A photochemical POCT all-in-one test system and test method

Abstract

The present invention discloses a photochemical POCT all-in-one test system, comprising: a test card, comprising an upper shell provided with a sample channel running through the inside and outside thereof, a lower shell movably connected to the upper shell, a diffusion layer at least partially arranged in the sample channel, and a reaction layer arranged opposite to the diffusion layer; the reaction layer is provided with at least one reaction area, and at least one identification module associated with the reaction area; a tray for supporting the test card, a window for exposing at least part of the reaction layer at the bottom thereof; an optical unit, comprising a light source and a receiver arranged near the light source; a bracket for connecting the optical unit and moving with the optical unit; when the light source irradiates the identification module, the light is reflected to the receiver to read the reaction area information associated with the identification module. The present invention also discloses a photochemical POCT all-in-one test method. The present invention realizes arbitrary coding of various types of reactions through the association of the identification module and the reaction area, and the coding amount is increased; the reaction result is more accurate.

Description

Technical Field

[0001] The present invention belongs to the technical field of photochemical detection, and in particular relates to a photochemical POCT all-in-one testing system and a testing method. Background Art

[0002] With the advancement of science and technology and the widespread application of point of care testing (POCT) in the field of laboratory medicine, more and more testing indicators and products have been developed. Among them, optical PCOT biochemical testing products occupy an indispensable proportion in in vitro diagnostic testing, including diabetes series indicators, renal function series indicators, liver function series indicators, blood / urine biochemical indicators, etc., which are made into dry chemical test strips and used in conjunction with supporting miniaturized testing instruments to provide fast, simple and accurate quantitative results. In terms of product form, they are mainly divided into two forms: test strips for single analyte detection and test strips for multiple analytes detection.

[0003] Compared with electrochemical POCT products, optical POCT biochemical products are often subject to differences in detection principles, which makes it difficult to achieve the aggregation of indicators in terms of light source selection, optical path design, etc. However, as the market gradually matures, and the indicators show a trend of segmentation, the market has put forward a more urgent demand for joint detection of different indicators.

[0004] Mission Hb product launched by Aikon Biotechnology Co., Ltd. uses a single-reagent test strip and a corresponding handheld instrument to detect the hemoglobin concentration and hematocrit in whole blood. When in use, insert the test strip into the corresponding position of the instrument, add the blood sample and wait for a few seconds to complete the test and obtain the result. The test strip and instrument of this product must be used in conjunction with each other, and the detection index is single. At the same time, the company also has products with other indicators, but these products are not interchangeable. Each set of reagents and instruments forms an independent closed-loop detection unit. Due to the problem of optical path adaptation, it will cause a waste of instrument design costs.

[0005] Polymer Technology System, an American company, produces a blood lipid test product (US10145854) for three items (total cholesterol, triglycerides and HDL-C). Each test card contains three reagents, which correspond to the detection of the above three indicators. When in use, drop the sample into the sample well, and the sample is evenly distributed on it through the diffusion effect of the diffusion layer. The red blood cells are then intercepted by the filter layer, and the plasma passes through the filter layer to reach the reaction layer which is evenly divided into three parts, and is mixed and reacted with the corresponding reagents on it. All the results can be obtained after a few minutes. However, this product still pairs the test card with the instrument one by one, and still lacks the scalability of more indicators.

[0006] The Reflotron series of products launched by Roche Diagnostics in the United States has three test chambers in one device, which can realize the detection of three indicators with one instrument. The corresponding test strip is selected according to the user's needs, and the blood sample is added and placed inside the instrument test chamber. The result can be obtained after waiting for a few minutes. However, due to the limitation of instrument detection, the form of the test strip is limited to a single reagent. Therefore, when the user needs to detect some composite indicators, such as the alanine aminotransferase / aspartate aminotransferase ratio, three blood lipid results, etc., it is necessary to use the reagent unit of each single indicator for detection, and then calculate the final result through the calculation of each single result. This not only requires multiple sampling and adding samples, which is cumbersome to operate, but also the differences between the test strips of different units will interfere with the calculation of the results of the composite indicators.

[0007] The Afinion series of products owned by Abbott of the United States has launched test cards with multiple composite indicators. When using, insert the collector with the blood sample into the test card, put it into the instrument, and wait for a few minutes to get the result. During the test, the pump needle inside the instrument will enter the test card to perform multiple suction and discharge operations. The entire test process is relatively complicated and has high requirements for instrument development, especially liquid circuit design and mechanical positioning. And the design complexity of this product makes it only suitable for detecting composite indicators, such as glycated hemoglobin.

[0008] Although there are some integrated products on the market, their integration methods are single and cannot be flexibly customized. The cost of different integrations is very high. Therefore, this solution aims to provide a new design, a multi-indicator PCOT miniaturized detection product. By establishing a system platform, one instrument can correspond to multiple detection indicators, or even all indicators detected by this principle, so that optical POCT detection indicators can be flexibly integrated and managed, and all detection indicators can be managed uniformly, so as to realize the needs of corresponding detection indicators on different reagent units according to market demand, so as to adapt to the rapidly changing needs of different markets. Summary of the invention

[0009] In order to overcome the deficiencies of the prior art, the present invention provides a photochemical POCT all-in-one testing system and testing method which has accurate test results, can perform multiple tests simultaneously, and has a simple and easy method.

