WO2017118128A1

WO2017118128A1 - Device for comprehensively testing multiple serum markers

Info

Publication number: WO2017118128A1
Application number: PCT/CN2016/101371
Authority: WO
Inventors: 张贯京
Original assignee: 深圳市贝沃德克生物技术研究院有限公司
Priority date: 2016-01-09
Filing date: 2016-09-30
Publication date: 2017-07-13
Also published as: CN105652023B; CN105652023A

Abstract

A device for comprehensively testing multiple serum markers. The device for comprehensively testing multiple serum markers comprises a blood collection device kit (1), an immunoassay test kit (2), and a kit body (10). The blood collection device kit (1) and the immunoassay test kit (2) are integrated by sharing the kit body (10). The blood collection device kit (1) is used for collecting blood, and transferring the blood to the immunoassay test kit (2). The immunoassay test kit (2) is used for separating serum from the blood and analyzing the concentration of biomarkers in the serum. The device for comprehensively testing multiple serum markers meets household needs and provides more comprehensive and reliable clinical support by simultaneously and quantitatively testing multiple serum markers.

Description

Specification Name of Invention: Comprehensive Test Equipment for Various Serum Markers

[0001] The present invention relates to the field of detection technology, and in particular, to a comprehensive detection device for a plurality of serum markers.

Background technique

[0002] Blood as the "source of life", its flow and the exchange of matter with its internal environment ensure the normal progress of life activities, and with the development of science and technology, people's research on blood is more and more extensive. , constantly find signs of disease in the blood. Biomarkers in serum are used as a basis for judging diseases such as serum cytokines IL-17 and Clara cell secretory proteins (clara cell secretory).

The protein, CCSP) content was used as a basis for the diagnosis of Mycoplasma pneumoniae infection. High-sensitivity C-reactive protein (hs-C RP) and creatine kinase isoenzyme (CK-MB) were identified as highly specific myocardial infarction serum. landmark,

[0003] As a new type of science and technology, microfluidic analysis chips are called "lab-on-a-chip" and are also called "micro-integrated analysis chips".

Systems), which is the main platform for the implementation of Microfluidics, which integrates basic operational units such as sample preparation, reaction, separation, and detection in biological, chemical, and medical analytical processes onto a micron-scale chip. Analyze the whole process. Microfluidic chips with light weight, low sample and reagent usage, fast reaction speed, large amount of parallel processing and ready-to-use, have great potential in biology, chemistry, medicine, etc. Developed into a new field of research that crosses disciplines such as biology, chemistry, medicine, fluids, electronics, materials, and machinery.

[0004] Home self-test is the eye-of-care testing (P0CT) concept in the field of home applications, and gradually independently called a family self-inspection industry form, considering microfluidic analysis The advantages of micro, automatic, and large throughput of the chip, its unique advantages in the field of home self-inspection, especially in blood testing. Using a highly integrated microfluidic analysis chip to produce a comprehensive detection platform for a variety of serum markers, not only can provide a method for judging the condition of the family self-test, family first aid, but also the quantitative detection of a variety of serum markers Provide more accurate and comprehensive judgment of the condition.

technical problem [0005] The main object of the present invention is to provide a plurality of serum marker comprehensive detecting devices, aiming at solving the complicated and laborious technical problems of the existing blood detecting process.

Problem solution

Technical solution

In order to achieve the above object, the present invention discloses a plurality of serum marker comprehensive detecting devices.

[0007] The plurality of serum marker comprehensive detecting devices include a blood collecting device box, an immunoassay box, and a box body, wherein the blood collecting device box and the immune detecting box are integrated by a shared box body, and the blood collecting device box is used for collecting And delivering blood to the immunoassay cassette for separating serum from the blood and analyzing the concentration of the biomarker in the serum.

[0008] Preferably, the box body is divided into a blood collection equipment warehouse and an immune detection warehouse.

[0009] Preferably, the blood collection device box includes a blood collection box cover and a painless blood collection pen, the painless blood collection pen is disposed on a side of the blood collection box cover, and the blood collection box cover seals the painless blood collection pen In the immunoassay cartridge.

