CN116539701A - Reagent card for urine detection and detection method - Google Patents
Reagent card for urine detection and detection method Download PDFInfo
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- CN116539701A CN116539701A CN202310825959.8A CN202310825959A CN116539701A CN 116539701 A CN116539701 A CN 116539701A CN 202310825959 A CN202310825959 A CN 202310825959A CN 116539701 A CN116539701 A CN 116539701A
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- 238000001514 detection method Methods 0.000 title claims abstract description 180
- 239000003153 chemical reaction reagent Substances 0.000 title claims abstract description 137
- 210000002700 urine Anatomy 0.000 title claims abstract description 41
- 239000012482 calibration solution Substances 0.000 claims abstract description 98
- 239000000523 sample Substances 0.000 claims description 90
- 239000000758 substrate Substances 0.000 claims description 37
- 238000002347 injection Methods 0.000 claims description 33
- 239000007924 injection Substances 0.000 claims description 33
- 238000007789 sealing Methods 0.000 claims description 30
- 238000004458 analytical method Methods 0.000 claims description 29
- 239000000243 solution Substances 0.000 claims description 28
- 239000007788 liquid Substances 0.000 claims description 24
- 239000002699 waste material Substances 0.000 claims description 23
- 238000004891 communication Methods 0.000 claims description 16
- 125000006850 spacer group Chemical group 0.000 claims description 11
- 238000000034 method Methods 0.000 claims description 9
- 230000008569 process Effects 0.000 claims description 5
- 238000012360 testing method Methods 0.000 claims description 3
- 238000007599 discharging Methods 0.000 claims description 2
- 238000010030 laminating Methods 0.000 claims description 2
- 238000010998 test method Methods 0.000 claims 1
- 239000010410 layer Substances 0.000 description 37
- 239000011159 matrix material Substances 0.000 description 17
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 10
- 229910052782 aluminium Inorganic materials 0.000 description 10
- 239000011888 foil Substances 0.000 description 10
- DDRJAANPRJIHGJ-UHFFFAOYSA-N creatinine Chemical compound CN1CC(=O)NC1=N DDRJAANPRJIHGJ-UHFFFAOYSA-N 0.000 description 8
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 6
- 239000011734 sodium Substances 0.000 description 6
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 description 5
- 239000002131 composite material Substances 0.000 description 5
- 229910052700 potassium Inorganic materials 0.000 description 5
- 239000011591 potassium Substances 0.000 description 5
- 229910001414 potassium ion Inorganic materials 0.000 description 5
- 229920002379 silicone rubber Polymers 0.000 description 5
- 229910052708 sodium Inorganic materials 0.000 description 5
- 229910001415 sodium ion Inorganic materials 0.000 description 5
- 238000009924 canning Methods 0.000 description 4
- 229940109239 creatinine Drugs 0.000 description 4
- 239000000463 material Substances 0.000 description 4
- 238000005192 partition Methods 0.000 description 4
- 235000021023 sodium intake Nutrition 0.000 description 4
- 206010020772 Hypertension Diseases 0.000 description 3
- 238000003556 assay Methods 0.000 description 3
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- 238000005353 urine analysis Methods 0.000 description 3
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- 108091003079 Bovine Serum Albumin Proteins 0.000 description 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 1
- 239000004698 Polyethylene Substances 0.000 description 1
- 239000002220 antihypertensive agent Substances 0.000 description 1
- 229940127088 antihypertensive drug Drugs 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000036772 blood pressure Effects 0.000 description 1
- 229940098773 bovine serum albumin Drugs 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 230000008094 contradictory effect Effects 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 230000002526 effect on cardiovascular system Effects 0.000 description 1
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- 210000003608 fece Anatomy 0.000 description 1
- 239000008103 glucose Substances 0.000 description 1
- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 description 1
- 238000001746 injection moulding Methods 0.000 description 1
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- 238000004806 packaging method and process Methods 0.000 description 1
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- 229920000573 polyethylene Polymers 0.000 description 1
- 229920001155 polypropylene Polymers 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 159000000000 sodium salts Chemical class 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 210000004243 sweat Anatomy 0.000 description 1
- 230000002485 urinary effect Effects 0.000 description 1
Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
- G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
- G01N27/416—Systems
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
- G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
- G01N27/416—Systems
- G01N27/4163—Systems checking the operation of, or calibrating, the measuring apparatus
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/483—Physical analysis of biological material
- G01N33/487—Physical analysis of biological material of liquid biological material
- G01N33/493—Physical analysis of biological material of liquid biological material urine
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Physics & Mathematics (AREA)
- Immunology (AREA)
- Engineering & Computer Science (AREA)
- Pathology (AREA)
- Analytical Chemistry (AREA)
- Biochemistry (AREA)
- General Health & Medical Sciences (AREA)
- General Physics & Mathematics (AREA)
- Biomedical Technology (AREA)
- Molecular Biology (AREA)
- Electrochemistry (AREA)
- Urology & Nephrology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Biophysics (AREA)
- Hematology (AREA)
- Food Science & Technology (AREA)
- Medicinal Chemistry (AREA)
- Investigating Or Analysing Biological Materials (AREA)
Abstract
The invention discloses a reagent card for urine detection and a detection method, the reagent card comprises a reagent card body, a calibration area and a microfluidic detection area for detection are arranged on the reagent card body, the calibration area comprises a calibration solution storage cavity, a calibration solution is stored in the calibration solution storage cavity, the calibration solution can be stored in the calibration solution storage cavity through simultaneously arranging the calibration area and the microfluidic detection area on the reagent card, and the microfluidic detection area can directly and simultaneously detect multiple items, so that the reagent card can ensure that the calibration and the detection can be realized, the transportation and the carrying are convenient, the automatic calibration of an electrochemical biosensor in the reagent card can be realized through the calibration solution before the detection, the use is extremely convenient, and the detection result is more accurate.