[0010] The technical solution adopted by the present invention to solve the technical problem is: a photochemical POCT all-in-one testing system, comprising:

[0011] The test card comprises an upper shell provided with a sample channel running through the upper and lower shells, a diffusion layer at least partially provided in the sample channel, and a reaction layer provided opposite to the diffusion layer; the reaction layer is provided with at least one reaction area, and at least one identification module associated with the reaction area;

[0012] A tray, used for supporting the test card, having a window at the bottom thereof for exposing at least a part of the reaction layer;

[0013] an optical unit, comprising a light source and a receiver disposed near the light source;

[0014] A bracket, used for connecting the optical unit and carrying the optical unit for movement;

[0015] When the light source illuminates the identification module, the light is reflected to the receiver to read the reaction area information associated with the identification module.

[0016] The present invention associates the reaction area with the identification module. When the light source illuminates the identification module, the reaction area information associated with the identification module can be read, so that one test system can detect multiple items at the same time, changing the form in which the test card and the instrument need to be paired one by one in the traditional detection method, and the detection is more flexible.

[0017] Furthermore, the identification module is a color block area. Differentiating different reaction areas by color is simple and easy, and due to the diversity of colors, the coding method of the color block area is more diverse, the coding amount is huge, and the needs of various detections can be met.

[0018] Furthermore, there is an isolation zone between the diffusion layer and the reaction layer. When the sample diffuses, the diffusion layer does not contact the reaction layer. After the sample diffuses, an external force is applied to drive the upper shell and the lower shell to approach each other, and the diffusion layer and the reaction layer cross the isolation zone and contact each other. After the sample is fully diffused in the diffusion layer, the diffusion layer is contacted with the reaction layer, which effectively avoids the situation where part of the sample reaches the reaction layer first, thereby ensuring the accuracy of the reaction result.

[0019] Furthermore, an elastic component for forming the isolation zone is provided between the upper shell and the lower shell, and the elastic component pushes the lower shell and the upper shell away from each other to ensure the separation of the upper shell and the lower shell, and at the same time, the operation is simple when the upper shell and the lower shell need to be in contact.

[0020] Furthermore, it also includes a pressure piece arranged above the tray and used to apply external force to drive the upper shell to move downward.

[0021] Furthermore, the reaction zone information includes test type and calibration equation.

[0022] Furthermore, the light source is a composite light source. By irradiating the recognition module with the composite light source, the information received by the receiver is more diverse, and the coding amount of the color block area is larger.

[0023] Furthermore, the reaction layer includes a plurality of independent reaction strips, each of which is provided with at least one reaction area or at least one color block area. The design of multiple reaction strips enables the same reaction layer to perform multiple different project tests, making the tests more diverse.

[0024] Furthermore, at least one blank control area is provided on the reaction layer, and the blank control area, the reaction area and the color block area are arranged in a ring shape; the bracket is arranged concentrically with the tray and the test card. The ring shape of several areas facilitates the circumferential rotation of the bracket to drive the optical unit to rotate and receive the signal sent by the color block area, and the structural design is more reasonable.

[0025] Furthermore, a filter layer is provided in the sample channel, and the design of the filter layer is convenient for intercepting components such as red blood cells, thereby reducing their adverse effects on the test.

[0026] Furthermore, the number of the optical units is one or more; when the number of the optical units is multiple, the multiple optical units are symmetrically distributed on the bracket and rotate synchronously with the bracket. Multiple optical units perform detection simultaneously, so that each reaction with the same time to reach the reaction level can be performed synchronously, and the detection accuracy is higher for detection with requirements on reaction time.

[0027] The present invention also discloses a photochemical POCT all-in-one testing method, comprising the following steps:

[0028] S1. Select a test card with associated color block area and reaction area information, add a blood sample to the sample channel, and place the test card into the tray;

[0029] S2, the bracket rotates with the optical unit, and measures the reflection signal of each color block area in turn to determine the test card information;

[0030] S3, the pressure piece applies downward pressure on the upper shell, and the diffusion layer contacts the reaction layer;

[0031] S4. While keeping the diffusion layer and the reaction layer in contact, the bracket rotates with the light source to measure the reflection signal of each reaction area, records the time of obtaining the reflection signal of each reaction area, and calculates the test results.

[0032] Preferably, the step S1 is preceded by the following steps: starting the instrument, entering a self-test program, and measuring a black level signal.

[0033] Preferably, the step S2 is preceded by the following step: the bracket rotates with the optical unit to measure the reflection signals of the blank control area and each reaction area in turn to determine whether the test card is usable.

[0034] Preferably, the step S3 is preceded by the following step: the support is rotated to the blank control area, and the reflection signal is continuously measured to determine whether the sample diffusion is complete.

[0035] Preferably, the step S4 is followed by the following steps: completing the test, resetting the optical unit and the pressure piece, displaying the test result on the instrument, and taking out the test card.

[0036] The test card of the present invention is equipped with an identification module, which is designed as a color block area. The collection of multiple color block areas can provide a rich amount of coding information. Through the corresponding red, green and blue light sources on the system instrument and the multiple composite background colors on the color block area, the coding value can be determined according to the received reflected light information, and the corresponding test card detection index information and the calibration equation corresponding to each detection index are found through the coding matrix pre-set in the program to ensure the accuracy of the result.

[0037] These coding values ​​can be used for two purposes. One is to define different combinations of indicator sets, such as three blood lipid items, ALT+AST, blood routine test, etc. When the user selects a test card that meets the expected needs, the instrument can automatically find the corresponding indicator items and complete the corresponding tests through the coding information on the color block area on the test card; the second is to define the calibration equation for calculating the results under a specific indicator. The instrument reads the coding information on the color block, automatically identifies the batch number of the corresponding indicator and finds the corresponding calibration equation for calculating the results.