[0010] Preferably, the immunoassay kit comprises an immunocap and an immunodetection component, the immunodetection component being disposed outside or inside the immunoassay cartridge, the immunocap and the immunoassay cartridge being seamless Encapsulating to protect the immunodetection component.

[0011] Preferably, the immunocap is provided with a first injection hole and a second injection hole, wherein the first injection hole and the second injection hole are used for delivering the blood to the immunodetection Detection analysis in the box.

[0012] Preferably, the immunodetection component comprises a control gate, a detection result display screen, a centrifugal servo motor, a centrifuge, a serum separation microfluidic chip, and an ELISA detection unit; the control gate and the display screen are disposed at the The outside of the immunoassay cartridge; the centrifugal servo motor, the centrifuge, the serum separation microfluidic chip, and the ELISA detection unit are all disposed inside the immunoassay cartridge; the centrifugal servo motor is disposed in the immunoassay cartridge a bottom center position for fixing and regulating the operation of the centrifuge; the centrifuge shaft of the centrifuge passes through the center of the serum separation microfluidic chip, and the serum separation microfluidic chip is a disc structure.

[0013] Preferably, the serum separation microfluidic chip comprises a first injection channel, a second injection channel, a mounting hole, a first microfluidic structure and a second microfluidic structure, the first injection a channel and a second injection channel for transferring blood, the mounting hole coupling the centrifuge, the first microfluidic structure and the second microflow The control structure is a mirror structure.

[0014] Preferably, the first microfluidic structure comprises a first blood injection chamber, a first expansion valve, a first blood separation chamber, a first blood waste liquid chamber, a first blood cell collection chamber, and a first serum siphon tube. a first serum collection chamber and a first serum flow outlet for separating serum in the blood by centrifugal force and Euler force, and delivering the serum to the ELISA detection unit.

[0015] Preferably, the ELISA detecting unit comprises an immunoreactive layer for specifically recognizing biomarkers in serum, and an electrochemical biosensor for using the antigen-antibody The specifically bound biosignal is converted to an electrochemical signal, which in turn is converted to an electrical signal for display by the display.

[0016] Preferably, the ELISA detection unit is provided in plurality, located under the serum separation microfluidic chip, and uniformly distributed around the centrifugal servo motor; the plurality of ELISA detection units are provided with different immunitys The reaction layer facilitates the detection of different serum markers by peers.

Advantageous effects of the invention

Beneficial effect

[0017] Compared with the prior art, the present invention provides a comprehensive detection platform for a plurality of serum markers, and a highly integrated microfluidic analysis chip for quantitatively detecting a plurality of serum markers in blood, which can be used not only for families Self-test, family first-aid provides a basis for the judgment of the condition, and the quantitative detection of multiple serum markers can provide a more accurate and comprehensive judgment of the disease.

Brief description of the drawing

DRAWINGS

1 is a structural exploded view of a preferred embodiment of a plurality of serum marker comprehensive detecting devices of the present invention;

2 is a top view of a serum separation microfluidic chip in various serum marker comprehensive detection devices of the present invention; [0020] FIG. 3 is a serum separation microfluidic chip in a plurality of serum marker comprehensive detection devices of the present invention; [0021] FIG. 4 is a schematic view showing the structure of an ELISA detecting unit in various serum marker comprehensive detecting apparatuses of the present invention.

[0022] The objects, features, and advantages of the present invention will be further described in conjunction with the embodiments.

BEST MODE FOR CARRYING OUT THE INVENTION

BEST MODE FOR CARRYING OUT THE INVENTION [0023] In order to further illustrate the technical means and efficacy of the present invention in order to achieve the above objects, the specific embodiments, structures, features and functions of the present invention are described below in conjunction with the accompanying drawings. It should be noted that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.

1, FIG. 2, FIG. 3 and FIG. 4, FIG. 1 is a structural exploded view of a preferred embodiment of a plurality of serum marker comprehensive detecting devices of the present invention; FIG. 2 is a plurality of serum markers of the present invention. A top view of a serum separation microfluidic chip in an integrated detection device; FIG. 3 is a cross-sectional view of a serum separation microfluidic chip in a plurality of serum marker comprehensive detection devices of the present invention; FIG. 4 is a plurality of serum marker comprehensive detection devices of the present invention. Schematic diagram of the structure of the ELISA detection unit.

