Combined test analysis device for functions of blood coagulation and blood platelets
By designing a joint test and analysis device for coagulation and platelet functions, using a blood sample to complete the joint detection of coagulation and platelets, the problem of increasing the burden on patients and detectors in the prior art is solved, and an efficient and automated detection process is achieved.
Patent Information
- Application Number
- CN202311637598.0
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2023-11-30
- Publication Date
- 2025-05-30
AI Technical Summary
In the prior art, the combined detection of coagulation index and platelet aggregation function requires multiple blood sample extraction and centrifugation, which increases the burden on patients and detectors.
A joint detection and analysis device for coagulation and platelet functions is designed. Through the sample management module, reagent consumables management module, sample reagent dispensing module, sample mixing module, coagulation analysis module and platelet function analysis module, the combined detection of coagulation and platelets can be achieved by only one blood sample.
It reduces the burden on patients, reduces the process steps of joint testing, reduces the operation burden of detectors, and realizes fully automated testing.
Smart Images
Figure CN120064624A_ABST
Abstract
Description
Technical Field
[0001] This application relates to the field of medical detection technologies, and particularly to a combined test and analysis device for coagulation and platelet function. Background Art
[0002] Common platelet function tests are platelet aggregation function tests. In the test, platelet aggregation inducers are used to induce platelet aggregation, and the proportion of platelet aggregation is measured and calculated by certain means. According to the detection principle, the measurement means are divided into optical turbidimetry, impedance method, etc.
[0003] For the combined detection requirements of coagulation indicators and platelet aggregation function in clinical practice, if optical turbidimetry is used, two types of plasma, platelet poor plasma (PPP) and platelet rich plasma (PRP), need to be prepared. To prepare these two types of plasma, either two tubes of blood are drawn from the patient and centrifuged separately, or one tube of blood is centrifuged twice and the plasma is sub-packed. In either case, the burden on the patient or the tester will be increased invisibly. If the whole blood impedance method is used, since the coagulation indicators are obtained by detecting the plasma in the centrifuged sample, two tubes of blood need to be drawn from the patient, one tube is centrifuged for coagulation detection, and one tube of whole blood is used to detect platelet function by the impedance method, which will also increase the burden on the operation of the patient or the tester. Summary of the Invention
[0004] The main purpose of this application is to provide a combined test and analysis device for coagulation and platelet function, which can solve the technical problem of increasing the burden on patients or testers in the preparation of samples in the combined detection of coagulation indicators and platelet aggregation function in the prior art.
[0005] To achieve the above purpose, the first aspect of this application provides a combined test and analysis device for coagulation and platelet function, which includes: a sample management module, a reagent and consumable management module, a sample and reagent dispensing module, a sample mixing module, a coagulation analysis module, and a platelet function analysis module;
[0006] The sample management module is used to load the blood sample after centrifugation;
[0007] The reagent and consumable management module is used to load coagulation detection reagents and platelet aggregation inducers;
[0008] The sample and reagent dispensing module is used to dispense the coagulation detection reagents and the plasma samples aspirated from the blood sample to prepare coagulation detection samples;
[0009] The coagulation analysis module is used to perform coagulation detection on the coagulation detection samples and output coagulation detection results;
[0010] The sample mixing module is further configured to mix the remaining blood sample after the plasma sample is dispensed to obtain a whole blood sample again;
[0011] The sample and reagent dispensing module is further configured to dispense the platelet aggregation inducer and the whole blood sample to prepare a platelet aggregation rate detection sample;
[0012] The platelet function analysis module is configured to detect the platelet aggregation rate of the platelet aggregation rate detection sample and output a platelet function detection result.
[0013] To achieve the above object, a second aspect of the present application provides a combined test and analysis device for coagulation and platelet function, the device includes: a sample management module, a reagent and consumable management module, a sample and reagent dispensing module, a centrifugation module, a coagulation analysis module, and a platelet function analysis module;
[0014] The sample management module is configured to load a blood sample containing whole blood;
[0015] The reagent and consumable management module is configured to load a coagulation detection reagent and a platelet aggregation inducer;
[0016] The sample and reagent dispensing module is configured to dispense the platelet aggregation inducer and the whole blood sample aspirated from the blood sample to prepare a platelet aggregation rate detection sample;
[0017] The platelet function analysis module is configured to detect the platelet aggregation rate of the platelet aggregation rate detection sample and output a platelet function detection result;
[0018] The centrifugation module is configured to centrifuge the remaining blood sample after the whole blood sample is dispensed to obtain a plasma sample;
[0019] The sample and reagent dispensing module is further configured to dispense the coagulation detection reagent and the plasma sample to prepare a coagulation detection sample;
[0020] The coagulation analysis module is configured to detect the coagulation of the coagulation detection sample and output a coagulation detection result.
[0021] Adopting the embodiments of the present application has the following beneficial effects:
[0022] The present application uses a tube of blood sample obtained after centrifugation. First, the plasma sample is aspirated for coagulation analysis, and then the remaining blood sample is mixed to obtain a whole blood sample, and then platelet function analysis is performed, completing the combined detection of coagulation and platelets with only one tube of blood sample, which not only reduces the burden on patients, but also reduces the process steps of combined detection, thus reducing the burden on testers.
[0023] Alternatively,
[0024] This application uses an uncentrifuged whole blood sample as the blood sample. First, the whole blood sample is aspirated for platelet function test and analysis, and then the remaining blood sample is centrifuged to obtain a plasma sample. Subsequently, the coagulation function test is performed based on the plasma sample, thus completing the combined test of coagulation and platelets, and only one tube of blood sample from the patient is required, reducing the burden on the patient. In addition, in this embodiment, plasma can be obtained only by centrifugation, without the need to add any extra steps, and the combined test of coagulation and platelets can be achieved, greatly reducing the operation burden on the tester. Brief Description of the Drawings
[0025] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the following will briefly introduce the drawings required for use in the description of the embodiments or the prior art. Obviously, the drawings in the following description are only some embodiments of the present application. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative efforts.
[0026] Among them:
[0027] Figure 1 is the structural block diagram of the combined test and analysis device for coagulation and platelet functions in an embodiment of the present application;
[0028] Figure 2 is the schematic effect diagram of the reagent and consumable management module in an embodiment of the present application;
[0029] Figure 3 is the schematic effect diagram of the sample management module in an embodiment of the present application;
[0030] Figure 4 is the schematic effect diagram of the sample and reagent dispensing module in an embodiment of the present application;
[0031] Figure 5 is the schematic effect diagram of the coagulation analysis module in an embodiment of the present application;
[0032] Figure 6 is the schematic effect diagram of the sample mixing module in an embodiment of the present application;
[0033] Figure 7 is the schematic effect diagram of the platelet function analysis module in an embodiment of the present application;
[0034] Figure 8 is the schematic effect diagram of the sample rack in an embodiment of the present application;
[0035] Figure 9 is the schematic diagram of the platelet count curve in an embodiment of the present application;
[0036] Figure 10 Schematic diagram of the impedance detection module in an embodiment of the present application;
[0037] Figure 11 Schematic diagram of the platelet aggregation curve in another embodiment of the present application;
[0038] Figure 12 Block diagram of the structure of the combined test and analysis device for coagulation and platelet function in an embodiment of the present application.
