CN107746804A - Coagulation and platelet function detection kit and its application for adding heparin blood sample - Google Patents
Coagulation and platelet function detection kit and its application for adding heparin blood sample Download PDFInfo
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- CN107746804A CN107746804A CN201711231754.8A CN201711231754A CN107746804A CN 107746804 A CN107746804 A CN 107746804A CN 201711231754 A CN201711231754 A CN 201711231754A CN 107746804 A CN107746804 A CN 107746804A
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING 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
- C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
- C12Q1/527—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving lyase
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/86—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood coagulating time or factors, or their receptors
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
- G01N2333/90—Enzymes; Proenzymes
- G01N2333/988—Lyases (4.), e.g. aldolases, heparinase, enolases, fumarase
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Abstract
The invention provides a kind of Coagulation and platelet function detection kit for addition heparin blood sample and its application, it is related to technical field of medical instruments.The detection kit includes reagent cup and detection probe, and the reagent cup is internally provided with bead and stirring rod；The reagent cup also includes a cup lid, and reagent cup is combined closely with cup lid, and cup lid center is provided with a groove and is used to install detection probe, contains Heparinase I inside the reagent cup.The detection kit can be detected using bead as activator by the method for Activation In Vitro blood coagulation to the Coagulation and platelet function for adding heparin blood sample, whether there is thrombotic danger to early detection patient, instruct anticoagulant therapy and component blood transfusion, the diagnosis of blood platelet relevant disease and treatment to have great significance, compensate for the deficiency detected in current in vitro study field to the Coagulation and platelet function for adding heparin blood of human body.
Description
Technical field
The present invention relates to technical field of medical instruments, more particularly, to a kind of blood coagulation for addition heparin blood sample and
Platelet function assay kit and its application.
Background technology
On-site rapid inspection (point-of-care testing, POCT) refer to it is being carried out in sampling location, using portable
Formula analytical instrument and matched reagent quickly obtain a kind of detection mode of testing result.On-site rapid inspection implication can be in terms of two
Understood：Spatially, the inspection carried out at one's side in patient, i.e., " examine by bed ", on the time, can carry out " real-time test ".
In recent years, due to the development of current new and high technology and the progress of medical science, and efficiently allegro work side
Formula so that there is laboratory apparatus miniaturization, simple operation, report that the POCT of result just-in-time increasingly receives the green grass or young crops of people
Look at.But be sent to laboratory after existing most coagulation analysis blood sampling and detected by automation Blood coagulation instrument, during turnover
Between it is long, censorship and store it is improper easily influence specimen quality.
Particularly in current in vitro study, in order that blood sample plays a part of anti-freezing, often will be to blood sample
Anti-coagulant heparin is added in this.These blood samples for adding heparin, the monitoring of platelet function are relative difficulties, state
It is interior to lack corresponding on-site rapid inspection technical support clinical detection.
Therefore, a kind of Coagulation and platelet function detection kit for addition heparin blood sample is researched and developed,
Compensate for the deficiency detected at present to the Coagulation and platelet function on-site rapid inspection class for adding heparin blood, and can be real-time
Coagulation process overall picture is shown with image format, reads activation whole blood coagulation time (ACT), blood coagulation speed (CR) and platelet function
The blood coagulation indexs of correlation such as parameter (PF), the blood coagulation to peri-operation period, which is monitored, becomes very necessary and urgent.
In view of this, it is special to propose the present invention.
The content of the invention
The first object of the present invention is to provide a kind of Coagulation and platelet function inspection for addition heparin blood sample
Test agent box, the detection kit can detect to the Coagulation and platelet function for adding heparin blood sample, and can
Coagulation process overall picture is shown with image format in real time, reads activation whole blood coagulation time, blood coagulation speed and platelet function parameter
Deng blood coagulation index of correlation, the blood coagulation to peri-operation period is monitored.
The second object of the present invention is to provide a kind of Coagulation and platelet function inspection for addition heparin blood sample
The application of test agent box, the detection kit can be widely applied to the sodium citrate anti-freezing of human body addition heparin blood sample
In the detection of the Coagulation and platelet function of whole blood and natural whole blood sample.
A kind of Coagulation and platelet function detection kit for addition heparin blood sample provided by the invention, it is described
Detection kit includes reagent cup and detection probe, and the reagent cup is internally provided with bead and stirring rod；
The reagent cup includes a cup lid, and reagent cup is combined closely with cup lid, cup lid center be provided with one it is recessed
Groove is used to install detection probe.