[0025] In this embodiment, the plurality of serum marker comprehensive detecting devices collect blood through a painless blood collection pen, and separate serum from the blood to be tested under the action of centrifugal force by a serum separation microfluidic chip, and the enzyme is linked. An Enzyme Linked Immunosorbent Assay (ELISA) detection unit specifically recognizes various biomarkers in the serum, and quantitatively analyzes the biomarkers using an electrochemical biosensor.

[0026] As shown in FIG. 1, the plurality of serum marker comprehensive detecting devices in the embodiment includes a blood collection equipment box 1, an immunoassay box 2, and a box main body 10, and the blood collection device box 1 and the immunodetection box 2 pass The shared box main body 10 is integrated, and the box main body 10 is divided into a blood collection equipment compartment 11 and an immunoassay cartridge 21.

[0027] The blood collection equipment box 1 includes a blood collection box cover 12 and a painless blood collection pen 13, the painless blood collection pen 13 is disposed on a side of the blood collection box cover 12, and the blood collection box cover 12 will be painless. The blood collection pen 13 is enclosed in the blood collection equipment compartment 11. The pain-free lancet 13 can be obtained by withdrawing the blood collection box cover 12 from the side of the blood collection equipment compartment 11 by using 吋. The painless blood collection pen 13 is for collecting human blood and injecting the collected blood into the immunodetection cartridge 2 for quantitatively analyzing a plurality of serum markers in the blood. The immunoassay cassette 2 includes an immunocapsule 22 and an immunodetection unit 23, and the immunodetection unit 23 is disposed outside or inside the immunoassay cartridge 21, and the immunocap 21 is seamlessly coupled to the immunoassay cartridge 21. Encapsulating and protecting the immunodetecting component 23, the immunocap 21 includes a first sampling hole 221 and a second sampling hole 222, and the first sampling hole 221 and the second sampling hole 222 are used before use. The plastic seal is injected into the immunodetection cartridge 2 by the puncture of the painless blood collection pen 13 using the fistula.

[0028] The immunodetection component 23 includes, but is not limited to, a control gate 231, a display screen 232, and a centrifugal servo The motor 233, the centrifuge 234, the serum separation microfluidic chip 235, and the ELISA detection unit 236. The control switch 231 and the display screen 232 are disposed outside the immunodetection chamber 21, and the control switch 231 is configured to regulate the operation of the centrifuge 234 by controlling the centrifugal servo motor 233. The display screen 232 is configured to output a plurality of biomarker concentration information in the serum analyzed by the immunodetecting unit 23. The centrifugal servo motor 233, the centrifuge 234, the serum separation microfluidic chip 235, and the ELISA detecting unit 236 are both disposed inside the immunoassay chamber 21, and the centrifugal servo motor 233 is located in the immunoassay chamber 21. a bottom center for fixing the centrifuge 234 at a specific position and regulating the operation opening/closing, rotation speed and orientation of the centrifuge 234, the centrifuge 234 including an engine 2 341, a crankshaft 2342, and a latch 2343. The engine 2341 is fixed to the bottom center of the immunoassay cartridge 21 by the centrifugal servo motor 233, and the shaft 2342 passes through the serum separation microfluidic chip 235 and is fixed by the plug 2343, the serum The separation microfluidic chip 235 is a disc structure for separating serum in the blood by centrifugal force. The ELISA detecting unit 236 is provided with at least eight, and the eight ELISA detecting units 236 are located in the serum separating microfluidic chip 235. Below it, it is evenly distributed around the centrifugal servo motor 233.

