Urine HCG automatic detection instrument and control method thereof

Abstract

The invention discloses an automatic urine HCG (human chorionic gonadotrophin) detection instrument and a control method thereof, and the instrument comprises an equipment shell, a workbench arranged in the equipment shell, a test tube rack transfer module, a test card module, a visual identification module, a test tube storage and arrangement rack, an uncovering sampling module and a control module, the control module is electrically connected with all the functional modules and used for conducting overall coordination control over all the functional modules, and through cooperation of all the functional modules, test tube rack transferring automation, uncovering and sampling automation, test card conveying automation and visual recognition of detection results are achieved; the whole urine HCG detection process forms an automatic and closely connected whole process, the whole-process automatic detection effect from sample preparation to detection result output is achieved, a large amount of time and labor cost are saved, instability and errors possibly caused by manual operation and observation are avoided, and the detection efficiency is improved. And the accuracy and timeliness of a detection result are improved while the detection work efficiency is improved.

Description

Technical Field

[0001] The invention belongs to the technical field of medical equipment, and in particular relates to an automatic urine HCG detection instrument and a control method thereof. Background Art

[0002] Human chorionic gonadotropin (HCG) is a glycoprotein hormone secreted by the placental syncytiotrophoblast. It has the function of gonadotropin development and has a high affinity for gonadotropin receptors. HCG is present in the blood, urine, colostrum, amniotic fluid of pregnant women and the fetus. After pregnancy, the HCG level in urine will increase significantly; for early pregnancy diagnosis, urine HCG test is usually the preferred method because this method has significant advantages. It is not only time-saving, but also convenient and fast. It can quickly give pregnancy diagnosis results, making it widely used in inpatient departments, outpatient clinics, and families.

[0003] At present, there are various methods for detecting HCG. Among them, colloidal gold immunoassay is highly favored in clinical practice due to its simple operation, fast detection speed, high accuracy and good repeatability. When the urine HCG colloidal gold immunoassay is actually carried out in the hospital, the traditional operation method is to manually immerse the test strip in urine, and then manually observe the test results within 5 to 15 minutes. If only the quality control line on the test strip turns red, it indicates that the test result is negative; if only a red strip appears in the quality control area on the test strip, it is a negative result. If two red strips appear and are located in the quality control area and the test area respectively, it is a positive result. If there is no red strip in the quality control area, the result is unreliable. This may be due to the expiration of the test strip or the interference of other factors in the test result.

[0004] As the number of specimens received by hospitals increases, this manual operation method has exposed obvious drawbacks: on the one hand, manual operation is time-consuming and laborious; on the other hand, staff members are prone to forget to observe the results within the specified time, which may lead to inaccurate test results or delayed diagnosis. In view of this, the development of an automated instrument and corresponding method that can automatically detect urine HCG has become an urgent need in the current medical field. Summary of the invention

[0005] The object of the present invention is to provide an automatic urine HCG detection instrument and a control method thereof to solve the problems existing in the above-mentioned prior art.

[0006] In order to achieve the above object, the technical solution adopted by the present invention is: A urine HCG automated detection instrument comprises an equipment housing, a workbench arranged in the equipment housing, a test tube rack transfer module, a test card module, a visual recognition module, a test tube storage and sorting rack, a cover opening and sampling module and a control module, wherein the control module is electrically connected to each functional module and is used for overall coordination and control of each functional module; The test tube rack transfer module is used to transport the test tube rack loaded with the sample test tube to be tested to the sampling position, and to recover the test tube rack after testing; The cover-opening sampling module comprises: a cover-opening device for opening or tightening the test tube cap of the sample test tube located at the sampling position, a sampling needle for sucking the sample liquid at the sampling position and discharging the sample liquid at the sample adding position, and an XYZ moving module for driving the cover-opening device and the sampling needle to move in the X, Y, and Z directions; The test card module includes: a test card, a storage bin for storing pre-loaded test cards, a waste bin for storing tested test cards, and a conveying mechanism for conveying the pre-loaded test cards in the storage bin to the loading position, conveying the loaded test cards to the visual recognition position, and finally conveying the tested test cards to the waste bin; The visual recognition module is used to obtain and analyze the test card result image on the visual recognition position; The cleaning module is used to clean the sample needle; The test tube storage and sorting rack can store sample test tubes after sampling in cooperation with the XYZ moving module and the cover opening device.

[0007] Preferably, the test tube rack transfer module includes: a moving device arranged on the workbench, and a barcode scanner for scanning a barcode attached to the sample test tube, the moving device includes: a sampling slot arranged along the X-axis direction on the workbench, a sample injection slot and a sample output slot arranged along the Y-axis direction and connected to both ends of the sampling slot, a first slide rail arranged in the sampling slot along the X-axis direction, an X-axis push rod slidably connected to the first slide rail, a first driving assembly that drives the X-axis push rod to move along the first slide rail, a second slide rail and a third slide rail that are respectively arranged in the sample injection slot and the sample output slot along the Y-axis direction, a sample injection push rod slidably connected to the second slide rail, a second driving assembly that drives the sample injection push rod to move along the second slide rail, a sample output push rod slidably connected to the third slide rail, and a third driving assembly that drives the sample output push rod to move along the third slide rail, when the sample test tube on the test tube rack is located in the middle of the sampling slot, the sample test tube is located at the sampling position.

[0008] Preferably, the XYZ movable module is arranged on the equipment housing and is located above the workbench, and the XYZ movable module includes: an X-axis movable module installed on the inner wall of the equipment housing, a Y-axis movable module connected to the X-axis movable module, and a Z-axis movable module connected to the Y-axis movable module, the cover opening device and the sampling needle are connected to the Z-axis movable module, the X-axis movable module is used to drive the Y-axis movable module to move along the X-axis direction, the Y-axis movable module is used to drive the Z-axis movable module to move along the Y-axis direction, the Z-axis movable module is used to drive the cover opening device and the sampling needle to move along the Z-axis direction, and a mounting plate is provided on the Z-axis movable module, and the cover opening device and the sampling needle are both fixedly connected to the mounting plate.

[0009] Preferably, the cover opening device includes: a tube body clamping assembly arranged on the bottom of the mounting plate through a fixing plate and used to clamp the test tube body, a tube cap clamping assembly arranged on the mounting plate and used to clamp the test tube cap, and a cover rotating driving assembly arranged on the mounting plate and used to drive the tube cap clamping assembly to rotate.

