Activated whole blood clotting time detection device and control method thereof

Abstract

The application discloses an activation whole blood clotting time detection device and a control method thereof. The detection device comprises a main body, a detection reagent card, a driving assembly, a light-emitting module and a detection module. The main body is provided with a detection bin, and the detection reagent card is detachably arranged in the detection bin. A sample adding cavity and a detection cavity are formed in the detection reagent card, and the sample adding cavity and the detection cavity are communicated. The distance from the sample adding cavity and the detection cavity to the first side edge of the main body gradually increases. The detection cavity has a V-shaped structure. A light transmission groove is arranged on the detection cavity and located on the side of the detection cavity away from the sample adding cavity. An activation substance is arranged in the detection cavity. The driving assembly is used for driving the detection reagent card to rotate in the detection bin. The light-emitting module is arranged in the detection bin and used for emitting light with a specific wavelength to the detection cavity. The detection module is arranged on the main body and used for detecting and analyzing the light intensity passing through the light transmission groove. The application at least solves the problem that the detection device in the related art is relatively complex.

Description

Technical Field

[0001] This application relates to the field of bioinformatics detection technology, and more specifically, to a detection device for activating whole blood clotting time and a control method thereof. Background Technology

[0002] In related technologies, methods for detecting activated clotting time include manual water bath method, rotating test tube magnetic bead method, gasket drop method, electrochemical method, and optical method. The various testing methods in these technologies require different testing equipment, and most of the equipment is quite complex. Summary of the Invention

[0003] The main objective of this application is to provide a detection device and control method for activating whole blood clotting time, so as to solve the problem of the complexity of detection devices in related technologies.

[0004] According to one aspect of this application, a detection device for activating whole blood clotting time is provided, comprising: The main body, on which a detection chamber is provided; A test reagent card is detachably disposed in the test chamber. The test reagent card has a sample dispensing cavity and a test cavity, which are connected. The distance from the sample dispensing cavity and the test cavity to the first side of the main body gradually increases. The test cavity has a V-shaped structure and a light-transmitting groove is provided on the test cavity. The light-transmitting groove is located on the side of the test cavity away from the sample dispensing cavity. An activating substance is disposed inside the test cavity. A driving component is disposed on the main body, and the driving component is at least used to drive the detection reagent card to rotate within the detection chamber; A light-emitting module is disposed in the detection chamber and is used to emit light of a specific wavelength into the detection chamber; A detection module is disposed on the main body, and the detection module is used to detect and analyze the light intensity passing through the light-transmitting groove.

[0005] In some embodiments, the detection cavity includes: A first cavity segment, which is connected to the sample application cavity and extends a first predetermined length in a direction away from the first side; The second cavity segment is connected to the first cavity segment via an arc-shaped connecting segment. The second cavity segment extends a second predetermined length in a direction close to the first side, so that the first cavity segment, the arc-shaped connecting segment and the second cavity segment form a V-shaped structure, and the opening of the V-shaped structure faces the rotation center of the test reagent card. The activating substance is disposed within the arc-shaped connecting section, and the light-transmitting groove is disposed at the end of the second cavity section opposite to the first cavity section.

[0006] In some embodiments, along the extending direction of the second cavity segment, the distance from the light-transmitting groove to the midpoint of the arc-shaped connecting segment is greater than or equal to the first predetermined length.

[0007] In some embodiments, the test kit further includes a ventilated chamber, which is connected to one end of the second cavity segment away from the first cavity segment and extends in a direction close to the first cavity segment, and the ventilated chamber is provided with vent holes.

[0008] In some embodiments, along the thickness direction of the test reagent card, the light-transmitting groove is disposed at the bottom of the second cavity segment, or; The light-transmitting groove is located on the inner wall surface of the second cavity section on the side opposite to the opening of the V-shaped structure.

[0009] In some embodiments, the test reagent card further includes a buffer chamber connected to the sample application chamber and the detection chamber, and the distances from the sample application chamber, the buffer chamber, and the detection chamber to the first side of the body gradually increase.

[0010] In some embodiments, the buffer chamber includes: A first buffer chamber, which is connected to the sample dispensing chamber; A connecting cavity is provided, which is in communication with the first buffer cavity; A second buffer cavity is connected to the connecting cavity and the detection cavity; The width of the connecting cavity is smaller than the width of the first buffer cavity and the second buffer cavity.

[0011] In some embodiments, the light-transmitting groove includes a circular groove, the diameter R of which satisfies the relationship: 0.5mm ≤ R ≤ 2mm; and / or, The volume L of the detection cavity satisfies the following relationship: 50μL≤L≤200μL.