[0029] In the present embodiment, the structure of the serum separation microfluidic chip 23 is as shown in FIG. 2 and FIG. 3, and the serum separation microfluidic chip 235 is shown on the surface including a first injection channel 2351, a second The injection channel 2352, the mounting hole 2353, and the four vent holes, the first sampling channel 2351 is in communication with the first sampling hole 221, and the second sampling channel 2352 and the second sampling hole 222 are In the middle, the mounting hole 2353 is located in the middle of the serum separation microfluidic chip 235, and the shaft 2342 passes through the mounting hole 2353 and is fixedly coupled to the centrifuge 234 and the serum through the plug 2433. The microfluidic chip 234 is separated, and the centrifuge 234 drives the serum separation microfluidic chip 235 to rotate to provide angular acceleration and centrifugal force for the serum separation microfluidic chip 235. The illustrated serum separation microfluidic chip 235 includes, but is not limited to, a first microfluidic structure 2354 and a second microfluidic structure 2355 that are mirror-distributed, the first microfluidic structure 2354 including a first blood injection Cavity 23541, first dilation valve 23542, first blood separation chamber 23543, first blood waste chamber 23544, first blood cell collection chamber 23545, first serum siphon 23546, first serum collection chamber 23547, and first serum outlet 23548 .

[0030] the first blood injection chamber 23541 is in communication with the first injection channel 2351, and the blood to be detected collected by the painless blood collection pen passes through the first injection hole 221 and the first injection channel. 2351 enters the first The blood injection chamber 23541, the control switch 231 is opened, and the centrifuge 234 starts to rotate the serum separation microfluidic chip 235 under the control of the centrifugal servo motor 233, under the action of centrifugal force, The first expansion valve 23542 is opened, the blood enters the first blood separation chamber 23543 from the first blood injection chamber 23541, and excess blood overflows into the first blood waste chamber 23544; The serum separates the microfluidic chip 235, the blood in the first blood separation chamber 23543 is initially separated, and the heavier blood cells enter the first blood cell collection chamber 23545; when the blood in the first blood separation chamber 23543 is completely separated Thereafter, the serum separation microfluidic chip 235 is decelerated and rotated for a while, and the serum separation microfluidic chip 235 obtains an angular acceleration, and the serum in the first blood separation chamber 23543 continues to enter under the action of the Euler force. a first serum siphon 23546, and flowing into the first serum collection chamber 23 547, the first serum collection chamber 23547 is a funnel structure, and the first serum outlet 23548 is at the bottom. The first serum outflow port 23548 is a small hole for controlling the serum to be dropped into the ELISA detecting unit 236 directly under the action of gravity.

[0031] The distribution and structure of the ELISA detecting unit 236 are as shown in FIG. 4, when the serum in the first serum collecting chamber 2354 is dropped from the first serum outflow port 23548 into the ELISA detecting unit 236 below it. Correspondingly, the separated serum in the second microfluidic chip 2355 is simultaneously flowed into the ELISA detecting unit opposite to the ELISA detecting unit, and under the action of the servo control 22, the first The serum collection chamber 23547 continuously changes orientation to the next ELISA detection unit during the set interval, thus changing the orientation of the first serum collection chamber 23546 three times, and all of the eight ELISA detection units 236 obtain equal amounts of serum. The ELISA detection unit 236 includes an immunoreactive layer 2361 and an electrochemical biosensor 2362, the immunoreactive layer 2361 comprising a layer of antibody modified on the electrochemical biosensor 236 2 for the antibody Specifically identifying and binding to a biomarker in serum to form an antigen-antibody complex, the electrochemical biosensor 2362 for converting a biosignal specifically recognized and bound by the antigen-antibody into an electrochemical signal, The electrochemical signal is converted to a digital signal output to the display screen 322 for quantitatively characterizing the blood marker content in the serum to be tested. The eight ELISA detection units 2 36 achieve the same purpose of quantitatively detecting a plurality of serum markers by separately selecting different antibodies as immunoreactive layers.

[0032] The multi-serum marker comprehensive detecting device provided by the invention can quantitatively detect various serum markers in blood through a highly integrated microfluidic analysis chip, and can not only provide for household self-test and family first aid. It provides a basis for the judgment of the disease, and the quantitative detection of multiple serum markers can provide a more accurate and comprehensive judgment of the condition.

The above are only the preferred embodiments of the present invention, and are not intended to limit the scope of the invention, and the equivalent structure or equivalent function transformations made by the description of the invention and the drawings are directly or indirectly applied to other related The technical field is equally included in the scope of patent protection of the present invention.

