JP2008518215A - Disposable immunodiagnostic test system - Google Patents

Abstract

  The disposable immunodiagnostic system is a system for inspecting a marker protein in a liquid analyte, and includes a passage layer, a protein layer, and an absorption layer that are in close contact with each other. The passage layer is non-porous and perforated. The protein layer is porous, and the binding protein is effectively immobilized thereon, and the analyte is passed therethrough. The protein layer has an effective surface area aligned with the holes in the passage layer. The analyte is effectively introduced onto the protein layer from the hole in the passage layer. If the result is positive, the marker protein is effectively bound to the binding protein and immobilized on the protein layer. In a negative result, the analyte effectively passes through the protein layer and is absorbed by the absorption layer. May have a housing. The system is made of combustible materials that produce non-toxic by-products upon incineration and can be disposed of in an environmentally responsible manner after the system is used for diagnosis.

Description

  The present invention relates to the fields of immunodiagnostic test systems, kits, and instruments. More specifically, the present invention relates to a disposable immunodiagnostic test system for testing the presence of a marker protein in a liquid analyte.

  Various diagnostic testing methods and kits are used in the clinical environment. For example, immunochromatographic assays, multi-immunoassay diagnostic systems that test for the presence of antigens and / or antibodies, assay sample analyzers, rapid immunoassay test strips, and the like. Other rapid assay test instruments and methods are more or less known in the art, depending on whether a test sample flows through the instrument and possibly such flow method and / or direction. It falls into one of many forms. For example, there are inspection devices such as a dipstick format, a flow-through format, and / or a lateral format.

  However, devices that produce faster and more accurate test results, equipment that does not require the purchase of specialized additional equipment or supplemental training of highly qualified inspectors, and / or virtually simultaneous causative agents. An apparatus capable of inspecting one sample to be analyzed by inspection is required. Similarly, there is a need for an immunodiagnostic test system, kit, and / or device (hereinafter simply referred to as an “immunodiagnostic test system”) that is effective, simple to use, and can be quickly implemented.

Also, “therapeutic sites” and / or “fields” (ie, outside of the traditional clinical environment, such as ad hoc outreach programs, field hospitals and / or farms where cereals and diseased livestock are used when trying emergency response) There is an urgent need for an inspection system that can be used and / or discarded that has not been adequately addressed.
There is a further need for an inspection system that can be manufactured and / or assembled on site and / or in a specially designed manufacturing facility. There is also a need for a system with low manufacturing and packaging costs.

  There is a need for a test system that can select quantitative and / or qualitative results depending on user preferences and / or the nature of the tests to be performed.

  In the past, the disposal of the “therapeutic” immunodiagnostic system may have been a significant problem or difficulty for workers undertaking this task. In the past, such equipment (equipment potentially contaminated by use) is usually transported to a waste landfill, which greatly increases the cost of environmental measures, and the pollutants that come out of this equipment will eventually fill the landfill and surrounding areas. There is concern about the possibility of leakage into the district. Some of the immunodiagnostic test systems that are currently on the market are usually made up of materials that cannot be safely combusted or incinerated without generating harmful and / or toxic gases (such as plastics) and are therefore discarded There is a real need for landfill disposal. When an inspection system is discarded at a landfill site, transportation costs, disposal costs, and labor are usually added. Part of the effort is that field workers must carry portable waste containers that are suitable for safe transport and processing of potentially contaminated inspection systems. Such disposal methods involve sterile glass instruments, plastic instruments, inspection instruments, and the like, as well as sterilization and handling methods performed with corresponding rigor. Accordingly, there is an urgent need for an inspection system that can be easily discarded by a simple and environmentally responsible method such as incineration.

  There is also a need for a test system that can be selectively applied to detect viruses, fungi, bacteria, and / or vector-induced infections, or a test system that can perform some or all of these tests on a single sample. ing.

  In addition to the foregoing, there is also a need for an inspection system that provides visually identifiable inspection results and / or inspection systems that provide inspection results in a relatively short period of time (eg, within 60-90 seconds).

  Accordingly, it is an object of the present invention to obviate, mitigate, and / or address one or more of the needs, disadvantages, and / or disadvantages associated with the prior art.

  The present invention is a disposable immunodiagnostic test system that tests for the presence or absence of a marker protein present in a liquid sample to be analyzed. The inspection system includes a substantially planar pass layer made of a first material of a substantially non-porous structure, the pass layer being shaped with at least one hole therethrough. The test system also includes a second material protein membrane used to effectively immobilize the binding protein in an effective configuration. Since this protein membrane has a substantially porous structure, the liquid sample to be analyzed passes through this hole. Since the protein layer is in close contact with the passage layer, it forms an effective surface on the protein, is in contact with the hole in the passage layer, and is virtually aligned. The inspection system also includes an absorption layer made of a third material that adsorbs at least a portion of the liquid analyte. This adsorption layer is in close contact with the protein layer. In an effective configuration, as described above, the binding protein is effectively fixed to the protein layer, and the liquid sample to be analyzed is injected into the protein layer from at least one hole in the passage layer. In a positive result configuration, the marker protein binds to the binding protein and is effectively immobilized on the protein layer. In a negative result configuration, at least a portion of the liquid analyte is effectively passed through the protein layer.

