TWI382177B - Combinatory testing strip - Google Patents

Description

Two-in-one fluid test strip

The present invention relates to a test strip, and more particularly to a test strip suitable for fluid detection.

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.

Moreover, 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), poly must be used. High-priced plastic polymers such as vinyl chloride (PVC) or polypropylene (PP) are used as materials and the molds are depleted faster, which in turn leads to an increase in the overall cost of the test piece.

In addition, different reaction materials or reagents are required due to the different reactions carried out. The test strips of the prior art are often designed to have only a single reagent or reaction material, so it is only suitable for a single reaction and A single type of test cannot perform multiple tests simultaneously for a single sample. If different tests are to be performed, different test strips will be used, which will cause inconvenience in use and time spent on testing.

In order to overcome the above disadvantages, the present invention provides a two-in-one fluid detection test piece which can be used for both biochemical detection and immunodetection. Mainly comprising a substrate, the substrate is recessed downwardly from the upper surface thereof for the first flow channel for biochemical detection and the second flow channel for immunodetection, and the first flow channel and the second flow channel each comprise a first fluid region sequentially connected a second fluid zone and a third fluid zone, the first fluid zone being for fluid injection. The two-in-one fluid detecting test piece is characterized in that a nitrocellulose layer is formed on each of the second fluid region and the third fluid region of the first flow channel and the second fluid channel, and the nitrocellulose layer comprises a hollow mesh structure, wherein The second fluid zone is for fluid transfer and the third fluid zone is for fluid reaction. Further, the average thickness of the nitrocellulose layer in the second fluid zone is not greater than the thickness of the nitrocellulose layer in the third fluid zone. A reactive material is formed in the hollow network configuration of the nitrocellulose layer. Furthermore, the substrate has a longitudinal axis such that the first flow channel and the third fluid zone of the second flow channel are simultaneously located on the longitudinal axis.

Therefore, the main object of the present invention is to provide a two-in-one fluid detecting test piece capable of simultaneously performing biochemical and immunological tests on a single sample.

Another object of the present invention is to provide a two-in-one fluid detecting test piece which can avoid liquid residue in a flow path because of a liquid nitriding fiber layer.

Another object of the present invention is to provide a two-in-one fluid detecting test piece having a liquid-absorbing nitrocellulose layer; since the amount of liquid absorbed per unit volume of nitrocellulose is constant, the nitrocellulose layer can be set on the substrate. The volume provides a quantitative measure of the fluid to be tested.

Another object of the present invention is to provide a two-in-one fluid detecting test piece having a hollow mesh structure of a nitrocellulose layer, and the bubbles in the fluid are destroyed due to the fluid flowing through the hollow network configuration, so Larger bubbles prevent the occurrence of bubbles blocking the flow path in the microfluidic technology, which in turn affects the quantitative analysis results.

Since the present invention discloses a two-in-one fluid detecting test piece, the physical, chemical, and solution coating techniques utilized therein are well known to those of ordinary skill in the relevant art, and therefore, 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.

Please refer to FIG. 1 for a preferred embodiment of the present invention, which is a two-in-one fluid test strip, which can be used for both biochemical detection and immunoassay. The two-in-one fluid detecting test piece 1 mainly includes a substrate 10 and a support member 19. The substrate 10 is recessed downward from its upper surface 100 with a first flow path 11 for biochemical detection and a second flow path 12 for immunodetection. The first flow path 11 includes a first fluid zone 111, a second fluid zone 112, and a third fluid zone 113 that are sequentially connected. The second flow path 12 includes a first fluid zone 121, a second fluid zone 122, and a third fluid zone 123 that are sequentially connected. The first fluid zone 111 of the first flow path 11 and the first fluid zone 121 of the second flow path 12 communicate with each other for fluid injection. When the fluids are injected into the first fluid regions 111 and 121 that are connected to each other, respectively, the first fluid channel 11 and the second fluid flow are transmitted through the first fluid channel 11 and the second fluid region 112 and 122 of the second flow channel 12, respectively. The third fluid zone 113 and 123 of the channel 12; and the fluid flowing to the first flow channel 11 flows to the third fluid zone 113, where the component to be tested in the fluid undergoes a biochemical reaction, generating a signal for detection Measurement. Similarly, the fluid flowing to the second flow path 12, when flowing to its third fluid zone 123, the component to be tested in the fluid will react there to generate a signal for detection. In a preferred embodiment, substrate 10 is a biocompatible material.