[0038] A set of optical units can detect the signals of multiple reaction areas and color block areas by rotating the annular bracket connected to it. This design minimizes the deviation of the results caused by the difference between light sources and light sources, while saving the cost of optical components. Because when the diffusion layer on the test card contacts the reaction layer, multiple reactions start at the same time, so a single set of optical units must be programmed to read the reflection signal value on each reaction layer in time-sharing and calculate the results. According to the curve and calculation logic of the color reaction, it is usually only necessary to read the reflection signal value of the maximum signal interval or the reaction interval with the fastest signal change. Therefore, the signal reading of multiple reaction areas can be completed by setting the reaction time of different indicators on the same test card in sequence (i.e., in the order of reaching the maximum signal interval), and then reading the reaction endpoints one by one. If multiple sets of optical units are set on the annular bracket, the reading time of each reaction area signal of each set of optical units will be greatly improved.

[0039] The beneficial effects of the present invention are: 1) by identifying the association between the module and the reaction zone, the feasibility of arbitrary coding of various types of reactions is realized, and the coding amount is greatly increased; 2) the same system instrument can detect multiple different indicators, and can more flexibly integrate multiple detection indicators; 3) the sample is fully diffused before contacting with the reaction layer for reaction, and the reaction result is more accurate; 4) the test operation is simple and easy, and the test cost is reduced. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] Figure 1 It is a three-dimensional diagram of the first embodiment of the present invention.

[0041] Figure 2 This is an exploded view of the second embodiment of the present invention.

[0042] Figure 3 It is a bottom view of the reaction layer in the second embodiment of the present invention.

[0043] Figure 4 It is a bottom view of the reaction layer structure 1 in the second embodiment of the present invention.

[0044] Figure 5 It is a bottom view of the reaction layer structure 2 in the second embodiment of the present invention.

[0045] Figure 6 It is a bottom view of the reaction layer structure 3 in the second embodiment of the present invention.

[0046] Figure 7 The cross-sectional view of the diffusion layer in the second embodiment of the present invention is shown in FIG. Figure 1 .

[0047] Figure 8 The cross-sectional view of the diffusion layer in the second embodiment of the present invention is shown in FIG. Figure 2 .

[0048] Fig. 9 This is an exploded view of embodiment 3 of the present invention.

[0049] Fig.10 It is a cross-sectional view of the initial state of the test card in the third embodiment of the present invention.

[0050] Fig.11 It is a cross-sectional view of the test card in the third embodiment of the present invention in the use state.

[0051] Fig.12 This is a simplified diagram of the elastic member in the third embodiment of the present invention when the deformation amount is ΔT1.

[0052] Fig.13 This is a simplified diagram of the elastic member in the third embodiment of the present invention when the deformation amount is ΔT2.

[0053] Fig.14 This is a simplified diagram of the elastic member in the third embodiment of the present invention when the deformation amount is ΔT3.

[0054] Fig.15 Schematic diagrams of three appearances of the test card in the third embodiment of the present invention.

[0055] Fig.16 It is a schematic diagram of the coordination between the optical unit and the reaction layer in the third embodiment of the present invention.

[0056] Fig.17 It is a schematic diagram of four optical units symmetrically distributed on a bracket in the third embodiment of the present invention.

[0057] Fig.18 This is a schematic diagram of a receiver placed at the center of a bracket in a third embodiment of the present invention.

[0058] Fig.19 This is a schematic diagram of three light sources being separately arranged in Embodiment 3 of the present invention.

[0059] Fig. 20 This is a schematic diagram of three light sources sharing one receiver in Embodiment 3 of the present invention. DETAILED DESCRIPTION

[0060] In order to enable those skilled in the art to better understand the solutions of the present invention, the following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work should fall within the scope of protection of the present invention.

[0061] Embodiment 1

[0062] like Figure 1 As shown, a reaction test paper for photochemical POCT detection includes a test paper body 20, at least one reaction area 22 formed on the test paper body 20, and at least one identification module associated with the reaction area 22, and the identification module can be a color block area 23 with color;

[0063] Of course, at least one blank control area 21 may be formed on the test paper body 20;

[0064] In this embodiment, there are multiple reaction areas 22 and color block areas 23, and the combination of multiple reaction areas 22 and multiple color block areas 23 is associated, and each combination of multiple color blocks contains information about the reaction area of ​​each test combination;

[0065] Of course, in other embodiments, the reaction areas 22 and the color block areas 23 are associated one to one, that is, the number of the reaction areas 22 is the same as the number of the color block areas 23, and one color block area contains the information of one reaction area;

[0066] Alternatively, in other embodiments, multiple reaction areas 22 may correspond to one color block area 23 , that is, one color block area 23 is associated with at least one reaction area 22 , and one color block area contains information of multiple reaction areas.

[0067] The test paper body 20 is divided into a plurality of independent test strips 201, each of which is provided with at least one reaction area 22, or at least one color block area 23, or a blank control area 21;

[0068] A plurality of reaction areas 22, a plurality of color block areas 23 and a blank control area 21 are arranged to form a ring structure;

[0069] like Fig.16 As shown, when a light source, which can be a monochromatic light source or a composite light source, is irradiated on the color block area 23, the light that is not absorbed is reflected to the receiver 62 to read the reaction area 22 information associated with the color block area 23. The reaction area 22 information includes the test type and the calibration equation, thereby realizing the function of obtaining the specific information such as the test type and the calibration equation of the reaction area 22 through the color block area 23.

[0070] Embodiment 2

[0071] like Figure 2 As shown, a photochemical POCT all-in-one test card includes an upper shell 11, a lower shell 12 movably connected to the upper shell 11, a reaction layer 2, and a diffusion layer 3 at least partially disposed in a body channel 111; a sample channel 111 is formed on the upper shell 11 and runs through the inside and outside of the thickness direction thereof, such as Fig.10 As shown, a filter layer 5 may be provided in the sample channel 111. In order to install the filter layer 5, a mounting groove 114 is formed on the lower surface of the upper shell 11. The mounting groove 114 may be arranged concentrically with the sample channel 111. The shape and size of the mounting groove 114 are adapted to the filter layer 5, so that the filter layer 5 may be tightly fitted in the mounting groove 114. Of course, in other embodiments, the test sample can be directly tested without filtering, and there is no need to set a filter layer and a structure corresponding to the filter layer.

