CN105092864A - 3-level thrombelastogram quality control product and application thereof - Google Patents
3-level thrombelastogram quality control product and application thereof Download PDFInfo
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Abstract
The invention relates to the field of quality control of blood coagulation testing items and provides a 3-level thrombelastogram quality control product. The quality control product is prepared by the following steps: respectively mixing pig blood with 3 different concentrations of sodium citrate, centrifuging, taking blood plasma, respectively adding a coagulation activator and a tissue factor and lyophilizing to prepare a powdery quality control product I, adding a coagulation activator and lyophilizing to prepare a powdery quality control product II, and adding a coagulation activator and human lyophilized platelets and lyophilizing to prepare a powdery quality control product III. The 3-level thrombelastogram quality control product provided by the invention is shaped as a lyophilized powder, can be used to monitor R and MA values simultaneously, is better used for quality control of an thromboelastography instrument and a thrombelastogram detection kit, is fast to detect, has accurate results and is simple to operate.
Description
Technical field
The present invention relates to detection of blood coagulation project integration field, particularly a kind of 3 horizontal thrombelastogram quality-control product and application thereof for thrombelastogram instrument or thrombelastogram detection kit.
Background technology
Average of operation periods blood product infusion is one of important method ensureing surgery patients peri-operation period safety.Along with the development of China's medical career, amount for surgical constantly promotes, and peri-operation period blood product demand also constantly increases thereupon, and the problem of blood product scarcity of resources highlights day by day.For the existing more objective standard of the indication of red blood cell transfusion in current world wide, but it is as quite different in Fresh Frozen blood dress, cryoprecipitate and hematoblastic infusion indication to correct the relevant blood product of coagulation function.Tradition coagulation function detects (conventionalcoagulationtests, CCT) index, mainly comprise prothrombin time (prothrombintime, PT), partial thromboplastin time (the activatedpartialthromboplastintime of activation, APTT), International Normalised ratio (internationalnormalizedratio, INR), fibrinogen (fibrinogen, and platelet count (plateletcount FBG), PLT) be widely used at present clinical, reference frame is provided for correcting coagulation function associated blood goods infusion.But, it is longer that CCT project obtains testing result required time, at-once monitor cannot be realized, and every index only reflects a part for patients Wits, can do nothing to help the overall coagulation function situation that clinician understands patient, therefore, the infusion indication of correcting coagulation function associated blood goods lacks unified objective standard always, micro-judgment still mainly with clinician is mainly instruct according to (TransfusionPB.105:1,2006).In order to more reasonably apply limited blood product resource, finding the method for more fast, accurate and comprehensive monitoring Blood Coagulation, instructing the use correcting coagulation function associated blood goods to be very necessary.
Blood examination elastic force figure (thrombelastography, TEG) mainly detects at the clinical coagulation function for whole blood sample.Thrombelastogram sample is the whole blood sample of patient, and during detection, the whole blood sample of patient is placed in sample cup, the test rod connecting motional induction and conducting system is inserted sample cup, detects after sample is activated by porcelain earth under the constant temperature of 37 DEG C.Sample cup is with the angular velocity uniform rotation of 4 degree 45 points, and the resistance that test rod then responds to sample motion line item of going forward side by side produces graphy figure and parameter (ReikvamH, SteienE, HaugeB etc., 40:2,2009).Graphy figure is roughly divided into two parts, blood coagulation stage and fibrinolytic stage.In the blood coagulation stage, the R time rises to 2mm required time for detection is initial to curve amplitude, and corresponding multiple clotting factor progressively activates and causes fibrin to start the process formed.The K time is that curve amplitude rises to 20mm required time by 2mm, corresponding fibrin crosslinked and with hematoblastic interaction.A angle is the tangent line of graphy figure maximum curve radian and horizontal angle, jointly reflects fibrin and hematoblastic interaction with the K time, becomes important Substitute Indexes when the serious low solidifying K value of patient cannot be measured.Peak swing (maximumamplitude, MA) is graphy figure crest amplitude, and corresponding clot maximum intensity, interacts relevant with PC, platelet function and platelet-fibrin.Clot just enters the fibrinolytic stage after reaching maximum intensity, wherein comparatively conventional index is Ly30 and Ly60, represent the number percent of thrombus fibrinolytic when graphy figure to reach after MA 30 minutes and 60 minutes respectively, calculated by the area under curve reduced, the thrombolytic degree of reaction fibrinolysin.TEG detects and exports schematic diagram as shown in Figure 1.The sludged blood morphological change that existing research electron microscopic observation TEG graphy figure different time points is corresponding, demonstrates the meaning (KawasakiJ, KatoriN, KodakaM, 99:5,2004) of above index.If add appropriate tissue factor to promote that coagulation process starts in TEG sample cup, then can save time further.
