CN113533312A - Photochemical POCT (point of care testing) all-in-one test card - Google Patents
Photochemical POCT (point of care testing) all-in-one test card Download PDFInfo
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- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
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- G01N21/84—Systems specially adapted for particular applications
- G01N21/8483—Investigating reagent band
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
- G01N21/77—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
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Abstract
The invention discloses a photochemical POCT (point of care testing) all-in-one test card, which comprises: the upper shell is provided with a sample channel penetrating through the inside and the outside of the upper shell; the lower shell is movably connected with the upper shell and is provided with a reaction layer; the diffusion layer is at least partially arranged in the sample channel and at least partially arranged opposite to the reaction layer; when the sample is diffused, the diffusion layer is not contacted with the reaction layer; the sample is diffused completely and the diffusion layer and the reaction layer are in contact. The sample is fully diffused and then contacts the reaction layer for reaction, so that the reaction result is more accurate; the same system instrument can detect a plurality of different indexes, and can integrate a plurality of detection indexes more flexibly; by identifying the association between the module area and the reaction area, the feasibility of various types of reaction arbitrary codes is realized, and the code amount is greatly increased; the test operation is simple and easy, and the test cost is reduced.
Description
Technical Field
The invention belongs to the technical field of photochemical detection, and particularly relates to a photochemical POCT (point of care testing) all-in-one test card.
Background
With the progress of scientific technology and the wide application of point of care testing (POCT) in the field of examining medicine, more and more detection indexes and products are developed. The optical PCOT biochemical detection product occupies an indispensable proportion in-vitro diagnosis and detection, comprises diabetes series indexes, renal function series indexes, liver function series indexes, blood/urine biochemical indexes and the like, is manufactured into a dry chemical test strip form, and is used together with a matched miniaturized detection instrument to provide a quick, simple and accurate quantification result. The product form is mainly divided into two forms of a single test strip for analyte detection and a plurality of test strips for analyte detection. However, so far, the test strips for detecting single analyte or multiple analyte have the traditional multilayer stacking design, and the design of the diffusion layer plus the reaction layer, or the design of the filter layer plus the diffusion layer plus the reaction layer, or the design of the diffusion layer plus the filter layer plus the reaction layer is selected according to the needs, and the layers are directly stacked, and after the test sample is added, the stay time of the sample in each layer completely depends on the characteristics of the sample and the characteristics of the layer material, and can generate certain influence on the reaction result.
The patent US10145854 provides a test card, and each test card of the corresponding product contains three reagents which respectively correspond to three indexes of total cholesterol, triglyceride and HDL-C. When the device is used, a sample is dripped into the sample adding hole, the sample is uniformly distributed on the sample by the diffusion action of the diffusion layer, then the red blood cells are intercepted by the filter layer, the plasma reaches the reaction layer which is uniformly divided into three parts by penetrating through the filter layer, and is respectively mixed and reacted with corresponding reagents on the reaction layer, and all results can be obtained after a plurality of minutes. The diffusion layer, the filter layer and the reaction layer of the product are mutually stacked and contacted, and under the condition that a sample is not uniformly diffused, part of the sample may reach the reaction layer after the sample is firstly filtered, so that the accuracy of a reaction result is influenced to a certain extent.
Disclosure of Invention
In order to overcome the defects of the prior art, the invention provides the photochemical POCT all-in-one test card which has accurate test results, can simultaneously carry out various tests and has a simple and easy method.
The technical scheme adopted by the invention for solving the technical problems is as follows: a photochemical POCT all-in-one test card, comprising:
the upper shell is provided with a sample channel penetrating through the inside and the outside of the upper shell;
the lower shell is movably connected with the upper shell and is provided with a reaction layer;
the diffusion layer is at least partially arranged in the sample channel and at least partially arranged opposite to the reaction layer;
when the sample is diffused, the diffusion layer is not contacted with the reaction layer; the sample is diffused and the diffusion layer is in contact with the reaction layer.
The diffusion layer and the reaction layer are mutually separated in the initial state, and the diffusion layer is contacted with the reaction layer after the sample is fully diffused in the diffusion layer, so that the condition that part of the sample reaches the reaction layer first is effectively avoided, and the accuracy of the reaction result is ensured.
Furthermore, an isolation region is arranged between the diffusion layer and the reaction layer, 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 are in contact across the isolation region. The separation of upper housing and lower casing has been guaranteed in the setting of isolation region, and is easy and simple to handle when needing upper housing and lower casing contact.
Furthermore, the reaction layer is provided with at least one reaction area and at least one identification module associated with the reaction area. The reaction area is associated with the identification module, and the reaction area information associated with the identification module can be read when the light source irradiates the identification module, so that one test system can simultaneously detect a plurality of items, the form that test cards and instruments need to be paired one by one in the traditional detection method is changed, and the detection is more flexible.
