Immunochromatography analyzer

Abstract

The invention provides an immunochromatography analyzer, which comprises: a sample introduction device, which is provided with at least one placing position for placing a reagent card, the reagent card is provided with a reaction zone, and the reaction zone is used for carrying a reagent for reacting with a sample; the optical detection device is used for performing optical detection on the reagent card; the image acquisition device is at least used for performing image acquisition; the control device is at least used for controlling the optical detection device to at least perform optical detection on a target area of the reagent card and analyzing a detection signal output by the optical detection device to obtain first detection data of the sample, and the target area at least comprises a reaction area; controlling the image acquisition device to at least acquire an area image corresponding to the target area of the reagent card, and analyzing the area image to obtain second detection data of the sample; and obtaining a target detection result of the sample according to the first detection data and the second detection data.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to an immunochromatographic analyzer. Background Art

[0002] Immunochromatography is a rapid diagnostic technology that has emerged in recent years. Its principle is to fix specific antibodies to a certain zone of nitrocellulose membrane. When one end of the dry nitrocellulose is immersed in the sample (urine or serum), the sample will move forward along the membrane due to capillary action. When it moves to the area where the antibody is fixed, the corresponding antigen in the sample will specifically bind to the antibody, thus achieving specific immunodiagnosis.

[0003] Immunochromatographic analyzers need to be used in conjunction with reagent cards. Traditional immunochromatographic analyzers usually use image detection or optical detection methods to detect the reaction area of ​​the reagent card to obtain the corresponding test results. However, due to interference factors such as sample concentration and reagent card damage, the test results obtained may have false negatives or false positives, resulting in insufficient test results accuracy. Summary of the invention

[0004] The main purpose of the embodiments of the present application is to provide an immunochromatographic analyzer to improve the accuracy of sample detection.

[0005] In a first aspect, an embodiment of the present application provides an immunochromatographic analyzer, comprising:

[0006] The sample injection device is provided with at least one placement position for placing a reagent card, wherein the reagent card is provided with a reaction area, and the reaction area is used to carry a reagent for reacting with the sample;

[0007] An optical detection device, used for optically detecting the reagent card;

[0008] An image acquisition device, at least used for performing image acquisition;

[0009] Control devices, at least for:

[0010] Controlling the optical detection device to perform optical detection on at least a target area of ​​the reagent card, and analyzing a detection signal output by the optical detection device to obtain first detection data of the sample, wherein the target area at least includes the reaction area;

[0011] Controlling the image acquisition device to at least acquire a regional image corresponding to the target area of ​​the reagent card, and analyzing the regional image to obtain second detection data of the sample;

[0012] A target detection result of the sample is obtained according to the first detection data and the second detection data.

[0013] In some embodiments, the control device obtains the target detection result of the sample according to the first detection data and the second detection data, including:

[0014] When the test result of the sample is determined to be negative according to the first test data, and when the test result of the sample is determined to be positive according to the second test data, it is determined that the target test result of the sample is positive.

[0015] In some embodiments, the control device obtains the target detection result of the sample according to the first detection data and the second detection data, including:

[0016] When the test result of the sample is judged to be positive according to the first test data, and the test result of the sample is judged to be negative according to the second test data, and the test value corresponding to the test line of the reagent card in the first test data is less than a first threshold value, it is determined that the target test result of the sample is positive.

[0017] In some embodiments, the control device obtains the target detection result of the sample according to the first detection data and the second detection data, including:

[0018] When the test result of the sample is judged to be positive according to the first test data, and the test result of the sample is judged to be negative according to the second test data, and the test value corresponding to the test line of the reagent card in the first test data is greater than or equal to a first threshold value, it is determined that the target test result of the sample is negative, and / or the information output device of the immunochromatographic analyzer is controlled to output an alarm prompt information.

[0019] In some embodiments, the information output device includes at least one of a display, an indicator light, and a buzzer;

[0020] The control device controls the information output device of the immunochromatographic analyzer to output the alarm prompt information in one of the following ways:

[0021] Controlling the display to display the alarm prompt information on a preset display interface;

[0022] Control the indicator light to output a color that matches the alarm prompt information;

[0023] The buzzer is controlled to output a sound matching the alarm prompt information.

[0024] In some embodiments, the reagent card is further provided with a coding region, the coding region is provided with a code, and the control device is further used for:

[0025] The image acquisition device is controlled to scan the coding area of ​​the reagent card to obtain sample information corresponding to the sample carried by the reagent card according to the scanning result.

[0026] In some embodiments, the control device is further used to obtain a sample calibration parameter corresponding to the sample carried by the reagent card according to the scanning result, and the control device performs the following steps when analyzing the detection signal output by the optical detection device to obtain the first detection data of the sample:

[0027] The detection signal output by the optical detection device is analyzed using the sample calibration parameter to obtain first detection data of the sample.

