WO2022088567A1

WO2022088567A1 - Integrated test paper-based detection method and apparatus, and production process therefor

Info

Publication number: WO2022088567A1
Application number: PCT/CN2021/078085
Authority: WO
Inventors: 王忠堂
Original assignee: 厦门波耐模型设计有限责任公司
Priority date: 2020-10-30
Filing date: 2021-02-26
Publication date: 2022-05-05

Abstract

An integrated test paper-based detection apparatus, comprising integrated detection test paper, a spray and reaction device, and an identification and interpretation device. The integrated detection test paper is produced by a printing process. Hundreds of reagent blocks are integrated on one base to enable detection of hundreds of indicators at one time; the spray and reaction device is customized according to the specifications of the integrated detection test paper; sample droplets are sprayed onto the integrated detection test paper; and the identification and interpretation device collects data to obtain the detection result, thereby achieving a multi-indicator detection effect by means of a small amount of samples.

Description

Integrated test strip detection method, device and preparation process thereof

technical field

The invention relates to the technical field of medical detection, in particular to an integrated test paper detection method, a detection device and a preparation process thereof.

Background technique

As a classic solid-phase detection technology, test strips can detect human and natural specimens, partially replacing complex and expensive liquid or gas-phase detection technologies.

Based on the consideration of satisfying the results of both the instrument and the naked eye interpretation, the size of the test strip reagent blocks is large. Based on the consideration of avoiding interference between different reagent blocks, the distance between the reagent blocks is large, and the number of reagent blocks contained in one test paper is limited. If multiple indicators are detected, a large number of test strips and samples are required, thus limiting the application and popularization of test strips.

Taking hospital blood tests as an example, the total number of blood biochemical indicators, immune indicators, and cancer indicators is as high as hundreds. It is necessary to repeatedly draw a large number of blood samples, use multiple complex and expensive equipment, and consume a large amount of medical expenses. If hundreds of tests are integrated into a test strip containing hundreds of micro-detection reagent blocks, a few blood samples can be drawn, and hundreds of index test results can be obtained in one test, which will definitely improve the efficiency of blood tests in hospitals and reduce the waste of medical resources.

Conventional test strip detection methods, such as test strip dipping into the specimen, dropper dripping, or specimen coating test paper, are not suitable for integrated test strips. The reasons include: (1) the infiltration of the integrated test strip is uneven, some of the samples are wasted due to excessive infiltration, and the results are inaccurate due to insufficient infiltration or omission; (2) the size of the reagent block of the integrated test strip is small, and samples or reagents are manually added. , the operation is difficult; (3) when the reagent block is reacting with color, temperature and humidity cannot be adjusted; (4) biological pollution cannot be controlled.

In view of this, the integrated detection test paper is prepared by printing process. One test paper is set with hundreds of reagent blocks. Each reagent block detects one or more indicators. The reagent block provides a suitable environment and uses computer vision to accurately interpret the test results, thereby achieving the effect of simplifying operations, controlling biological contamination, and saving samples and reagents with accurate detection.

technical problem

The purpose of the present invention is to provide an integrated test paper detection method, detection device and preparation process thereof. Hundreds of reagent blocks are set on a test paper, and each reagent block detects one or more indicators, so as to realize a few samples, and only one test is required. Obtain hundreds of index inspection results to improve the efficiency of medical services and reduce waste of resources.

technical solutions

The detection method of the integrated test paper according to an embodiment of the present invention includes the following steps: (1) collecting and preprocessing samples; (2) spraying the sample to soak the integrated test paper; (3) coloring the reagent block of the integrated detection test paper; (4) Identify and interpret, and obtain the test results of the specimen.

The flow of the spray sample method according to an embodiment of the present invention includes transferring the prepared test sample to a syringe, the syringe is connected to the spray and color reaction device, the integrated detection test paper is placed in the spray and color reaction device, and the spray and color reaction device is sprayed according to a preset setting. In the shower procedure, push the syringe, the test sample in the syringe forms sample droplets through the spray head, and the sample droplets infiltrate part of the reagent block of the integrated detection test paper, move the spray head, and push the syringe again until the sample droplets infiltrate the integrated detection test paper. up to all reagent blocks.

The identification and interpretation method of one embodiment of the present invention includes taking out the integrated detection test paper that has completed the color reaction, inserting the identification and interpretation device, and a microscopic computer vision sensor of the identification and interpretation device to identify and collect the dot matrix points of the integrated detection test paper reagent block The color reaction data and the reagent block identification code, refer to the color reaction data of the reagent block, the negative control, the standard control, and the dilution ratio when preprocessing the sample, and use a specific algorithm to obtain the test result of the sample.

An integrated test paper detection device according to an embodiment of the present invention includes an integrated detection test paper, a spray and color reaction device, and an identification and interpretation device. The integrated detection test paper is placed in the spray and color reaction device for sample addition. , and then insert the identification and interpretation device to obtain the detection result.

An integrated detection test paper according to an embodiment of the present invention includes a substrate, a baffle array, a reagent block lattice, and a graphic code. The substrate includes a front and a back. The front is provided with a baffle array, a reagent block lattice, and a graphic code, which are reagent blocks. A block lattice and a graphic code carrier, the baffle array is arranged on the front of the substrate to divide and surround the reagent blocks, the reagent block lattice is arranged on the front of the substrate, and the graphic code is arranged in the blank area of the substrate.

Preferably, the reagent blocks are distributed in the baffle array space in a dot matrix, and their types include dry chemical detection test paper blocks, immunological detection test paper blocks, and chip test paper blocks, and their structures include sample pads, reagent binding pads, reaction pads, water absorption pads The pad, the backing plate and the protective film, and the reagent combination includes a single-item detection reagent combination and a multi-item detection reagent combination.

Preferably, the multi-item detection reagent combination is to integrate two or more item detection reagents into the same reagent block, and the detection substrate display includes different color display and the same color display, and the same color display is based on different The components to be detected of the project migrate and gather at different positions on the reagent block, and then analyze and detect. The different color displays will develop together. According to the principle of three primary colors, according to the algorithm, the intensity of the original single color is analyzed, and the detection of the specific component to be detected is obtained separately. The color value of the substrate is analyzed and detected.

The spray and color reaction device of one embodiment of the present invention includes a casing, a displacement regulator, a shower head, and a chamber, the casing includes a cover, a casing, and an opening, and the cover includes a main body, a lens structure, and a top groove , Side groove, the top groove is used for the interface to move along the long axis, the side groove is used for the gear shaft to move along the long axis, the chamber is used for accommodating the sprinkler head, the displacement adjustment a device and an integrated detection test paper, and the opening is arranged at the bottom of the chamber for inserting the integrated detection test paper.

Preferably, the displacement adjuster includes a rack, a gear, a knob, a pinion, and a slot, the rack and the gear are paired in the chamber and fixed on the housing wall, and the gears are arranged in pairs. Connected by the pinion, the middle section of the pinion is provided with the slot, the slot is used to connect the shower head, the knob is provided at the end of the pinion on one side, and the knob is provided with a scale, Rotating the knob by one scale drives the gear to move along the rack, and pushes the shower head connected with the card slot to generate one displacement unit.

Preferably, the shower head comprises an interface, a buffer chamber, a micro-hole, and a bayonet, one end of the interface is connected to a syringe, and one end of the interface is connected to the buffer chamber, a plurality of the micro-holes are arranged on the side and bottom of the buffer chamber, and the syringe The inner sample or reagent enters the buffer chamber through the interface, and is ejected through the micropore.

Preferably, the casing can also be disc-shaped, which is used for the detection of the disc-shaped integrated detection test paper, a rotating shaft is arranged in the center of the chamber, the number of the rack and the gear is one, and they are arranged at the center of the chamber. the outer casing wall, one end of the pinion is connected to the gear, the other end of the pinion is connected to the rotating shaft, and the shower head is connected to the slot through the bayonet. The head rotates around the rotating shaft, and sprays the sample or reagent onto the disc-shaped integrated detection test paper reagent block.