Please refer to FIG. 2 for a top view of the two-in-one fluid detecting test piece of the present invention. For ease of detection, the third fluid zone 113 of the first flow path 11 and the third fluid zone 123 of the second flow path 12 on the two-in-one fluid detection test strip 1 are disposed on the same longitudinal axis 14 of the substrate 10. . In this way, the detector coupled with the detection can detect the reaction of the third fluid region 113 of the first flow channel 11 and the third fluid region 123 of the second flow channel 12 as long as it moves on the same longitudinal axis 14. Signal.

Please refer to FIG. 3 again, which is a cross-sectional view of the first flow path 11 along the AA line in FIG. 1 . in The second fluid zone 112 of the first flow path 11 and the bottom of the third fluid zone 113 are respectively formed with nitrocellulose layers 1121 and 1131 of a hollow network configuration. The average thickness Da of the nitrocellulose layer 1121 of the second fluid region 112 of the first flow channel 11 is smaller than the thickness Db of the nitrocellulose layer 1131 of the third fluid region 113 of the first flow channel 11. Further, in the hollow network configuration of the nitrocellulose layers 1121 and 1131, a reaction material is included, and the composition of the reaction 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.

Please refer to FIG. 4 again, which is a cross-sectional view of the second flow path 12 along the BB line in FIG. 1 . The second flow path 12 is also the same as the first flow path 11, and nitrocellulose layers 1221 and 1231 of a hollow network configuration are formed at the bottoms of the second fluid region 122 and the third fluid region 123, respectively. Further, in the hollow mesh configuration of the nitrocellulose layers 1221 and 1231, the same as the nitrocellulose layers 1121 and 1131 in the first flow path, both of which contain a reactive material, and also have a porous hollow network structure, so The fluid flowing in from the first fluid zone 121 is absorbed, and the component to be tested in the fluid reacts with the reaction material present in the nitrocellulose layer 1231.

Since the first flow path 11 and the second flow path 12 have liquid-absorbable nitrocellulose layers 1121, 1131, 1221, and 1231, fluid can be prevented from remaining in the first flow path 11 and the second flow path 12. Further, when the fluid flows through the nitrocellulose layers 1121, 1131, 1221, and 1231 having a hollow network configuration, the bubbles in the fluid are destroyed, so that the bubbles are prevented from blocking the first flow path 11 and the second flow path 12.

In addition, in order to reduce the influence of the capillary action between the flow path and the fluid, the first flow path and the second flow path proposed by the present invention are not so-called micro flow paths of the prior art, and are designed as shown in FIG. The second fluid region 112 width Wa of the first flow path 11, the third fluid region 113 width Wb of the first flow channel 11, the second fluid region 122 width Wc of the second flow channel 12, and the third flow channel 12 third The width Wd of the fluid zone 123 is preferably at least 0.3 mm.

In the production, the manner in which the nitrocellulose layers 1121, 1131, 1221, and 1231 are formed is as follows. First, nitrocellulose powder with esters and ketones The organic solvent is mixed to form a nitrocellulose solution; the nitrocellulose solution is cast in the second fluid region 112 of the first flow channel 11 and the bottom of the third fluid region 113 and the second fluid region 122 of the second flow channel 12 and The bottom of the third fluid zone 123. After drying, a nitrocellulose layer 1121 is formed at the bottom of the second fluid region 112 of the first flow channel 11, and a bottom portion of the third fluid region 113 of the first flow channel 11 forms a nitrocellulose layer 1131, and the second flow channel 12 A nitrocellulose layer 1221 is formed at the bottom of the second fluid region 122, and a nitrocellulose layer 1231 is formed at the bottom of the third fluid region 123 of the second flow channel 12. For better casting, the surface roughness (Ra value) of the first flow path 11 and the second flow path 12 is preferably between 3 micrometers and 50 micrometers.