[0028] In some embodiments, the reagent card is further provided with a hand-drawn area, the regional image includes a hand-drawn area image corresponding to the hand-drawn area, and the control device is further used to:

[0029] Acquire a hand-painted area image corresponding to the hand-painted area from the area image;

[0030] Output a detection report of the target object according to the hand-drawn area image or the hand-drawn information in the hand-drawn area image, or control the immunochromatography analyzer to display the hand-drawn area image or the hand-drawn information in the hand-drawn area image on a preset display interface on a display device.

[0031] In some embodiments, the control device is further configured to:

[0032] Identify a target line segment of the reagent card in the regional image, and obtain position information corresponding to the target line segment, wherein the target line segment includes a quality control line and / or a detection line;

[0033] The detection signal output by the optical detection device is analyzed according to the position information to obtain first detection data of the sample.

[0034] In some embodiments, the position information includes first position information corresponding to the quality control line and second position information corresponding to the detection line, and the detection signal output by the optical detection device is analyzed according to the position information to obtain the first detection data of the sample, including:

[0035] A target detection signal to be analyzed is determined from the detection signal output by the optical detection device according to the first position information and the second position information, and the target detection signal is analyzed to obtain first detection data of the sample.

[0036] In some embodiments, the control device identifies the quality control line and / or the detection line in the reagent card in the regional image, and obtains the position information corresponding to the quality control line and / or the detection line, including:

[0037] The contour information of the quality control line and / or the detection line in the reagent card in the regional image is identified by a preset edge detection algorithm, and the position information corresponding to the quality control line and / or the detection line is determined according to the contour information.

[0038] In some embodiments, the optical detection device includes a signal transmitting component, a signal receiving component, and a signal processing component;

[0039] The signal emitting component is used to emit a first optical signal to the reagent card;

[0040] The signal receiving component is used to receive a reflected light signal of the first light signal reflected by the reagent card, and / or to receive an excitation light signal generated by the first light signal exciting the reagent card.

[0041] In some embodiments, the first optical signal includes at least one of a visible light signal and an infrared light signal.

[0042] It can be seen from the above embodiments that the immunochromatographic analyzer provided in the implementation of the present application is provided with an optical detection device and an image acquisition device, and the reagent card carrying the sample can be detected by the optical detection device and the image acquisition device respectively, thereby obtaining two different detection data, so that the two different detection data can be comprehensively analyzed to determine the final detection result of the sample to be tested, thereby effectively improving the accuracy of the final detection result of the sample to be tested. It should be understood that the above general description and the detailed description below are only exemplary and explanatory, and cannot limit the disclosure of the embodiments of the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0043] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings required for use in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0044] Figure 1 is a block diagram of an immunochromatographic analyzer provided in one embodiment;

[0045] Figure 2 is a schematic structural diagram of a reagent card provided in one embodiment;

[0046] Figure 3 is a block diagram of an optical detection device of an immunochromatographic analyzer provided in one embodiment;

[0047] Figure 4This is a schematic diagram of a scenario in which an immunochromatographic analyzer detects a reagent card using a photoelectric method and an imaging method in one embodiment;

[0048] Figure 5 It is a schematic diagram of another embodiment of the immunochromatographic analyzer detecting a reagent card by photoelectric method and imaging method;

[0049] Figure 6 This is a schematic diagram of a scenario in which an immunochromatographic analyzer locates a detection signal corresponding to a C / T line in a detection signal collected by an optical detection device through an image collected by an image acquisition device in an embodiment. DETAILED DESCRIPTION

[0050] The following will be combined with the drawings in the embodiments of the present application to clearly and completely describe the technical solutions in the embodiments of the present application. Obviously, the described embodiments are part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of this application.

[0051] In the description of this application, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" 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 an indirect connection 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 this application can be understood according to specific circumstances.

[0052] The flowcharts shown in the accompanying drawings are only examples and do not necessarily include all the contents and operations / steps, nor must they be executed in the order described. For example, some operations / steps may also be decomposed, combined or partially merged, so the actual execution order may change according to actual conditions.

[0053] Some implementation methods of the present application are described in detail below in conjunction with the accompanying drawings. In the absence of conflict, the features in the following embodiments and implementation methods can be combined with each other.

[0054] See also Figure 1 , Figure 1 A schematic diagram of the framework structure of an immunochromatographic analyzer provided in an embodiment of the present application.

[0055] like Figure 1As shown, the immunochromatographic analyzer 100 includes a sample injection device 10, an optical detection device 20, an image acquisition device 30 and a control device 40. Among them, the sample injection device 10 is provided with at least one placement position for placing a target object to be tested, and the target object to be tested includes but is not limited to a test paper card or a reagent card containing a sample to be tested. The optical detection device 20 is used to perform optical detection on the target object and output a corresponding detection signal. The image acquisition device 30 is at least used to perform image acquisition, for example, to acquire an image of the target object, and the target object includes but is not limited to a reagent card. The control device 40 is at least used to analyze the detection signal output by the optical detection device 20, so as to obtain the first detection data of the sample to be tested, and to analyze the image acquired by the image acquisition device 30, so as to obtain the second detection data corresponding to the sample to be tested, and to analyze the first detection data and the second detection data by a preset analysis method, so as to obtain the final detection result corresponding to the sample to be tested.