Further, Heparinase I is contained inside the reagent cup.
Further, the bead is the SiO of 5~35 μm of particle size2。
Further, the reagent cup, cup lid and detection probe are plastic material.
Further, the detection probe is strong, the highly polished plastics of toughness.
Further, the stirring rod has magnetic, and stirring rod length is less than the diameter of reagent cup.
Further, the reagent cup and the cup lid are to be detachably connected.
Further, the reagent cup with the cup lid by snapping connection.
Further, the kit also includes a box, and the box is mainly by test glass groove and detection probe
Groove forms.
A kind of Coagulation and platelet function detection kit for addition heparin blood sample provided by the invention is in people
In the Coagulation and platelet function detection of the sodium citrate anticoagulated whole blood and natural whole blood sample of body addition heparin blood sample
Using.
Compared with prior art, beneficial effects of the present invention are：
A kind of Coagulation and platelet function detection kit for addition heparin blood sample provided by the invention, it is described
Detection kit can be to the blood coagulation of addition heparin blood sample by the method for Activation In Vitro blood coagulation by activator of bead
And platelet function is detected, and coagulation process overall picture can be shown with image format in real time, read activation whole blood coagulation time
(ACT), the blood coagulation index of correlation such as blood coagulation speed (CR) and platelet function parameter (PF), whether there is thrombus to early detection patient
The danger of formation, anticoagulant therapy and component blood transfusion, the diagnosis of blood platelet relevant disease and treatment is instructed to have great significance, more
The deficiency detected in current in vitro study field to the Coagulation and platelet function for adding heparin blood of human body is mended.
In addition, the present invention is existing as one kind for the Coagulation and platelet function detection kit of addition heparin blood sample
Field quick detection, coagulation process overall picture can be shown with image format in real time, it is more timely, accurate to be provided than conventional detection
Bed by coagulation function assess, this for peri-operation period blood coagulation monitoring be very significant.
A kind of Coagulation and platelet function detection kit for addition heparin blood sample provided by the invention is answered
The sodium citrate anticoagulated whole blood and naturally entirely of human body addition heparin blood sample is can be widely applied to, the detection kit
In the Coagulation and platelet function detection of blood specimen.
Brief description of the drawings
, below will be to specific in order to illustrate more clearly of the specific embodiment of the invention or technical scheme of the prior art
The required accompanying drawing used is briefly described in embodiment or description of the prior art, it should be apparent that, in describing below
Accompanying drawing is some embodiments of the present invention, for those of ordinary skill in the art, before creative work is not paid
Put, other accompanying drawings can also be obtained according to these accompanying drawings.
Fig. 1 is the Coagulation and platelet function detection examination for addition heparin blood sample that the embodiment of the present invention 1 provides
The overall structure diagram of agent box；
Fig. 2 is the structural representation for the box that the embodiment of the present invention 1 provides；
Fig. 3 is the Coagulation and platelet function detection figure for the anti-freezing blood sample that effect example 1 of the present invention provides；
Fig. 4 is the Coagulation and platelet function detection figure for the natural whole blood sample that effect example 1 of the present invention provides.
Icon：1- reagent cups；2- detection probes；11- beades；12- stirring rod；13- cup lids；131- grooves；4- gloves
Box；41- test glass grooves；42- detection probe grooves.
Embodiment
Technical scheme is clearly and completely described below, it is clear that described embodiment is the present invention
Part of the embodiment, rather than whole embodiments.Based on the embodiment in the present invention, those of ordinary skill in the art are not having
The every other embodiment obtained under the premise of creative work is made, belongs to the scope of protection of the invention.
In the description of the invention, it is necessary to explanation, term " " center ", " on ", " under ", "left", "right", " vertical ",
The orientation or position relationship of the instruction such as " level ", " interior ", " outer " be based on orientation shown in the drawings or position relationship, merely to
Be easy to the description present invention and simplify description, rather than instruction or imply signified device or element must have specific orientation,
With specific azimuth configuration and operation, therefore it is not considered as limiting the invention.In addition, term " first ", " second ",
" the 3rd " is only used for describing purpose, and it is not intended that instruction or hint relative importance.
