TWM460273U - A blood filtering electrochemical test strip - Google Patents

Description

Electrochemical detection test piece with blood filtering function

The present invention relates to an electrochemical detection test piece, and in particular to a disposable electrochemical test piece with a function of filtering blood and exhausting.

With the advancement of medical technology, the average life expectancy of human beings has gradually prolonged. However, various civilized diseases are also widespread in society. According to reports published by the World Health Organization, non-communicable diseases such as cancer and cardiovascular diseases have become the main threat to human health. According to the World Health Organization, about 17 million people worldwide die from cardiovascular disease each year, and it is estimated that the number of people dying from cardiovascular disease worldwide will increase to 25 million by 2030. In addition, the Ministry of Health of China also counts about 1.45 million heart patients in China.

According to past studies, it is known that cholesterol is closely related to cardiovascular disease. The increase or decrease of the cholesterol index in the blood is very important for disease prevention or control. However, methods for detecting blood cholesterol in the past, such as "optical quantitative method" and "chromatographic method", need to be used for a long time. Time test, and the former is susceptible to hemoglobin shadowing effect, the latter is semi-quantitative, the operation method is more complicated, and it is difficult to judge the result.

Due to the popularity of home detectors, test strips for various applications have been developed. Cholesterol test strips are also one of the main products. In the past, combined with the principle of electrochemical analysis, the method of filtering blood cells was combined with filter paper. The structure is complicated and the process is complicated. The cumbersome process of filtering the blood cells combined with the filter paper needs to provide an exhaust pipe to effectively deliver the blood to the designated reaction area. In the past, it was necessary to provide an escape passage to exhaust, thereby increasing the cost. It is a problem to be solved by those skilled in the art to provide a test piece which has both a blood filtering and a venting function and a simplified structure.

Therefore, the main object of the present invention is to provide an electrochemical test strip having a blood filtering function, which utilizes a multi-layered porous filter membrane and a hydrophilic layer to achieve the function of filtering blood and forming an escape passage, and the blood passes through the filter membrane. When the hydrophilic layer is used, the blood cells can be filtered, and the gas is exhausted by the channels formed by the left and right sides.

Another object of the present invention is to provide an electrochemical test strip having a blood filtering function, wherein the filter membrane can be coated with a reagent having a specific function, and the reagent can be biochemically reacted with the non-test substance in the sample. To achieve a screening function, which can detect low-density lipoprotein or high-density lipoprotein.

Another object of the present invention is to provide an electrochemical test piece with a blood filtering function, a clamp fixture is clamped on the front end of the test piece, and the clamp can fix the test piece and achieve a function of sucking and fixing the blood volume.

Another object of the present invention is to provide an electrochemical test strip having a blood filtering function, wherein the reaction pad is coated with a specific reaction reagent, such as a cholesterol reaction reagent, and the reaction mat has a three-dimensional structure, so when coating specificity The reaction reagent is beneficial to increase the collision probability between the reaction reagent and the sample to be tested, thereby enhancing the reaction signal.

A further object of the present invention is to provide an electrochemical test strip having a blood filtering function, which utilizes a multi-layered porous filter membrane and a hydrophilic layer to achieve an exhausting action without requiring an additional escape passage, thereby reducing manufacturing. cost.

Based on the above object, the present invention provides an electrochemical test strip having a blood filtering function, comprising: a first substrate having a first surface and a second surface, the second surface facing away from the first surface; and an electrode The system is located on the first surface of the first substrate and has at least one working electrode and a reference electrode; a reaction pad covering the electrode system and coating at least one reagent for filtering with a fluid to be tested Forming one sample contact to generate a biochemical reaction; a second substrate covering the first substrate, the electrode system and the surface of the reaction pad, and the second substrate having a first opening to cause a reaction pad a filter membrane disposed above the first opening of the second substrate and covering the reaction pad for filtering the fluid to be tested to make the fluid to be tested into a sample; a hydrophilic layer covering the filter membrane for filtering the fluid to be tested a third substrate covering the hydrophilic layer, the third substrate having a second opening corresponding to the first opening position, the hydrophilic layer is exposed and the hydrophilic layer, the filter film and the reaction pad are fixed at the same position; a fourth substrate, Covering the third substrate, one side has a concave channel at a position corresponding to the second opening for the fluid to be tested to enter; and a fifth substrate covering the fourth substrate.