[0072] The outer peripheral edge of the upper shell 11 forms a clamping portion 112 , and the inner wall of the top opening of the lower shell 12 forms a buckle portion 122 that cooperates with the clamping portion 112 . The clamping portion 112 and the buckle portion 122 cooperate to realize the movable connection between the upper shell 11 and the lower shell 12 .

[0073] Specifically, the clamping portion 112 is an annular flange extending radially from the lower portion of the upper shell 11, the buckle portion 122 is formed by a partial protrusion of the inner wall of the top opening of the lower shell 12, the outer wall of the clamping portion 112 forms an arcuate surface, and the buckle portion 122 also forms an arcuate structure on the side of the opening of the lower shell 11 to facilitate the sliding of the clamping portion 112; in order to ensure that the clamping portion 112 has sufficient deformation space, an annular groove is formed on the lower surface of the upper shell 11 near the annular flange, and the annular groove serves as a notch portion 113 that provides deformation space for the clamping portion 112, so that the clamping portion 112 has sufficient elasticity, thereby ensuring that the movable connection between the upper shell 11 and the lower shell 12 is more stable.

[0074] The diffusion layer 3 can be directly placed under the upper shell 11, or can be fixedly connected to the lower surface of the upper shell 11 by bonding or other means, so as to contact the filter layer 5 and firmly press it into the installation groove 114; Figure 7 , 8 As shown, the cross section of the diffusion layer 3 can be a cross shape or a convex shape. This shape design can satisfy the requirement that the sample diffuses to multiple sites after passing through the filter layer 5, realizes the reaction and detection of multiple indicators, and can also reduce the loss of scraps during cutting, saving costs. In other embodiments, the test sample does not need to be filtered, and can be directly diffused to multiple sites to realize the reaction and detection of multiple indicators;

[0075] The reaction layer 2 is disposed on the lower shell 12 , and may be directly placed on the lower shell 12 or fixedly connected to the inner surface of the lower shell 12 . The diffusion layer 3 is disposed vertically opposite to the reaction layer 2 .

[0076] The structure of the reaction layer 2 is the same as that of the above-mentioned reaction test paper, including a plurality of independent reaction strips 24, each of which is formed with at least one reaction area 22, or at least one color block area 23 serving as an identification module, or a blank control area 21; an observation window 123 is formed on the lower shell 12, which is opposite to at least a part of the area of ​​the reaction layer 2. In this embodiment, at least the reaction area 22, the color block area 23 and the blank control area 21 are exposed to the observation window 123.

[0077] The reaction areas 22 and the color block areas 23 are associated with each other. In the present embodiment, the number of the reaction areas 22 is the same as the number of the color block areas 23, that is, a plurality of reaction areas 22 and a plurality of color block areas 23 are uniquely associated with each other; of course, a plurality of reaction areas 22 may correspond to one color block area 23, that is, one color block area 23 is associated with at least one reaction area 22.

[0078] In this embodiment, the filter layer 5 is cut from a sheet into a 5 mm × 5 mm square sheet, which is made of dense filter paper, glass fiber and other materials, and is used to intercept red blood cells during whole blood testing;

[0079] The diffusion layer 3 is cut into a cross-shaped or convex-shaped sheet by a die-cutting process, and a glass fiber material with good hydrophilicity is selected for diffusion of plasma samples;

[0080] The reaction layer 2 is formed by membrane treatment, membrane cutting, membrane pasting and slitting, and is an asymmetric porous membrane containing a reaction reagent;

[0081] The color block area 23 as the identification module is formed by color block calibration, printing, pasting and cutting, and contains color blocks with specific color values ​​(refer to standard color blocks such as Pantone).

[0082] Specifically, the reaction layer 2 is composed of three groups of reaction strips 24, which are divided into three parts: left, middle and right. The manufacturing process of each group of reaction strips 24 is similar to that of dry chemical test strips. The middle of the left reaction strip is a blank control area or a reaction area, and the upper and lower parts are color block areas; the middle of the middle reaction strip is a connection hole, and the upper and lower parts are reaction areas; the middle of the right reaction strip is a reaction area, and the upper and lower parts are color block areas;

[0083] After the three groups of reaction strips are installed on the lower housing 12, a plurality of reaction areas 22, a plurality of color block areas 23 and a blank control area 21 are arranged to form a ring structure, and the reaction areas 22 and the color block areas 23 are arranged alternately and spaced apart, and the position of the reaction area 22 corresponds to the diffusion layer 3; Figure 3 As shown, T1, T2 and T3 represent three reaction areas respectively; C1, C2, C3 and C4 represent four color block areas respectively, and the coded information corresponding to their combination is associated with the information corresponding to the test combination of the three reaction areas T1, T2 and T3, including test type information, batch number information, calibration equation, etc. When testing, corresponding detection can be performed based on this information to obtain accurate results; B represents the blank control area; of course, the distribution of the reaction area 22 and the color block area 23 at each point can also be redistributed according to actual conditions, and the shape of the corresponding diffusion layer 3 can also be cut as needed. The reaction layer 2 can also be a whole reaction strip, and the design of dividing it into three reaction strips can make customized combinations more convenient.

