CN209821209U

CN209821209U - Detection kit

Info

Publication number: CN209821209U
Application number: CN201822243216.7U
Authority: CN
Inventors: 何毅
Original assignee: Shenzhen Heto Medical Tech Co Ltd
Current assignee: Shenzhen Heto Medical Tech Co Ltd
Priority date: 2018-12-29
Filing date: 2018-12-29
Publication date: 2019-12-20
Anticipated expiration: 2028-12-29

Abstract

The utility model discloses a detection kit, which comprises a box body and a micro-fluidic chip; the micro-fluidic chip comprises a micro-fluidic panel positioned in the box body, and the micro-fluidic panel is provided with a sample injection cavity, a lighting interpretation cavity, at least one reaction cavity, reagent cavities, uniform mixing cavities, a sample injection flow channel and a switch control valve, wherein the number of the reagent cavities is the same as that of the reaction cavities and is respectively communicated with the reaction cavities, the number of the uniform mixing cavities is the same as that of the reaction cavities, the sample injection flow channel is connected between the sample injection cavity and the reaction cavities, and the switch; the box body is provided with sample injection holes communicated with the sample injection cavity, first control pieces connected with the switch control valves, second control pieces with the same number as that of the reagent cavities, third control pieces with the same number as that of the reaction cavities, and lighting holes arranged towards the lighting interpretation cavity. The detection kit adopts the microfluidic chip technology to test biochemical immunity projects, so that the volume of a full-automatic biochemical immunity analyzer is smaller, the test precision is improved, and the test result is stable and reliable.

Description

Detection kit

Technical Field

The utility model relates to the technical field of medical equipment, especially, relate to a detect reagent box.

Background

The content and concentration change of various protein and components in blood in human body and various substance components in the human body are indexes reflecting the health function of the human body, and the content and concentration value of various protein can be measured in blood and body fluid collected from the human body by applying biochemical technology and immune principle, so as to guide the diagnosis and treatment of a clinician to a patient.

The biochemical items clinically determined include: liver function (total protein, albumin, globulin, leukocyte ratio, transaminase, etc.); blood fat; fasting blood glucose; renal function; uric acid; the biochemical examination of the series of lactic dehydrogenase and creatine kinase is generally used for routine physical examination general examination, disease screening and confirmation tests, and various biochemical examination items reflect health indexes of different functions of the body, so people in modern society can regularly and irregularly perform physical examination and examination of various biochemical items so as to master and understand self health at any time and discover potential lesions as soon as possible for further confirmation and treatment.

A biochemical analyzer: the instrument for detecting and analyzing the vital chemical substances provides information basis for clinical diagnosis, treatment, prognosis and health status of diseases.

The automatic analyzer automatically operates all or part of the steps of sampling, uniformly mixing, warm bath (37 ℃) detection, result calculation, judgment, result display, result printing, cleaning and the like in the original manual operation process. Nowadays, biochemical tests basically realize automatic analysis, and fully automatic biochemical analysis systems specially designed for large-scale or ultra-large-scale clinical laboratories and commercial laboratories can be configured arbitrarily according to the detection amount of the laboratory.

The full-automatic biochemical analyzer is completely and automatically completed by the analyzer in the whole process from sample adding to result outputting. The operator can wait for the test report by placing the sample at a specific position of the analyzer and starting the analyzer by selecting a program.

Since the first full-automatic biochemical analyzer (ACA) in the world was successfully produced by the American Technicon company in 1957, the full-automatic biochemical analyzers with different models and functions are emerging continuously, which is an important step for the automation of clinical biochemical tests in hospitals. Since the first introduction of the principle of a clinical biochemical analyzer in skeggs in the 50 s, along with the development of scientific technology, especially medical science, various biochemical automatic analyzers and diagnostic reagents have been developed greatly, and according to the structural principle of the analyzer, the analyzer can be divided into: continuous flow (pipeline), discrete, separated and dry sheet.

The flow type automatic biochemical analyzer is characterized in that chemical reactions of samples to be measured with the same measuring items after being mixed with reagents are completed in the process of flowing in the same pipeline. The automatic biochemical analyzer is a first generation automatic biochemical analyzer, and what the biochemical analyzers of which channels are said in the past are the biochemical analyzers, so that relatively serious cross contamination exists, the result is not accurate, and the automatic biochemical analyzers are eliminated at present.

The main difference between the discrete automatic biochemical analyzer and the flow type is that the chemical reaction between each sample to be tested and the reagent mixture is respectively completed in respective reaction vessels, so that cross contamination is not easy to occur, and the result is reliable.

