Immunoassay analyzer

Abstract

The invention relates to the technical field of fluorescence immunoassay, in particular to an immunoassay instrument. The immunity analyzer comprises: a detection module suitable for inserting a plurality of test pieces; a scanning unit, a light path unit and a camera shooting unit are arranged in the detection module; the scanning unit is used for acquiring information parameters of the test pieces, the light path unit is used for exciting light to enable all the test pieces to generate light spots, and the camera shooting unit is used for acquiring image information of the light spots; the shell module is in communication connection with the detection module; the shell module is used for dividing the image information into an edge area and a middle area and adjusting the edge area; and calculating the concentration value of the to-be-tested object on the test piece based on the middle area. According to the embodiment, the edge and the middle area can be accurately distinguished, and interference of edge brightness on the middle area is avoided. Meanwhile, only the marginal area is processed, the detection result of other parts is not influenced, and the accuracy of a fluorescence signal is ensured.

Description

Technical Field

[0001] The invention relates to the technical field of fluorescent immunoassay, and in particular to an immunoassay analyzer. Background Art

[0002] At present, fluorescent immunoassay equipment usually adopts a single-channel immunoassay method. In order to improve the detection efficiency, some fluorescent immunoassay equipment adopts a multi-channel method, thereby increasing the number of single detections.

[0003] However, in actual applications, when using photodiodes to receive the fluorescence intensity of the reagent card, the photodiode’s photosensitive surface is usually small and cannot cover all channels at the same time, resulting in the inability to obtain fluorescence signals from all channels at the same time. When using lamp beads to excite the fluorescent markers on the reagent card, the uneven distribution of light from the lamp beads causes the fluorescence signal at the edge of the reagent card to be overestimated or underestimated. At the same time, the light between adjacent channels may interfere with each other, resulting in low accuracy of the fluorescence signal. Summary of the invention

[0004] In view of this, the present invention provides an immunoassay analyzer to solve the problems of low detection efficiency of fluorescent immunoassay equipment and low accuracy of fluorescent signals.

[0005] In a first aspect, the present invention provides an immunoassay analyzer, comprising:

[0006] A detection module, suitable for inserting a plurality of test pieces; the detection module is provided with a scanning unit, an optical path unit and a camera unit; the scanning unit is used to obtain information parameters of the test pieces, the optical path unit is used to excite light to make all the test pieces generate light spots, and the camera unit is used to obtain image information of the light spots;

[0007] A shell module is communicatively connected with the detection module; the shell module is used to divide the image information into an edge area and a middle area, adjust the edge area; and calculate the concentration value of the object to be tested on the test piece based on the middle area.

[0008] Beneficial effect: This embodiment divides the image information into edge areas and middle areas, which can accurately distinguish the edge areas from the middle areas and avoid the interference of edge brightness on the middle areas. At the same time, only the edge areas are processed without affecting the detection results of other parts, so as to ensure the accuracy and reliability of the fluorescence signal.

[0009] In an optional implementation, dividing the image information into an edge area and a middle area includes:

[0010] Using an edge detection algorithm to identify the edge of the test piece in the image information;

[0011] The image information is divided into the edge area and the middle area, and the edge brightness value and the middle brightness value are obtained respectively.

[0012] In an optional implementation, the adjusting the edge brightness value of the edge area includes:

[0013] dividing the edge region into a plurality of sub-regions;

[0014] Get the sub-brightness value of each sub-area;

[0015] When the sub-brightness value is lower than a preset brightness value, removing the sub-region from the image information;

[0016] When the sub-brightness value is not lower than the preset brightness value, adjusting the sub-area to the middle area;

[0017] The preset brightness value is the average brightness value of the middle area.

[0018] In an optional implementation, the calculating the concentration value of the object to be detected on the test piece based on the middle area includes:

[0019] Determine the position area of ​​the T band and the C band according to the middle area;

[0020] Extracting brightness values ​​of the T band and the C band from the position area respectively to obtain corresponding T values ​​and C values;

[0021] Based on the T value, the C value and the corresponding concentration threshold, the concentration value of the analyte is obtained.

[0022] In an optional embodiment, the concentration value of the analyte is obtained by the following formula:

[0023] logy=a*log(xc)+b;

[0024] Wherein, y is the concentration value of the analyte, x is the ratio of the T value to the C value, c is the concentration threshold of the analyte, and a and b are coefficients;

[0025] If y exceeds c, it is considered positive; otherwise, it is negative.

