TWI402500B - Testing strip - Google Patents

Description

Fluid test strip

The present invention relates to a test strip, and more particularly to a fluid test strip for use in biochemical assays and immunoassays.

In the conventional technique of performing biochemical detection and immunodetection using a fluid detecting test piece, the fluid detecting test piece is designed with a flow path or a micro flow path structure and a surface hydrophobicity treatment on the substrate or the substrate, and the water around the flow path is not water absorbing. The material and the fluid to be tested are mostly composed of a high viscosity such as protein or sugar, so when the fluid to be tested flows, it will remain on the flow path, so that the fluid to be tested cannot be completely reacted, thus, Not only does it cause waste of the fluid to be tested, it is more likely to cause errors in the final test results.

In addition, the fluid detecting test piece of the prior art can be designed with a micro-flow channel structure in fluid transfer, and utilizes the capillary phenomenon generated by the micro-flow path structure to passively transfer the fluid through the flow path to the reaction detecting area; The method is to give a driving force to the fluid by using a pressurized or vacuum negative pressure when injecting the fluid to be tested, or to design one or more micro-actuator or valve in the flow channel to make the fluid It can actively and sequentially pass through the flow path to reach the reaction detection area. However, in either of the above manners, the fluid to be tested is often injected or entangled into the flow passages to cause the flow passage to block, causing an error in the actual measurement, and even causing the test to fail, and the micro-actuator or valve The addition of additional design increases the difficulty of design and the cost of test strips.

Finally, the test strips of the prior art use a die casting, injection molding or imprinting method to make a flow path or a micro flow path structure on the substrate, so polyethylene (PE) must be used. High-priced plastic polymers such as polyvinyl chloride (PVC) or polypropylene (PP) are used as materials and the molds are worn faster, which in turn leads to an increase in the overall cost of the test piece.

In order to overcome the above disadvantages, the present invention provides a fluid detecting test piece, which mainly comprises a substrate, a base The upper surface of the upper surface of the upper surface of the upper surface is recessed downwardly. The flow path includes a first fluid zone, a second fluid zone and a third fluid zone connected in sequence, and the first fluid zone is for fluid injection. The fluid detecting test piece is characterized by having a nitrocellulose layer formed at the bottom of the second fluid zone and the third fluid zone, the nitrocellulose layer comprising a hollow network configuration, wherein the second fluid zone is for fluid transfer, The third fluid zone is for the reaction of the fluid, and the average thickness of the nitrocellulose layer of the second fluid zone is not greater than the thickness of the nitrocellulose layer of the third fluid zone. In addition, the fluid test strip also has a reactive material formed in the hollow network configuration of the nitrocellulose layer.

Accordingly, it is a primary object of the present invention to provide a fluid detecting test piece which is capable of avoiding liquid residue in a flow path because it has a layer of nitrocellulose which can absorb liquid.

Another object of the present invention is to provide a fluid detecting test piece having a water absorbing nitrocellulose layer. Since the amount of nitrocellulose absorbed per unit volume is constant, the volume of the nitrocellulose layer on the substrate can be set. Provide quantitative detection of the fluid to be tested.

Another object of the present invention is to provide a fluid detecting test piece having a hollow network structure of a nitrocellulose layer, and the bubbles in the fluid are destroyed due to the fluid flowing through the hollow network configuration, so that it can be eliminated. Large bubbles prevent the occurrence of bubbles blocking the flow path in the micro-channel technology, which in turn affects the quantitative analysis results.

Since the present invention discloses a fluid detecting test piece in which the physical, chemical, and solution coating techniques utilized are well known to those skilled in the art, the description below will not be fully described. At the same time, the drawings in the following texts are indicative of the features related to the features of the present invention, and are not required to be completely drawn according to the actual situation.

FIG. 1A is a schematic view showing a first embodiment of the present invention. The fluid detecting test piece 1 includes a substrate 10 and a support member 19. The substrate 10 is recessed downwardly from the upper surface 100 with a flow path 11 including a first fluid region 111, a second fluid region 112 and a third fluid region 113 which are sequentially connected. The first fluid zone 111 is for the injection of fluid. After the fluid is injected into the first fluid zone 111, the fluid is transferred to the third fluid zone 113 via the second fluid zone 112, and the components to be tested in the fluid are produced here. Or immune response. In a preferred embodiment, the substrate 1 is a biocompatible material.

