Novel household self-test reagent packaging clamping shell

Abstract

The utility model discloses a novel household self-test reagent packaging card shell, which is characterized in that a test strip is arranged in the card shell, the surface of the card shell is provided with a color developing area or / and a sample adding hole, and the card shell is also provided with a view finding limiting frame, a gray scale correction module, a positioning module and a data information module; the view-finding limiting frame is an equal-size concentric graph arranged at the edge of the card shell; the gray scale correction module is composed of a plurality of gray scale color blocks which are arranged around the color development area and are the same in size and arranged at equal intervals, and the gray scale color blocks are distributed in a central symmetry mode; the positioning module is a positioning bar code with two-dimensional coordinates; the data information module is a one-dimensional or two-dimensional code containing a plurality of data information. The kit can be matched with a mobile phone camera module and an APP (Application) to realize quantitative detection of in-vitro diagnosis family self-test, and is suitable for production and application of family self-test quantitative reagents, dry chemistry or immunochromatography reagents.

Description

Technical Field

[0001] The utility model relates to the technical field of in vitro diagnosis, in particular to a novel family self-test reagent packaging card. Background Art

[0002] In vitro diagnostic home tests are usually qualitative reagents, which can only give "yes" or "no", "negative" or "positive" test results. Occasionally, the reagents are equipped with colorimetric cards, which can only perform semi-quantitative tests, and the results are not accurate if they rely on the naked eye. For a long time, home quantitative testing has required the purchase of portable handheld analyzers, which has increased the cost of testing. Except for people who need to monitor chronic diseases or key groups, few people buy supporting instruments, so quantitative home testing for the general population cannot be rolled out.

[0003] In recent years, some manufacturers have used mobile phone cameras to analyze the images of reagents with visible light results for quantitative testing and developed APPs to match them. However, there are three key problems that cannot be solved: first, the difference in pixels and shooting color effects between different mobile phone cameras; second, the height and level of the camera from the test reagent reading area cannot be accurately controlled, which may cause the captured image to be distorted; third, without the specific closed track of the handheld analyzer, the light intensity at different angles around the test card or test strip during shooting affects the image. Therefore, the results of direct detection by mobile phone cameras are not accurate.

[0004] Therefore, it is urgent to provide a novel home self-test kit packaging card to solve the above problems. Utility Model Content

[0005] The technical problem to be solved by the utility model is to provide a novel home self-test reagent packaging card shell, which can cooperate with a mobile phone camera module and an APP to realize quantitative detection of in vitro diagnostic home self-testing.

[0006] In order to solve the above technical problems, a technical solution adopted by the utility model is: to provide a new type of home self-test reagent packaging card shell, the card shell surface is provided with a color development area and / or a sample addition hole, the card shell contains a test strip, and the card shell surface is also provided with a framing limit frame, a grayscale correction module, a positioning module, and a data information module;

[0007] The framing limit frame is a concentric figure of equal size arranged on the edge of the card shell;

[0008] The grayscale correction module is a plurality of grayscale blocks of the same size and arranged at equal intervals around the color development area, and the grayscale blocks are distributed in a centrally symmetrical manner;

[0009] The positioning module is a positioning barcode with two-dimensional coordinates;

[0010] The data information module is a one-dimensional or two-dimensional code containing some data information.

[0011] In a preferred embodiment of the present invention, the graphic shape of the framing limit frame includes a rectangle and a circle.

[0012] In a preferred embodiment of the present invention, the shape of the grayscale color block is the same as the color development shape of dry chemistry or immunochromatography, the gradient of the grayscale color block located above the color development area is arranged from low to high, and the gradient of the grayscale color block located below the color development area is arranged from high to low.

[0013] In a preferred embodiment of the present invention, the positioning barcode of the positioning module includes coordinate origin position information and grayscale color block positioning information.

[0014] In a preferred embodiment of the present invention, the one-dimensional or two-dimensional code content of the data information module includes common information on reagent detection and standard camera test values ​​after recalibration of different gradient grayscale color blocks.

[0015] The beneficial effects of the utility model are as follows: the card shell of the utility model can cooperate with the mobile phone camera module and APP to realize quantitative detection. Compared with the traditional photo-taking method, it can accurately control the height and level of the photo-taking to standardize the imaging, and can reduce the differences between different mobile phone cameras and the interference of external light during shooting. It is suitable for the production and application of home self-measurement quantitative reagents, dry chemistry or immunochromatography reagents. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 This is a structural schematic diagram of a preferred embodiment of the novel home self-test kit packaging cartridge of the utility model;

[0017] Figure 2 is a structural schematic diagram of the grayscale correction module;

[0018] Figure 3 It is a structural schematic diagram of the grayscale correction module and the positioning module.