[0026] In an optional embodiment, the immunoassay analyzer further comprises:

[0027] When only the position area of ​​the T zone is determined according to the middle area, a prompt message is issued.

[0028] In an optional embodiment, the scanning unit is used to obtain a QR code of the test piece, wherein the QR code contains the information parameters, and the information parameters include at least: reagent card number, reagent card batch number, test duration, test items, and calculation formula.

[0029] In an optional embodiment, the housing module includes:

[0030] The upper shell component is provided with an upper shell, a button unit, a touch screen and a control mainboard; the control mainboard is communicatively connected with the button unit, the touch screen and the detection module at the same time.

[0031] In an optional embodiment, the housing module further includes:

[0032] The lower shell assembly is provided with a lower shell, a battery, and a data interface; the lower shell and the upper shell surround to form an installation cavity, and the battery is arranged in the installation cavity; the data interface is connected to the battery and the control mainboard.

[0033] In an optional embodiment, the housing module further includes:

[0034] A printing device is communicatively connected to the control main board. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] In order to more clearly illustrate the specific embodiments of the present invention or the technical solutions in the related technologies, the drawings required for use in the specific embodiments or the related technical descriptions will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0036] Figure 1 It is a structural schematic diagram of an immunoassay analyzer in an embodiment of the present invention;

[0037] Figure 2 Schematic diagram of the optical path of the detection module in an embodiment of the present invention.

[0038] Description of reference numerals:

[0039] 1. Detection module; 11. Scanning unit; 12. Optical path unit; 121. Lamp beads; 122. Dichroic mirror; 123. Filter; 13. Camera unit;

[0040] 2. Shell module;

[0041] 21. upper shell assembly; 211. upper shell; 212. key unit; 213. touch screen; 214. control main board;

[0042] 22. lower shell assembly; 221. lower shell; 222. battery; 223. data interface;

[0043] 3. Printing equipment; 4. Test piece; 41. Testing area. DETAILED DESCRIPTION

[0044] 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 those skilled in the art without creative work are within the scope of protection of the present invention.

[0045] In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying 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 limiting the present invention. In addition, the terms "first", "second", and "third" are used for descriptive purposes only, and cannot be understood as indicating or implying relative importance.

[0046] In the description of the present invention, it should be noted that, 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 it can be indirectly connected through an intermediate medium, it can also be the internal connection of two components, it can be a wireless connection, or it can be a wired connection. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0047] In addition, the technical features involved in the different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0048] At present, fluorescent immunoassay equipment usually adopts a single-channel immunoassay method. In order to improve the detection efficiency, some fluorescent immunoassay equipment adopts a multi-channel method, thereby increasing the number of single detections.

[0049] However, in actual application, when a photodiode is used to receive the fluorescence intensity of the reagent card, since the photosensitive surface of the photodiode is usually small, it is impossible to cover all channels at the same time, resulting in the inability to obtain the fluorescence signals of all channels at the same time. When the fluorescent markers on the reagent card are excited by the lamp beads 121, the fluorescent signals at the edge of the reagent card are overestimated or underestimated due to the uneven distribution of light from the lamp beads 121. At the same time, the light between adjacent channels may interfere with each other, resulting in low accuracy of the fluorescence signal.

[0050] In view of this, the present invention provides an immunoassay analyzer to solve the problems of low detection efficiency of fluorescent immunoassay equipment and low accuracy of fluorescent signals.

[0051] Combine the following Figure 1 to Figure 2 , describing an embodiment of the present invention.

[0052] According to an embodiment of the present invention, on one hand, an immunoassay analyzer is provided. The immunoassay analyzer includes a detection module 1 and a housing module 2 .

[0053] Specifically, in this embodiment, the test piece 4 is usually a reagent card, and the detection module 1 is suitable for inserting multiple test pieces 4, that is, multi-channel detection. For example, four, six, eight, ten, and other detection channels can be set. Of course, this embodiment is only an example to illustrate the number of detection channels, but it is not limited to this. Those skilled in the art can change it according to actual conditions as long as the same technical effect can be achieved.

[0054] Furthermore, in this embodiment, the detection module 1 is provided with a scanning unit 11, an optical path unit 12 and a camera unit 13. The scanning unit 11 is used to obtain information parameters of the test piece 4, such as the code of the test piece 4, the detection item, the detection personnel information, etc. Further, the optical path unit 12 is used to excite light to make all the test pieces 4 generate light spots. For example, Figure 2 As shown, the optical path unit 12 includes a lamp bead 121, a dichroic mirror 122 and a filter 123. Along the optical path, a detection channel is provided between the dichroic mirror and the filter 123. The detection channel is suitable for inserting the test piece 4. After the light passes through the dichroic mirror and irradiates the detection area 41 of the test piece 4, the test piece 4 reflects the light to the dichroic mirror, and then reflects the light to the filter 123 by the dichroic mirror, and finally emits from the filter 123 to generate a light spot. The camera unit 13 is used to obtain image information of the light spot.