[0010] Preferably, the conveying mechanism includes: a conveying rail arranged between the storage bin and the waste bin, a fourth slide rail arranged parallel to the conveying rail, a conveying push rod slidably connected to the fourth slide rail, a fourth driving assembly driving the conveying push rod to move along the fourth slide rail, and a push plate assembly for pushing the test card out of the storage bin, the storage bin is hollow inside and has an open upper end, a discharge port is provided at the lower part of the side wall of the storage bin close to the conveying rail, and the push plate assembly includes: a push plate with one end movably penetrating the lower part of the side wall of the storage bin away from the conveying rail, and a push plate assembly with one end rotatably connected to the storage bin A connecting rod at the other end of the push plate, a rotating disk eccentrically connected to the other end of the connecting rod, and a rotating driving member arranged on the workbench for driving the rotating disk to rotate; the conveying push rod includes: a vertical rod passing through the fourth slide rail and connected to the fourth driving mechanism, a horizontal rod connected to the top of the vertical rod and located at the upper end of the conveying rail, a ┌-shaped connecting plate connected to the two ends of the side of the horizontal rod away from the storage bin, a valve plate rotatably connected to the lower end of the horizontal plate of the ┌-shaped connecting plate, and a spring connected between the valve plate and the horizontal rod, and the two valve plates are arranged opposite to each other.

[0011] Preferably, the test card comprises: an internally hollow mounting shell, which respectively penetrates a sample loading hole and a detection slot arranged on the top of the mounting shell, an identification line arranged on the upper end surface of the mounting shell and having a specific color, a support member arranged on the bottom end of the mounting shell, a water-absorbing layer arranged on the support member, and a urine HCG test reagent strip arranged on the water-absorbing layer, wherein the quality control area and the test area on the reagent strip are adapted to the detection slot.

[0012] Preferably, the control module includes a program controller and a display, the program controller is used to control and monitor the signals of the entire machine, the display is used to input and output instrument operation parameters, record the instrument operation status and sample detection process, and the control module is configured with a data transmission interface and a network interface for communication with a laboratory information system.

[0013] The present invention also provides the above-mentioned detection method based on the urine HCG automated detection instrument, comprising the following steps: S1. Place the test tube with the sample liquid on the test tube rack, start the test tube rack transfer module to transport the test tube rack loaded with the sample test tube to be tested to the sampling position, start the XYZ moving module to drive the cover opening device to move the upper end of the sampling position, and then unscrew the test tube cap of the sample test tube through the cooperation of the XYZ moving module and the cover opening device; S2. After the test tube cap is unscrewed, the sampling needle is driven to the sampling position by the XYZ moving module. With the cooperation of the XYZ moving module, the sampling needle absorbs the urine sample in the test tube; S3. While steps S1 and S2 are being performed, the transfer mechanism is started to transfer the test card in the storage bin to the sample loading position; S4. Move the sampling needle after absorbing the urine sample to the sample adding position through the XYZ moving module, and drip the urine sample into the sample adding hole on the test card and let it stand for 5 to 10 minutes. During the test card standing, move the sampling needle to the cleaning module for cleaning through the XYZ moving module; S5. Start the transmission mechanism to transmit the test card after sample addition and resting to the visual recognition position. The visual recognition module first recognizes the recognition line on the test card. If the recognition line is accurately recognized, the visual recognition module analyzes the image of the quality control area and the test area in the test card detection slot, and transmits the analysis result to the control template; if the recognition line fails to be recognized, it means that there is another fault in the visual recognition module or the reagent card is an illegal reagent card, and the recognition result is transmitted to the control template to prompt the user to re-test; S6. Start the transmission mechanism to transmit the test card after testing to the waste bin for disposal; S7. Start the XYZ moving module to drive the cover opening device to move to the upper end of the sampling position, and then put the test tube cap back on the sample test tube and tighten it through the cooperation of the XYZ moving module and the cover opening device, and then release the clamping of the tube body clamping assembly. Finally, with the cooperation of the XYZ moving module and the tube cap clamping assembly, the sample test tube after sampling is transferred to the test tube storage and sorting rack, and stored in order.

[0014] In the above step S5, the method for the visual recognition module to recognize the recognition line is as follows: when the test card is transmitted to the visual recognition position, if the visual recognition module does not obtain the recognition line on the test card, the recognition line recognition fails; if the recognition line on the test card is obtained, but the grayscale feature value of the recognition line is not within the preset threshold range, the recognition line recognition fails; if the recognition line on the test card is obtained and the grayscale feature of the recognition line is within the preset threshold range, the recognition line is accurately recognized; The calibration steps of the preset threshold interval are: select a large number of accurate test cards for standardized testing, calculate all grayscale feature values ​​to obtain the average value and standard deviation, and the preset threshold interval is (X-2sd, X+2sd), where X is the average value of the grayscale feature value and 2sd is twice the standard deviation.

[0015] Among them, in the above-mentioned step S5: the method by which the visual recognition module analyzes the images of the quality control area and the test area in the detection slot of the test card is: if a red strip appears only in the quality control area on the test card recognized by the visual recognition module, the test result is negative; if two red strips appear and are respectively located in the quality control area and the test area, the result is positive; if there are no red strips in both the quality control area and the test area, the result is a detection failure.

