CN104749228A - Test strip and method for detecting blood glucose and blood lipid simultaneously - Google Patents

Abstract

The invention discloses a test strip and a method for simultaneously detecting blood sugar and blood lipid, belonging to the technical field of biochemical index detection. The test strip includes a substrate layer, a reaction pad and a diffusion layer; there are at least two reaction pads, on which are respectively provided enzymes for detecting blood sugar and enzymes for detecting blood lipids; the at least two reaction pads are all connected to the diffusion layer. The layers are connected; the substrate layer is provided with detection electrode pairs, the number of the detection electrode pairs is consistent with the number of reaction pads, and each detection electrode pair corresponds to a reaction pad. The method for simultaneously detecting blood sugar and blood lipid of the present invention adopts the above-mentioned test strip, and the liquid sample is evenly diffused to each reaction pad by the diffusion layer, thereby respectively obtaining the contents of blood sugar and blood lipid in the liquid sample. The test strip and the method of the present invention detect blood sugar and blood lipid at the same time through one sample injection, which reduces the volume of the liquid sample, shortens the detection time, and reduces the cumbersome degree of operation.

Description

Test strip and method for simultaneously detecting blood sugar and blood lipid

technical field

The invention relates to a biochemical index detection technology, in particular to a test strip and a method for simultaneously detecting blood sugar and blood lipid.

Background technique

In the detection of biochemical indicators, the electrochemical determination method is the electron transfer generated by the enzyme after the biochemical reaction, according to the current flow proportional to the concentration of the substance to be tested in the specimen, and then detected by the conductive electrode, its rapid response and rapid electron transfer The characteristics of the measurement to the electrode make the electrochemical measurement method a rapid and reliable detection method. Electrode test strips have been widely used in various detection products, such as various biochemical detectors such as blood sugar, uric acid, and cholesterol, due to their easy manufacture, low cost, and portability.

As we all know, diabetic patients belong to the high-risk group of cardiovascular disease. According to the survey, nearly 80% of diabetic patients eventually die of cardiovascular disease. In order to defend cardiovascular health, diabetic patients need to build three "firewalls"-blood sugar, blood pressure, and blood lipids. Blood sugar is naturally more likely to be valued by diabetic patients, and blood pressure is easier to monitor and control because of the economical and convenient measurement methods. Relatively speaking, the control of blood lipids is more likely to be ignored. However, dyslipidemia happens to be the direct destroyer of cardiovascular health, therefore, the majority of diabetic patients must pay attention to it. Therefore, for diabetics, in addition to the monitoring of blood sugar, the monitoring of blood lipids is also very important.

However, so far, there is no test strip that can simultaneously detect the indicators of blood sugar and blood lipids, so that the blood sugar and blood lipids of diabetic patients can be well controlled.

Contents of the invention

Based on this, the purpose of the present invention is to overcome the defect of prior art, provide a kind of test paper strip that detects blood sugar and blood lipid at the same time, adopt this test paper, can detect blood sugar and blood fat simultaneously on a test paper by one injection , to achieve integrated detection.

To achieve the above object, the present invention takes the following technical solutions:

A test strip for simultaneously detecting blood sugar and blood lipids, comprising a substrate layer, a reaction pad and a diffusion layer; said reaction pads are at least two, on which are respectively provided enzymes for detecting blood sugar and enzymes for detecting blood lipids; The at least two reaction pads are all in communication with the diffusion layer; the substrate layer is provided with detection electrode pairs, the number of the detection electrode pairs is consistent with the number of reaction pads, and each detection electrode pair is connected to a reaction pad. correspond.

The test strip of the present invention has a plurality of reaction pads, the number of the reaction pads can be flexibly set according to the biochemical index to be detected, and a plurality of detection electrode pairs are used, so that each reaction pad corresponds to a pair of detection electrode pairs , can realize the detection of different items. And through the setting of the diffusion layer, the liquid sample can be evenly diffused to the reaction pad connected to the diffusion layer, ensuring that each reaction pad can obtain enough liquid sample for detection, so that blood sampling and sample addition can be detected at the same time Blood sugar and blood lipid purposes.