Please continue to refer to Figure 1B, which is a cross-sectional view along line AA of Figure 1A. The nitrocellulose layers 1121 and 1131 of a hollow network configuration are formed at the bottom of the second fluid region 112 and the third fluid region 113, and the reaction material is contained in the hollow network configuration of the nitrocellulose layers 1121 and 1131. The composition of the reactive material is related to the type of the component to be tested contained in the fluid. Further, since the nitrocellulose layers 1121 and 1131 have a porous hollow network structure, the fluid flowing in from the first fluid region 111 can be absorbed, and the components to be tested in the fluid are reacted with the reaction material present in the nitrocellulose layer 1131. reaction. Since the nitrocellulose layers 1121 and 1131 are made of a liquid absorbing material, fluid can be prevented from remaining in the flow path 11, and since the fluid flows through the nitrocellulose layers 1121 and 1131 of the hollow network configuration, the bubbles in the fluid will It is destroyed, so that the air bubbles 11 can be prevented from being blocked by the air bubbles.

Due to the different components to be tested, the reactions required for the detection are also different; and depending on the type of reaction, various signals are generated. For example, in biochemical detection, an enzyme is used to catalyze a substance to be tested and a luminescent chemical in a fluid to generate a specific wavelength of light for detection. Therefore, for biochemical testing, the reaction material will contain enzymes and corresponding chemical reagents. On the other hand, if it is necessary to detect the presence of certain proteins (eg, fetal protein, -fetoprotein) in the sample, it is to use a specific antibody to specifically bind to the protein to be tested, and then use other chemical reagents. The antibody that has been bound to the protein to be tested is reacted to emit a signal for detection. Therefore, an immunoassay is required, and the reaction material contains immunological reagents such as chemicals and antibodies. Therefore, the fluid detecting test piece provided by the present invention can be used for detecting various components to be tested in various biological samples (such as urine, blood, and the like).

In addition, the average thickness Da of the nitrocellulose layer 12 of the second fluid region 112 is not greater than the thickness Db of the nitrocellulose layer 1131 of the third fluid region 113, that is, Da is less than or equal to Db, and in this embodiment, as shown in FIG. 1B, nitrification The average thickness Da of the fibrous layer 12 is smaller than the thickness Db of the nitrocellulose layer 1131 of the third fluid region 113. Further, in order to reduce the volume of the desired biological specimen, the widths Wa and Wb of the second fluid region 112 and the third fluid region 113 are preferably at least 0.3 mm.

In the production, the manner in which the nitrocellulose layers 1121 and 1131 are formed and the manner in which the reaction material is formed are as follows. First, a nitrocellulose powder is mixed with an organic solvent containing an ester and a ketone to form a nitrocellulose solution; and the nitrocellulose solution is cast in the second fluid region 112 and the first The bottom of the three-fluid zone 113, after drying, forms a nitrocellulose layer 1121 at the bottom of the second fluid zone 112, and forms a nitrocellulose layer 1131 at the bottom of the third fluid zone 113. For better casting, the surface roughness (Ra value) of the flow path 11 is preferably between 3 and 50 microns.

After the nitrocellulose solution is dried, a nitrocellulose layer having a hollow network configuration is formed. In order to adjust a preferred hollow network configuration, the nitrocellulose powder of the nitrocellulose solution of the present invention is mixed with an organic solvent containing an ester and a ketone. The preferred volume ratio is 1:9. Since the amount of nitrocellulose absorbed per unit volume is constant, the volume of the corresponding nitrocellulose solution can be derived from the volume of the fluid to be absorbed, and then cast. This makes it possible to fix the volume of the liquid required for detection and to be suitable for micro-testing.

After the nitrocellulose layers 12 and 13 are respectively dried and formed at the bottoms of the second fluid region 112 and the third fluid region 113, the reaction solution containing the reaction material is injected into the nitrocellulose layers 1121 and 1131, and air-dried or lyophilized. Thereafter, it remains in the form of a powder in the nitrocellulose layers 1121 and 1131.

The manner in which the nitrocellulose layer 1121, 1131 and the reaction material are formed is formed by sequentially forming a nitrocellulose layer and then injecting the reaction material, and the reaction solution containing the reaction material may be added to the nitrocellulose powder. (nitrocellulose powder) in a nitrocellulose solution consisting of an organic solvent containing an ester and a ketone; after mixing, the mixed solution is cast in the second fluid zone 112 and the third The bottom of the fluid zone 113 is subjected to an air drying or freeze drying process, and the nitrocellulose solution is formed into the nitrocellulose layers 1121 and 1131, and the reaction material is powdered and left in the nitrocellulose layers 1121 and 1131.

