Multi-system blood coagulation detection chip

Abstract

According to the multi-system blood coagulation detection chip, a detection sample is added into a sample adding part of a detection unit, the chip is centrifuged, platelet-poor plasma and blood cells in the detection sample are separated after the first centrifugation is completed, then the chip is centrifuged for the second time, and blood coagulation is detected after the second centrifugation is completed. The detection method comprises the following steps: adding platelet-poor plasma into a chip, enabling the platelet-poor plasma to enter a quantification part for quantification, carrying out third centrifugation on the chip, enabling the platelet-poor plasma to be transferred from the quantification part into a detection part, finally adding a detection reagent into the detection part, and carrying out fourth centrifugation, so that a detection sample and the detection reagent are fully mixed and react; according to the multi-system blood coagulation detection chip, the two detection parts with different volumes are provided, blood coagulation items of different reaction systems can be detected in a compatible mode, the detection items can be arranged at will, and the purpose that any number of blood coagulation detection items freely selected by all testees can be mixed and spliced on each chip is achieved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of detection equipment, in particular to a multi-system coagulation detection chip. BACKGROUND

[0002] Coagulation item detection belongs to one of the clinical examination items in the clinical laboratory, and is a preoperative examination item. Before a patient is hospitalized for surgery, the doctor will always ask the patient to take blood for coagulation item examination. The coagulation items include the most common six items: prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT), fibrinogen (FIB), D-dimer (DD), fibrinogen degradation product (FDP), and other items.

[0003] Using a whole blood disc to perform coagulation item detection is a more convenient method. The whole blood disc can achieve whole blood separation of a whole blood sample on the disc to obtain poor platelet plasma (PPP), and the liquid formed by subsequent mixing reaction of the poor platelet plasma and reagents corresponding to the items can be used for coagulation item detection.

[0004] During detection, different detection items have different reaction systems, and a "customized package" method is generally used. This method divides the entire disc into multiple identical sectors, each sector is adapted to one subject, and each sector is divided into four, five or six, so that each sector includes four, five or six passage structures, and each sector is forced to bind a plurality of fixed items corresponding to the passage structures.

[0005] The defect of this "customized package" method is that the degree of freedom is low when different items are detected, which easily causes waste of detection hole sites. Since each passage structure has only one detection hole site, it can only provide detection of one item, so if the subject only detects one or two of the total coagulation detection items, the disc hole sites in the package will be left after the one or two coagulation detection items are completed, and the disc will be discarded, thus causing waste and reducing throughput.

[0006] For example, the existing common whole blood disc is often divided into four sectors, each sector includes six passage structures, and the six passage structures detect six items to form a package. Each sector corresponds to one subject, and the subject A uses one of the sectors, but the subject A actually does not do all six items, but only does one item, so only one passage structure and detection hole site in the sector are used, and the remaining five passage structures and detection hole sites are wasted.

[0007] Therefore, it is urgent to develop a universal full blood multi-system coagulation detection disc, which can not only detect different reaction system coagulation items, but also realize arbitrary arrangement of detection items, so as to achieve the purpose that each disc can mix and match any number of coagulation detection items freely selected by each subject. Contents of the utility model

[0008] Therefore, it is necessary to provide a multi-system coagulation detection chip in view of the problem that the existing coagulation detection chip can only detect one system at a time, and it is difficult to simultaneously detect and compare different system items when multiple different system items need to be detected, so as to meet the detection requirements of multiple system items.

[0009] The present application provides a multi-system coagulation detection chip, which comprises:

[0010] A disc body is provided as a disc with a fixing hole at the center, and a plurality of detection units are uniformly arranged in a ring around the fixing hole on the disc body, each detection unit having a plurality of grooves forming a passage therebetween;

[0011] A sealing film is attached to the bottom of the disc body to seal the bottom of the groove of the detection unit;

[0012] Each detection unit comprises:

[0013] A sample adding part is arranged near the fixing hole;

[0014] A detection part is arranged away from the fixing hole, and the sample adding part communicates with the detection part;

[0015] A quantification part is arranged between the sample adding part and the detection part, and the quantification part guides the liquid in the sample adding part to flow to the detection part;

[0016] The detection part comprises a first detection part and a second detection part, both of which communicate with the quantification part, and the volumes of the first detection part and the second detection part are different, and the first detection part and the second detection part are used for detection of different system items.

