TW201700969A - Blood sugar test strip and the manufacturing method thereof comprising a circuit board, a septal layer, an insulating layer, an enzyme layer, a grating removal layer, and an upper cover layer - Google Patents

Abstract

The invention discloses a blood sugar test strip and the manufacturing method thereof. The blood sugar test strip comprises: a circuit board comprising a reactive circuit region; a septal layer, which is provided on the circuit board and covers the reactive circuit region, comprises an opening that is connected to the reactive circuit region; an insulating layer, which is provided on the circuit board, has a through hole; an enzyme layer, which is provided on the septal layer and covers the opening, generates reaction with blood by enzyme, and the reaction is interpreted by the reactive circuit region for measuring a corresponding concentration of blood sugar; a grating removal layer, which is provided on the enzyme layer, is made of materials including polymeric material, nonionic surfactants and water to grate and discharging partial blood cells in blood from entering into the enzyme layer; and an upper cover layer, which is provided on the insulating layer and the grating removal layer, has a transparent window for observing the condition of blood under test.

Description

Blood glucose test piece and method of manufacturing same

The present invention relates to a blood glucose test piece and a method of manufacturing the same, and more particularly to a blood glucose test piece which is resistant to hematocrit (Hct) differential interference and a method of manufacturing the same.

There are more and more delicate foods in today's life, and people are suffering from more and more diseases due to changes in eating habits, especially when the age increases, people's basal metabolic rate will become slower and slower, and some related diseases. More and more patients, such as diabetes, people are increasingly valued for the detection of blood sugar. For patients with abnormal blood glucose and long-term need to monitor blood sugar levels, blood glucose is an indispensable health care instrument in daily life. .

Generally, in the blood glucose test, a blood sample is taken from the blood glucose test piece, and after the reaction between the enzyme layer in the blood glucose test piece and the blood, the reaction circuit in the blood glucose test piece is interpreted, and the interpretation message is transmitted to the blood glucose machine for performing. Calculation and display of blood glucose concentration.

When the blood glucose meter measures blood sugar, the whole blood (plasma and blood cells) is tested, and the hematocrit (Hct) ratio in the blood will affect the blood glucose meter. Hct varies from person to person. The average person's range is between 35% and 45%. However, there are still many special cases of physical differences or abnormal physical conditions, and the high and low range will be extended to 20% to 60%. However, in the current blood glucose test piece, when Hct is high, because the amount of blood cells and blood viscosity increase, the proportion of plasma entering the enzyme layer for test reaction will be reduced, and thus, the difference in blood cell volume ratio In the case of interference, Blood sugar levels are underestimated and cause false positives.

In view of the above-mentioned problems of the prior art, the object of the present invention is to provide a blood glucose test piece and a method of manufacturing the same, which solves the problem that the conventional blood glucose test piece cannot eliminate the interference caused by the blood cell volume ratio being too high.

According to an object of the present invention, a method for manufacturing a blood glucose test piece is provided, which comprises the steps of: setting a silver layer and a carbon layer on a PET base layer by screen printing to form a circuit including a reactive circuit region; The plate is printed on the circuit board to form an insulating layer; the intermediate layer is adhered to the circuit board and covers the reaction circuit area to make the intermediate layer The opening is in communication with the reaction circuit region; the reaction reagent containing the GDH enzyme is coated by screen printing or dispensing to form an enzyme layer covering the opening of the intermediate layer; by screen printing or dispensing Applying a polymer material, a non-ionic surfactant, and a water-mixed material to the enzyme layer to form a gate layer for removing the blood cells that will enter the blood layer of the enzyme layer; The surface is glued on the insulating layer to form a glue layer; a hydrophilic layer is adhered to the glue layer and the gate layer to accelerate the flow of blood to the gate layer; and an upper cover layer is adhered to the hydrophilic layer, and is transparent through one of the upper cover layers Window observation Test blood condition.

Preferably, the gate removing layer may comprise 10 to 25 wt% of a nonionic surfactant and 20 to 50 wt% of a polymer material, and comprises doping corresponding to the amount of the polymer material and the nonionic surfactant. Water by weight.

Preferably, the material of the gate removing layer further comprises a nano-sized cerium oxide or aluminum oxide.

Preferably, the polymer material of the gate removing layer may include, for example, polyethylene, polypropylene, polyvinyl acetate, polyacrylic acid or paraffin wax.