[0012] In some embodiments, the activating substance includes at least one of a diatomaceous earth layer, a kaolin layer, an ellagic acid layer, or a glass layer.

[0013] On the other hand, this application also provides a control method for a detection device for activating whole blood clotting time, the control method for the detection device for activating whole blood clotting time is used to control the detection device for activating whole blood clotting time, the method comprising: The sample is injected into the sample dispensing chamber, and the driving component is controlled to rotate the test reagent card so that the sample in the sample dispensing chamber enters the test chamber under the action of centrifugal force; The light-emitting module is controlled to emit light to illuminate the detection cavity, and the light intensity passing through the light-transmitting groove is detected by the detection module. The driving component is controlled to drive the detection reagent card to rotate in both directions so that the sample oscillates back and forth in the detection cavity, while the detection time is recorded. When the detection module detects that the light intensity passing through the light-transmitting groove has decreased to a predetermined value within a predetermined time, the recorded detection time is taken as the clotting time of the sample.

[0014] In some embodiments, the relative centrifugal force RCF provided by the driving component when rotating the test reagent card satisfies the relationship: 200g ≤ RCF ≤ 500g; and / or, The frequency T at which the driving component drives the test reagent card to oscillate satisfies the following relationship: 1Hz≤T≤5Hz.

[0015] Compared to existing technologies, the detection device of this application has a simple structure and is easy to operate. Furthermore, it is highly adaptable, as none of the components on the detection device are designed independently for activated clotting time detection. In other words, by changing different test reagent cards, the detection device can perform different tests on samples, such as fluorescence detection, biochemical or immunological detection. Attached Figure Description

[0016] The accompanying drawings, which are included to provide a further understanding of this application and form part of this application, are illustrative and descriptive, serving to explain this application and do not constitute an undue limitation thereof. In the drawings: Figure 1 This is a simplified diagram of the testing equipment disclosed in the embodiments of this application; Figure 2 This is a schematic diagram of the structure of the test reagent card disclosed in the embodiments of this application; Figure 3 This is a flowchart illustrating the changes of a sample within a test reagent card as disclosed in an embodiment of this application; Figure 4 This is a diagram showing the positional relationship of the sample dispensing chamber on the test reagent card as disclosed in the embodiments of this application; Figure 5 This is a logical schematic diagram of the control method for the detection equipment disclosed in the embodiments of this application.

[0017] The above figures include the following reference numerals: 10. Main body; 20. Test reagent card; 21. Sample dispensing chamber; 22. Detection chamber; 23. Arc-shaped connecting section; 24. Light transmission groove; 25. Air permeable chamber; 26. Buffer chamber; 27. Activating substance; 30. Driving component; 40. Light emission module; 50. Detection module; 221. First cavity section; 222. Second cavity section; 251. Air vent; 261. First buffer chamber; 262. Connecting chamber; 263. Second buffer chamber. Detailed Implementation

[0018] It should be noted that, unless otherwise specified, the embodiments and features described in this application can be combined with each other. This application will now be described in detail with reference to the accompanying drawings and embodiments.

[0019] It should be noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the exemplary embodiments according to this application. As used herein, the singular form is intended to include the plural form as well, unless the context clearly indicates otherwise. Furthermore, it should be understood that when the terms "comprising" and / or "including" are used in this specification, they indicate the presence of features, steps, operations, devices, components, and / or combinations thereof.

[0020] Unless otherwise specifically stated, the relative arrangement, numerical expressions, and values ​​of the components and steps described in these embodiments do not limit the scope of this application. It should also be understood that, for ease of description, the dimensions of the various parts shown in the drawings are not drawn to actual scale. Techniques, methods, and devices known to those skilled in the art may not be discussed in detail, but where appropriate, such techniques, methods, and devices should be considered part of the specification. In all examples shown and discussed herein, any specific values ​​should be interpreted as merely exemplary and not as limitations. Therefore, other examples of exemplary embodiments may have different values. It should be noted that similar reference numerals and letters in the following drawings denote similar items; therefore, once an item is defined in one drawing, it need not be further discussed in subsequent drawings.