The invention further provides an electrochemical test strip with a blood filtering function, comprising: a first substrate having a first surface and a second surface, the second surface facing away from the first surface; an electrode system located at The first surface of the first substrate has at least one working electrode and a reference electrode; a reaction pad covers the electrode system and is coated with at least one reagent for forming the same as the fluid to be tested The contact generates a biochemical reaction; a second substrate covering the first substrate, the electrode system and the surface of the reaction pad, having a first opening thereon for exposing the reaction pad; and a filtration membrane system including at least an upper filter film With a filter membrane, the lower filter membrane is covered on the reaction mat to filter a fluid to be tested, so that the fluid to be tested becomes a sample, the upper filter membrane covers the lower filter membrane, and the upper filter membrane is used to filter the fluid to be tested; a layer covering the upper filter membrane for filtering the fluid to be tested; a third substrate covering the hydrophilic layer, having a second opening corresponding to the first opening position, so that the hydrophilic layer is violent And fixing the hydrophilic layer, the filter membrane and the reaction pad at the same position; a fourth substrate covering the third substrate, having a concave channel on one side thereof, the concave channel corresponding to the second opening for the fluid to be tested to enter And a fifth substrate covering the fourth substrate.

The novel provides the following advantages: 1. The test strip has a function of filtering blood. 2. The test strip has a screening function and can further detect low density lipoprotein or high density lipoprotein. 3. Make test strips detect total blood cholesterol. 4. Make the test strips have the effect of venting. 5. Make the exhaust of the test piece naturally formed without additional setting Escape channels to reduce costs.

2,3,5‧‧‧Electrochemical test strips with blood filtration function

10, 30, 40‧‧‧ first substrate

101, 301, 401‧‧‧ first surface

102, 302, 402‧‧‧ second surface

11, 31, 41‧‧‧ electrode system

111, 311, 411‧‧‧ working electrodes

112, 312, 412‧‧‧ reference electrode

12, 32, 42‧‧‧Reactive mat

13, 33, 43‧‧‧ second substrate

131, 331, 431‧‧ first opening

14, 34‧‧‧ filter membrane

44‧‧‧Filter membrane system

442‧‧‧Upper filter membrane

441‧‧‧ under the filter membrane

15, 35, 45‧‧ ‧ hydrophilic layer

16, 36, 46‧‧‧ third substrate

161, 361, 461‧‧‧ second opening

17, 37, 47‧‧‧ fourth substrate

171, 371, 471 ‧ ‧ concave channels

18, 38, 48‧‧‧ fifth substrate

39‧‧‧fixed clip

391‧‧‧ Plane

392‧‧‧Fixed claws

W1, W2, W3, W4‧‧‧ fluid flow to be tested

In order to make the above and other objects, features, advantages and embodiments of the present invention more obvious, the description of the drawings is as follows: FIG. 1A is an exploded view showing one of the first embodiment of the present invention. Electrochemical detection of various components of the test piece of the blood filter function.

Fig. 1B is a schematic view showing the entirety of an electrochemical test strip having a blood filtering function according to a first embodiment of the present invention.

1C is a cross-sectional view showing the filtration and screening of the fluid to be tested of the electrochemical test strip having the blood filtering function according to the first embodiment of the present invention.

Fig. 2A is an exploded view showing the components of the electrochemical test strip having the blood filtering function of the second embodiment of the present invention.

2B is a schematic view showing the entirety of an electrochemical test strip having a blood filtering function according to a second embodiment of the present invention.

Fig. 3A is an exploded view showing the components of the electrochemical test strip having the blood filtering function according to the third embodiment of the present invention.

Fig. 3B is a schematic view showing the entirety of an electrochemical test strip having a blood filtering function according to a third embodiment of the present invention.