The most common optional third-generation discrete biochemical analyzer and detection technology on the market breaks through the conventional biochemical test principle and thought, and fully-automatic biochemical test is performed according to the procedures of adding a sample and a reagent, stirring and uniformly mixing, incubating, reacting, testing and interpreting, and washing a reaction cup in sequence. The discrete automatic biochemical analyzer is an automatic biochemical analyzer commonly used in laboratories at present, can generally select measurement items at will, and is also called an optional automatic biochemical analyzer. However, the technology has the defects that the required equipment is complex, large in size and complex to operate, professional personnel are required to operate, the equipment needs to be cleaned to realize full automation, consumables such as cleaning liquid and the like are prepared, the consumables need to be replaced and added regularly in use, the requirements on use and operators are high, the equipment price is high, the cleaning liquid needs to meet the requirements of large dead volume of a full pipeline, the amount of the reagent required at one time is large, and the technology is suitable for occasions with large sample volumes.

The dry biochemical immunity technology adopts turbidimetric reflection method, and solid phase chemical technology, i.e. the reagent is solid-phase fixed on the carrier such as film or small piece of filter paper, and when it is used for determination, a certain quantity of sample to be determined is distributed on a test paper, and after a certain period of time, it is measured by using reflection photometer. However, this technique is limited by the requirement of storage and packaging of reagents, and the reagents of a general dry test strip must be used as soon as possible after being unsealed, and are easily affected by conditions such as environmental humidity and temperature, so that the test reliability and stability of this technique are poor, and due to the limitation of the packaging volume of the test strip, the size and volume of the automation equipment of this technique are large, and the stability of the test result of the semi-automatic equipment is not good.

SUMMERY OF THE UTILITY MODEL

In order to overcome the defects of the prior art, the utility model aims to provide a detection kit, which solves the problems of complicated equipment, large volume, complicated operation and high use and maintenance cost of the discrete automatic biochemical analyzer in the existing market; the dry biochemical immunity technology is easily influenced by the conditions of the environment such as humidity, temperature and the like, and the stability of the test result is poor.

The utility model discloses a following technical scheme realizes:

the utility model provides a detection kit, which comprises a box body and a micro-fluidic chip;

the micro-fluidic chip comprises a micro-fluidic panel positioned in the box body, wherein the micro-fluidic panel is provided with a sample injection cavity, a lighting interpretation cavity, at least one reaction cavity, reagent cavities, a mixing cavity, a sample injection channel and an on-off control valve, the reagent cavities are the same in number as the reaction cavities and are respectively communicated with the reaction cavities, the mixing cavity is the same in number as the reaction cavities and is used for respectively communicating each adjacent reaction cavity with the lighting interpretation cavity and one reaction cavity, the sample injection channel is connected between the sample injection cavity and the reaction cavity, and the on-off control valve is arranged on the sample injection channel and is used for controlling the on-off of the sample injection channel;

the box body is provided with a sample inlet hole communicated with the sample inlet cavity for a sample to be detected to enter the sample inlet cavity, a first control piece connected with the switch control valve for controlling the switch control valve, a second control piece, a third control piece and a light collecting hole, wherein the number of the second control piece is equal to that of the reagent cavities, the second control piece is used for respectively driving reagents in the reagent cavities to flow into the reaction cavities, the third control piece is used for respectively driving mixed liquid in the reaction cavities to flow into the mixing cavities, and the light collecting hole faces the light collecting interpretation cavity.

Further, the lighting hole comprises a transmission light lighting hole arranged at the bottom of the box body and/or a scattered light lighting hole arranged at the side of the box body.

Further, still be equipped with on the micro-fluidic panel with advance kind runner intercommunication in order to be used for the buffer chamber of storage buffer solution, still be equipped with on the box body and be used for the drive buffer solution in the buffer chamber advance in the kind runner wait to detect the sample and flow to one fourth control piece in the reaction chamber.

Furthermore, the fourth control part is a buffer press plug arranged at the top of the box body and used for regulating and controlling the volume of the buffer cavity.

Furthermore, the microfluidic panel is also provided with air pumps which are the same in number as the reaction chambers and are respectively communicated with the reaction chambers, and the third control part is an air pump press plug which is arranged at the top of the box body and used for controlling the air pumps.

Furthermore, the mixing cavity comprises a curved and extended curved mixing flow passage, and the curved mixing flow passage comprises a plurality of sequentially connected curved parts.

Further, the bending part is in a U-shaped bending arrangement.

Furthermore, the first control element is a control valve plug arranged at the top of the box body and used for controlling the switch control valve; and/or the presence of a gas in the atmosphere,

the second control part is a reagent press plug arranged at the top of the box body and used for regulating and controlling the volume of the reagent cavity.