[0039] Explanation of reference numerals:
[0040] Sample management module 10, reagent and consumable management module 20, sample and reagent dispensing module 30, sample mixing module 41, centrifugation module 42, coagulation analysis module 50, platelet function analysis module 60. Detailed implementation manners
[0041] Next, the technical solutions in the embodiments of the present application will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present application.
[0042] Participating in thrombosis and hemostasis is the main biological function of platelets. The connection between platelets is called platelet aggregation, which is an important link for platelets to realize their functions. The measurement of platelet aggregation function is of great significance for clinically diagnosing pre-thrombotic states and thrombotic diseases. For a long time, the detection of platelet aggregation function has been the gold standard for evaluating the in vitro function of platelets. It is of great significance for the diagnosis of hemorrhagic diseases, monitoring the risk of thrombotic diseases, observing the efficacy of antiplatelet drugs, guiding treatment, preventing cardio-cerebrovascular embolism, evaluating the bleeding risk during the perioperative period, and selecting the appropriate time for surgery.
[0043] Coagulation detection Coagulation examination is also called coagulation function examination. It is a relatively common index clinically and is generally mainly seen in the hematology department. In addition, some surgery-related departments also need to perform this examination before surgery. It is used to examine the coagulation function of the body, belongs to the examination of thrombotic diseases, and is a necessary examination item before surgery, a pre-thrombotic examination item, and for monitoring clinical patients taking oral anticoagulants.
[0044] In clinical practice, there is a need for combined detection of coagulation indicators and platelet aggregation function. However, the blood samples used for these two detections are different and different preparation methods are required. How to complete the combined detection of coagulation indicators and platelet aggregation function with as little blood sample as possible without increasing the burden on patients and testers is an urgent problem to be solved at present.
[0045] As Figure 1 shown, in one embodiment, a combined test analysis device for coagulation and platelet function is provided. The device includes: a sample management module 10, a reagent and consumable management module 20, a sample and reagent dispensing module 30, a sample mixing module 41, a coagulation analysis module 50, and a platelet function analysis module 60;
[0046] The sample management module 10 is used to load the centrifuged blood sample;
[0047] The reagent and consumable management module 20 is used to load coagulation detection reagents and platelet aggregation inducers;
[0048] The sample and reagent dispensing module 30 is used to dispense the coagulation detection reagent and the plasma sample aspirated from the blood sample to prepare a coagulation detection sample;
[0049] The coagulation analysis module 50 is used to perform coagulation detection on the coagulation detection sample and output a coagulation detection result;
[0050] The sample mixing module 41 is further used to mix the remaining blood sample after the plasma sample is dispensed to obtain a whole blood sample again;
[0051] The sample and reagent dispensing module 30 is further used to dispense the platelet aggregation inducer and the whole blood sample to prepare a platelet aggregation rate detection sample;
[0052] The platelet function analysis module 60 is used to perform platelet aggregation rate detection on the platelet aggregation rate detection sample and output a platelet function detection result.
[0053] Specifically, referring to Figure 3 , the sample management module 10 is specifically used for sample storage, sample tube information reading, sample scheduling, etc.
[0054] Referring to Figure 4 , the sample and reagent dispensing module 30 is specifically used to aspirate the coagulation detection reagent from the carrier container storing the coagulation detection reagent in the reagent and consumable management module 20 into the reaction container, aspirate the plasma sample from the carrier container storing the blood sample into the reaction container, and mix the coagulation detection reagent and the plasma sample in the reaction container through the sample and reagent mixing module to obtain a coagulation detection sample. Among them, the blood sample is the plasma sample and blood cells obtained by centrifuging the anticoagulated whole blood sample.
[0055] If the plasma sample and blood cells are stored in the same sample tube, the upper layer of the blood sample contains the plasma sample and the lower layer contains blood cells. The sample and reagent dispensing module 30 specifically aspirates the plasma sample from the upper layer of the sample tube.
[0056] If the plasma sample and blood cells of the same patient are stored in two different sample tubes, the sample reagent dispensing module 30 specifically aspirates the plasma sample from one of the sample tubes.
[0057] The reaction vessel can be a test cup or a test tube at the reagent consumable management module 20. The anticoagulated whole blood sample can be obtained by collecting venous blood or peripheral blood of the patient using a citrate anticoagulant tube.
[0058] In addition, the sample reagent dispensing module 30 can first aspirate the plasma sample from the blood sample into the coagulation reaction vessel, and then transfer the coagulation reaction vessel containing the plasma sample to the incubation position of the coagulation analysis module 50 for incubation. After a preset time, the sample reagent dispensing module 30 injects the coagulation detection reagent into the coagulation reaction vessel to prepare a coagulation detection sample.
[0059] Alternatively, the sample reagent dispensing module 30 can add the plasma sample and the coagulation detection reagent into the same reaction vessel to prepare a coagulation detection sample, and then transfer the reaction vessel containing the coagulation detection sample to the incubation position of the coagulation analysis module 50 for incubation. After incubation, the coagulation analysis module 50 performs coagulation detection.
[0060] The device can also include a transfer module, which is specifically used to transfer the reaction vessel containing the coagulation detection sample to the coagulation analysis module 50 after the coagulation detection sample is prepared. Alternatively, the tester transfers the reaction vessel containing the coagulation detection sample to the coagulation analysis module 50.
[0061] Reference Figure 5 , the coagulation analysis module 50 is specifically used to incubate the reaction vessel dispensed with the plasma sample and the coagulation detection reagent and detect the coagulation process and output the coagulation detection result. Among them, the coagulation detection result includes coagulation index test results, such as one or more of PT (prothrombin time), APTT (activated partial thromboplastin time), TT (thrombin time), FIB (fibrinogen), etc.
[0062] Reference Figure 6 , the sample mixing module 41 is used to mix the sample. Only a part of the plasma in the blood sample is used for coagulation analysis, and the remaining blood sample still contains plasma and blood cells. Therefore, by mixing the plasma and blood cells in the blood sample through the sample mixing module 41, a whole blood sample can be obtained.
[0063] If the plasma sample and blood cells are stored in the same sample tube, the sample mixing module 41 directly mixes the remaining plasma sample and the underlying blood cells in the same sample tube to obtain a whole blood sample.
[0064] If the plasma sample and blood cells of the same patient are stored in two different sample tubes, after the sample mixing module 41 mixes the remaining plasma sample and blood cells in the two sample tubes into the same sample tube, the plasma sample and blood cells in the same sample tube are then mixed to obtain a whole blood sample.