FIG. 3C is a cross-sectional view showing the filtration and screening of the fluid to be tested of the electrochemical test piece with the blood filtering function according to the third embodiment of the present invention.

The presently disclosed embodiments are disclosed herein, however, it is to be understood that the embodiments disclosed herein In addition, the drawings drawn in the present invention are for illustrative purposes only and are primarily intended to aid in the description of the preferred embodiments of the present invention. The scope of the invention to be protected is subject to the scope of the patent application.

The present invention provides an electrochemical test piece with a blood filtering function, which has the advantages of The multi-layered porous filter membrane and the hydrophilic hydrophilic layer are used to make the test strip filter the blood and naturally form the exhaust function. The electrochemical test strip has a screening function by using a coating reagent or a reaction reagent on the filter membrane or the reaction pad, and can further detect low density lipoprotein, high density lipoprotein, or total cholesterol. In addition, since there is no need to additionally provide an escape passage, the cost can be reduced.

The above detailed description of the preferred embodiments of the present invention will be apparent from the accompanying drawings.

The following definitions clarify the meaning of the nouns used in this specification.

The term "escape", "exhaust action" or similar term means that when the fluid to be tested enters the entrance of the electrochemical test strip, the fluid is guided by capillary action through each layer of the porous filter membrane or hydrophilic layer to reach the reaction zone. The filter membrane and the hydrophilic membrane are porous materials, and the layers do not adhere to each other, and the excess gas in the fluid to be tested will escape from the pores between the layers and the gap between the layers, so that the electrochemical test strip can quickly inhale the sample without affecting The accuracy of the test.

The term "fluid to be tested" or a similar noun herein refers to whole blood or blood from which a non-test substance has not been removed.

The term "sample" or similar term, as used herein, refers to the removal of blood from the detection of a non-subject, which will produce a biochemical reaction with a reagent such as low-density lipoprotein, high-density lipoprotein, or total cholesterol.

The term "reference electrode" or similar noun herein refers to an electrode having a stable and reproducible electrode potential. It can be used as a reference to measure the potential of other electrodes. An electrode used to provide a standard potential that does not change with the composition and concentration of the measurement system. Commonly used reference electrodes are hydrogen electrode, calomel electrode (SHE), Ag/AgCl, Hg/Hg2Cl2 electrode, especially the calomel electrode.

The term "working electrode" or similar term refers to the significant concentration of the test solution when a large current is passed during the test of the electrochemical test strip. The electrode is changed. The electrode is not limited to a cathode or an anode. The reaction occurs at the end of the electrode. When the electrode is oxidized, it is an anode. Conversely, when the reduction reaction occurs, it is a cathode.

Referring to Figures 1A to 1C, an electrochemical test strip 2 having a blood filtering function according to a first embodiment of the present invention is shown. FIG. 1A shows an electrochemical test strip 2 having a blood filtering function, comprising: a first substrate 10, an electrode system 11, a reaction pad 12, a second substrate 13, at least one filter film 14, a hydrophilic layer 15, A third substrate 16, a fourth substrate 17, and a fifth substrate 18.

The first substrate 10 has a first surface 101 and a second surface 102 opposite to the first surface 101, and the electrode system 11 is located on the first surface 101. The electrode system 11 includes a working electrode 111, a reference electrode 112, and an electrode. The upper layer of the system 11 is covered with a reaction pad 12, which is made of glass fiber or cotton fiber, has a thickness of 0.1 to 0.3 mm, a pore size of 0.2 to 1 μm, and the reaction pad 12 has a three-dimensional structure, so when a specific reaction is applied The reagent is beneficial to increase the collision probability between the reaction reagent and the sample to be tested, thereby enhancing the reaction signal. The position where the reaction pad 12 is placed is referred to as a reaction zone, and the reaction pad 12 contains at least one reaction reagent for generating a biochemical reaction with the same contact, and the reaction reagent used in the present embodiment is used for interaction with cholesterol.

