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CN215415190U - Biosensor with self-calibration function - Google Patents

Biosensor with self-calibration function Download PDF

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CN215415190U
CN215415190U CN202121238425.8U CN202121238425U CN215415190U CN 215415190 U CN215415190 U CN 215415190U CN 202121238425 U CN202121238425 U CN 202121238425U CN 215415190 U CN215415190 U CN 215415190U
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electrode
layer
biosensor
self
calibration
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侯超
季子菡
秦玉
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Nanjing Jingjie Biotechnology Co ltd
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Nanjing Jingjie Biotechnology Co ltd
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Abstract

The utility model discloses a biosensor with a self-calibration function, and belongs to the technical field of medical equipment. The biosensor with self-calibration function comprises: an electrode layer comprising a detection electrode, a calibration electrode, and a counter electrode; a confining layer on the electrode layer; a middle spacer layer located on the confining layer. The limiting layer is provided with a reagent concave hole, the electrode layer is exposed, and a reaction reagent covers the limiting layer; the middle interlayer is provided with an exhaust hole; and a label layer positioned on the electrode layer, thereby forming the complete biosensor with the self-calibration function. The utility model has the advantages of simple manufacturing process, rapidness and accuracy.

Description

Biosensor with self-calibration function
Technical Field
The utility model belongs to the technical field of medical equipment, and particularly relates to a biosensor with a self-calibration function, which is used in biological sample detection equipment.
Background
The accuracy of disposable biosensors is crucial in practical clinical tests. Factors influencing accuracy are various, and for the situation that the enzyme activity is reduced in the heat treatment and oxidation processes, so that detection results are wrong, the optimized production process and the selection of a proper enzyme protective agent are economical and effective methods. For the situation that the accuracy of the test result is influenced by the fluctuation of background signals caused by poor stability of reagent components such as the electronic mediator, the optimization can be carried out by screening the combination of the electronic mediator and adjusting the reagent. However, the influence on the interferents often lacks effective measures, and finally, the detection result is greatly influenced.
SUMMERY OF THE UTILITY MODEL
In order to overcome the disadvantages and shortcomings of the prior art, the present invention is directed to a biosensor having a self-calibration function.
The technical scheme adopted by the utility model for solving the technical problems is as follows:
there is provided a biosensor having a self-calibration function, comprising:
an electrode layer (1), the electrode layer (1) comprising a detection electrode (11), a calibration electrode (12) and a counter electrode (13); a confining layer (2) on the electrode layer (1); a middle barrier layer (3) positioned on the limiting layer (2); the limiting layer (2) is provided with a reagent concave hole (21), the electrode layer is exposed, and a reaction reagent covers the electrode layer; the middle interlayer (3) is provided with an exhaust hole (31); and a label layer (4) positioned on the electrode layer (1), thereby forming a complete biosensor (5) with a self-calibration function.
Furthermore, the limiting layer (2) is a pressure-sensitive adhesive with a certain thickness and is adhered on the electrode layer (1); the middle interlayer (3) is a transparent high polymer sheet subjected to hydrophilic treatment and is adhered to the limiting layer (2).
The electrode layer (1) is a metal layer attached to a high polymer material, and a corresponding electrode pattern is realized through laser etching or mask sputtering; the electrode material may be gold, platinum, palladium, etc. or an alloy thereof.
The electrode layer of the biosensor can be composed of a plurality of detection electrodes, a plurality of calibration electrodes and a plurality of counter electrodes; preferably, one detection electrode, one calibration electrode and one counter electrode.
The detection sample of the biosensor with the self-calibration function can be a blood sample such as whole blood, blood plasma, blood serum and the like, and can also be other types of samples such as urine, sweat, tears, interstitial fluid and the like.
The preparation method of the biosensor with the self-calibration function comprises the following steps:
the method comprises the following steps that a metal layer attached to a high polymer material is subjected to laser etching or mask sputtering to form a corresponding electrode pattern, then a limiting layer is adhered, and then a liquid reaction reagent is configured into a concave hole of the limiting layer in a liquid spotting mode; and drying to remove the solvent in the liquid reaction reagent, thereby obtaining the dried reagent. And then adhering the middle interlayer and the label layer to finally obtain the biosensor with the signal calibration function.
The test method of the biosensor with the self-calibration function comprises the following steps:
after the sample is drawn by capillary action, the same excitation voltage is applied simultaneously between the detection electrode and the counter electrode and between the calibration electrode and the counter electrode. The excitation voltage can adopt a positive potential or a negative potential, and is preferably-600 mV to 600 mV. And simultaneously collecting current signal values of the detection electrode and the calibration electrode. And finally, taking the current signal difference value of the detection electrode and the calibration electrode as a final response signal, eliminating the interference signal by using a difference method, and then converting into the analyte concentration value of the biological sample through a calibration curve.
The utility model has the following beneficial effects:
1. the biosensor with the self-calibration function takes the signal difference value of the detection electrode and the calibration electrode as a final response signal, and can effectively eliminate the influence of interferents. Structural design is reasonable, and the exhaust is unobstructed, advances kind fast, and check-out time is short, can accomplish the purpose of instant measuring.
2. The biosensor with the self-calibration function has the advantages of simple manufacturing process, contribution to industrial production and strong practicability.
Drawings
FIG. 1 is a schematic structural diagram of a biosensor having a self-calibration function according to the present invention;
an electrode layer (1), the electrode layer (1) comprising a detection electrode (11), a calibration electrode (12) and a counter electrode (13); a confining layer (2) on the electrode layer; a middle barrier layer (3) positioned on the limiting layer (2); the limiting layer (2) is provided with a reagent concave hole (21), the electrode layer is exposed, and a reaction reagent covers the electrode layer; the middle interlayer (3) is provided with an exhaust hole (31); and a label layer (4) positioned on the electrode layer (1), thereby forming a complete biosensor (5) with a self-calibration function.
Detailed Description
The technical solutions of the present invention are further described in detail by the following specific examples, but it should be noted that the following examples are only used for describing the content of the present invention and should not be construed as limiting the scope of the present invention.
DETAILED DESCRIPTION OF EMBODIMENT (S) OF INVENTION
As shown in fig. 1, the structure of the creatinine biosensor of the present embodiment includes:
an electrode layer (1), the electrode layer (1) comprising a detection electrode (11), a calibration electrode (12) and a counter electrode (13); a confining layer (2) on the electrode layer (1); a middle barrier layer (3) positioned on the limiting layer (2); the limiting layer (2) is provided with a reagent concave hole (21), the electrode layer is exposed, and a reaction reagent covers the electrode layer; the middle interlayer (3) is provided with an exhaust hole (31); and a label layer (4) positioned on the electrode layer (1), thereby forming a complete biosensor (5) with a self-calibration function.
The electrode layer (1) is a 30 nm-thick gold film with polyethylene terephthalate (PET) as a base layer, and corresponding electrode patterns are realized through laser etching. The limiting layer (2) is polyacrylic acid pressure-sensitive adhesive with the thickness of 0.1mm and is adhered to the electrode layer (1); the middle interlayer (3) is a transparent polyethylene terephthalate (PET) sheet subjected to hydrophilic treatment and is adhered on the limiting layer (2).
The blood creatinine can reflect the kidney damage condition, so the detection of the blood creatinine has certain clinical significance. However, endogenous creatine, which is present in blood at a concentration close to that of creatinine, often interferes with creatinine detection.
The reaction principle of the creatinine biosensor is as follows:
Figure DEST_PATH_GDA0003391081780000031
Figure DEST_PATH_GDA0003391081780000032
Figure DEST_PATH_GDA0003391081780000033
Figure DEST_PATH_GDA0003391081780000034
oxidized electron mediator + e----->Reduced electron mediator (5)
As is clear from the reaction principle, the analyte creatinine is converted into a product creatine (1) under the catalysis of creatinine hydrolase, the creatine hydrolase catalyzes the conversion of creatine into sarcosine (2), sarcosine oxidase converts the sarcosine into a product hydrogen peroxide (3), and finally response currents (4) and (5) of the hydrogen peroxide are detected. However, there is a significant concentration of endogenous creatine in the blood, which can also generate a response current through steps (2) - (5), in other words, endogenous creatine can interfere with the determination of creatinine concentration. In order to realize accurate detection of creatinine, interference caused by creatine must be effectively eliminated. In this example, liquid reagents were prepared according to the composition ratios shown in Table 1, and the liquid reagents were dispensed into reagent wells (21) formed in the limiting layer (2) by spotting, each well being loaded at a level of 0.03mg to 0.3mg, preferably 0.15 mg. Drying in a drying tunnel at 50 ℃ for 10 minutes. And (5) attaching the middle interlayer and the label layer, and cutting and storing.
Table 1: liquid reaction reagent composition
Figure DEST_PATH_GDA0003391081780000041
The experimental process comprises the following steps: four sets of creatinine samples were prepared at room temperature using phosphate buffer (0.1M, pH7) as the matrix. Sample one (creatinine concentration of 1.5mg/dL, creatine concentration of 0mg/dL) and sample two (creatinine concentration of 1.5mg/dL, creatine concentration of 3 mg/dL); sample three (creatinine concentration 3mg/dL, creatine concentration 0mg/dL) and sample four (creatinine concentration 3mg/dL, creatine concentration 3 mg/dL). Each sample was tested in duplicate and the current data are shown in table 2. In the embodiment, the current signal values of the detection electrode and the calibration electrode at 20 seconds are acquired simultaneously by adopting the excitation voltage of-200 mV.
Table 2: current data for creatinine biosensor
Figure DEST_PATH_GDA0003391081780000042
As can be seen from table 2, the test data of sample one and sample two, and sample three and sample four are compared. When the interfering substance creatine is present in the sample, it may cause a large interference to the detection signal. By subtracting the calibration electrode current signal value from the detection electrode current signal value, the interference signal can be substantially eliminated by means of a difference method.
The above description is only a preferred embodiment of the present invention, and is not intended to limit the scope of the present invention. Any modification, equivalent replacement, and improvement made within the spirit and principle of the present invention should be included in the scope of the claims of the present invention.

