Multifunctional test strip

Abstract

The multifunctional test strip comprises a blood glucose detection layer group, a substrate, a blood ketone detection layer group and a uric acid detection layer group which are sequentially arranged from top to bottom, the top of the blood glucose detection layer group is separated from the outside through a blood glucose detection hydrophilic membrane spacer, and the blood glucose detection layer group and the blood ketone detection layer group are separated through the substrate; the blood ketone detection layer group and the uric acid detection layer group are separated through a blood ketone detection hydrophilic membrane spacer located at the bottom layer of the blood ketone detection layer group, and the bottom of the uric acid detection layer group is separated from the outside through a uric acid detection hydrophilic membrane spacer. According to the utility model, blood glucose detection, blood ketone detection and uric acid detection can be integrated on the same test strip.

Description

Technical Field

[0001] The utility model relates to the technical field of electrochemistry, in particular to the technical field of test strips. Background Art

[0002] Hyperglycemia, hyperuricemia and hyperketosis are all metabolic diseases that seriously endanger human health. With the gradual improvement of living standards, the number of people suffering from hyperglycemia, hyperuricemia or hyperketosis is increasing. In addition, blood sugar, uric acid and blood ketosis will affect each other. Therefore, regular testing of blood sugar, uric acid and blood ketone levels is of great significance for the prevention and diagnosis of chronic diseases.

[0003] At present, the detection of blood sugar, uric acid and blood ketone content at home is usually based on three independent test strips. Among them, blood sugar test strips are electrochemical barcode-free blood sugar test strips and preparation methods disclosed in the invention patent with publication number CN113588935A, uric acid test strips are high-sensitivity electrode-type uric acid test strips disclosed in the invention patent with publication number CN104330448A, and blood ketone test strips are high-precision electrochemical blood ketone test strips with hematocrit compensation disclosed in the invention patent with publication number CN109115852A. In other words, users need to use blood sugar test strips, uric acid test strips and blood ketone test strips and use them in conjunction with corresponding instruments to test the blood sugar, uric acid and blood ketones in their blood. This process often requires pricking the finger three times, which increases the pain of the patient.

[0004] In addition, hematocrit (HCT) refers to the volume ratio of red blood cells that sink to the whole blood after a certain amount of anticoagulated whole blood is centrifuged. At present, the mainstream blood glucose meters on the market are basically electrochemical type. However, when measuring blood glucose, the accuracy of electrochemical blood glucose meters will be affected by hematocrit.

[0005] In summary, the development of a multifunctional electrochemical test strip with hematocrit correction is of great significance for improving the accuracy of test results and facilitating users to monitor blood glucose, uric acid, and blood ketones in a timely manner. Summary of the invention

[0006] The purpose of the utility model is to solve the problems in the prior art and to provide a multifunctional test strip that can combine blood sugar detection, blood ketone detection and uric acid detection on the same test strip.

[0007] To achieve the above-mentioned purpose, the utility model proposes a multifunctional test strip, comprising a blood glucose detection layer group, a substrate, a blood ketone detection layer group and a uric acid detection layer group which are arranged in sequence from top to bottom, the top of the blood glucose detection layer group is separated from the outside by a blood glucose detection hydrophilic membrane spacer, the blood glucose detection layer group and the blood ketone detection layer group are separated by the substrate, the blood ketone detection layer group and the uric acid detection layer group are separated by a blood ketone detection hydrophilic membrane spacer located at the bottom of the blood ketone detection layer group, and the bottom of the uric acid detection layer group is separated from the outside by a uric acid detection hydrophilic membrane spacer.

[0008] Preferably, the blood glucose detection layer group includes a blood glucose detection hydrophilic membrane spacer, a blood glucose detection film, a blood glucose detection insulating sheet and a blood glucose detection electrode layer which are arranged in sequence from top to bottom, a blood glucose detection notch is provided at one end of the blood glucose detection film, a blood glucose detection enzyme layer is provided in the blood glucose detection notch, and a first electrode for hematocrit detection, a second electrode for hematocrit detection, a blood glucose detection counter electrode and a blood glucose detection working electrode are provided on the top surface of the blood glucose detection electrode layer.