The first embodiment described above is a test strip having three fluid regions, and according to the spirit of the present invention, a fourth fluid region may be added to the flow passage for storing excess fluid in the flow passage. A test piece having four fluid zones of the second embodiment of the present invention will be described below.

Please refer to FIG. 2A, which is a schematic diagram of a fluid detecting test piece according to a second embodiment of the present invention. The substrate 20 of the fluid detecting test piece 2 is recessed from the upper surface 200 with a flow path 21, and the flow path 21 includes a first fluid region 211, a second fluid region 212, a third fluid region 213, and a fourth region which are sequentially connected. Fluid zone 214. The first fluid zone 211 is for the injection of fluid. After the fluid is injected into the first fluid zone 211, the fluid is transferred to the third fluid zone 213 via the second fluid zone 212, where the components in the fluid undergo biochemical or immunological reactions. .

Please refer to FIG. 2B, which is a cross-sectional view along line AA of FIG. 2A. The bottom of the fourth fluid region 214 is the same as the second and third fluid regions 212 and 213, and a nitrocellulose layer 2141 is also formed, which is also hollow. A mesh configuration for the storage of excess fluid. Also in the hollow network configuration of the nitrocellulose layer 2141, the nitrocellulose layers 2121 and 2131 at the bottom of the second and third fluid regions 212, 213 are identical, and also contain a reactive material that reacts with the component to be tested in the fluid.

The nitrocellulose layer 2141 at the bottom of the fourth fluid zone 214 is identical in fabrication to the nitrocellulose layers 2121 and 2131 at the bottom of the second and third fluid zones 212, 213, and is cast in the second fluid zone with the nitrocellulose solution. 212, the third fluid zone 213 and the bottom of the fourth fluid zone 214 are further dried; and the formation of the reaction material in the nitrocellulose layers 2121, 2131 and 2141 can also be dried in the nitrocellulose layers 2121, 2131 and 2141. After being formed in the bottoms of the second, third and fourth fluid regions 212, 213, 214, the reaction solution containing the reaction material is injected, and the reaction material is dried into a powder form and left in the nitrocellulose by air drying or freeze drying. Among the layers 2121, 2131 and 2141. Or mixing the reaction solution containing the reaction material with the nitrocellulose solution, pouring together with the second, third, and fourth fluid regions 212, 213, and 214, and drying or freeze-drying to form a hollow network structure. The nitrocellulose layers 2121, 2131 and 2141, and the reaction material retained therein in powder form.

In addition, the structure and size of the first fluid zone, the second fluid zone, and the third fluid zone in this embodiment The relationship with the interconnection, the preferred material of the substrate, the surface roughness, the configuration of the nitrocellulose layer of the test piece, the formation mode, the composition and preferred ratio of the nitrocellulose solution used, and the composition of the reaction material are all related to the first implementation. The examples are the same and will not be repeated here.

The above description is only for the preferred embodiment of the present invention, and is not intended to limit the present invention. The above description is to be understood by those skilled in the art, and thus the other embodiments are not disclosed. Equivalent changes or modifications made in the spirit of the invention are to be included in the scope of the claims below.

Fluid testing test piece ‧‧1,2

Substrate ‧‧10,20

Upper surface ‧‧‧100,200

Runner ‧‧11,21

First fluid area ‧‧‧111, 211

Second fluid zone ‧‧‧112, 212

Third fluid zone ‧‧‧113,213

Fourth fluid area ‧ ‧ 214

Nitrocellulose layer ‧‧1 1981, 1131, 2121, 2131, 2141

Average thickness of nitrocellulose layer ‧‧Da

Nitrocellulose layer thickness ‧‧‧Db

Wa‧‧‧Width of the second fluid zone

Wb‧‧‧ width of the third fluid zone

19, 29 ‧ ‧ support

Fig. 1A is a schematic view showing a fluid detecting test piece according to a first embodiment of the present invention.

Fig. 1B is a schematic view showing a cross section of a fluid detecting test piece according to a first embodiment of the present invention.

Fig. 2A is a schematic view showing a fluid detecting test piece according to a second embodiment of the present invention.

Fig. 2B is a schematic view showing a cross section of a fluid detecting test piece according to a second embodiment of the present invention.