[0065] After obtaining the whole blood sample, the sample reagent dispensing module 30 is specifically configured to aspirate the whole blood sample from the carrier container storing the whole blood sample and inject it into the platelet aggregation rate detection channel of the platelet function analysis module 60, and aspirate the platelet aggregation inducer from the carrier container storing the platelet aggregation inducer and inject it into the platelet aggregation rate detection channel of the platelet function analysis module 60, thereby realizing the mixing of the whole blood sample and the platelet aggregation inducer to obtain a platelet aggregation rate detection sample.
[0066] Reference Figure 7 , the platelet function analysis module 60 is used to perform platelet function detection on the sample dispensed with the sample and reagent, such as calculating the platelet aggregation rate by testing the difference in platelet count before and after adding the platelet aggregation inducer.
[0067] Among them, reference Figure 2 , the above reagent and consumable management module 20 is used for the storage and management of reaction containers such as reagents, reaction cups, detection cups, test cups, etc. For example, various reaction cups such as coagulation detection reagents, platelet aggregation inducers, optical detection cups, and magnetic bead detection cups required for testing can be stored at the reagent and consumable management module 20.
[0068] This embodiment integrates the coagulation analysis module 50 and the platelet function analysis module 60. After a tube of centrifuged blood sample is loaded onto the machine, it is first sub-sampled to the coagulation analysis module 50 to detect coagulation indicators, and then the sample tube is mixed by the sample tube mixing module to restore the centrifuged sample to the whole blood state, and then the next platelet function analysis is completed; this embodiment only requires 1 tube of blood, and the operator does not need to perform additional operations to automatically realize the combined detection of coagulation and platelet function on 1 machine, which greatly reduces the burden on patients and operators and shortens the report output time.
[0069] This embodiment uses a tube of centrifuged blood sample, first aspirates the plasma sample for coagulation analysis, then mixes the remaining blood sample to obtain a whole blood sample, and then performs platelet function analysis, completing the combined detection of coagulation and platelets with only one tube of blood sample, which not only reduces the burden on patients, but also reduces the process steps of the combined detection, thus reducing the burden on the detector.
[0070] In one embodiment, the device further includes a centrifugation module 42, and the centrifugation module 42 is used to centrifuge the anticoagulated whole blood sample to obtain a blood sample with plasma sample on the upper layer and blood cells on the lower layer.
[0071] In one embodiment, the sample management module 10 includes a sample tube holding container, the sample tube holding container includes a plurality of sample tube placement positions, the sample tubes are used to hold the centrifuged blood samples, the upper layer of the centrifuged blood sample is the plasma sample, and the lower layer is blood cells;
[0072] The sample reagent dispensing module 30 is specifically configured to dispense a part of the plasma sample on the upper layer of the sample tube into a reaction container to prepare a coagulation detection sample;
[0073] The sample mixing module 41 is specifically configured to mix the remaining plasma sample and blood cells in the same sample tube to re-obtain a whole blood sample;
[0074] The sample reagent dispensing module 30 is also specifically configured to dispense the re-obtained whole blood sample to prepare a platelet aggregation rate detection sample.
[0075] Specifically, the sample tube holding container may be a sample rack or a sample tray, etc., and this application does not limit this. The sample tube holding container includes a plurality of sample tube placement positions. If the sample tube holding container is a sample rack, the sample tubes are usually stored in the placement positions of the sample rack in a vertical placement manner; if the sample tube holding container is a sample tray, the sample tubes are usually stored in a lying manner in the placement positions of the sample tray. The placement position may be a planar area that can accommodate a plurality of sample tubes, or the placement position includes a plurality of grooves or recessed positions, and each groove or recessed position can place one sample tube. Among them, the schematic effect diagram of the sample tube placed on the sample rack refers to Figure 8 .
[0076] The sample tube is used to hold the centrifuged blood sample. In this embodiment, the plasma sample and blood cells in the blood sample of the same patient are stored in the same sample tube. In the sample tube, the upper layer of the centrifuged blood sample is the plasma sample, and the lower layer is blood cells.
[0077] The sample reagent dispensing module 30 is specifically configured to dispense a part of the plasma sample on the upper layer of the sample tube and a coagulation detection reagent into a reaction container to prepare a coagulation detection sample.
[0078] The sample mixing module 41 is specifically configured to mix the remaining plasma sample and blood cells in the same sample tube to re-obtain a whole blood sample.
[0079] The sample reagent dispensing module 30 is also specifically configured to dispense the re-obtained whole blood sample and a platelet aggregation inducer to prepare a platelet aggregation rate detection sample.
[0080] In this embodiment, through centrifugation technology, the plasma sample and blood cells of the same patient are stored in the upper and lower layers of the same sample tube. Only one tube of the patient's blood is used to complete the combined detection of coagulation and platelets, reducing the burden on the patient. In addition, this embodiment can achieve the combined detection of coagulation and platelets without adding any extra steps, greatly reducing the operation burden on the detector.
[0081] In one embodiment, the sample reagent dispensing module 30 is further configured to additionally dispense a part of the plasma sample in the upper layer of the sample tube into a backup container for use as a coagulation retest sample.
[0082] The sample mixing module 41 is configured to mix the remaining plasma sample and blood cells in the same sample tube to re-obtain a whole blood sample.
[0083] Specifically, for samples with coagulation retest requirements, after the sample reagent dispensing module 30 completes the dispensing of coagulation test samples, a part of the plasma sample can be additionally dispensed into a backup container for use in coagulation retesting. The process during coagulation retesting is the same as the above-mentioned conventional process and will not be elaborated here.
[0084] After backing up the plasma sample, the sample reagent dispensing module 30 prepares a platelet aggregation rate detection sample for platelet aggregation function analysis. Specifically, the sample reagent dispensing module 30 mixes and homogenizes the remaining plasma sample and blood cells to obtain a platelet aggregation rate detection sample.
[0085] This embodiment can support the coagulation retest function of the combined test analysis device for coagulation and platelet function by backing up the plasma sample.
[0086] Similarly, in one embodiment, the sample reagent dispensing module 30 is further configured to additionally dispense a part of the whole blood sample in the sample tube into a backup container for use as a platelet aggregation rate retest sample.
[0087] This embodiment can support the platelet aggregation rate retest function of the combined test analysis device for coagulation and platelet function by backing up the whole blood sample.
[0088] In one embodiment, the sample mixing module 41 is specifically configured to mix the remaining plasma sample and blood cells in the sample tube at a preset swing angle and a preset swing speed for a preset number of times, where the preset swing angle is 90-150 degrees, and / or the preset swing speed is 1 second / round trip, and / or the preset number of times is 5-15 times.
[0089] Specifically, the sample management module 10 can transfer the sample tube holding container (such as a sample rack or a sample tray) carrying the sample tube to the sample mixing position, and the gripper of the sample mixing module 41 takes out the sample tube from the sample tube holding container. Alternatively, the sample tube remains placed in the sample tube holding container in the loading area of the sample management module 10, and the gripper of the sample mixing module 41 goes to the loading area of the sample management module 10 to take out the sample tube from the sample tube holding container. Alternatively, the tester takes out the sample tube from the sample tube holding container and places it on the gripper of the sample mixing module 41.