Industrial applicability

Compared with the prior art, the present invention provides a comprehensive detection platform for a plurality of serum markers, and uses a highly integrated microfluidic analysis chip to quantitatively detect various serum markers in blood, which can be used not only for families. Self-test, family first-aid provides a basis for the judgment of the condition, and the quantitative detection of multiple serum markers can provide a more accurate and comprehensive judgment of the disease.

Claims

Claim

a plurality of serum marker comprehensive detecting devices, wherein the plurality of serum marker comprehensive detecting devices comprise a blood collecting device box, an immunoassay box and a box body, wherein the blood collecting device box and the immunoassay box are integrated through a shared box body Together, the blood collection device cartridge is for collecting and delivering blood to the immunoassay cartridge, the immunoassay cartridge is for separating serum in the blood, and analyzing the concentration of the biomarker in the serum.

A plurality of serum marker comprehensive detecting apparatuses according to claim 1, wherein the box body is divided into a blood collection equipment compartment and an immunological detection compartment.

The apparatus for comprehensively detecting serum markers according to claim 2, wherein the blood collection device cartridge comprises a blood collection box cover and a painless blood collection pen, and the painless blood collection pen is disposed on a side of the blood collection cover The blood collection box seals the painless blood collection pen in the immune detection chamber.

The multiple serum marker comprehensive detecting apparatus according to claim 2, wherein the immunoassay kit comprises an immunocap and an immunodetecting component, and the immunodetecting component is disposed outside or inside the immunoassay cartridge The immunocap is seamlessly packaged with the immunoassay cartridge to protect the immunodetection component.

The multiple serum marker comprehensive detecting device according to claim 4, wherein the immunocap lid is provided with a first sample hole and a second sample hole, the first sample hole and the second inlet A well is used to deliver the blood to the immunoassay cassette for detection analysis.

The multi-score marker comprehensive detecting device according to claim 4, wherein the immunodetecting component comprises a control gate, a detection result display screen, a centrifugal servo motor, a centrifuge, a serum separation microfluidic chip, and an ELISA. a detection unit; the control switch and the display screen are disposed outside the immune detection chamber; the centrifugal servo motor, the centrifuge, the serum separation microfluidic chip, and the ELISA detection unit are both disposed inside the immune detection chamber The centrifugal servo motor is disposed at a bottom center position of the immunoassay cartridge for fixing and regulating the operation of the centrifuge; the centrifuge shaft of the centrifuge passes through the center of the serum separation microfluidic chip, The serum separation microfluidic chip is a disc structure.

A plurality of serum marker comprehensive detecting apparatuses according to claim 6, wherein The serum separation microfluidic chip includes a first injection channel, a second injection channel, a mounting hole, a first microfluidic structure, and a second microfluidic structure, the first injection channel and the second injection The channel is for transporting blood, the mounting hole is coupled to the centrifuge, and the first microfluidic structure and the second microfluidic structure are mirror images.

[Claim 8] The plurality of serum marker comprehensive detecting apparatus according to claim 7, wherein the first microfluidic structure comprises a first blood sampling chamber, a first expansion valve, and a first blood separation a cavity, a first blood waste chamber, a first blood cell collection chamber, a first serum siphon, a first serum collection chamber, and a first serum flow outlet, the microfluidic structure for separating serum from blood by centrifugal force and Euler force And delivering the serum to the ELISA detection unit

[Claim 9] The plurality of serum marker comprehensive detecting devices according to claim 7, wherein the ELISA detecting unit comprises an immune reaction layer and an electrochemical biosensor, and the immune reaction layer is used for specific recognition A biomarker in serum for converting a biosignal-specifically bound biosignal into an electrochemical signal, which is then converted to an electrical signal for display by the display screen.

[Claim 10] The plurality of serum marker comprehensive detecting apparatuses according to claim 9, wherein the ELISA detecting unit is provided in plurality, located under the serum separating microfluidic chip, and uniformly distributed in The circumference of the centrifugal servo motor; the plurality of ELISA detection units are provided with different immune reaction layers, so that different serum markers can be detected by the peers.