Further, the reaction chamber the reagent chamber the mixing chamber the second control piece the third control piece set up quantity and all be two reaction chamber, two reagent chamber, two the mixing chamber is first reaction chamber, second reaction chamber, first reagent chamber, second reagent chamber, first mixing chamber and second mixing chamber respectively, the both ends in first mixing chamber are connected to respectively first reaction chamber with the second reaction chamber, the both ends in second mixing chamber are connected to respectively the second reaction chamber with daylighting interpretation chamber, first reagent chamber with advance a kind runner respectively with first reaction chamber connects, second reagent chamber with the second reaction chamber is connected.

Furthermore, the box body comprises a lower shell, an upper sealing plate and a lower sealing plate, wherein the upper shell covers the lower shell and encloses the lower shell to form an accommodating cavity, the upper sealing plate, the lower sealing plate and the microfluidic panel are arranged in the accommodating cavity, and the upper sealing plate and the lower sealing plate are respectively packaged at the top and the bottom of the microfluidic panel.

Compared with the prior art, the beneficial effects of the utility model reside in that:

the utility model discloses detection kit adopts micro-fluidic chip technical test biochemical immune project, through be equipped with on the micro-fluidic panel and advance the appearance chamber, the chamber is interpreted to the daylighting, the reaction chamber, the reagent chamber, the mixing chamber, advance kind runner and on-off control valve, traditional biochemical immunoassay's mode has been broken, the detection kit who collects micro-fluidic chip technique lets the volume of full-automatic biochemical immunoassay appearance (ACA) become littleer, equipment module and system simplify, the instability that complicated liquid path and cleaning system brought among the current biochemical analysis appearance have been abandoned, cross contamination's risk has been solved, testing accuracy and reliability have been improved, it is reliable and stable to have guaranteed test result, detection kit is with low costs, to all hospital departments, village and town detection institute mechanism and community health mechanism can satisfy the user demand.

Drawings

FIG. 1 is an exploded view of a test kit according to an embodiment of the present invention;

FIG. 2 is a schematic front perspective view of a detection kit provided in an embodiment of the present invention;

FIG. 3 is a schematic reverse perspective view of the detection kit provided in the embodiment of the present invention;

fig. 4 is a schematic structural diagram of a microfluidic chip according to an embodiment of the present invention;

fig. 5 is a schematic back structure diagram of a microfluidic core plate according to an embodiment of the present invention.

In the figure: 100. a detection kit; 110. a box body; 111. a lower case; 112. an upper shell; 113. an upper sealing plate; 114. a lower sealing plate; 11. a sample inlet hole; 12. controlling a valve plug; 13. a first reagent tamponade; 14. the second reagent is pressed and plugged; 15. a first air pump press plug; 16. a second air pump press plug; 17. lighting holes; 171. a transmitted light daylighting aperture; 172. scattered light daylighting holes; 173. an upper transparent cover plate; 174. a lower transparent cover plate; 175. a scatter detection window mount; 18. buffering and pressing the plug; 101. a first reaction chamber plug; 102. a second reaction chamber plug; 103. a first reaction chamber upper cover; 104. the second reaction chamber upper cover; 120. a microfluidic chip; 121. a microfluidic panel; 20. switching the control valve; 201. a bending section; 21. a sample injection cavity; 22. a lighting interpretation cavity; 23. a first reaction chamber; 24. a second reaction chamber; 25. a first reagent chamber; 26. a second reagent chamber; 27. a first mixing chamber; 28. a second mixing cavity; 29. a sample injection flow channel; 31. a buffer chamber; 32. a first air pump; 33. a second air pump; 122. and an outer extension plate.

Detailed Description

The present invention will be further described with reference to the accompanying drawings and the detailed description, and it should be noted that the embodiments or technical features described below can be arbitrarily combined to form a new embodiment without conflict.

As shown in fig. 1-5, the utility model provides a detection kit 100, the detection kit 100 includes a box body 110 and a microfluidic chip 120, the microfluidic chip 120 includes a microfluidic panel 121 located in the box body 110 and an outer extension plate 122 located outside the box body 110, the microfluidic panel 121 is provided with a sample injection cavity 21, a lighting interpretation cavity 22, a reaction cavity, a reagent cavity, a mixing cavity, a sample injection runner 29 and a switch control valve 20, the number of the reaction cavity, the number of the reagent cavity and the mixing cavity are the same and two, which can be respectively defined as a first reaction cavity 23, a second reaction cavity 24, a first reagent cavity 25, a second reagent cavity 26, a first mixing cavity 27 and a second mixing cavity 28, wherein the first reagent cavity 25 is communicated with the first reaction cavity 23, the second mixing cavity 26 is communicated with the second reaction cavity 24, the first reaction cavity 27 is respectively communicated with the first reaction cavity 23 and the second reaction cavity 24, the second mixing cavity 28 is respectively communicated with the second reaction cavity 24 and the lighting interpretation cavity 22, the sample injection flow channel 29 is arranged between the sample injection cavity 21 and the first reaction cavity 23, and the switch control valve 20 is arranged on the sample injection flow channel 29 to control the switch of the sample injection flow channel 29. The utility model discloses detection kit 100 adopts micro-fluidic chip technology test biochemical immunity project, has broken traditional biochemical immunity detection's mode, and the volume that detection kit 100 of collection micro-fluidic chip technology can make full-automatic biochemical immunoassay appearance (ACA) becomes littleer, and equipment module and system simplify, have avoided the instability that complicated liquid way and cleaning system brought among the current biochemical analyzer. The on-off control valve 20 in this embodiment is a shutoff valve.