The identification and interpretation device of an embodiment of the present invention includes an illumination component, a Cartesian coordinate robot, and an end effector, the illumination component includes visible light, infrared light, laser light, and ultraviolet light, the end effector includes a microscopic computer vision sensor, and the end effector includes a microscopic computer vision sensor. The microscopic computer vision sensor identifies and collects the reflected light or excitation light data and the reagent block data of the dot matrix site of the integrated detection test paper reagent block.

The preparation process of the integrated test paper detection device according to an embodiment of the present invention includes the preparation of integrated detection test paper, and the integrated detection test paper preparation process includes substrate preparation, reagent preparation, reagent block preparation, and reagent block printing.

The substrate preparation process of one embodiment of the present invention includes designing a floor plan according to the inspection project scheme, 3D modeling, designing a 3D mold, opening the mold, and fabricating a substrate including a baffle array structure, wherein the plan layout includes blank ends, baffles Plate array, reagent block dot matrix, graphic code.

The reagent block preparation process of one embodiment of the present invention includes preparing a large piece of test paper, soaking the large piece of test paper with adsorbing reagents, cutting the large piece of test paper into small pieces of reagent blocks, loading the reagent blocks into solid refills, and making a large number of different test items. The solid refill of the test paper block, the solid refill includes a pen tube, a reagent block, a buffer pad, and a bayonet, the upper end of which is the outlet of the reagent block, and the lower end is the bayonet, which is used to connect with the base, and the buffer pad is above the reagent block. , Connect the propulsion device under the cushion pad.

The reagent block printing process of an embodiment of the present invention includes designing a layout diagram, typesetting, gluing the substrate, and printing to obtain a finished product of the integrated detection test paper. , the typesetting includes arranging a solid refill array on the base according to the plan layout, connecting the propelling end of the propulsion device and the solid refill buffer, the substrate gluing includes the reagent block dot matrix spot gluing, and the printing Including transferring the glued substrate to the base, the substrate reagent block dot matrix point corresponds to the base solid refill array, the propulsion device pushes the buffer pad, the buffer pad discharges the reagent block from the solid refill, and sticks the reagent block according to the floor plan On the substrate, at the same time, the graphic code is printed on the blank end of the substrate to produce a complete integrated test paper.

Preferably, it also includes cutting a large piece of test paper into small pieces of test paper, pasting the small pieces of test paper to the substrate through a printing process, making a test paper dot matrix substrate, typesetting and fixing the liquid refill with reagents preloaded on the base, so as to The spray method makes the small pieces of test paper on the test paper dot matrix substrate infiltrate the adsorption reagent, and after drying, an integrated detection test paper is produced.

The propulsion device of one embodiment of the present invention includes a charge force drive system, a lead screw system, and a pneumatic propulsion system.

Preferably, the charge force driving system includes applying glue to the substrate to carry charges, and during printing, the reagent block in the solid refill carries an opposite charge, which urges the reagent block to separate from the solid refill and stick to the substrate.

Preferably, the lead screw system includes a push end, a support plate, a motor slider complex, and a lead screw column, the push end is arranged on the support plate in an array, the support plate is connected with the motor slider complex, and the motor slider complex Move along the lead screw column, and the lead screw column is fixed on the base.

Preferably, the pneumatic propulsion system includes a gas compressor, a gas pipeline, a gas valve, and a gas nozzle. The gas generated by the gas compressor reaches the gas nozzles arranged in an array through the gas pipeline and its branches, and each gas nozzle is configured with one gas nozzle. Air valve, the gas enters the lower end of the solid refill through the air nozzle, and the gas pressure pushes the reagent block in the solid refill to be discharged from the solid refill outlet, and is pasted on the substrate.

beneficial effect

(1) The detection test paper is highly integrated and can perform multi-item detection with high efficiency: the integrated detection of the present invention is provided with a baffle array, and the baffle separates different reagent blocks to avoid interference between reagents and sample overflow between different reagent blocks. The spacing is reduced to the micron level. In addition, by setting different reagent block lattice areas on one test paper, it is possible to integrate the reagent blocks with different reaction principles and reaction conditions into the same test paper. It is possible to set hundreds of reagent blocks on the same test paper. Check hundreds of metrics. With the help of micro-processing technology, robotic technology and computer vision micro-recognition result interpretation technology, the size of reagent blocks and graphic codes can be reduced to millimeter and micron levels, and hundreds of reagent blocks can be set on a common size test paper, which greatly increases the number of the same test paper. The number of detection indicators.

(2) Precisely and efficiently prepare integrated test strips by using typesetting and printing processes: the present invention uses millimeter-scale and micron-scale reagent blocks to prepare test strips, and with the help of a robot processing scheme, pre-designs the floor plan, and pre-installs reagent blocks or special pens for reagents Core typesetting, with the help of electric charge force, mechanical or pneumatic propulsion device, the reagent block or reagent in the special refill is printed on the substrate, the reagent block or reagent is equivalent to the printing ink, the special refill is equivalent to the single letter plate of the printing process, specially made The typesetting of the pen core is equivalent to the movable letter version of the single-character stereotype collection of printing technology, and the substrate is equivalent to the paper of printing technology, so that reagent blocks or reagents of different types and shapes are pasted or sprayed onto the substrate to form a reagent block lattice.

(3) There are two technical solutions for the production of refills, which use exquisite designs to meet the needs of different printing processes and prepare integrated test paper: one is: each solid refill is pre-installed with a reagent block, and the upper end of the solid refill is a reagent The block outlet, the lower end bayonet is connected to the base, the propulsion device is intelligently controlled, and the reagent block in the solid refill is pushed to the outlet, so that the uppermost reagent block in the solid refill is pasted to the base plate, and an integrated detection test paper is prepared. The pressure sensor collects the pressure data between the reagent block and the substrate, and the pressure data information is fed back to the propulsion device to form a closed loop of intelligent control; the second is: each liquid refill is pre-installed with a detection reagent, and one end of the liquid refill is the detection reagent nozzle, which is connected with The intelligently controlled pump device is connected to print the reagent in the liquid refill to the blank test paper block of the substrate by inkjet, and the amount of the sprayed reagent is precisely controlled to prepare an integrated test paper.

(4) The spray and color reaction device is a transparent and closed structure. Through the cover with the function of magnifying lens, the lattice of the inserted integrated test paper reagent blocks can be observed, and at the same time, biological contamination during the detection process can be avoided.

(5) The spray head of the spray and color reaction device has a compact structure, which reduces the loss of samples caused by contamination. The magnifying glass can be operated under the visibility. Excessive, insufficient or missing block infiltration improves sample utilization and detection accuracy.

(6) Before the test, based on the minimum infiltration amount of the integrated test strip, accurately estimate the amount of clinical specimens to be obtained, so as to avoid insufficient sample amount, the need for secondary collection, or the excessive amount of clinical specimens obtained, resulting in a waste of medical resources.

(7) The spray and color reaction device has simple structure, cheap materials, easy customization, and can be reused, which helps to reduce medical testing costs.

Description of drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the accompanying drawings that need to be used in the description of the embodiments or the prior art. In other words, other drawings can also be obtained based on these drawings without the premise of creative labor. Furthermore, these descriptions do not constitute limitations on the embodiments.

Figure 1 is a schematic structural diagram of an integrated detection test paper, including a substrate and a baffle array; Figure 2 is a schematic structural diagram of a baffle unit; Figure 3 is a schematic structural diagram of an integrated detection test paper, including a substrate, a baffle array, a reagent block lattice, and a graphic code. ; Figure 4 is a schematic structural diagram of the integrated detection test paper, including two-area baffle arrays and reagent block lattices; Figure 5 is a schematic structural diagram of the integrated detection test paper, including three-area baffle arrays and reagent block lattices; Figure 6 is Figure 7 is a schematic diagram of the cross-sectional structure of the immunological detection reagent block; Figure 8 is a schematic diagram of the production process and structure of the solid refill; Figure 9 is a schematic diagram of the layout structure of the solid refill on the base; Figure 10 11 is a schematic structural diagram of a liquid refill; FIG. 12 is a schematic structural diagram of a liquid refill printing integrated detection test paper flow; Fig. 14 is the structural schematic diagram of the displacement regulator of the detection device of the integrated detection test paper; Fig. 15 is the structural schematic diagram of the sprinkler head of the detection device of the integrated detection test paper; 17 is a schematic structural diagram of the disc-type displacement regulator of the detection device of the integrated detection test paper.