Further, the identification module is a color patch area, and when the light source irradiates the color patch area, the light is reflected to the receiver to read the reaction area information associated with the color patch area. The method is simple and easy to implement by distinguishing different reaction areas through colors, and due to the diversity of the colors, the coding modes of the color block areas are more diversified, the coding amount is huge, and the requirements of various types of detection can be met.
Further, the reaction zone information comprises a test type and a calibration equation.
Further, at least one blank control area is arranged on the reaction layer.
Furthermore, the blank control area, the reaction area and the color block area are arranged in a surrounding manner to form a ring shape. Several regions enclose to establish the ring-shaped signal of being convenient for support circumference rotation to drive the rotatory receipt color lump district of optical element and send, and structural design is more reasonable.
Further, the light source is a composite light source. Through the composite light source irradiation identification module, the information received by the receiver is more diversified, and the coding amount of the color block area is larger.
Further, the reaction layer comprises a plurality of mutually independent reaction strips, and each reaction strip is provided with at least one reaction area or at least one recognition module or blank control area. The design of a plurality of reaction strips realizes that the same reaction layer carries out the function that multiple different projects detected, detects more diversified.
The test card of the invention can have the function of automatic filtration of red blood cells, when a sample is dripped, the red blood cells are intercepted by penetrating through the filter membrane under the action of self gravity, and the plasma components continuously permeate downwards and are absorbed and filled by the diffusion layer, which is a dynamically changing process. This process can vary depending on sample differences, such as hematocrit.
The optical unit on the system monitors the process in real time and judges the variation of the reflected signal through the wetting effect on the extension of the diffusion layer. When the amount of change exceeds a threshold value, it is determined that the plasma fills the entire diffusion layer, and the instrument provides a downward pressure to the upper housing, causing the diffusion layer on the upper housing to contact the reaction layer on the lower housing, whereupon the plasma components are transferred to the reaction layer and react with the reagent thereon to develop color. Meanwhile, the optical unit monitors the color reaction on the reaction layer, reads the reflection signal, and gives a result through calculation.
By the method, the whole reaction is marked as the starting point of the reaction from the contact of the plasma and the reagent, and is marked as the ending point of the reaction when the color development intensity reaches the peak value, so that the measurement of the reaction time sequence is more accurate. Other similar products also have the red blood cell filtering function, but the diffusion layer and the reaction layer are not separated in advance through a reasonable method, the plasma filtered out firstly in the filtering process is contacted with the reaction reagent through the diffusion layer at the same time to start the chromogenic reaction, and the plasma sample which is not filtered out needs to be delayed for being filtered and then contacted with the reaction reagent to generate the chromogenic reaction, so the design can be interfered by the difference of the filtering efficiency of the sample to generate the interference on the result, and the detection result is inaccurate.
The test card is also provided with an identification module which is designed into color block areas, the set of the color block areas can provide abundant coding information, the coding value can be determined according to the received reflected light information through corresponding red, green and blue light sources on a system instrument and various composite bottom colors on the color block areas, the information of the corresponding test card detection indexes and the calibration equation corresponding to each detection index are found through a coding matrix preset in a program, and the accuracy of the result is ensured.
The coded values can be used for two purposes, one of which is to define index sets with different combinations, such as three items of blood fat, ALT + AST, blood routine and the like, and when a user selects a test card meeting expected requirements, the instrument can automatically find the corresponding index items and complete corresponding tests through the coded information on the color block areas on the test card; and the other is used for defining a calibration equation used for calculating a result under a specific index, and the instrument reads the coding information on the color block, automatically identifies the batch number of the corresponding index and finds the corresponding calibration equation for calculating the result.
And a set of optical units capable of detecting signals of the plurality of sets of reaction regions and color patch regions by rotation of the ring-shaped support connected thereto. The design reduces deviation of results caused by difference between the light sources as much as possible, and saves cost of optical components. Because multiple reactions begin simultaneously when the diffusion layer on the test card is brought into contact with the reaction layer, a single set of optical elements must be programmed to read the reflected signal values on each reaction layer at a time and calculate the results. According to the curve of the color reaction and the calculation logic, generally, only the reflection signal value of the maximum signal interval or the reaction interval with the fastest signal change needs to be read, so that the signal reading of a plurality of reaction areas can be completed by setting the reaction time of different indexes on the same test card in sequence (namely, according to the sequence of reaching the maximum signal interval) and then reading the reaction end point one by one. If multiple sets of optical units are arranged on the ring support, the reading time of each set of optical units for each reaction area signal is greatly improved.
The invention has the beneficial effects that: 1) the sample is fully diffused and then reacts with the reaction layer, so that the reaction result is more accurate; 2) the same system instrument can detect a plurality of different indexes, and can integrate a plurality of detection indexes more flexibly; 3) by identifying the association between the module area and the reaction area, the feasibility of various types of reaction arbitrary codes is realized, and the code amount is greatly increased; 4) the test operation is simple and easy, and the test cost is reduced.