  In the present invention, the first material, the second material, and the third material are further composed of one or more combustible materials that produce non-toxic by-products upon incineration.

  According to the preferred embodiment of the present invention, the test system preferably includes a reagent, which effectively binds the marker protein in a positive result configuration and effectively immobilizes it to the protein layer.

  According to the preferred embodiment of the present invention, the reagent may include a visual marker that effectively displays color in a positive result configuration.

  According to another preferred embodiment of the present invention, the reagent may include a protein enzyme complex. In this example, the test system preferably includes an enzyme substrate that effectively binds to the protein-enzyme complex in a positive result configuration, and preferably provides an effective color display in the positive result configuration.

  According to a preferred embodiment of the invention, at least a visible part of the effective surface can be seen from the hole in the passage layer.

  According to the preferred embodiment of the present invention, the inspection system is preferably a structure in which at least one sealant is effectively inserted between the passage layer and the protein layer and between the protein layer and the adsorption layer.

  According to the preferred embodiment of the present invention, the visible portion of the effective surface preferably comprises a first test surface to which the binding protein is effectively immobilized in an effective configuration. The visible portion of the effective surface preferably further includes a test control surface. The test control plane is preferably used to evaluate control readings in a positive result configuration and a negative result configuration, which can effectively verify that the test system is being used properly.

  In a further preferred embodiment of the invention, the inspection system preferably includes a housing that substantially encloses the passage layer, the protein layer, and the absorbent layer. The lower part of the housing is in close contact with the absorbing layer, and the upper part is in close contact with the passing layer. The upper part of the housing has a shape in which a hole of at least one housing is penetrated. The housing holes are effectively arranged in such a way that the liquid acting on at least one hole of the passage layer flows.

  In a further preferred embodiment of the invention, the housing is preferably composed of at least one combustible material as described above.

  In the preferred embodiment of the present invention, the housing is preferably constructed of a housing material of a substantially non-porous housing structure.

  In the preferred embodiment of the present invention, at least one sealant may preferably be effectively inserted between the upper part of the housing and the passage layer and between the lower part of the housing and the adsorption layer.

  In the preferred embodiment of the present invention, the housing preferably has an outer surface marked with at least one label. This outer surface is preferably the outer surface of the upper part of the housing.

According to a preferred embodiment of the present invention, the binding protein is not necessarily required, but is preferably a fungal marker protein, a viral marker protein, a bacterial marker protein, a vector derived marker protein, a plant marker protein, and / or at least one liquid. Contains proteins that are used to bind the virtually healthy cells in the degradable material and the native protein that biosynthesizes.
According to the preferred embodiment of the present invention, there is preferably a second inspection surface area in the visible portion of the effective surface. In an effective configuration, the second binding protein is effectively fixed in the second test surface area. In a positive result configuration, the marker protein binds to the second binding protein and is effectively immobilized on this protein layer.

  According to a further preferred embodiment of the present invention, the visible part of the effective surface area preferably further comprises a supplementary first inspection surface area and a supplementary second inspection surface area. In an effective configuration, a binding protein is not necessarily required, but is preferably substantially fixed in each of the first test surface area and the supplementary first test surface area. Although effective and not necessarily required, preferably, the second binding protein is effectively immobilized in each of the second test surface area and the supplementary second test surface area.

  According to the preferred embodiment of the present invention, the supplementary first test surface area has a substantially higher binding protein concentration in effect than the binding protein on the first test surface area.

  According to the preferred embodiment of the present invention, both the first inspection surface area and the supplementary first inspection surface area are not necessarily required, but preferably, a substantially flat first inspection ring can be conceptually depicted. Both areas are conceptually within the ring. Similarly, both the second inspection surface area and the supplementary second inspection surface area are not necessarily required, but preferably, a substantially flat second inspection ring can be conceptually depicted, and both areas are within the ring. In. The second inspection ring is not necessary, but preferably substantially surrounds the first inspection ring.

  Similarly, according to the preferred embodiment of the present invention, the first test ring is not necessarily required, but preferably substantially surrounds the test control surface.

  According to an preferred embodiment of the invention, at least one hole in the passage layer is not necessarily required, but preferably comprises at least two holes. The upper surface of the passage layer is not necessarily required, but preferably forms a recess that is substantially in contact with at least the two holes and is substantially aligned with the holes in the housing.