[0016] Compared with the prior art, the advantages of the present invention are: 1. The present invention ensures the orderly operation of various links such as test tube rack transfer, cover opening sampling, test card transmission, and visual recognition through the coordinated cooperation of various functional modules, so that the entire urine HCG detection process forms an automated and closely connected overall process, and realizes the full-process automated detection effect from sample preparation to test result output, saving a lot of time and labor costs, avoiding the instability and errors that may be caused by manual operation and observation, improving the detection efficiency while also improving the accuracy and timeliness of the test results, reducing the chances of medical staff contacting urine samples, protecting the health of staff, and reducing the risk of microbial infection; 2. The automated testing instrument provided by the present invention operates according to a preset program, and each link has strict time control and process arrangement, which avoids the situation in which the diagnosis is delayed due to forgetting to observe the results within the specified time in the traditional manual testing process, and ensures the timeliness of the test results; 3. The test tube rack transfer module of the present invention can automatically transport the test tube rack loaded with the sample test tube to be tested to the sampling position, and can also recycle the test tube rack after the test is completed, thereby realizing the automation of sample test tube transportation, avoiding the cumbersome process of manual handling of the test tube rack, and greatly improving the sample processing efficiency. In the case of a large number of sample tests, there is no need to manually handle the test tube racks one by one, thereby improving the overall detection throughput; 4. Driven by the XYZ moving module, the cover opening device and the sampling needle of the present invention realize a series of actions of automatically opening the cover, sucking samples, adding samples and covering the test tube cap, which not only reduces the errors that may be caused by manual operation, but also can complete the sample processing at a faster and more stable speed, avoiding the tedious and inefficient manual operation, ensuring the consistency of the detection conditions, and is conducive to improving the accuracy of the detection results; 5. The visual recognition module in the present invention automatically obtains and analyzes the test card result image, and transmits the analysis result to the control module, replacing the traditional manual observation of the test card result, avoiding subjective errors such as inaccurate observation time, inaccurate judgment of color and lines, etc. that may occur in manual observation, so that the test results can be obtained more accurately and objectively; 6. The present invention facilitates orderly storage of sample test tubes by means of the test tube storage and sorting rack on the workbench, which is conducive to keeping the working environment clean and orderly, and improves the overall practicality and management convenience of the equipment. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for use in the embodiments will be briefly introduced below. It should be understood that the following drawings only show certain embodiments of the present invention and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other related drawings can be obtained based on these drawings without paying creative work.

[0018] Figure 1 This is a schematic diagram of the structure of an automated urine HCG detection instrument; Figure 2 This is a schematic diagram of the structure of the components on the workbench of an automated urine HCG detection instrument; Figure 3 This is a schematic diagram of the structure of a test tube rack transfer module (with the workbench cut open) of an automated urine HCG detection instrument; Figure 4 This is a schematic diagram of the structure of a test tube rack transfer module (without the workbench) of an automated urine HCG detection instrument; Figure 5 This is a schematic diagram of the structure of an opening and sampling module of an automated urine HCG detection instrument; Figure 6 This is a schematic diagram of the transmission mechanism structure of an automated urine HCG detection instrument; Figure 7 This is a schematic diagram of the structure of a transmission mechanism (without the workbench) of an automated urine HCG detection instrument; Figure 8 This is a schematic diagram of the push plate assembly structure of an automated urine HCG detection instrument; Fig. 9This is a schematic diagram of the transmission push rod structure of a urine HCG automated detection instrument; Fig.10 This is a schematic diagram of the test card structure of an automated urine HCG detection instrument; Figure numerals: 1-equipment housing, 2-workbench, 3-test tube rack, 4-opening device, 5-sampling needle, 6-XYZ moving module, 7-test card, 8-storage bin, 9-waste bin, 10-transmission mechanism, 11-storage and sorting rack, 12-barcode scanner, 13-sampling slot, 14-injection slot, 15-output slot, 16-first slide rail, 17-X-axis push rod, 18-first drive assembly, 19-second slide rail, 20-third slide rail, 21-injection push rod, 22-second drive assembly, 23-output push rod, 24-third drive assembly, 25-X-axis moving module , 26-Y-axis moving module, 27-Z-axis moving module, 28-mounting plate, 29-fixed plate, 30-tube body clamping assembly, 31-tube cap clamping assembly, 32-screw cap driving assembly, 33-transmission rail, 34-fourth slide rail, 35-fourth driving assembly, 36-discharging port, 37-connecting rod, 38-rotating disk, 39-push plate, 40-rotating driving part, 41-vertical rod, 42-cross rod, 43-┌-shaped connecting plate, 44-valve plate, 45-spring, 46-mounting shell, 47-sample adding hole, 48-detection slot, 49-identification line, 50-visual recognition module. DETAILED DESCRIPTION

[0019] In order to make the purpose, technical solution and advantages of the embodiments of the present invention clearer, the technical solution in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0020] It should be noted that similar reference numerals and letters denote similar items in the following drawings, and therefore, once an item is defined in one drawing, further definition and explanation thereof is not required in subsequent drawings.

[0021] In the description of the present invention, it should be noted that if the terms "center", "up", "down", "left", "right", "vertical", "horizontal", "inside", "outside" and the like appear, the orientation or position relationship indicated is based on the orientation or position relationship shown in the accompanying drawings, or is the orientation or position relationship in which the product of the invention is usually placed when used. It is only for the convenience of describing the present invention and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present invention.

[0022] In addition, the terms “first”, “second”, “third”, etc., if used, are merely used to distinguish between the descriptions and should not be understood as indicating or implying relative importance.

[0023] In addition, the terms "horizontal", "vertical", "overhanging", etc. do not mean that the components are required to be absolutely horizontal or overhanging, but can be slightly tilted. For example, "horizontal" only means that its direction is more horizontal than "vertical", and does not mean that the structure must be completely horizontal, but can be slightly tilted.

[0024] In the description of the present invention, it is also necessary to explain that, unless otherwise clearly specified and limited, the terms "set", "install", "connect", "connection", etc. should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0025] It should be noted that, in the absence of conflict, the features in the embodiments of the present invention may be combined with each other.

[0026] like Figure 1-2 As shown, the embodiment of the present invention provides a urine HCG automated detection instrument, including an equipment housing 1, a workbench 2 arranged in the equipment housing 1, a test tube rack transfer module, a test card module, a test tube storage and sorting rack, a visual recognition module 50, a cover opening sampling module and a control module, wherein the control module is electrically connected to each functional module and is used to perform overall coordination and control on each functional module; The test tube rack 3 transfer module is used to transport the test tube rack 3 loaded with the sample test tube to be tested to the sampling position, and to recover the test tube rack 3 after testing; The cover-opening sampling module comprises: a cover-opening device 4 for opening or tightening the test tube cap of the sample test tube located at the sampling position, a sampling needle 5 for sucking the sample liquid at the sampling position and discharging the sample liquid at the sample adding position, and an XYZ moving module 6 for driving the cover-opening device 4 and the sampling needle 5 to move in the X, Y, and Z directions; The test card 7 module includes: a test card 7, a storage bin 8 for storing pre-loaded test cards 7, a waste bin 9 for storing tested test cards 7, and a conveying mechanism 10 for conveying the pre-loaded test cards 7 in the storage bin 8 to the loading position, then conveying the loaded test cards 7 to the visual recognition position, and finally conveying the tested test cards 7 to the waste bin 9.