BEST MODE FOR CARRYING OUT THE INVENTION

The detection method of the integrated test paper according to the preferred embodiment of the present invention includes the following steps: (1) collecting and pre-processing specimens; (2) spraying the samples to soak the integrated test paper; (3) coloring the reagent block of the integrated detection test paper; (4) Identify and interpret, and obtain the test results of the specimen.

The flow of the spray sample method in the preferred embodiment of the present invention includes transferring the prepared test sample to a syringe, the syringe is connected to the spray and color reaction device, the integrated detection test paper is placed in the spray and color reaction device, and the spray and color reaction device are sprayed according to preset settings. In the shower procedure, push the syringe, the test sample in the syringe forms sample droplets through the spray head, and the sample droplets infiltrate part of the reagent block of the integrated detection test paper, move the spray head, and push the syringe again until the sample droplets infiltrate the integrated detection test paper. up to all reagent blocks.

The identification and interpretation method of the preferred embodiment of the present invention includes taking out the integrated detection test paper that has completed the color reaction, inserting the identification and interpretation device, and a microscopic computer vision sensor of the identification and interpretation device to identify and collect the integrated detection test paper reagent block lattice site The color reaction data and the reagent block identification code, refer to the color reaction data of the reagent block, the negative control, the standard control, and the dilution ratio when preprocessing the sample, and use a specific algorithm to obtain the test result of the sample.

The detection device of the integrated test paper in the preferred embodiment of the present invention includes an integrated detection test paper, a spray and color reaction device, and an identification and interpretation device, and the integrated detection test paper is placed in the spray and color reaction device for sample addition. , and then insert the identification and interpretation device to obtain the detection result.

The integrated detection test paper of the preferred embodiment of the present invention includes a substrate, a baffle array, a reagent block lattice, and a graphic code. A block lattice and a graphic code carrier, the baffle array is arranged on the front of the substrate to divide and surround the reagent blocks, the reagent block lattice is arranged on the front of the substrate, and the graphic code is arranged in the blank area of the substrate.

The shower and color reaction device of the preferred embodiment of the present invention includes a casing, a displacement regulator, a shower head, and a chamber, the casing includes a cover, a casing, and an opening, and the cover includes a main body, a lens structure, a top groove , Side groove, the top groove is used for the interface to move along the long axis, the side groove is used for the gear shaft to move along the long axis, the chamber is used for accommodating the sprinkler head, the displacement adjustment a device and an integrated detection test paper, and the opening is arranged at the bottom of the chamber for inserting the integrated detection test paper.

The identification and interpretation device of a preferred embodiment of the present invention includes an illumination assembly, a Cartesian coordinate robot, and an end effector, the illumination assembly includes visible light, infrared light, laser, and ultraviolet light, the end effector includes a microscopic computer vision sensor, and the end effector includes a microscopic computer vision sensor. The microscopic computer vision sensor identifies and collects the reflected light or excitation light data and the reagent block data of the dot matrix site of the integrated detection test paper reagent block.

The preparation process of the integrated test paper detection device of the preferred embodiment of the present invention includes the preparation of integrated detection test paper, and the integrated detection test paper preparation process includes substrate preparation, reagent preparation, reagent block preparation, and reagent block printing.

The substrate preparation process of the preferred embodiment of the present invention includes designing a plan layout, 3D modeling, designing a 3D mold, opening the mold, and fabricating a substrate including a baffle array structure according to the inspection project plan, and the plan layout includes blank ends, baffles Plate array, reagent block dot matrix, graphic code.

The reagent block preparation process of the preferred embodiment of the present invention includes preparing a large test paper, infiltrating the large test paper with adsorption reagents, cutting the large test paper into small pieces of reagent blocks, loading the reagent blocks into solid refills, and making a large number of different test items. The solid refill of the test paper block, the solid refill includes a pen tube, a reagent block, a buffer pad, and a bayonet, the upper end of which is the outlet of the reagent block, and the lower end is the bayonet, which is used to connect with the base, and the buffer pad is above the reagent block. , Connect the propulsion device under the cushion pad.

The reagent block printing process of the preferred embodiment of the present invention includes designing a layout diagram, typesetting, gluing the substrate, and printing to obtain a finished product of the integrated detection test paper. , the typesetting includes arranging a solid refill array on the base according to the plan layout, connecting the propelling end of the propulsion device and the solid refill buffer, the substrate gluing includes the reagent block dot matrix spot gluing, and the printing Including transferring the glued substrate to the base, the substrate reagent block dot matrix point corresponds to the base solid refill array, the propulsion device pushes the buffer pad, the buffer pad discharges the reagent block from the solid refill, and sticks the reagent block according to the floor plan On the substrate, at the same time, the graphic code is printed on the blank end of the substrate to produce a complete integrated test paper.

Embodiments of the present invention

In order to make the objectives, technical solutions and advantages of the present application clearer, the present invention is further illustrated below with reference to specific embodiments. It should be understood that these embodiments are only used to illustrate the present invention and not to limit the scope of the present invention. After reading the present invention, modifications of various equivalent forms of the present invention by those skilled in the art all fall within the appended claims of the present application limited range.

It should be noted that the orientation terms such as up, down, left, right, front, rear, front, back, and side in this embodiment are only relative concepts to each other or refer to the normal use state of the product, and should not be used. considered restrictive.

As shown in FIGS. 1-17 , embodiments of the present invention disclose a detection method, a detection device and a preparation process for an integrated test paper.

An embodiment of the present invention discloses a detection method for an integrated detection test paper. The process 1000 includes the following steps: 1010: Collecting a sample includes that the amount of the sample collected is not less than the minimum amount required by the integrated detection test paper 5, and the sample is collected. Including clinical specimens, environmental specimens, including but not limited to blood, urine, feces, pleural and ascites, cerebrospinal fluid, prostatic fluid, semen, leucorrhea, saliva, vomit, wound or body surface eluate, the environment Specimens include but are not limited to soil, water, animal tissue, and plant tissue; 1020: Preprocess the specimen, including preprocessing the specimen collected in step 1010 to obtain a test sample, the form of the test sample is liquid, and the amount of the test sample Not less than the minimum infiltration amount of the integrated test paper, among which, blood is drawn from veins or peripheral puncture, plasma or plasma dilution is prepared, feces are prepared as fecal filtrate, and plant tissue and animal tissue are prepared as eluate or tissue homogenate; 1030: Set Insert the integrated detection test paper 5, including the selected integrated detection test paper 5 into the spray and color reaction device 810 with matching specifications, the detection area of the integrated detection test paper 5 is upward, and the blank area of the integrated detection test paper 5 is partially exposed in the spray In addition to the color reaction device 810, it is convenient to insert and remove the integrated detection test paper 5; 1040: spray the sample, including the test sample prepared in step 1020 and transfer it to the syringe, and the syringe is connected to the spray and color reaction device 810 in step 1030, According to the preset spray program, push the syringe step by step, the lens structure 811-1-2 can be operated under magnification, and the test sample in the syringe forms sample droplets through the spray head 813, and the sample droplets infiltrate the integrated detection test paper 5. Part of the reagent block 4, move the spray head 813, push the syringe again, the sample droplets infiltrate other reagent blocks 4 of the integrated detection test paper 5; The displacement distance of the spray head 813, the total spray dose, the number of sprays is calculated, and a few reagent blocks 4 are allowed to overlap spraying to avoid the omission of reagent blocks 4; 1050: color reaction, including integrated detection test paper 5 Reagent blocks 4 through the steps 1040 spray the detection sample and fully infiltrate the color reaction, and the spray and color reaction device 810 in step 1030 provides suitable conditions for the color reaction, which further includes the following steps: 1052: temperature control, including real-time monitoring of spray and color reaction. The internal temperature of the color reaction device 810, if necessary, start the temperature control component to maintain the optimal color reaction temperature of 42 ° C, or adjust to the specific suitable temperature required by the specific integrated detection test paper 1; 1054: humidity control, including real-time monitoring The internal humidity of the spray and color reaction device 810, activate the humidity control component if necessary to maintain the optimum color reaction humidity; 1056: Add reagents, including integrated detection test paper 5 Reagent block 4 Substrate color reaction or marker color reaction During the process, reagents need to be added, and the reagent addition procedure is the same as the spray operation in step 1040; 1060: identification and interpretation, including step 1050 to complete the integrated detection test paper 5 of the color reaction from spraying and color reaction. The device 810 is taken out, and then, the identification and interpretation device is inserted, and the microscopic computer vision sensor of the identification and interpretation device identifies and collects the color reaction data of the dot matrix points of the reagent block 4 on the integrated detection test paper 5 and the identification code of the reagent block 4; 1070: After analyzing the results, the data processor receives the data collected by the microscopic computer vision sensor in step 1060, refers to the color reaction data of the reagent block 4, the negative control, the standard control, and the dilution ratio of the sample pretreatment, and uses a specific algorithm to obtain the test result of the sample.