A preferred volume ratio of the nitrocellulose powder to the organic solvent containing the ester and the ketone is 1:9. Since the amount of nitrocellulose absorbed per unit volume is constant, the volume of the corresponding nitrocellulose solution can be calculated from the volume of the fluid to be absorbed, and then cast, thereby fixing the volume of the required liquid. And for micro-testing.

The manner in which the reaction material is formed in the nitrocellulose layers 1121, 1131, 1221, and 1231 is as follows. After the nitrocellulose layers 1121, 1131, 1221, and 1231 are respectively dried and formed, the reaction solution containing the reaction material is injected, and after air drying or lyophilization, the reaction material remains in the form of powder in the nitrocellulose layer. Among 1121, 1131, 1221 and 1231. The reaction material is formed in a manner other than the sequential formation method after the nitrocellulose layer is first formed and then injected into the reaction material, and the reaction solution containing the reaction material may be added to the nitrocellulose powder and the ester-containing compound ( And a nitrocellulose solution composed of an organic solvent of a ketone; after the mixing is completed, the mixed solution is cast in the second fluid region 112 and the third fluid region 113 of the first flow channel 11. The bottom portion and the second fluid region 122 of the second flow channel 12 and the bottom portion of the third fluid region 123 are subjected to an air drying or freeze-drying process, and the nitrocellulose solution is simultaneously formed into the nitrocellulose layers 1121, 1131, 1221, and 1231, and the reaction material is It is formed into a powder and remains in the nitrocellulose layers 1121, 1131, 1221, and 1231.

As described above, the first flow path 11 is for biochemical detection and the second flow path 12 is for immunodetection. Since the reaction required for biochemical and immunoassay is different, the nitrate formed in the first flow channel 11 The composition of the reaction material in the chemical fiber layers 1121 and 1131 is also different from the composition of the reaction material in the nitrocellulose layers 1221 and 1231 formed in the second flow path 12. For example, in the biochemical test, an enzyme is used to catalyze a substance to be tested and a chemical reagent in a fluid, thereby generating a signal for detection. Therefore, biochemical tests are required. For biochemical tests, the reaction materials in the nitrocellulose layers 1121 and 1131 of the first flow path 11 contain enzymes and chemical reagents. On the other hand, if it is necessary to detect certain proteins in the sample, for example, whether the alpha-fetoprotein is present, it is to use a specific antibody to specifically bind to the protein to be tested, and then to use other The chemical reagent reacts with the antibody that has been bound to the protein to be detected, and emits a signal for detection. Therefore, in the second flow path 12 for immunoassay, the reaction material in the nitrocellulose layers 1221 and 1231 contains reagents such as antibodies and chemicals.

In addition, in a preferred embodiment, a fourth fluid zone (not shown) may be added to the second flow path 12, and a nitrocellulose layer is formed at the bottom thereof to absorb excess fluid. Further, as shown in FIG. 4, the thickness Dc of the second fluid region 122 of the second flow path 122 of the second fluid region 122 is the same as the thickness Dd of the third fluid region 123 nitrocellulose layer 1231.

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.

1‧‧‧2 in 1 fluid test strip

10‧‧‧Substrate

19‧‧‧Support

100‧‧‧ upper surface

11‧‧‧First runner

12‧‧‧Second runner

14‧‧‧ longitudinal axis

111, 121‧‧‧First fluid zone

112, 122‧‧‧Second fluid zone

113, 123‧‧‧ third fluid zone

1121, 1131, 1221, 1231‧‧ ‧ nitrocellulose layer

Average thickness of Da‧‧‧ nitrocellulose layer 1121

Db‧‧‧Nitrocellulose layer 1131 thickness

Average thickness of Dc‧‧‧ nitrocellulose layer 1221.