Claims (5)

1. Biosensor with self-calibration functionality, characterized in that it comprises:
an electrode layer (1), the electrode layer (1) comprising a detection electrode (11), a calibration electrode (12) and a counter electrode (13); a confining layer (2) on the electrode layer (1); a middle barrier layer (3) positioned on the limiting layer (2); the limiting layer (2) is provided with a reagent concave hole (21), the electrode layer is exposed, and a reaction reagent covers the electrode layer; the middle interlayer (3) is provided with an exhaust hole (31); and a label layer (4) positioned on the electrode layer (1), thereby forming a complete biosensor (5) with a self-calibration function.
2. Biosensor with self-calibration function according to claim 1, wherein the limiting layer (2) is a pressure sensitive adhesive with a certain thickness, which is stuck on the electrode layer (1); the middle interlayer (3) is a transparent high polymer sheet subjected to hydrophilic treatment and is adhered to the limiting layer (2).
3. The biosensor with self-calibration function according to claim 1, wherein the electrode layer (1) is a metal layer attached on a polymer material, and the corresponding electrode pattern is realized by laser etching or mask sputtering; the electrode material may be gold, platinum or palladium.
4. The biosensor with self-calibration function according to any one of claims 1 to 3, wherein the electrode layer is composed of a plurality of detection electrodes, a plurality of calibration electrodes and a plurality of counter electrodes.
5. The biosensor with self-calibration function according to claim 4, wherein the electrode layer comprises a detection electrode, a calibration electrode and a counter electrode.
CN202121238425.8U 2021-06-04 2021-06-04 Biosensor with self-calibration function Active CN215415190U (en)

Priority Applications (1)

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Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
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Publications (1)

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