[0017] The application relates to a multi-system coagulation detection chip, which is fixed in position through a fixing hole, then a detection sample is added into a sample adding part of a detection unit, and the multi-system coagulation detection chip is centrifuged, after the first centrifugation, anemic platelet plasma and blood cells in the detection sample are separated, then the multi-system coagulation detection chip is centrifuged again, after the second centrifugation, the anemic platelet plasma enters a quantitative part for quantification, then the multi-system coagulation detection chip is centrifuged again, the quantified anemic platelet plasma is transferred from the quantitative part into a detection part, finally, a detection reagent is added into the detection part and the fourth centrifugation is carried out, so that the detection sample and the detection reagent are fully mixed, and the detection of the mixed sample in the detection part is completed, the multi-system coagulation detection chip can not only be compatible with coagulation items of different reaction systems, but also can realize arbitrary arrangement of detection items, so that each chip can mix and match an arbitrary number of coagulation detection items freely selected by each subject. BRIEF DESCRIPTION OF DRAWINGS

[0018] Figure 1 A structural schematic diagram of a multi-system coagulation detection chip is provided for an embodiment of the application.

[0019] Figure 2 A structural schematic diagram of a detection unit of a multi-system coagulation detection chip is provided for an embodiment of the application.

[0020] Figure 3 A structural schematic diagram of a first detection part of a multi-system coagulation detection chip is provided for an embodiment of the application.

[0021] Figure 4 A structural schematic diagram of a second detection part of a multi-system coagulation detection chip is provided for an embodiment of the application.

[0022] Figure 5 A side sectional view of a disc body of a multi-system coagulation detection chip is provided for an embodiment of the application.

[0023] Figure 6 A three-dimensional schematic diagram of a disc body (without a sealing film) of a multi-system coagulation detection chip is provided for an embodiment of the application.

[0024] REFERENCE SIGNS:

[0025] 50, disc body; 51, fixing hole; 52, sealing film; 100, detection unit; 200, sample adding part;

[0026] 201, sample adding area; 201a, sample adding hole; 202, first centrifugation area; 203, first channel;

[0027] 204, second channel; 205, third channel; 206, first centrifugal pool; 207, first sedimentation pool;

[0028] 300, detection part; 301, first detection part; 302, second detection part; 303, post-waste liquid area;

[0029] 304, first reagent pool; 304a, first reagent hole; 305, first reaction pool;

[0030] 306, first detection pool; 307, second reagent pool; 307a, second reagent hole;

[0031] 308, second reaction pool; 309, second detection pool; 310, partition plate;

[0032] 311, first capillary valve channel; 311a, first capillary valve; 312, second capillary valve channel;

[0033] 312a, second capillary valve; 400, metering part;

[0034] 401, buffer area; 402, pre-waste liquid area; 403, first metering pool; 404, second metering pool. DETAILED DESCRIPTION

[0035] In order to make the purpose, technical scheme and advantages of the present application more clear, the present application is further described in detail below in combination with the drawings and examples. It should be understood that the specific examples described herein are only used to explain the present application, and are not used to limit the present application.

[0036] The present application provides a multi-system coagulation detection chip.

[0037] As shown in Figure 1 and Figure 5 , in an embodiment of the present application, the multi-system coagulation detection chip comprises a disc body 50 and a sealing film 52.

[0038] The disc body 50 is arranged as a disc with a fixing hole 51 at the center, and a plurality of detection units 100 are arranged uniformly in a ring around the fixing hole 51 on the disc body 50. Each detection unit 100 has a plurality of grooves forming passages with each other, and the sealing film 52 is attached to the bottom of the disc body 50 to seal the bottom of the grooves of the detection unit 100.

[0039] As shown in Figure 2 , each detection unit 100 comprises a sample adding part 200, a detection part 300 and a metering part 400.

[0040] The sample adding part 200 is arranged close to the fixed hole 51. The detection part 300 is arranged away from the fixed hole 51, and the sample adding part 200 is communicated with the detection part 300. The quantitative part 400 is arranged between the sample adding part 200 and the detection part 300, and the quantitative part 400 is used to guide the liquid in the sample adding part 200 to flow to the detection part 300.

[0041] The detection part 300 comprises a first detection part 301 and a second detection part 302, the volumes of the first detection part 301 and the second detection part 302 are different, the first detection part 301 and the second detection part 302 are both communicated with the quantitative part 400, and the first detection part 301 and the second detection part 302 are used for detecting samples of different systems.