Dd‧‧‧Nitrocellulose layer 1231 thickness

Wa‧‧‧Width of the second fluid zone 112

Wb‧‧‧Width of the third fluid zone 113

Wc‧‧‧ width of the second fluid zone 122

Wd‧‧‧Width of the third fluid zone 123

Fig. 1 is a schematic view showing a two-in-one fluid detecting test piece according to a preferred embodiment of the present invention.

Fig. 2 is a plan view showing a two-in-one fluid detecting test piece according to a preferred embodiment of the present invention.

Figure 3 is a schematic view showing a first flow path section of a two-in-one fluid detecting test piece according to a preferred embodiment of the present invention.

4 is a schematic view showing a second flow path section of a two-in-one fluid detecting test piece according to a preferred embodiment of the present invention.

1‧‧‧2 in 1 fluid test strip

10‧‧‧Substrate

19‧‧‧Support

100‧‧‧ upper surface

11‧‧‧First runner

12‧‧‧Second runner

111, 121‧‧‧First fluid zone

112, 122‧‧‧Second fluid zone

113, 123‧‧‧ third fluid zone

Wa‧‧‧Width of the second fluid zone 112

Wb‧‧‧Width of the third fluid zone 113

Wc‧‧‧ width of the second fluid zone 122

Wd‧‧‧Width of the third fluid zone 123

Claims (12)

A two-in-one fluid detecting test piece can be simultaneously used for biochemical detection and immunoassay, and mainly comprises a substrate, the substrate is recessed from the upper surface thereof to a first flow channel for biochemical detection and a second flow channel for immunodetection, The first flow path and the second flow path each comprise a first fluid zone, a second fluid zone and a third fluid zone connected in sequence, the first fluid zone is for fluid injection, characterized by: a nitrocellulose layer, Forming at the bottom of the second fluid region and the third fluid region of the first flow channel and the second flow channel, the nitrocellulose layer comprises a hollow network configuration, wherein the second fluid region is for fluid transfer, the first a three-fluid zone for reacting with a fluid; and a minimum width of the second fluid zone and the third fluid zone is 0.3 mm, and an average thickness of the nitrocellulose layer of the second fluid zone is less than a thickness of the nitrocellulose layer of the third fluid zone; a reaction material formed in the hollow network configuration of the nitrocellulose layer; and the substrate having a longitudinal axis such that the first flow channel and the third fluid region of the second flow channel are located on the longitudinal axis at the same time. The two-in-one fluid detecting test piece according to claim 1, wherein the first flow path and the first fluid area of the second flow path are in communication with each other. A two-in-one fluid test strip according to claim 1, wherein the nitrocellulose layer is formed by casting a nitrocellulose solution after casting at a bottom of the second fluid zone and the third fluid zone. A two-in-one fluid test test piece according to claim 3, wherein the nitrocellulose solution is formed by mixing a nitrocellulose powder ester with a ketone solvent. A two-in-one fluid test test piece according to claim 4, wherein a preferred ratio of the nitrocellulose powder to the ester and the ketone solvent is 1:9. A two-in-one fluid test strip according to claim 1, wherein the substrate is a biocompatible material. The two-in-one fluid detecting test piece according to Item 1, wherein the first flow path and the second flow path have a surface roughness Ra of between 3 micrometers and 50 micrometers. For example, the two-in-one fluid test strip of claim 3, wherein the reaction material is reversed The nitrocellulose layer is injected into the solution and formed into a powder after the drying process. The two-in-one fluid detecting test piece according to claim 3, 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. shape. A two-in-one fluid test strip according to claim 1, wherein the reaction material is a chemical and an enzyme reagent. A two-in-one fluid test strip according to claim 1, wherein the reaction material is an antibody and a chemical reagent. The two-in-one fluid detecting test piece according to claim 1, wherein the second 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 Shape configuration for the storage of excess fluid.