  According to another preferred embodiment of the present invention, the upper surface of the protein layer is not necessarily required, but preferably forms a depression. The indented portion is not necessarily required, but is preferably substantially in contact with the visible portion of the active area and is substantially aligned with the apertures in the passage layer.

  For other advantages, functions, and features of the present invention, as well as methods and functions of operation of related elements of the structure, and combinations and manufacturing costs of components, the appended claims with reference to the following detailed description and the accompanying drawings It is explained clearly in the section. The drawings are briefly described below.

  Regarding the novelty considered as a feature of the disposable immunodiagnostic test system according to the present invention, the structure, tissue, use and method of use, and the detailed purpose and advantages thereof can be better understood from the following drawings. The drawings are shown by way of example in at least one preferred embodiment of the present invention, but are not necessarily drawn to scale, and are clearly for illustration and description purposes only. For this reason and for other reasons, it should be understood that this figure is not intended to represent the limits of the invention. The accompanying drawings are described below.

  1A, 1B, 5A, and 5B show a preferred embodiment of a disposable immunodiagnostic test system 70 according to the present invention to test for the presence of a marker protein in a liquid analyte (not shown). As best seen in FIG. 5A, one preferred embodiment of the present inspection system 70 comprises a combined inspection assembly 50 and housing 60.

  Also, as best seen in FIGS. 1A and 1B, the inspection system 70 may be a simple combined inspection subassembly 50 without a housing 60.

  Further in FIG. 1B, the combined test subassembly 50 includes a substantially planar pass layer 12, protein layer 14, and absorbent layer 16, each preferably made of a combustible material that produces non-toxic byproducts upon combustion. . Thus, the combined inspection subassembly 50 may be easily disposed of in an environmentally responsible manner, such as incineration.

  As described above, the passage layer 12 is substantially planar and has a through hole 24 that forms the corresponding inner edge 26 of the passage layer 12. Although the preferred embodiment shown in FIGS. 1A, 1B, 5A, and 5B has one hole 24 through the passage layer 12, other embodiments (eg, FIGS. 2D to 2F; these will be discussed in detail below) ) May have a plurality of holes 24. Since this passage layer 12 is a substantially non-porous structure, it is preferably virtually non-permeable, non-spongeous, and non-woven. The passage layer 12 is not necessarily required, but is preferably made of a high-density paper material such as cardboard paper. Other relatively hard materials, such as bark and / or compressed plant material, are also used in the construction of the passage layer 12 according to the present invention. This passage layer 12 preferably provides the inspection system 70 with some degree of hardness, preferably due to the densely compressed nature, the inherent nature of the constituent materials, or other factors. This passage layer 12 is not necessarily required, but is preferably in the range of about 0.2 to 10 mm, more preferably about 2 to 4 mm in thickness.

  As best seen in FIGS. 1A and 1B, the protein layer 14 is in intimate contact with the passage layer 12. This protein layer 14 has an effective surface 30 that is substantially adjacent to and substantially aligned with the holes 24 in the passage layer 12 (generally indicated by the imaginary line “A” in FIG. 1B). As best seen in FIG. 1A, the effective surface 30 preferably has at least a portion 31 visible from the hole 24.

  The protein layer 14 is not necessarily required, but can preferably be composed of nitrocellulose, nylon, and / or acetate, and other materials to which reactants and / or binding proteins are bound or effectively immobilized. Although not essential for the inspection system 70 to function, nitrocellulose is considered an effective protein binding material that can be used in the protein layer 14. A suitable commercially available nitrocellulose membrane may be formed on a thin backing support paper and used in the protein layer 14 in accordance with the preferred embodiment of the present invention. The protein layer 14 is not necessarily required, but preferably has a thickness of about 5 mm or less, and a more preferable thickness is practically in the range of about 0.5 to 2.0 mm.

  This protein layer 14 is porous in nature and preferably has a plurality of pores therethrough (not shown). When a nitrocellulose membrane and other preferred protein layer 14 materials are used, if the pore size of the protein layer 14 is large, it is considered that the protein binding capacity and / or protein binding capacity is correspondingly reduced. It is not essential for the function of the system 70. As will be discussed in detail below, using a protein layer 14 with a low protein binding capacity may reduce the sensitivity of the test performed by the system 70. The nitrocellulose protein membrane 14 is not necessarily required, but preferably has a pore diameter size of about 0.1 to 25 microns, more preferably a diameter size in the range of about 0.4 to 2.0 microns. . In fact, the protein layer 14 having pores (not shown) having a size within the above-described range is considered to have a high protein binding ability.