[0090] The sample mixing module 41 simulates the operator to invert the sample tube up and down several times. To avoid abnormal situations such as hemolysis of blood cells caused by excessive mixing, it is necessary to control the mixing strength. Preferably, the number of mixing times is 5 to 15 times; preferably, the swing angle of the gripper is 90 to 150 degrees; preferably, the swing speed is about 1 second / round trip. After the mixing is completed, the sample mixing module 41 places the sample tube back into the sample tube holding container.
[0091] Of course, the above is only an exemplary description, and the swing angle, swing speed, and number of mixing times can be configured according to the actual situation, and the present application does not limit this.
[0092] In this embodiment, by reasonably setting at least one of the swing angle, swing speed, number of mixing times, etc. of the sample mixing module 41 to control the mixing strength, it is possible to effectively avoid abnormal situations such as hemolysis of blood cells caused by excessive mixing, and effectively ensure the quality of the re-obtained whole blood sample.
[0093] In one embodiment, the sample tube has a tube cap, and the sample reagent dispensing module 30 includes a pierceable pipette needle, which is used to pierce the tube cap of the sample tube and dispense the plasma sample or the whole blood sample.
[0094] Specifically, if the sample tube has a tube cap, the sample reagent dispensing module 30 will pierce the tube cap of the sample tube through the pipette needle (or, liquid separation needle, or dispensing needle), and penetrate into the sample tube to aspirate the plasma sample required for coagulation detection.
[0095] Among them, the sample reagent dispensing module 30 includes the same pipette needle that can be used to aspirate the sample and the coagulation detection reagent, a drive motor (such as two motors for two-dimensional movement) that drives the pipette needle, and a guide rail, etc. After the sample reagent dispensing module 30 first aspirates the plasma sample with the pipette needle, it cleans the pipette needle, and then uses the cleaned pipette needle to aspirate the coagulation detection reagent.
[0096] Or,
[0097] The sample and reagent dispensing module 30 includes a sample needle for aspirating samples, a reagent needle for aspirating reagents, and a driving motor (e.g., two motors for two-dimensional motion) and a guide rail for driving the sample and reagent needles. The sample and reagent needles are both pipetting needles (or, dispensing needles, or, dispensing needles).
[0098] This embodiment configures a tube cap on the sample tube to ensure that the sample does not spill during the mixing process and the movement of the sample tube, and also reduces external contamination of the blood sample to a certain extent.
[0099] In another embodiment, if the sample tube does not contain a tube cap, the sample reagent dispensing module 30 directly uses a pipetting needle (or a dispensing needle, or a dispensing needle) to absorb the plasma sample required for coagulation testing from the sample tube. Not having a tube cap can make it easier to absorb the blood sample.
[0100] In one embodiment, the platelet function analysis module 60 is specifically used to count platelets in the whole blood sample before and after adding the platelet aggregation inducer to obtain the platelet aggregation rate test result;
[0101] or,
[0102] The platelet function analysis module 60 is specifically used to detect the impedance or current change of the whole blood sample before and after the addition of the platelet aggregation inducer to obtain the platelet aggregation rate detection result.
[0103] Specifically, this embodiment provides two methods for detecting platelet aggregation rate. One impedance method is a platelet counting method of a blood cell analyzer, which monitors the changes in platelet volume and number in anticoagulated whole blood before and after the addition of a platelet aggregation inducer, obtains the changes in the number of platelets before and after aggregation, and then obtains the platelet aggregation function level.
[0104] The principle of the impedance method is to add platelet aggregation inducers to the whole blood sample to activate the platelets and aggregate them on the electrodes. The aggregation curve formed by recording the tiny current or resistance changes between the blood electrodes is used to measure the degree of platelet aggregation, and the maximum aggregation rate is recorded to evaluate platelet function.
[0105] The advantage of the electrical impedance method is that it directly uses anticoagulated whole blood, uses less blood, and does not require centrifugation or PRP preparation.
[0106] In one embodiment, the platelet function analysis module 60 includes a platelet aggregation rate detection channel and a processor module;
[0107] The sample reagent dispensing module 30 is specifically used to dispense the recovered whole blood sample into the platelet aggregation rate detection channel for the first time;
[0108] The platelet aggregation rate detection channel is specifically configured to perform a first detection and PLT counting based on the first-injected whole blood sample, and obtain 1 PLT counting result;
[0109] The sample reagent dispensing module 30 is further specifically configured to, after the first detection, aspirate and dispense a cleaning solution into the platelet aggregation rate detection channel for cleaning the detection channel. After the cleaning is completed, aspirate the whole blood sample again and secondarily dispense the aspirated whole blood sample into the platelet aggregation rate detection channel, and inject the platelet aggregation inducer aspirated from the reagent consumable management module 20 into the platelet aggregation rate detection channel;
[0110] The platelet aggregation rate detection channel is specifically configured to perform a second detection based on the second-injected whole blood sample, perform multiple platelet countings at preset time intervals until the platelet aggregation reaction ends, and obtain multiple PLT counting results;
[0111] The processor module is specifically configured to perform fitting based on all PLT counting results to obtain a platelet aggregation curve.
[0112] Specifically, based on the impedance-based platelet counting method (i.e., the PLT detection function of the hematology analyzer), after the sample reagent dispensing module 30 aspirates the whole blood sample and injects it into the platelet aggregation rate detection channel for the first time, the counting module will start the first PLT counting to obtain the PLT counting result without adding the platelet aggregation inducer. After the first detection, the sample reagent dispensing module 30 injects a cleaning solution into the platelet aggregation rate detection channel to clean the platelet aggregation rate detection channel. Cleaning the detection channel can reduce the interference with subsequent PLT counting.
[0113] After the cleaning is completed, the sample reagent dispensing module 30 aspirates the whole blood sample and injects it into the platelet aggregation rate detection channel for the second time, and at the same time adds the platelet aggregation inducer. After reacting for a certain time, such as 1 minute or 1.5 minutes or other preset reaction durations not limited to this, the counting module starts the second PLT counting. After an interval of a preset duration, such as 1 minute or 1.5 minutes or 50 seconds, 70 seconds, etc., not limited to this, the third PLT counting is started. After the same preset duration interval, the fourth PLT counting is started, and so on, performing multiple platelet countings until the platelet aggregation reaction ends, and obtaining multiple PLT counting results. For example, if the platelet aggregation reaction ends within 6 minutes, 7 PLT counting results can be obtained, and these results are fitted into an aggregation curve. By calculating the ratio of PLT before and after aggregation, the aggregation function of platelets under this platelet aggregation inducer can be evaluated.
[0114] Figure 9 It is a schematic diagram of a platelet counting curve in an embodiment of the present application; refer to Figure 9, there are a total of 7 PLT count results, and the PLT count results gradually decrease.