[0027] The visual recognition module 50 is used to obtain and analyze the result image of the test card 7 on the visual recognition position; The cleaning module is used to clean the sample needle; The test tube storage and sorting rack 11 can store sample test tubes after sampling under the cooperation of the XYZ moving module 6 and the cover opening device 4 .

[0028] It should be noted that: when the automated detection instrument is working, the sampling needle 5 realizes three-dimensional movement in space through the XYZ moving module 6. The sampling needle 5 needs to move to a predetermined position to absorb the sample, and the position where the sample is absorbed is called the sampling position, and then the sampling needle 5 needs to move to a predetermined position to discharge the sample, and the position where the sample is discharged is called the sample adding position; the test card 7 needs to be visually identified under the visual recognition module 50 of the conveying mechanism 10, and this position is called the visual recognition position; the cleaning module may include structures such as a cleaning pool, and the present application does not limit the specific implementation method of the cleaning module.

[0029] Among them, the control module includes a program controller and a display. The program controller is used to control and monitor the signals of the entire machine. The display is used to input and output the parameters of the instrument operation, record the status of the instrument operation and the sample detection process. The control module is equipped with a data transmission interface and a network interface for communication with the laboratory information system. The test results of urine samples tested by this equipment can be transmitted to the laboratory information system for issuing a test report.

[0030] The control module is electrically connected to each functional module and is responsible for overall coordination and control of each functional module, ensuring that each link such as the transfer of the test tube rack 3, the opening of the cover for sampling, the transmission of the test card 7, and visual recognition can be operated in an orderly manner according to the preset program and logic. The test tube rack 3 transfer module can automatically transport the test tube rack 3 loaded with the sample test tube to be tested to the sampling position, and recycle the test tube rack 3 after the test is completed, thereby completing the automation of sample test tube transportation. The opening device 4 and the sampling needle 5 in the opening and sampling module, driven by the XYZ moving module, realize a series of actions such as automatic opening of the cover, sample suction, sample addition, and cover back the test tube cap, thereby realizing the automation of opening and sampling. The transmission mechanism 10 of the test card 7 module automatically completes the transmission process of the test card 7 from the storage bin 8 to the sample addition position, the visual recognition position, and then to the waste bin 9, thereby realizing the automation of the test card 7 transmission. The visual recognition module 50 automatically obtains and analyzes the test card 7 result image, thereby avoiding the subjective errors that may occur in manual observation, thereby making the entire urine HCG The detection process forms an automated and tightly connected overall process, achieving fully automated detection effects from sample preparation to test result output, saving a lot of time and labor costs, avoiding the instability and errors that may be caused by manual operation and observation, and improving the efficiency of detection work while also improving the accuracy and timeliness of test results, reducing the chances of medical staff coming into contact with urine samples, protecting the health of staff, and reducing the risk of microbial infection.

[0031] like Figure 3-Figure 4 As shown, the test tube rack transfer module includes: a moving device arranged on the workbench 2, and a barcode scanner 12 for scanning a barcode attached to a sample test tube, the moving device includes: a sampling slot 13 arranged along the X-axis direction on the workbench 2, a sampling slot 14 and a sampling slot 15 arranged along the Y-axis direction and connected to both ends of the sampling slot 13, a first slide rail 16 arranged in the sampling slot 13 along the X-axis direction, an X-axis push rod 17 slidably connected to the first slide rail 16, and driving the X-axis push rod 17 to move along the first slide rail 16 A first driving assembly 18, a second slide rail 19 and a third slide rail 20 respectively arranged in the sample injection slot 14 and the sample output slot 15 along the Y-axis direction, a sample injection push rod 21 slidably connected to the second slide rail 19, a second driving assembly 22 that drives the sample injection push rod 21 to move along the second slide rail 19, a sample output push rod 23 slidably connected to the third slide rail 20, and a third driving assembly 24 that drives the sample output push rod 23 to move along the third slide rail 20. When the sample test tube on the test tube rack 3 is located in the middle of the sampling slot 13, the sample test tube is located at the sampling position.

[0032] It should be noted that: the barcode scanner 12 is a prior art, which is used to scan the barcode attached to the sample tube and transmit the scan result to the control module. The specific structures of the first drive component 18, the second drive component 22 and the third drive component 24 are not too limited, as long as the X-axis push rod 17, the sample injection push rod 21 and the sample output push rod 23 can reciprocate in the first slide rail 16, the second slide rail 19 and the third slide rail 20 respectively; specifically, as Figure 3 The above-mentioned drive assembly shown can be a pulley drive assembly, which mainly includes a motor, a driving pulley, a driven pulley, and a belt. The driving pulley and the driven pulley are respectively arranged at both ends of the corresponding slide rails. The motor drives the belt to move, thereby driving the push rod to move along the slide rail. The reciprocating motion of the push rod is achieved by the forward and reverse motion of the motor. This structure is one of the specific implementation methods and should not be limited to this structure in specific applications.

[0033] When the device is in use, the test tube rack 3 with the sample test tube is placed in the sampling slot 14, and the second driving component 22 drives the sampling push rod 21 to move in the second slide rail 19, thereby pushing the test tube rack 3 into the sampling slot 13. When the test tube rack 3 reaches the first sampling slot 13, the first driving component 18 drives the X-axis push rod 17 to slide in the first slide rail 16 to push the test tube rack 3 horizontally. When the first test tube at the end of the test tube rack 3 reaches the sampling position, the first driving component 18 stops driving the X-axis push rod 17. After the first test tube at the end of the test tube rack 3 is transferred to the test tube storage and sorting rack 11, the first driving component 18 is started again to drive the X-axis push rod 17 to push the test tube rack 3 horizontally, and the test tubes on the test tube rack 3 are sent to the sampling slot in turn. After the sampling of the sample tubes on the test tube rack 3 is completed, the X-axis push rod 17 pushes the test tube rack 3 into the sample outlet slot 15, and the third driving assembly 24 drives the sample outlet push rod 23 to move in the third slide rail 20, and then pushes the test tube rack 3 to the end of the sample outlet slot 15, so that the staff can recover the test tube rack 3. After completing the sample in and out operation, the X-axis push rod 17, the sample injection push rod 21 and the sample outlet push rod 23 need to move in the opposite direction to the initial position. The automated sample tube transportation avoids the tedious process of manually carrying the test tube rack 3, greatly saving manpower and time. In hospitals and other testing institutions, faced with a large number of urine samples, this automated transportation method can quickly prepare the samples for testing, thereby improving the overall detection throughput.