The second substrate 13 covers the surface of the first substrate 10, the electrode system 11 and the reaction pad 12. The second substrate 13 has a first opening 131, so that the reaction pad 12 of the reaction zone is exposed, that is, the first The opening 131 is sized to expose the reaction pad 12 in most of the area. The reaction pad 12 is covered with at least one filter film 14 for filtering a fluid to be tested to be a sample. The filter film 14 can be made of glass fiber or cotton fiber, and has a thickness of 0.3 to 0.5 mm. 0.5 to 2 μm; a hydrophilic layer 15 is coated on the filtration membrane 14 to filter the fluid to be tested.

The third substrate 16 covers the hydrophilic layer 15 such that the positions of the hydrophilic layer 15, the filtration membrane 14, and the reaction pad 12 are fixed above the reaction zone, and the third substrate 16 corresponds to the An opening 131 is located and has a second opening 161 to expose the hydrophilic layer 15. The fourth substrate 16 is covered with a fourth substrate 17 and has a concave channel 171 at its edge. The concave channel 171 is corresponding to the second opening 161. It is a fluid inlet to be tested, and its function is to quantify the volume of the fluid to be tested. The fifth substrate 18 is covered with a fifth substrate 18, and the whole is an electrochemical detection test piece 2 having a blood filtering function as shown in FIG. 1B.

1C is a cross-sectional view of the electrochemical test strip 2 having a blood-splitting function along the section line AA of FIG. 1B, and the first substrate 10, the reaction pad 12, and the second substrate 13 are sequentially arranged from bottom to bottom. The filter film 14, the hydrophilic layer 15, the third substrate 16, the fourth substrate 17, and the fifth substrate 18, the fluid to be tested (not shown) enters the test piece from the concave channel 171 of the fourth substrate 17, and is guided by capillary action. The fluid to be tested moves to the inside of the test piece along the direction W1, and the second opening 161 moves downward in the W2 direction, and the fluid to be tested is filtered through layers to form a biochemical reaction between the sample and the reaction pad 12 in contact with the reaction reagent. In the filtration process, since the filter membrane 14, the hydrophilic layer 15 and the reaction pad 12 are porous materials, and the layers are not sealed, when the fluid to be tested moves in the W2 direction, the excess gas in the fluid to be tested will be between the layers. The gap between the pores and the layers escapes, which naturally produces an exhaust effect.

Referring to FIG. 2A to FIG. 2B, an electrochemical test strip 3 having a blood filtering function according to a second embodiment of the present invention includes: a first substrate 30, an electrode system 31, a reaction pad 32, and a first The second substrate 33, at least one filter film 34, a hydrophilic layer 35, a third substrate 36, a fourth substrate 37, a fifth substrate 38, and a fixing clip 39.

Referring to FIG. 2A, the components of the electrochemical test strip 3 having the blood filtering function of the present embodiment are arranged in the same manner as the first embodiment, and the first substrate 30 has a first surface 301 and a first surface. One of the surfaces 301 is a second surface 302, and the electrode system 31 is located on the first surface 301. The electrode system 31 includes a working electrode 311 and a reference electrode 312. The upper layer of the electrode system 31 is covered with a reaction pad 32, which may be made of glass fiber or cotton fiber, and has a thickness of 0.1 to 0.3 mm and a pore size of 0.2 to 1 μm. The reaction pad 32 has a three-dimensional structure, so when a specific reaction reagent is applied, it is advantageous to increase the collision probability between the reaction reagent and the sample to be tested, thereby enhancing the reaction signal. The position at which the reaction pad 32 is placed is referred to as a reaction zone, and the reaction pad 32 contains at least one reaction reagent for generating a biochemical reaction with the same contact, and the reaction reagent used in the present embodiment is used for interaction with cholesterol.

The second substrate 33 covers the surface of the first substrate 30, the electrode system 31 and the reaction pad 32. The second substrate 33 has a first opening 331 thereon, so that the reaction pad 32 of the reaction zone is exposed, that is, the first The opening 331 is sized to expose the reaction pad 32 in most of the area. The reaction pad 32 is covered with at least one filter film 34 for filtering a fluid to be tested to be a sample of the foregoing. The filter film 34 can be made of glass fiber or cotton fiber, and has a thickness of 0.3 to 0.5 mm and a pore size of 0.5 to 2 μm; a hydrophilic layer 35 is coated on the filtration membrane 34 to filter the fluid to be tested.