[0042] Specifically, the disc body 50 and the sealing film 52 are attached to form the multi-system coagulation detection chip.

[0043] In the embodiment, 12 detection units can be arranged, and therefore the sample adding part 200 can be provided with 12 sample adding parts.

[0044] The multi-system coagulation detection chip provided by the application can be used for testing coagulation items of whole blood or plasma, and the most common test is six items (four coagulation items and two turbidity items), specifically including PT (prothrombin time) item, APTT (activated partial thromboplastin time) item, TT (thrombin time) item, FIB (fibrinogen) item, DD (D-dimer) item and FDP (fibrinogen degradation product) item.

[0045] When the multi-system coagulation detection chip is used to detect coagulation items, the multi-system coagulation detection chip is centrifuged four times.

[0046] Before the detection starts, the multi-system coagulation detection chip is fixed on the detection platform through the fixed hole 51, so that the installation position of the multi-system coagulation detection chip can be prevented from being wrong.

[0047] After the multi-system coagulation detection chip is installed, the sample is added into the sample adding area 201 through the sample hole 201a.

[0048] After the whole blood sample enters, the disc body 50 is centrifuged for the first time to separate the whole blood sample into poor platelet plasma (English abbreviation: PPP) and blood cells, wherein the poor platelet plasma enters the first centrifugal pool 206, and the blood cells enter the first sedimentation pool 207.

[0049] Specifically, the first centrifugation is high-speed centrifugation. Alternatively, the first centrifugation is counterclockwise centrifugation at a speed of 2900 rpm, and the centrifugation time is 420 s.

[0050] Afterwards, the multi-system coagulation detection chip is centrifuged for the second time, so that the platelet-poor plasma in the first centrifugation area 206 enters the buffer area 401 through the third channel 205, and then flows through the buffer area 401 and is quantitatively transferred into the first quantitative pool 403 and the second quantitative pool 404, respectively.

[0051] The third channel 205 is a siphon channel and has a capillary effect. Optionally, the capacities of the first quantitative pool 403 and the second quantitative pool 404 can be equal, both being 10 μL (all the volumes in the present application are described in the unit of μL, i.e., microliter). Optionally, the capacities of the first quantitative pool 403 and the second quantitative pool 404 can also be unequal. During the process of the platelet-poor plasma in the first centrifugation area 206 being quantitatively transferred into the first quantitative pool 403 and the second quantitative pool 404, respectively, the excess platelet-poor plasma enters the waste liquid pool 303 for storage.

[0052] After the second centrifugation, the platelet-poor plasma in the first centrifugation pool 206 is transferred into the first quantitative pool 403, the second quantitative pool 404 and the waste liquid pool 303 almost synchronously, but there is a slight difference in the order. Specifically, after the second centrifugation, the platelet-poor plasma in the first centrifugation pool 206 first enters the second quantitative pool 404, then enters the first quantitative pool 403, and finally enters the waste liquid pool 303.

[0053] Specifically, the second centrifugation is slow-speed centrifugation. Optionally, the second centrifugation is clockwise centrifugation at a speed of 700 rpm and a centrifugation time of 10 s.

[0054] After the first quantitative pool 403 and the second quantitative pool 404 are filled with platelet-poor plasma, the multi-system coagulation detection chip is centrifuged for the third time, so that the platelet-poor plasma in the first quantitative pool 403 enters the first detection part 301, the platelet-poor plasma in the second quantitative pool 404 enters the second detection part 302, and the platelet-poor plasma remaining in the third channel 205 and the bottom of the separation pool 206 all enter the pre-waste liquid area 402.

[0055] Specifically, the third centrifugation is high-speed centrifugation. Optionally, the third centrifugation is clockwise centrifugation at a speed of 4000 rpm and a centrifugation time of 10 s.

[0056] After the platelet-poor plasma enters the first detection part 301, a first reagent is added into the first reagent pool 304 through the first reagent hole 304a, and after the platelet-poor plasma enters the second detection part 302, a second reagent is added into the second reagent pool 307 through the second reagent hole 307a. The first reagent can be an enzyme reagent, an activator, etc. required for the detection item. The second reagent can be a reagent, etc. required for the detection item. The first reagent and the second reagent can be different.