Drawings
Fig. 1 is a perspective view of a first embodiment of the present invention.
Fig. 2 is an exploded view of a second embodiment of the present invention.
FIG. 3 is a bottom view of the reaction layer in the second embodiment of the present invention.
Fig. 4 is a bottom view of a first reaction layer structure in a second embodiment of the invention.
Fig. 5 is a bottom view of a second reaction layer structure in the second embodiment of the present invention.
Fig. 6 is a bottom view of a third reaction layer structure in the second embodiment of the present invention.
Fig. 7 is a schematic cross-sectional view of a diffusion layer according to a second embodiment of the invention.
Fig. 8 is a second cross-sectional view of a diffusion layer in a second embodiment of the invention.
Fig. 9 is an exploded view of a third embodiment of the present invention.
Fig. 10 is a cross-sectional view of an initial state of the test card according to the third embodiment of the present invention.
Fig. 11 is a sectional view showing a use state of the test card according to the third embodiment of the present invention.
Fig. 12 is a simplified diagram of the state of the elastic element with the deformation amount Δ T1 according to the third embodiment of the present invention.
Fig. 13 is a simplified diagram of the state of the elastic element with the deformation amount Δ T2 according to the third embodiment of the present invention.
Fig. 14 is a simplified diagram of the state of the elastic element with the deformation amount Δ T3 according to the third embodiment of the present invention.
FIG. 15 is a schematic diagram of three shapes of a test card according to a third embodiment of the present invention.
FIG. 16 is a schematic diagram of the optical unit and the reaction layer in the third embodiment of the present invention.
Fig. 17 is a schematic view illustrating four optical units symmetrically disposed on a bracket according to a third embodiment of the present invention.
Fig. 18 is a schematic view of a receiver placed in the center of a bracket according to a third embodiment of the present invention.
Fig. 19 is a schematic diagram of three light sources separately arranged in the third embodiment of the present invention.
Fig. 20 is a schematic diagram of a receiver shared by three light sources according to a third embodiment of the present invention.
Detailed Description
In order to make the technical solutions of the present invention better understood, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
Example one
As shown in fig. 1, a reaction strip for photochemical POCT detection includes a strip body 20, at least one reaction area 22 formed on the strip body 20, and at least one identification module associated with the reaction area 22, wherein the identification module may be a color block area 23;
of course, at least one blank control area 21 may be formed on the test strip body 20;
in this embodiment, there are a plurality of reaction regions 22 and color block regions 23, the combination of the reaction regions 22 and the color block regions 23 is related, and each combination of the color blocks includes information of the reaction region of each test combination;
of course, in other embodiments, the reaction regions 22 and the color block regions 23 are associated one by one, that is, the number of the reaction regions 22 is the same as the number of the color block regions 23, and one color block region contains information of one reaction region;
or in other embodiments, the plurality of reaction regions 22 may correspond to one color block region 23, that is, one color block region 23 is associated with at least one reaction region 22, and one color block region contains information of a plurality of reaction regions.
The test strip body 20 is divided into a plurality of mutually independent test strips 201, and each test strip 201 is provided with at least one reaction area 22, or at least one color block area 23, or a blank control area 21;
a plurality of reaction zones 22, a plurality of color lump zones 23 and a blank control zone 21 are encircled to form a ring-shaped structure;
as shown in fig. 16, when a light source, which may be a single-color light source or a composite light source, irradiates on the color block area 23, the unabsorbed light is reflected to the receiver 62 to read the information of the reaction area 22 associated with the color block area 23, where the information of the reaction area 22 includes the test type and the calibration equation, so as to achieve the function of acquiring specific information of the reaction area 22, such as the test type and the calibration equation, through the color block area 23.
Example two
As shown in fig. 2, a photochemical POCT all-in-one test card includes an upper housing 11, a lower housing 12 movably connected to the upper housing 11, a reaction layer 2, and a diffusion layer 3 at least partially disposed in a body channel 111; a sample passage 111 penetrating the inside and outside of the upper case 11 in the thickness direction is formed, as shown in fig. 10, a filter layer 5 may be provided in the sample passage 111, and a mounting groove 114 may be formed in the lower surface of the upper case 11 for mounting the filter layer 5, the mounting groove 114 may be concentrically disposed with the sample passage 111; the shape and size of the mounting groove 114 are matched with those of the filter layer 5, so that the filter layer 5 can be tightly clamped in the mounting groove 114, and in other embodiments, a detection sample can be directly detected without filtering, and a filter layer and a structure corresponding to the filter layer are not required to be arranged;
the peripheral edge of the upper shell 11 forms a clamping part 112, the top opening inner wall of the lower shell 12 forms a buckling part 122 matched and connected with the clamping part 112, and the clamping part 112 and the buckling part 122 are matched and connected to realize the movable connection of the upper shell 11 and the lower shell 12.