[0055] Furthermore, in this embodiment, the shell module 2 is communicatively connected with the detection module 1. The shell module 2 is used to divide the image information into an edge area and a middle area. For example, each light spot reflected to the camera unit 13 will have a certain predetermined range. Normally, the fluorescent part of the test piece 4 is located in the middle area of ​​the light spot, and the shell of the test piece 4 is located in the edge area of ​​the light spot. Therefore, when light is irradiated to the shell of the test piece 4, part of the light will also be reflected back to the dichroic mirror. Alternatively, part of the light irradiates the edge area of ​​the fluorescent part, and because it is too close to the shell of the test piece 4, the fluorescent component is insufficient and the brightness is low.

[0056] Therefore, it is necessary to adjust the edge area to prevent the fluorescence brightness of the edge area from interfering with the fluorescence brightness of the middle area.

[0057] In this embodiment, the relationship between the brightness value and the concentration of the object to be detected can be established based on experimental data or a known model. Then, based on the fluorescence brightness of the middle area, the concentration value of the object to be detected on the test piece 4 can be calculated.

[0058] In this way, the present embodiment divides the image information into the edge area and the middle area, which can accurately distinguish the edge and the middle area, and avoid the interference of the edge brightness on the middle area. At the same time, only the edge area is processed without affecting the detection results of other parts, so as to ensure the accuracy and reliability of the fluorescence signal.

[0059] Further, in an optional implementation manner, dividing the image information into an edge area and a middle area includes:

[0060] S1, using an edge detection algorithm to identify the edge of the test piece 4 in the image information;

[0061] In this embodiment, an edge detection algorithm such as Canny identifies the edge of the reagent card, and first performs Gaussian blur processing on the image to reduce the impact of noise. The gradient amplitude and direction of each pixel in the image are calculated using the Sobel operator or other gradient operators. The pixel points with the local maximum gradient value are retained, and the pixel points with non-maximum values ​​are suppressed, thereby refining the edge. Two thresholds are set, namely a high threshold and a low threshold. Pixel points above the high threshold are determined as edge points; pixel points below the low threshold are excluded; pixel points between the two are only retained when there is a pixel point above the high threshold around them, and then a continuous edge is formed by connecting strong edge points. Ensure that the middle area and edge area of ​​the test piece 4 can be accurately distinguished, thereby providing an accurate basis for subsequent analysis.

[0062] S2. Divide the image information into the edge area and the middle area, and obtain the edge brightness value and the middle brightness value respectively.

[0063] Then, according to the result of edge detection, the entire image information is divided into two parts. For example, a binary mask can be created, in which the edge area is marked as 1 and other areas are marked as 0. The mask is used to divide the image information into the edge area and the middle area. Then, the brightness values ​​of the edge area and the middle area are calculated respectively.

[0064] Further, in an optional implementation manner, the adjusting the edge brightness value of the edge area includes:

[0065] S3, dividing the edge area into a plurality of sub-areas;

[0066] S4, obtaining the sub-brightness value of each sub-region;

[0067] S5, when the sub-brightness value is lower than a preset brightness value, removing the sub-region from the image information;

[0068] S6. When the sub-brightness value is not lower than the preset brightness value, adjusting the sub-area to the middle area;

[0069] The preset brightness value is the average brightness value of the middle area.

[0070] In this embodiment, the edge region is divided into a plurality of sub-regions, so that the edge region can be processed more finely, thereby more accurately identifying and processing the brightness difference of different parts, avoiding a one-size-fits-all processing method.

[0071] The preset brightness value is used as a reference standard to determine whether the brightness of each sub-area in the edge area is qualified. In addition, when the sub-brightness value of a sub-area is lower than the average brightness value of the middle area, it means that the sub-area may be close to the shell of the test piece 4, rather than the fluorescent spot itself on the test piece 4. Therefore, the sub-area can be removed from the image and no longer participate in subsequent analysis. This step can remove possible noise or irrelevant areas and improve the purity and accuracy of the image.