The third substrate 36 covers the hydrophilic layer 35 such that the positions of the hydrophilic layer 35, the filter film 34, and the reaction pad 32 are fixed above the reaction zone, and the third substrate 36 corresponds to the position of the first opening 331 and has a second opening. 361 to expose the hydrophilic layer 35. The fourth substrate 36 is covered with a fourth substrate 37, and has an inner concave channel 371 at its edge. The concave channel 371 is corresponding to the second opening 361, and is a fluid inlet to be tested, and its function is to quantify the volume of the fluid to be tested. A fifth substrate 38 is covered over the fourth substrate 37.

In addition, the fixing clip 39 is clamped to the electrochemical test strip 3 having the blood filtering function, and the fixing clip 39 includes a plane 391 and a plurality of fixing claws 392 protruding upward from the four corners of the plane 391, and the plane 391 and the first The second surface 302 of the substrate 30 is in contact with each other, and a plurality of fixing claws 392 are hooked on the fifth substrate 38, so that the fixing clip 39 is clamped to the reaction end of the electrochemical test strip 3 having the blood filtering function, and the fixing clip 39 can be used. The volume of the fluid to be inhaled is a fixed value. Therefore, the entirety of the electrochemical test piece 3 having the blood filtering function formed is as shown in Fig. 2B.

Please refer to FIG. 3A-3C for a display of a third embodiment of the present invention. The electrochemical test strip 5 having a blood filtering function comprises: a first substrate 40, an electrode system 41, a reaction pad 42, a second substrate 43, a filter membrane system 44, a hydrophilic layer 45, and a third The substrate 46, a fourth substrate 47 and a fifth substrate 48.

The first substrate 40 has a first surface 401 and a second surface 402 opposite to the first surface 401, and the electrode system 41 is located on the first surface 401. The electrode system 41 includes a working electrode 411 and a reference electrode 412. The upper layer of the electrode system 41 is covered with a reaction pad 42 made of glass fiber or cotton fiber, having a thickness of 0.1 to 0.3 mm and a pore size of 20 to 100 μm. The reaction pad 42 has a three-dimensional structure, so when a specific reaction is applied The reagent is beneficial to increase the collision probability between the reaction reagent and the sample to be tested, thereby enhancing the reaction signal. The position where the reaction pad 42 is placed is referred to as a reaction zone, and the reaction pad 42 contains at least one reaction reagent for generating a biochemical reaction with the same contact, and the reaction reagent used in the present embodiment is used for interaction with cholesterol.

The second substrate 43 covers the surface of the first substrate 40, the electrode system 41 and the reaction pad 42. The second substrate 43 has a first opening 431, so that the reaction pad 42 of the reaction zone is exposed, that is, the first The opening 431 is sized to expose the reaction pad 42 in most of the area. The reaction membrane 42 is covered with a filtration membrane system 44 for filtering a fluid to be tested to form the aforementioned sample. The filtration membrane system 44 includes at least an upper filtration membrane 442 and a lower filtration membrane 441, and the lower filtration membrane 441 covers the reaction. On the pad 42, a first reagent is applied as needed, and the lower filter film 441 may be made of glass fiber or cotton fiber, having a thickness of 0.3 to 0.5 mm, a pore size of 50 to 200 μm, and the upper filter membrane 442 is covered by the lower filter. The film 441 is coated with a second reagent. The upper filter film 442 can be made of glass fiber or cotton fiber, and has a thickness of 0.1 to 0.5 mm and a pore size of 10 to 30 μm. The hydrophilic layer 45 covers the upper filter film 442. For filtering the fluid to be tested.