Specifically, the fastening portion 112 is an annular flange extending radially from the lower portion of the upper housing 11, the fastening portion 122 is formed by a partial protrusion of the inner wall of the top opening of the lower housing 12, the outer wall of the fastening portion 112 forms an arc-shaped surface, and the fastening portion 122 also forms an arc-shaped structure towards the opening side of the lower housing 11 for facilitating the fastening portion 112 to slide in; 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 housing 11 near the annular flange, and the annular groove serves as a notch portion 113 for providing deformation space for the clamping portion 112, so that the clamping portion 112 has sufficient elasticity, and the movable connection between the upper housing 11 and the lower housing 12 is ensured to be more stable.
The diffusion layer 3 can be directly arranged below the upper shell 11, or can be fixedly connected to the lower surface of the upper shell 11 by means of bonding and the like, and is in contact with the filter layer 5 to firmly support the filter layer in the mounting groove 114; as shown in fig. 7 and 8, the cross section of the diffusion layer 3 may be cross-shaped or convex, and the shape design can meet the requirement that a sample is diffused to multiple sites after passing through the filter layer 5, so as to realize the reaction and detection of multiple indexes, reduce the loss of leftover materials during cutting, and save cost;
the reaction layer 2 is arranged on the lower shell 12 and can be directly arranged on the lower shell 12 or fixedly connected with the inner surface of the lower shell 12, and the diffusion layer 3 is arranged opposite to the reaction layer 2 up and down.
The structure of the reaction layer 2 is the same as that of the reaction test paper, and comprises a plurality of mutually independent reaction strips 24, wherein each reaction strip 24 is provided 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; the lower case 12 is formed with an observation window 123 facing at least a partial region of the reaction layer 2, and in this embodiment, at least the reaction region 22, the color patch region 23 and the blank control region 21 are exposed to the observation window 123.
The reaction regions 22 and the color block regions 23 are associated with each other, and in the present embodiment, the number of the reaction regions 22 is the same as the number of the color block regions 23, that is, the plurality of reaction regions 22 and the plurality of color block regions 23 are uniquely associated with each other; of course, it is also possible to have a plurality of reaction zones 22 corresponding to one color patch 23, i.e., one color patch 23 is associated with at least one reaction zone 22.
In this embodiment, the filter layer 5 is a square sheet cut from a sheet material to 5mm × 5mm, and is made of dense filter paper, glass fiber, etc. for blocking red blood cells in whole blood test;
the diffusion layer 3 is formed by cutting a sheet into a cross-shaped or convex-shaped sheet through a die cutting process, and a glass fiber material with good hydrophilicity is selected for diffusion of a plasma sample;
the reaction layer 2 is formed by membrane treatment, membrane cutting, membrane pasting and cutting, and is an asymmetric porous membrane containing a reaction reagent;
the color patch area 23 as the identification module is formed by color patch setting, printing, pasting, and cutting, and contains color patches of specific color values (refer to standard color patches such as Pantone).
Specifically, the reaction layer 2 is composed of three groups of reaction strips 24, which are divided into a left part, a middle part and a right part, the manufacturing process of each group of reaction strips 24 is similar to that of a dry chemical test strip, the middle of the left reaction strip is a blank control area or a reaction area, and the upper part and the lower part of the left reaction strip are color block areas; the middle of the middle reaction strip is provided with a connecting hole site, and the upper part and the lower part of the middle reaction strip are reaction zones; the middle of the right reaction strip is a reaction area, and the upper part and the lower part of the reaction strip are color lump areas;
after the three groups of reaction strips are arranged on the lower shell 12, a plurality of reaction areas 22, a plurality of color block areas 23 and a blank contrast area 21 are encircled to form a ring-shaped structure, the reaction areas 22 and the color block areas 23 are alternately arranged at intervals, and the positions of the reaction areas 22 correspond to the diffusion layer 3; as shown in fig. 3, T1, T2, and T3 represent 3 reaction zones, respectively; c1, C2, C3 and C4 respectively represent 4 color block areas, the coded information corresponding to the combination of the color block areas is related to the information corresponding to the test combination of the three reaction areas T1, T2 and T3, the information comprises test type information, batch number information, a calibration equation and the like, and when the test is carried out, corresponding detection can be carried out according to the information to obtain an accurate result; b represents a blank control zone; in this embodiment, the color block corresponding to each reaction area is associated with the information of the respective reaction area, the color block corresponding to the blank control area is associated with the combination information of the whole reaction test paper, in other embodiments, the blank control area is replaced by the reaction area, and the color block corresponding to the blank control area is associated with the information of the replaced reaction area. Of course, the distribution of the reaction region 22 and the color lump region 23 at each site may be redistributed as the case may be, and the shape of the corresponding diffusion layer 3 may be cut as needed. The reaction layer 2 can also be a whole reaction strip, and the design of dividing into three reaction strips can make the customization combination more convenient.