Description
Technical Field
The invention relates to the technical field of medical instruments and microfluidics for detecting urine by an electrochemical method, in particular to a reagent card for urine detection and a detection method.
Background
Urine detection can reflect the physical function of a part of a human body, for example, 90-95% of sodium in the human body's dietary intake is discharged through urine, so sodium in urine largely reflects sodium intake, and 24h sodium in urine is a gold standard for evaluating sodium intake. High sodium intake is a recognized independent risk factor causing the onset and progress of hypertension, and sodium salt in diet cannot be estimated accurately, so that the lifestyle supervision of hypertension can be realized by indirectly evaluating sodium intake by detecting sodium in urine. In addition, the main functions of potassium in the human body are to maintain the functions of cardiac muscle and neuromuscular normal functions and participate in metabolism, while 90% of the ingested potassium is discharged with urine through kidneys, and only 10% is discharged with feces and sweat, so the correlation of dietary intake potassium and 24h urinary potassium is self-evident.
The concentration of sodium and potassium ions in urine is monitored to obtain the intake of sodium and potassium every day, diet is interfered to control hypertension or the variety and dosage of antihypertensive drugs are reduced in a non-drug treatment mode, the side effect of the blood pressure can be controlled to be reduced on the basis of reaching standards, the occurrence rate of cardiovascular and cerebrovascular complications is reduced, and the life quality of patients is improved.
Disclosure of Invention
The invention mainly aims to provide a reagent card for urine detection and a detection method, and aims to solve the technical problem that a household reagent card cannot be conveniently calibrated in the prior art.
Based on the above object, the invention provides a reagent card for urine detection, comprising a reagent card body, wherein a calibration area and a microfluidic detection area for detection are arranged on the reagent card body, the calibration area comprises a calibration solution storage cavity, and a calibration solution is stored in the calibration solution storage cavity.
Further, the reagent card body is provided with an air outlet hole, and the calibration solution storage cavity and the microfluidic detection area are communicated with the air outlet hole.
Further, the first communication position of the calibration solution storage cavity and the air outlet hole, the second communication position of the microfluidic detection area and the air outlet hole are positioned at different axial positions of the air outlet hole, and a sealing spacer layer capable of puncturing is arranged in the air outlet hole between the first communication position and the second communication position.
Further, the calibration area comprises a first air hole channel, one end of the first air hole channel is connected with the calibration solution storage cavity, and the other end of the first air hole channel is connected with the air outlet.
Further, the microfluidic detection area comprises a sample inlet, a detection channel, a waste liquid cavity and a second air hole channel which are sequentially communicated, one end of the second air hole channel is communicated with the waste liquid cavity, and the other end of the second air hole channel is communicated with the air outlet.
Further, the reagent card body comprises a reagent card matrix, the calibration area is arranged on the front surface of the reagent card matrix, and the microfluidic detection area is arranged on the back surface of the reagent card matrix.
Further, the reagent card body further comprises a solution sealing layer, the front surface of the reagent card substrate is recessed inwards to form a solution groove, and the solution sealing layer and the solution groove are sealed and enclosed to form the calibration solution storage cavity.