In one of the embodiments, it also includes a hydrophilic film and an adhesive layer, the adhesive layer is provided with a hollow part, and the hollow part is provided with a siphon channel connecting the edge of the test strip; the hydrophilic film covers the Hollow out. Due to the existence of the hollow part, a fixed-sized sample loading space is formed between the hydrophilic membrane and the diffusion layer. Through the limitation of the sample loading space, it is ensured that the sample loading is the same each time, ensuring that the test strips high repeatability and precision.

In one of the embodiments, the detection electrode pair includes a working electrode and a counter electrode opposite to each other, and the substrate layer includes a first substrate layer and a second substrate layer, and the first substrate layer is provided with a working electrode, a working electrode The wire and the electrode terminal joint of the working electrode are provided with the counter electrode, the counter electrode wire and the electrode terminal joint of the counter electrode on the second substrate layer. The detection electrode pair is carbon electrode, graphite electrode or metal electrode, etc.; the wire is silver wire or gold wire, etc. The working electrode and the counter electrode are arranged on different substrate layers, and the current needs to flow through the entire reaction pad during detection, which can provide a larger test volume.

In one embodiment, an insulating layer is further included, the insulating layer is arranged between the first substrate layer and the second substrate layer, and the insulating layer is provided with a first opening matching the shape of the reaction pad. Through the use of the insulating layer, the working electrode and the counter electrode can be better isolated to ensure the accuracy of the detection, and the reaction pad is exposed through the hole on the insulating layer to ensure the connection between the reaction pad and the working electrode and the counter electrode. .

In one of the embodiments, it further includes a separation pad and a deflector, the separation pad is disposed between the diffusion layer and the reaction pad, and the deflector is disposed between the separation pad and the reaction pad. Through the arrangement of the separation pad, the interfering substances can be separated and prevented from entering the reaction pad. The separation pad can be made of glass fiber filter paper and other materials. In addition, the deflector is used to ensure that the liquid sample can smoothly pass through the separation pad and enter the reaction pad.

In one embodiment, the enzyme used to detect blood lipids is at least one of cholesterol esterase, cholesterol oxidase, peroxidase, catalase, lipoprotein esterase, glycerol kinase, and glycerol phosphate oxidase species, the enzyme used to detect blood sugar is at least one of catalase, peroxidase, and glucose oxidase. Use the above-mentioned enzymes for detecting blood lipids to detect TC (total cholesterol), HDL (high-density lipoprotein), TG (triglyceride), LDL (low-density lipoprotein), VLDL (very low-density lipoprotein) in blood lipids Any one or several components, wherein, the enzyme for detecting TC, HDL, LDL, VLDL is at least one of cholesterol esterase, cholesterol oxidase, peroxidase; the enzyme for detecting TG is lipoprotein esterase, At least one of glycerol kinase, glycerol phosphate oxidase, and peroxidase. According to different needs, the required enzymes can be flexibly selected.

In one of the embodiments, an electron transfer medium and a buffer are also provided on the reaction pad; the electron transfer medium is ferricyanate (such as potassium ferricyanide, etc.), ferrocene (that is, cyclopentadienyl iron) or p-benzoquinone; the buffer is phosphate buffer, tris (hydroxymethyl) aminomethane-hydrochloric acid buffer (TRIS buffer) or 2-(N-morpholine) ethanesulfonic acid buffer (MES buffer liquid). At the same time, some other substances, such as Triton X-100 (polyethylene glycol octyl phenyl ether), etc., can be added as needed to improve the solubility of ester cholesterol. In order to achieve better detection results, according to different situations, various electron transfer media can be selected to reduce the potential required for redox reactions, or surfactants can be selected to increase the solubility of the analyte.

In one of the embodiments, the substrate layer is polystyrene, polyester, polycarbonate, polyether, polyethylene, polypropylene, polyethylene terephthalate or polyethylene terephthalate substrate layer. The substrate layer is made of insulating polymer material to ensure that the work of the detection electrode pair is not disturbed.