There is many advantages because TEG compares CCT, mainly comprise: (1) can be formed until the overall process of Fibrinolysis from sludged blood by reflected sample blood, more comprehensive than CCT; (2) its Testing index can interaction between anti-clotting factor, fibrinogen and blood platelet, more fully can show the overall blood coagulation situation of clinical middle patient; (3) existing test proves that the early stage index of TEG is as R, K and PT, APTT significant correlation, late period, index was as A angle, MA and PT, APTT and PLT significant correlation, but TEG test findings produces speed significantly faster than CCT, can immediately reflect patients Wits (CottonBA, FazG, HatchQM, 71:2,2011), better for quick guiding clinical treatment decision-making; (4) detect and can carry out bed is other, testing result can simultaneous display in face of clinician and experimental technique person, increase work efficiency.Therefore, TEG has more and more been applied to clinical, especially at openheart surgery (PlotkinAJ, WadeCE, JenkinsDH, 64:2,2008), liver transfer operation (GurusamyKS, 12:1,2011), emergency (SchochIH, NienaberU, MaegeleM, 15:R83,2011) etc. may occur in the disease of severe coagulation disorder, TEG instructs clinical decision to reducing composition transfusion volume, improve patient's prognosis, reduce the research of the aspects such as amount of bleeding and all obtained certain achievement.Intraoperative hemorrhage is the key factor affecting patients Wits, and the coagulation function of patient with operation is then the important reference index of peri-operation period, has substantial connection with patient's intraoperative hemorrhage and prognosis.CCT, due to above-mentioned restriction, fails to be widely used in the monitoring of patients Wits in art.TEG compensate for many deficiencies of CCT, and future may be the fine selection that patient with operation Perioperative Coagulation Function is monitored.Just publish an article as far back as AnesthesiaandAnalgesia magazine in 1987 and illustrated that the hemorrhage impact on coagulation function can obtain reflecting (TumanKJ, 66:9,1987) by the change of TEG index.The people such as Madsen in 2012 propose TEG index especially and can be used for predicting blood loss volume during the operation, for TEG provides new direction (MadsenDE, 70:10,2012) in the application of peri-operation period in the research aligning song operation patients.As can be seen here, TEG will probably become the important reference of correcting coagulation function associated blood goods infusion indication future.
Therefore, the Stability and veracity of thrombelastogram instrument just seems very important.The quality-control product detecting thrombelastogram instrument stability also just becomes the key of thrombelastogram in clinical practice.The present inventors are devoted to seek a kind of quality-control product that effectively can detect thrombelastogram instrument accuracy, repeatability and stability fast, calibrate and debug thrombelastogram instrument, more excellent to obtaining quality, the thrombelastogram instrument that Detection results is better.Thus provide more secure service and treatment for hospital clinical and patient.
But, at present also not about the report adopting single animal blood plasma Swine plasma to prepare 3 horizontal thrombelastogram quality-control products, therefore, the present invention's first time openly prepares the methods and applications of 3 horizontal thrombelastogram quality-control products by adding the agent of variable concentrations citrate anticoagulation in pig blood.
Summary of the invention
Not enough for prior art, the object of this invention is to provide a kind of 3 horizontal thrombelastogram quality-control products, effectively can detect the quality-control product of thrombelastogram instrument accuracy, repeatability and stability fast.
For achieving the above object, the invention provides a kind of 3 horizontal thrombelastogram quality-control products not mixed with the sodium citrate of 3 kinds of variable concentrations by pig blood system, centrifugal, get blood plasma, coagulation activation agent is added respectively and tissue factor freeze-drying obtains Powdered quality-control product I in 3 parts of blood plasma, add coagulation activation agent freeze-drying and obtain Powdered quality-control product II, add coagulation activation agent and lyophilized platelet freeze-drying obtains Powdered quality-control product III.3 horizontal quality-control products energy realize carrying out quality control to thrombelastogram instrument and detection kit thereof from clotting time (R) and clot strength (MA) two aspects simultaneously, have more practical value and validity compared to 2 horizontal quality-control products.