[0019] The markings of the components in the accompanying drawings are as follows: 1. framing limit frame, 2. grayscale correction module, 3. positioning module, 4. data information module, 5. color display area. DETAILED DESCRIPTION

[0020] The preferred embodiments of the present invention are described in detail below in conjunction with the accompanying drawings so that the advantages and features of the present invention can be more easily understood by those skilled in the art, thereby making a clearer and more definite definition of the protection scope of the present invention.

[0021] See also Figure 1 , the utility model embodiment includes:

[0022] A novel family self-test reagent packaging cartridge, in different methodologies such as dry chemistry or immunochromatography, contains a test strip, the surface of the cartridge is provided with a color development area 5 (or called an observation window) and / or a sample addition hole, and the surface of the cartridge is also provided with several functional modules, namely, a framing limit frame 1, a grayscale correction module 2, a positioning module 3, and a data information module 4.

[0023] The framing limit frame 1 is a concentric double-frame figure of equal size, rectangular or circular, set at the edge of the card shell. When using the APP to take pictures, the framing edge in the APP (shown by the dotted line in the figure) must fall within the framing limit frame, that is, between the edges of the concentric figures. At this time, the framing edge in the APP can be changed from a red dotted line to a green dotted line to indicate that you can take pictures. Pictures taken in an unqualified state will not be saved for analysis.

[0024] The function of the framing limit frame 1 is to keep the captured image flat and not deformed. At the same time, the height of the camera from the detection card is fixed, so that the image analysis does not need to be scaled, avoiding changes in pixel grayscale.

[0025] Combination Figure 2 The grayscale correction module 2 is a plurality of grayscale blocks of the same size and arranged at equal intervals around the color development area 5. The shape of the grayscale blocks is the same as the color development shape of dry chemistry or immunochromatography. The grayscale blocks surround the color development area and are divided into two rows in a centrally symmetrical manner. If the gradient of the blocks above the color development area is arranged from low to high, the gradient of the blocks below the color development area is arranged from high to low.

[0026] like Figure 2 As shown, the gradient Level 1 is composed of two color blocks A1 and A2, Level 2 is composed of B1 and B2, and Level 5 is composed of E1 and E2. A standard camera is set up, and the imaging height is standardized through fixture control. The average value of two color blocks of a certain Level is tested by the standard camera, and the average value is used as the standard value of the Level, and the information is stored in the barcode of the data information module.

[0027] When the reagent is performing the test, the user's mobile phone camera takes a picture of the test card to form an image, and the retest value of each Level of the grayscale correction module is obtained again through image analysis (still calculated according to the mean of the two-color blocks); the mobile phone program forms a regression curve between the retest value of each Level of the module and the standard value, and then substitutes the test signal of the color development area reagent in the image into the regression curve to inversely calculate the real signal value of the color development area test signal when tested by the standard camera; then substitute the real signal value into the standard curve of the reagent under the standard camera test (each batch of reagents has it when it leaves the factory) for calculation to obtain the concentration value.

[0028] The purpose of designing multiple levels is to cover the actual linearity of the detection reagents and facilitate fitting of the regression equation.

[0029] The design of two rows of grayscale blocks symmetrically around the center of the color rendering area is to balance the influence of external light at different angles by taking the average of the two blocks. Since the color rendering area is at the center of the same grayscale block, when the light is strong at a certain angle (such as the upper left), the influence on the A1 block, the color rendering area, and the A2 block is a gradient trend. Taking the average of A1 and A2 can be closer to the influence of light on the color rendering area.

[0030] The positioning module 3 is a positioning barcode with two-dimensional coordinates. It uses barcode positioning and other methods to analyze the positioning barcode after shooting to determine the coordinate origin. Then, according to the coordinate origin, the image is analyzed within the set (x1~x2, y1~y2) rectangular range, and the edge detection algorithm is used to determine the area of ​​accumulated pixel grayscale.

[0031] like Figure 3 Taking immunochromatography as an example, the barcode contains the coordinate origin position information and the grayscale color block positioning information. During detection, the lower right corner of the positioning barcode is used as the coordinate origin, and the coordinate axis is established in the vertical direction of the barcode. Under the condition that y1~y2 is the ordinate limit range, the edge detection algorithm is used to find the left and right edges of the color block in the preset x1~x2 range, and then the grayscale of each pixel in the determined chromaticity range is accumulated as the signal value of the color block.