The box body 110 includes a lower shell 111, an upper shell 112, an upper sealing plate 113 and a lower sealing plate 114, the lower shell 111 is a fixed support component of the whole detection kit 100, and is made of environment-friendly medical plastics, and the upper shell 112 is processed by a mold forming technology, and is low in cost and convenient for batch production, the upper shell 112 covers the lower shell 111 and encloses to form an accommodation cavity, the upper sealing plate 113, the lower sealing plate 114 and the microfluidic panel 121 are all arranged in the accommodation cavity, the upper sealing plate 113 and the lower sealing plate 114 are respectively packaged at the top and the bottom of the microfluidic panel 121, and the upper sealing plate 113 and the upper shell 112 are respectively provided with a plurality of hole sites which have the same structure and respectively correspond to each cavity on the microfluidic.

Specifically, the box body 110 further includes a first reaction chamber upper cover 103 covering the first reaction chamber 23, a first reaction chamber plug 101 installed on the first reaction chamber upper cover 103, a second reaction chamber upper cover 104 covering the second reaction chamber 24, and a second reaction chamber plug 102 installed on the second reaction chamber upper cover 104, wherein the upper covers all penetrate through corresponding holes on the upper sealing plate 113 and the upper shell 112.

In this embodiment, the box body 110 is provided with a sample inlet 11, a first control element, a second control element, a third control element and a lighting hole 17, the sample inlet 11 sequentially penetrates through the upper shell 112 and the upper sealing plate 113, the sample inlet 11 is communicated with the sample inlet cavity 21 for allowing a sample to be detected to enter the sample inlet cavity 21, and the first control element is arranged at the top of the box body 110.

Preferably, the first control member is connected with the on-off control valve 20 for controlling the control valve plunger 12 of the on-off control valve 20. When the on-off control valve 20 needs to be opened, only the control valve plunger 12 needs to be pressed, and the operation is very simple and convenient.

Preferably, the second control part is a reagent press plug arranged at the top of the box body 110 for regulating the volume of the reagent chamber, in this embodiment, the number of the second control parts is the same as that of the third control parts, and the two second control parts are a first reagent press plug 13 for regulating the volume of the first reagent chamber 25 and a second reagent press plug 14 for regulating the volume of the second reagent chamber 26. When the first reagent in the first reagent chamber 25 needs to be driven to flow into the first reaction chamber 23, only the first reagent press plug 13 needs to be pressed, so that the operation is very simple and convenient; when the second reagent in the second reagent chamber 26 needs to be driven to flow into the second reaction chamber 24, only the second reagent press plug 14 needs to be pressed, and the operation is very simple and convenient.

Preferably, two air pumps are further disposed on the microfluidic panel 121, the two air pumps are respectively defined as a first air pump 32 and a second air pump 33, the first air pump 32 is communicated with the first reaction chamber 23, the second air pump 33 is communicated with the second reaction chamber 24, and the two third control components are a first air pump plunger 15 and a second air pump plunger 16, both disposed on the top of the box body 110 for controlling the first air pump 32 and the second air pump plunger 16 for controlling the second air pump 33. When the mixed liquid in the first reaction cavity 23 needs to be pushed to the first mixing cavity 27, only the first air pump press plug 15 needs to be pressed, and the operation is very simple and convenient; when the mixed liquid in the second reaction cavity 24 needs to be pushed to the second mixing cavity 28, only the press plug 16 of the second air pump needs to be pressed, and the operation is very simple and convenient.

Preferably, the first blending chamber 27 and the second blending chamber 28 both include curved extending curved blending flow passages, each curved blending flow passage includes a plurality of curved portions 201 connected in sequence, and the detection kit 100 adopts a curved pipeline blending technique, so that the mixed liquid forms high-speed blending through curved gullies, and the sample to be detected and the mixed liquid are in full contact reaction. This embodiment of a bending part 201 is the crooked setting of U type, and of course, crooked mixing runner also can be realized through other spiral or non-linear path, as long as can constantly change the direction of flowing liquid for the mode of flowing liquid rapid motion is all in the utility model discloses a protection scope.