Of course, the reaction strips 24 on the reaction layer 2 may 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; as shown in fig. 4, 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, each first splicing unit 251 is respectively provided with one color lump area 23 and one reaction area 22, and the four first splicing units 251 are spliced to surround the reaction layer 2; or, as shown in fig. 5, two second splicing units 252 with the same structure are movably arranged on the reaction layer 2, the second splicing units 252 are in an L-shaped structure, each second unit 252 is respectively provided with one color block area 23 and two reaction areas 22, and the two second splicing units 252 are symmetrically spliced; alternatively, as shown in fig. 6, two first splicing units 251 and one second splicing unit 252 may be movably disposed on the reaction layer 2; of course, a blank control area can be arranged on any splicing unit of the reaction layer for detecting the control. The structure of the reaction layer 2 can be changed more conveniently and rapidly by combining splicing units with different shapes, and the combination and the application are more flexible. The coded information associated with the color block area in each splicing unit is information of a reaction area thereon, including test type information, batch number information, scaling equation and the like, and can be that one color block area is associated with one reaction area, or one color block area is associated with a plurality of reaction areas (if two reactions have a certain relation, only one color block area can be associated), or at least one piece of reaction area information associated with coded information corresponding to a combination of two or more color block areas is associated with the coded information thereon, the number of information that each color block can code is determined by the number of colors that can be obtained by printing, and the number of information that a combination of a plurality of color blocks can code is determined by the calculation result of the number of combinations.
The color block is taken as a composite light source in the scheme, blue light, green light and red light are taken as composite light sources, when the composite light is irradiated on a target substrate, one or more kinds of light are absorbed, and the light which is not absorbed is reflected and then received by a receiver, in this embodiment, a PD receiver (namely a photodiode).
According to the principle of complementary colors, the absorption characteristics of different color materials for light with specific wavelength can be summarized as the following cases:
cyan + blue, so cyan materials reflect blue and green light and absorb red light.
Yellow is red + green, so yellow material reflects red and green light, absorbing blue light.
Magenta is red + blue, so the magenta material reflects red and blue light, absorbing green light.
White-red + green + blue, all three lights are reflected.
While all three lights are absorbed by black. The color blocks are obtained by substituting different colors of light and complementary colors thereof with English initials as follows:
| name of Chinese | English initials |
| Red + green + blue (simulation white light) | W |
| Red wine | R |
| Green | G |
| Blue (B) | B |
| Green leaf of Chinese cabbage | C |
| Fuchsin | M |
| Yellow colour | Y |
| Cyan + magenta + yellow (Black) | K |
The color block making process refers to standard color blocks of Pantone, etc. and selects suitable color blocks of RGB value or CMYK value for printing and copying to obtain color blocks corresponding to color values. In general, a light source is irradiated onto a color patch, and an instrument detects reflected light not absorbed by the color patch as a determination result. For example, blue and yellow are complementary colors, and when three colors of red, green and blue are respectively irradiated to a certain color block, the reflected light amounts of red and green light acquired by the PD receiver substantially correspond to the incident light amount, and the reflected light amount of blue light is significantly smaller than the incident light amount, the color block can be determined to be yellow. For two or more color patches having light absorption effects, for example, when the amount of reflected light of red light acquired by the PD receiver is substantially equal to the amount of incident light, and the amount of reflected light of green light and blue light is significantly smaller than the amount of incident light, the color patch can be determined to be a composite color containing yellow and magenta. Typically, the color values of the selected color patches are all complementary colors of the corresponding light sources so that the instrument can better recognize them.
The corresponding relation among the composite light source, the color block ground color and the reflected light is as follows:
| light source | Color block ground color | Reflected light | Reflection value code | |
| RGB | M+Y | R | 1 | |
| RGB | C+ | G | 2 | |
| RGB | M+ | B | 3 | |
| | C | GB | 23 | |
| RGB | M | RB | 13 | |
| | Y | RG | 12 | |
| | W | RGB | 123 | |
| RGB | K | Is free of | 4 |
With the above color arrangement, 8 combinations of reflected light per color patch can be detected, and then 4 color patches can theoretically achieve 8 × 8 — 4096 amounts of encoded information. In the invention, the difference of existence or nonexistence of the four primary colors of the ground color is set, the color value of each four primary color can be set in practical application, the coding amount is expanded, 279840 colors which can be obtained by setting the color value are known theoretically at present, actually, the colors which can be obtained by four-color printing are much less than the colors which can be obtained theoretically due to the deformation error of the dot in the printing process and the limitation of visual identification threshold, but even if the colors which can be obtained practically are used for coding information, the obtained coding information amount is huge, and the requirements of various types of detection at present can be completely met. In another case, a monochrome value setting mode can also be adopted, information is coded by using only monochrome light, and accordingly, the composite light source in the scheme can be replaced by the monochrome light source.
The code values can be used for matrix management of batch information of each index on a certain test card, and can also be used for management of index unified combination among different test cards. For example, there are 10 test card products in total, each test card has 3 indexes, each index is provided with 100 scaling equations, and then the actual code amount needs 10 × 3 × 100 — 3000 code amount.