[0056] The embodiment of the present application is described by taking the target object as a reagent card as an example.

[0057] See also Figure 2 The reagent card 50 is provided with a reaction area (also called a test strip detection area) 501 and a sample addition area 502. The reaction area 501 is used to carry a reagent that reacts with the sample to be tested. After the sample is added to the sample addition area 502, the sample reacts with the reagent in the reaction area 501, and after a preset reaction time, the reaction area 501 will display a detection line (T line) and / or a quality control line (C line). The sample to be tested is judged to be a positive sample or a negative sample by judging whether the detection line (T line) and the quality control line (C line) appear in the reaction area 501. For example, if the detection line (T line) and the quality control line (C line) appear in the reaction area 501 at the same time, it can be judged that the sample added to the reagent card 50 is positive. If only the quality control line (C line) appears in the reaction area 501, it can be judged that the sample added to the reagent card 50 is negative.

[0058] However, when the immunochromatographic analyzer 100 detects the reagent card 50 only through the optical detection device 20, the colloidal gold particles in the reagent card 50 may be aggregated on one side of the T line and the C line due to interference factors such as the product quality of the reagent card 50 itself, the sample concentration, and the sample incubation, resulting in a very narrow width of the T line and the C line, resulting in no T peak in the test result, thereby causing a false negative. At this time, by using the image acquisition device 30 to collect the image of the reaction area 501 of the reagent card 50 for judgment, this type of detection without recognition can be reduced and the accuracy of the test result can be improved.

[0059] In the process of analyzing the image of the reagent card 50 collected by the image acquisition device 30, the immunochromatographic analyzer 100 is affected by the product quality and product concentration of the reagent card 50 itself. When the T line color is low, the test result has no T peak, resulting in a false negative. By using the optical detection device 20 to collect the reaction area 501 of the reagent card 50 for detection, this type of detection without recognition can be reduced and the accuracy of the test result can be improved.

[0060] In some embodiments, the optical detection device 20 includes a signal emitting component 21 and a signal receiving component 22. The signal emitting component 21 is used to emit a first light signal to the reagent card. The signal receiving component 22 is used to receive a reflected light signal of the first light signal reflected by the reagent card 50, and to generate a detection signal based on the reflected light signal and output it to the control device 40. And / or, the signal receiving component 22 is used to receive an excitation light signal (e.g., a fluorescent signal) generated by the reagent card 50 when the first light signal excites the reagent card 50, and to generate a detection signal based on the excitation light signal and output it to the control device 40, such as Figure 3 As shown. For example, the signal emitting component 21 includes at least a light source (such as a light-emitting diode, LED for short), and the light emitted by the light source irradiates the reaction area 501 (also called the test strip detection area) of the reagent card 50 to generate fluorescence or reflected light. That is, the light signal emitted by the light source can be a visible light signal or an ultraviolet light signal, such as the light signal emitted by the light source is visible light with a wavelength of 577nm to 492nm, or the light signal emitted by the light source is visible ultraviolet light with a wavelength of 400nm to 315nm.

[0061] The signal receiving component 22 includes a photosensitive device (such as a photodiode, Photo-Diode, abbreviated as PD), which detects the fluorescence or reflected light to obtain a corresponding detection signal, and outputs the detection signal to the control device 40. Therefore, the control device 40 can obtain the first detection data of the sample according to the detection signal, and analyze the detection result of the sample according to the first detection data, such as the content of the target substance in the sample, the content of the target substance in the sample, or whether the sample to be tested is a negative sample or a positive sample.

[0062] For example, the detection signal may indicate the wavelength and / or light intensity of the fluorescence or reflected light. For example, when the content of the target substance in the sample is different, the light intensity of the preset wavelength in the detected detection signal is also different, so the control device 40 can obtain the first detection data of the sample according to the detection signal, and analyze the detection result of the sample according to the first detection data, such as the content of the target substance in the sample, or whether the sample to be tested is a negative sample or a positive sample.

[0063] In some embodiments, the image acquisition device 30 can obtain an image of the reaction area 501 of the reagent card 50, and the detection data of the sample can be obtained by performing graphic processing on the image, and the detection result of the sample is analyzed according to the detection data, such as the content of the target substance in the sample, or whether the sample to be tested is a negative sample or a positive sample. For example, the detection signal may include an image of the reaction area 501 of the reagent card 50. For example, the image acquisition device 30 includes but is not limited to a two-dimensional code scanner (also called a scanner), a CMOS (Complementary Metal Oxide Semiconductor) camera, and a CCD (Charge-coupled Device) camera.

[0064] Optionally, the image acquisition device 30 is also used to scan the target object, for example, to scan the QR code, barcode, etc. set on the reagent card 50 to obtain the corresponding code scanning result. For example, when the reagent card 50 moves to the first position, the control device 40 controls the image acquisition device 30 to at least capture the image of the reaction area 501 of the reagent card 50. When the reagent card 50 moves to the second position, the control device 40 controls the image acquisition device 30 to scan the code area of ​​the reagent card 50.