[0057] After the first reagent and the second reagent are added, the multi-system coagulation detection chip is centrifuged for the fourth time, so that the first reagent enters the first reaction pool 305 and the first reagent and the platelet-poor plasma in the first reaction pool 305 complete mixing and reaction, and the second reagent enters the second reaction pool 308 and the second reagent and the platelet-poor plasma in the second reaction pool 308 complete mixing and reaction. The multi-system coagulation detection chip provides two detection pools with different volumes, so that the disc body 50 can simultaneously detect multiple different system projects.

[0058] Specifically, the fourth centrifugation is high-speed centrifugation at a speed of -3000 rpm, and the centrifugation time is 5 seconds.

[0059] After the platelet-poor plasma in the first reaction pool 305 and the first reagent complete the reaction and / or the platelet-poor plasma in the second reaction pool 308 and the second reagent complete the reaction, the mixed sample in the first detection pool 306 and / or the second detection pool 309 is detected by the detection platform to complete the detection.

[0060] It should be noted that the corresponding centrifugation conditions can be set according to the corresponding reaction conditions to complete the reaction and detection. That is, different speeds of the fourth centrifugation and different centrifugation times can be set according to different detection projects. The speed and detection time given in the application are only for illustrative purposes and do not limit the scope of protection of the application.

[0061] In this embodiment, the position of the multi-system coagulation detection chip is fixed by the fixed hole 51, then the detection sample is added to the sample adding unit 200 of the detection unit 100, and the disc body 50 is centrifuged. After the first centrifugation is completed, the plasma and blood cells in the detection sample are separated, then the multi-system coagulation detection chip is centrifuged for the second time, and after the second centrifugation is completed, the platelet-poor plasma enters the quantification unit 400 for quantification. Then the multi-system coagulation detection chip is centrifuged for the third time, so that the quantified platelet-poor plasma is transferred from the quantification unit to the detection unit 300. Finally, the detection reagent is added to the detection unit 300 and centrifuged for the fourth time, so that the detection sample and the detection reagent are fully mixed, and the detection of the mixed liquid in the detection unit 300 is completed. The multi-system coagulation detection chip provides two detection units 300 with different volumes, which can not only be compatible with different reaction systems of coagulation projects, but also can realize arbitrary arrangement of detection projects, so as to achieve the purpose of mixing and matching of any number of coagulation detection projects freely selected by each subject on each chip.

[0062] The detection of different system projects refers to different detection projects, and the proportion of the sample in the whole reaction system is different.

[0063] AsFigure 2 As shown in the embodiment of the present application, the sample adding part 200 comprises a sample adding area 201 and a first centrifugal area 202. The proximal end of the sample adding area 201 is arranged close to the fixed hole 51. The proximal end of the first centrifugal area 202 communicates with the distal end of the sample adding area 201. The top surface of the sample adding area 201 is provided with a sample adding hole 201a.

[0064] In the embodiment, the whole blood sample is added into the sample adding area 201 through the sample adding hole 201a. The whole blood sample enters into the first centrifugal area 202 through the first channel 203. Then, the disc body 50 is subjected to the first centrifugation, so as to separate the whole blood sample in the first centrifugal area 202 into platelet-poor plasma and blood cells, and realize plasma separation.

[0065] As shown in the embodiment of the present application, the first centrifugal area 202 comprises a first channel 203, a second channel 204, a third channel 205, a first centrifugal pool 206 and a first sedimentation pool 207. Figure 4

[0066] The other end of the first channel 203 communicates with the proximal end of the first centrifugal pool 206. The one end of the second channel 204 communicates with the proximal end of the first centrifugal pool 206. The other end of the second channel 204 communicates with the first sedimentation pool 207. The one end of the third channel 205 communicates with the distal end of the first centrifugal pool 206. The other end of the third channel 205 communicates with the quantifying part 400.

[0067] Specifically, the third channel 205 is arranged in a U shape. The third channel 205 is arranged as a siphon pipe with capillary effect. Each detection unit 100 mentioned in the foregoing embodiments has a plurality of grooves which form passages between each other. These grooves actually refer to the first centrifugal pool 206 and the first sedimentation pool 207, and the subsequent first reagent pool 304, the second reagent pool 307, the first detection pool 306 and the second detection pool 309, and also refer to some areas, such as the buffer area 401 and the pre-waste liquid area 402. They are essentially recesses which can contain liquid, only with different names in the present application.