Further, the reagent card body further comprises a sensor substrate, wherein the sensor substrate is provided with an electrochemical biosensor and a contact point for contacting and connecting external equipment, and the electrochemical biosensor is connected with the contact point;
the back of reagent card base member inwards sunken in proper order forms detection groove, waste liquid groove and passageway groove, reagent card base member runs through have the sample inlet, the sample inlet is located the one end of detection groove, sensor base plate sealed laminating connect in the back of reagent card base member, respectively with detection groove, waste liquid groove and passageway groove enclose and form detection passageway, waste liquid chamber and second gas pocket passageway, just electrochemical biosensor corresponds the position of detection passageway.
Further, the device also comprises a sample injection cover, wherein the sample injection cover is covered and sealed on the sample injection port.
The invention also comprises a detection method for urine detection, which is realized by adopting the reagent card for urine detection, and the method comprises the following steps:
s1: detection starts: the analysis equipment completes a self-checking function;
s2: the reagent card interfaces with the analysis device: extracting the reagent card, conveying the reagent card to a detection position of the analysis equipment, and tightly contacting a contact point of the reagent card with a probe in a reagent card slot of the analysis equipment;
s3: automatic calibration: puncturing a sealing spacer layer of an air outlet hole of the reagent card through a sample injection needle so as to enable the calibration solution storage cavity and the microfluidic detection area to be communicated with the atmosphere; the sample injection needle absorbs the calibration solution in the calibration solution storage cavity, and injects the calibration solution into the detection channel of the microfluidic detection area through the sample injection port, so that the calibration solution is fully contacted with the electrochemical biosensor to generate a calibration electrochemical signal, and the calibration electrochemical signal is collected and processed by the analysis equipment through the contact point for calibration;
s4: sample detection: after calibration, discharging the calibration solution, sucking a sample by a sample injection needle, injecting the sample into the detection channel through the sample injection port, and generating a detection electrochemical signal after the sample is fully contacted with the electrochemical biosensor, wherein the detection electrochemical signal is collected and processed by the analysis equipment through a contact point for detection;
s5: outputting a detection result: the analysis equipment processes the collected detection electrochemical signals and calculates the concentration value of each detection item.
According to the reagent card for urine detection, the calibration area and the microfluidic detection area are arranged on the reagent card at the same time, the calibration solution can be stored in the calibration solution storage cavity, and the microfluidic detection area can directly and simultaneously detect multiple items, so that the reagent card can be used for realizing calibration and detection, is convenient to transport and carry, and can be used for automatically calibrating an electrochemical biosensor in the reagent card through the calibration solution before detection, so that the use is extremely convenient, and the detection result is more accurate.
Drawings
FIG. 1 is a front view of one embodiment of a reagent card for urine detection of the present invention;
FIG. 2 is a cross-sectional view of the A-A plane in FIG. 1;
FIG. 3 is a rear view of one embodiment of a reagent card for urine detection of the present invention;
FIG. 4 is a schematic diagram of the front structure of an embodiment of a reagent card substrate of the present invention;
FIG. 5 is a schematic view of the reverse structure of an embodiment of a reagent card substrate of the present invention;
FIG. 6 is an exploded view of one embodiment of a reagent card for urine detection of the present invention;
fig. 7 is a rear view of a sensor substrate of the present invention.
The achievement of the objects, functional features and advantages of the present invention will be further described with reference to the accompanying drawings, in conjunction with the embodiments.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. It will be apparent that the described embodiments are only some, but not all, embodiments of the invention. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
It should be noted that all directional indicators (such as up, down, left, right, front, and rear … …) in the embodiments of the present invention are merely used to explain the relative positional relationship, movement, etc. between the components in a particular posture (as shown in the drawings), and if the particular posture is changed, the directional indicator is changed accordingly.
Furthermore, the description of "first," "second," etc. in this disclosure is for descriptive purposes only and is not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include at least one such feature. In addition, the technical solutions of the embodiments may be combined with each other, but it is necessary to base that the technical solutions can be realized by those skilled in the art, and when the technical solutions are contradictory or cannot be realized, the combination of the technical solutions should be considered to be absent and not within the scope of protection claimed in the present invention.
It should be understood that the specific embodiments described herein are for purposes of illustration only and are not intended to limit the scope of the invention.
Referring to fig. 1-7, the reagent card for urine detection provided by the invention can be matched with analysis equipment to realize various detection items, the analysis equipment can be a urine miniature analyzer or a household sanitary ware with a urine analysis function module, such as a closestool, a urinal and the like, and the detection items can be detection items for detecting sodium ions, potassium ions, creatinine molecules and the like in urine, and can also be expanded according to medical requirements.