[0021] As described in the background section, in related technologies, the manual water bath method involves adding 1 to 2 mL of whole blood to a test tube pre-filled with 12 mg of diatomaceous earth, placing it in a 37°C water bath, manually tilting the tube, observing and timing the process, and marking the first blood clot as the endpoint. This method is cumbersome, relies heavily on operator experience, is highly subjective, difficult to standardize, and requires large sample sizes. In contrast, the rotating test tube magnetic bead method involves adding whole blood to a test tube pre-filled with an activator. The test tube is kept at a constant temperature of 37°C and rotated around an axis, containing a freely rolling magnetic bead. When the blood coagulates to form a sufficiently strong clot, the magnetic bead is "bound" to the clot and rotates with the test tube to a specific angle, triggering a magnetic induction switch and recording the clotting time. This type of device automates temperature control and endpoint detection and is currently the most mainstream clinical method for ACT (Acute Coagulation) testing. However, this method requires the blood clot to have sufficient mechanical strength to push the magnetic bead to a preset angle at the detection endpoint. In scenarios such as extracorporeal circulation, including high-dose heparin, hypothermia, blood dilution, platelet function inhibition, or the use of drugs like aprotinin, the resulting blood clots are often loose and unstable, unable to effectively push the magnetic bead, leading to falsely prolonged ACT values, poor repeatability, or even no results due to timeouts. Furthermore, due to differences in the types of activating substances, detection principles, and endpoint definitions, the ACT values ​​measured on the same blood sample on different devices exhibit systematic deviations. The gasket falling method, on the other hand, works by placing a ferromagnetic gasket inside the test chamber. An electromagnet attracts the gasket to the top of the test chamber and then releases it, allowing the gasket to fall through the blood sample under gravity. As the blood coagulates and viscosity increases, the falling time of the gasket is prolonged; when the falling time exceeds a preset threshold, it is determined to be the coagulation endpoint. To overcome the difficulty of detecting weak blood clots under high heparinization, complex detection algorithms have also been developed in related technologies. However, this technology has limitations: it still requires specialized instruments and is incompatible with existing coagulation analyzers; it relies on moving parts, resulting in complex structures and high costs; the algorithm is complex, making development and verification difficult; and the sample size is large. The electrochemical method determines the endpoint by detecting electroactive substances generated in the coagulation cascade reaction. Its advantages include detecting the early coagulation stage, independence from clot strength, good repeatability, and small sample size. However, the electrochemical method requires specialized equipment, is incompatible with conventional optical coagulation analyzers used in hospitals, and the test cards are expensive. The optical method involves adding a whole blood sample to a test card. The instrument accurately measures 15 microliters of blood and automatically introduces it into the test channel. The blood sample is driven to move back and forth within the test channel. LED light sources and photodetectors are located on both sides of the channel to monitor the movement speed of the blood sample. When a clot begins to form, blood flow is obstructed, and the movement speed slows down; when the movement speed drops below a preset rate, the instrument determines that the coagulation endpoint has been reached and outputs the ACT value. This technology enables small sample size testing, but its core detection logic remains the velocity monitoring method: it determines coagulation by detecting a decrease in the speed of blood sample movement, essentially relying on the effect of blood clots on blood viscosity. Under high heparinization conditions, weak blood clots may not significantly alter blood viscosity, resulting in insignificant velocity changes and decreased detection sensitivity.In addition, this technology still requires specialized instruments to drive the blood sample back and forth, which is incompatible with the hospital's existing optical coagulation analyzers.

[0022] To address the problems existing in the relevant technologies, see [link / reference]. Figures 1 to 4 As shown, this application embodiment provides a detection device for activating whole blood clotting time, including a main body 10, a test reagent card 20, a driving component 30, a light-emitting module 40, and a detection module 50. The main body 10 is provided with a detection chamber, and the test reagent card 20 is detachably disposed in the detection chamber. The test reagent card 20 has a sample application chamber 21 and a detection chamber 22, which are connected. The distance from the sample application chamber 21 and the detection chamber 22 to the first side of the main body 10 gradually increases. The detection chamber 22 has a V-shaped structure and a light-transmitting groove 24 is provided on the side of the detection chamber 22 away from the sample application chamber 21. An activating substance 27 is disposed inside the detection chamber 22. The driving component 30 is disposed on the main body 10 and is used at least to drive the test reagent card 20 to rotate within the detection chamber. The light-emitting module 40 is disposed in the detection chamber and is used to emit light of a specific wavelength to the detection chamber 22. The detection module 50 is disposed on the main body 10. The detection module 50 is used to detect and analyze the light intensity passing through the light-transmitting groove 24.