[0009] Preferably, the blood sugar detection enzyme layer is a glucose dehydrogenase layer.

[0010] Preferably, a first blood sugar detection pore and a second blood sugar detection pore which are connected to the blood sugar detection notch are respectively provided on the blood sugar detection hydrophilic membrane spacer and the blood sugar detection insulating sheet.

[0011] Preferably, the blood ketone detection layer group includes a blood ketone detection electrode layer, a blood ketone detection insulating sheet, a blood ketone detection film and a blood ketone detection hydrophilic membrane spacer arranged in sequence from top to bottom, the top surface of the blood ketone detection electrode layer is respectively provided with a blood ketone detection counter electrode and a blood ketone detection working electrode, one end of the blood ketone detection film is provided with a blood ketone detection notch, and a blood ketone detection enzyme layer is provided in the blood ketone detection notch.

[0012] Preferably, the blood ketone detection enzyme layer is a β-hydroxybutyrate dehydrogenase layer.

[0013] Preferably, a first blood ketone detection pore and a second blood ketone detection pore connected to the blood ketone detection notch are respectively provided on the blood ketone detection hydrophilic membrane spacer and the blood ketone detection insulating sheet.

[0014] Preferably, the uric acid detection layer group comprises a uric acid detection electrode layer, a uric acid detection insulating sheet, a uric acid detection film and a uric acid detection hydrophilic membrane spacer arranged in sequence from top to bottom, the top surface of the uric acid detection electrode layer is respectively provided with a uric acid detection counter electrode and a uric acid detection working electrode, one end of the uric acid detection film is provided with a uric acid detection notch, and a uric acid detection enzyme layer is provided in the uric acid detection notch.

[0015] Preferably, the uric acid detection enzyme layer is a uricase layer.

[0016] Preferably, a first uric acid detection pore and a second uric acid detection pore which are connected to the uric acid detection notch are respectively provided on the uric acid detection hydrophilic membrane spacer and the uric acid detection insulating sheet.

[0017] Beneficial effects of the utility model:

[0018] 1) The utility model arranges the blood sugar detection layer group, the blood ketone detection layer group and the uric acid detection layer group in sequence from top to bottom, and uses the blood sugar detection hydrophilic membrane spacer, the substrate, the blood ketone detection hydrophilic membrane spacer and the uric acid detection hydrophilic membrane spacer to separate the layer groups or the layer groups from the outside, thereby integrating the blood sugar detection, the blood ketone detection and the uric acid detection on the same test strip, so as to realize the function that one drop of blood can make the test strip cooperate with the test instrument to simultaneously complete the detection of the three indicators of blood sugar, blood ketone and uric acid;

[0019] 2) The utility model allows each group of detection electrodes and each group of reaction enzymes to be independently set, so that not only can the optimal voltage be applied to each group of electrodes as needed to improve the accuracy of the test results, but also each group of reaction enzymes can be freely replaced as needed, which is convenient for use;

[0020] 3) The utility model adds a first hematocrit detection electrode and a second hematocrit detection electrode to the blood sugar detection layer group, so that the test strip has a hematocrit (HCT) correction function on the basis of blood sugar detection.

[0021] The features and advantages of the present invention will be described in detail through embodiments in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 This is the front view of the multifunctional test strip of the utility model;

[0023] Figure 2 It is a top view of the multifunctional test strip of the utility model;

[0024] Figure 3 It is a bottom view of the multifunctional test strip of the utility model;

[0025] Figure 4 It is an exploded view of the blood sugar detection layer group of the multifunctional test strip of the utility model;

[0026] Figure 5 It is a top view of the substrate of the multifunctional test strip of the utility model;

[0027] Figure 6 It is an exploded view of the blood ketone detection layer group of the multifunctional test strip of the utility model;

[0028] Figure 7It is an exploded view of the uric acid detection layer group of the multifunctional test strip of the utility model.