[0032] The positioning module 3 is designed to locate the color development area 5 and the grayscale correction module 2, so as to facilitate the APP software to perform image analysis, such as determining the calculation area of ​​color development in dry chemical reagents, or determining the specific positions of C and T lines in immunochromatography reagents.

[0033] The data information module 4 is a one-dimensional or two-dimensional code containing a number of data information. In addition to the commonly used information for reagent detection such as batch number, project, standard curve, etc., it also contains the standard camera test value after recalibration of different gradient standard color blocks, which is used for regression fitting with the actual measured value of the grayscale color block (the value taken by the terminal user with the mobile phone camera) during detection.

[0034] The preparation method of the packaging card shell is:

[0035] (1) Generate a barcode of the positioning module 3 according to product information and positioning information;

[0036] (2) arranging the framing limit frame 1, the grayscale correction module 2, and the positioning module 3 and printing them on the card shell according to the set image;

[0037] (3) Use a standard camera device combined with a fixed track fixture to test the grayscale correction module parameters of each card in turn, and combine it with other curve information to produce a unique barcode for the test card;

[0038] (4) After printing, the barcode printer is pasted on the card shell as a data information module to complete the unique calibration of the printing effect of each test card.

[0039] Since the grayscale correction color blocks on each card shell are calibrated by a standard camera, the impact of the differences in printing effects on different cards when printing grayscale color blocks is reduced.

[0040] The detection process of the package jam is as follows:

[0041] (1) In the mobile phone APP, the dotted area for taking photos falls within the framing limit frame 1, and a green prompt indicates that the photo can be taken.

[0042] (2) After taking the photo, the APP software uses the coordinate origin and peak search interval contained in the positioning barcode and the edge detection algorithm to find the area to be tested and the grayscale color block;

[0043] (3) The APP software calculates the average measured value of each grayscale color block of the central symmetry, and performs curve fitting with the standard result of the detection card calculated by the standard camera in the data information module 4 to obtain a regression curve;

[0044] (4) The measured value of the reagent reaction is corrected according to the regression curve, and finally the reagent standard curve is used to calculate the reactant concentration value.

[0045] The card shell of the utility model can cooperate with the mobile phone camera module and APP to realize quantitative detection. Compared with the traditional photo-taking method, it can accurately control the height and level of the photo-taking to standardize the imaging, and can reduce the difference between different mobile phone cameras and the interference of external light during shooting. It is suitable for the production and application of home self-measurement quantitative reagents, dry chemistry or immunochromatography reagents.

[0046] The above description is only an embodiment of the present invention, and does not limit the patent scope of the present invention. Any equivalent structure or equivalent process transformation made by using the contents of the specification and drawings of the present invention, or directly or indirectly applied in other related technical fields, are also included in the patent protection scope of the present invention.

Claims

1. A novel home self-test reagent packaging cartridge, wherein the cartridge surface is provided with a color development area and / or a sample addition hole, and the cartridge contains a test strip, characterized in that: The surface of the card shell is also provided with a framing limit frame, a grayscale correction module, a positioning module, and a data information module; The framing limit frame is a concentric figure of equal size arranged on the edge of the card shell; The grayscale correction module is a plurality of grayscale blocks of the same size and arranged at equal intervals around the color development area, and the grayscale blocks are distributed in a centrally symmetrical manner; The positioning module is a positioning barcode with two-dimensional coordinates; The data information module is a one-dimensional or two-dimensional code containing some data information.

2. The novel home self-test kit packaging cartridge according to claim 1 is characterized in that: The graphic shape of the framing limit frame includes a rectangle and a circle.

3. The novel home self-test kit packaging cartridge according to claim 1 is characterized in that: The shape of the grayscale color block is the same as the color development shape of dry chemistry or immunochromatography. The gradient of the grayscale color block located above the color development area is arranged from low to high, and the gradient of the grayscale color block located below the color development area is arranged from high to low.

4. The novel home self-test kit packaging cartridge according to claim 1 is characterized in that: The positioning barcode of the positioning module includes coordinate origin position information and grayscale color block positioning information.

5. The novel home self-test kit packaging cartridge according to claim 1 is characterized in that: The one-dimensional or two-dimensional code content of the data information module includes common information on reagent detection and standard camera test values ​​after recalibration of different gradient grayscale color blocks.

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