In the description of the invention, it is necessary to illustrate, unless otherwise clearly defined and limited, term " installation ", " phase
Even ", " connection " should be interpreted broadly, for example, it may be being fixedly connected or being detachably connected, or be integrally connected；Can
To be mechanical connection or electrical connection；Can be joined directly together, can also be indirectly connected by intermediary, Ke Yishi
The connection of two element internals.For the ordinary skill in the art, with concrete condition above-mentioned term can be understood at this
Concrete meaning in invention.
With reference to specific embodiments and the drawings, the invention will be further described.
Embodiment 1
Fig. 1 is the Coagulation and platelet function detection examination for addition heparin blood sample that the embodiment of the present invention 1 provides
The overall structure diagram of agent box；
As shown in figure 1, present embodiments provide a kind of Coagulation and platelet function inspection for addition heparin blood sample
Test agent box, the detection kit include reagent cup 1 and detection probe 2, and the reagent cup 1 is internally provided with the He of bead 11
Stirring rod 12；
The reagent cup 1 includes a cup lid 13, and reagent cup 1 is combined closely with cup lid 13, and the center of cup lid 13 is set
There is a groove 131 to be used to detection probe 2 be installed.
A kind of Coagulation and platelet function detection kit for addition heparin blood sample provided by the invention, it is described
Detection kit can be used for external solid phase for activator with bead 11 and promote to coagulate, and the negative electrical charge that its surface carries can activate solidifying
The blood material factor, so as to start endogenous blood coagulation system, make blood preparation quick solidification, and then the application principle is to adding heparinemia
The Coagulation and platelet function of liquid sample is detected, and can show coagulation process overall picture in real time with image format, reads activation
The blood coagulation indexs of correlation such as whole blood coagulation time (ACT), blood coagulation speed (CR) and platelet function parameter (PF), early detection is suffered from
Whether person has thrombotic danger, instructs anticoagulant therapy and component blood transfusion, the diagnosis of blood platelet relevant disease and treatment to have
Important meaning, compensate in current in vitro study field to add heparin blood of human body Coagulation and platelet function detect
Deficiency.
In the preferred embodiment of the present invention, Heparinase I is contained inside the reagent cup 1.
As a preferred embodiment, contain Heparinase I inside mentioned reagent cup 1, Heparinase I is that one kind can be with
The specific polysaccharide lyases of degraded heparin or heparan molecule.Reagent in the present invention can be used for high dose heparin levels
Sodium citrate anticoagulated whole blood and natural whole blood sample detection.The heparinase of addition is for the heparin in blood of degrading.The present invention
The characteristic that heparinase degraded heparin, bead 11 are activated to blood coagulation is combined, and devises a kind of containing applied to blood of human body
The preparation method of the Coagulation and platelet function detection kit of heparin.
In the preferred embodiment of the present invention, the bead 11 is the SiO of 5~35 μm of particle size2。
As a preferred embodiment, above-mentioned SiO2Bead 11 can be used for external solid phase as activator and promote
It is solidifying, SiO2The negative electrical charge that the surface of bead 11 carries can activate the blood coagulation substance factor, so as to start endogenous blood coagulation system, make blood
Liquid sample quick solidification.
In the preferred embodiment of the present invention, the reagent cup 1, cup lid 13 and detection probe 2 are plastics material
Matter.
As a preferred embodiment, mentioned reagent cup 1, cup lid 13 and detection probe 2 are plastic material, modeling is used
Material material obtained reagent cup 1, cup lid 13 and the light weight of detection probe 2 and firm, resistance to corrosion is strong, not with acid and alkali reaction
The advantages of.
Preferably, the plastics are that ABS plastic or food-grade PP expect.
It is furthermore preferred that the plastics are ABS plastic, ABS plastic is by the ternary of acrylonitrile, butadiene and styrene composition
Copolymer, it has the advantages of flexible, highly polished.
In the preferred embodiment of the present invention, the stirring rod 12 has magnetic, and the length of stirring rod 12 is less than examination
The diameter of agent cup 1.
As a preferred embodiment, there is stirring rod 12 of the present invention magnetic can apply in magnetic stirrer enter
Row automatic stirring.
In the preferred embodiment of the present invention, the reagent cup 1 and the cup lid 13 are to be detachably connected.
In the present embodiment, reagent cup 1 and cup lid 13 are using dismountable connection, i.e., the active link of cup lid 13 is in reagent cup 1
On.
Using detachable attachment structure, it is possible to increase the sealing property of detection kit of the present invention, reduce extraneous ring
Influence of the border for sample cavity.
In above-mentioned preferred embodiment, the reagent cup 1 is with the cup lid 13 by snapping connection.