As shown in FIG. 1 to FIG. 12 , an embodiment of the present invention discloses an integrated detection test paper and a preparation process thereof.

Referring to FIGS. 1-3 , an integrated detection test paper 5 according to an embodiment of the present invention includes a substrate 1 , an array of baffles 2 , a dot matrix of reagent blocks 4 , and a graphic code 3 . In order to show the main points of the structure of the embodiment of the present invention concisely and clearly, in the legend, the array of baffles 2 and the dot matrix of reagent blocks 4 are taken as an example with an array and a lattice of three rows and five columns. In fact, according to requirements, the array of baffles 2, The number of rows and columns of the reagent block 4 dot matrix can be set to several, tens or hundreds. Take one main graphic code 3 and three auxiliary graphic codes 3-1 as an example. In fact, according to requirements, the main graphic Multiple code 3 and auxiliary graphic code 3-1 can be set.

The substrate 1 includes a front side 1-4 and a back side 1-3. The front side 1-4 includes a blank end 1-1 and a test end 1-2. The blank end 1-1 is provided with a main graphic code 3 and an auxiliary graphic code 3-1. The test terminal 1-2 Set the baffle 2 array and the reagent block 4 dot matrix, and the back 1-3 is smooth and flat. The graphic code 3 and the auxiliary graphic code 3-1 are not only arranged on the blank end 1-1 of the base plate 1, but also can be arranged on the upper edge of the wall 2-1-1 of the baffle 2, or the edge of the test end 1-2. Two-dimensional code, three-dimensional code, and chip carry the basic information corresponding to the integrated test strip.

The baffle 2 is arranged on the front surface 1-4 of the base plate 1, and a plurality of baffle 2 units are combined and arranged to form an array of baffle 2. The thickness of the baffle 2 wall 2-1-1 does not exceed 0.5mm, and the baffle 2 wall 2-1 -1 The height is not less than the thickness of the reagent block 4 contained, the length and width of the wall 2-1-1 of the baffle 2 depends on the size of the reagent block 4 accommodated, the area 2-1 surrounded by the wall 2-1-1 of the baffle 2 -2 is used to hold reagent block 4. The baffle 2 array forms a one-to-one corresponding site relationship with the reagent block 4 dot matrix, which is used to divide and surround the reagent block 4 to avoid contact between reagent components and reagent reaction products between the reagent blocks 4, as well as the overflow of detection samples and reagents.

Referring to FIG. 4 , according to an embodiment of the present invention, the front side 1-4 of the substrate 1 is provided with a blank end 1-1 in the center, a test end 1-2A and a test end 1-2B are respectively set on both sides, and the blank end 1-1 is used for printing testing The main graphic code 3 and the auxiliary graphic code 3-1 of the terminal 1-2A and the test terminal 1-2B, the test terminal 1-2A and the test terminal 1-2B are respectively provided with a baffle 2 array and a reagent block 4 dot matrix for setting Two types of testing items with large differences, such as dry chemical testing, immunological testing, chip testing, and other testing, are conducive to applying different intervention steps, such as heating and cooling, in two different sections of the same test strip. , moisturizing, drying, adding reagents, special light irradiation, special wavelength color collection and analysis.

Referring to FIG. 5 , the front surface 1-4 of the substrate 1 according to an embodiment of the present invention is provided with a test end 1-2A, a blank end 1-1A, a test end 1-2B, a blank end 1-1B, and a test end 1 respectively from left to right -2C, blank terminal 1-1A, blank terminal 1-1B are used to print the main graphic code 3 and auxiliary graphic code 3-1 of test terminal 1-2A, test terminal 1-2B, test terminal 1-2C, test terminal 1 -2A, test end 1-2B, and test end 1-2C are respectively provided with baffle 2 array and reagent block 4 dot matrix, which are used to set up three types of detection items with large differences, such as dry chemical detection, immunological detection , chip detection, and other detections, it is beneficial to apply different intervention steps in three different sections of the same test strip, such as heating, cooling, moisturizing, drying, adding reagents, special light irradiation, special wavelength color collection and analysis.

By analogy, according to the type and characteristics of the test items, the partitions and quantities of the test end 1-2 and the blank end 1-1 can be flexibly set on the front 1-4 of the substrate 1, and the partitions of the baffle 2 array and the reagent block 4 dot matrix can be flexibly set. Partition and quantity to meet detection needs.

Referring to FIGS. 1 , 3 , 6 and 7 , the reagent block 4 according to an embodiment of the present invention is arranged on the front surface 1-4 of the substrate 1 , and is distributed in a lattice pattern in the space of the area 2-1-2 surrounded by the array of the baffle 2 Inside. The 4 types of reagent blocks include but are not limited to dry chemical detection reagent blocks, immunological detection reagent blocks, and chip reagent blocks. The structure of the reagent block 4 includes at least sample pad 10 , reagent binding pad 20 , reaction pad 30 , absorbent pad 40 , and back plate 50 , a protective film 60 and the like. Reagent block 4 The reagent combination method includes single-item detection and multi-item detection. The reagent substrate for single-item detection displays a single color and is used for single-component analysis and inspection. The reagents for multi-item detection include two or more item detection reagents , integrated into the same reagent block 4, the detection substrates of different items display different colors, such as dry chemical detection test paper, two or more colors, according to the principle of three primary colors, according to the algorithm, analyze the intensity of the original single color, and obtain the color rendering value of the specific component respectively, Qualitative or quantitative detection and analysis are carried out respectively, or the substrate shows the same color, such as immunological detection test paper and chip test paper, but the migration distance or aggregation position of the components to be detected in different items is different on the reagent block 4, and the same reagent block 4 is analyzed. Multiple ingredients.