In this embodiment, the lighting hole 17 is disposed toward the lighting interpretation cavity 22, the lighting hole 17 includes a transmitted light lighting hole 171 disposed at the bottom of the box body 110 and a scattered light lighting hole 172 disposed at the side of the box body 110, an upper transparent cover 173 and a lower transparent cover 174 are respectively disposed above and below the lighting interpretation cavity 22 on the box body 110, and the upper transparent cover 173 and the lower transparent cover 174 are both made of transparent plastics, so as to facilitate the collection of light paths through the transmitted light lighting hole 171 after subsequent reactions. The scattered light collecting hole 172 is designed for some samples to be tested by using the scattering principle, and a scattering detection window seat 175 is provided in the case body 110 and aligned with the scattered light collecting hole 172. In this embodiment, the lighting hole 17 includes both the transmitted light lighting hole 171 and the scattered light lighting hole 172, so that in specific applications, the transmission method or the scattering method can be selected as needed to collect the light path, which is beneficial to meeting the detection requirements of different detection items, and is beneficial to expanding the application range of the detection kit 100. Of course, as an alternative embodiment, in a specific application, the lighting hole 17 may be configured to include only one of the transmitted light lighting hole 171 and the scattered light lighting hole 172, and may be configured as needed.

Preferably, the microfluidic panel 121 is further provided with a buffer chamber 31 communicated with the sample injection channel 29 for storing a buffer solution, and the cartridge 110 is further provided with a fourth control element for driving the buffer solution in the buffer chamber 31 and the sample to be detected in the sample injection channel 29 to flow into one reaction chamber. The buffer solution is a reagent which is set according to specific requirements; in specific application, different reagents can be adopted as buffer solutions according to different detection items; of course, it is not necessary to add a buffer to the test items, depending on the requirements of the items.

Preferably, in this embodiment, the fourth control element is a buffer pressure plug 18 which is arranged at the top of the box body 110 and is used for regulating and controlling the volume of the buffer cavity 31. When the buffer solution is needed to push the sample to be detected into the first reaction cavity 23, only the buffer press plug 18 needs to be pressed, and the operation is very simple and convenient.

The microfluidic panel 121 in this embodiment is specifically fixed on the lower shell 111, and encloses with the inside of the lower shell 111 to form a cavity for storing waste liquid formed in a test, so as to facilitate recovery and treatment of medical waste of the detection kit 100, the microfluidic panel 121 is a core part of the whole detection kit 100, and the part is manufactured by adopting a high-precision mold, and includes a sealed chamber of the whole microfluidic chip 120, and reagents, places, blending, packaging and the like participating in a reaction all occur at the part.

The upper sealing plate 113 and the lower sealing plate 114 are mainly fixed on the microfluidic panel 121, the upper sealing plate 113, the lower sealing plate 114 and the microfluidic panel 121 together form a closed flow channel system, the flow channel system can enable the microfluidic panel 121 to be added with a certain amount of samples to be detected, the samples to be detected can enter the first mixing cavity 27 from the first reaction cavity 23 along the internal flow channel, then enter the second reaction cavity 24, enter the lighting interpretation cavity 22 after passing through the second mixing cavity 28, and finally enter the waste liquid cavity in the specified sequence and direction for flowing, and the design can ensure that the internal flow channel cannot reversely flow.

The utility model discloses detect reagent box 100 has following advantage:

1. the detection kit 100 has a compact and small structure and high detection rate, and ensures the accuracy and reliability of detection results;

2. the detection kit 100 has less demand for samples to be detected, can meet the requirements of patients of various types of patients, reduces the amount and times of blood drawing, and has low requirements for the amount of the samples to be detected particularly for part of newborn and old patients;

3. the detection kit 100 adopts the micro-fluidic chip technology, the amount of reagents packaged in the micro-fluidic chip 120 is small, and the detection cost is low;

4. the detection method of the detection kit 100 is simple to operate, all experiments are performed in the highly integrated microfluidic chip 120, the requirements on detection personnel and environment are low, the whole microfluidic chip 120 can be recycled after the test, the requirements on the subsequent medical waste treatment and classification work are low, and the risks of medical pollution and infection are reduced.

5. The detection kit 100 can be applied to small-sized automatic equipment and semi-automatic equipment, has low requirements on application places, can meet the requirements of large, medium and small hospitals, departments, inspection and quarantine institutions and health clinics, has low requirements on testers, and has no requirements on other consumables and matched reagents.