As shown in Fig. 2 in the preferred embodiment of the present invention, the kit also includes a box 4, institute
Box is stated mainly to be made up of test glass groove 41 and detection probe groove 42.
As a preferred embodiment, mentioned reagent box also includes a box 4, the box is mainly by trying
Cup groove 41, detection probe groove 42 form, wherein, test glass groove 41 is used to place reagent cup 1, and probe slot 42 is used to place detection probe
2 and drier or freezer bag.
According to an aspect of the present invention, a kind of Coagulation and platelet function detection examination for addition heparin blood sample
Application of the agent box in the detection of the Coagulation and platelet function of human body sodium citrate anticoagulated whole blood and natural whole blood sample.
In the present invention, for adding the Coagulation and platelet function detection kit of heparin blood sample as a kind of scene
Quick detection, coagulation process overall picture can be shown with image format in real time, can be provided than conventional detection more timely, accurate
The other coagulation function of bed is assessed, and this blood coagulation monitoring for peri-operation period is very significant.
Effect example 1
As shown in Figure 3 and Figure 4, examination is detected for the Coagulation and platelet function of addition heparin blood sample using the present invention
Agent box, respectively to being detected containing 0,2.5, the natural whole blood sample of 5U/ml heparin levels and anti-freezing blood sample, wherein：Fig. 3 and
What the smoothed curve started in Fig. 4 represented is ACT change, i.e. activated coagulation time；The slope of curve of rising represents CR
Change, i.e. blood coagulation speed；Last curve peak cartographic represenation of area PF, i.e. platelet function.
The sample of each heparin levels is parallel to do 3 detections.Natural whole blood sample and anti-freezing blood sample heparin processing mode
Using external additive process, sample is same healthy individuals sample, and entering blood by adding heparin in vitro meets different heparin levels,
As a result shown in following Tables 1 and 2：
Table 1：
Table 2：
Drawn a conclusion by above-mentioned experiment：In the case of 0,2.5,5U/ml heparin are present, kit of the present invention detects blood coagulation
And during platelet function, for its ACT value in effective range, CR values differ smaller, PF value stabilizations.As can be seen here, heparin is deposited
Coagulation and platelet function detection is not being had influence on, and kit of the present invention can be used for the detection of high dose heparin blood sample.
Effect example 2
Gather the natural whole blood sample and anti-freezing blood sample totally 20 of hospital's different crowd.Wherein sequence number 1~7 is source
Natural whole blood and corresponding anti-freezing blood sample in people taking physical examination, sequence number 8-10 are from the disease for receiving anticoagulant therapy
People, sample is by 10 minutes after the injecting heparin natural whole bloods gathered and corresponding anti-freezing blood sample.Testing result is as follows：
Drawn a conclusion by above-mentioned experiment：1~7 natural whole blood of sequence number and anti-freezing blood sample due to from healthy population,
Its ACT values measured, CR values, PF values are in normal range (NR).Sequence number 8 derives from the patient through anticoagulant therapy, the ACT values measured,
CR values, PF values be not in normal range (NR).Sequence number 9 and 10 derives from the patient through anticoagulant therapy, but the anticoagulant therapy received is low
Dosage anticoagulant therapy, the ACT values measured, CR values, PF values are in normal range (NR).Come with reference to the testing result of this 20 clinical cases
See, the detection kit that preparation method of the present invention obtains can be very good the detection applied to clinical samples.
Finally it should be noted that：Various embodiments above is merely illustrative of the technical solution of the present invention, rather than its limitations；To the greatest extent
The present invention is described in detail with reference to foregoing embodiments for pipe, it will be understood by those within the art that：Its according to
The technical scheme described in foregoing embodiments can so be modified, either which part or all technical characteristic are entered
Row equivalent substitution；And these modifications or replacement, the essence of appropriate technical solution is departed from various embodiments of the present invention technology
The scope of scheme.
Claims (10)
- A kind of 1. Coagulation and platelet function detection kit for addition heparin blood sample, it is characterised in that the inspection Test agent box includes reagent cup (1) and detection probe (2), and the reagent cup (1) is internally provided with bead (11) and stirring rod (12)；The reagent cup (1) includes a cup lid (13), and reagent cup (1) is combined closely with cup lid (13), cup lid (13) centre bit Install and be equipped with a groove (131) for installing detection probe (2).
- 2. detection kit according to claim 1, it is characterised in that contain Heparinase I inside the reagent cup (1).