When a light source, which may be a single-color light source or a composite light source, is irradiated on the color block area 23, the unabsorbed light is reflected to the receiver 62 to read the information of the reaction area 22 associated with the color block area 23, and the information of the reaction area 22 includes the test type and the calibration equation, so as to achieve the function of acquiring specific information of the test type, the calibration equation, and the like of the reaction area 22 through the color block area 23.
EXAMPLE III
As shown in fig. 9, an all-in-one photochemical POCT test system includes a test card 7, a tray 8 for holding the test card 7, an optical unit 6 located below the tray 8, a support 63 for connecting the optical unit 6, and a pressure member 9 located above the test card 7.
The structure of the test card 7 is the same as that of the photochemical POCT all-in-one test card, and is not described again. Except that an isolation region 31 is provided between the diffusion layer 3 and the reaction layer 2.
Defining the direction of the upper shell 11 as the upper direction, as shown in fig. 2 and 10, the elastic component 4 is connected to the lower shell 12, and the elastic component 4 includes a central shaft 41 with a top end surface abutting against the lower surface of the diffusion layer 3 and an elastic member 42 sleeved outside the central shaft 41; the middle shaft 41 comprises an upper body 410, a middle body 411 and a lower body 412, the outer diameter of the lower body 412 is smaller than that of the middle body 411, the outer diameter of the middle body 411 is smaller than that of the upper body 410, one end of the elastic element 42 is abutted to the joint of the upper body 410 and the middle body 411, one end of the elastic element is abutted to the limiting groove 121 of the lower shell 12, and the lower body 412 penetrates out of the center of the limiting groove 121; of course, in other embodiments, the elastic element 4 can also be another structural part with a certain rigidity, made of elastic material, against the diffusion layer 3; the depth of the stopper groove 121 corresponds to the sum of the heights of the upper body 410 and the middle body 411. Of course, in other embodiments, the lower portion 412 may not be provided.
As shown in fig. 12, the length of the elastic element 42 is greater than the height of the lower body 412, in the initial state, the elastic element 42 is in a slightly compressed state, the deformation amount is Δ T1, the elastic element 4 presses the diffusion layer 3 upward, i.e. away from the reaction layer 2, so that an isolation region 31 is formed between the diffusion layer 3 and the reaction layer 2, i.e. as shown in fig. 10, the isolation region 31 is H;
as shown in fig. 13, when the upper housing 11 is pressed downward by applying an external force, the lower housing 12 is kept relatively still, but it is also possible to apply an external force to the upper housing 11 and the lower housing 12 simultaneously so that the distance between the upper housing 11 and the lower housing 12 is reduced, the elastic member 42 is further compressed, the deformation amount is Δ T2, and at this time, the portion of the lower housing 412 passes through the center of the lower housing 12, the diffusion layer 3 moves downward to approach the reaction layer 2 until it passes through the isolation region 31, the upper housing 410 and the middle housing 411 of the elastic member 4 sink into the stopper groove 121, the diffusion layer 3 contacts the reaction layer 2, and the reaction starts.
The amount of deformation of the spring 42 is limited by its length when no pressure is applied, and the maximum amount of deformation Δ T3 does not exceed the length of the spring 42, i.e., Δ T1< Δ T2< Δ T3, as shown in fig. 12-14.
In this embodiment, a pressure member 9 is disposed above the test card 7, and the pressure member 9 is used for applying an external force to drive the upper housing 11 to move downward.
The shape and size of the inside 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, and the bottom of the tray 8 forms a window 81, which is used to expose at least a part of the area of the reaction layer 2 on the test card 7, especially the area where the blank control area 21, the reaction area 22 and the color block area 23 are located.
The optical unit 6 is arranged below the tray 8 and comprises a light source 61 and a receiver 62 which is arranged along the same radial direction with the light source 61, and the optical unit 6 is integrally and fixedly connected to a bracket 63 and synchronously rotates along with the bracket 63 in the circumferential direction; the holder 63 is concentrically arranged with the tray 8 and the test card 7.
In order to satisfy the detection diversity of the reaction layer 2, light sources including red, green, and blue light are generally selected, but a monochromatic light source may be selected; if a light source is considered to be used, the detection of the optical reaction generally selects more green light, then the color chart of the color block area 23 selects magenta color, and then the magenta value of different color charts is different, and the green light is illuminated to obtain different reflection values as the encoding signal. The smallest optical unit can thus be designed as a light source or group of light sources and one PD receiver 62. The optical unit 6 is fixed to a ring-shaped holder 63 with the light source 61 facing a certain reaction region 22 or color patch region 23, as shown in FIG. 16. When the test card corresponding to the reaction test paper shown in fig. 3 is tested, the annular support 63 concentrically rotates around the test card 7 in the testing process, and each rotation angle is 45 °, so that the annular support 63 rotates one circle, the optical unit 6 can acquire 8 sets of signal values, including 4 sets of color block area 23 encoding values, 3 sets of reaction area 22 signal values and 1 set of blank control area 21 background values, the encoding information of 4 sets of color block areas 23 respectively corresponds to the information of 3 sets of reaction areas 22, and the remaining one color block area is associated with the combination information of the whole reaction test paper.