Preferably, the gate layer may comprise, for example, 10% by weight of nonionic Surfactant and 25 wt% paraffin.

Preferably, the gate layer may comprise, for example, 12% by weight of a nonionic surfactant and 25% by weight of polyvinyl acetate.

Preferably, the gate layer may comprise, for example, 15% by weight of a nonionic surfactant and 35% by weight of polyethylene.

According to the purpose of the present invention, a blood glucose test piece is further provided, comprising: a circuit board comprising a reaction circuit area; a middle compartment layer disposed on the circuit board and covering the reaction circuit area, and the middle compartment layer The invention comprises an opening, the opening is connected to the reaction circuit area; an insulating layer is disposed on the circuit board, and the insulating layer has a through hole; an enzyme layer is disposed on the intermediate layer and covers the opening, and the enzyme layer is separated by an enzyme and The blood reacts and then passes through the reaction circuit area to perform the interpretation, thereby measuring the corresponding blood glucose concentration; a gate layer is disposed on the enzyme layer, and the gate removing layer is made of a polymer material and a nonionic surfactant. And water for removing the blood cells of the portion of the blood that will enter the enzyme layer; and an upper cap layer disposed on the insulating layer and the gate removing layer, and the upper cap layer has a transparent window to observe the blood condition.

Preferably, the blood glucose test piece of the present invention further comprises a hydrophilic layer disposed between the upper cap layer and the intermediate layer to accelerate the flow of blood into the gate removing layer.

Preferably, the blood glucose test piece of the present invention further comprises a glue layer disposed between the hydrophilic layer and the intermediate layer.

Preferably, the circuit board comprises a PET base layer, a silver layer and a carbon layer, and the silver layer and the carbon layer are disposed on the PET base layer via screen printing to correspondingly form a reaction circuit region.

According to the above, the blood glucose test piece proposed by the present invention can use the grid layer disposed on the enzyme layer to remove the blood cells of the interference measurement result in the blood, and avoid the blood cell volume ratio of the blood entering the enzyme layer being too high. And the situation where the blood glucose concentration is misjudged. Wherein, the invention can detect the blood cell volume ratio in the range of 20% to 60%, anti-blood The ball volume ratio difference interference can be less than 30%, and the blood glucose concentration detection error can be less than 10%.

11‧‧‧PET layer

12‧‧‧ carbon layer

13‧‧‧ Silver layer

2‧‧‧Insulation

21‧‧‧ wearing a mouth

3‧‧‧Interval

31‧‧‧ openings

4‧‧‧Enzyme layer

5‧‧‧ Grid layer

6‧‧‧ glue layer

7‧‧‧Hydrophilic layer

8‧‧‧Upper cover

81‧‧‧Transparent window

S1~S8‧‧‧Steps

Fig. 1 is a first schematic view showing an embodiment of a blood glucose test piece of the present invention.

Fig. 2 is a second schematic view showing an embodiment of the blood glucose test piece of the present invention.

Fig. 3 is a flow chart showing a method of manufacturing a blood glucose test piece of the present invention.

The technical features, contents, and advantages of the present invention, as well as the advantages thereof, can be understood by the present inventors, and the present invention will be described in detail with reference to the accompanying drawings. The subject matter is only for the purpose of illustration and description. It is not intended to be a true proportion and precise configuration after the implementation of the present invention. Therefore, the scope and configuration relationship of the attached drawings should not be interpreted or limited. First described.

Please refer to FIG. 1 and FIG. 2 , which are respectively a first schematic diagram and a second schematic diagram of an embodiment of the blood glucose test strip of the present invention. The main components of the blood glucose test piece include a PET layer 11, a carbon layer 12, a silver layer 13, an insulating layer 2, a middle layer 3, an enzyme layer 4, a gate removing layer 5, and an upper cap layer 8, and further may include a glue layer. 6 and hydrophilic layer 7.