[0115] In this embodiment, by injecting whole blood samples twice, the PLT count results before adding the platelet aggregation inducer and multiple PLT count results at preset time intervals after adding the platelet aggregation inducer are obtained. By fitting all the PLT count results, an accurate aggregation curve can be obtained. Moreover, in this embodiment, the impedance method is used, with less blood volume required and no need to prepare PRP, which reduces the burden on patients and testers.
[0116] The sample scheduling module transfers the sample tube holding container to the suction position, and the sample reagent dispensing module 30 aspirates the samples required for platelet function analysis.
[0117] In one embodiment, the processor module is further configured to correct each PLT count result using a preset formula to obtain the corrected PLT count result;
[0118] Among them, the preset formula is as follows:
[0119] PLT (corrected) = PLT (test) * (original sample volume) / (original sample volume - plasma volume aspirated for coagulation test)
[0120] The processor module is specifically further configured to fit according to all the corrected PLT count results to obtain a platelet aggregation curve.
[0121] Specifically, since a part of the plasma is aspirated during the coagulation test, and this part of the plasma is platelet-poor plasma, which causes the concentration of PLT in the sample to change compared with the initial sample. Therefore, there are some deviations between the PLT results and the PLT in the initial sample. Thus, the preset formula can be used to correct the PLT count results:
[0122] PLT (corrected) = PLT (test) * (original sample volume) / (original sample volume - plasma volume aspirated for coagulation test).
[0123] Among them, PLT (test) refers to any obtained PLT count result, the original sample volume is the sample volume of the blood sample before the coagulation test. The plasma volume aspirated for coagulation test is the volume of the plasma sample consumed or aspirated during the coagulation test.
[0124] Each obtained PLT count result can be corrected using the preset formula to obtain the corrected PLT count result corresponding to each PLT count result.
[0125] In this embodiment, by correcting the PLT count results, the error of the PLT count results caused by the consumption of the plasma sample during the coagulation test can be compensated, which ensures the accuracy of the PLT count results to a certain extent.
[0126] In a specific embodiment, if, after the coagulation detection and before the platelet aggregation rate function detection, the sample reagent dispensing module 30 is further configured to additionally dispense a part of the upper-layer plasma sample in the sample tube into a backup container as a coagulation retest sample, the preset formula is as follows:
[0127] PLT (corrected) = PLT (test) * (original sample volume) / (original sample volume - coagulation aspirated plasma volume - backup aspirated plasma volume);
[0128] Wherein, the backup aspirated plasma volume is the volume of the additionally aspirated plasma sample used as a backup.
[0129] In this embodiment, by correcting the PLT count result, the error in the PLT count result caused by the consumption of the plasma sample in the coagulation detection can be compensated, and the accuracy of the PLT count result is guaranteed to a certain extent.
[0130] In an embodiment, the platelet function analysis module 60 is provided with a platelet detection cup. The platelet detection cup is equipped with two platinum electrodes at a fixed distance, and a stirrer is placed in the platelet detection cup;
[0131] The sample reagent dispensing module 30 is specifically configured to dispense the re-obtained whole blood sample into the platelet detection cup;
[0132] The stirrer is used to stir the whole blood sample in the platelet detection cup;
[0133] The sample reagent dispensing module 30 is specifically configured to inject a platelet aggregation inducer into the platelet detection cup;
[0134] The platelet function analysis module 60 is specifically configured to use a detection circuit including the platinum electrodes to detect the change in the impedance of the whole blood sample and record the impedance change curve in real time, and calculate the area under the curve to obtain the platelet aggregation rate.
[0135] Specifically, in this embodiment, the impedance method is used to detect platelet aggregation. As the platelet aggregation rate increases, the resistance of the whole blood increases. Based on this principle, a platelet detection cup equipped with two platinum electrodes at a fixed distance is provided (the platelet detection cup can be disposable or can be reused after cleaning, and the present application does not limit this), specifically refer to Figure 10, a stir bar is put into a platelet detection cup, and a whole blood sample anticoagulated with sodium citrate is added to the platelet detection cup. At the same time, the stir bar is started to stir the whole blood sample to provide the shear force required for platelet aggregation. Then, a platelet aggregation inducer is added to activate platelet receptors. Platelets adhere to the surfaces of two platinum electrodes, and the detection circuit containing the platinum electrodes detects the change in impedance and records the impedance change curve in real time. The area under the curve is calculated to represent the platelet aggregation rate. The aggregation curve corresponding to this aggregation rate is referenced Figure 11 . Among them, the stir bar is a magnetic small rod, which can be added to the platelet detection cup in advance.
[0136] Among them, the platelet aggregation inducer can be any one of arachidonic acid, adenosine diphosphate, epinephrine, etc., and the present application does not limit this.
[0137] In this embodiment, the impedance change of the sample is detected by a circuit to calculate the platelet aggregation rate. Anticoagulated whole blood is directly used, and the blood volume used is small. There is no need to prepare PRP, which reduces the burden on patients and testers.
[0138] As Figure 12 shown, in one embodiment, a combined test and analysis device for coagulation and platelet function is further provided. The device includes: a sample management module 10, a reagent and consumable management module 20, a sample and reagent dispensing module 30, a centrifugation module 42, a coagulation analysis module 50, and a platelet function analysis module 60;
[0139] The sample management module 10 is used to load a blood sample containing whole blood;
[0140] The reagent and consumable management module 20 is used to load coagulation detection reagents and platelet aggregation inducers;
[0141] The sample and reagent dispensing module 30 is used to dispense the platelet aggregation inducer and the whole blood sample aspirated from the blood sample to prepare a platelet aggregation rate detection sample;
[0142] The platelet function analysis module 60 is used to detect the platelet aggregation rate of the platelet aggregation rate detection sample and output the platelet function detection result;
[0143] The centrifugation module 42 is used to centrifuge the remaining blood sample after the whole blood sample is dispensed to obtain a plasma sample;
[0144] The sample and reagent dispensing module 30 is further used to dispense the coagulation detection reagent and the plasma sample to prepare a coagulation detection sample;
[0145] The coagulation analysis module 50 is used to detect the coagulation of the coagulation detection sample and output the coagulation detection result.
[0146] Specifically, the sample reagent dispensing module 30 aspirates a whole blood sample from a carrier container storing the whole blood sample and injects it into the platelet aggregation rate detection channel of the platelet function analysis module 60, and aspirates a platelet aggregation inducer from a carrier container storing the platelet aggregation inducer and injects it into the platelet aggregation rate detection channel of the platelet function analysis module 60, thereby realizing the mixing of the whole blood sample and the platelet aggregation inducer to obtain a platelet aggregation rate detection sample. The carrier container can be a sample tube or other vessels, and the present application does not limit this.
[0147] The platelet function analysis module 60 is specifically configured to perform platelet function detection on the sample dispensed with the sample and the reagent, such as calculating the platelet aggregation rate by testing the difference in the number of platelets before and after adding the platelet aggregation inducer.
[0148] Only a part of the whole blood in the whole blood sample is used for platelet function detection and analysis. By centrifuging the remaining whole blood sample through the centrifugation module 42, a plasma sample can be obtained.