[0084] Of course, the reaction strips 24 on the reaction layer 2 can also be designed in a unitized manner, that is, the reaction layer 2 is formed by splicing and combining a plurality of splicing units 25; Figure 4 As shown, four first splicing units 251 with the same structure are movably arranged on the reaction layer 2. The first splicing units 251 are in a square structure. A color block area 23 and a reaction area 22 are respectively arranged on each first splicing unit 251. The four first splicing units 251 are spliced ​​around the reaction layer 2; or Figure 5 As shown, two second splicing units 252 with the same structure are movably arranged on the reaction layer 2, and the second splicing units 252 are in an L-shaped structure. Each second unit 252 is respectively provided with a color block area 23 and two reaction areas 22, and the two second splicing units 252 are symmetrically spliced; or, as Figure 6 As shown, two first splicing units 251 and a second splicing unit 252 are movably arranged on the reaction layer 2; of course, a blank control area can also be arranged on any splicing unit of the reaction layer for detection and control. The structure of the reaction layer 2 can be changed more conveniently and quickly by combining splicing units of different shapes, and the combined application is more flexible. The coded information associated with the color block area in each splicing unit is the information of the reaction area thereon, including test type information, batch number information, calibration equation, etc., which can be a color block area associated with a reaction area, or a color block area associated with multiple reaction areas (such as when two reactions have a certain connection, that is, it can only correspond to one color block area), or the coded information corresponding to the combination of more than two color block areas is associated with at least one reaction area information thereon, and the number of information that each color block can encode is determined by the number of colors that can be obtained by printing, and the number of information that the combination of multiple color blocks can encode is determined by the calculation result of the number of combinations.

[0085] The method of taking the value of the color block, in this scheme, blue, green and red light will be used as a composite light source. When this composite light is irradiated onto the target substrate, one or more lights are absorbed, and the unabsorbed light is reflected and received by the receiver, which is a PD receiver (i.e., photodiode) in this embodiment.

[0086] According to the principle of complementary colors, using the absorption characteristics of different color materials to specific wavelengths of light, it can be summarized into the following situations:

[0087] Cyan = green + blue, so cyan materials reflect blue and green light and absorb red light.

[0088] Yellow = red + green, so yellow materials reflect red and green light and absorb blue light.

[0089] Magenta = red + blue, so magenta materials reflect red and blue light and absorb green light.

[0090] White = red + green + blue, all three lights are reflected.

[0091] At the same time, all three kinds of light are absorbed by black. The color blocks use the first letters of English letters to represent different colors of light and their complementary colors as follows:

[0092] Chinese name English initials Red+green+blue (simulating white light) W red R green G blue B green C magenta M yellow Y Cyan+Magenta+Yellow(Black) K

[0093] The method of making color blocks refers to standard color blocks such as Pantone, and color blocks with suitable RGB values ​​(three primary colors) or CMYK values ​​(four primary colors) are selected for printing and reproduction to obtain various color blocks corresponding to the color values. In general, the light source is irradiated onto the color block, and the instrument detects the reflected light that is not absorbed by the color block as the judgment result. For example, blue and yellow are complementary colors. When red, green, and blue light are irradiated onto a certain color block, the amount of reflected light of red and green light obtained by the PD receiver is basically equivalent to the amount of incident light, and the amount of reflected light of blue light is significantly less than the amount of incident light, the color block can be judged to be yellow. For color blocks with two or more light absorption effects, such as the amount of reflected light of red light obtained by the PD receiver is basically equivalent to the amount of incident light, and the amount of reflected light of green and blue light is significantly less than the amount of incident light, the color block can be judged to be a composite color containing yellow and magenta. In general, the color values ​​of the selected color blocks are complementary colors of the corresponding light sources, so that the instrument can better identify them.

[0094] The corresponding relationship between the composite light source, the color block background and the reflected light is as follows:

[0095]

[0096]

[0097] According to the above color settings, each color block has 8 combinations of reflected light that can be detected, so 4 color blocks can theoretically achieve 8*8*8*8=4096 types of coded information. In the present invention, the four primary colors of the background color are set to be either yes or no. In practical applications, the color value of each of the four primary colors can be set to expand the amount of coding. It is currently known that there are 279,840 colors that can be obtained by setting the color value in theory. In fact, due to the deformation error of the "dot" in the printing process and the limitation of the visual recognition threshold, the color that can be obtained by four-color printing is much less than the theoretical value. However, even so, the color that can be obtained is used to encode information, and the amount of coded information that can be obtained is also very huge, which can fully meet the current needs of various detections. In another case, the method of monochrome color value setting can also be adopted, and only monochrome light is used to encode information. Correspondingly, the composite light source in the scheme can be replaced by a monochrome light source.

[0098] These code values ​​can not only be used for the matrix management of batch information of each indicator on a certain test card, but also for the management of unified combination of indicators between different test cards. For example, there are 10 test card products in total, each test card has 3 indicators, and each indicator is set with 100 calibration equations, then the actual code amount required is 10*3*100=3000 code amounts.

[0099] When a light source, which can be a monochromatic light source or a composite light source, is irradiated on the color block area 23, the light that is not absorbed is reflected to the receiver 62 to read the reaction area 22 information associated with the color block area 23. The reaction area 22 information includes the test type and the calibration equation, thereby realizing the function of obtaining specific information such as the test type and the calibration equation of the reaction area 22 through the color block area 23.

[0100] Embodiment 3

[0101] like Fig. 9 As shown, a photochemical POCT all-in-one test system includes a test card 7, a tray 8 for supporting the test card 7, an optical unit 6 located below the tray 8, a bracket 63 for connecting the optical unit 6, and a pressure piece 9 located above the test card 7.

[0102] Part of the structure of the test card 7 is the same as that of the above-mentioned photochemical POCT all-in-one test card, and will not be described in detail. The difference is that there is an isolation area 31 between the diffusion layer 3 and the reaction layer 2.