[0072] Furthermore, when the sub-brightness value of a certain sub-area is not lower than the average brightness value of the middle area, it means that the sub-area may be close to the fluorescent spot, but the position is closer to the shell of the test piece 4, so the sub-area needs to be reclassified as the "middle area" and included in the analysis range of the middle area. This ensures that all areas with higher brightness are used as effective detection areas 41, and ensures that only effective sample areas are used for concentration calculation. This more accurately reflects the distribution of the object to be tested on the test piece 4.

[0073] Further, in an optional implementation manner, the calculating the concentration value of the object to be tested on the test piece 4 based on the middle area includes:

[0074] S7, determining the position areas of the T band and the C band according to the middle area;

[0075] S8, respectively extracting the brightness values ​​of the T band and the C band from the position area to obtain corresponding T values ​​and C values;

[0076] S9. Obtaining the concentration value of the analyte based on the T value, the C value and the corresponding concentration threshold.

[0077] In this embodiment, the position range of the two strips is selected according to the fluorescent luminous area in the image information, that is, the middle area, and the positions of the two strips are usually identified through image processing technology, such as morphological operation, template matching, etc.

[0078] Then extract the brightness of each strip in the image information and calculate the T value and C value. Among them, the T band is used to detect the presence or concentration of the object to be tested. The C band is used to verify whether the test strip is working effectively to ensure the reliability of the results.

[0079] Further, in an optional embodiment, the concentration value of the analyte is obtained by the following formula:

[0080] logy=a*log(xc)+b;

[0081] Wherein, y is the concentration value of the analyte, x is the ratio of the T value to the C value, c is the concentration threshold of the analyte, and a and b are coefficients;

[0082] If y exceeds c, it is considered positive; otherwise, it is negative.

[0083] Of course, the obtained concentration value of the object to be tested can also be output to the touch screen 213 of the housing module 2 for display.

[0084] Furthermore, in an optional embodiment, the immunoassay analyzer further comprises:

[0085] S10. When only the location area of ​​the T band is determined according to the middle area, a prompt message is issued.

[0086] That is, this embodiment can determine the fluorescence brightness of the C band area, thereby detecting only the T band. The abnormality detection card without the C band can also be output to the touch screen 213 of the housing module 2 for display.

[0087] Furthermore, in an optional embodiment, the scanning unit 11 is used to obtain the QR code of the test piece 4, and the QR code contains the information parameters, and the information parameters include at least: reagent card number, reagent card batch number, test time, test items, and calculation formula.

[0088] Further, in an optional embodiment, the housing module 2 includes an upper housing assembly 21, the upper housing assembly 21 is provided with an upper housing 211, a key unit 212, a touch screen 213 and a control mainboard 214, and the key unit 212, the touch screen 213 and the control mainboard 214 are all arranged in the upper housing 211. The control mainboard 214 is communicatively connected with the key unit 212, the touch screen 213 and the detection module 1 at the same time.

[0089] In this embodiment, the upper shell component 21 mainly completes human-computer interaction, and the human-computer interaction function is realized through the touch screen 213. The analyzer software interface can be displayed on the touch screen 213, and the user can operate the instrument by touch, thereby realizing various functional items in the design requirements.

[0090] The control mainboard 214 is the control core of the analyzer, and is connected to the detection module 1, the key unit 212, and the touch screen 213 respectively. The control mainboard 214 is mainly used to display the human-computer interaction interface on the touch screen 213, receive user instructions and execute corresponding functions. The functions executed by the control mainboard 214 cover all functions. The upper housing 211 mainly carries the touch screen 213, the control mainboard 214 and the key unit 212.

[0091] Further, in an optional embodiment, the shell module 2 also includes a lower shell assembly 22, and the lower shell assembly 22 is provided with a lower shell 221, a battery 222, and a data interface 223. The lower shell 221 and the upper shell 211 surround and form an installation cavity, and the battery 222 is arranged in the installation cavity. The data interface 223 is connected to the battery 222 and the control motherboard 214. The data interface 223 can be a Type-c interface, which is mainly used for exporting data and charging. The lower shell 221 is mainly used to carry the battery 222. Of course, the detection module 1 can also be set in the installation cavity of the shell module 2.

[0092] Furthermore, in an optional embodiment, the housing module 2 further includes a printing device 3, which is connected to the control mainboard 214 in communication, so that the detection result can be printed. As for the communication method, it can be wireless communication or wired communication. This embodiment is only an example for illustration. Those skilled in the art can make changes according to actual conditions as long as the same technical effect can be achieved.