A method of testing a blood sample, comprising the steps of:

s101: taking out the detection kit 100, removing the protective film at the sample inlet 11, and adding the sample to be detected into the sample inlet cavity 21 from the sample inlet 11 by using a manual sample injector or a full-automatic measuring equipment matched with the detection kit 100; the sample to be detected passing through the sample inlet hole 11 can be filled at the position of the switch control valve 20, and cannot continuously flow under the condition of not applying other external force, the length and the diameter of the flow channel pipeline at the position ensure that the volume of the sample to be detected participating in the reaction is constant, the quantification accuracy of the sample to be detected is realized, and the redundant sample to be detected cannot enter the flow channel to participate in the subsequent reaction after the control valve press plug 12 is pressed. The utility model discloses in also can realize quantitative application of sample to the reaction intracavity to the ration sampling of on-off control valve 20 department through syringe or pipettor, here wait to detect the sample and can be whole blood or plasma or serum.

S102: after the plug 12 is pressed down by the switch control valve 20, the first control part is operated to open the switch control valve 20, the buffer plug 18 is pressed down by hand or special equipment, the buffer solution flows through the switch control valve 20 and generates pressure, and the buffer solution pushes the sample to be detected in the sample injection cavity 21 to enter the first reaction cavity 23 through the sample injection flow channel 29.

S103: the first reagent press plug 13 is pressed, and the first reagent press plug 13 is operated to drive the first reagent in the first reagent chamber 25 into the first reaction chamber 23, so as to form a first mixed solution.

S104: the first air pump press plug 15 is operated to drive a first mixed liquid formed by mixing the reagent and the sample to be detected in the reaction cavity to enter the first mixing cavity 27.

S105: pressing the second reagent press plug 14 operates the second reagent press plug 14 to drive the second reagent in the second reagent chamber 26 into the second reaction chamber 24 to form a second mixed solution.

S106: and operating the second air pump press plug 16 to drive a second mixed solution formed by mixing the reagent and the sample to be detected in the second reaction cavity 24 to enter the second mixing cavity 28, and performing the whole process in constant-temperature incubation.

S107: the light path information of the second mixed liquid entering the lighting interpretation cavity 22 from the second mixing cavity 28 is collected through the lighting hole 17, and the lighting interpretation device in the lighting hole 17 outputs the detection result.

It should be noted that most samples are collected through the light path through the transmitted light collecting hole 171 located on the lighting interpretation cavity 22, those samples need to be collected through the scattering light path through the side scattered light collecting hole 172 by the scattering method, and finally the final result of the item detected by the sample to be detected on the microfluidic chip 120 is read on the lighting interpretation device.

The specific operation method of the detection kit 100 is as follows: firstly, a sample to be detected is added into a sample inlet hole 11 by using a manual sample adding device or a full-automatic measuring device matched with the detection kit 100, after a switch control valve 20 is pressed down, redundant sample to be detected cannot enter a flow channel to participate in subsequent reaction, a buffer press plug 18 is pressed down by manual or special equipment, a buffer solution flows through the switch control valve 20, moves downwards through the buffer press plug 18, the volume of a buffer cavity 31 is reduced and generates pressure, the buffer solution pushes the sample to be detected to continuously enter a first reaction cavity 23 along the flow channel, then, a first reagent press plug 13 is pressed down, a first reagent flows into the first reaction cavity 23, a first reaction cavity plug 101 on a first reaction cavity upper cover 103 is pressed down, the first reaction cavity plug 101 is mainly used for balancing the internal and external atmospheric pressures during the movement of the flow channel, the internal and external atmospheric pressures of the first reaction cavity 23 are guaranteed to be balanced before the first reaction cavity is blocked, and the liquid can normally flow into the first, after the blocking, the first reaction chamber 23 is isolated from the outside, by pressing the first air pump 32, the cavity of the first air pump 32 is communicated with the upper part of the first reaction chamber 23, the cavity volume of the first air pump 32 is reduced, the internal air pressure is increased, the buffer solution, the first reagent and the sample to be detected in the first reaction chamber 23 are pushed to the first mixing chamber 27 together (the first mixing chamber 27 and the second mixing chamber 28 both utilize a slender curved flow channel, the flowing liquid is fully mixed under the conditions of high-speed flow and flow direction change, so that each reagent and the sample to be detected are fully contacted, a first mixed solution is formed, the complete proceeding of immune reaction is ensured), then the reagent enters the second reaction chamber 24, and the liquid in the first reaction chamber 23 can only enter the first mixing chamber 27 along the flow channel.

