claim 5, which is characterized in that the white blood cell count(WBC) The ingredient of reagent includes potassium dihydrogen phosphate, disodium hydrogen phosphate, cetyl trimethylammonium bromide, disodium ethylene diamine tetraacetate, grass Sour ammonium and glacial acetic acid.
7. the kit of bleeding risk after detection thrombolysis according to claim 6, which is characterized in that the white blood cell count(WBC) Reagent further includes anti-coagulants;
Preferably, the anti-coagulants is included in edta salt, heparinate, citrate, oxalates, hirudin, potassium fluoride, sodium fluoride One or more.
8. serum creatinine detection reagent and white blood cell count(WBC) reagent the answering in the kit of bleeding risk after detection thrombolysis is prepared With.
9. application according to claim 8, which is characterized in that bleeding is molten for ST sections of elevation myocardial infarctions after the thrombolysis Bleeding after bolt.
10. the method for bleeding risk after a kind of ST sections of elevation thrombolysis in myocardial infarction of prediction, which is characterized in that including:
For meeting the patient of thromboembolism treatment indication, usage right requires 1~7 any one of them kit measurement to obtain patient Serum creatinine level and white blood cell count(WBC) data in measuring samples, transfer patient and symptom occur to consultation time, systolic pressure value And the data that diabetic history whether there is, above-mentioned all data are distinguished into assignment and calculate gross score, by the gross score and in advance The correspondence of bleeding risk is compared to go out after obtaining thrombolysis after established gross score-ST sections of elevation thrombolysis in myocardial infarction Blood Risk Results;
Preferably, the measuring samples include whole blood, serum or blood plasma.
CN201711378493.2A 2017-12-19 2017-12-19 The kit of bleeding risk after a kind of detection thrombolysis Pending CN108048525A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201711378493.2A CN108048525A (en) 2017-12-19 2017-12-19 The kit of bleeding risk after a kind of detection thrombolysis

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN201711378493.2A CN108048525A (en) 2017-12-19 2017-12-19 The kit of bleeding risk after a kind of detection thrombolysis

Publications (1)

Publication Number Publication Date
CN108048525A true CN108048525A (en) 2018-05-18

Family

ID=62130217

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201711378493.2A Pending CN108048525A (en) 2017-12-19 2017-12-19 The kit of bleeding risk after a kind of detection thrombolysis

Country Status (1)

Country Link
CN (1) CN108048525A (en)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109287661A (en) * 2018-11-13 2019-02-01 武汉瀚海新酶生物科技有限公司 One kind being used for enzyme process creatinine reagent corrosion-resistant antiseptic composition
CN109557088A (en) * 2019-01-11 2019-04-02 四川沃文特生物技术有限公司 A kind of reagent card for detecting excrement lactose content and the excrement lactose detection method based on this
CN113640195A (en) * 2021-02-03 2021-11-12 深圳市帝迈生物技术有限公司 Kit and POCT blood cell analyzer

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103323582A (en) * 2013-06-18 2013-09-25 南京普朗医疗设备有限公司 Leukocyte classification hemolytic agent and kit thereof

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103323582A (en) * 2013-06-18 2013-09-25 南京普朗医疗设备有限公司 Leukocyte classification hemolytic agent and kit thereof

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
姚朱华等: "注射用重组人尿激酶原治疗急性 ST 段抬高型心肌梗死的疗效和安全性及影响因素分析", 《中国全科医学》 *
张示渊: "关于血清肌酐酶法分析特异性的几点讨论", 《临床检验杂志》 *
杨胜科: "《血液分析仪技术及应用》", 31 October 2002 *

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109287661A (en) * 2018-11-13 2019-02-01 武汉瀚海新酶生物科技有限公司 One kind being used for enzyme process creatinine reagent corrosion-resistant antiseptic composition
CN109557088A (en) * 2019-01-11 2019-04-02 四川沃文特生物技术有限公司 A kind of reagent card for detecting excrement lactose content and the excrement lactose detection method based on this
CN113640195A (en) * 2021-02-03 2021-11-12 深圳市帝迈生物技术有限公司 Kit and POCT blood cell analyzer

Similar Documents

Publication Publication Date Title
Lippi et al. Preanalytical variability: the dark side of the moon in laboratory testing
Gaw et al. Clinical Biochemistry E-Book: An Illustrated Colour Text
Wilding et al. Patterns of change for various biochemical constituents detected in well population screening
CN105452857B (en) Evaluate the Severity of illness index of chronic liver disease
Hohn et al. Childhood familial and racial differences in physiologic and biochemical factors related to hypertension.
CN101013137A (en) Reagent casing for detecting blood-lacking modification albumin and method thereof
CN108133754B (en) The forecasting system of bleeding risk after a kind of thrombolysis
JPH02263163A (en) Test agent for measuring density of seram fructosamine in sample derived from blood sample or blood
CN108048525A (en) The kit of bleeding risk after a kind of detection thrombolysis
CN108072618A (en) The forecasting system of mortality risk after a kind of heart infarction
US6277070B1 (en) Medical analysis and treatment method and system
Mascini et al. An L-lactate sensor with immobilized enzyme for use in in vivo studies with an endocrine artificial pancreas.
CN103293250B (en) Diabetic nephropathy diagnostic kit and application thereof
CN1318849C (en) Spectrophotometric measurement in color-based biochemical and immunologigal assays
WO2017006962A1 (en) Blood test kit and blood analysis method
US9547899B1 (en) Mobile hemolysis detection in whole blood samples
Torjman et al. Accuracy of the hemocue portable glucose analyzer in a large nonhomogeneous population
CN106556705A (en) A kind of enzyme-linked immunologic detecting kit of soluble ST2 and preparation method thereof
CN108267601B (en) The system and kit of adverse events after a kind of prediction heart infarction
RU2538219C2 (en) Method of determining platelet resistance to acetylsalicylic acid
Logan Evaluation of commercial kits
CN109470533A (en) A kind of preparation method of the source of people whole blood matrix quality-control product for portable glucose meter
CN103344768B (en) Ischemic heart disease detection kit and application thereof
CN107941722B (en) Blood sample analysis and test system
CN108181246A (en) The kit of mortality risk after a kind of prediction heart infarction

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
RJ01 Rejection of invention patent application after publication

Application publication date: 20180518