[0034] like Figure 5 As shown, the XYZ moving module 6 is arranged on the equipment housing 1 and located above the workbench 2. The XYZ moving module 6 includes: an X-axis moving module 25 installed on the inner wall of the equipment housing 1, a Y-axis moving module 26 connected to the X-axis moving module 25, and a Z-axis moving module 27 connected to the Y-axis moving module 26. The cover opening device 4 and the sampling needle 5 are connected to the Z-axis moving module 27. The X-axis moving module 25 is used to drive the Y-axis moving module 26 to move along the X-axis direction, the Y-axis moving module 26 is used to drive the Z-axis moving module 27 to move along the Y-axis direction, and the Z-axis moving module 27 is used to drive the cover opening device 4 and the sampling needle 5 to move along the Z-axis direction. A mounting plate 28 is arranged on the Z-axis moving module 27, and the cover opening device 4 and the sampling needle 5 are both fixedly connected to the mounting plate 28.

[0035] It should be noted that: this embodiment does not impose too many restrictions on the specific structures of the X-axis moving module 25, the Y-axis moving module 26 and the Z-axis moving module 27, as long as they can perform linear motion in the three directions of X-axis, Y-axis and Z-axis. For example, a base in the X-axis direction is set on the device housing 1, a slide rail is set on the base, a slide table is slidably set on the slide rail, a motor is set on the base, and the output shaft of the motor drives the screw rod connected to the threaded matching screw of the slide table. This structure is one of the specific ways to realize linear motion, and should not be limited to this structure in specific applications.

[0036] like Figure 5 As shown, the cover opening device 4 includes: a tube body clamping assembly 30 arranged at the bottom of the mounting plate 28 through a fixing plate 29 for clamping the tube body of the test tube, a tube cap clamping assembly 31 arranged on the mounting plate 28 for clamping the test tube cap, and a cover rotating driving assembly 32 arranged on the mounting plate 28 for driving the tube cap clamping assembly 31 to rotate.

[0037] It should be noted that: this embodiment is described with respect to the bottle body and the test tube cap being screwed together. Both the bottle body clamping assembly and the bottle cap clamping assembly may have a flexible clamping head that can be opened and closed. When the clamping head is opened, it is used to put in or take out the bottle body or the test tube cap to be clamped. When the clamping head is closed, it is used to clamp the object to be clamped. There are no excessive restrictions on the specific structure of the bottle body clamping assembly and the tube cap clamping assembly 31, as long as the clamping and loosening actions can be realized. The capping drive assembly 32 can be a stepping motor, a servo motor or other rotating drive structure without restriction.

[0038] The XYZ moving module can drive the sampling needle 5 and the cover opening device 4 to move accurately in three-dimensional directions. When the cover opening device 4 opens the cover of the test tube, the cover opening device 4 is located directly above the test tube under the drive of the XYZ moving module, and then the Z-axis moving module drives the cover opening device 4 to move downward, so that the tube body clamping assembly 30 and the tube cap clamping assembly 31 clamp the tube cap of the test tube respectively, and then under the drive of the cap screwing drive assembly 32 and the Z-axis moving module, the tube cap clamping assembly 31 rotates and moves upward, thereby realizing the automatic cover opening operation. The operation of covering the test tube cap is the same as the principle of opening the cover; when the sampling needle 5 performs the suction and discharge operation, it is also driven by the XYZ moving module to move to the top of the opened test tube, and then driven by the Z-axis moving module to move downward to accurately absorb the urine sample in the test tube, and then driven by the Z-axis moving module to move upward, and the X-axis moving module 25, the Y-axis moving module 26 and the Z-axis moving module are driven to move upward. Under the joint action of the axis moving module, it moves to the sample adding position and accurately drops the urine sample into the sample adding hole 47 of the test card 7, avoiding problems such as inaccurate sample volume or sample adding position deviation that may be caused by manual operation, ensuring the consistency of the test conditions, which is conducive to improving the accuracy of the test results; Driven by the XYZ moving module, the cover opening device 4 and the sampling needle 5 realize a series of actions of automatically opening the cover, sucking samples, adding samples and replacing the test tube cap, which not only reduces the errors that may be caused by manual operation, but also completes the sample processing at a faster and more stable speed, avoiding the tediousness and inefficiency of manual operation.

[0039] like Figure 6-Figure 9As shown, the conveying mechanism 10 includes: a conveying rail 33 arranged between the storage bin 8 and the waste bin 9, a fourth slide rail 34 arranged parallel to the conveying rail 33, a conveying push rod slidably connected to the fourth slide rail 34, a fourth driving assembly 35 driving the conveying push rod to move along the fourth slide rail 34, and a push plate assembly for pushing the test card 7 out of the storage bin 8. The storage bin 8 is hollow inside and has an open upper end. A discharge port 36 is provided at the lower part of the side wall of the storage bin 8 close to the conveying rail 33. The push plate assembly includes: a push plate 39 at one end of which movably penetrates the lower part of the side wall of the storage bin 8 away from the conveying rail 33, and a push plate 39 at one end of which is rotatably connected to the push plate The connecting rod 37 at the other end of 39, the rotating disk 38 eccentrically connected to the other end of the connecting rod 37, and the rotating driving member 40 arranged on the workbench 2 for driving the rotating disk 38 to rotate; the conveying push rod includes: a vertical rod 41 passing through the fourth slide rail 34 and connected to the fourth driving mechanism, a horizontal rod 42 connected to the top of the vertical rod 41 and located at the upper end of the conveying rail 33, a ┌-shaped connecting plate 43 connected to the two ends of the side of the horizontal rod 42 away from the storage bin 8, a valve plate 44 rotatably connected to the lower end of the horizontal plate of the ┌-shaped connecting plate 43, and a spring 45 connected between the valve plate 44 and the horizontal rod 42, and the two valve plates 44 are arranged opposite to each other.