The third substrate 46 covers the hydrophilic layer 45 such that the positions of the hydrophilic layer 45, the filtration membrane system 44, and the reaction pad 42 are fixed above the reaction zone, and the third substrate 46 corresponds to the position of the first opening 431 and has a second Opening 461 to expose hydrophilic layer 45. The third substrate 46 is covered with a fourth substrate 47, and the edge thereof has a concave channel 471. The concave channel 471 is corresponding to the second opening 461, and is a fluid inlet to be tested, and the function is to be quantitatively entered. Fluid volume. The fifth substrate 47 is covered with a fifth substrate 48 so as to be an electrochemical detection test piece 5 having a blood filtering function as shown in FIG. 3B.

3C is a cross-sectional view of the electrochemical test strip 5 having a blood filtering function along the section line BB of FIG. 3B, and the first substrate 40, the reaction pad 42, and the second substrate 43 are sequentially arranged from bottom to top. Filter membrane system 44 (including lower filter membrane 441, upper filter membrane 442), hydrophilic layer 45, third substrate 46, fourth substrate 47 and fifth substrate 48, the fluid to be tested (not shown) is composed of fourth substrate 47 The concave channel 471 enters the test piece, and the fluid to be tested is guided by capillary action, and moves to the inside of the test piece along the direction W3, and the second opening 461 moves downward in the W4 direction, and the fluid to be tested is filtered layer by layer to become a sample. Contacting the reaction pad 42 with the reagents produces a biochemical reaction. In the filtration process, since the filtration membrane system 44, the hydrophilic layer 45 and the reaction pad 42 are porous materials, and the layers are not sealed, when the fluid to be tested moves in the W4 direction, the excess gas in the fluid to be tested will be between the layers. The pores and the gaps between the layers escape, that is, naturally generate an exhaust effect.

In addition, the electrochemical test strip 5 with the blood filtering function of the present embodiment can also be provided with a fixing clip 39 as shown in FIGS. 2A and 2B according to requirements, and the fixing clip 39 is clamped to the electrochemical test with the blood filtering function. The test piece 5 is fixed to fix the volume of the fluid to be inhaled.

When the electrochemical test strip 5 having the blood filtering function of the third embodiment of the present invention is used as a test strip for detecting high density lipoprotein (HDL), it is not necessary to apply the first reagent to the lower filter membrane 441. The upper filter membrane 442 is coated with an interface active agent that will precipitate non-high density lipoprotein (non-HDL).

When the electrochemical test strip 5 having the blood filtering function of the third embodiment of the present invention is used as a test strip for detecting low density lipoprotein (LDL), the lower filter membrane 441 is coated for low density lipoprotein specificity. Interface active agent for low density lipoprotein eggs The white matter structure is opened; and the upper filter membrane 442 is coated with an interface active agent that will encapsulate non-low density lipoprotein (non-LDL).

In summary, the electrochemical test strip with the blood filtering function of the present invention can provide the following advantages: 1. The electrochemical test strip has a function of filtering blood. 2. The electrochemical test strip has a screening function and can further detect low density lipoprotein or high density lipoprotein. 3. Make electrochemical test strips detect total blood cholesterol. 4. Make the electrochemical test strips have the effect of venting. 5. The exhausting action of the electrochemical test strip is naturally formed, and no additional escape passage is required, which can reduce the cost.

Although the electrochemical test strip having the blood filtering function of the present invention is disclosed above in the preferred embodiment of the foregoing, it is not intended to limit the present invention, and any skilled artisan skilled in the art may not deviate from the present invention. In the spirit and scope, the scope of patent protection of this new type shall be subject to the definition of the patent application scope attached to this specification.

10‧‧‧First substrate

101‧‧‧ first surface

102‧‧‧ second surface

11‧‧‧Electrode system

111‧‧‧Working electrode

112‧‧‧ reference electrode

12‧‧‧Reaction pad

13‧‧‧second substrate

131‧‧‧First opening

14‧‧‧Filter membrane

15‧‧‧Hydrophilic layer

16‧‧‧ Third substrate

161‧‧‧ second opening

17‧‧‧4th substrate

171‧‧‧ recessed channels

18‧‧‧ fifth substrate

Claims (12)