[0065] like Figure 1 As shown, in some embodiments, the control device 40 can be one or more, and the control device 40 can be set in at least one of the sample injection device 10, the optical detection device 20, and the image acquisition device 30, or can be set independently of the sample injection device 10, the optical detection device 20, and the image acquisition device 30, which is not limited here.

[0066] Optionally, the control device 40 includes at least a processor 401, a memory 402, a communication interface (not shown) and an I / O interface (not shown). The processor 401, the memory 402, the communication interface, and the I / O interface communicate through a bus. The processor 401 can be a central processing unit (CPU), and the processor can also be other general-purpose processors, digital signal processors (DSP), application-specific integrated circuits (ASIC), field-programmable gate arrays (FPGA) or other programmable logic devices, discrete gates or transistor logic devices, discrete hardware components, etc. Among them, the general-purpose processor can be a microprocessor or the processor can also be any conventional processor, etc.

[0067] The memory 402 is equipped with various computer programs such as operating systems and applications for the processor 401 to execute and the data required for executing the computer programs. During the detection process of the sample to be tested, if there is data that needs to be stored locally, it can be stored in the memory 402. The I / O interface includes but is not limited to serial interfaces such as USB, IEEE1394 or RS-232C, parallel interfaces such as SCSI, IDE or IEEE1284, and analog signal interfaces composed of D / A converters and converters. An input component is connected to the I / O interface, and the user can use the input component to directly input data to the control device 40. The input component includes but is not limited to a keyboard, a mouse, a touch screen or a control button. The display component can be connected to the control device 40 through the I / O interface to communicate with the control device 40 to provide relevant information prompts. The communication interface can be an interface of any currently known communication protocol. The communication interface communicates with the outside world through a network. The control device 40 can transmit data between any components connected through the network through the communication interface with a preset communication protocol.

[0068] In some embodiments, the control device 40 is at least used to perform the following operations, specifically, the processor 401 of the control device 40 calls the computer program in the memory 402 to perform the following operations:

[0069] Control the optical detection device 20 to perform optical detection on at least the target area of ​​the reagent card 50, and analyze the detection signal output by the optical detection device 20 to obtain first detection data of the sample, wherein the target area at least includes the reaction area 501;

[0070] Controlling the image acquisition device 30 to at least acquire a regional image corresponding to the target area of ​​the reagent card 50, and analyzing the regional image to obtain second detection data of the sample;

[0071] A target detection result of the sample is obtained according to the first detection data and the second detection data.

[0072] Exemplarily, the optical detection device 20 is controlled to perform optical detection on at least the reaction area 501 of the reagent card 50 , and the image acquisition device 30 is controlled to acquire an image of the reaction area 501 of the reagent card 50 .

[0073] During the optical detection process, the signal emitting component 21 is used to emit a first optical signal to the reagent card 50. Under the irradiation of the first optical signal, the reaction area 501 of the reagent card 50 generates fluorescence or reflected light. The photosensitive device of the signal receiving component 22 detects the fluorescence or reflected light to obtain a corresponding detection signal, and outputs the inspection signal to the control device 40 for processing and analysis. For example, the detection signal can indicate the wavelength and / or light intensity of the fluorescence or reflected light of the C line and / or T line in the reaction area 501.

[0074] For example, when the content of the target substance in the sample is different, the color development degree of the C line and / or T line in the reaction area 501 is different, so that the light intensity of the preset wavelength in the detection signal obtained by detection is also different. Therefore, the control device 40 can obtain the first detection data of the sample according to the detection signal, and analyze the first detection result of the sample according to the first detection data, such as the content of the target substance in the sample, the content of the target substance in the sample, or whether the sample to be tested is a negative sample or a positive sample.

[0075] Based on the different color development levels of the C line and / or T line in the reaction area 501 when the content of the target substance in the sample is different, during the image acquisition process, the image of the reaction area 501 of the reagent card 50 can be obtained, and by performing graphic processing on the image, it can be determined whether there are T lines and / or C lines in the reaction area 51 of the reagent card 50, thereby obtaining the second test data of the corresponding sample, and analyzing the second test result of the sample based on the second test data, such as the content of the target substance in the sample, or whether the sample to be tested is a negative sample or a positive sample.

[0076] A comprehensive evaluation is performed using the first detection data and the second detection data, which fully utilizes the high sensitivity of the optical detection method (also known as the photoelectric method) and the strong anti-interference ability of the image method. The first detection data and the second detection data are cross-checked to obtain the target detection result corresponding to the sample to be tested, which can effectively reduce the misjudgment rate of instrument detection and make the obtained target detection result more accurate.

[0077] In some embodiments, the control device 40 obtains a target detection result of the sample according to the first detection data and the second detection data, including:

[0078] When the test result of the sample is determined to be negative according to the first test data, and the test result of the sample is determined to be positive according to the second test data, it is determined that the target test result of the sample is positive.

[0079] Exemplarily, if the test result of the sample is judged to be positive based on the second test data, it indicates that the color development of the C line and the T line in the reaction area 501 of the reagent card 50 is relatively strong. At this time, if the test result of the sample is judged to be negative based on the first test data, it indicates that the ratio of the test data of the T line (such as the test signal intensity) to the test data of the C line (such as the test signal intensity) is less than the preset value, that is, it indicates that there is a problem with the stability of the C line and / or the T line in the reaction area 501 of the reagent card 50.