[0040] It should be noted that the present invention does not impose too many restrictions on the specific structure of the fourth driving mechanism, as long as the transmission push rod is driven to reciprocate in the fourth slide rail 34; specifically, Figure 5 As shown, the fourth driving mechanism can be a pulley drive assembly, which mainly includes a motor, a driving pulley, a driven pulley, and a belt. The driving pulley and the driven pulley are respectively arranged at the two ends of the corresponding slide rails. The motor drives the belt to move, thereby driving the transmission push rod along the fourth slide rail 34. The reciprocating motion of the push rod is realized by the forward and reverse motion of the motor. This structure is one of the specific implementation methods and should not be limited to this structure in specific applications; the rotating drive member 40 can be a stepping motor, a servo motor or other rotating drive structure, without limitation; the size of the inner cavity of the storage bin 8 should be compatible with the size of the test card 7, so that the test is overlapped in the storage bin 8, and when the two valve plates 44 are in the initial position, the distance between the two valve plates 44 is less than the length of the test card 7, and the distance between the two ┌-shaped connecting plates 43 should be greater than the length of the test card 7.

[0041] When the conveying mechanism 10 is performing the conveying operation on the test card, the rotating driving member 40 drives the rotating disk 38 to rotate. Since the connecting rod 37 is eccentrically connected to the rotating disk 38, the rotation of the rotating disk 38 will first drive the pushing plate 39 at the other end of the connecting rod 37 to move toward the discharge port 36 to push the test card 7 out of the storage bin 8, and then drive the pushing plate 39 to move in the direction away from the discharge port 36, drive the pushing plate 39 to reset, and wait for the next task of pushing out the test card 7. In the process of the test card 7 being pushed out from the storage bin 8 to the conveying rail 33, the two side ends of the test card 7 first contact with the two valve plates 44. Under the thrust of the pushing plate 39, the two valve plates 44 rotate in the direction away from the storage bin 8, thereby causing the test card 7 to be pushed out of the storage bin 8 by the pushing plate 39. Under the push, it passes through between the two valve plates 44 and moves to the side of the transmission push rod away from the storage bin 8. At this time, the test card 7 is no longer in contact with the valve plate 44. The valve plate 44 rotates to the initial position under the action of the spring 45. At this time, the fourth drive assembly 35 is started to drive the transmission push rod to move along the fourth slide rail 34. The valve plate 44 located on the cross bar 42 contacts the test card 7 again. The cross bar 42 restricts the valve plate 44 from rotating in the direction of the storage bin 8. Then, with the movement of the transmission push rod, the valve plate 44 pushes the test card 7 to move on the transmission rail 33 until it reaches the specified position, thereby realizing the automatic ejection and transmission function of the test card 7; after completing the transmission of the test card 7, the fourth drive assembly 35 is started in the reverse direction to drive the transmission push rod to return to the initial position along the fourth slide rail 34.

[0042] like Fig.10 As shown, the test card 7 includes: an internally hollow mounting shell 46, a sample loading hole 47 and a detection slot 48 respectively penetrating the top of the mounting shell 46, an identification line 49 with a specific color disposed on the upper end surface of the mounting shell 46, a support member disposed on the bottom end of the mounting shell 46, a water absorbing layer disposed on the support member, and a urine HCG test reagent strip disposed on the water absorbing layer, wherein the quality control area and the test area on the reagent strip are adapted to the detection slot 48.

[0043] When the above-mentioned urine HCG automated detection instrument is used to detect a urine sample, the detection method includes the following steps: S1. Place the test tube with the sample liquid on the test tube rack 3, start the test tube rack 3 transfer module to transport the test tube rack 3 loaded with the sample test tube to be tested to the sampling position, start the XYZ moving module 6 to drive the cover opening device 4 to move the upper end of the sampling position, and then unscrew the test tube cap of the sample test tube through the cooperation of the XYZ moving module 6 and the cover opening device 4; S2. After the test tube cap is unscrewed, the sampling needle 5 is moved to the sampling position by the XYZ moving module 6. With the cooperation of the XYZ moving module 6, the sampling needle 5 absorbs the urine sample in the test tube; S3. While steps S1 and S2 are being performed, the transfer mechanism 10 is started to transfer the test card 7 in the storage bin 8 to the sample loading position; S4. The sampling needle 5 after absorbing the urine sample is moved to the sample adding position by the XYZ moving module 6, and the sampling needle 5 drips the urine sample into the sample adding hole 47 on the test card 7 and leaves it to stand for 5 to 10 minutes. During the standing of the test card 7, the sampling needle 5 is moved to the cleaning module by the XYZ moving module 6 for cleaning; S5. The transmission mechanism 10 is started to transmit the test card 7 after the sample is added and allowed to stand to the visual recognition position. The visual recognition module 50 first recognizes the recognition line 49 on the test card 7. If the recognition line 49 is accurately recognized, the visual recognition module 50 analyzes the image of the quality control area and the test area in the detection slot 48 of the test card 7, and transmits the analysis result to the control template; if the recognition line 49 fails to be recognized, it means that the visual recognition module 50 has other faults or the reagent card is an illegal reagent card, and the recognition result is transmitted to the control template to prompt the user to re-test; S6. Start the conveying mechanism 10 to transfer the test card 7 after the test to the waste bin 9 and discard; S7. Start the XYZ moving module 6 to drive the cover opening device 4 to move to the upper end of the sampling position, and then put the test tube cap back on the sample test tube and tighten it through the cooperation of the XYZ moving module 6 and the cover opening device 4, and then release the clamping of the tube body clamping assembly 30. Finally, with the cooperation of the XYZ moving module 6 and the tube cap clamping assembly 31, the sample test tube after sampling is transferred to the test tube storage and sorting rack 11, and stored in order.