Since the rotation angles of the bracket 63 are preset and fixed, the detection hole position at the bottom should be a determined position when the test card 7 is placed in the photochemical POCT all-in-one test system, so that the housing of the test card 7 needs to be slightly modified and designed to be not completely circular, so as to conveniently determine the position and direction of the test card in the instrument. As shown in fig. 15, the test card 7 may be formed with square or pointed positioning portions 71 in the peripheral edge portion region to facilitate discrimination of the start position.
Generally, the entire photochemical POCT all-in-one test system instrument can be designed in such a way that the hatch door is opened, the test card 7 is placed on the tray 8 in the instrument after the hatch door is opened, the hatch door is closed, and then the instrument is started. The pressure piece 9 is arranged above the instrument and is opposite to the tray 8, the pressure piece is folded upwards in an initial state, after the optical unit 6 confirms that the sample is completely diffused through the detection blank contrast area 21, or after a set certain time, the pressure piece 9 is in downward telescopic contact with the upper shell 11 and applies a downward force, so that the upper shell 11 is integrally sunk, and the diffusion layer 3 is in contact with the reaction layer 2 on the lower shell 12. On the other hand, the ring support 63 below the tray 8 and the optical unit 6 thereon start to detect and receive signals on the reaction regions 22 and the patch regions 23.
The outer diameter of the pressure member 9 is not larger than the outer diameter of the upper case 11 of the test card 7, and the inner diameter is not smaller than the outer diameter of the sample passage 111 at the central opening of the upper case 11. The outer diameter of the tray 8 is not less than the outer diameter of the test card 7, and the inner diameter of the tray is matched with the outer diameter of the test card 7, so that the test card can be just placed in the tray. The outer diameter and the inner diameter of the annular support 63 of the optical unit 6 are not required, and only the optical unit 6 needs to be capable of performing the functions of transmitting and receiving light sources.
The number of the optical units 6 may be one or more, and if there are a plurality of optical units 6, the plurality of optical units 6 are symmetrically distributed on the support 63. That is, considering that a plurality of groups of optical units 6 participate in the measurement, the optical units 6 can be symmetrically distributed on the annular support 63, and the simultaneous measurement of a plurality of groups of reaction regions 22 can be realized only by rotating a certain angle during the test.
A single set of optical units 6 comprising a set of red, green and blue light sources 61 and a PD receiver 62. In the test shown in fig. 16, the optical unit 6 rotates clockwise by 45 °, 90 ° and 90 ° from the start position to complete the reading of the coded signals of the four color block regions 23, and then completes the reading of the signals of each reaction region 22 according to the program setting.
As shown in fig. 17, the optical units 6 are added in four groups, each group including one red, green and blue light source 61 and one PD receiver 62. When the same test card as that shown in fig. 16 is tested, the ring-shaped support 63 rotates 45 ° from the initial position to complete the reading of the coded information of the four color block regions 23, and then rotates 45 ° counterclockwise to return each optical unit 6 to the detection position of the reaction region 22 to complete the reading of the signal.
As shown in fig. 18, the PD receiver 62 may also be placed at the center of the ring-shaped holder 63, and the holder 63 is rotated clockwise by 45 ° to complete reading of the code signal of the color block area 23 during the test, and then rotated counterclockwise by 45 ° to complete reading of the signal of the reaction area 22.
The number of light sources of each group of optical units 6 is reduced, and as shown in fig. 19, three light sources of red, green, and blue are separately provided, and each light source is assigned to one PD receiver. During testing, the annular support 63 rotates clockwise 45 °, 90 ° and 90 °, and each light source 61 respectively completes reading of the coded signals of the four color patch areas 23, and then 1 to 3 light sources among the four color patch areas rotate to the corresponding reaction area 22 according to the program setting to complete reading of the signals. Alternatively, as shown in fig. 20, 3 light sources share one PD receiver, and only one light source is turned on for each test.
The photochemical POCT all-in-one test system has the working process that in an initial state, the diffusion layer 3 and the reaction layer 2 are separated from each other, the deformation amount of the elastic piece 42 is delta T1, after a sample is added into the sample channel 111, the sample reaches the diffusion layer 3 through the filter layer 5 and is uniformly diffused, the uniform diffusion time is determined, then the upper shell 11 is extruded by the external force of the pressure piece 9, the elastic piece 42 is compressed, the diffusion layer 3 is contacted with the reaction layer 2, the sample uniformly distributed in the diffusion layer 3 is mixed with the reagent in the reaction layer 2, at the moment, the deformation amount of the elastic piece 42 is delta T2, and when the lower body 412 is arranged, the part of the lower body 412 penetrates out of the central opening of the lower shell 12;
the light source 61 irradiates the color block area 23, the light which is not absorbed is reflected to the receiver 62, and the receiver 62 reads the information of the reaction area 22 which is related to the color block area 23, so as to obtain the test type and the calibration equation of the reaction area 22; then, the light source 61 irradiates the reaction region 22, the unabsorbed light is reflected to the receiver 62, and the receiver 62 reads the unabsorbed light and calculates the result to obtain the test result.