As shown in Figures 1-12, the process 2000 of the preparation process of the integrated detection test paper according to an embodiment of the present invention includes the following steps: 2100: preparation of the substrate 1, including the preparation of the substrate 1 and the array of baffles 2 on the substrate 1; 2200 : Reagent preparation, including preparing detection reagents and auxiliary reagents according to the test item setting scheme, the reagents include but are not limited to enzymes, reaction substrates, reaction intermediates, reaction primers, chromogenic luminescent substrates, buffers, labeled antigens, Labeled antibodies, nucleotides, polypeptides, DNA, RNA, probes, stabilizers; 2300: Preparation of reagent block 4, including but not limited to dry chemical detection reagent block 4 production, immunological detection reagent block 4 production, chip reagent block 4 Manufacture, integrate the reagent of step 2200 into the test paper, make small pieces of reagent block 4, and put the reagent block 4 into the solid refill 300; 2400: print the reagent block 4, including the solid refill 300 produced in step 2300, on the base Typesetting, by printing, transfer the reagent block 4 to the substrate 1 prepared in step 2100, form a dot matrix of the reagent block 4 in the baffle 2 array of the substrate 1, and at the same time, print the graphic code 3; 2500: drying treatment, including normal temperature Drying treatment, low-temperature drying treatment, and vacuum low-temperature drying treatment make the reagent block 4 stick firmly to the substrate 1, and obtain the finished product of the integrated detection test paper 5; 2600: Quality inspection, including the use of computer vision recognition to detect the presence or absence of the dot matrix site of the reagent block 4 Reagent block 4 falls off, is missing, graphic code 3 is missing, and the accuracy, sensitivity and stability of sampling batch inspection reagent block 4 provide a basis for improving the technological process; 2700: Package, including a single integrated test paper 5 package, To isolate air and moisture, if necessary, encapsulate into stabilizer or inert gas.

Referring to FIG. 1 , a process flow 2100 for preparing a substrate 1 according to an embodiment of the present invention includes the following steps: 2110 : Design a floor plan according to the requirements of the test item setting scheme. The design of the floor plan includes the position and number of blank ends 1-1, The position and quantity of the detection end 1-2, the position and quantity of the graphic code 3, the shape and size of the baffle 2 of the baffle 2 array, the arrangement method, and the corresponding detection item category planning of the corresponding reagent block 4 dot matrix ; 2120: perform 3D modeling according to the plan layout of step 2110, design a 3D mold, the 3D mold includes a substrate 1 and baffle 2 array integrated mold, a substrate 1 mold and a baffle 2 array mold; 2130: According to step 2120 3D modeling, open the mold; 2140: mold trial production, mold revision, mold finalization; 2150: Integrate the mold with the substrate 1 and the baffle 2 array, and make the substrate 1, and the substrate 1 selects PVC, PE, carbon fiber , glass fiber and other materials; 2160-1: Use the substrate 1 mold to make the substrate 1; 2160-2: Use the baffle 2 array mold to make the baffle 2 array; 2170: Use the substrate 1 produced in step 2160-1 and step 2160 -2 The baffle 2 array bonding combination; 2180: You can also use 3D printing to make the substrate 1 and the baffle 2 array according to the 3D modeling in step 2120; 2190: Step 2150 is integrally formed, and step 2170 Bonds the combined substrate 1 And the baffle 2 array, the 3D printing substrate 1 and baffle 2 array in step 2180, the finished product of the substrate 1 and baffle 2 array can be obtained.

Referring to FIGS. 8 and 9 , the manufacturing process 2310 of the dry chemical detection reagent block 4 according to an embodiment of the present invention includes the following steps: 2311 : preparing a large test paper and preparing reagents; 2312 : soaking the large test paper 200 in step 2311 to adsorb the reagents ; 2313: Dry the large piece of test paper 200 that adsorbs the reagent in step 2312, and the processing methods include vacuum low-temperature drying and vacuum room temperature drying; 2314: Cut the large piece of test paper 200 dried in step 2313 into small pieces of reagent block 4; 2315 : Load the reagent block 4 made in step 2314 into the solid refill 300, and the solid refill 300 is made by micro-machining and robotic technology, including the pen tube 300-1, the reagent block 4, the buffer pad 300-2, the bayonet 300-3, the outlet 300-4, the upper end of which is the outlet 300-4 of the reagent block 4, the lower end is the bayonet 300-3 connected with the base of the base 400, the upper end of the bayonet 300-3 is the buffer pad 300-2, the buffer The pad 300-2 has a built-in pressure sensor, the buffer pad 300-2 is connected to the advancing end 500-1 of the lead screw system 500 of the base 400, the buffer pad 300-2 can move along the pen tube 300-1 within a certain damping range, and the screw The pushing end 500-1 of the lever system 500 pushes the buffer pad 300-2, and pushes the reagent block 4 in the solid refill 300 to the outlet 300-4 at the upper end, so that the uppermost reagent block 4 in the solid refill 300 is discharged; 2316: put The large test paper 200 in step 2311 is soaked and adsorbed with different kinds of reagents, and a large number of solid refills 300 containing test paper blocks 4 of different detection items are produced.

6-9, the manufacturing process 2320 of the immunological detection reagent block 4 according to an embodiment of the present invention includes the following steps: 2321: preparing a large sample pad 10, making a large binding pad 20 coated with a labeled antibody, and a large water absorption The pad 40, the large back plate 50, and the large protective film 60. The labeled antibody is usually labeled with colloidal gold, or enzyme-labeled in combination with a chromogenic substrate reagent. The large protective film 60 is usually made of a water-repellent transparent material. Preparation; 2322: Prepare a large sheet of nitrocellulose membrane to coat the antibody or antigen of the object to be tested, make a large sheet of reaction pad 30, and coat the large sheet of reaction pad 30 with antigens or antibodies of various objects to be tested, which can be prepared for For the reagent block 4 that simultaneously detects a variety of analytes, the nitrocellulose membrane can also be replaced by other materials; 2323: Combine the large sample pads 10, large binding pads 20, and large reaction pads in step 2321 and step 2322 30. The large absorbent pad 40, the large back plate 50, and the large protective film 60 are cut into strip-shaped sample pads 10-1, binding pads 20-1, reaction pads 30-1, absorbent pads 40-1, The back plate 50-1 and the protective film 60-1, the width of which is determined by the size of the reagent block 4 preset in the floor plan; 2324: the strip-shaped sample pad 10-1, the binding pad 20-1, the reaction The pad 30-1 and the absorbent pad 40-1 are assembled and assembled according to the top-to-bottom plane sequence of the sample pad 10-1, the binding pad 20-1, the reaction pad 30-1, and the absorbent pad 40-1, and are pasted on the back of the strip. On the plate 50-1, a strip-shaped composite body 600 is produced; 2325: The strip-shaped composite body 600 produced in step 2324 is attached to the strip-shaped protective film 60-1, and the protective film 60-1 covers the strip-shaped bonding pad 20- 1. The reaction pad 30-1 and the absorbent pad 40-1 keep the strip-shaped sample pad 10-1 exposed; 2326: Obtain different types of strip-shaped complex test strips by coating antibodies or antigens of different types of analytes 100; 2227: Re-cut the strip composite test paper 100 made in step 2326 into reagent blocks 4; 2228: Load the reagent block 4 made in step 2327 into the solid refill 300; 2229: Change the large binding pad 20 in step 2321 The type of coated labeled antibody and the type of antibody or antigen of the object to be tested are coated on a large sheet of nitrocellulose membrane in step 2322 to produce a large number of solid refills 300 containing reagent blocks 4 of different detection items.