The present invention also provides a method for simultaneously detecting blood sugar and blood lipids. Using the above-mentioned test strip, the liquid sample is added to the diffusion layer, and the liquid sample is evenly diffused to each reaction pad by the diffusion layer. The different reaction pads react with the enzyme for detecting blood sugar and the enzyme for detecting blood lipid respectively to generate electric current. According to the magnitude of the electric current, the contents of blood glucose and blood lipid in the liquid sample are respectively obtained.

The method for simultaneously detecting blood sugar and blood lipids of the present invention enables the liquid sample to be evenly diffused to multiple reaction pads connected to the diffusion layer through the setting of the diffusion layer, ensuring that each reaction pad can obtain enough liquid for detection Samples, and set the enzymes required for different detection items on multiple reaction pads, so as to achieve the purpose of simultaneous detection of blood glucose and blood lipids in one blood collection and sample addition.

In one of the embodiments, the test strip also includes a hydrophilic film and an adhesive layer, and the adhesive layer is provided with a hollow part, and the hollow part is provided with a siphon channel communicating with the edge of the test strip; The film covers the hollow part; guided by the hydrophilic film, the liquid sample is sucked into the hollow part from the siphon channel in a siphon way, and the amount of the liquid sample is limited by the space of the hollow part, and then the liquid test The sample is evenly diffused from the diffusion layer to each reaction pad for subsequent reactions. The sample is injected by siphon. Once the siphon channel on the edge of the test strip touches the liquid sample, the liquid sample can automatically enter the reaction area, which reduces the difficulty of testing for users and reduces the amount of liquid sample. At the same time, due to the existence of the hollow part, a sample loading space with a fixed size is formed between the hydrophilic membrane and the diffusion layer. Through the limitation of the sample loading space, it is ensured that the sample loading is the same each time, ensuring High repeatability and precision of test strips.

Compared with the prior art, the present invention has the following beneficial effects:

A test strip for simultaneously detecting blood sugar and blood lipid according to the present invention has a plurality of reaction pads, can simultaneously detect blood sugar and blood lipid, and realizes integrated detection. Simultaneous detection of blood glucose and blood lipids through a single sample injection reduces the volume of liquid samples, shortens the detection time, and reduces the cumbersome degree of operation. It avoids the trouble caused by changing test strips, can prompt diabetic patients to recognize dyslipidemia early and give correct intervention, and can prevent and treat atherosclerosis, reduce cardiovascular and cerebrovascular events, and reduce mortality.

Moreover, the test strip can also ensure the same amount of sample added each time through the limitation of the sample adding space, ensuring the high repeatability and precision of the test strip.

The method for simultaneously detecting blood sugar and blood lipids of the present invention can quickly and simultaneously detect blood sugar and blood lipids through one sample injection, reducing the cumbersome degree of operation.

Description of drawings

Fig. 1 is the test strip schematic diagram in embodiment 1;

Figure 2 is a schematic diagram of the test strip in Example 2.

Detailed ways

The present invention will be described in detail below in conjunction with the accompanying drawings and specific embodiments.

Example 1

A test strip 100 for simultaneously detecting blood sugar and blood lipid, this embodiment adopts a blood drop method for sample injection. The test strip 100 includes a first substrate layer 110, an insulating layer 120, four reaction pads (131, 132, 133, 134), a second substrate layer 140, and flow deflectors (151, 152, 153, 154 ), separation pad 160 , diffusion layer 170 and cover sheet 180 , as shown in FIG. 1 . in:

In this embodiment, a polyethylene terephthalate (PET) sheet substrate is used as the first substrate layer 110 and the second substrate layer 140, and then screen printed on the first substrate layer 110. forming working electrodes (111, 112, 113, 114), working electrode wires, electrode terminal joints (115, 116, 117, 118) of the working electrodes, the electrode terminal joints being used for electrical connection with the device for applying voltage, On the second substrate layer 140, counter electrodes (141, 142, 143, 144), counter electrode wires, and electrode terminal connectors 149 of the counter electrode are formed, and a second opening is set at the position where the counter electrode faces the four working electrodes. The holes (145, 146, 147, 148) are used for liquid samples to pass through, the working electrode and the counter electrode are carbon electrodes, and the wires are silver wires.