[0068] In the embodiment, the whole blood sample is separated into platelet-poor plasma and blood cells in the first centrifugal area 202. The platelet-poor plasma separated from the whole blood sample enters into the quantifying part 400 through the third channel 205. The blood cells separated from the whole blood sample enter into the first sedimentation pool 207 through the second channel 204.

[0069] As shown in the embodiment of the present application, the first centrifugal area 202 comprises a first channel 203, a second channel 204, a third channel 205, a first centrifugal pool 206 and a first sedimentation pool 207. Figure 2 ​As shown, in one embodiment of this application, the metering unit 400 includes a buffer zone 401, a pre-waste liquid zone 402, a first metering pool 403, and a second metering pool 404. The proximal end of the buffer zone 401 is connected to the other end of the third channel 205, and the pre-waste liquid zone 402, the first metering pool 403, and the second metering pool 404 are all located at the distal end of the buffer zone 401 and are connected to it.

[0070] Optionally, the volume of the first metering cell 403 and the volume of the second metering cell 404 are equal. Alternatively, the volumes of the first metering cell 403 and the second metering cell 404 may not be equal.

[0071] In this embodiment, the anemic platelet plasma after the first centrifugation enters the first centrifugation chamber 206.

[0072] After a second centrifugation, the anemic platelet plasma in the first centrifugation chamber 206 enters the buffer chamber 401 through the third channel 205. The anemic platelet plasma in the buffer chamber 401 then enters the first quantitative chamber 403 and the second quantitative chamber 404 after the second centrifugation.

[0073] like Figure 2 As shown, in one embodiment of this application, the detection unit 300 further includes a post-waste liquid area 303, which is connected to the buffer zone 401. The first detection unit 301 is connected to the first quantitative pool 403, and the second detection unit 302 is connected to the second quantitative pool 404.

[0074] Specifically, a first capillary valve channel 311 is provided between the first detection unit 301 and the first quantitative cell 403. One end of the first capillary valve channel 311 is connected to the distal end of the first quantitative cell 403, and the other end of the first capillary valve channel 311 is connected to the distal end of the first reagent cell 304. The first quantitative cell 403 and the first reagent cell 304 are connected through the first capillary valve channel 311. Since the connection point between the other end of the first capillary valve channel 311 and the first reagent cell 304 is located between the first reagent hole 304a and the first reaction cell 305, the sample can come into contact with the first reagent and react before entering the first reaction cell 305, thereby making the reaction between the sample and the first reagent in the first reaction cell 305 more complete.

[0075] A second capillary valve channel 312 is also provided between the second detection unit 302 and the second quantitative cell 404. One end of the second capillary valve channel 312 is connected to the distal end of the second quantitative cell 404, and the other end of the second capillary valve channel 312 is connected to the distal end of the second reagent cell 307. The second capillary valve channel 312 enables communication between the second quantitative cell 404 and the second reagent cell 307. Since the connection point between the other end of the second capillary valve channel 312 and the second reagent cell 307 is located between the second reagent hole 307a and the second reaction cell 308, the sample can come into contact with the second reagent and react before entering the second reaction cell 308, thereby making the reaction between the sample and the second reagent in the second reaction cell 308 more complete.

[0076] A first capillary valve 311a is provided on the first capillary valve channel 311, preventing liquid from passing through when the centrifugal force is low, thus creating a barrier; however, when the centrifugal force is high, the liquid can pass through the first capillary valve channel 311. Similarly, a second capillary valve 311a is provided on the second capillary valve channel 312, preventing liquid from passing through when the centrifugal force is low, thus creating a barrier; however, when the centrifugal force is high, the liquid can pass through the second capillary valve channel 311. Therefore, the rotational speed of the third centrifugation is greater than that of the second centrifugation.

[0077] The first reaction tank 305 can have a volume of 30 μL, and the second reaction tank 308 can have a volume of 90 μL, or the first reaction tank 305 can have a volume of 90 μL, and the second reaction tank 308 can have a volume of 30 μL. The two reaction tanks have different volumes.

[0078] In this embodiment, after the sample enters the first quantitative pool 403 and the second quantitative pool 404 from the buffer 401 respectively, a third centrifugation is performed, so that the sample in the first quantitative pool 403 enters the first detection unit 301, the sample in the second quantitative pool 404 enters the second detection unit 302, and the excess sample in the buffer 401 enters the pre-waste liquid area 402.