Specifically, the reagent card comprises a reagent card body, wherein a calibration area 1 and a microfluidic detection area 2 for detection are arranged on the reagent card body, the calibration area 1 comprises a calibration solution storage cavity 11, and a calibration solution is stored in the calibration solution storage cavity 11. The calibration solution is used to calibrate the reagent card and the analytical device so that both are in the optimal state to be detected.
The present invention is not limited to the components of the calibration solution as long as the calibration of the reagent card and the analytical device can be achieved, for example, the calibration solution may be formulated from glucose and bovine serum albumin standard substances and phosphate buffer.
Through setting up calibration area 1 and micro-fluidic detection zone 2 simultaneously on the reagent card, calibration solution storage chamber 11 can store the calibration solution, and micro-fluidic detection zone 2 can directly carry out the detection of multiple project simultaneously, and such a reagent card alright guarantee to realize calibration and detection, and convenient transportation carries, carries out automatic calibration through the calibration solution to the electrochemical biosensor 71 in the reagent card before detecting, and it is extremely convenient to use, and makes the testing result more accurate.
In one embodiment, the reagent card body is provided with an air outlet hole 3, and the calibration solution storage cavity 11 and the microfluidic detection area 2 are both communicated with the air outlet hole 3. Thus, the air pressure in the calibration solution storage cavity 11 and the air pressure in the microfluidic detection area 2 are consistent with the outside through the air outlet hole 3, so that the liquid can smoothly circulate.
Preferably, referring to fig. 2, the communicating position of the calibration solution storage cavity 11 and the air outlet hole 3 and the communicating position of the microfluidic detection area 2 and the air outlet hole 3 are located at different axial positions of the air outlet hole 3, the communicating position of the calibration solution storage cavity 11 and the air outlet hole 3 between the communicating positions of the microfluidic detection area 2 and the air outlet hole 3 are provided with a seal spacer layer 31 which can be pierced, that is, a seal spacer layer 31 which can be pierced is arranged in the air outlet hole 3 between the two communicating positions, for convenience of description, the communicating position of the calibration solution storage cavity 11 and the air outlet hole 3 is marked as a first communicating position, the communicating position of the microfluidic detection area 2 and the air outlet hole 3 is marked as a second communicating position, the air outlet hole 3 between the first communicating position and the second communicating position is provided with a seal spacer layer 31 which can be pierced easily, the seal spacer layer 31 can be pierced easily by a pierced partition plate or an aluminum foil, etc., and the sample injection needle can be pierced. The design of the air outlet hole 3 is equivalent to a double-channel structure formed by three layers of materials, and the operation of puncturing the air outlet hole 3 in one step can realize that the air hole channels of the calibration solution storage cavity 11 and the microfluidic detection area 2 are simultaneously communicated with the atmosphere, so that the calibration and the detection are smoothly completed and are not influenced by pressure.
When the opening of the sealed air outlet hole 3 is sealed by adopting aluminum foil, the calibration solution storage cavity 11 and the microfluidic detection area 2 are in a sealed state, and when the opening of the air outlet hole 3 and the sealing spacer layer 31 are simultaneously stamped by the sample injection needle, the calibration solution storage cavity 11 and the microfluidic detection area 2 are communicated with the outside, so that the internal and external air pressures are consistent, the calibration solution in the calibration solution storage cavity 11 can easily flow to the suction port, and then can be sucked by the sample injection needle, and the sample or the calibration solution entering the microfluidic detection area 2 can easily flow to the detection channel 22 or enter the waste liquid cavity 23 due to the communication with the outside.
In one embodiment, referring to fig. 4, the calibration area 1 includes a first air hole channel 12, one end of the first air hole channel 12 is connected to the calibration solution storage cavity 11, the other end is connected to the air outlet hole 3, and the two air holes are communicated through the first air hole channel 12, and a communication position between the calibration solution storage cavity 11 and the air outlet hole 3, that is, a communication position between the first air hole channel 12 and the air outlet hole 3, that is, the first communication position, preferably, the calibration area 1 further includes a calibration solution sucking port 13 and a calibration solution canning port 14, the calibration solution sucking port 13 is used for taking out the calibration solution, and the calibration solution canning port 14 is used for filling the calibration solution into the calibration solution storage cavity 11.