Preferably, described centrifugal be low-speed centrifugal, best with centrifugal 5 minutes of 4000r/min, the object of low-speed centrifugal is that the albumen such as the fibrin ferment prevented in blood plasma, clotting factor is centrifuged out, thus affects the use of quality-control product.
Preferably, the mass ratio that described pig blood mixes with described sodium citrate is 1:9, and this ratio is the optimal proportion of anti-coagulants and blood, adopts the blood of the anti-freezing of this ratio or blood plasma can realize after adding calcium ion multiple solidifying.
Preferably, in described quality-control product I, the concentration of sodium citrate is 2%, in described quality-control product II, the concentration of sodium citrate is 3%, in described quality-control product III, the concentration of sodium citrate is 4%, in the quality-control product of 3 levels, the concentration of sodium citrate is respectively 2%, 3% and 4% relative to other concentration, and its R value can be better separated with MA value.
Preferably, the addition of described coagulation activation agent is 2% of described plasma purity, and the addition of described tissue factor is 2% of described plasma purity, and the addition of described lyophilized platelet is 3% of described plasma purity.
Preferably, the purity of described tissue factor is greater than 90%.
Preferably, described coagulation activation agent is porcelain earth.
Preferably, described blood plasma is prepared by the pig blood of fresh collection, and the fibrinogen inside fresh pig blood is active best, and is beneficial to preservation.And wide material sources, cheap, and dangerous little with infection pathogeny, the quality-control product stable in properties be made into.
Preferably, described quality-control product I, described quality-control product II, described quality-control product III are sub-packed in cillin bottle by 1mL/ bottle further respectively.
Present invention also offers above-mentioned quality-control product and detect the application in thrombelastogram instrument Stability and veracity.
Preferably, described 3 horizontal thrombelastogram quality-control products add after lime chloride reagent supplements the calcium ion of citric acid complexing in the application, confirm the R of 3 horizontal thrombelastogram quality-control products, K, Angel, MA parameter is all stable, and R value and MA value have good degree of separation, the stability of energy effecting reaction thrombelastogram instrument system.
Present invention also offers above-mentioned quality-control product and detect the application in thrombelastogram detection kit Stability and veracity.
Beneficial effect of the present invention: the present invention adopts the blood plasma of single animal as quality-control product, not only reduces the cost of product, and has good stability and repeatability, by adding the citrate anticoagulation of variable concentrations in pig blood, the thrombelastogram quality-control product of 3 levels of preparation, in lyophilized powder, compared to the horizontal thrombelastogram quality-control product in 2 on current domestic and international market, the thrombelastogram quality-control product of 3 levels can be monitored R and MA value simultaneously, better for the quality control of thrombelastogram instrument and thrombelastogram detection kit, detect fast, result is accurate, easy and simple to handle, and the thrombelastogram quality-control product of 2 levels only has R value to have discrimination, the Stability and veracity of thrombelastogram instrument cannot be detected from MA value.
Accompanying drawing explanation
Fig. 1 thrombelastogram detects and exports schematic diagram;
Fig. 2 tissue factor purity detecting figure;
Fig. 3 thrombelastogram quality-control product I thrombelastogram;
Fig. 4 thrombelastogram quality-control product II thrombelastogram;
Fig. 5 thrombelastogram quality-control product III thrombelastogram;
The compound collection of illustrative plates of Fig. 6 thrombelastogram quality-control product I, quality-control product II, quality-control product III.
Embodiment
Following examples for illustration of the present invention, but are not used for limiting the scope of the invention.
R: detect and initially rise to 2mm required time to curve amplitude, corresponding multiple clotting factor progressively activates and causes fibrin to start the process formed.
K: curve amplitude rises to 20mm required time by 2mm, corresponding fibrin crosslinked and with hematoblastic interaction.
Angel: the tangent line of graphy figure maximum curve radian and horizontal angle, reflects fibrin and hematoblastic interaction jointly with the K time, becomes important Substitute Indexes when the serious low solidifying K value of patient cannot be measured.