[0023] Specifically, when performing activated coagulation time (ACT) testing on a sample, the test reagent card 20 is first installed into the testing chamber. Then, the sample is injected into the sample application chamber 21. Next, the drive assembly 30 is activated, causing the test reagent card 20 to rotate. This allows the sample in the application chamber 21 to enter the testing chamber 22 under centrifugal force. Simultaneously, the light-emitting module 40 and the detection module 50 are activated, causing the light-emitting module 40 to emit light of a specific wavelength into the detection chamber 22. Since the detection chamber 22 has a light-transmitting groove 24, the light emitted by the light-emitting module 40 is detected and analyzed by the detection module 50 through the light-transmitting groove 24. During testing, the drive assembly 30 drives the test reagent card 20 to rotate back and forth, causing the sample to oscillate within the V-shaped detection chamber 22. When the sample comes into contact with the activating substance 27, the negative charge of the activating substance 27 activates coagulation factor XII in the sample, initiating an intrinsic coagulation cascade reaction, causing the sample to gradually coagulate. When the sample is not coagulated, the sample entering the light-transmitting groove 24 will leave the light-transmitting groove 24 under the action of centrifugal force, and the light intensity passing through the light-transmitting groove 24 detected by the detection module 50 will not change much. However, when the sample coagulates, the sample entering the light-transmitting groove 24 coagulates into a blood clot, blocking the light-transmitting groove 24. Most of the light is blocked by the blood clot and cannot pass through the light-transmitting groove 24. At this time, the light intensity detected by the detection module 50 drops sharply, and the detection time at this time is the activation coagulation time of the sample.

[0024] Compared to existing technologies, the detection device of this application has a simple structure and is easy to operate. Furthermore, it is highly adaptable, as none of the components on the detection device are designed independently for activated clotting time detection. In other words, by changing different test reagent cards 20, the detection device can perform different tests on the sample, such as fluorescence detection, biochemical or immunological detection.

[0025] In some embodiments, the detection cavity 22 includes a first cavity segment 221 and a second cavity segment 222. The first cavity segment 221 communicates with the sample application cavity 21 and extends a first predetermined length in a direction away from the first side. The second cavity segment 222 communicates with the first cavity segment 221 through an arc-shaped connecting segment 23, and the second cavity segment 222 extends a second predetermined length in a direction close to the first side, so that the first cavity segment 221 and the second cavity segment 222 form a V-shaped structure, and the opening of the V-shaped structure faces the rotation center of the test reagent card 20. The activating substance 27 is disposed within the arc-shaped connecting segment 23, and the light-transmitting groove 24 is disposed at the end of the second cavity segment 222 away from the first cavity segment 221.

[0026] See appendix for details Figure 4 As shown, the V-shaped opening facing the rotation center of the test kit 20 refers to the attached... Figure 4 Cases from d to f, not... Figure 4 The design aims to ensure that when the driving component 30 drives the test reagent card 20 to rotate in both directions, the centrifugal force experienced by the sample in the first cavity section 221 and the second cavity section 222 is almost the same, preventing excessive differences in the centrifugal force experienced by the sample in either cavity section 221 or the second cavity section 222, which could lead to sample residue in either cavity section 221 or the second cavity section 222. Simultaneously, the activating substance 27 is disposed within the arc-shaped connecting section 23, allowing the sample to contact the activating substance 27 evenly, facilitating uniform activation. On the other hand, the light-transmitting groove 24 is disposed at the end of the second cavity section 222 opposite to the first cavity section 221. This design prevents the sample from constantly submerging the light-transmitting groove 24 when the sample volume is excessive, thus preventing false positives. Specifically, if the sample constantly submerges the light-transmitting groove 24, the light intensity transmitted through the light-transmitting groove 24 would be much lower than the initial light intensity emitted by the light-emitting module 40, ultimately causing the detection module 50 to incorrectly determine the clotting time. In addition, the light-transmitting groove 24 is located at the end of the second cavity section 222 away from the first cavity section 221, which can keep the light-transmitting groove 24 away from the activating material 27, so as to avoid the activating material 27 from affecting the detection light and thus causing detection errors.

[0027] In some embodiments, along the extending direction of the second cavity segment 222, the distance from the light-transmitting groove 24 to the midpoint of the arc-shaped connecting segment 23 is greater than or equal to a first predetermined length.