[0079] like Figure 3 As shown, in one embodiment of this application, the first detection unit 301 includes a first reagent pool 304, a first reaction pool 305 and a first detection pool 306. The first reagent pool 304 has a first reagent hole 304a. The first reagent pool 304 is connected to the first reaction pool 305, and the first reaction pool 305 is also connected to the first detection pool 306.

[0080] Specifically, the detection reagent added to the first reagent pool 304 is referred to as the first reagent. The detection reagent can be an enzyme reagent or an activator, or other reagents required for the detection items.

[0081] In the embodiment, after the sample enters the first detection part 301 from the first quantitative pool 403, a quantitative first reagent is added into the first detection part 301 through the first reagent hole 304a. After the addition of the first reagent and the second reagent is completed, the disc body 50 is centrifuged for the fourth time, so that the first reagent quickly enters the first reaction pool 305, and the first reagent and the platelet-poor plasma are fully mixed and reacted in the first reaction pool 305. After the reaction is completed, the mixed liquid in the first detection pool 306 is detected to complete the detection.

[0082] As shown in the embodiment of the present application, the second detection part 302 comprises a second reagent pool 307, a second reaction pool 308 and a second detection pool 309. The second reagent pool 307 is provided with a second reagent hole 307a, the second reagent pool 307 communicates with the second reaction pool 308, and the second reaction pool 308 further communicates with the second detection pool 309. Figure 4 Specifically, the detection reagent in the second reagent pool 307 is referred to as a second reagent.

[0083] In the embodiment, after the sample enters the second detection part 302 from the second quantitative pool 404, a quantitative second reagent is added into the second detection part 302 through the second reagent hole 307a.

[0084] After the addition of the first reagent and the second reagent is completed, the disc body 50 is centrifuged for the fourth time, so that the second reagent quickly enters the second reaction pool 308, and the second reagent and the platelet-poor plasma are fully mixed and reacted in the second reaction pool 308. After the reaction is completed, the mixed liquid in the second detection pool 309 is detected to complete the detection.

[0085] Optionally, as shown in the embodiment of the present application, the first reagent pool 304 is further provided with a third reagent hole 304b for placing a third reagent.

[0086] Figure 3 Optionally, as shown in the embodiment of the present application, the first reagent pool 304 is further provided with a fourth reagent hole 307b for placing a fourth reagent.

[0087] Optionally, as shown in the embodiment of the present application, the first reagent pool 304 is further provided with a fourth reagent hole 307b for placing a fourth reagent. Figure 4

[0088] ​​The third reagent hole 304b and the fourth reagent hole 307b are arranged so that not only single-reagent coagulation detection items can be performed, but also double-reagent coagulation detection items can be performed. For example, in the most common six tests, the PT (prothrombin time) item and the TT (thrombin time) item are single-reagent coagulation detection items, while the APTT (activated partial thromboplastin time) item, the FIB (fibrinogen) item, the DD (D-dimer) item, and the FDP (fibrin degradation product) item are double-reagent coagulation detection items.

[0089] For example, as shown in FIG. 3, if a double-reagent coagulation detection item is performed, two reagents are placed in the first reagent hole 304a and the third reagent hole 304b, and then a fourth centrifugation is performed. Figure 3

[0090] As shown in FIG. 3, in an embodiment of the present application, the first reaction pool 305 and the first detection pool 306 are further provided with a partition plate 310, and the partition plate 310 is provided with two partition plates 310, which are symmetrically arranged about the central axis of the first detection pool 306, and the two partition plates 310 have a gap to form a channel. Figure 3 In the embodiment, the two partition plates 310 form a channel, so that the mixed sample in the first reaction pool 305 is prevented from flowing back into the first reagent pool 304, so as to ensure that the first reagent and the whole blood plasma sample can be fully mixed in the first reaction pool 305.

[0091] As shown in FIG. 3, in an embodiment of the present application, the first detection pool 306 is arranged in a circular shape.

[0092] Figure 3 Specifically, the volume of the first detection pool 306 is greater than the volume of the second detection pool 309.

[0093] In the embodiment, the first detection pool 306 is arranged in a circular shape, so that the first detection pool 306 has a larger volume.