A photochemical POCT (point of care testing) all-in-one testing method comprises the following steps:
s1, starting the instrument, enabling the instrument to enter a self-checking program, and measuring black signals (if a plurality of test cards are tested simultaneously, the step is only needed to be carried out during the first test);
s2, selecting a test card with associated color block area and reaction area information;
s3, adding a blood sample to the sample channel;
s4, opening the door of the instrument, placing the test card into the tray, and closing the door; starting a test program;
s5, the bracket drives the optical unit to rotate, the optical unit rotates to the blank control area and each reaction area in sequence, the reflection signals of each area are measured and recorded, and whether the test card is available is judged;
s6, if the test card is available, the optical unit rotates by a fixed angle through the annular support, sequentially measures the reflection signal of each color block area, and determines the type of the test card and a calibration equation; for example, when the initial detection position is a color block area, and 4 color block areas are arranged on the reaction area, the annular bracket is fixed and rotated clockwise for 4 times to measure the reflection signal of each color block area, and the type of the test card and the calibration equation are correspondingly determined through the reflection signal;
s7, the annular bracket drives the optical unit to rotate to a blank control area, and the reflection signal is continuously measured and the result is recorded for judging whether the sample is completely diffused; when the reflection signal of the blank control area changes, the result is marked as T0; continuing to detect, and marking as T1 when the reflected signal tends to a stable state;
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 for sample diffusion in steps S4-S6, the S7 step may be omitted;
s8, the pressure piece extends downwards to give a downward pressure to the upper shell, so that the upper shell sinks, and the diffusion layer on the upper shell is contacted with the reaction layer on the lower shell;
s9, maintaining the pressure, rotating the optical unit on the annular bracket to each reaction area, measuring the reflection signal, recording the time of obtaining the reflection signal of each reaction area, recording the time as T2, T3, T4 and the like, and calculating the result;
s10, the optical unit on the annular support returns, the pressure piece contracts upwards, the test card restores the original shape, and the test is finished;
s11, displaying the result by the instrument, and prompting to take out the test card;
and S12, opening the hatch door and taking out the test card.
The foregoing detailed description is intended to illustrate and not limit the invention, which is intended to be within the spirit and scope of the appended claims, and any changes and modifications that fall within the true spirit and scope of the invention are intended to be covered by the following claims.
Claims (9)
1. A photochemical POCT all-in-one test card is characterized by comprising:
an upper case (11) provided with a sample passage (111) penetrating the inside and outside thereof;
the lower shell (12) is movably connected with the upper shell (11) and is provided with a reaction layer (2);
the diffusion layer (3) is at least partially arranged in the sample channel (111) and at least partially arranged opposite to the reaction layer (2);
when the sample is diffused, the diffusion layer (3) is not contacted with the reaction layer (2); the sample is diffused, and the diffusion layer (3) is contacted with the reaction layer (2).
2. The photochemical POCT integrated test card of claim 1, wherein: an isolation region (31) is arranged between the diffusion layer (3) and the reaction layer (2), external force is applied to drive the upper shell (11) and the lower shell (12) to be close to each other, and the diffusion layer (3) and the reaction layer (2) are in contact with each other across the isolation region (31).
3. The photochemical POCT integrated test card of claim 1, wherein: 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).
4. The photochemical POCT integrated test card of claim 3, wherein: the identification module is a color block area (23), and when the light source (61) irradiates the color block area (23), light is reflected to the receiver (62) to read information of the reaction area (22) related to the color block area (23).
5. The photochemical POCT integrated test card of claim 3, wherein: the reaction zone (22) information comprises test types and calibration equations.
6. The photochemical POCT integrated test card of claim 1, wherein: the reaction layer (2) is provided with at least one blank control area (21).
7. The photochemical POCT integrated test card of claim 6, wherein: the blank control area (21), the reaction area (22) and the color block area (23) are arranged in a surrounding way to form a ring shape.
8. The photochemical POCT integrated test card of claim 1, wherein: the light source (61) is a composite light source.
9. The photochemical POCT integrated test card of claim 1, wherein: the reaction layer (2) comprises a plurality of mutually independent reaction strips (24), and each reaction strip (24) is provided with at least one reaction area (22) or at least one identification module or blank control area (21).
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| CN202010312231.1A CN113533312A (en) | 2020-04-20 | 2020-04-20 | Photochemical POCT (point of care testing) all-in-one test card |
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