[0028] It is known that during the test, the amount of sample entering the detection cavity 22 may vary each time. If the distance from the midpoint of the light-transmitting groove 24 to the arc-shaped connecting section 23 is less than the first predetermined length, when the sample amount is too large, the sample may always submerge the light-transmitting groove 24 during the oscillation process, causing the light intensity passing through the light-transmitting groove 24 to remain at a low level for a certain period of time, ultimately leading to the detection device erroneously detecting the clotting time of the sample. However, when the distance from the midpoint of the light-transmitting groove 24 to the midpoint of the arc-shaped connecting section 23 is greater than or equal to the first predetermined length, even if the sample amount in the detection cavity 22 is large, during the sample oscillation process, because the distance between the light-transmitting groove 24 and the midpoint of the arc-shaped connecting section 23 is relatively large, the sample can be prevented from always submerging the light-transmitting groove 24 by controlling the magnitude of the centrifugal force of the oscillation. In a specific embodiment, when the sample enters the detection cavity 22 and is not oscillating, when the sample almost reaches the top of the end of the first cavity section 221 away from the second cavity section 222, because the detection cavity 22 has a V-shaped structure, the sample in the second cavity section 222 will also reach the same height. However, since the distance between the light-transmitting groove 24 and the connection point of the first cavity segment 221 and the second cavity segment 222 is greater than or equal to the first predetermined length, it is only necessary to reduce the driving force of the driving component 30, thereby reducing the centrifugal force on the sample in the detection cavity 22, to avoid the sample from constantly submerging the light-transmitting groove 24 and prevent detection errors.

[0029] As attached Figure 2 As shown, in some embodiments, the test reagent card 20 further includes a ventilated chamber 25, which is connected to one end of the second cavity section 222 away from the first cavity section 221, and the ventilated chamber 25 extends in a direction close to the first cavity section 221, and a vent hole 251 is provided on the ventilated chamber 25.

[0030] It is understood that if the test kit 20 does not have a vented chamber 25, the pressure inside the test chamber 22 may gradually increase during the process of the sample entering the chamber, eventually preventing some samples from entering the chamber. Therefore, in this embodiment, the vented chamber 25 is connected to the test chamber 22 to avoid excessively high air pressure inside the test chamber 22. Furthermore, in this embodiment, the vented chamber 25 is connected to the end of the second cavity section 222 opposite to the first cavity section 221, and the vented chamber 25 extends in a direction close to the first cavity section 221. This arrangement prevents the sample from entering the vented chamber 25 through the second cavity section 222 under centrifugal force, which would cause the sample to flow out from the vent hole 251, affecting the accuracy of the coagulation test. In other words, when the sample enters the second cavity section 222 under the action of centrifugal force, since the ventilated chamber 25 extends in the direction close to the first cavity section 221, the direction of the centrifugal force on the sample is opposite to the direction of extension of the ventilated chamber 25, thus making it difficult for the sample to enter the ventilated chamber 25.

[0031] In some embodiments, the light-transmitting groove 24 is disposed at the bottom of the second cavity segment 222 along the thickness direction of the test reagent card 20. Specifically, as the sample gradually solidifies, because the light-transmitting groove 24 is disposed at the bottom of the second cavity segment 222, the sample can remain in the light-transmitting groove 24 under the action of gravity, eventually blocking the light-transmitting groove 24.

[0032] In other embodiments, the light-transmitting groove 24 is disposed on the inner wall surface of the second cavity segment 222 on the side opposite to the opening of the V-shaped structure. Similarly, this design aims to allow the sample to enter the light-transmitting groove 24 under centrifugal force. Once the sample solidifies, it can block the light-transmitting groove 24.

[0033] In some embodiments, the test reagent card 20 further includes a buffer chamber 26, which is connected to the sample application chamber 21 and the detection chamber 22, and the distances from the sample application chamber 21, the buffer chamber 26 and the detection chamber 22 to the first side of the body 10 gradually increase.

[0034] Specifically, the buffer chamber 26 is designed to prevent the sample from entering the detection chamber 22 at an excessively high flow rate. If the sample enters the detection chamber 22 at an excessively high flow rate, it will cause the sample to mix with the air inside the detection chamber 22, resulting in excessive air bubbles within the sample and leading to errors in the sample's clotting time. On the other hand, an excessively high flow rate of the sample entering the detection chamber 22 will impact the activating substance 27 within the detection chamber 22, ultimately causing the activating substance 27 to be impacted into either the first cavity segment 221 or the second cavity segment 222, rather than at the connection point between the first cavity segment 221 and the second cavity segment 222.

[0035] In some embodiments, the buffer chamber 26 includes a first buffer chamber 261, a connecting chamber 262, and a second buffer chamber 263. The first buffer chamber 261 communicates with the sample application chamber 21, the connecting chamber 262 communicates with the first buffer chamber 261, and the second buffer chamber 263 communicates with the connecting chamber 262 and the detection chamber 22. The width of the connecting chamber 262 is smaller than the width of the first buffer chamber 261 and the second buffer chamber 263.