[0094] Since the volume of the first quantitative pool 403 and the volume of the second quantitative pool 404 are equal, the sample volume entering the first reaction pool 305 and the sample volume entering the second reaction pool 308 are equal, and now the volume of the first detection pool 306 is greater than the volume of the second detection pool 309, so that more detection reagents can be injected into the first detection part 301, thereby distinguishing the first detection pool 306 from the second detection pool 309 to meet different reaction systems. In essence, the purpose of controlling the proportion of different detection items in the whole reaction system is achieved.

[0095] As shown in FIG. 3, in an embodiment of the present application, the first quantitative pool 403 and the second quantitative pool 404 are arranged in a circular shape.

[0096] As shown in FIG. 3, in an embodiment of the present application, the first quantitative pool 403 and the second quantitative pool 404 are arranged in a circular shape.​​Figure 4 In an embodiment of the present application, the second detection pool 309 is semicircular.

[0097] In this embodiment, the second detection pool 309 is semicircular, so that the volume of the second detection pool 309 is smaller than that of the first detection pool 306, so that the second detection pool 309 can store less detection reagent, thereby distinguishing from the first detection pool 306, thereby meeting different reaction systems.

[0098] The multi-system coagulation detection chip provided by the present application has a reasonable overall design, and the functional units are arranged closely, aesthetically and reasonably, which is beneficial to mold development. The disc diameter is 120 mm, the thickness is 5.15 mm (the main body of the chip is 5.0 mm thick, and the auxiliary pressure-sensitive film is 0.15 mm thick), and has the same fixed hole structure as the 32-channel universal disc and the 16-channel platelet disc of the same series, which can adapt to the full-automatic analyzer equipment of Party A, complete the coagulation project detection, and realize the purpose of product serialization. The multi-system coagulation detection chip provided by the present application has the characteristics of low sample quantity requirement, short detection period, low cost, and can realize rapid separation and detection of multiple samples, high detection efficiency, high reliability and accurate detection results after centrifugation, transfer and other steps. At the same time, it is expected to carry more detection projects, and further enrich the product line.

[0099] The overall disc structure of the multi-system coagulation detection chip is in the form of 12 equally distributed detection units. The multi-system coagulation detection chip can realize full blood sampling detection, plasma separation, quantitative transfer and other fluid precise control technologies, as well as multi-stage step transfer function. The multi-system coagulation detection chip provided by the present application has the advantages of simple operation, high throughput, automation and full integration. The chip structure mainly includes a sampling area, a separation area, a precipitation area, a quantitative area, a pre / post-waste liquid storage area, a reaction / detection area and various channels. Each channel is subdivided into two quantitative areas for 30 μL and 90 μL volume detection and two reaction / detection areas below the two quantitative areas, which are connected through a microvalve structure (i.e. a capillary valve channel). The volume of the quantitative area is 11.5 μL, which can be accurately quantified by low-speed and high-speed centrifugation and transferred to the reaction / detection pool, with a transfer success rate of 100% and a leakage rate of 0%.

[0100] Table 1 is a performance test table of the multi-system coagulation detection chip provided by the present application.

[0101] As shown in Table 1, it can be seen that the repeatability and accuracy of the multi-system coagulation detection chip provided by the present application in FIB project, DD project, PT project, TT project and APTT project all meet the acceptance standard.

[0102] The multi-system coagulation detection chip provided in the application also meets the acceptance standard in the clinical accuracy of FIB project, PT project and TT project.

[0103] Table 1 - Performance detection table of multi-system coagulation detection chip

[0104]

[0105]

[0106] The CV in Table 1 refers to coagulation factor CV value, coagulation factor CV value, also known as coefficient of variation or relative deviation, refers to the representation method of repeatability error of coagulation factor activity determination. The smaller the CV, the higher the accuracy of the detection.

[0107] The technical features of the above-described embodiments can be combined in any manner, and the method steps are not limited in execution order. In order to make the description simple, all possible combinations of the technical features in the above-described embodiments are not described, however, as long as the combination of the technical features does not exist contradictory, it should be considered as the scope of the present application.

[0108] The above-described embodiments only express several implementation manners of the present application, the description is more specific and detailed, but it should not be understood as a limitation on the patent scope of the present application. It should be pointed out that for ordinary skilled in the art, without departing from the concept of the present application, a number of modifications and improvements can be made, which all belong to the protection scope of the present application. Therefore, the protection scope of the present application should be subject to the appended claims.