[0029] In the figure: 1-blood glucose detection layer group, 11-blood glucose detection hydrophilic membrane spacer, 111-blood glucose detection first pore, 12-blood glucose detection film, 121-blood glucose detection notch, 13-blood glucose detection enzyme layer, 14-blood glucose detection insulating sheet, 141-blood glucose detection second pore, 15-blood glucose detection electrode layer, 151-hematocrit detection first electrode, 152-hematocrit detection second electrode, 153-blood glucose detection counter electrode, 154-blood glucose detection working electrode, 2-blood ketone detection layer group, 21-blood ketone detection electrode layer, 211-blood glucose detection counter electrode, 212-blood glucose detection working electrode, 22- Blood ketone detection insulating sheet, 221-blood ketone detection second pore, 23-blood ketone detection enzyme layer, 24-blood ketone detection film, 241-blood ketone detection gap, 25-blood ketone detection hydrophilic membrane spacer, 251-blood ketone detection first pore, 3-uric acid detection layer group, 31-uric acid detection electrode layer, 311-uric acid detection counter electrode, 312-uric acid detection working electrode, 32-uric acid detection insulating sheet, 321-uric acid detection second pore, 33-uric acid detection enzyme layer, 34-uric acid detection film, 341-uric acid detection gap, 35-uric acid detection hydrophilic membrane spacer, 351-uric acid detection first pore, 4-substrate. DETAILED DESCRIPTION

[0030] See also Figures 1 to 7 The utility model multifunctional test strip comprises a blood glucose detection layer group 1, a substrate 4, a blood ketone detection layer group 2 and a uric acid detection layer group 3 which are arranged in sequence from top to bottom. The top of the blood glucose detection layer group 1 is separated from the outside world by a blood glucose detection hydrophilic membrane spacer 11, the blood glucose detection layer group 1 and the blood ketone detection layer group 2 are separated by a substrate 4, the blood ketone detection layer group 2 and the uric acid detection layer group 3 are separated by a blood ketone detection hydrophilic membrane spacer 25 located at the bottom of the blood ketone detection layer group 2, and the bottom of the uric acid detection layer group 3 is separated from the outside world by a uric acid detection hydrophilic membrane spacer 35. In this test paper, since the blood glucose detection layer group 1, the blood ketone detection layer group 2 and the uric acid detection layer group 3 are separated in pairs, simultaneous measurement of blood glucose, blood ketones and uric acid can be achieved. Among them, the front side of the test paper is used to detect blood glucose, and the back side of the test paper is used to detect blood ketones and uric acid respectively. This double-sided sampling design not only enables the test instrument to obtain multiple data indicators when using only one test strip, but also allows the test instrument to reduce the number of test strip ports.

[0031] The blood glucose detection layer group 1 includes a blood glucose detection hydrophilic membrane spacer 11, a blood glucose detection film 12, a blood glucose detection insulating sheet 14 and a blood glucose detection electrode layer 15 which are arranged in sequence from top to bottom. One end of the blood glucose detection film 12 is provided with a blood glucose detection notch 121, and a blood glucose detection enzyme layer 13 is arranged in the blood glucose detection notch 121. The top surface of the blood glucose detection electrode layer 15 is respectively provided with a first hematocrit detection electrode 151, a second hematocrit detection electrode 152, a blood glucose detection counter electrode 153 and a blood glucose detection working electrode 154. When in use, the test instrument applies an AC signal to the first hematocrit detection electrode 151 and the second hematocrit detection electrode 152 respectively, so that a circuit is formed between the first hematocrit detection electrode 151, the second hematocrit detection electrode 152 and the filled blood, and the impedance and phase angle of the blood are measured, and finally the hematocrit of the blood is obtained through the corresponding relationship between the impedance, the phase angle and the hematocrit. The test instrument also measures blood sugar through the blood sugar detection counter electrode 153 and the blood sugar detection working electrode 154, and uses the blood hematocrit to correct the result, thereby greatly improving the accuracy of blood sugar detection. In addition, the hematocrit test electrode group (hematocrit detection first electrode 151 and hematocrit detection second electrode 152) can be set closer to the blood inlet than the blood sugar test electrode group (blood sugar detection counter electrode 153 and blood sugar detection working electrode 154), so as to monitor whether there is an impedance value between the hematocrit detection first electrode 151 and the hematocrit detection second electrode 152, thereby judging whether blood has entered the test paper.