[0036] In other words, since the buffer chamber 26 includes a first buffer chamber 261 and a second buffer chamber 263, the sample undergoes two buffering processes during its entry into the detection chamber 22, thereby significantly reducing the flow rate of the sample into the detection chamber 22. On the other hand, since the connecting chamber 262 connects the first buffer chamber 261 and the second buffer chamber 263, and the width of the connecting chamber 262 is smaller than the width of the first buffer chamber 261 and the second buffer chamber 263, this means that when the sample in the first buffer chamber 261 enters the second buffer chamber 263 through the connecting chamber 262, the width of the connecting chamber 262 is too small, which would cause larger impurities in the sample to be retained in the first buffer chamber 261. In addition, because the width of the connecting chamber 262 is too small, it can, to some extent, prevent the sample in the second buffer chamber 263 from flowing back into the first buffer chamber 261.

[0037] In some embodiments, the light-transmitting groove 24 includes a circular groove, the diameter R of which satisfies the relationship: 0.5mm ≤ R ≤ 2mm. Specifically, if the diameter of the circular groove is too small, for example less than 0.5mm, the sample will have difficulty entering the circular groove after solidification; while if the diameter of the circular groove is too large, the sample will have difficulty blocking the circular groove, resulting in unstable optical signals and unclear endpoint determination. In this embodiment, the diameter R of the circular groove is 0.5mm, 1mm, 1.5mm, and 2mm. In addition, the light-transmitting groove 24 is set as a circular groove, which is convenient to manufacture, and the light transmission area is uniform, resulting in stable detection signals.

[0038] In some embodiments, the volume L of the detection chamber 22 satisfies the relationship: 50μL≤L≤200μL. When the volume L of the detection chamber 22 satisfies the above relationship, the design of the detection chamber 22 can ensure that there is a sufficient sample volume to complete the coagulation reaction and optical detection, avoiding detection failure due to insufficient sample volume, while significantly reducing the sample volume used, alleviating the patient's blood collection pain, and also reducing consumable costs. In related technologies, 1mL to 2mL is usually required for sample detection, while in this application, only a sample volume smaller than the volume of the detection chamber 22 is needed, significantly reducing the sample volume used.

[0039] In some embodiments, the activating substance 27 includes at least one of a diatomaceous earth layer, a kaolin layer, an ellagic acid layer, or a glass layer. The diatomaceous earth layer, kaolin layer, ellagic acid layer, or glass layer can be pre-positioned within the detection chamber 22. Specifically, the diatomaceous earth layer is highly sensitive to heparin, has a wide linear range, can completely cover the high heparin concentrations required for extracorporeal circulation, and has a fast activation speed and moderate clotting time. The kaolin layer has slightly stronger activation ability than diatomaceous earth, a lower baseline ACT value, and is more sensitive to low concentrations of heparin, but its linearity is slightly worse at high concentrations, and it is less expensive. The glass layer provides gentle activation, and the clotting process is closer to the physiological state; the activation intensity can be controlled by adjusting the surface area of ​​the glass layer.

[0040] On the other hand, as attached Figure 5 As shown, this application provides a control method for a detection device that activates whole blood clotting time. This control method is used to control the aforementioned detection device. The method includes: injecting a sample into a sample application chamber 21; controlling a drive assembly 30 to rotate a test reagent card 20 so that the sample in the application chamber 21 enters the detection chamber 22 under centrifugal force; controlling a light-emitting module 40 to emit light to illuminate the detection chamber 22; using a detection module 50 to detect the light intensity passing through a light-transmitting groove 24; controlling the drive assembly 30 to rotate the test reagent card 20 in both directions so that the sample oscillates back and forth within the detection chamber 22; and simultaneously recording the detection time. When the detection module 50 detects that the light intensity passing through the light-transmitting groove 24 has decreased to a predetermined value within a predetermined time, the recorded detection time is taken as the clotting time of the sample.