In one embodiment, referring to fig. 5, the microfluidic detection area 2 includes a sample inlet 21, a detection channel 22, a waste liquid cavity 23 and a second air hole channel 24 that are sequentially communicated, one end of the second air hole channel 24 is communicated with the waste liquid cavity 23, the other end is communicated with the air outlet hole 3, and the two are communicated through the second air hole channel 24, where the communication between the microfluidic detection area 2 and the air outlet hole 3 is the communication between the second air hole channel 24 and the air outlet hole 3, that is, the second communication. The sample inlet 21 is used for inputting a sample or a calibration solution, the sample or the calibration solution flows into the detection channel 22, the detection channel 22 corresponds to the electrochemical biosensor 71 and is used for detecting the sample or the calibration solution, the waste liquid cavity 23 is used for storing the calibrated calibration solution or the redundant sample, preferably, a step is arranged between the second air hole channel 24 and the waste liquid cavity 23, that is, the bottom of the waste liquid cavity 23 is lower than the second air hole channel 24, so that the waste liquid is blocked from flowing into the second air hole channel 24 on the basis of communication.
In one embodiment, the reagent card body comprises a reagent card matrix 4, the reagent card matrix 4 can be formed by injection molding of PP material with extremely low water permeability, and a calibration solution storage cavity 11 is formed by heat sealing, so that the shelf life of the calibration solution can reach 1 year, the calibration area 1 is arranged on the front surface of the reagent card matrix 4, the microfluidic detection area 2 is arranged on the back surface of the reagent card matrix 4, and the calibration area 1 and the microfluidic detection area 2 are both arranged on the reagent card matrix 4, so that the space is reduced, the volume is controlled, and the cost is saved.
In another embodiment, the reagent card substrate 4 may be divided into an upper layer and a lower layer, wherein one layer is the calibration area 1 and the other layer is the microfluidic detection area 2, and the positions of the calibration area 1 and the microfluidic detection area 2 in the reagent card substrate 4 are not limited by the present invention.
In one embodiment, referring to fig. 6, the reagent card body further includes a solution sealing layer 5, the front surface of the reagent card substrate 4 is recessed inwards to form a solution tank, the shape of the solution tank is not limited herein, the section of the solution tank can be rectangular, water drop-shaped or oval, one end of the solution tank is a calibration solution sucking port 13, the opposite end is a calibration solution canning port 14, the first air hole channel 12 is communicated with the side wall of the solution tank, and the solution sealing layer 5 and the solution tank are sealed and enclosed to form a calibration solution storage cavity 11. At this time, the solution sealing layer 5 seals the opening of the air outlet hole 3 at the same time, and the calibration solution sucking opening 13 and the calibration solution canning opening 14, when the calibration solution needs to be sucked, the calibration solution can be sucked from the calibration solution sucking opening 13 by directly stamping the solution sealing layer 5 at the position of the air outlet hole 3, and similarly, the air outlet hole 3 can be communicated with the outside by stamping the solution sealing layer 5 at the opening of the air outlet hole 3, and the solution sealing layer 5 can be aluminum foil, such as composite aluminum foil, and further, three layers of composite aluminum foil can be adopted.
In another embodiment, the protective film 6 is further included, and the protective film 6 is disposed on the solution sealing layer 5 for further sealing protection, and the protective film 6 may also be made of a puncture-able material, such as a polyethylene film, a polypropylene film, and the like.
In one embodiment, referring to fig. 7, the reagent card body further includes a sensor substrate 7, the sensor substrate 7 being provided with an electrochemical biosensor 71 and a contact 72 for contact connection with an external device, the electrochemical biosensor 71 being connected with the contact 72; the electrochemical biosensor 71 is a micro solid-state biosensor directly fabricated on the biosensor substrate 7, the electrochemical biosensor 71 and the contacts 72 are respectively distributed on the upper surface and the lower surface of the sensor substrate 7, i.e. the electrochemical biosensor 71 is disposed on the upper surface of the sensor substrate 7, and the contacts 72 are disposed on the lower surface of the sensor substrate 7, and are connected by hidden wires, for example, inside the sensor substrate 7. The electrochemical biosensor 71 is used for directly detecting the concentration of detection items such as sodium ions, potassium ions, creatinine molecules and the like through an electrochemical method, so that the calibration and detection of multiple items are realized.
The electrochemical biosensor 71 is completed by directly and integrally manufacturing the substrate, which is more beneficial to saving space and convenient for combination, and also solves the simultaneous detection of a plurality of urine index items.