[0044] In the above step S5, the method for the visual recognition module 50 to recognize the recognition line 49 is as follows: when the test card 7 is transmitted to the visual recognition position, if the visual recognition module 50 does not obtain the recognition line 49 on the test card 7, the recognition of the recognition line 49 fails; if the recognition line 49 on the test card 7 is obtained, but the grayscale feature value of the recognition line 49 is not within the preset threshold range, the recognition of the recognition line 49 fails; if the recognition line 49 on the test card 7 is obtained and the grayscale feature of the recognition line 49 is within the preset threshold range, the recognition line 49 is accurately recognized; The calibration steps of the preset threshold interval are as follows: select a large number of accurate test cards 7 for standardized testing, calculate all grayscale feature values ​​to obtain the average value and standard deviation, and the preset threshold interval is (X-2sd, X+2sd), where X is the average value of the grayscale feature value, and 2sd is twice the standard deviation; the number of test cards for determining the preset threshold interval may preferably be no less than 20, and the device works for a period of time (usually about 20 days), and a 20-day grayscale feature value average value and twice the standard deviation can be regained, and then an optimal preset threshold interval is calculated to replace the previous preset threshold interval.

[0045] Among them, in the above-mentioned step S5: the method by which the visual recognition module 50 analyzes the images of the quality control area and the test area in the detection slot 48 of the test card 7 is: if a red stripe appears only in the quality control area on the test card 7 recognized by the visual recognition module 50, the test result is negative; if two red stripes appear and are respectively located in the quality control area and the test area, the result is positive; if there are no red stripes in both the quality control area and the test area, the result is a detection failure.

[0046] The entire urine HCG detection process, from the transfer, opening of the cover, sampling of the sample tube, to the transmission and addition of the test card 7, to visual identification and subsequent processing, etc., all links are closely coordinated and highly automated, which can effectively reduce the overall detection time, improve the detection throughput, and can quickly handle a large number of urine sample detection tasks. Through clear identification line 49 recognition and test result judgment methods, as well as reasonable fault prompts, the detection method of the entire urine HCG automated detection instrument has been significantly improved in reliability, which helps to reduce erroneous detection results caused by equipment failure or reagent card problems, and ensures the accuracy and effectiveness of the detection.

[0047] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention rather than to limit it. Although the present invention has been described with reference to the preferred embodiments of the present invention, it should be understood by those skilled in the art that various changes may be made in form and details without departing from the spirit and scope of the present invention as defined in the appended claims.

Claims

1. An automated urine HCG detection instrument, characterized in that: The device comprises an equipment housing (1), a workbench (2) arranged in the equipment housing (1), a test tube rack transfer module, a test card module, a visual recognition module (50), a test tube storage and sorting rack, a cover opening and sampling module and a control module, wherein the control module is electrically connected to each functional module and is used to perform overall coordination and control on each functional module; The test tube rack transfer module is used to transport the test tube rack (3) loaded with sample test tubes to be tested to the sampling position, and to recover the test tube rack (3) after testing; The cover-opening sampling module comprises: a cover-opening device (4) for opening or tightening the test tube cap of a sample test tube located at a sampling position, a sampling needle (5) for sucking sample liquid at the sampling position and discharging the sample liquid at the sample adding position, and an XYZ moving module (6) for driving the cover-opening device (4) and the sampling needle (5) to move in the three-axis directions of X, Y and Z; The test card module comprises: a test card (7), a storage bin (8) for storing pre-loaded test cards (7), a waste bin (9) for storing tested test cards (7), and a conveying mechanism (10) for conveying the pre-loaded test cards (7) in the storage bin (8) to a sample loading position, conveying the loaded test cards (7) to a visual recognition position, and finally conveying the tested test cards (7) to the waste bin (9); The visual recognition module (50) is used to obtain and analyze the result image of the test card (7) on the visual recognition position; The cleaning module is used to clean the sample needle; The test tube storage and sorting rack (11) can store sample test tubes after sampling in cooperation with the XYZ moving module (6) and the cover opening device (4).

2. The automatic urine HCG detection instrument according to claim 1, characterized in that: The test tube rack transfer module comprises: a moving device arranged on the workbench (2), and a barcode scanner (12) for scanning a barcode attached to a sample test tube, the moving device comprising: a sampling slot (13) arranged along the X-axis direction on the workbench (2), a sampling inlet slot (14) and a sampling outlet slot (15) arranged along the Y-axis direction and connected to both ends of the sampling slot (13), a first slide rail (16) arranged in the sampling slot (13) along the X-axis direction, an X-axis push rod (17) slidably connected to the first slide rail (16), and a first driving group for driving the X-axis push rod (17) to move along the first slide rail (16). A component (18), a second slide rail (19) and a third slide rail (20) respectively arranged in the sample injection slot (14) and the sample output slot (15) along the Y-axis direction, a sample injection push rod (21) slidably connected to the second slide rail (19), a second driving component (22) driving the sample injection push rod (21) to move along the second slide rail (19), a sample output push rod (23) slidably connected to the third slide rail (20), a third driving component (24) driving the sample output push rod (23) to move along the third slide rail (20), when the sample test tube located on the test tube rack (3) is located in the middle of the sampling slot (13), the sample test tube is located at the sampling position.

3. The automatic urine HCG detection instrument according to claim 1, characterized in that: The XYZ movable module (6) is arranged on the device housing (1) and is located above the workbench (2). The XYZ movable module (6) comprises: an X-axis movable module (25) mounted on the inner wall of the device housing (1), a Y-axis movable module (26) connected to the X-axis movable module (25), and a Z-axis movable module (27) connected to the Y-axis movable module (26). The cover opening device (4) and the sampling needle (5) are connected to the Z-axis movable module (27). The X-axis moving module (25) is used to drive the Y-axis moving module (26) to move along the X-axis direction, the Y-axis moving module (26) is used to drive the Z-axis moving module (27) to move along the Y-axis direction, and the Z-axis moving module (27) is used to drive the cover opening device (4) and the sampling needle (5) to move along the Z-axis direction. A mounting plate (28) is provided on the Z-axis moving module (27), and the cover opening device (4) and the sampling needle (5) are both fixedly connected to the mounting plate (28).

4. The automatic urine HCG detection instrument according to claim 3, characterized in that: The cover opening device (4) comprises: a tube body clamping assembly (30) arranged at the bottom of the mounting plate (28) via a fixing plate (29) and used to clamp the tube body of the test tube, a tube cap clamping assembly (31) arranged on the mounting plate (28) and used to clamp the test tube cap, and a cover rotating driving assembly (32) arranged on the mounting plate (28) and used to drive the tube cap clamping assembly (31) to rotate.