[0103] The direction where the upper housing 11 is located is defined as upward. Figure 2 and Fig.10 As shown, an elastic component 4 is connected to the lower shell 12, and the elastic component 4 includes a middle axis 41 whose top surface abuts against the lower surface of the diffusion layer 3 and an elastic member 42 sleeved outside the middle axis 41; the middle axis 41 includes an upper body 410, a middle body 411 and a lower body 412, the outer diameter of the lower body 412 is smaller than the outer diameter of the middle body 411, and the outer diameter of the middle body 411 is smaller than the outer diameter of the upper body 410, one end of the elastic member 42 abuts against the intersection of the upper body 410 and the middle body 411, and one end abuts against the limiting groove 121 of the lower shell 12, and the lower body 412 passes through the center of the limiting groove 121; of course, in other embodiments, the elastic component 4 can also be other structural components with a certain rigidity, made of elastic material, and abutting against the diffusion layer 3; the depth of the limiting groove 121 is equivalent to the sum of the heights of the upper body 410 and the middle body 411. Of course, in other embodiments, the lower body 412 may not be provided.

[0104] like Fig.12 As shown, the length of the elastic member 42 is greater than the height of the lower body 412. In the initial state, the elastic member 42 is in a slightly compressed state, and the deformation is recorded as ΔT1. The elastic component 4 presses the diffusion layer 3 upward, that is, in a direction away from the reaction layer 2, so that an isolation zone 31 is formed between the diffusion layer 3 and the reaction layer 2, that is, Fig.10 As shown in , the isolation region 31 is H;

[0105] like Fig.13As shown, when external force is applied to press the upper shell 11 downward, the lower shell 12 remains relatively still. Of course, external force can also be applied to the upper shell 11 and the lower shell 12 at the same time to reduce the distance between the upper shell 11 and the lower shell 12, and the elastic member 42 is further compressed, and the deformation is recorded as ΔT2. At this time, part of the lower body 412 passes through the center of the lower shell 12, and the diffusion layer 3 moves down close to the reaction layer 2 until it passes over the isolation area 31. The upper body 410 and the middle body 411 of the elastic component 4 are trapped in the limiting groove 121, the diffusion layer 3 and the reaction layer 2 are in contact, and the reaction begins.

[0106] The deformation of the elastic member 42 is limited by its length when there is no pressure, and the maximum deformation ΔT3 does not exceed the length of the elastic member 42. Figure 12-14 As shown, ΔT1<ΔT2<ΔT3.

[0107] In this embodiment, a pressure member 9 is disposed above the test card 7 , and the pressure member 9 is used to apply an external force to drive the upper housing 11 to move downward.

[0108] The shape and size of the interior of the tray 8 are adapted to the shape and size of the test card 7. The test card 7 can be placed in the tray 8. A window 81 is formed at the bottom of the tray 8. The window 81 is used to expose at least part of the reaction layer 2 on the test card 7, especially the blank control area 21, the reaction area 22 and the color block area 23.

[0109] The optical unit 6 is arranged below the tray 8, and includes a light source 61 and a receiver 62 arranged along the same radial direction as the light source 61. The optical unit 6 is integrally fixedly connected to a bracket 63 and rotates synchronously with the bracket 63. The bracket 63, the tray 8 and the test card 7 are arranged concentrically.

[0110] In order to meet the diversity of detection of the reaction layer 2, a light source containing red, green and blue light is usually selected, but a monochromatic light source can also be selected; for example, the wavelength of blue light is 400-450nm, the wavelength of green light is 490-550nm, and the wavelength of red light is 600-630nm. If you consider using a light source, the detection of optical reactions generally chooses green light. Then the color card of the color block area 23 chooses magenta, and then different color cards have different magenta values. Different reflection values ​​are obtained after green light irradiation as coding signals. Therefore, the smallest optical unit can be designed as a light source or a light source group and a PD receiver 62. The optical unit 6 is fixed on an annular bracket 63, and the light source 61 is facing a certain reaction area 22 or color block area 23. Fig.16 When the detection is as Figure 3When the reaction test paper shown corresponds to the test card, the annular bracket 63 rotates concentrically around the test card 7 during the detection process, and the rotation angle is 45° each time. Therefore, when the annular bracket 63 rotates one circle, the optical unit 6 can collect a total of 8 groups of signal values, including 4 groups of color block area 23 coding values, 3 groups of reaction area 22 signal values ​​and 1 group of blank control area 21 background values. The coding information of the 4 groups of color block areas 23 corresponds to the information of the 3 groups of reaction areas 22 respectively, and the remaining one color block area is associated with the combination information of the entire reaction test paper.

[0111] Since the rotation angle of the bracket 63 is pre-set and fixed, the detection hole position at the bottom of the test card 7 should also be fixed when it is placed in the photochemical POCT all-in-one test system instrument. Therefore, it is necessary to make a small improvement to the shell of the test card 7 and design it into an incomplete circle to facilitate the determination of its position and direction in the instrument. Fig.15 As shown, the test card 7 may form a square or pointed positioning portion 71 at a peripheral edge portion to facilitate identification of the starting position.

[0112] Generally, the entire photochemical POCT all-in-one test system instrument can be designed in a hatch opening manner. After the hatch is opened, the test card 7 is placed on the tray 8 in the instrument, the hatch is closed, and then the instrument is started. The pressure piece 9 is set at a position above the instrument directly opposite the tray 8. In the initial state, it is retracted upward. After the optical unit 6 confirms that the sample is fully diffused by detecting the blank control area 21, or after a certain set time, the pressure piece 9 extends downward to contact the upper shell 11 and exerts a downward force, so that the upper shell 11 sinks as a whole, and the diffusion layer 3 contacts the reaction layer 2 on the lower shell 12. On the other hand, the annular bracket 63 below the tray 8 and the optical unit 6 thereon begin to detect and receive signals from the reaction area 22 and the color block area 23.