The insulating layer 120 is located between the first substrate layer 110 and the second substrate layer 140, and the insulating layer 120 is provided with first openings (121, 122, 123) matching the shape of the reaction pads (131, 132, 133, 134) , 124 ), the insulating layer 120 also exposes the electrode terminal joints of the detection electrode pair for electrical connection with the electronic device for applying voltage.

The reaction reagents contained in the reaction pads (131, 132, 133, 134) include electron transfer media, enzymes and buffers that react with the liquid sample to generate electric current. Among them, the electron transfer medium is ferrocene. The enzymes that react with the liquid sample and generate current are cholesterol esterase, cholesterol oxidase, catalase, and glucose oxidase, which are respectively arranged on four reaction pads (131, 132, 133, 134). The buffer is TRIS buffer. In this embodiment, some other substances, such as Triton X-100, etc. may also be added to improve the solubility of the ester cholesterol.

The baffles (151, 152, 153, 154) are arranged above the second openings (145, 146, 147, 148) on the second substrate layer 140, coincident with the second openings, and then separate The pad 160 and the diffusion layer 170 are sequentially covered on the second substrate layer 140 , and then a cover sheet 180 is added, and a sample inlet 181 is provided on the cover sheet 180 . The different layers of the test strip are bonded by adhesive.

The test strip workflow of the present embodiment is as follows:

First, the liquid sample is added dropwise to the sample inlet 181 on the cover sheet 180, and through the uniform diffusion of the diffusion layer 170, it diffuses from the center of the diffusion layer 170 to the surroundings, and passes through the guide sheet (151, 152, 153, 154), so that the liquid sample smoothly passes through the separation pad 160 under the diffusion layer 170, and after the separation pad 160 removes the interfering substances, the liquid sample is respectively sent to the counter electrode (141, 142, 143, 144). The second openings (145, 146, 147, 148) are arranged to enter the reaction pads (131, 132, 133, 134) under the second substrate layer 140, in the reaction pads (131, 132, 133, 134) , the analyte reacts with cholesterol esterase, cholesterol oxidase, catalase or glucose oxidase respectively to generate a current. At this time, the instrument has started the acquisition program, but does not prompt the user to start the detection until the collected signal strength is greater than the predetermined Threshold, indicating that the blood volume is just sufficient, at this time the instrument displays and reminds the user that the measurement has started, and the user stops adding blood. Finally, the contents of blood glucose and blood lipid in the liquid sample are respectively obtained according to the magnitude of the current generated by the reaction between the analyte in the liquid sample and the enzymes in different reaction pads (131, 132, 133, 134).

Example 2

As shown in Figure 2, the test strip 200 for simultaneous detection of blood sugar and blood lipids in this embodiment is basically the same as the test strip 200 in Example 1, the difference is that:

The test strip is further laminated with an adhesive layer 290 and a hydrophilic film 291 between the diffusion layer and the cover sheet. The adhesive layer 290 is made of sticky material and can adhere the hydrophilic film 291 . The hydrophilic membrane 291 is made of a material with a hydrophilic group, and can absorb liquid samples.

The adhesive layer is provided with a hollow part 293 , and the hollow part 292 is provided with a siphon channel 293 connected to the edge of the test strip; the hydrophilic film 291 covers the hollow part 292 .

The test strip work of the present embodiment is basically the same as the test strip work flow of embodiment 1, the difference is:

The test strip adopts the method of siphon sampling, utilizes the guidance of the hydrophilic film 291, sucks the liquid sample from the siphon channel 293 to the hollow part 292, and limits the amount of the liquid sample to be added by the space size of the hollow part 292, and then The liquid sample is uniformly diffused from the diffusion layer 270 to each reaction pad (231, 232, 233, 234) for subsequent reaction.