The PET layer 11 is a PET film substrate, and the carbon layer 12 and the silver layer 13 are respectively disposed on the PET layer 11 by carbon paste and silver paste to form a flexible circuit board including a reaction circuit region. Among them, the carbon layer 12 can be used to protect the silver wire formed by the silver layer 13 to prevent the silver wire from being oxidized by contact with air. The insulating layer 2 is disposed on the circuit board formed by the PET layer 11, the carbon layer 12 and the silver layer 13 and covers the reaction circuit region, and the insulating layer 2 includes a through hole 21 which communicates with the reaction circuit region. , wherein the insulating layer 2 has an increased conductivity, a calibration reaction area, and an insulation thereof The role of his wire space. The intermediate layer 3 is disposed on the circuit board and the insulating layer 2, and the intermediate layer 3 has an opening to expose the through opening 21 of the insulating layer 2. The enzyme layer 4 is disposed on the insulating layer 2 and covers the opening 21, and the enzyme layer 4 reacts with the test blood by the GDH enzyme, and then passes through the reaction circuit area for interpretation, and then transmits the interpretation message to the blood glucose meter to measure and The corresponding blood glucose concentration is displayed. The gate removing layer 5 is the main technical feature of the present invention, and is disposed on the enzyme layer 4, and the material of the gate removing layer 5 comprises a polymer material, a nonionic surfactant and water, which can be used for grid removal. The blood cells that will enter the test blood layer of the enzyme layer 4 are removed to prevent the blood cell volume ratio of the blood entering the enzyme layer 4 from being too high to cause a misjudgment of the blood glucose concentration.

In the above, the material of the gate removing layer 5 mainly comprises 10 to 25 wt% of a nonionic surfactant and 20 to 50 wt% of a polymer material, and includes addition according to a nonionic surfactant and a polymer material. And doping the corresponding weight percentage of water, the above materials are disposed on the enzyme layer 4 by screen printing or dispensing to form a gate layer 5 having a thickness of 0.1 mm, wherein the polymer material For example, it may be polyethylene, polypropylene, polyvinyl acetate, polyacrylic acid or paraffin wax. As a preferred example, the gate layer 5 may comprise 10% by weight of a nonionic surfactant and 25% by weight of paraffin wax, or another preferred combination case comprising 12% by weight of a nonionic surfactant and 25% by weight. Polyvinyl acetate, or barrier layer 5, can be made using 15% by weight of a nonionic surfactant and 35% by weight of polyethylene. The gate removing layer 5 is made of water except for the nonionic surfactant and the polymer material containing the above doping ratio. Alternatively or in addition to water, the material of the barrier layer 5 may further comprise a nano-scale oxide or aluminum oxide, thereby promoting the performance of interlayer ion distribution.

Further, a double-sided tape is attached on the intermediate layer 3 to form a glue layer 6, which can be used to provide a hydrophilic layer 7 fixedly disposed on the intermediate layer 3, and the hydrophilic layer 7 is covered. In the gate layer 5, the hydrophilic layer 7 can be used to enhance the test blood inhalation. The rate of the layer 5 to the gate. The upper cover layer 8 is disposed on the hydrophilic layer 7 to protect the internal structure of the test piece, and the upper cover layer 8 has a transparent window 81 for the tester to observe the blood instillation to perform the blood glucose concentration. Measurement.

Please refer to FIG. 3 , which is a flow chart of a method for manufacturing a blood glucose test piece according to the present invention. The flow includes the following steps: Step S1: setting a silver layer and a carbon layer on a PET base layer by screen printing. To form a circuit board containing one of the reactive circuit regions.

Step S2: Avoiding the portion of the reaction circuit region, the insulating material is screen printed on the circuit board to form an insulating layer.

Step S3:. A spacer layer is adhered to the circuit board and covers the reaction circuit area, so that one of the openings of the intermediate layer communicates with the reaction circuit area.

Step S4: Screen printing or dispensing, applying a reaction reagent containing GDH enzyme to the intermediate layer to form an enzyme layer covering the opening.

Step S5: Applying a polymer material, a non-ionic surfactant, and a water mixed material to the enzyme layer by screen printing or dispensing to form a gate layer for removing the enzyme into the enzyme. The blood cells of the blood in the layer. In addition, the material of the gate removing layer may further comprise a nano-sized cerium oxide or aluminum oxide.

Step S6: Adhering a layer of double-sided tape on the insulating layer to form a glue layer.

Step S7: pasting a hydrophilic layer on the adhesive layer and the gate removing layer to accelerate the flow of blood into the gate removing layer.

Step S8: Pasting an upper cap layer on the hydrophilic layer, and observing the test blood condition through a transparent window of one of the upper cap layers.