Referring to FIG. 9 , a reagent block printing process flow 2400 according to an embodiment of the present invention includes the following steps: 2410 : According to requirements, design the reagent block 4 dot matrix layout diagram of the integrated detection test paper, the graphic code 3 plane layout diagram, and the substrate 1 block Board 2 array plan; 2420: Typesetting, including the reagent block 4 dot matrix plan designed in step 2410, the graphic code 3 plan, the substrate 1 baffle 2 array plan, the solid refill 300 is arranged on the base, and the specific It includes the following three sub-steps: 2420-1: Prepare the solid pen refill 300, including different types of reagent blocks 4 are loaded into the solid pen refill 300 respectively for use; 2420-2: Prepare the base 400, including laying on the base 400 2420-3: The solid pen refill 300 prepared in step 2420-1 is installed in an array; 2420-3: The solid pen refill 300 prepared in step 2420-1 is connected to the advancing end of the lead screw system 500 of the base 400 through the bayonet 300-3 at its lower end 500-1; the lead screw system 500 includes a push end 500-1, a support plate 500-2, an intelligent control motor slider complex 500-3, and a lead screw column 500-4, wherein the push end 500-1 is arranged in an array The method is arranged on the support plate 500-2, the propelling end 500-1 can adjust the spacing on the support plate 500-2 to meet the layout requirements, and the support plate 500-2 is connected with the intelligent control motor slider complex 500-3 , intelligently control the motor slider complex 500-3 to move along the lead screw column 500-4, and the lead screw column 500-4 is fixed on the base 400, and further, controls the direction and distance of the movement of the propulsion end 500-1; A pressure sensor is arranged in the buffer pad 300-2 of the core 300 to sense the resistance between the reagent block 4 and the substrate 1, and feedback the resistance between the reagent block 4 and the substrate 1 to the intelligent control motor slider complex 500-3, so that the intelligent control The controller that controls the motor makes timely decisions, and automatically controls the operation of the intelligent control motor slider complex 500-3; according to actual needs, the base 400 can be connected to one or more sets of screw systems 500 to meet the reagents in the solid refill 300. Different requirements for the advancing distance of the block 4; in addition, the buffer pad 300-2 of the solid refill 300 can be additionally provided with a spring device to reduce the strict restriction requirement on the advancing accuracy of the lead screw system 500; 2430: The substrate 1 is coated with glue, including glue Apply to the test end 1-2 of the front side 1-4 of the substrate 1, then wipe off the glue on the upper edge of the wall 2-1-1 of the baffle 2, and keep the glue that accommodates the 4 dot matrix sites of the reagent block; 2440: printing, including the The glue-coated substrate 1 prepared in step 2430 is transferred to the base 400 prepared in step 2420, and by means of the screw system 500, the reagent block 4 in the solid refill 300 is pasted to the substrate 1, the reagent block 4 lattice site, and the integrated detection is produced. Test paper; 2450: Prepare a series of solid refills 30 with different reagent blocks 4 by designing different integrated detection test paper reagent blocks 4 dot matrix plan, graphic code 3 plan layout, substrate 1 baffle array plan 0, carry out combined typesetting, print reagent block 4 to substrate 1, obtain different types of integrated detection test strips, and mass produce.

9 and 10 , the printing process flow 2440 of an embodiment of the present invention includes the following steps: 2441 : the glue-coated substrate 1 prepared in step 2430 is transferred to the base 400 ; 2442 : the reagent blocks on the front side 1-4 of the glue-coated substrate 1 4 dot matrix points According to the floor plan, accurately align the solid refill 300 array typed by the base 400; 2443: The intelligent motor of the screw system 500 starts, and pushes the reagent block 4 in the solid refill 300 through the push end 500-1. The solid refill 300 is discharged and pasted on the dot matrix site of the reagent block 4 on the substrate 1. A pressure sensor is set in the buffer pad 300-2 to sense that the resistance between the reagent block 4 and the substrate 1 reaches a predetermined value, and the motor-slider complex 500 is intelligently controlled. The motor of -3 stops; 2444: Use silk screen technology to print the graphic code to the blank side of the substrate according to the floor plan; 2445: Remove the substrate 1 that has completed the printing of the reagent block 4, the base 400 receives the new substrate 1, and implements the reagent block 4 Printing operations, such a cycle, batch preparation of integrated test strips; 2446: Design different floor plans, typesetting and printing, and prepare different types of integrated test strips.

The manufacturing process 3000 of a solid refill according to an embodiment of the present invention includes the following steps: 3100: prepare a large piece of test paper, reagents, and a blank solid refill 300; 3200: cut the large piece of test paper into small pieces of test paper; 3300: step 3200 3400: the solid refill 300 with the test paper block produced in step 3300 is infiltrated with the adsorption reagent; 3500: the solid refill 300 produced in step 3400 is dried; 3600: batch production Solid refills 300 for specific testing items; according to requirements, change the reagent combination scheme to make solid refills 300 for different testing items.

Referring to FIG. 11 and FIG. 12 , a manufacturing process 4000 of an integrated detection test paper according to another embodiment of the present invention includes the following steps: 4100 : preparing a large test paper 200 , a substrate 1 , a reagent, and an empty liquid refill 700 ; the liquid The refill 700 includes a pen tube 700-1, a reagent 700-4, a smart pump 700-5, and a nozzle 700-6. The smart pump 700-5 is turned on, and the reagent 700-4 contained in the pen tube 700-1 passes through the nozzle 700-6. Spray out; 4200: The large test paper 200 is cut into small test paper blocks; 4300: The test paper block produced in step 4200 is pasted to the reagent block 4 dot matrix position of the baffle 2 array of the substrate 1 using the process of step 2440 4400: different types of reagents are loaded into the empty liquid refill 700, and the liquid refill 700 is completed; according to the pre-designed floor plan, the liquid refill 700 is typeset and fixed to the base 400; 4500: The blank integrated test paper made in step 4300 is placed under the base 400, so that the front side has 1-4 reagent blocks and 4 dot matrix points, and the liquid refill 700 nozzles 700-6 arranged in the array are precisely aligned, and the intelligent pump 700- 5 Turn on, the reagent 700-4 pre-installed in the pen tube 700-1 is sprayed through the nozzle 700-6 to the test paper block on the front side of the substrate 1 1-4 detection end 1-2 Reagent block 4, the test paper block soaks and adsorbs specific types of reagents 700-4, the spraying reagent reaches the predetermined dose, and the intelligent pump 700-5 is turned off; 4600: The integrated test paper made in step 4500 soaked with the adsorption reagent is dried to obtain an integrated detection test paper; 4700: According to requirements, empty liquid refills The 700 is loaded with different kinds of reagents to make different kinds of liquid refills 700, and the different kinds of liquid refills 700 are arranged and combined, and typeset is used for batch preparation of integrated test paper.

In addition, the reagent block printing process 5000 according to another embodiment of the present invention, which is used to replace the lead screw system 500, includes the following steps: 5100: pretreating the substrate 1, so that the substrate 1 is glued to carry a positive charge; 5200: a solid refill 300 Typesetting, array arrangement is fixed on the base 400, the solid refill 300, the pen tube 300-1, the buffer pad 300-2, and the bayonet 300-3 are made of insulating materials, the pen tube 300-1 has a built-in conductive circuit, and the base The stage 400 is equipped with a negative charge generating device, and the built-in conductive circuit is connected to the negative charge generating device; 5300: The substrate 1 with the positive charge glue made in step 5100 is transferred to the base 400, so that the front surfaces 1-4 of the substrate 1 are The reagent block has 4 dot matrix sites, and the solid refill 300 is precisely aligned at the exit 300-4 of the array; 5400: the negative charge generating device is activated, and the negative charge is transmitted to the reagent block in the solid refill 300 through the built-in conductive circuit 4. Under the action of the charge force, the reagent block 4 is separated from the solid refill 300, adsorbed to the position of the reagent block 4 on the substrate 1, and adhered to complete the printing of the reagent block 4 to the substrate 1; 5500: The negative charge generating device stops In operation, the remaining reagent blocks 4 in the solid refill 300 are discharged, and the integrated detection test paper produced in step 5400 is removed; 5600: Appropriately pressurize and dry the integrated detection test paper produced in step 5500 to obtain a finished integrated detection test paper. Of course, the substrate 1 can also be pretreated to make the glue carry negative charges. Correspondingly, the base 400 is equipped with a positive charge generating device.