[0080] For example, due to reasons such as film scratching, sample problems, or incubation reactions, the colloidal gold particles gather on one side of the T and C lines in the reaction area 501 of the reagent card 50, resulting in very narrow T and C line widths. For example, the normal line width is above 0.7 mm, and the abnormal line width is less than 0.2 mm.

[0081] However, the colloidal gold detection spot in the reaction area 501 is relatively wide, so that the T line is visible visually (the T line is visible in the collected image), but there is no T peak when detected by the instrument (immunochromatographic analyzer), resulting in a false negative test result of the sample. Therefore, using the test result corresponding to the second test data as the target test result can effectively improve the accuracy of the test result.

[0082] Optionally, the control device 40 obtains a target detection result of the sample according to the first detection data and the second detection data, including:

[0083] When the test result of the sample is judged to be positive according to the first test data, and the test result of the sample is judged to be negative according to the second test data, and the test value corresponding to the test line of the reagent card 50 in the first test data is less than the first threshold, the target test result of the sample is determined to be positive.

[0084] Exemplarily, if the first test data determines that the test result of the sample is positive, it indicates that the ratio of the T-line test data to the C-line test data is greater than or equal to the preset value, the T-line corresponding test value of the reagent card 50 in the first test data is less than the first threshold value, and the second test data determines that the test result of the sample is negative, it indicates that the T-line test data in the second test data is low, that is, the T-line color rendering in the image is low.

[0085] When the color rendering index is lower than the threshold, the T line in the image captured by the optical detection device 20 is not easy to identify, that is, T line identification through image recognition is prone to errors. At this time, the detection result corresponding to the first detection data is used as the target detection result, which can effectively improve the accuracy of the detection result.

[0086] Optionally, the control device 40 obtains a target detection result of the sample according to the first detection data and the second detection data, including:

[0087] When the test result of the sample is judged to be positive according to the first test data, and the test result of the sample is judged to be negative according to the second test data, and the test value corresponding to the test line of the reagent card 50 in the first test data is greater than or equal to the first threshold value, the target test result of the sample is determined to be negative, and / or the information output device of the immunochromatographic analyzer is controlled to output an alarm prompt information.

[0088] Optionally, the information output device includes at least one of a display, an indicator light and a buzzer;

[0089] The control device 40 controls the information output device of the immunochromatographic analyzer to output the alarm prompt information in one of the following ways:

[0090] Control the display to display the alarm prompt information on the preset display interface;

[0091] Control the indicator light to output a color that matches the alarm prompt information;

[0092] Control the buzzer to output a sound that matches the alarm prompt information.

[0093] See also Figure 4 For example, if the first test data determines that the test result of the sample is positive, it indicates that the ratio of the T-line test data to the C-line test data is greater than or equal to the preset value, the T-line corresponding test value of the reagent card 50 in the first test data is greater than or equal to the first threshold value, and the second test data determines that the test result of the sample is negative, it indicates that the T-line test data in the first test data is higher.

[0094] At this time, the test strip in the reagent card 50 may be scratched, contaminated, or unevenly assembled, causing refraction and diffuse reflection on the paper strip membrane surface, resulting in a decrease in light reflectivity at the T line position, which in turn causes the optical detection method to detect a larger detection signal at the T line position, resulting in a false positive with a larger T peak.

[0095] Since there is a high probability of false positive, in the actual reagent card 50, the color development of the T line after the sample and the reagent react is low or no color is developed, so the T line cannot be identified by the imaging method, and the test result of the sample is negative.

[0096] At this time, the detection result of the image method is closer to the visual perception of the human eye, so the result of the image method is used, or the information output device of the immunochromatographic analyzer is controlled to output an alarm prompt message to encourage the user to retest.

[0097] Optionally, the control device 40 obtains a target detection result of the sample according to the first detection data and the second detection data, including:

[0098] When the test result of the sample is determined to be positive according to the first test data, and the test result of the sample is determined to be positive according to the second test data, determining that the target test result of the sample is positive;

[0099] When the test result of the sample is determined to be negative according to the first test data, and the test result of the sample is determined to be negative according to the second test data, it is determined that the target test result of the sample is negative.

[0100] like Figure 5As shown, according to the first detection data, the detection data corresponding to the T line and the C line are obtained, and the ratio between the T line detection data and the C line detection data is calculated. If the ratio is less than a first preset value, it indicates that the preliminary detection result of the sample obtained according to the first detection data is negative. If the ratio is greater than or equal to the first preset value, it indicates that the preliminary detection result of the sample obtained according to the first detection data is positive.

[0101] According to the second detection data, the detection data corresponding to the T-line position and the C-line position (e.g., the image characteristic signal of the T-line position and the image characteristic signal of the C-line position) are obtained. When the detection data of the T-line position is greater than or equal to the second threshold, it indicates that the preliminary detection result of the sample obtained according to the second detection data is positive. When the detection data of the T-line position is less than the second threshold, it indicates that the preliminary detection result of the sample obtained according to the second detection data is negative.