[0032] The blood sugar detection enzyme layer 13 is a glucose dehydrogenase layer.

[0033] The blood sugar detection hydrophilic membrane spacer 11 and the blood sugar detection insulating sheet 14 are respectively provided with a first blood sugar detection pore 111 and a second blood sugar detection pore 141 which are connected to the blood sugar detection notch 121. The first blood sugar detection pore 111 and the second blood sugar detection pore 141 can help the blood to contact the blood sugar detection enzyme layer 13 more quickly and smoothly.

[0034] The blood ketone detection layer group 2 includes a blood ketone detection electrode layer 21, a blood ketone detection insulating sheet 22, a blood ketone detection film 24 and a blood ketone detection hydrophilic membrane spacer 25 arranged in sequence from top to bottom, the top surface of the blood ketone detection electrode layer 21 is respectively provided with a blood ketone detection counter electrode 211 and a blood ketone detection working electrode 212, one end of the blood ketone detection film 24 is provided with a blood ketone detection notch 241, and a blood ketone detection enzyme layer 23 is arranged in the blood ketone detection notch 241. Similar to the blood glucose detection layer group 1, the test instrument can measure blood ketones by applying voltage on the blood ketone detection counter electrode 211 and the blood ketone detection working electrode 212 respectively.

[0035] The blood ketone detection enzyme layer 23 is a β-hydroxybutyrate dehydrogenase layer.

[0036] The blood ketone detection hydrophilic membrane spacer 25 and the blood ketone detection insulating sheet 22 are respectively provided with a first blood ketone detection pore 251 and a second blood ketone detection pore 221 connected to the blood ketone detection notch 241. The first blood ketone detection pore 251 and the second blood ketone detection pore 221 can help the blood to contact the blood ketone detection enzyme layer 23 more quickly and smoothly.

[0037] The uric acid detection layer group 3 includes a uric acid detection electrode layer 31, a uric acid detection insulating sheet 32, a uric acid detection film 34 and a uric acid detection hydrophilic membrane spacer 35 arranged in sequence from top to bottom, and the top surface of the uric acid detection electrode layer 31 is respectively provided with a uric acid detection counter electrode 311 and a uric acid detection working electrode 312, and one end of the uric acid detection film 34 is provided with a uric acid detection notch 341, and a uric acid detection enzyme layer 33 is provided in the uric acid detection notch 341. Similar to the blood sugar detection layer group 1, the test instrument can measure uric acid by applying voltage on the uric acid detection counter electrode 311 and the uric acid detection working electrode 312 respectively.

[0038] The uric acid detection enzyme layer 33 is a uricase layer.

[0039] The uric acid detection hydrophilic membrane spacer 35 and the uric acid detection insulating sheet 32 ​​are respectively provided with a first uric acid detection pore 351 and a second uric acid detection pore 321 connected to the uric acid detection notch 341. The first uric acid detection pore 351 and the second uric acid detection pore 321 can help the blood to contact the uric acid detection enzyme layer 33 more quickly and smoothly.

[0040] In the present application, since the blood glucose detection enzyme layer 13, the blood ketone detection enzyme layer 23 and the uric acid detection enzyme layer 33 are respectively located in independent enzyme reaction spaces, they are not only independent of each other but can also react synchronously, reducing interference between multiple measurements, and allowing manufacturers to replace enzymes according to the items that need to be tested, thereby freely combining test items.

[0041] Since the present application uses four independent pairs of electrodes for blood sugar detection, hematocrit detection, blood ketone detection and uric acid detection, the most appropriate voltage can be applied to each electrode pair, so that the obtained test value is more accurate. In addition, when in use, the test instrument can also apply voltage to the four independent pairs of electrodes through a time-sharing multiplexing algorithm to continuously sample. During the sampling period, if current is found, it means that the blood has come into contact with the reaction enzyme.

[0042] The above embodiments are intended to illustrate the present invention, not to limit the present invention. Any solution that is a simple transformation of the present invention falls within the protection scope of the present invention.