In addition, the reagent block printing process 6000 according to another embodiment of the present invention, which is used to replace the lead screw system 500, includes the following steps: 6100: The glue-coated substrate 1 prepared in step 2430 is transferred to the base 400, and the base 400 is configured A pneumatic system, the pneumatic system includes an intelligently controlled gas compressor, a gas pipeline, an intelligently controlled gas valve, and a gas nozzle, and the high-pressure gas generated by the intelligently controlled gas compressor passes through the gas pipeline and its branches to the gas nozzles arranged in an array , each air nozzle is equipped with an intelligent control air valve; 6200: 1-4 reagent blocks 4 dot matrix points on the front side of the glued substrate 1, according to the plan layout, the solid refills 300 arrays of the base 400 typesetting are precisely aligned, the said The bottom bayonet 300-3 of the solid refill 300 has a built-in air seal, and the air nozzle is inserted into the air seal; 6300: The intelligent control gas compressor is started, the intelligent control air valve is opened, and the high-pressure gas enters the lower end bayonet of the solid refill 300 through the air nozzle. In 300-3, the high pressure gas pushes the reagent block 4 in the solid refill 300 to be discharged from the outlet 300-4 of the solid refill 300, and is pasted on the substrate 1 at the reagent block 4 dot matrix site, and the pressure sensor in the buffer pad 300-2 senses the reagent. When the resistance between the block 4 and the substrate 1 reaches a predetermined value, the intelligently controlled gas valve is closed, and the intelligently controlled gas compressor is shut down; 6400: Remove the substrate 1 on which the printing of the reagent block 4 is completed to obtain an integrated detection test paper.

An embodiment of the present invention provides a detection device 800 for an integrated detection test paper, including a sample collection device, a sample pretreatment device, a spray and color reaction device 810, and an identification and interpretation device, see FIG. 13 , FIG. 14 and FIG. 15 , which discloses a spraying and coloring reaction device 810 suitable for a strip-shaped integrated detection test paper 5 .

The shower and color reaction device 810 according to an embodiment of the present invention includes a housing 811 , a displacement regulator 812 , a shower head 813 , and a chamber 814 . The housing 811 includes a cover 811 - 1 , a housing 811 - 2 , and an opening 811 -3, the cover 811-1 includes a main body 811-1-1, a lens structure 811-1-2, a top groove 811-1-3, a side groove 811-1-4, the top groove 811-1-3 For the interface 813-1 to move along the long axis, the side grooves 811-1-4 for the gear shaft 812-4 to move along the long axis, and the chamber 814 for accommodating the shower head 813 , the displacement regulator 812 , the integrated detection test paper 5 , the opening 811 - 3 is arranged on the right side of the bottom of the chamber 814 , and is used for inserting the long strip-shaped integrated detection test paper 5 .

The displacement adjuster 812 includes a rack 812-1, a gear 812-2, a knob 812-3, a pinion 812-4, and a slot 812-5, and the rack 812-1 includes a proximal rack 812-1A and A distal rack 812-1B, the gear 812-2 includes a proximal gear 812-2A and a distal gear 812-2B, respectively, and the proximal rack 812-1A and the proximal gear 812-2A are disposed in the chamber 814 and fixed to the proximal wall of the housing 811, the distal rack 812-1A and the distal gear 812-2A are arranged in the chamber 814 and fixed to the distal wall of the housing 811, the proximal gear 812 -2A and the distal gear 812-2B are connected by the pinion 812-4, the middle section of the pinion 812-4 is provided with the slot 812-5, and the slot 812-5 passes through the slot 813-4 In connection with the shower head 813, the slot 812-5 can be changed in position on the pinion 812-4 as required, wherein the proximal end of the pinion 812-4 protrudes from the housing 811, where The pinion 812-4 extends out of the casing 811 to install the knob 812-3, the knob 812-3 is set with a scale, and the knob 812-3 is rotated by one scale to drive the gear 812-2 along the The rack 812-1 moves, and pushes the shower head 813 connected to the slot 812-5 to generate one displacement unit.

The shower head 813 includes an interface 813-1, a buffer chamber 813-2, a micro-hole 813-3, and a bayonet 813-4. The upper end of the interface 813-1 is connected to a syringe, and the lower end of the interface 813-1 is connected to the buffer chamber. 813-2, the side and bottom of the buffer chamber 813-2 are provided with a plurality of the micro holes 813-3, the sample or reagent in the syringe enters the buffer chamber 813-2 through the interface 813-1, The hole 813-3 is ejected.

When using, refer to the technical standards of the integrated detection test paper 5, and specify the length and width of the detection area of the integrated detection test paper 5, the minimum and maximum sample volume for complete infiltration of the reagent block, and the prepared sample volume is between the minimum and the minimum amount for complete infiltration of the reagent block. Between the sample size and the maximum sample size, select the matching spray and color reaction device 810 and shower head 813, open the cover 811-1, install the shower head 813, close the cover 811-1, and open the cover 811-3 from the opening 811-3. , insert the long strip of integrated detection test paper 5, the detection area of the integrated detection test paper 5 is upward, and the blank area of part of the integrated detection test paper 5 is exposed outside the opening 811-3, turn the knob 812-3, and move the shower head 813 To the far left, through the lens structure 811-1-2 of the cover 811-1, turn the knob 812-3, and adjust the shower head 813 to face the left part of the detection area of the integrated test paper 5; Each time the dose is injected, the spray head 813 moves each time; the syringe draws the sample, injects a certain dose of sample, rotates the knob 812-3, the spray head 813 moves a certain distance, and injects a certain dose of sample again until the injection After the sample is completed, it is observed through the lens structure 811-1-2 of the cover 811-1 that all the reagent blocks of the integrated detection test paper 5 are fully infiltrated; refer to the technical standards of the integrated detection test paper 5 to clarify the suitable environment for the integrated detection test paper 5 The temperature and humidity are adjusted according to the real-time monitoring of the ambient temperature and humidity in the chamber 814 by starting the temperature and humidity control components; referring to the technical operation process of the integrated detection test paper 5, if necessary, special reagents need to be added into the syringe, Reagent addition is carried out in conjunction with the shower head 813 .

Referring to FIG. 16 and FIG. 17 , a spray and color reaction device 810 suitable for the disc-shaped integrated detection test paper 5 is disclosed.

The spray and color reaction device 810 according to an embodiment of the present invention includes a casing 811, a displacement regulator 812, a shower head 813, and a chamber 814. The casing 811 is cylindrical and includes a cover 811-1, a casing 811- 2. The cover 811-1 includes a main body 811-1-1, a lens structure 811-1-2, a top groove 811-1-3, and a side groove 811-1-4. The top groove 811-1-3 is used for As the interface 813-1 moves along the long axis, the side grooves 811-1-4 are used for the gear shaft 812-4 to move along the long axis, and the chamber 814 is used for accommodating the shower head 813, The displacement regulator 812 , the rotating shaft 812 - 6 , and the disc-shaped integrated detection test paper 5 .

The displacement adjuster 812 includes a rack 812-1, a gear 812-2, a knob 812-3, a pinion 812-4, a rotating shaft 812-6, a card slot 812-5, the rack 812-1 and the gear 812 -2 is surrounded and fixed on the wall of the cover 811-1, the gear 812-2 and the rotating shaft 812-6 are connected by the gear shaft 812-4, the middle section of the gear shaft 812-4 is provided with the slot 812-5 , the slot 812-5 is connected to the shower head 813 through the bayonet 813-4, wherein the end of the pinion 812-4 protrudes from the main body 811-1-1 and the knob 812-3 is installed, so The knob 812-3 is set with a scale, and turning the knob 812-3 one scale drives the gear 812-2 to move along the rack 812-1, and pushes the spray connected to the card slot 812-5. The head 813 is displaced by one unit. When the operation is performed, the spray head 813 rotates around the rotating shaft 812-6 to spray the sample or reagent onto the disc-shaped integrated detection test paper 5 reagent block.

When using, refer to the technical standards of the integrated detection test paper 5, and specify the length and width of the detection area of the integrated detection test paper 5, the minimum and maximum sample volume for complete infiltration of the reagent block, and the prepared sample volume is between the minimum and the minimum amount for complete infiltration of the reagent block. Between the sample size and the maximum sample size, select the matching spray and color reaction device 810 and the shower head 813, open the cover 811-1, insert the disc-shaped integrated detection test paper 5, install the shower head 813, Close the cover 811-1, and other operations are the same as the strip-shaped integrated test strip 5.