[0102] If the results obtained by the first test data and the second test data are the same, the test result corresponding to any test data is selected as the target detection result. For example, when the results of the scanning method and the imaging method are both positive, it indicates that the target detection result of the sample is positive. For example, when the results of the scanning method and the imaging method are both negative, it indicates that the target detection result of the sample is negative.

[0103] See also Figure 2 In some embodiments, the reagent card 50 is further provided with a coding area 503, the coding area 503 is provided with a code, and the control device 40 is further used for:

[0104] The image acquisition device 30 is controlled to scan the coding area 503 of the reagent card 50 to obtain sample information corresponding to the sample carried by the reagent card 50 according to the scanning result.

[0105] Exemplarily, the coding area 503 of the reagent card 50 is provided with a code such as a QR code or a barcode, and the image acquisition device 30 scans the code in the coding area 503 of the reagent card 50, thereby identifying the sample information carried by the code in the coding area 503, and the sample information includes but is not limited to the sample type and the sample detection item. That is, the image acquisition device 30 can be a code scanner, for example, the image acquisition device 30 is a QR code scanner.

[0106] like Figure 2 As shown, in some embodiments, the reagent card 50 is further provided with a coding area 503, the coding area 503 is provided with a code, and the control device 40 is further used for:

[0107] Control the image acquisition device 30 to scan the coding area 503 of the reagent card 50, and obtain the sample calibration parameters corresponding to the sample carried by the reagent card 50 according to the scanning result;

[0108] Furthermore, when the control device 40 analyzes the detection signal output by the optical detection device 20 to obtain the first detection data of the sample, the control device 40 executes:

[0109] The detection signal output by the optical detection device 20 is analyzed using the sample calibration parameters to obtain the first detection data of the sample, wherein the sample calibration parameters include a calibration curve and / or a correction coefficient.

[0110] Exemplarily, the calibration curve corresponding to the calibration sample type and the correction coefficient of the current sample type can be obtained to determine the calibration curve of the current sample type. Based on the calibration curve of the current sample type, the test result of the current sample is determined according to the test signal of the current sample. For example, if the calibrator used in the calibration is serum, when the sample type is whole blood, the test result of the whole blood sample can be determined according to the calibration curve obtained by making corresponding corrections to the serum calibration curve.

[0111] Exemplarily, a calibration curve corresponding to the calibration sample type can be obtained, and based on the calibration curve corresponding to the calibration sample type, the test result to be corrected is determined according to the test signal of the sample. The test result to be corrected is corrected according to the correction coefficient of the current sample type to obtain the test result of the current sample. For example, when the sample type is whole blood, the test result corresponding to the test signal can be obtained according to the serum calibration curve, and the test result is corrected accordingly to obtain the test result of the whole blood sample.

[0112] Exemplarily, the calibration curve of the current sample type may be directly obtained, and based on the calibration curve of the current sample type and the detection signal of the current sample, the detection result of the current sample may be determined. For example, for the same detection item, different sample types have their own calibration curves, and the calibration curves of different sample types may be the same or different, or may be partially the same and partially different. The detection result corresponding to the detection signal of the sample may be determined based on the calibration curve corresponding to the sample type.

[0113] Optionally, the calibration curve can be obtained by scanning the barcode or QR code on the reagent card 50 through the image acquisition device 30. For example, the calibration curve of the calibrator (such as serum) and the calibration curve correction coefficients of other sample types and calibrators can be obtained by scanning the barcode or QR code on the reagent card 50 through the image acquisition device 30, so as to correct the calibration curve of the calibrator according to the calibration curve correction coefficients of other sample types and calibrators. For example, the calibration curves of various sample types corresponding to the test items can be obtained by scanning the barcode or QR code on the reagent card 50 through the image acquisition device 30, the same calibration curve of different sample types can be obtained only once, and different calibration curves of different sample types can be obtained separately.

[0114] In some embodiments, the reagent card 50 is further provided with a hand-drawn area 504, the regional image includes a hand-drawn area image corresponding to the hand-drawn area, and the control device 40 is further used to:

[0115] Obtain a hand-painted area image corresponding to the hand-painted area from the regional image;

[0116] Output a corresponding test report according to the hand-drawn area image or the hand-drawn information in the hand-drawn area image, or control the immunochromatographic analyzer to display the hand-drawn area image or the hand-drawn information in the hand-drawn area image on a preset display interface on a display device.

[0117] Exemplarily, during the image acquisition process of the target area of ​​the reagent card 50 by the image acquisition device 30, the corresponding area image is obtained, and the area image includes the hand-drawn area image corresponding to the hand-drawn area 504, and the hand-drawn information (such as text information) in the hand-drawn area image is obtained by image recognition technology, or the hand-drawn area image is segmented from the area image by image recognition technology. Optionally, the hand-drawn information is used to characterize the object information of the sample to be tested, such as object name, object type, object number, etc.