The back of the reagent card matrix 4 is inwards sunken to form a detection groove, a waste liquid groove and a channel groove in sequence, the reagent card matrix 4 penetrates through the sample inlet 21, the sample inlet 21 is positioned at one end of the detection groove, the sensor substrate 7 is connected to the back of the reagent card matrix 4 in a sealing fit mode, a detection channel 22, a waste liquid cavity 23 and a second air hole channel 24 are formed by surrounding the detection groove, the waste liquid groove and the channel groove respectively, and the electrochemical biosensor 71 corresponds to the position of the detection channel 22. In this embodiment, since the sample inlet 21 penetrates the reagent card substrate 4, that is, the opening of the sample inlet 21 is located on the front surface of the reagent card substrate 4, the bottom of the sample inlet 21 is sealed and hidden by the sensor substrate 7.
Similarly, the bottom of the air outlet hole 3 is sealed by the sensor substrate 7, the sealing spacer layer 31 can be a reagent card matrix partition board, and the opening of the air outlet hole 3 is sealed by aluminum foil. Namely, the air outlet hole 3 is designed to be a double-channel structure formed by three layers of materials of an aluminum foil, a reagent card matrix partition board and a sensor substrate 7.
In one embodiment, the sample injection cover 8 is further included, and the sample injection cover 8 is sealed to the sample injection port 21 in a covering manner. The sample inlet 21 is sealed by a silicone rubber layer, the silicone rubber can be automatically sealed, the repeated insertion and extraction of the sample injection needle can be born, and the calibration solution and the sample can enter the microfluidic detection channel 22, so that the sample cannot leak out at the sample inlet 21.
During operation, a calibration solution is introduced to perform automatic calibration, and then a sample is introduced to perform detection, so that the whole detection process is completed. The calibration solution is sucked from the calibration solution storage area through the sample injection needle, injected into the detection channel 22, automatically calibrated to the electrochemical biosensor 71, and then injected into the urine sample for sample concentration detection. The calibration solution or sample enters the detection channel 22 and covers the surface of the electrochemical biosensor 71, the electrochemical biosensor 71 can generate electrochemical signals, the electrochemical signals can be collected and processed by the analyzer or the analysis module through the contact 72, and the concentration of detection items such as sodium ions, potassium ions, creatinine molecules and the like can be directly obtained, so that the calibration or detection of multiple indexes together is realized. Of course, the detection index can also be designed and combined differently according to medical requirements, detection frequency and the like.
In another embodiment, the reagent card device further comprises a sealing film 9, wherein the sealing film 9 is arranged between the reagent card substrate 4 and the sensor substrate 7, that is, the sealing film 9 is laminated and sealed to cover the sensor substrate 7, and the back surface of the reagent card substrate 4 is laminated and sealed to the sealing film 9, so that the sensor substrate 7 can be further protected from being damaged easily. In this embodiment, a slit 91 is left in the sealing film 9 corresponding to the position of the electrochemical biosensor 71, so that the calibration solution or sample can directly contact the electrochemical biosensor 71, and the electrochemical biosensor 71 performs the collection and processing operation.
In this embodiment, the back of the reagent card has 6 contacts 72, and after the reagent card is extracted from the reagent kit, the reagent card is pulled to the detection position, and the reagent card can be in close contact with a small urine analyzer or a detection module carried by a household common sanitary ware through a simple pulling action, so as to perform electrochemical detection. The reagent card back contact 72 is just in close contact with the probe extending from the lower surface of the reagent card slot of the analysis device for electrochemical detection, and it is noted that the design of the number of the contacts 72 can be changed along with the change of the detection index.
In one embodiment, the reagent card is assembled by simple adhesion of the sensor substrate 7, the sealing film 9, the reagent card matrix 4, the composite aluminum foil, the silicone rubber layer, and the protective layer. Wherein, the detection reagent card matrix 4 is taken as a main body structure, and the upper layer comprises a protective layer, a silicon rubber layer, a composite aluminum foil and the reagent card matrix 4 to form a calibration area 1; the lower layer structure is a microfluidic detection area 2, and is formed by simply sealing and splicing a reagent card matrix 4, a sealing film and a sensor substrate 7. The sample inlet 21 penetrates through the upper and lower layer structures of the reagent card, the opening is covered by silicon rubber, the sensor substrate 7 is used as the bottom to jointly form, a plurality of electrochemical biosensors 71 are arranged in the reaction area of the detection channel 22, the detection of multiple indexes can be carried out in the same row, the waste liquid cavity 23 is a large-space cavity, and the calibration solution discharged from the detection channel 22 after the automatic calibration is finished and the redundant sample flowing out from the detection channel 22 during the detection can be stored.