[0113] The outer diameter of the pressure member 9 is not larger than the outer diameter of the upper shell 11 of the test card 7, and the inner diameter is not smaller than the outer diameter of the sample channel 111 at the central opening of the upper shell 11. The outer diameter of the tray 8 is not smaller than the outer diameter of the test card 7, and the inner diameter matches the outer diameter of the test card 7, so that the test card can just fit into the tray. There is no requirement for the outer diameter and inner diameter of the annular bracket 63 of the optical unit 6, as long as the optical unit 6 can complete the functions of light source emission and reception.

[0114] The number of optical units 6 can be one or more. If there are more than one, the multiple optical units 6 are symmetrically distributed on the bracket 63. That is, considering that multiple groups of optical units 6 participate in the measurement, the optical units 6 can be symmetrically distributed on the annular bracket 63. During the test, it only needs to be rotated by a certain angle to achieve simultaneous measurement of multiple groups of reaction areas 22.

[0115] The single optical unit 6 includes a red, green and blue light source 61 and a PD receiver 62. Fig.16 During the test shown, the optical unit 6 rotates clockwise from the starting position by 45°, 90°, 90° and 90° in sequence to complete the reading of the coded signals of the four color block areas 23, and then completes the signal reading of each reaction area 22 according to the program setting.

[0116] like Fig.17 As shown, the optical unit 6 is increased to four groups, each group includes a red, green and blue light source 61 and a PD receiver 62. Fig.16 For the same test card, the annular bracket 63 rotates 45° from the initial position to complete the reading of the coded information of the four color block areas 23, and then rotates 45° counterclockwise to return each optical unit 6 to the detection position of the reaction area 22 to complete the signal reading.

[0117] like Fig.18 As shown, the PD receiver 62 can also be placed at the center of the annular bracket 63. During testing, the bracket 63 rotates 45° clockwise to complete the reading of the coded signal of the color block area 23, and then rotates 45° counterclockwise to complete the reading of the signal of the reaction area 22.

[0118] Reduce the number of light sources in each optical unit 6, such as Fig.19 As shown, the red, green and blue light sources are set separately, and each light source is assigned a PD receiver. During the test, the ring bracket 63 rotates clockwise by 45°, 90°, 90° and 90° in sequence, and each light source 61 completes the reading of the coded signal of the four color block areas 23 respectively, and then according to the program setting, 1 to 3 of the light sources are rotated to the corresponding reaction area 22 to complete the signal reading. It can also be as Fig. 20 As shown, three light sources share one PD receiver, and only one light source is turned on during each test.

[0119] The working process of the photochemical POCT all-in-one test system is that, in the initial state, the diffusion layer 3 and the reaction layer 2 are separated from each other, and the deformation of the elastic member 42 is ΔT1. After the sample is added to the sample channel 111, the sample passes through the filter layer 5 to reach the diffusion layer 3 and diffuses evenly. The time for the uniform diffusion is determined. Then, after the upper shell 11 is squeezed by the external force of the pressure member 9, the elastic member 42 is compressed, the diffusion layer 3 and the reaction layer 2 are in contact, and the sample evenly distributed in the diffusion layer 3 is mixed with the reagent in the reaction layer 2. At this time, the deformation of the elastic member 42 is ΔT2. When the lower body 412 is provided, part of the lower body 412 passes through the central opening of the lower shell 12.

[0120] The light source 61 illuminates the color block area 23, and the light that is not absorbed is reflected to the receiver 62. The receiver 62 reads the information of the reaction area 22 associated with the color block area 23, thereby obtaining the test type and calibration equation of the reaction area 22; then the light source 61 illuminates the reaction area 22, and the light that is not absorbed is reflected to the receiver 62. The receiver 62 reads and calculates to obtain the test result. This calculation step is a prior art and will not be repeated here.

[0121] A photochemical POCT all-in-one testing method comprises the following steps:

[0122] S1. Start the instrument, the instrument enters the self-test program, and measures the black level signal (if multiple test cards are tested at the same time, this step only needs to be performed during the first test);

[0123] S2, selecting a test card with associated color block area and reaction area information;

[0124] S3, after adding blood sample to the sample channel;

[0125] S4. Open the instrument door, place the test card in the tray, close the door, and start the test program.

[0126] S5. The bracket rotates with the optical unit, and rotates to the blank control area and each reaction area in turn, measures and records the reflection signal of each area, and determines whether the test card is usable;

[0127] S6. If the test card is available, the optical unit rotates a fixed angle through the annular bracket to measure the reflection signal of each color block area in turn to determine the test card type and calibration equation; for example, when the initial detection position is the color block area, and there are 4 color block areas on the reaction area, the annular bracket is fixedly rotated clockwise 4 times to measure the reflection signal of each color block area, and the test card type and calibration equation are determined by the reflection signal correspondence;

[0128] S7, the annular bracket rotates with the optical unit to the blank control area, continuously measures the reflection signal and records the result to judge whether the sample diffusion is complete; when the reflection signal of the blank control area changes, it is recorded as T0; continue to detect, when the reflection signal tends to be stable, it is recorded as T1;

[0129] Of course, if the time of steps S4-S6 is greater than the maximum time required for sample diffusion or sufficient time has been given to the sample to diffuse in steps S4-S6, step S7 can be omitted;

[0130] S8, the pressure piece extends downward to apply a downward pressure to the upper shell, causing the upper shell to sink, and the diffusion layer on the upper shell contacts the reaction layer on the lower shell;

[0131] S9, maintaining this pressure, the optical unit on the annular support rotates to each reaction area, measures the reflection signal, records the time of obtaining the reflection signal of each reaction area, recorded as T2, T3, T4, etc., and calculates the result;

[0132] S10, the optical unit on the annular bracket returns to its original position, the pressure piece shrinks upward, the test card returns to its original state, and the test is completed;

[0133] S11. The instrument displays the result and prompts you to take out the test card;

[0134] S12. Open the door and take out the test card.