[0118] In some embodiments, the control device 40 is further configured to:

[0119] Identify a target line segment of the reagent card 50 in the regional image and obtain position information corresponding to the target line segment, where the target line segment includes a quality control line and / or a detection line;

[0120] The detection signal output by the optical detection device 20 is analyzed according to the position information to obtain first detection data of the sample.

[0121] Optionally, the position information includes first position information corresponding to the quality control line (C line) and second position information corresponding to the detection line (T line), and the detection signal output by the optical detection device 20 is analyzed according to the position information to obtain first detection data of the sample, including:

[0122] The target detection signal to be analyzed is determined from the detection signal output by the optical detection device 20 according to the first position information and the second position information, and the target detection signal is analyzed to obtain the first detection data of the sample.

[0123] Optionally, the control device 40 identifies the quality control line and / or the detection line in the reagent card 50 in the regional image, and obtains the position information corresponding to the quality control line and / or the detection line, including:

[0124] The contour information of the quality control line and / or the detection line in the reagent card 50 in the regional image is identified by a preset edge detection algorithm, and the position information corresponding to the quality control line and / or the detection line is determined according to the contour information.

[0125] Exemplarily, after obtaining the first detection data by the photoelectric method using the optical detection device 20, a first detection curve is obtained based on the first detection data, and the peak area of ​​the C peak corresponding to the C line and the peak area of ​​the T peak corresponding to the T line are calculated by a preset algorithm to determine the detection data of the C line based on the peak area of ​​the C peak, and determine the detection data of the T line based on the peak area of ​​the T peak.

[0126] In this process, in order to reduce the impact of interference data, the preset algorithm often only recognizes C peaks and T peaks within a specific range. However, the accuracy of the C and T line positions in the test strip production process is difficult to guarantee, and the C and T line positions of different batches of test strips may also vary greatly, which will cause the C and T peaks on the test curve to exceed the algorithm's identifiable range, resulting in large errors in the output test results, or even wrong and invalid test results.

[0127] In this embodiment, after the image acquisition device 30 acquires the image of the reaction area 501 of the test strip 50, the C line in the image is identified to obtain the first position information of the C line. The T line in the image is identified to obtain the second position information of the T line. The C line and the T line in the image are identified to obtain the first position information corresponding to the C line and the second position information corresponding to the T line.

[0128] For example, the C line and / or T line in the reaction area 501 of the test strip 50 is identified by an edge detection algorithm. Common edge detection methods include Canny operator, Prewitt operator, Sobel operator, etc.

[0129] Furthermore, when only one of the C line or the T line is obtained, the position information of the other line can be calculated based on the estimated spacing between the C line and the T line. Preferably, after the image of the reaction area 501 of the test strip 50 is acquired by the image acquisition device 30, the C line and the T line in the image are identified, and the first position information corresponding to the C line and the second position information corresponding to the T line are acquired.

[0130] The control device 40 corrects the recognition range of the preset algorithm according to the acquired position information corresponding to the C line and / or the T line, so that the target detection signal to be analyzed can be determined from the detection signal output by the optical detection device 20. For example, the detection signal corresponding to the position of the C line is determined from the detection signal output by the optical detection device 20 according to the first position information, and the detection signal corresponding to the position of the T line is determined from the detection signal output by the optical detection device 20 according to the second position information, thereby effectively reducing the deviation of the C and T lines in the production process of the test strip. Even if there is a large deviation, the optical detection device 20 can still effectively identify the peaks corresponding to the C peak and the T peak through the photoelectric method and output a valid peak area result.

[0131] like Figure 6As shown, after the image acquisition device 30 acquires the image of the reaction area 501 of the test strip 50, it identifies the C line and the T line in the image, and obtains the first position information corresponding to the C line and the second position information corresponding to the T line. According to the first position information, the detection signal corresponding to the position of the C line is determined from the detection signal output by the optical detection device 20, and according to the second position information, the detection signal corresponding to the position of the T line is determined from the detection signal output by the optical detection device 20, thereby more accurately calculating the peak values ​​corresponding to the C peak and the T peak.

[0132] It should be understood that the terms used in this application specification are only for the purpose of describing specific embodiments and are not intended to limit the application. As used in this application specification and the appended claims, unless the context clearly indicates otherwise, the singular forms "a", "an" and "the" are intended to include plural forms.

[0133] It should also be understood that the term "and / or" used in the specification of this application and the appended claims refers to any combination of one or more of the associated listed items and all possible combinations, including these combinations. It should be noted that, in this article, the terms "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or system including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or system. In the absence of further restrictions, an element defined by the sentence "including a..." does not exclude the presence of other identical elements in the process, method, article or system including the element.

[0134] The serial numbers of the embodiments of the present application are for description only and do not represent the advantages and disadvantages of the embodiments. The above is only a specific implementation of the present application, but the protection scope of the present application is not limited thereto. Any technician familiar with the technical field can easily think of various equivalent modifications or replacements within the technical scope disclosed in the present application, and these modifications or replacements should be included in the protection scope of the present application. Therefore, the protection scope of the present application shall be based on the protection scope of the claims.