[0149] The sample reagent dispensing module 30 is specifically configured to aspirate a coagulation detection reagent from a carrier container storing the coagulation detection reagent into a reaction container, and aspirate a plasma sample from a carrier container storing the plasma sample into the reaction container. The coagulation detection reagent and the plasma sample in the reaction container can be mixed by a sample reagent mixing module to obtain a coagulation detection sample. Alternatively, the tester mixes the coagulation detection reagent and the plasma sample in the reaction container to obtain a coagulation detection sample. Among them, the plasma sample is obtained by centrifuging an anticoagulated whole blood sample. If the plasma sample and blood cells are stored in the same carrier container, such as a sample tube, the upper layer of the blood sample in the sample tube contains plasma, and the lower layer contains blood cells. The reaction container can be a detection cup.
[0150] The device may further include a transfer module, which is specifically configured to transfer the reaction container containing the coagulation detection sample to the coagulation analysis module 50 after the coagulation detection sample is prepared.
[0151] Alternatively, if there is no transfer module, the tester is notified to transfer the reaction container containing the coagulation detection sample to the coagulation analysis module 50.
[0152] The coagulation analysis module 50 is specifically configured to incubate the reaction container dispensed with the plasma sample and the coagulation detection reagent, detect the coagulation process, and output the coagulation detection result. Among them, the coagulation detection result includes coagulation index test results, such as one or more of PT (prothrombin time), APTT (activated partial thromboplastin time), TT (thrombin time), FIB (fibrinogen), etc.
[0153] In this embodiment, an uncentrifuged whole blood sample tube is used as the blood sample. First, the whole blood sample is aspirated for platelet function test and analysis, and then the remaining blood sample is centrifuged to obtain a plasma sample. Subsequently, the coagulation function test is performed based on the plasma sample. Thus, the combined detection of coagulation and platelets is completed, and only one tube of blood sample from the patient is required, which reduces the burden on the patient. In addition, in this embodiment, only centrifugation is needed to obtain the plasma, and no additional steps are required to achieve the combined detection of coagulation and platelets, which greatly reduces the operation burden on the tester.
[0154] In one embodiment, the sample management module 10 is specifically configured to store the sample tube containing the blood sample in a sample tube carrier container.
[0155] The sample management module 10 is further specifically configured to send the sample tube to the label scanning position for reading sample information.
[0156] The sample and reagent dispensing module 30 is configured to aspirate the plasma sample required for the coagulation test from the sample tube and inject the plasma sample into the coagulation test cup.
[0157] If the device further includes a transfer module, the transfer module is configured to transfer the coagulation test cup containing the plasma sample to the incubation position of the coagulation test module.
[0158] The coagulation test module is configured to incubate the plasma sample in the coagulation test cup.
[0159] The sample and reagent dispensing module 30 is further configured to aspirate the coagulation test reagent from the reagent consumable management module 20 and add it to the coagulation test cup after the incubation duration reaches the preset duration to obtain a coagulation test sample.
[0160] If the device further includes a transfer module, the transfer module is configured to transfer the coagulation test cup to the detection position of the coagulation analysis module 50.
[0161] The coagulation analysis module 50 is specifically configured to perform a coagulation test on the coagulation test cup at the detection position and output the coagulation test result.
[0162] Specifically, the sample management module 10 is used for functions such as sample storage, sample tube information reading, and sample scheduling.
[0163] In the sample loading area, the sample tube containing the blood sample is stored in a sample tube carrier container. The blood sample is a plasma sample obtained by centrifuging anticoagulated whole blood or a whole blood sample. The anticoagulated whole blood can specifically be citrated anticoagulated whole blood. The sample tube carrier container specifically includes a sample rack, a sample tray, etc.
[0164] The sample management module 10 includes a sample scheduling module. The sample scheduling module is used to send the sample tube from the sample loading area to the label scanning position according to the detection instructions issued by the host or the upper computer, so as to read the sample information to obtain and record information such as the sample number and the detection item.
[0165] After the sample information is read, the sample scheduling module can move the sample tube to the aspiration position together with the sample tube carrier, or the sample scheduling module can move the sample tube back to the sample loading area together with the sample tube carrier.
[0166] The sample reagent dispensing module 30 is used to aspirate samples and reagents and dispense them into the test cups or channels.
[0167] If coagulation detection is performed first, the upper layer of the blood sample is plasma and the lower layer is blood cells. The sample reagent dispensing module 30 is specifically used to move to the aspiration position or the sample loading area, aspirate the plasma sample required for coagulation detection from the sample tube at the aspiration position or the sample loading area, and inject the plasma sample into the reaction container. The reaction container is, for example, the test cup or the test cup at the reagent consumable management module 20, specifically the coagulation detection cup.
[0168] Among them, if the sample tube has a tube cap, the sample reagent dispensing module 30 will puncture the tube cap of the sample tube through a pipetting needle (or, a liquid separation needle, or, a dispensing needle), and penetrate into the sample tube to aspirate the plasma sample required for coagulation detection.
[0169] If the sample tube does not have a tube cap, the sample reagent dispensing module 30 will directly penetrate into the sample tube through a pipetting needle (or, a liquid separation needle, or, a dispensing needle) to aspirate the plasma sample required for coagulation detection.
[0170] If the device further includes a transfer module, the transfer module is used to transfer the coagulation detection cup containing the plasma sample to the incubation position of the coagulation detection module.
[0171] Or, if there is no transfer module, the detector can be notified to transfer the coagulation detection cup to the incubation position of the coagulation detection module.
[0172] The coagulation detection module is specifically used to incubate the plasma sample in the coagulation detection cup at the incubation position through the incubation module.
[0173] The sample reagent dispensing module 30 is also used to aspirate the coagulation detection reagent from the reagent consumable management module 20 and add it to the coagulation detection cup after the incubation duration reaches the preset duration.
[0174] In addition, the sample reagent dispensing module 30 can also have a mixing function to mix the plasma sample and the coagulation detection reagent in the coagulation detection cup.
[0175] Or,
[0176] The device can also be provided with a sample reagent mixing module. After the plasma sample and the coagulation detection reagent are dispensed into the coagulation detection cups by the sample reagent dispensing module 30, the sample reagent mixing module mixes the plasma sample and the coagulation detection reagent in the coagulation detection cups.
[0177] Alternatively, the transfer module can also have a mixing function to mix the plasma sample and the coagulation detection reagent in the coagulation detection cups.
[0178] The coagulation detection module includes an optical detection module or a magnetic bead detection module. If the coagulation detection module includes an optical detection module, the coagulation detection cup is an optical detection cup, and the optical detection module detects the coagulation detection cup at the optical detection position through projection and scattering to obtain the coagulation detection result.
[0179] If the coagulation detection module includes a magnetic bead detection module, the coagulation detection cup is a magnetic bead detection cup, and the magnetic bead detection module detects the coagulation detection sample in the magnetic bead detection cup at the magnetic bead detection position to obtain the coagulation detection result.