5. The automatic urine HCG detection instrument according to claim 1, characterized in that: The conveying mechanism (10) comprises: a conveying rail (33) arranged between a storage bin (8) and a waste bin (9), a fourth slide rail (34) arranged parallel to the conveying rail (33), a conveying push rod slidably connected to the fourth slide rail (34), a fourth driving assembly (35) driving the conveying push rod to move along the fourth slide rail (34), and a push plate assembly for pushing the test card (7) out of the storage bin (8), wherein the storage bin (8) is hollow inside and has an open upper end, and a discharge port (36) is provided at the lower part of the side wall of the storage bin (8) close to the conveying rail (33), and the push plate assembly comprises: a push plate (39) having one end movably penetrating the lower part of the side wall of the storage bin (8) away from the conveying rail (33), one end rotatably connected to the push plate (39) and the other end The transmission push rod comprises: a connecting rod (37) at one end, a rotating disk (38) eccentrically connected to the other end of the connecting rod (37), and a rotating driving member (40) arranged on the workbench (2) for driving the rotating disk (38) to rotate; the transmission push rod comprises: a vertical rod (41) passing through the fourth slide rail (34) and connected to the fourth driving mechanism, a horizontal rod (42) connected to the top of the vertical rod (41) and located at the upper end of the transmission rail (33), a ┌-shaped connecting plate (43) connected to the two ends of the side of the horizontal rod (42) away from the storage bin (8), a valve plate (44) respectively connected to the lower end of the horizontal plate of the ┌-shaped connecting plate (43), and a spring (45) connected between the valve plate (44) and the horizontal rod (42), and the two valve plates (44) are arranged opposite to each other.

6. The automatic urine HCG detection instrument according to claim 1, characterized in that: The test card (7) comprises: an internally hollow mounting shell (46), a sample loading hole (47) and a detection slot (48) respectively penetrating the top of the mounting shell (46), a color identification line (49) disposed on the upper end surface of the mounting shell (46), a support member disposed on the bottom end of the mounting shell (46), a water absorption layer disposed on the support member, and a urine HCG test reagent strip disposed on the water absorption layer, wherein the quality control area on the reagent strip is matched with the test area detection slot (48).

7. The automatic urine HCG detection instrument according to claim 1, characterized in that: The control module includes a program controller and a display. The program controller is used to control and monitor the signals of the entire machine. The display is used to input and output instrument operation parameters, record the instrument operation status and sample detection process. The control module is configured with a data transmission interface and a network interface for communication with the laboratory information system.

8. A control method for an automated urine HCG detection instrument, characterized in that: The following steps are involved: S1. Place the test tube with the sample liquid on the test tube rack (3), start the test tube rack transfer module to transport the test tube rack (3) loaded with the sample test tube to be tested to the sampling position, start the XYZ moving module (6) to drive the cover opening device (4) to move the upper end of the sampling position, and then unscrew the test tube cap of the sample test tube through the cooperation of the XYZ moving module (6) and the cover opening device (4); S2. After the test tube cap is unscrewed, the sampling needle (5) is moved to the sampling position by the XYZ moving module (6). With the cooperation of the XYZ moving module (6), the sampling needle (5) absorbs the urine sample in the test tube; S3. While steps S1 and S2 are being performed, the transport mechanism (10) is started to transport the test card (7) in the storage bin (8) to the sample loading position; S4. The sampling needle (5) after absorbing the urine sample is moved to the sample adding position by the XYZ moving module (6), and the sampling needle (5) drips the urine sample into the sample adding hole (47) on the test card (7) and leaves it to stand for 5 to 10 minutes. During the standing of the test card (7), the sampling needle (5) is moved to the cleaning module by the XYZ moving module (6) for cleaning; S5. Start the transmission mechanism (10) to transmit the test card (7) after the sample is added and allowed to stand to the visual recognition position. The visual recognition module (50) first recognizes the recognition line (49) on the test card (7). If the recognition line (49) is accurately recognized, the visual recognition module (50) analyzes the image of the quality control area and the test area in the detection slot (48) of the test card (7), and transmits the analysis result to the control template. If the recognition line (49) fails to be recognized, it means that the visual recognition module (50) has other faults or the reagent card is an illegal reagent card, and the recognition result is transmitted to the control template to prompt the user to re-test. S6. Start the conveying mechanism (10) to convey the tested test card (7) to the waste bin (9) for disposal; S7. Start the XYZ moving module (6) to drive the cover opening device (4) to move to the upper end of the sampling position, and then through the cooperation of the XYZ moving module (6) and the cover opening device (4), put the test tube cap back on the sample test tube and tighten it, then release the clamping of the tube body clamping assembly (30), and finally, with the cooperation of the XYZ moving module (6) and the tube cap clamping assembly (31), transfer the sampled sample tube to the test tube storage and sorting rack (11) and organize and store it in order.

9. The control method of a urine HCG automated detection instrument according to claim 8, characterized in that: In the above step S5, the method for the visual recognition module (50) to recognize the recognition line (49) is as follows: when the test card (7) is transmitted to the visual recognition position, if the visual recognition module (50) does not obtain the recognition line (49) on the test card (7), the recognition of the recognition line (49) fails; if the recognition line (49) on the test card (7) is obtained, but the grayscale feature value of the recognition line (49) is not within a preset threshold range, the recognition of the recognition line (49) fails; if the recognition line (49) on the test card (7) is obtained and the grayscale feature value of the recognition line (49) is within the preset threshold range, the recognition line (49) is accurately recognized; The calibration steps of the preset threshold interval are: selecting a large number of accurate test cards (7) for standard detection, calculating all grayscale feature values ​​to obtain the average value and standard deviation, and the preset threshold interval is (X-2sd, X+2sd), where X is the average value of the grayscale feature value and 2sd is twice the standard deviation.

10. The control method of a urine HCG automated detection instrument according to claim 8, characterized in that: In the above step S5: the method in which the visual recognition module (50) analyzes the images of the quality control area and the test area in the detection slot (48) of the test card (7) is as follows: if a red stripe appears only in the quality control area on the test card (7) recognized by the visual recognition module (50), the test result is negative; if two red stripes appear and are located in the quality control area and the test area respectively, the result is positive; if there are no red stripes in both the quality control area and the test area, the result is a test failure.

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