The first mixed liquid forms high-speed mixing through the curved gullies of the first mixing cavity 27, so that the sample to be detected is in full contact reaction with the reagent, the first mixed liquid passes through the first mixing cavity 27 and then continuously enters the second reaction cavity 24 along the flow channel, then the second reagent press plug 14 is pressed through manual work or matched equipment, the second reagent is pressed into the second reaction cavity 24, the second reaction cavity plug 102 on the second reaction cavity upper cover 104 is pressed, so that the second reaction cavity 24 forms vacuum, finally, the volume in the cavity of the second air pump 33 is reduced and the pressure is increased by pressing the second air pump press plug 16, the flow channel is communicated with the upper part of the second reaction cavity 24, the pressure presses the sample to be detected, the buffer solution, the first reagent and the second reagent in the second reaction cavity 24 into the second mixing cavity 28 through the flow channel at the bottom of the second reaction cavity 24, and each liquid forms high-speed mixing effect through the curved gullies of the second mixing cavity 28, the sample to be detected and the mixed solution are in full contact reaction to form a second mixed solution, the second mixed solution passes through the second mixing chamber 28 and then continues to enter the lighting interpretation chamber 22 along the flow channel, the second mixed solution is placed in constant-temperature incubation in the whole process of the above actions, light path acquisition is finally carried out through the transmission light daylighting hole 171, a scattering method is adopted for part of reagents, scattering light path acquisition is carried out through the side scattering light daylighting hole 172, and finally the final result of the item detected by the sample to be detected on the microfluidic chip 120 is read on the detection interpretation device in the daylighting hole 17.

The final detection principle of the detection kit 100 provided by this embodiment is still based on the immunoturbidimetry principle, and by combining the characteristics of the antigen and the antibody, the transmission or scattering property after absorption of visible light with a specific wavelength finally calculates the concentration of a certain antibody (antigen) in the sample to be detected, so as to perform qualitative (quantitative) detection on the detection item of the sample to be detected, and the whole detection kit 100 and the detection method adopt the latest microfluidic chip technology, so that the detection cost is greatly reduced, and the reliability and stability of the detection result are obviously improved. The detection kit 100 has high determination accuracy, low cost, high speed and good stability, is suitable for full-automatic and semi-automatic detection equipment, adopts a high-integration microfluidic technology to the field of biochemical immunoassay, and has a series of advantages of small volume, small reagent amount, stable and reliable test result, simple and efficient test method, low cost of the detection kit 100 and the like.

The utility model discloses well detect arrangement mode of kit 100 runner is only for explaining the attached drawing, also can reach the effect of this patent technique through the position that changes each function cavity in the runner.

In this embodiment, the detection kit 100 is mainly used for biochemical immunoassay, and can measure the content and concentration of various proteins in blood and body fluid collected from a human body, so as to guide a clinician to diagnose and treat a patient, and can achieve a series of effects of small volume, small reagent amount, stable and reliable test result, simple and efficient test method, low cost of the detection kit 100, and the like of the detection kit 100. Of course, in specific applications, the above-described assay kit 100 may also be used to perform specific protein or glycated protein assays.

The specific protein is a protein having "a specific antigenicity", and is usually detected by an immunological method. The specific proteins can change correspondingly under a plurality of pathological conditions, so that the quantitative detection of the specific proteins can provide important basis for clinical diagnosis, judgment of curative effect and analysis and prognosis. The clinical application range of specific proteins is mainly focused on: diagnosis of neurological diseases such as Albumin (ALB), alpha 2-macroglobulin (AMG), immunoglobulin A (IgA, cerebrospinal fluid), immunoglobulin G (IgG cerebrospinal fluid), immunoglobulin M (IgM cerebrospinal fluid); cardiovascular disease risk assessment, such as apolipoprotein a-1(α poA-1), apolipoprotein B (α poB), lipoprotein (a) (Lp (α)), hypersensitive crp (crph); renal function monitoring, such as urinary Microalbumin (MA), urinary Transferrin (TRU), alpha 1-microglobulin (alpha 1-M), beta 2-microglobulin (beta 2-M), urinary immunoglobulin (IgU), liver disease, such As Antitrypsin (AAT), antithrombin III (AT-III), Ceruloplasmin (CER), complement C3, complement C4, immunoglobulin A, immunoglobulin M, urinary transferrin, Prealbumin (PAB). Adopt the embodiment of the utility model provides a detection kit 100 and blood sample's detection method carries out specific protein test, the reagent is based on the test principle of latex immunoturbidimetry, and simultaneously, detection kit 100 and test method have adopted micro-fluidic chip technique, it has originally broken the mode that the specific protein of traditional technique detected, the specific protein detection kit 100 of collection micro-fluidic chip technique and the test method of innovation, let full-automatic specific protein immunoassay appearance's volume become littleer, equipment module and system simplify, the instability that complicated liquid way and cleaning system brought in the current specific protein analysis appearance has been abandoned, cross contamination's risk has been solved, precision of software testing and reliability have been improved. Adopt the embodiment of the utility model provides a detection kit 100 and blood sample's detection method carries out specific protein test, has that the test result is reliable and stable, test method is simple high-efficient, detection kit 100 is with a series of advantages such as with low costs, detects institute and mechanism to all kinds of hospital departments and villages and towns to and community health mechanism can all satisfy the user demand. The glycated protein test specifically detects the concentration of glycated hemoglobin in a blood sample. The blood glucose concentration in human body is an important basis and reference index for clinically judging and diagnosing diabetes, nephropathy, neuropathy and other diseases. In normal humans, there are generally three haemoglobins: HbA, HbF, and HbA2, whereas adult red blood cells mainly contain HbA, when hemoglobin is separated by chromatography, 3 kinds of components with sugar content can be separated: HbAla, HbAlb, and HbAlc are collectively referred to as glycated hemoglobin. Glycated hemoglobin (HbAlc) is a product of hemoglobin bound to glucose in blood, and its value is proportional to blood glucose concentration, and is irreversibly bound and disappears as red blood cells die (red blood cell life is about 120 days). Because the glycosylated hemoglobin is related to the service life of red blood cells and the average blood sugar level, the glycosylated hemoglobin is an ideal index for evaluating the long-term blood sugar control of a diabetic patient, can reflect the average blood sugar level of the past 2-3 months, is not influenced by daily blood sugar fluctuation, and is closely related to the occurrence of microvascular and macrovascular complications. The glycosylated hemoglobin has the advantages of high level of glycosylated hemoglobin, correspondingly increased occurrence risks of diabetic retinopathy, nephropathy, neuropathy and cardiovascular events, and better prediction capability of the glycosylated hemoglobin on the occurrence of diabetes. Adopt the embodiment of the utility model provides a detection kit 100 and blood sample's detection method carries out the glycated protein test, the reagent is based on the test principle of latex immunoturbidimetry, and simultaneously, detection kit 100 and test method have adopted the micro-fluidic chip technique, and it has broken the shortcoming that exists with high costs among the traditional art, at the bottom of the integrated level, bulky, measuring accuracy and reliability are poor, have detection kit 100 small, the reagent volume is few, the test result is reliable and stable, test method is simple high-efficient, detection kit 100 advantage of a series of with low costs etc..