[0180] The device can also include a sample reagent mixing module, which is used to shake the coagulation detection cup added with the sample and the coagulation detection reagent to obtain the coagulation detection sample.
[0181] If the device includes a transfer module, the transfer module transfers the mixed coagulation detection cup to the detection position of the coagulation analysis module 50.
[0182] If the device does not include a transfer module, the detector is notified to mix the coagulation detection reagent and the plasma sample in the coagulation detection cup, and then the mixed coagulation detection cup is transferred to the detection position of the coagulation analysis module 50.
[0183] The coagulation detection and analysis module is used to perform coagulation detection on the coagulation detection cup at the detection position and output the coagulation detection result.
[0184] Among them, the sample reagent dispensing module 30 includes the same pipetting needle that can be used to aspirate the sample and the coagulation detection reagent, a driving motor (such as two motors for two-dimensional movement) for driving the pipetting needle, a guide rail, etc. The sample reagent dispensing module 30 first aspirates the plasma sample with the pipetting needle, then cleans the pipetting needle, and then aspirates the coagulation detection reagent with the cleaned pipetting needle.
[0185] Or,
[0186] The sample reagent dispensing module 30 includes a sample needle for aspirating the sample, a reagent needle for aspirating the reagent, a driving motor (such as two motors for two-dimensional movement) for driving the sample needle and the reagent needle, a guide rail, etc. The sample needle and the reagent needle both belong to pipetting needles (or, liquid separation needles, or dispensing needles).
[0187] In this embodiment, a blood sample obtained after centrifugation of a tube is used. First, the plasma sample is aspirated for coagulation analysis, and then the remaining blood sample is mixed to obtain a whole blood sample, and then platelet function analysis is performed, realizing the combined detection of coagulation and platelets with only one tube of blood sample. This not only reduces the burden on patients, but also reduces the process steps of the combined detection. Moreover, it basically realizes fully automated detection, reduces manual participation, and thus reduces the burden on the detector.
[0188] In one embodiment, the sample management module 10 is specifically configured to store the sample tube containing the blood sample through a sample tube carrying container.
[0189] The sample mixing module 41 is specifically configured to take out the sample tube from the sample tube carrying container, invert and mix the remaining blood sample after the plasma sample is dispensed into the sample tube, and after the mixing is completed, obtain a whole blood sample again, and put the sample tube back into the sample tube carrying container.
[0190] The sample reagent dispensing module 30 is further configured to inject the whole blood sample aspirated from the sample tube into the platelet aggregation rate detection channel of the platelet function analysis module 60.
[0191] The sample reagent dispensing module 30 is further configured to inject the platelet aggregation inducer aspirated from the reagent consumable management module 20 into the platelet aggregation rate detection channel.
[0192] Specifically, the sample management module 10 is used for functions such as sample storage, sample tube information reading, and sample scheduling.
[0193] In the sample loading area, the sample tube containing the blood sample is stored through a sample tube carrying container, where the blood sample is a plasma sample obtained by centrifuging anticoagulated whole blood; the anticoagulated whole blood can specifically be sodium citrate anticoagulated whole blood, and the sample tube carrying container specifically includes: sample racks, sample trays, etc.
[0194] The sample management module 10 includes a sample scheduling module. The sample scheduling module is configured to, according to the detection instruction issued by the host or the upper computer, send the sample tube from the sample loading area to the label scanning position for sample information reading to obtain and record information such as the sample number and the detection item. After the sample information is read, the sample scheduling module moves the sample tube to the aspiration position together with the sample tube carrying container. Alternatively, the sample scheduling module moves the sample tube back to the sample loading area together with the sample tube carrying container.
[0195] After aspirating the plasma sample during coagulation detection, the sample scheduling module is further configured to transfer the sample tube carrying container from the aspiration position to the sample mixing position.
[0196] The sample mixing module 41 is specifically configured to take out the sample tube from the sample tube carrying container at the sample mixing position, invert the plasma and blood cells in the sample tube up and down for mixing. After the mixing is completed, the sample tube is put back into the sample tube carrying container. At this time, the whole blood sample is obtained in the sample tube.
[0197] Alternatively, the sample mixing module 41 takes out the sample tube from the sample loading area or the aspiration position, inverts the plasma and blood cells in the sample tube up and down for mixing. After the mixing is completed, the sample tube is put back into the sample tube carrying container. At this time, the whole blood sample is obtained in the sample tube.
[0198] After the sample tube carrying the whole blood sample and the sample tube carrying container are re - placed back at the aspiration position, the sample reagent dispensing module 30 aspirates the whole blood sample from the sample at the aspiration position and injects it into the platelet detection channel. The sample reagent dispensing module 30 aspirates the platelet aggregation inducer from the reagent consumable management module 20 and injects it into the platelet detection channel, obtaining the platelet detection sample.
[0199] Among them, the reagent consumable management module 20 is used for the management and storage of the consumables used in the detection, specifically for reagent, reaction cup loading and unloading, storage, etc.
[0200] It should be noted that the sample tube can be moved to the aspiration position or can always wait in the loading area of the sample management module 10 to be aspirated. This application does not limit this.
[0201] This application integrates a coagulation analysis module and a platelet function analysis module. After 1 tube of centrifuged sample is loaded onto the machine, by first dispensing the sample to the coagulation analysis module to detect coagulation indicators, and then using the sample tube mixing module to mix the sample tube, the centrifuged sample is restored to the whole blood state, and then the next platelet function analysis is completed. This application only requires 1 tube of blood and can automatically realize the combined test of coagulation and platelet function on 1 machine without additional operation by the operator, greatly reducing the burden on patients and operators and shortening the report output time.
[0202] This application integrates a coagulation analysis module and a platelet function analysis module. After 1 tube of un - centrifuged whole blood sample is loaded onto the machine, by first dispensing the sample to the platelet analysis module to detect platelet indicators, and then using the centrifugation module to centrifuge the remaining whole blood sample to obtain a plasma sample, and then the next coagulation function analysis is completed. This application only requires 1 tube of blood and can automatically realize the combined test of coagulation and platelet function on 1 machine without additional operation by the operator, greatly reducing the burden on patients and operators and shortening the report output time.
[0203] In the description of the present application, the description referring to terms such as "one embodiment", "some embodiments", "example", "specific example", or "some examples" means that the specific features, structures, materials, or characteristics described in connection with the embodiment or example are included in at least one embodiment or example of the present application. In this specification, the schematic descriptions of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials, or characteristics described can be combined in a suitable manner in any one or more embodiments or examples. In addition, without contradiction, those skilled in the art can combine and combine the different embodiments or examples described in this specification and the features of different embodiments or examples.
[0204] In addition, the terms "first" and "second" are only used for descriptive purposes and cannot be construed as indicating or implying relative importance or implicitly specifying the quantity of the indicated technical features. Thus, the features defined with "first" and "second" may explicitly or implicitly include at least one of such features. In the description of the present application, the meaning of "a plurality" is at least two, such as two, three, etc., unless otherwise specifically defined.