Fluid testing test piece ‧‧1

Substrate ‧‧10

First fluid area ‧‧11111

Second fluid zone ‧‧‧112

Third fluid zone ‧‧‧113

Nitrocellulose layer ‧‧11121, 1131

Average thickness of nitrocellulose layer ‧‧Da

Nitrocellulose layer thickness ‧‧‧Db

Width of the second fluid zone ‧‧Wa

Width of the third fluid zone ‧‧‧Wb

Support ‧‧19

Claims (27)

A fluid detecting test piece mainly comprises a substrate, the substrate is recessed downwardly from the upper surface thereof, at least a first channel, the flow channel comprises a first fluid zone, a second fluid zone and a third fluid zone connected in sequence, the first a fluid zone for fluid injection, characterized in that the surface roughness Ra of the flow channel is between 3 micrometers and 50 micrometers; a layer of nitrocellulose is formed at the bottom of the second fluid zone and the third fluid zone, The nitrocellulose layer comprises a hollow network structure, and the nitrocellulose layer is an absorbable liquid material, wherein the nitrocellulose layer is cast in the second fluid zone and the third fluid zone by using a nitrocellulose solution. The bottom portion is further formed by drying, the second fluid region is for conveying fluid, the third fluid region is for reacting with the fluid, and the average thickness of the nitrocellulose layer of the second fluid region is not more than the nitrocellulose of the third fluid region. a layer thickness; and a reactive material formed in the hollow network configuration of the nitrocellulose layer. The fluid detecting test piece according to claim 1, wherein the average thickness of the nitrocellulose layer in the second fluid region is smaller than the thickness of the nitrocellulose layer in the third fluid region. The fluid test piece according to claim 1, wherein the nitrocellulose solution is formed by mixing a nitrocellulose powder ester and a ketone solvent. A fluid detecting test piece according to claim 3, wherein a preferred ratio of the nitrocellulose powder to the ester and the ketone solvent is 1:9. The fluid detecting test piece of claim 2, wherein the second fluid zone and the third fluid zone have a minimum width of 0.3 mm. The fluid detecting test piece according to claim 1, wherein the reaction material is injected into the nitrocellulose layer by a reaction solution, and then formed into a powder after drying. A fluid test strip according to claim 6 wherein the drying process is freeze drying. A fluid test strip as claimed in claim 6 wherein the drying process is air drying. The fluid detecting test piece according to claim 1, wherein the reaction material is injected into the nitrocellulose solution by a reaction solution, and the nitrocellulose solution is simultaneously formed into a nitrocellulose layer by a drying process, and the reaction material is formed into a powder. A fluid test strip according to claim 9 wherein the drying process is freeze drying. The fluid test strip of claim 9, wherein the drying process is air drying. The fluid test strip of claim 2, wherein the reaction material is a chemical and an enzyme reagent. The fluid test strip of claim 2, wherein the reaction material is an antibody and a chemical reagent. The fluid test strip of claim 1, wherein the average thickness of the nitrocellulose layer of the second fluid zone is equal to the thickness of the nitrocellulose layer of the third fluid zone. The fluid detecting test piece of claim 14, wherein the flow path further comprises a fourth fluid zone, and a bottom of the fourth fluid zone is also formed with a nitrocellulose layer, the nitrocellulose layer comprising a hollow mesh structure. For the storage of excess fluid. The fluid test strip of claim 15 wherein the nitrocellulose layer is formed by casting a nitrocellulose solution into the second fluid zone, the third fluid zone and the bottom of the fourth fluid zone and drying. The fluid test piece according to claim 16, wherein the nitrocellulose solution is formed by mixing a nitrocellulose powder ester and a ketone solvent. A fluid detecting test piece according to claim 17, wherein a preferred ratio of the nitrocellulose powder to the ester and the ketone solvent is 1:9. The fluid detecting test piece of claim 15 wherein the second fluid zone and the third fluid zone have a minimum width of 0.3 mm. The fluid test strip according to claim 16, wherein the reaction material is injected into the nitrocellulose layer by a reaction solution, and then formed into a powder after drying. A fluid test strip according to claim 20, wherein the drying process is freeze drying. A fluid test strip according to claim 20, wherein the drying process is air drying. The fluid detecting test piece according to claim 16, wherein the nitrocellulose layer further comprises a powdery reaction material which is injected into the nitrification by a reaction solution containing the reaction material. The fiber solution is formed through a drying process. A fluid test strip according to claim 23, wherein the drying process is freeze drying. A fluid test strip according to claim 23, wherein the drying process is air drying. A fluid test strip according to claim 15 wherein the reaction material is a chemical and an enzyme reagent. A fluid test strip according to claim 15 wherein the reaction material is an antibody and a chemical reagent.