MA: peak swing is graphy figure crest amplitude, corresponding clot maximum intensity, interacts relevant with PC, platelet function and platelet-fibrin.
Owing to observing 4 major parameter R of quality-control product coagulation process and blood coagulation, K, A, MA value, just can carry out quality control to thrombelastogram instrument and thrombelastogram detection kit, therefore in following examples when MA value reaches stable, after namely coagulation process completes, just can stop running software, not need to observe fibrinolytic process.
Embodiment 1
1, the preparation of Swine plasma
Take 2.0g, 3.0g, 4.0g sodium citrate (AR) respectively with electronic balance, be sub-packed in 3 1000mL beakers.Respectively add 100mL distilled water, dissolve, shake up.Namely the liquor sodii citratis of 2%, 3% and 4%3 kind of variable concentrations is obtained.Get fresh not solidifying pig blood 2700mL, pig blood color requires peony (peony is the color of fresh pig blood, mainly prevents from adopting rotten pig blood).Classify in three categories part, every part of 900mL, is mixed in 1000mL beaker respectively with the liquor sodii citratis of variable concentrations, can obtain Swine plasma A1, A2, A3 of 3 kinds of different anti-freezing concentration.Low-speed centrifugal, 4000r/min, centrifugal 5 minutes, gets supernatant blood plasma.Yield after Swine plasma is centrifugal is as shown in table 1.
Yield after table 1 Swine plasma is centrifugal
2, tissue factor purity detecting
Tissue factor (TF) is added in Swine plasma, can promote that coagulation process starts, the clotting time can be accelerated further, thus the clotting time of 3 horizontal thrombelastogram quality-control products is well separated, can at the Stability and veracity of some monitoring of different clotting times thrombelastogram.The composition of tissue factor is protein, and purity is higher, and the effect of generation is better.Therefore, the purity of SDS-polyacrylamide gel electrophoresis to tissue factor is adopted to measure.As shown in Figure 2, SDS-gel electrophoresis measurement result is that TF1 purity is greater than 95%.Therefore TF1 is selected to add quality-control product I to.
3, the preparation of thrombelastogram quality-control product
Get Swine plasma A1, A2, A3 of the 3 kinds of different anti-freezing concentration prepared in step 1, wherein in Swine plasma A1, add the porcelain earth of 2% and the tissue factor of 2%; The porcelain earth of 2% is added in Swine plasma A2; Porcelain earth and 3% lyophilized platelet of 2% is added in Swine plasma A3.The powdered product of freeze drying can obtain 3 horizontal thrombelastogram quality-control products under vacuo.Be sub-packed in cillin bottle by 1mL/ bottle.
Embodiment 2
1, quality-control product I thrombelastogram test
Get quality-control product I 1 bottles, accurately add 1mL distilled water and redissolve, place more than 30min at normal temperature, make reagent remain to room temperature.Open thrombelastogram instrument and be connected terminal, on corresponding software interface, input Quality Control type, Quality Control lot number, test-types are selected " L1 " in combobox.The passage of thrombelastogram instrument loads a set of sample cup, pipettes 20 μ LCaCl with 20 μ L pipettors
2to in sample cup.After reagent adds, pipette the quality-control product I of 340 μ L redissolution in sample cup.Fast cup is pushed into test position, reference test bar is allocated to " test " position, clicks " beginnings " or " Start ", start to test, parallel laboratory test 3 times, table 2 is quality-control product I target value.
Table 2 quality-control product I target value
Fig. 3 is the solidifying again lab diagram of quality-control product I, and as can be seen from Fig. 3 and table 2, quality-control product I adds due to tissue factor, have activated external source coagulation pathway, clotting time R value significantly shortens, and within 0.8 minute, just can complete coagulation activation process, i.e. figure opening, amplitude reaches 2mm.K value and Angel angle also show the blood coagulation speed of quality-control product I soon simultaneously, and clot is formed stable.Confirm that the product design of quality-control product I is reasonable, parallel laboratory test shows the reproducible of quality-control product I, and stability is high, is suitable for the quality control of thrombelastogram instrument.