Claims

1. A multi-system coagulation detection chip, characterized in that, The multi-system coagulation detection chip comprises: A disc body (50) provided as a disc with a fixing hole (51) at the center, the disc body (50) being provided with a plurality of detection units (100) arranged uniformly in a ring around the fixing hole (51), each detection unit (100) having a plurality of grooves forming passages with each other; A sealing film (52) attached to the bottom of the disc body (50) to seal the bottoms of the grooves of the detection units (100); Each detection unit (100) comprises: A sample adding part (200) arranged close to the fixing hole (51); A detection part (300) arranged away from the fixing hole (51), the sample adding part (200) and the detection part (300) being in communication; A quantification part (400) arranged between the sample adding part (200) and the detection part (300), the quantification part (400) guiding the flow of liquid in the sample adding part (200) to the detection part (300); The detection part (300) comprises a first detection part (301) and a second detection part (302), both the first detection part (301) and the second detection part (302) being in communication with the quantification part (400), the first detection part (301) and the second detection part (302) having different volumes, and the first detection part (301) and the second detection part (302) being used for detecting different system items.

2. The multi-kinetics blood coagulation test chip according to claim 1, wherein, The sample adding part (200) comprises a sample adding area (201) and a first centrifugal area (202), the proximal end of the sample adding area (201) being arranged close to the fixing hole (51), the proximal end of the first centrifugal area (202) being in communication with the distal end of the sample adding area (201), and the top surface of the sample adding area (201) being provided with a sample adding hole (201a).

3. The multi-kinetics blood coagulation test chip according to claim 2, wherein, The first centrifugal area (202) comprises a first channel (203), a second channel (204), a third channel (205), a first centrifugal pool (206), and a first sedimentation pool (207), one end of the first channel (203) being in communication with the distal end of the sample adding area (201), the other end of the first channel (203) being in communication with the proximal end of the first centrifugal pool (206), one end of the second channel (204) being in communication with the proximal end of the first centrifugal pool (206), the other end of the second channel (204) being in communication with the first sedimentation pool (207), one end of the third channel (205) being in communication with the distal end of the first centrifugal pool (206), and the other end of the third channel (205) being in communication with the quantification part (400).

4. The multi-kinetics blood coagulation test chip according to claim 3, wherein, The quantification part (400) comprises a buffer area (401), a pre-waste liquid area (402), a first quantification pool (403), and a second quantification pool (404), the proximal end of the buffer area (401) being in communication with the other end of the third channel (205), the pre-waste liquid area (402), the first quantification pool (403), and the second quantification pool (404) all being arranged at the distal end of the buffer area (401) and in communication.

5. The multi-kinetics blood coagulation detection chip according to claim 4, wherein, The detection part (300) further comprises: A rear waste liquid area (303) is in communication with a buffer area (401), the first detection part (301) is in communication with the first quantitative pool (403), and the second detection part (302) is in communication with the second quantitative pool (404).

6. The multi-kinetics blood coagulation detection chip according to claim 5, wherein, The first detection part (301) comprises a first reagent pool (304), a first reaction pool (305) and a first detection pool (306), the first reagent pool (304) is provided with a first reagent hole (304a), the first reagent pool (304) is in communication with the first reaction pool (305), and the first reaction pool (305) is further in communication with the first detection pool (306).

7. The multi-kinetics blood coagulation test chip according to claim 6, wherein The second detection part (302) comprises a second reagent pool (307), a second reaction pool (308) and a second detection pool (309), the second reagent pool (307) is provided with a second reagent hole (307a), the second reagent pool (307) is in communication with the second reaction pool (308), and the second reaction pool (308) is further in communication with the second detection pool (309).

8. The multi-kinetics blood coagulation test chip according to claim 7, wherein, The first reaction pool (305) and the first detection pool (306) are further provided with a partition plate (310), the partition plate (310) is provided with two, the two partition plates (310) are symmetrically arranged about the central axis of the first detection pool (306), and the two partition plates (310) have a gap to form a channel.

9. The multi-kinetics blood coagulation detection chip according to claim 8, wherein, The shape of the first detection pool (306) is circular.

10. The multi-kinetics blood coagulation detection chip according to claim 9, wherein, The shape of the second detection pool (309) is semicircular.

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