[0041] In one specific embodiment, the driving component 30 includes a driving motor, the light-emitting module 40 includes an LED, and the detection module 50 may be a photodiode. 35 μL of blood is added to the sample application chamber 21, and then the driving motor is controlled to rotate at 3000 rpm, allowing the sample in the sample application chamber 21 to pass through the buffer chamber 26 into the detection chamber 22 before the driving motor is stopped. The LED is then activated, emitting 600 nm light with a light intensity of 500 lx. When the light passes through the light transmission groove 24 and is detected by the detection module 50, the detected light intensity is 300 lx. At this time, the driving motor is started to rotate in both directions at 1500 rpm for 1 second intervals, causing the sample in the sample application chamber 21 to oscillate back and forth within the first chamber section 221 and the second chamber section 222. The driving motor is activated while the detection time is recorded. The preset value is 150 lx. When the detection module 50 detects that the light intensity passing through the light transmission groove 24 is less than 150 lx within 3 seconds, it determines that the sample has coagulated, and the detection time is taken as the coagulation time of the sample. It should be noted that the preset time can be adaptively adjusted according to the size of the test reagent card 20 and the volume of the sample. The preset value is usually set to half of the initial light intensity.

[0042] Compared to related detection methods, the method in this application requires no complex operation and uses relatively simple equipment, eliminating the need to construct separate components for coagulation testing. Furthermore, it offers high detection accuracy; during the testing process, the sample remains independently within the test reagent card 20, preventing contact with the external environment and thus avoiding sample contamination. Moreover, due to its innovative detection method, this approach can complete the test without requiring a large sample volume.

[0043] In some embodiments, the relative centrifugal force (RCF) provided by the drive component 30 when rotating the test reagent card 20 satisfies the relationship: 200g ≤ RCF ≤ 500g. Specifically, if the relative centrifugal force is too small, for example, RCF less than 200g (where g refers to the acceleration due to gravity), the sample moves slowly within the detection chamber 22, making it difficult for the sample to enter the light transmission groove 24, resulting in excessively long detection times or frequent detection failures. Conversely, if the relative centrifugal force is too large, for example, RCF greater than 500g, the sample is easily destroyed under the action of centrifugal force after solidification, causing false negatives. In this embodiment, the relative centrifugal force (RCF) can be 200g, 300g, 400g, or 500g.

[0044] In some embodiments, the frequency T at which the driving component 30 drives the test reagent card 20 to oscillate satisfies the relationship: 1Hz≤T≤5Hz. When the frequency is within this range, the blood can flow completely from one cavity segment to another within each oscillation cycle. If the frequency is too low, for example, less than 1Hz, the blood may remain in the first cavity segment 221 when coagulation occurs and cannot enter the light-transmitting groove 24, resulting in a delayed test result. If the frequency is too high, for example, greater than 5Hz, the blood will generate turbulence and bubbles, affecting the test result.

[0045] For ease of description, spatial relative terms such as "above," "on top of," "on the upper surface of," "above," etc., are used herein to describe the spatial positional relationship of a device or feature as shown in the figures to other devices or features. It should be understood that spatial relative terms are intended to encompass different orientations in use or operation beyond the orientation of the device as described in the figures. For example, if the device in the figures were inverted, a device described as "above" or "on top of" other devices or structures would subsequently be positioned as "below" or "under" other devices or structures. Thus, the exemplary term "above" can include both "above" and "below." The device may also be positioned in other different ways (rotated 90 degrees or in other orientations), and the spatial relative descriptions used herein will be interpreted accordingly.

[0046] Furthermore, it should be noted that the use of terms such as "first" and "second" to define components is merely for the purpose of distinguishing the corresponding components. Unless otherwise stated, the above terms have no special meaning and therefore cannot be construed as limiting the scope of protection of this application.

[0047] The above are merely preferred embodiments of this application and are not intended to limit this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the protection scope of this application.

Claims

1. A detection device for activating whole blood clotting time, characterized in that, include: The main body (10) is provided with a detection chamber; A test reagent card (20) is detachably disposed in the test chamber. The test reagent card (20) has a sample dispensing cavity (21) and a test cavity (22). The sample dispensing cavity (21) and the test cavity (22) are connected. The distance from the sample dispensing cavity (21) and the test cavity (22) to the first side of the main body (10) gradually increases. The test cavity (22) has a V-shaped structure. A light-transmitting groove (24) is provided on the test cavity (22). The light-transmitting groove (24) is located on the side of the test cavity (22) away from the sample dispensing cavity (21). An activating substance (27) is provided inside the test cavity (22). A drive assembly (30) is disposed on the main body (10). The drive assembly (30) is at least used to drive the test reagent card (20) to rotate in the test chamber. The drive assembly (30) drives the test reagent card (20) to rotate back and forth in both directions. A light-emitting module (40) is disposed in the detection chamber and is used to emit light of a specific wavelength to the detection cavity (22); A detection module (50) is disposed on the main body (10), and the detection module (50) is used to detect and analyze the light intensity passing through the light-transmitting groove (24); The detection chamber (22) includes a first cavity segment (221) and a second cavity segment (222). The first cavity segment (221) is connected to the sample application chamber (21) and extends for a first predetermined length in a direction away from the first side. The second cavity segment (222) is connected to the first cavity segment (221) through an arc-shaped connecting segment (23). The second cavity segment (222) extends for a second predetermined length in a direction close to the first side, so that the first cavity segment (221), the arc-shaped connecting segment (23) and the second cavity segment (222) form a V-shaped structure, and the opening of the V-shaped structure faces the rotation center of the test reagent card (20). The activating substance (27) is disposed in the arc-shaped connecting section (23), and the light-transmitting groove (24) is disposed at the end of the second cavity section (222) away from the first cavity section (221).