The whole detection mode is to extract a reagent card and pull the reagent card to a detection position, wherein a contact 72 on the back of the reagent card is closely contacted with a probe extending out of the lower part of a reagent card slot of a urine analysis functional module carried by a small urine analyzer or a household common sanitary ware; the sample injection needle punctures the opening of the air outlet hole 3 and the sealing spacing layer 31, and at the moment, the microfluidic detection area 2 and the air hole channel of the calibration reagent storage cavity can be communicated with the atmosphere; the sample injection needle absorbs the calibration solution, the calibration solution is injected into the detection channel 22 through the sample injection port 21, and after the calibration solution is fully contacted with the electrochemical biosensor 71, a calibration electrochemical signal is generated, and the calibration electrochemical signal is collected and processed by the analyzer or the analysis module through the contact 72 for automatic calibration; after calibration, the sample is sucked by the sample injection needle, the sample is injected into the detection channel 22 through the sample injection port 21, the sample is fully contacted with the electrochemical biosensor 71 to generate a detection electrochemical signal, the detection electrochemical signal is collected and processed by the analyzer or the analysis module through the contact 72, the detection of the electrochemical sample is finished, the reagent card is recovered, and the detection is finished.
It should be noted that the size and shape of the reagent card are not limited, and can be adjusted according to the different reagent cassettes and the detecting device card slots, but the whole components and functions are not changed, such as the functional areas of the calibration area 1, the detecting channel 22, the waste liquid cavity 23, the air hole channel and the like are unchanged. In this embodiment, the whole cross section of the reagent card is a rectangular structure, and in addition, different shapes, such as square, round, oval, etc., can be set according to actual requirements, and different sizes can be set.
In addition, the device can be designed into different calibration solution packaging structures, such as the solution sealing layer 5 directly packages the whole reagent card substrate 4, and can be set into corresponding shapes according to the shape of the solution tank, and the detection indexes can be designed into different detection indexes and numbers according to different medical requirements.
The reagent card for urine detection provided by the invention is divided into an upper space and a lower space, wherein the upper space is used for storing a calibration solution, and the lower space is used for flowing and electrochemical reaction of a sample; the first air hole channel 12 of the upper layer and the second air hole channel 24 of the lower layer are isolated from each other, and the sample injection needle punctures the composite aluminum foil at the air hole 3 and the partition plate between the first air hole channel 12 of the upper layer and the second air hole channel 24 of the lower layer by one-time puncturing action, so that the two channels are communicated with the atmosphere at the same time; the reagent card and the detection module can be in butt joint in an extraction mode; the reagent card can store the calibration solution, and can automatically realize the automatic calibration and detection of the biosensor.
The invention also provides a detection method for urine detection, which is realized by adopting the reagent card, and the specific method comprises the following steps:
s1: detection starts: the analysis device completes the self-checking function.
The analysis equipment can be the small urine analyzer or the household sanitary ware with the urine analysis function module, such as a closestool, a urinal and the like, and the analysis equipment performs self-checking firstly so as to ensure that the equipment can work normally.
S2: the reagent card interfaces with the analysis device: the reagent card is withdrawn and sent to the assay site of the assay device, and the contacts 72 of the reagent card are brought into intimate contact with the probes in the reagent card slot of the assay device.
And extracting the reagent card, and then sending the reagent card to a detection position corresponding to the analysis equipment so as to complete the butt joint.
S3: automatic calibration: puncturing the sealing spacer layer 31 of the reagent card air outlet hole 3 through a sample injection needle so as to ensure that the calibration solution storage cavity 11 and the microfluidic detection area 2 are communicated with the atmosphere; the sample needle sucks the calibration solution in the calibration solution storage cavity 11, and injects the calibration solution into the detection channel 22 of the microfluidic detection area 2 through the sample inlet 21, so that the calibration solution is fully contacted with the electrochemical biosensor 71 to generate a calibration electrochemical signal, and the calibration electrochemical signal is collected and processed by the analysis device through the contact 72 for calibration.
S4: sample detection: after calibration, the calibration solution is drained, the sample is sucked by the sample injection needle, and is injected into the detection channel 22 through the sample injection port 21, so that the sample is fully contacted with the electrochemical biosensor 71, and then a detection electrochemical signal is generated and is collected and processed by the analysis equipment through the contact 72 for detection.
Specifically, after calibration, the calibration solution is discharged to the waste liquid cavity 23 by the sample injection needle through the air intake mode, then the sample is sucked by the sample injection needle, and is injected into the detection channel 22 from the sample injection port 21, so that the sample is fully contacted with the electrochemical biosensor 71, and then a detection electrochemical signal is generated, collected and processed by the analysis equipment through the contact 72, and then the detection electrochemical signal is detected.