2, quality-control product II thrombelastogram test
Get quality-control product II 1 bottles, accurately add 1mL distilled water and redissolve, place more than 30min at normal temperature, make reagent remain to room temperature.Open thrombelastogram instrument and be connected terminal, on corresponding software interface, input Quality Control type, Quality Control lot number, test-types are selected " L2 " in combobox.The passage of thrombelastogram instrument loads a set of sample cup, pipettes the CaCl of 20 μ L0.2mol/L with 20 μ L pipettors
2to in sample cup.After reagent adds, pipette the quality-control product II of 340 μ L redissolution in sample cup.Fast cup is pushed into test position, reference test bar is allocated to " test " position, clicks " beginnings " or " Start ", start to test, table 3 is quality-control product Level II target value.
Table 3 quality-control product II target value
Fig. 4 is the multiple solidifying figure of quality-control product II, and Fig. 4 and table 3 can find out, quality-control product II is not owing to having adding of tissue factor, and rely on intrinsic coagulation pathway to complete coagulation process, clotting time R extends relative to quality-control product I, completes coagulation activation process within 4 minutes.The blood coagulation speed that Angel angle also shows quality-control product II does not have quality-control product I fast.This is because the concentration of the citrate anticoagulation agent added in quality-control product II is higher than quality-control product I, therefore cruor time extending, blood coagulation rate reduction, but the intensity that clot is formed is greater than quality-control product I, and therefore MA value is large.Experimental result confirms that the product design of quality-control product II is reasonable, and parallel laboratory test shows the reproducible of quality-control product II, and stability is high, is suitable for the quality control of thrombelastogram instrument.
3, quality-control product III thrombelastogram test
Get quality-control product III 1 bottles, accurately add 1mL distilled water and redissolve, place more than 30min at normal temperature, make reagent remain to room temperature.Open thrombelastogram instrument and be connected terminal, on corresponding software interface, input Quality Control type, Quality Control lot number, test-types is selected " L3 " in combobox.The passage of thrombelastogram instrument loads a set of sample cup, pipettes the CaCl of 20 μ L0.2mol/L with 20 μ L pipettors
2to in sample cup.After reagent adds, pipette the quality-control product III of 340 μ L redissolution in sample cup.Fast cup is pushed into test position, reference test bar is allocated to " test " position, clicks " beginnings " or " Start ", start to test, table 4 is quality-control product III target value.
Table 4 quality-control product III target value
Fig. 5 is the multiple solidifying figure of quality-control product III, and Fig. 5 and table 4 can find out, quality-control product III is the highest in 3 horizontal quality-control products due to the concentration of citrate anticoagulation agent, and does not add tissue factor, completes coagulation process by intrinsic coagulation pathway.Therefore the clotting time is the longest, reaches 7 minutes, reaches and is effectively separated, as shown in Figure 6 with quality-control product I and II.Simultaneously also to show the blood coagulation speed of quality-control product III minimum K value and Angel angle.But owing to the addition of lyophilized platelet in quality-control product III, blood platelet and fibrin net are cross-linked, and enhance clot strength, so the good stability that clot is formed, clot strength is large, and namely MA value is large, can distinguish with quality-control product I and II.Experimental result confirms that the product design of quality-control product III is reasonable, and parallel laboratory test result also shows the reproducible of quality-control product III, and stability is high, is suitable for the quality control of thrombelastogram instrument.
Embodiment 3
10 quality-control products I of same lot number, quality-control product II and quality-control product III is detected respectively with reagent, projects (R, K, Angel, MA) detect 1 time respectively, calculate respectively R (clotting time), K (blood coagulation speed), Angel (tangent line and horizontal sextant angle), MA (peak swing) value mean value (
) and standard deviation (S
1); Same method, to arbitrary bottle of continuous detecting in 10 quality-control products to be checked 2 times, calculate measurement result mean value (
) and standard deviation (S
2).Calculate the coefficient of variation (CV) by formula (1), acquired results CV should be less than 10%, and between 3 horizontal thrombelastogram quality-control product bottles, difference data is as shown in table 5.
Work as S
1<S
2time, make CV=0
Difference data between table 53 horizontal thrombelastogram quality-control product bottle
Experimental result shows, between the bottle of thrombelastogram quality-control product I, quality-control product II, quality-control product III, difference CV value is all within 10%, and good stability, effectively can be applied to the quality control of thrombelastogram.