2. The detection device for activated whole blood clotting time according to claim 1, characterized in that, Along the extension direction of the second cavity segment (222), the distance from the light-transmitting groove (24) to the midpoint of the arc-shaped connecting segment (23) is greater than or equal to the first predetermined length.

3. The detection device for activated whole blood clotting time according to claim 1, characterized in that, The test reagent card (20) also includes a breathable chamber (25), which is connected to the end of the second cavity section (222) away from the first cavity section (221) and extends in a direction close to the first cavity section (221). A breathable hole (251) is provided on the breathable chamber (25).

4. The detection device for activated whole blood clotting time according to claim 1, characterized in that, Along the thickness direction of the test reagent card (20), the light-transmitting groove (24) is disposed at the bottom of the second cavity segment (222), or; The light-transmitting groove (24) is disposed on the inner wall surface of the second cavity section (222) on the side away from the opening of the V-shaped structure.

5. The detection device for activated whole blood clotting time according to any one of claims 1 to 4, characterized in that, The test reagent card (20) also includes a buffer chamber (26), which is connected to the sample application chamber (21) and the detection chamber (22), and the distances from the sample application chamber (21), the buffer chamber (26) and the detection chamber (22) to the first side of the main body (10) gradually increase.

6. The detection device for activated whole blood clotting time according to claim 5, characterized in that, The buffer chamber (26) includes: The first buffer chamber (261) is connected to the sample application chamber (21); A connecting cavity (262) is connected to the first buffer cavity (261); The second buffer cavity (263) is connected to the connecting cavity (262) and the detection cavity (22). The width of the connecting cavity (262) is smaller than the width of the first buffer cavity (261) and the second buffer cavity (263).

7. The detection device for activated whole blood clotting time according to any one of claims 1 to 4, characterized in that, The light-transmitting groove (24) includes a circular groove, the diameter R of which satisfies the relationship: 0.5mm ≤ R ≤ 2mm; and / or, The volume L of the detection cavity (22) satisfies the following relationship: 50μL≤L≤200μL.

8. The detection device for activated whole blood clotting time according to any one of claims 1 to 4, characterized in that, The activating substance (27) includes at least one of diatomaceous earth layer, kaolin layer, ellagic acid layer or glass layer.

9. A control method for a detection device for activating whole blood clotting time, characterized in that, The control method for the detection device for activated whole blood clotting time is used to control the detection device for activated whole blood clotting time according to any one of claims 1 to 8, the method comprising: The sample is injected into the sample loading chamber (21), and the drive component (30) is controlled to drive the test reagent card (20) to rotate, so that the sample in the sample loading chamber (21) enters the test chamber (22) under the action of centrifugal force; The light-emitting module (40) is controlled to emit light to illuminate the detection cavity (22), and the light intensity passing through the light-transmitting groove (24) is detected by the detection module (50). The driving component (30) is controlled to drive the detection reagent card (20) to rotate forward and backward so that the sample oscillates back and forth in the detection cavity (22), and the detection time is recorded at the same time. When the detection module (50) detects that the light intensity passing through the light-transmitting groove (24) has dropped to a predetermined value within a predetermined time, the recorded detection time is taken as the clotting time of the sample.

10. The control method for the detection device for activating whole blood clotting time according to claim 9, characterized in that, The relative centrifugal force RCF provided by the drive assembly (30) when it drives the test reagent card (20) to rotate satisfies the following relationship: 200g ≤ RCF ≤ 500g; and / or, The frequency T of the oscillation of the test reagent card (20) driven by the driving component (30) satisfies the relationship: 1Hz≤T≤5Hz.

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