[0135] The above specific implementation modes are used to explain the present invention rather than to limit the present invention. Any modification and change made to the present invention within the spirit of the present invention and the protection scope of the claims shall fall within the protection scope of the present invention.

Claims

1. A photochemical POCT all-in-one test system, characterized in that include: A test card (7) comprises an upper shell (11) provided with a sample channel (111) running through the upper and lower shells (12), a diffusion layer (3) at least partially arranged in the sample channel (111), and a reaction layer (2) arranged opposite to the diffusion layer (3); the cross section of the diffusion layer (3) is cross-shaped or convex-shaped so that the sample can diffuse to multiple sites; the reaction layer (2) is provided with at least one reaction area (22) and at least one identification module associated with the reaction area (22); an isolation area (31) is provided between the diffusion layer (3) and the reaction layer (2), and when the sample diffuses, the diffusion layer (3) and the reaction layer (2) do not contact each other; After the diffusion of the sample is completed, an external force is applied to drive the upper shell (11) and the lower shell (12) to approach each other, and the diffusion layer (3) and the reaction layer (2) cross the isolation zone (31) and come into contact with each other; an elastic component (4) for forming the isolation zone (31) is provided between the upper shell (11) and the lower shell (12); the elastic component (4) is located at the center of the upper shell (11) and the lower shell (12); the outer peripheral edge of the upper shell (11) forms a clamping portion (112); the inner wall of the top opening of the lower shell (12) forms a buckle portion (122) that is matched and connected with the clamping portion (112); the clamping portion (112) and the buckle portion (122) are matched and connected to realize the movable connection between the upper shell (11) and the lower shell (12); The body (12) is provided with a limiting groove (121), and part of the elastic component (4) abuts against the limiting groove (121); the elastic component (4) comprises a central axis (41) and an elastic member (42) sleeved outside the central axis (41); the central axis (41) comprises an upper body (410) whose top end surface abuts against the lower surface of the diffusion layer (3), and a middle body (411); the outer diameter of the middle body (411) is smaller than the outer diameter of the upper body (410); one end of the elastic member (42) abuts against the intersection of the upper body (410) and the middle body (411), and the other end abuts against the limiting groove (121) of the lower shell body (12); a plurality of reaction areas (22), a plurality of identification modules and a blank control area (21) are arranged to form a ring structure; The diffusion layer (3) has multiple sites and multiple reaction areas (22) so that multiple tests can be performed simultaneously. A tray (8) for supporting the test card (7), wherein a window (81) is provided at the bottom thereof for exposing at least a part of the reaction layer (2); An optical unit (6) comprising a light source (61) and a receiver (62) disposed near the light source (61); The bracket (63) is annular and is used to connect the optical unit (6) and move with the optical unit (6); When the light source (61) illuminates the identification module, the light is reflected to the receiver (62) to read the information of the reaction area (22) associated with the identification module.

2. The photochemical POCT all-in-one test system according to claim 1, characterized in that: The identification module is a color block area (23).

3. The photochemical POCT all-in-one test system according to claim 2, characterized in that: It also includes a pressure piece (9) disposed above the tray (8) and used to apply external force to drive the upper shell (11) to move downward.

4. The photochemical POCT all-in-one test system according to claim 3, characterized in that: The reaction layer (2) comprises a plurality of mutually independent reaction strips (24), each reaction strip (24) being provided with at least one reaction area (22) or at least one color block area (23); the information of the reaction area (22) comprises a test type and a calibration equation.

5. The photochemical POCT all-in-one test system according to claim 4, characterized in that: At least one blank control area (21) is provided on the reaction layer (2); the support (63) is arranged concentrically with the tray (8) and the test card (7).

6. The photochemical POCT all-in-one test system according to claim 1, characterized in that: The number of the optical units (6) is one or more; when the number of the optical units (6) is more than one, the multiple optical units (6) are symmetrically distributed on the bracket (63) and rotate synchronously with the bracket (63).

7. A photochemical POCT all-in-one testing method, implemented by the system described in any one of claims 3, 4, and 5, characterized in that The following steps are involved: S1. Select the test card with associated color block area and reaction area information, add the blood sample to the sample channel, and place the test card into the tray; S2, the bracket rotates with the optical unit, and measures the reflection signal of each color block area in turn to determine the test card information; S3, the pressure piece applies downward pressure on the upper shell, and the diffusion layer contacts the reaction layer; S4. While keeping the diffusion layer and the reaction layer in contact, the bracket rotates with the light source to measure the reflection signal of each reaction area, records the time of obtaining the reflection signal of each reaction area, and calculates the test results.

8. The photochemical POCT all-in-one testing method according to claim 7, characterized in that: The following steps are performed before step S1: starting the instrument, entering the self-test program, and measuring the black level signal.

9. The photochemical POCT all-in-one testing method according to claim 7, characterized in that: The step S2 is preceded by the following step: the bracket rotates with the optical unit, and the reflection signals of the blank control area and each reaction area are measured in turn to determine whether the test card is usable.

10. The photochemical POCT all-in-one testing method according to claim 7, characterized in that: The step S3 is preceded by the following steps: the support is rotated to the blank control area, and the reflection signal is continuously measured to determine whether the sample diffusion is complete.

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