Claims

1. An immunochromatographic analyzer, characterized in that: include: The sample injection device is provided with at least one placement position for placing a reagent card, wherein the reagent card is provided with a reaction area, and the reaction area is used to carry a reagent for reacting with the sample; An optical detection device, used for optically detecting the reagent card; An image acquisition device, at least used for performing image acquisition; Control devices, at least for: Controlling the optical detection device to perform optical detection on at least a target area of ​​the reagent card, and analyzing a detection signal output by the optical detection device to obtain first detection data of the sample, wherein the target area at least includes the reaction area; Controlling the image acquisition device to at least acquire a regional image corresponding to the target area of ​​the reagent card, and analyzing the regional image to obtain second detection data of the sample; A target detection result of the sample is obtained according to the first detection data and the second detection data.

2. The immunochromatographic analyzer according to claim 1, characterized in that: The control device obtains a target detection result of the sample according to the first detection data and the second detection data, including: When the test result of the sample is determined to be negative according to the first test data, and when the test result of the sample is determined to be positive according to the second test data, it is determined that the target test result of the sample is positive.

3. The immunochromatographic analyzer according to claim 1, characterized in that: The control device obtains a target detection result of the sample according to the first detection data and the second detection data, including: When the test result of the sample is judged to be positive according to the first test data, and the test result of the sample is judged to be negative according to the second test data, and the test value corresponding to the test line of the reagent card in the first test data is less than a first threshold value, it is determined that the target test result of the sample is positive.

4. The immunochromatographic analyzer according to claim 1, characterized in that: The control device obtains a target detection result of the sample according to the first detection data and the second detection data, including: When the test result of the sample is judged to be positive according to the first test data, and the test result of the sample is judged to be negative according to the second test data, and the test value corresponding to the test line of the reagent card in the first test data is greater than or equal to a first threshold value, it is determined that the target test result of the sample is negative, and / or the information output device of the immunochromatographic analyzer is controlled to output an alarm prompt information.

5. The immunochromatographic analyzer according to claim 4, characterized in that: The information output device includes at least one of a display, an indicator light and a buzzer; The control device controls the information output device of the immunochromatographic analyzer to output the alarm prompt information in one of the following ways: Controlling the display to display the alarm prompt information on a preset display interface; Control the indicator light to output a color that matches the alarm prompt information; The buzzer is controlled to output a sound matching the alarm prompt information.

6. The immunochromatographic analyzer according to claim 1, characterized in that: The reagent card is also provided with a coding area, the coding area is provided with a code, and the control device is also used for: The image acquisition device is controlled to scan the coding area of ​​the reagent card to obtain sample information corresponding to the sample carried by the reagent card according to the scanning result.

7. The immunochromatographic analyzer according to claim 6, characterized in that: The control device is also used to obtain a sample calibration parameter corresponding to the sample carried by the reagent card according to the scanning result, and the control device performs the following steps when analyzing the detection signal output by the optical detection device to obtain the first detection data of the sample: The detection signal output by the optical detection device is analyzed using the sample calibration parameter to obtain first detection data of the sample.

8. The immunochromatographic analyzer according to claim 1, characterized in that: The reagent card is also provided with a hand-drawn area, the regional image includes a hand-drawn area image corresponding to the hand-drawn area, and the control device is further used for: Acquire a hand-painted area image corresponding to the hand-painted area from the area image; Output a corresponding test report according to the hand-drawn area image or the hand-drawn information in the hand-drawn area image, or control the immunochromatography analyzer to display the hand-drawn area image or the hand-drawn information in the hand-drawn area image on a preset display interface on a display device.

9. The immunochromatographic analyzer according to any one of claims 1 to 8, characterized in that: The control device is also used for: Identify a target line segment of the reagent card in the regional image, and obtain position information corresponding to the target line segment, wherein the target line segment includes a quality control line and / or a detection line; The detection signal output by the optical detection device is analyzed according to the position information to obtain first detection data of the sample.

10. The immunochromatographic analyzer according to claim 9, characterized in that: The position information includes first position information corresponding to the quality control line and second position information corresponding to the detection line, and the detection signal output by the optical detection device is analyzed according to the position information to obtain the first detection data of the sample, including: A target detection signal to be analyzed is determined from the detection signal output by the optical detection device according to the first position information and the second position information, and the target detection signal is analyzed to obtain first detection data of the sample.

11. The immunochromatographic analyzer according to claim 10, characterized in that: The control device identifies the quality control line and / or the detection line in the reagent card in the regional image, and obtains the position information corresponding to the quality control line and / or the detection line, including: The contour information of the quality control line and / or the detection line in the reagent card in the regional image is identified by a preset edge detection algorithm, and the position information corresponding to the quality control line and / or the detection line is determined according to the contour information.

12. The immunochromatographic analyzer according to any one of claims 1 to 8, characterized in that: The optical detection device includes a signal transmitting component and a signal receiving component; The signal emitting component is used to emit a first optical signal to the reagent card; The signal receiving component is used to receive a reflected light signal of the first light signal reflected by the reagent card, and / or to receive an excitation light signal generated by the first light signal exciting the reagent card.

Images