An electrochemical test strip having a blood filtering function, comprising: a first substrate having a first surface and a second surface, the second surface facing away from the first surface; an electrode system located at the first The first surface of the substrate has at least one working electrode and a reference electrode; a reaction pad covers the electrode system and is coated with at least one reagent for forming the same as the fluid to be tested The contact generates a biochemical reaction; a second substrate covers the first substrate, the electrode system and the surface of the reaction pad, the second substrate has a first opening to expose the reaction pad; a filter film, the The filter film is located above the first opening of the second substrate and covers the reaction pad for filtering the fluid to be tested to make the sample to be tested into the sample; a hydrophilic layer covering the filter film for filtering The third substrate is covered on the hydrophilic layer, and the third substrate has a second opening corresponding to the first opening position, so that the hydrophilic layer exposes and fixes the hydrophilic layer, the filter film and The reaction substrate is in the same position; a fourth substrate covers the third substrate, and has a concave channel on one side thereof, the concave channel position corresponding to the second opening for the fluid to be tested to enter; and a fifth a substrate covering the fourth substrate. The electrochemical test piece having the blood filtering function according to claim 1, wherein the material of the reaction pad is a fiber material selected from the group consisting of glass fiber and cotton fiber. An electrochemical test strip having a blood filtering function as described in claim 1, wherein the reaction mat has an average thickness of between 0.1 and 0.3 mm and a pore size of between 0.2 and 1 μm. An electrochemical test strip having a blood filtering function as described in claim 1, wherein the reaction reagent is a cholesterol reaction reagent. An electrochemical test strip having a blood filtering function as described in claim 1 of the patent application, wherein the The material of the filter is a fiber material selected from the group consisting of glass fibers and cotton fibers. An electrochemical test strip having a blood filtering function as described in claim 1, wherein the filter membrane has an average thickness of between 0.3 and 0.5 mm and the pore size of the filter membrane is between 0.5 and 2 μm. . The electrochemical test strip having the blood filtering function according to claim 1 further includes a fixing clip having a plane and a plurality of fixing claws protruding upward from the plane, the plane and the first substrate The second surface contacts, and the plurality of fixing claws hook the fifth substrate. An electrochemical test strip having a blood filtering function, comprising: a first substrate having a first surface and a second surface, the second surface facing away from the first surface; an electrode system located at the first The first surface of the substrate has at least one working electrode and a reference electrode; a reaction pad covers the electrode system and is coated with at least one reagent for forming the same as the fluid to be tested The contact generates a biochemical reaction; a second substrate covering the first substrate, the electrode system and the surface of the reaction pad, the second substrate having a first opening to expose the reaction pad; a filter membrane system, Included in the upper filter membrane and the lower filter membrane, the lower filter membrane covers the reaction mat for filtering a fluid to be tested, so that the fluid to be tested becomes the sample, and the upper filter membrane covers the lower filter membrane. The upper filter membrane is used for filtering the fluid to be tested; a hydrophilic layer covering the upper filter membrane for filtering the fluid to be tested; a third substrate covering the hydrophilic layer, the third substrate corresponding to The first opening position has a second opening, the hydrophilic layer is exposed and fixed, the filter film and the reaction pad are at the same position; a fourth substrate covers the third substrate, and one side thereof has a a concave channel corresponding to the second opening for the fluid to be tested to enter; and a fifth substrate covering the fourth substrate. An electrochemical test strip having a blood filtering function as described in claim 8 wherein the upper filter membrane has an average thickness of between 0.1 and 0.5 mm and a pore size of between 10 and 30 μm. An electrochemical test strip having a blood filtering function as described in claim 8 wherein the lower filter membrane has an average thickness of between 0.1 and 0.3 mm and a pore size of between 20 and 100 μm. An electrochemical test strip having a blood filtering function as described in claim 8 wherein the lower filter membrane is coated with a low density lipoprotein specific surfactant. The electrochemical test strip having the blood filtering function according to claim 8 , wherein the upper filter membrane coating reagent is selected from a surfactant coated with non-low density lipoprotein and A group consisting of non-high density lipoprotein precipitated surfactants.