S5: outputting a detection result: the analysis equipment processes the collected detection electrochemical signals and calculates the concentration value of each detection item, such as the concentration value of sodium ions, potassium ions and creatinine molecules, and the detection is completed and the reagent card is recovered.
The foregoing description is only of the preferred embodiments of the present invention and is not intended to limit the scope of the invention, and all equivalent structures or equivalent processes using the descriptions and drawings of the present invention or directly or indirectly applied to other related technical fields are included in the scope of the invention.
Claims (10)
1. The reagent card for urine detection is characterized by comprising a reagent card body, wherein a calibration area and a microfluidic detection area for detection are arranged on the reagent card body, the calibration area comprises a calibration solution storage cavity, and a calibration solution is stored in the calibration solution storage cavity.
2. The reagent card for urine detection according to claim 1, wherein the reagent card body is provided with an air outlet, and the calibration solution storage cavity and the microfluidic detection area are both communicated with the air outlet.
3. The reagent card for urine detection according to claim 2, wherein a first communication place of the calibration solution storage cavity and the air outlet hole and a second communication place of the microfluidic detection area and the air outlet hole are located at different axial positions of the air outlet hole, and a seal spacer layer capable of being penetrated is arranged in the air outlet hole between the first communication place and the second communication place.
4. A reagent card for urine detection according to claim 3, wherein the calibration area comprises a first air vent passage having one end connected to the calibration solution storage chamber and the other end connected to the air outlet.
5. The reagent card for urine detection according to claim 4, wherein the microfluidic detection area comprises a sample inlet, a detection channel, a waste liquid cavity and a second air hole channel which are communicated in sequence, one end of the second air hole channel is communicated with the waste liquid cavity, and the other end of the second air hole channel is communicated with the air outlet hole.
6. The reagent card for urine detection according to claim 5, wherein the reagent card body comprises a reagent card substrate, the calibration area is provided on a front surface of the reagent card substrate, and the microfluidic detection area is provided on a back surface of the reagent card substrate.
7. The reagent card for urine detection according to claim 6, wherein the reagent card body further comprises a solution sealing layer, the front surface of the reagent card substrate is recessed inward to form a solution tank, and the solution sealing layer and the solution tank are sealed and enclosed to form the calibration solution storage cavity.
8. The reagent card for urine detection according to claim 6, wherein the reagent card body further comprises a sensor substrate provided with an electrochemical biosensor and a contact for contact connection with an external device, the electrochemical biosensor being connected with the contact;
the back of reagent card base member inwards sunken in proper order forms detection groove, waste liquid groove and passageway groove, reagent card base member runs through have the sample inlet, the sample inlet is located the one end of detection groove, sensor base plate sealed laminating connect in the back of reagent card base member, respectively with detection groove, waste liquid groove and passageway groove enclose and form detection passageway, waste liquid chamber and second gas pocket passageway, just electrochemical biosensor corresponds the position of detection passageway.
9. The reagent card for urine detection according to claim 8, further comprising a sample cap, the sample cap being sealed to the sample port.
10. A test method for urine testing, characterized in that the method is implemented with a reagent card for urine testing according to any one of claims 1-9, the method comprising:
s1: detection starts: the analysis equipment completes a self-checking function;
s2: the reagent card interfaces with the analysis device: extracting the reagent card, conveying the reagent card to a detection position of the analysis equipment, and tightly contacting a contact point of the reagent card with a probe in a reagent card slot of the analysis equipment;
s3: automatic calibration: puncturing a sealing spacer layer of an air outlet hole of the reagent card through a sample injection needle so as to enable the calibration solution storage cavity and the microfluidic detection area to be communicated with the atmosphere; the sample injection needle absorbs the calibration solution in the calibration solution storage cavity, and injects the calibration solution into the detection channel of the microfluidic detection area through the sample injection port, so that the calibration solution is fully contacted with the electrochemical biosensor to generate a calibration electrochemical signal, and the calibration electrochemical signal is collected and processed by the analysis equipment through the contact point for calibration;
s4: sample detection: after calibration, discharging the calibration solution, sucking a sample by a sample injection needle, injecting the sample into the detection channel through the sample injection port, and generating a detection electrochemical signal after the sample is fully contacted with the electrochemical biosensor, wherein the detection electrochemical signal is collected and processed by the analysis equipment through a contact point for detection;
s5: outputting a detection result: the analysis equipment processes the collected detection electrochemical signals and calculates the concentration value of each detection item.
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