[0205] The above are only the implementation manners of the present application and do not limit the patent scope of the present application. Any equivalent structure or equivalent process transformation made by using the content of the specification and drawings of the present application, or directly or indirectly applied in other related technical fields, shall equally be included in the patent protection scope of the present application.
[0206] The technical features of the above embodiments can be combined arbitrarily. For the sake of brevity of description, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, it should be considered as the scope described in this specification.
[0207] The above-described embodiments only represent several implementation manners of the present application. Their descriptions are relatively specific and detailed, but they should not be construed as limiting the patent scope of the present application. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present application, several modifications and improvements can still be made, and these all belong to the protection scope of the present application. Therefore, the protection scope of the patent of the present application shall be subject to the appended claims.
Claims
1. A combined test analysis device for blood coagulation and platelet function, characterized in that, the device includes: a sample management module, a reagent and consumable management module, a sample and reagent dispensing module, a sample mixing module, a blood coagulation analysis module, and a platelet function analysis module; the sample management module is used to load the centrifuged blood sample; the reagent and consumable management module is used to load the blood coagulation detection reagent and the platelet aggregation inducer; the sample and reagent dispensing module is used to dispense the blood coagulation detection reagent and the plasma sample aspirated from the blood sample to prepare a blood coagulation detection sample; the blood coagulation analysis module is used to perform blood coagulation detection on the blood coagulation detection sample and output the blood coagulation detection result; the sample mixing module is further used to mix the remaining blood sample after the plasma sample is dispensed to obtain a whole blood sample again; the sample and reagent dispensing module is further used to dispense the platelet aggregation inducer and the whole blood sample to prepare a platelet aggregation rate detection sample; the platelet function analysis module is used to perform platelet aggregation rate detection on the platelet aggregation rate detection sample and output the platelet function detection result.
2. The device according to claim 1, characterized in that, the sample management module includes a sample tube holding container, the sample tube holding container includes a plurality of sample tube placement positions, the sample tubes are used to hold the centrifuged blood sample, the upper layer of the centrifuged blood sample is the plasma sample, and the lower layer is the blood cells; the sample and reagent dispensing module is specifically used to dispense a part of the plasma sample on the upper layer of the sample tube to a reaction container to prepare a blood coagulation detection sample; the sample mixing module is specifically used to mix the remaining plasma sample and blood cells in the same sample tube to obtain a whole blood sample again; the sample and reagent dispensing module is further specifically used to dispense the obtained whole blood sample to prepare a platelet aggregation rate detection sample.
3. The device according to claim 2, characterized in that, the sample and reagent dispensing module is further used to additionally dispense a part of the plasma sample on the upper layer of the sample tube to a backup container for leaving as a blood coagulation retest sample; the sample mixing module is used to mix the remaining plasma sample and blood cells in the same sample tube to obtain a whole blood sample again.
4. The device according to any one of claims 1-3, characterized in that, the sample mixing module is specifically used to mix the remaining plasma sample and blood cells in the sample tube at a preset swing angle and a preset swing speed for a preset number of times, wherein the preset swing angle is 90-150 degrees, and / or the preset swing speed is 1 second / back and forth, and / or the preset number of times is 5-15 times.
5. The device according to claim 4, characterized in that, the sample tube has a tube cap, the sample and reagent dispensing module includes a pierceable pipette needle, and the pipette needle is used to pierce the tube cap of the sample tube and dispense the plasma sample or the whole blood sample.
6. The device according to any one of claims 1-3, characterized in that: the platelet function analysis module is specifically used to perform platelet counting on the whole blood sample before and after adding the platelet aggregation inducer to obtain the platelet aggregation rate detection result; or, The platelet function analysis module is specifically configured to detect impedance or current changes in a whole blood sample before and after adding a platelet aggregation inducer to obtain a platelet aggregation rate detection result.
7. The device according to claim 1, wherein, the platelet function analysis module includes a platelet aggregation rate detection channel and a processor module; the sample reagent dispensing module is specifically configured to first dispense the re-obtained whole blood sample into the platelet aggregation rate detection channel; the platelet aggregation rate detection channel is specifically configured to perform a first detection and PLT counting based on the first-injected whole blood sample to obtain 1 PLT counting result; the sample reagent dispensing module is further specifically configured to, after the first detection, aspirate a cleaning solution and dispense it into the platelet aggregation rate detection channel for cleaning the detection channel. After the cleaning is completed, aspirate the whole blood sample again and second-dispense the aspirated whole blood sample into the platelet aggregation rate detection channel, and inject the platelet aggregation inducer aspirated from the reagent consumable management module into the platelet aggregation rate detection channel; the platelet aggregation rate detection channel is specifically configured to perform a second detection based on the second-injected whole blood sample, perform multiple platelet counts at preset time intervals until the platelet aggregation reaction ends to obtain multiple PLT counting results; the processor module is specifically configured to perform fitting based on all PLT counting results to obtain a platelet aggregation curve.
8. The device according to claim 7, wherein, the processor module is further configured to correct each PLT counting result using a preset formula to obtain a corrected PLT counting result; wherein, the preset formula is as follows: PLT (corrected) = PLT (test) * (original sample volume) / (original sample volume - coagulation aspirated plasma volume); the processor module is specifically further configured to perform fitting based on all corrected PLT counting results to obtain a platelet aggregation curve.
9. The device according to claim 1, wherein, the platelet function analysis module is provided with a platelet detection cup, the platelet detection cup is equipped with two platinum electrodes at a fixed distance, and a stirrer is placed in the platelet detection cup; the sample reagent dispensing module is specifically configured to dispense the re-obtained whole blood sample into the platelet detection cup; the stirrer is used to stir the whole blood sample in the platelet detection cup; the sample reagent dispensing module is specifically configured to inject a platelet aggregation inducer into the platelet detection cup; the platelet function analysis module is specifically configured to detect changes in the impedance of the whole blood sample using a detection circuit including the platinum electrodes and record the impedance change curve in real time, and calculate the area under the curve to obtain the platelet aggregation rate.
10. A combined test and analysis device for coagulation and platelet function, wherein, the device includes: a sample management module, a reagent consumable management module, a sample reagent dispensing module, a centrifugation module, a coagulation analysis module, and a platelet function analysis module; the sample management module is used to load a blood sample containing whole blood; The reagent and consumable management module is used for loading coagulation detection reagents and platelet aggregation inducers; The sample and reagent dispensing module is used for dispensing the platelet aggregation inducers and whole blood samples aspirated from the blood samples to prepare platelet aggregation rate detection samples; The platelet function analysis module is used for detecting the platelet aggregation rate of the platelet aggregation rate detection samples and outputting platelet function detection results; The centrifugation module is used for centrifuging the remaining blood samples after the whole blood samples have been dispensed to obtain plasma samples; The sample and reagent dispensing module is also used for dispensing the coagulation detection reagents and the plasma samples to prepare coagulation detection samples; The coagulation analysis module is used for performing coagulation detection on the coagulation detection samples and outputting coagulation detection results.