An integrated test strip detection system according to an embodiment of the present invention includes an integrated test strip 5 , a detection device 800 , an identification and interpretation algorithm, software, and a server. Graphical code 3. Reagent block color reaction data, blank control, negative control, positive standard control, color reaction dose-response relationship, to obtain integrated test paper 5 hundreds of test results for hundreds of reagent blocks, the software It includes a rectangular coordinate robot operation code, a microscopic computer vision sensor operation code, a recognition and interpretation algorithm code, and a data security code, and the server includes a cloud server.

This application is intended to cover any variations, uses or adaptations of the invention which follow the general principles of the invention and which include common knowledge or conventional techniques in the art not disclosed by the invention . The description and examples are to be regarded as exemplary only, and the scope of the invention is limited only by the appended claims.

The above are only the embodiments of the present invention and do not limit the technical scope of the present invention. Therefore, any minor modifications, equivalent changes and modifications made to the above embodiments according to the technical essence of the present invention still belong to the present invention. within the scope of the technical solution. Skilled artisans should appreciate that skilled artisans may implement the described functionality using different methods for each particular application, but such implementations should not be considered beyond the scope of the present invention.

Industrial Applicability

(1) Implementability: After reading the overall technical content disclosed in this application document, those of ordinary skill in the technical field can objectively reproduce the subject matter of the invention-creation.

(2) Reproducibility: According to the disclosed technical content, those of ordinary skill in the art can repeatedly implement the technical solutions adopted in this application to achieve its purpose. This repeated implementation has no quantitative limit and does not rely on any random factors. , and each implementation yields the same result.

(3) Benefit: The technical solution of the present application adopts the printing process to prepare the integrated test paper, which can produce positive economic and social benefits.

Claims

A detection method for an integrated test paper, which is characterized by comprising the following steps: (1) collecting and pre-processing specimens; (2) spraying the sample to infiltrate the integrated test paper; (3) coloring the reagent block of the integrated test paper ; (4) Identify and interpret, and obtain the test results of the specimen.
The detection method according to claim 1, characterized in that: the spraying of the sample comprises transferring the detection sample prepared in step (1) to a syringe, the syringe is connected to the spraying and color reaction device, and the integrated detection test paper is placed in the spraying And the color reaction device, according to the preset spray program, push the syringe, the test sample in the syringe forms sample droplets through the spray head, and the sample droplets infiltrate part of the reagent block of the integrated detection test paper, move the spray head, and push it again Syringe until the sample droplet has soaked all the reagent blocks of the integrated test strip.
The detection method according to claim 1, wherein the identification and interpretation comprises taking out the integrated detection test paper that has completed the color reaction in step (3), inserting the identification and interpretation device, and the identification and interpretation device recognizes and collects the integrated detection test paper The color reaction data of the reagent block and the identification code of the reagent block are used to obtain the test result of the sample.
The detection method according to claim 1, wherein the identification and interpretation comprises taking out the integrated detection test paper that has completed the color reaction in step (3), inserting the identification and interpretation device, and the identification and interpretation device recognizes and collects the integrated detection test paper The color reaction data of the reagent block and the identification code of the reagent block are used to obtain the test result of the sample.
The detection device according to claim 4, wherein the integrated detection test paper comprises a substrate, a baffle array, a reagent block lattice, and a graphic code, and the substrate is provided with a baffle array, a reagent block lattice, and a graphic code. , the baffle array divides and surrounds the reagent block.
The detection device according to claim 5, wherein the reagent blocks are distributed in a dot matrix in the baffle array space, including dry chemical detection test paper blocks, immunological detection test paper blocks, chip test paper blocks, and single-item detection reagent combinations Test paper block and multi-item detection reagent combination test paper block.
The detection device according to claim 4, wherein the spray and color reaction device comprises a casing, a displacement regulator, a shower head, and a chamber, the casing comprises a cover, a casing, and an opening, and the The chamber accommodates the shower head, the displacement regulator, and the integrated detection test paper, and the opening is arranged at the bottom of the chamber.
The detection device according to claim 7, wherein the displacement adjuster comprises a rack, a gear, a knob, a pinion, and a slot, and the rack and the gear are paired in the chamber and arranged in a pair. Fixed on the housing wall, the gears are connected by the pinion, the middle of the pinion is provided with the slot, the slot is used to connect the shower head, one side of the pinion end The knob is set, and the knob is rotated to drive the gear to move along the rack and push the shower head connected with the card slot.
The detection device according to claim 7, wherein the shower head comprises an interface, a buffer chamber, a micro-hole, and a bayonet, one end of the interface is connected to the syringe, the other end is connected to the buffer chamber, and the side surface of the buffer chamber is and the bottom surface is provided with a plurality of the micro holes.
The detection device according to claim 7, characterized in that: the casing can also be a disc type, a rotating shaft is arranged in the center of the chamber, the number of the rack and the gear is one, and the number of the Shell wall, one end of the pinion is connected with the gear, the other end of the pinion is connected with the rotating shaft, and the shower head is connected with the slot through the bayonet.
The detection device according to claim 4, wherein the identification and interpretation device includes an illumination assembly, a Cartesian coordinate robot, and an end effector, and the end effector includes a microscopic computer vision sensor.
A preparation process of an integrated test paper detection device, characterized in that it includes the preparation of an integrated detection test paper, and the integrated detection test paper preparation includes substrate preparation, reagent preparation, reagent block preparation, and reagent block printing.
The preparation process according to claim 12, wherein the preparation of the substrate comprises designing a plan layout, 3D modeling, designing a 3D mold, opening the mold, and fabricating a substrate including a baffle array structure, and the plan layout includes: Blank end, baffle array, reagent block dot matrix, graphic code.
The preparation process according to claim 12, wherein the preparation of the reagent block comprises preparing a large test paper, infiltrating the large test paper with the adsorption reagent, cutting the large test paper into small reagent blocks, and loading the reagent block into a solid refill, A large number of solid refills are made with test paper blocks of different detection items. The solid refills include a pen tube, a reagent block, a buffer pad, and a bayonet. The upper end is the outlet of the reagent block, and the lower end is the bayonet. The bayonet is used for It is connected with the base, the upper surface of the buffer pad receives the reagent block, and the lower part of the buffer pad is connected to the propulsion device.
The preparation process according to claim 12, wherein the reagent block printing includes designing a layout diagram, typesetting, gluing a substrate, printing, and obtaining a finished product of an integrated detection test paper, and the layout diagram is an integrated detection test paper The reagent block lattice arrangement and combination scheme according to the invention, the typesetting includes arranging the solid refill array on the base according to the plan layout, the printing includes transferring the glued substrate to the base, and the substrate reagent block lattice site corresponds to the base Solid refill array, the reagent block is discharged from the solid refill, and the reagent block is pasted on the substrate according to the plan layout, and at the same time, the graphic code is printed to produce an integrated detection test paper.
The preparation process of claim 12, further comprising cutting a large piece of test paper into small pieces of test paper, and pasting the small pieces of test paper to the substrate through a printing process to produce a test paper dot matrix substrate, and the pre-installed reagents The liquid refill is typeset and fixed on the base, and the liquid refill is printed by inkjet, so that the test paper dot matrix substrate is soaked in small pieces of test paper to absorb the reagent, and an integrated detection test paper is produced.
The preparation process according to claim 15, wherein the propulsion device comprises a charge force drive system, a lead screw system, and a pneumatic propulsion system, and the charge force drive system includes a substrate coated with glue to carry a charge, and a reagent in a solid refill. The block carries opposite charges, and the reagent block is separated from the solid refill and adhered to the substrate; the lead screw system includes a push end, a support plate, a motor-slider complex, and a lead screw column, the push end is arranged on the support plate in an array, and the lead screw The upright column is fixed on the base; the pneumatic propulsion system includes a gas compressor, a gas pipeline, a gas valve, and a gas nozzle. The gas generated by the gas compressor reaches the gas nozzles arranged in an array through the gas pipeline and its branches. The gas nozzle enters into the lower end bayonet of the solid refill, and the gas pressure pushes the reagent block in the solid refill to be discharged from the outlet of the solid refill and sticks to the base plate.