Claims

1. Multifunctional test strip, characterized in that: The invention comprises a blood glucose detection layer group (1), a substrate (4), a blood ketone detection layer group (2) and a uric acid detection layer group (3) which are arranged in sequence from top to bottom. The top of the blood glucose detection layer group (1) is separated from the outside by a blood glucose detection hydrophilic membrane spacer (11), the blood glucose detection layer group (1) and the blood ketone detection layer group (2) are separated by the substrate (4), the blood ketone detection layer group (2) and the uric acid detection layer group (3) are separated by a blood ketone detection hydrophilic membrane spacer (25) located at the bottom of the blood ketone detection layer group (2), and the bottom of the uric acid detection layer group (3) is separated from the outside by a uric acid detection hydrophilic membrane spacer (35).

2. The multifunctional test strip according to claim 1, characterized in that: The blood sugar detection layer group (1) comprises a blood sugar detection hydrophilic membrane spacer (11), a blood sugar detection film (12), a blood sugar detection insulating sheet (14) and a blood sugar detection electrode layer (15) which are arranged in sequence from top to bottom. A blood sugar detection notch (121) is provided at one end of the blood sugar detection film (12), a blood sugar detection enzyme layer (13) is provided in the blood sugar detection notch (121), and a first hematocrit detection electrode (151), a second hematocrit detection electrode (152), a blood sugar detection counter electrode (153) and a blood sugar detection working electrode (154) are provided on the top surface of the blood sugar detection electrode layer (15).

3. The multifunctional test strip according to claim 2, characterized in that: The blood sugar detection enzyme layer (13) is a glucose dehydrogenase layer.

4. The multifunctional test strip according to claim 2, characterized in that: The blood sugar detection hydrophilic membrane spacer (11) and the blood sugar detection insulating sheet (14) are respectively provided with a first blood sugar detection air hole (111) and a second blood sugar detection air hole (141) which are connected to the blood sugar detection notch (121).

5. The multifunctional test strip according to claim 1, characterized in that: The blood ketone detection layer group (2) comprises a blood ketone detection electrode layer (21), a blood ketone detection insulating sheet (22), a blood ketone detection film (24) and a blood ketone detection hydrophilic membrane spacer (25) which are arranged in sequence from top to bottom. A blood ketone detection counter electrode (211) and a blood ketone detection working electrode (212) are respectively arranged on the top surface of the blood ketone detection electrode layer (21). A blood ketone detection notch (241) is arranged at one end of the blood ketone detection film (24), and a blood ketone detection enzyme layer (23) is arranged in the blood ketone detection notch (241).

6. The multifunctional test strip according to claim 5, characterized in that: The blood ketone detection enzyme layer (23) is a β-hydroxybutyrate dehydrogenase layer.

7. The multifunctional test strip according to claim 5, characterized in that: The blood ketone detection hydrophilic membrane spacer (25) and the blood ketone detection insulating sheet (22) are respectively provided with a first blood ketone detection pore (251) and a second blood ketone detection pore (221) which are connected to the blood ketone detection notch (241).

8. The multifunctional test strip according to claim 1, characterized in that: The uric acid detection layer group (3) comprises a uric acid detection electrode layer (31), a uric acid detection insulating sheet (32), a uric acid detection film (34) and a uric acid detection hydrophilic membrane spacer (35) which are arranged in sequence from top to bottom; a uric acid detection counter electrode (311) and a uric acid detection working electrode (312) are respectively arranged on the top surface of the uric acid detection electrode layer (31); a uric acid detection notch (341) is arranged at one end of the uric acid detection film (34); and a uric acid detection enzyme layer (33) is arranged in the uric acid detection notch (341).

9. The multifunctional test strip according to claim 8, characterized in that: The uric acid detection enzyme layer (33) is a uricase layer.

10. The multifunctional test strip according to claim 8, characterized in that: The uric acid detection hydrophilic membrane spacer (35) and the uric acid detection insulating sheet (32) are respectively provided with a first uric acid detection pore (351) and a second uric acid detection pore (321) which are connected to the uric acid detection notch (341).

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