In summary, the blood glucose test piece of the present invention sets a polymer material containing a nonionic surfactant on a layer of an enzyme by screen printing or dispensing to form a gate layer by means of the gate layer. The blood cell barrier causing interference can be removed to improve the accuracy of the blood glucose concentration test, thereby effectively reducing the test error. And the gate layer can also enter A nano-sized cerium oxide or aluminum oxide is added in one step to promote the performance of interlayer ion distribution.

The above is intended to be illustrative only and not limiting. Any equivalent modifications or alterations to the spirit and scope of the invention are intended to be included in the scope of the appended claims.

11‧‧‧PET layer

12‧‧‧ carbon layer

13‧‧‧ Silver layer

2‧‧‧Insulation

21‧‧‧ wearing a mouth

3‧‧‧Interval

31‧‧‧ openings

4‧‧‧Enzyme layer

5‧‧‧ Grid layer

6‧‧‧ glue layer

7‧‧‧Hydrophilic layer

8‧‧‧Upper cover

81‧‧‧Transparent window

Claims (10)

A method for manufacturing a blood glucose test piece, comprising the steps of: setting a silver layer and a carbon layer on a PET base layer by screen printing to form a circuit board including a reaction circuit region; avoiding the reaction circuit a portion of the region, the insulating material is screen printed on the circuit board to form an insulating layer; a dielectric layer is adhered to the circuit board and covers the reaction circuit region, so that one of the intermediate layers is opened The reaction circuit area is in communication; the reaction reagent containing GDH enzyme is coated by screen printing or dispensing to form an enzyme layer covering the opening of the intermediate layer; by screen printing or dispensing, Applying a polymer material, a non-ionic surfactant, and a water-mixed material to the enzyme layer to form a gate layer for removing a blood cell that will enter a portion of the blood of the enzyme layer; a double-sided tape is formed on the insulating layer to form a glue layer; a hydrophilic layer is adhered to the glue layer and the gate layer to accelerate blood flow to the gate layer; and an upper cap layer is adhered to the hydrophilic layer, Transparent through one of the upper cover layers Blood test to observe the situation. The method for producing a blood glucose test piece according to claim 1, wherein the gate layer comprises 10 to 25 wt% of a nonionic surfactant and 20 to 50 wt% of a polymer material, and comprises a nonionic surfactant. The amount of the agent and the polymer material added is doped with water corresponding to the weight percentage. The method for producing a blood glucose test piece according to claim 1 or 2, wherein the material of the gate removing layer further comprises a nano-sized cerium oxide or aluminum oxide. The method for producing a blood glucose test piece according to claim 2, wherein the gate layer has a polymer material comprising polyethylene, polypropylene, polyvinyl acetate, polyacrylic acid or paraffin. The method for producing a blood glucose test piece according to claim 4, wherein the gate layer comprises 10% by weight of a nonionic surfactant and 25% by weight of paraffin wax. The method for producing a blood glucose test piece according to claim 4, wherein the gate layer comprises 12% by weight of a nonionic surfactant and 25% by weight of polyvinyl acetate. The method for producing a blood glucose test piece according to claim 4, wherein the gate layer comprises 15% by weight of a nonionic surfactant and 35% by weight of polyethylene. A blood glucose test piece comprising: a circuit board comprising a reaction circuit region; a middle spacer layer disposed on the circuit board and covering the reaction circuit region, wherein the intermediate layer comprises an opening, The opening is connected to the reaction circuit region; an insulating layer is disposed on the circuit board and the intermediate layer, and the insulating layer has a through opening to expose the opening of the intermediate layer; an enzyme layer is disposed therein The opening layer covers the opening, and the enzyme layer reacts with the blood by the enzyme, and then passes through the reaction circuit area to perform the interpretation, thereby measuring the corresponding blood glucose concentration; a grid layer is disposed on the enzyme layer, The material of the gate removing layer comprises a polymer material, a non-ionic surfactant and water for removing a blood cell of a portion of the blood which will enter the enzyme layer; and an upper cap layer disposed on the insulating layer And the gate layer, and the upper cap layer has a transparent window. The blood glucose test piece according to claim 8, further comprising a hydrophilic layer disposed between the upper cap layer and the intermediate layer to accelerate blood flow into the gate removing layer. The blood glucose test strip of claim 9, further comprising a glue layer disposed between the hydrophilic layer and the intermediate layer.