[0093] The specific testing process of this embodiment is as follows:

[0094] 1. Start the startup test.

[0095] 2. Detection module 1 starts to determine whether the reagent card is inserted;

[0096] 3. If not inserted, the screen will display an alarm message, indicating that the reagent card is not inserted;

[0097] 4. If the reagent card has been inserted, the scanning unit 11 performs scanning;

[0098] 5. If the QR code is not scanned or the QR code is incorrect, a QR code error message will be displayed;

[0099] 6. If the QR code is recognized, the optical path unit 12 starts to work, and the camera unit 13 collects the fluorescent image of the detection area 41 of the reagent card;

[0100] 7. Then the control mainboard 214 in the housing module 2 analyzes and calculates the image, and finally ends the detection.

[0101] Although the embodiments of the present invention have been described in conjunction with the accompanying drawings, those skilled in the art may make various modifications and variations without departing from the spirit and scope of the present invention, and such modifications and variations are all within the scope defined by the appended claims.

Claims

1. An immunoassay analyzer, characterized in that: include: A detection module (1) is suitable for inserting a plurality of test pieces (4); the detection module (1) is provided with a scanning unit (11), an optical path unit (12) and a camera unit (13); the scanning unit (11) is used to obtain information parameters of the test pieces (4), the optical path unit (12) is used to generate light spots on all the test pieces (4), and the camera unit (13) is used to obtain image information of the light spots; A shell module (2) is communicatively connected to the detection module (1); the shell module (2) is used to divide the image information into an edge area and a middle area, adjust the edge area; and calculate the concentration value of the object to be tested on the test piece (4) based on the middle area.

2. The immunoassay analyzer according to claim 1, characterized in that: The step of dividing the image information into an edge area and a middle area includes: Using an edge detection algorithm to identify the edge of the test piece (4) in the image information; The image information is divided into the edge area and the middle area, and the edge brightness value of the edge area and the middle brightness value of the middle area are respectively obtained.

3. The immunoassay analyzer according to claim 2, characterized in that: The step of adjusting the edge brightness value of the edge area includes: dividing the edge region into a plurality of sub-regions; Get the sub-brightness value of each sub-area; When the sub-brightness value is lower than a preset brightness value, removing the sub-region from the image information; When the sub-brightness value is not lower than the preset brightness value, adjusting the sub-area to the middle area; The preset brightness value is the average brightness value of the middle area.

4. The immunoassay analyzer according to any one of claims 1 to 3, characterized in that: The step of calculating the concentration value of the object to be tested on the test piece (4) based on the middle area comprises: Determine the position area of ​​the T band and the C band according to the middle area; Extracting brightness values ​​of the T band and the C band from the position area respectively to obtain corresponding T values ​​and C values; Based on the T value, the C value and the corresponding concentration threshold, the concentration value of the analyte is obtained.

5. The immunoassay analyzer according to claim 4, characterized in that: The concentration value of the analyte is obtained by the following formula: logy=a*log(xc)+b; Wherein, y is the concentration value of the analyte, x is the ratio of the T value to the C value, c is the concentration threshold of the analyte, and a and b are coefficients; If y exceeds c, it is considered positive; otherwise, it is negative.

6. The immunoassay analyzer according to claim 4, characterized in that: Also includes: When only the position area of ​​the T zone is determined according to the middle area, a prompt message is issued.

7. The immunoassay analyzer according to any one of claims 1 to 3, characterized in that: The scanning unit (11) is used to obtain the two-dimensional code of the test piece (4), wherein the two-dimensional code contains the information parameters, and the information parameters at least include: reagent card number, reagent card batch number, test duration, test items, and calculation formula.

8. The immunoassay analyzer according to any one of claims 1 to 3, characterized in that: The housing module (2) comprises: The upper shell component (21) is provided with an upper shell (211), a key unit (212), a touch screen (213) and a control mainboard (214); the control mainboard (214) is simultaneously communicatively connected with the key unit (212), the touch screen (213) and the detection module (1).

9. The immunoassay analyzer according to claim 8, characterized in that: The housing module (2) further comprises: A lower shell assembly (22) is provided with a lower shell (221), a battery (222), and a data interface (223); the lower shell (221) and the upper shell (211) surround a mounting cavity, and the battery (222) is arranged in the mounting cavity; the data interface (223) is connected to the battery (222) and a control mainboard (214).

10. The immunoassay analyzer according to claim 9, characterized in that: The housing module (2) further comprises: The printing device (3) is communicatively connected to the control main board (214).

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