The above embodiments are only preferred embodiments of the present invention, and the protection scope of the present invention cannot be limited thereby, and any insubstantial changes and substitutions made by those skilled in the art based on the present invention are all within the protection scope of the present invention.

Claims

1. The detection kit is characterized by comprising a kit body and a microfluidic chip;

2. The detection kit according to claim 1, wherein the light collecting hole comprises a light transmitting hole provided at the bottom of the case and/or a light scattering hole provided at a side of the case.

3. The detection kit of claim 1, wherein the microfluidic panel further comprises a buffer chamber communicating with the sample injection channel for storing a buffer solution, and the cartridge further comprises a fourth control member for driving the buffer solution in the buffer chamber and the sample to be detected in the sample injection channel to flow into one of the reaction chambers.

4. The detection kit as claimed in claim 3, wherein the fourth control member is a buffer plug provided at the top of the case body for regulating the volume of the buffer chamber.

5. The detection kit of claim 1, wherein the microfluidic panel further comprises air pumps which are provided with the same number as the reaction chambers and are respectively communicated with the reaction chambers, and the third control element is an air pump press plug which is provided at the top of the box body and is used for controlling the air pumps.

6. The detection kit of any one of claims 1 to 5, wherein the mixing chamber comprises a curved mixing flow channel extending in a curved manner, and the curved mixing flow channel comprises a plurality of curved portions connected in sequence.

7. The detection kit according to claim 6, wherein the bending portion is bent in a U-shape.

8. The detection kit according to any one of claims 1 to 5, wherein the first control member is a control valve plug provided on the top of the case body for controlling the on-off control valve; and/or the presence of a gas in the atmosphere,

9. The detection kit according to any one of claims 1 to 5, wherein the number of the reaction chamber, the reagent chamber, the mixing chamber, the second control member and the third control member is two, the number of the reaction chamber, the number of the reagent chamber, the number of the mixing chamber are respectively a first reaction chamber, a second reaction chamber, a first reagent chamber, a second reagent chamber, a first mixing chamber and a second mixing chamber, two ends of the first mixing chamber are respectively connected to the first reaction chamber and the second reaction chamber, two ends of the second mixing chamber are respectively connected to the second reaction chamber and the lighting interpretation chamber, the first reagent chamber and the sample injection flow channel are respectively connected to the first reaction chamber, and the second reagent chamber is connected to the second reaction chamber.

10. The detection kit of any one of claims 1 to 5, wherein the kit body comprises a lower shell, an upper sealing plate and a lower sealing plate, the upper shell covers the lower shell and encloses a receiving cavity, the upper sealing plate, the lower sealing plate and the microfluidic panel are all disposed in the receiving cavity, and the upper sealing plate and the lower sealing plate are respectively packaged at the top and the bottom of the microfluidic panel.