- 3. detection kit according to claim 1, it is characterised in that the bead (11) is the μ of particle size 5~35 M SiO2。
- 4. detection kit according to claim 1, it is characterised in that the reagent cup (1), cup lid (13) and detection are visited Pin (2) is plastic material.
- 5. detection kit according to claim 4, it is characterised in that the detection probe (2) is that toughness is strong, finish High plastics.
- 6. detection kit according to claim 1, it is characterised in that the stirring rod (12) has magnetic, stirring rod (12) length is less than the diameter of reagent cup (1).
- 7. detection kit according to claim 1, it is characterised in that the reagent cup (1) and the cup lid (13) are It is detachably connected.
- 8. detection kit according to claim 7, it is characterised in that the reagent cup (1) is logical with the cup lid (13) Cross and snap connection.
- 9. according to the detection kit described in any one of claim 1~8, it is characterised in that the kit also includes one Box (4), the box are mainly made up of test glass groove (41) and detection probe groove (42).
- 10. a kind of detection kit according to any one of claim 1~9 is in the citron of human body addition heparin blood sample Application in the detection of the Coagulation and platelet function of sour sodium anticoagulated whole blood and natural whole blood sample.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711231754.8A CN107746804A (en) | 2017-11-28 | 2017-11-28 | Coagulation and platelet function detection kit and its application for adding heparin blood sample |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711231754.8A CN107746804A (en) | 2017-11-28 | 2017-11-28 | Coagulation and platelet function detection kit and its application for adding heparin blood sample |
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| CN107746804A true CN107746804A (en) | 2018-03-02 |
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| CN201711231754.8A Pending CN107746804A (en) | 2017-11-28 | 2017-11-28 | Coagulation and platelet function detection kit and its application for adding heparin blood sample |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109709292A (en) * | 2018-12-29 | 2019-05-03 | 贵州金玖生物技术有限公司 | A kind of heparin detection kit and its application |
| CN112941143A (en) * | 2021-01-28 | 2021-06-11 | 南京可诺医疗技术有限公司 | Simple and convenient reagent for detecting blood coagulation and platelet functions and application thereof |
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| US5451509A (en) * | 1990-04-17 | 1995-09-19 | Analytical Control Systems, Inc. | Coagulation assays and reagents |
| US5972712A (en) * | 1997-04-30 | 1999-10-26 | Medtronic, Inc. | Heparin-independent, high sensitivity platelet function evaluation technique |
| US20040224416A1 (en) * | 2003-05-06 | 2004-11-11 | Jyotsna Ghai | Method and kit for testing a multi-channel blood assay cartridge |
| US20050233466A1 (en) * | 2004-04-19 | 2005-10-20 | Wright David W | Blood coagulation test cartridge, system, and method |
| WO2007072197A1 (en) * | 2005-12-23 | 2007-06-28 | Dsm Ip B.V. | Methods and systems for detecting and quantifying indirect thrombin inhibitors |
| CN102980993A (en) * | 2012-11-06 | 2013-03-20 | 北京乐普医疗科技有限责任公司 | Platelet aggregation function detection kit and detection method |
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2017
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Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5451509A (en) * | 1990-04-17 | 1995-09-19 | Analytical Control Systems, Inc. | Coagulation assays and reagents |
| US5972712A (en) * | 1997-04-30 | 1999-10-26 | Medtronic, Inc. | Heparin-independent, high sensitivity platelet function evaluation technique |
| US20040224416A1 (en) * | 2003-05-06 | 2004-11-11 | Jyotsna Ghai | Method and kit for testing a multi-channel blood assay cartridge |
| US20050233466A1 (en) * | 2004-04-19 | 2005-10-20 | Wright David W | Blood coagulation test cartridge, system, and method |
| WO2007072197A1 (en) * | 2005-12-23 | 2007-06-28 | Dsm Ip B.V. | Methods and systems for detecting and quantifying indirect thrombin inhibitors |
| CN102980993A (en) * | 2012-11-06 | 2013-03-20 | 北京乐普医疗科技有限责任公司 | Platelet aggregation function detection kit and detection method |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109709292A (en) * | 2018-12-29 | 2019-05-03 | 贵州金玖生物技术有限公司 | A kind of heparin detection kit and its application |
| CN112941143A (en) * | 2021-01-28 | 2021-06-11 | 南京可诺医疗技术有限公司 | Simple and convenient reagent for detecting blood coagulation and platelet functions and application thereof |
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