Embodiment 4
Quality-control product is applied to and carries out quality control to the common cup of thrombelastogram and heparinase cup detection kit.Get each one bottle of quality-control product I, quality-control product II and quality-control product III, add 1mL distilled water respectively and redissolve, place more than 30min at normal temperature, make reagent remain to room temperature.The quality-control product I of redissolution, quality-control product II and quality-control product III are respectively got in the reagent 1 bottle that 1mL joins in common cup detection kit or heparinase cup detection kit respectively, put upside down 3 times, mixing.Leave standstill 4-6 minute.Open thrombelastogram instrument and be connected terminal, on corresponding software interface, input Quality Control type, Quality Control lot number, test-types is selected " L1, L2, L3 " in combobox.The passage of thrombelastogram instrument loads the sample cup in the three common cups of cover or heparinase cup kit, pipettes reagent 2 in the common cup of 20 μ L or heparinase cup kit in the sample cup loaded with 20 μ L pipettors.340 μ L blood plasma are pipetted to sample cup from the reagent 1 bottle that quality-control product I is housed, fast cup is pushed into test position, reference test bar is allocated to " test " position, click " beginning " or " Start ", start test, all the other two passages pipette quality-control product II and quality-control product III respectively to remaining sample cup, operate identical with quality-control product I.The data that 3 horizontal quality-control products detect thrombelastogram detection kit are as shown in table 6.
The horizontal quality-control product of table 63 is to the quality control of the common cup of thrombelastogram and heparinase cup kit
In the common cup of thrombelastogram and heparinase cup detection kit, the composition of reagent 1 is porcelain earth, and the composition of reagent 2 is CaCl of 0.2mol/L
2, therefore can complete quality-control product by the effect of reagent 1 and reagent 2 and coagulate again, thus the Stability and veracity of common cup and heparinase cup seminal plasma fructose detection kit 1 and reagent 2 can be detected.As can be seen from Table 6, the present invention relates to 3 horizontal thrombelastogram quality-control products can well be applied to the Stability and veracity detecting common cup and heparinase cup kit, the quality-control product parameter value R of 3 levels, K, A, MA, within the scope of target value, proves that the Stability and veracity of common cup and heparinase cup kit is better, meets the requirements.
Although above with general explanation, embodiment and test, the present invention is described in detail, and on basis of the present invention, can make some modifications or improvements it, this will be apparent to those skilled in the art.Therefore, these modifications or improvements without departing from theon the basis of the spirit of the present invention, all belong to the scope of protection of present invention.
Claims (10)
1. a horizontal thrombelastogram quality-control product, it is characterized in that, described quality-control product is not mixed with the sodium citrate of 3 kinds of variable concentrations by pig blood system, centrifugal, get blood plasma, in 3 parts of blood plasma, add coagulation activation agent respectively and tissue factor freeze-drying obtains Powdered quality-control product I, add coagulation activation agent freeze-drying and obtain Powdered quality-control product II, add coagulation activation agent and the freeze-drying of people's lyophilized platelet obtains Powdered quality-control product III.
2. quality-control product according to claim 1, is characterized in that, the mass ratio that described pig blood mixes with described sodium citrate is 1:9.
3. quality-control product according to claim 2, is characterized in that, in described quality-control product I, the concentration of sodium citrate is 2%, and in described quality-control product II, the concentration of sodium citrate is 3%, and in described quality-control product III, the concentration of sodium citrate is 4%.
4., according to the arbitrary described quality-control product of claim 1-3, it is characterized in that, the purity of described tissue factor is greater than 90%.
5. quality-control product according to claim 4, is characterized in that, described coagulation activation agent is porcelain earth.
6. according to the arbitrary described quality-control product of claim 5, it is characterized in that, the addition of described coagulation activation agent is the 2%-5% of described plasma purity, the addition of described tissue factor is the 2%-4% of described plasma purity, and the addition of described lyophilized platelet is the 3%-5% of described plasma purity.
7. quality-control product according to claim 6, is characterized in that, described blood plasma is prepared by the pig blood of fresh collection.
8. the arbitrary described quality-control product of claim 1-7 is detecting the application in thrombelastogram instrument Stability and veracity.
9. application according to claim 8, is characterized in that, adds lime chloride reagent to complete the multiple solidifying of quality-control product in the application of quality-control product I, quality-control product II, quality-control product III.
10. the arbitrary described quality-control product of claim 1-7 is detecting the application in thrombelastogram detection kit Stability and veracity.
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