The above-mentioned embodiments only express several implementation modes of the present invention, and the description thereof is relatively specific and detailed, but should not be construed as limiting the patent scope of the present invention. It should be pointed out that those skilled in the art can make several modifications and improvements without departing from the concept of the present invention, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the patent for the present invention should be based on the appended claims.

Claims (10)

1. detect a test strips for blood sugar and blood fat simultaneously, it is characterized in that, comprise substrate layer, reacting pad and diffusion layer; Described reacting pad is at least two, it is respectively equipped with the enzyme for detecting blood sugar and the enzyme for detecting blood fat; Described at least two reacting pads are all communicated with described diffusion layer; Described substrate layer is provided with detecting electrode pair, and the right quantity of this detecting electrode is consistent with the quantity of reacting pad, and each detecting electrode is to all corresponding with a reacting pad.

2. the test strips simultaneously detecting blood sugar and blood fat according to claim 1, it is characterized in that, also comprise hydrophilic film and bonding coat, described bonding coat is provided with hollow-out parts, and this hollow-out parts is provided with the siphon passage being communicated with test strips edge; Described hydrophilic film covers described hollow-out parts.

3. the test strips simultaneously detecting blood sugar and blood fat according to claim 1, it is characterized in that, described detecting electrode is to comprising the relative working electrode in position and to electrode, described substrate layer comprises first substrate layer and second substrate layer, this first substrate layer is provided with the electrode tips joint of working electrode, working electrode wire and working electrode, and this second substrate layer is provided with to electrode, to electrode cable and the electrode tips joint to electrode.

4. the test strips simultaneously detecting blood sugar and blood fat according to claim 3, it is characterized in that, also comprise insulation course, described insulation course is located between first substrate layer and second substrate layer, and this insulation course is provided with the first perforate with reacting pad form fit.

5. the test strips simultaneously detecting blood sugar and blood fat according to claim 1, it is characterized in that, also comprise separating pad and flow deflector, described separating pad is located between diffusion layer and reacting pad, and described flow deflector is located between separating pad and reacting pad.

6. the test strips simultaneously detecting blood sugar and blood fat according to claim 1, it is characterized in that, the described enzyme for detecting blood fat is at least one in cholesterol esterase, cholesterol oxidase, peroxidase, hydrogen peroxidase, lipoproteinesterase, glycerokinase, GPO, and the described enzyme for detecting blood sugar is at least one in hydrogen peroxidase, peroxidase, glucose oxidase.

7. the test strips simultaneously detecting blood sugar and blood fat according to claim 1, is characterized in that, described reacting pad is also provided with electron transfer mediator and damping fluid; Described electron transfer mediator is ferricyanate, ferrocene or 1,4-benzoquinone; Described damping fluid is phosphate buffer, three (methylol) aminomethane-hydrochloride buffer or 2-(N-morpholine) ethanesulfonic acid buffer.

8. the test strips simultaneously detecting blood sugar and blood fat according to claim 1, it is characterized in that, described substrate layer is polystyrene, polyester, polycarbonate, polyethers, tygon, polypropylene, polyethylene terephthalate or PET substrate's layer.

9. one kind is detected the method for blood sugar and blood fat simultaneously, it is characterized in that: adopt test strips according to claim 1, liquor sample is added on diffusion layer, by diffusion layer, liquor sample is diffused to each reacting pad uniformly, liquor sample on different reacting pads respectively with detect the enzyme of blood sugar and detect the enzyme reaction of blood fat, generation current, according to size of current, draws the content of blood sugar and blood fat in liquor sample respectively.

10. the method simultaneously detecting blood sugar and blood fat according to claim 9, it is characterized in that, this test strips also comprises hydrophilic film and bonding coat, and described bonding coat is provided with hollow-out parts, and this hollow-out parts is provided with the siphon passage being communicated with test strips edge; Described hydrophilic film covers described hollow-out parts; Utilize the guiding of hydrophilic film, in the mode of siphon, liquor sample is sucked into hollow-out parts by siphon passage, with the application of sample amount of the space size confined liquid sample of hollow-out parts, then make liquor sample diffuse to each reacting pad uniformly by diffusion layer, carry out subsequent reactions.