  As best seen in FIG. 1B, the absorbent layer 16 is in intimate contact with the passage layer 12. As can be inferred from the name, the absorption layer 16 is preferably based on the nature of the test to be performed in order to capture or absorb at least a portion (more preferably more) of the liquid analyte to be tested. Made of absorbent material. The absorption layer 16 is preferably made of a sponge-like material or other material that can take in or absorb at least a portion of the liquid sample to be analyzed (not shown). For example, the absorbent layer 16 can be a paper towel and / or an acetate material. This absorbent layer 16 is not necessarily required, but preferably has a thickness of about 1-50 mm, more preferably in the range of about 5-20 mm in nature. The absorption layer 16 is preferably made of a material capable of absorbing and holding at least three times the volume of the liquid sample to be used in one test.

  As described above, the absorption layer 16 is in close contact with the protein layer 14, and the protein layer 14 is in close contact with the passage layer 12. Although not essential to the basic function of the inspection system 70, preferably, the passage layer 12 and the protein layer 14 are effectively connected to each other using a sealant (not shown) between them when they are both placed. Adhere closely. Similarly, the protein layer 14 and the passage layer 16 are brought into close contact with each other using a sealant (not shown) when they are effectively disposed. Suitable sealants according to the present invention are not necessarily required, but are desirably glues and other adhesives, as well as staples, stitches, thermal and / or ultrasonic sealing methods, and layers 12, 14, 16 Other suitable materials or treatments are included to ensure that is substantially maintained in close contact with each other as described above. In order to simplify the production, it is considered that a conventional heat sealer and glue used in Japan can sufficiently obtain the sealability required for the present invention.

  As best seen in FIGS. 1A and 5A, the combined inspection subassembly 50 also preferably includes a subassembly peripheral sealing 34. As shown in FIGS. 1A and 5A, the preferred embodiment subassembly perimeter seal 34 of the inspection system 70 acts reliably around each of the layers 12, 14, 16. The subassembly perimeter seal 34 is the same or different adhesive as discussed above. For example, the subassembly perimeter sealing 34 may be an adhesive that adheres around the layers 12, 14, 16. In addition to the sealant and sealing method described above, the subassembly perimeter sealing 34 may instead be made of a material or shape that physically presses the layers 12, 14, 16 to ensure that they are in close contact with each other. Is used (possibly adjacent to the surroundings). For example, as the subassembly peripheral sealing 34, a fastener (not shown) that acts around the passage layer 12 and the absorption layer 16 and presses all the three layers 12, 14, and 16 to adhere to each other is used. .

  As best seen in FIGS. 5A and 5B, the housing 60 effectively encloses the passage layer 12, the protein layer 14, and the absorbent layer 16, which are not necessarily required, but are preferably combined together as a test subassembly. 50 is formed. The housing 60 preferably includes an upper housing portion 10 and a lower housing portion 18. The housing upper part 10 and the housing lower part 18 are not necessarily required, but are preferably bonded to the passage layer 12 and the absorbing layer 16, respectively. The housing top 10 and the passage layer 12 are preferably adhered to each other using the same or different adhesive (not shown) as described above, and a sealant is inserted between both in effect. Yes. Similarly, the housing lower portion 18 and the absorbent layer 16 are preferably adhered to each other using the same or different adhesive (not shown) as the sealant described above, and the adhesive is effectively placed between the two disposed. Has been inserted.

  As best seen in FIG. 5B, the housing 60 preferably includes a housing end 36 that is in substantial contact with a plurality of ends 36 of the housing upper portion 10 and the lower portion 18. The housing edge 36 of the preferred embodiment of the inspection system 70 acts firmly on the edge 34 of the combined inspection subassembly 50 (shown in FIG. 5B) and / or acts on the edge of each layer 12, 14, 16 (FIG. 2A, 2D, and 3 and will be discussed in detail below). The housing edge 36 uses the same or different sealant as described above. This preferably includes alternative sealants, alternative adhesive methods, and / or schemes described above in the subassembly peripheral sealing 34 such that the combined inspection subassembly 50 adheres to the housing 60.

  As best seen in FIGS. 5A and 5B (also shown in FIGS. 2A, 2B, 2D, 2E, and 3 illustrating other encouraged embodiments of the inspection system 70; these will be discussed in detail below). The housing top 10 has a housing hole 20 that forms a corresponding inner edge 22 of the housing top 10. The housing 60 is preferably made of a substantially non-porous material, which means that it is preferably substantially impermeable and / or non-absorbable and / or non-woven.

  Since all parts of the housing 60 are preferably made of materials that produce non-toxic by-products upon combustion, the inspection system 70 can be more reliably disposed of in an environmentally responsible manner, such as incineration. One incentive material that is considered suitable for the construction of the housing 60 is paper. Other similar materials can also be used in the housing 60 in accordance with the present invention, such materials include fabric, nylon, silk, and / or biodegradable membranes. Each of the housing upper portion 10 and the lower portion 18 is not necessarily required, but preferably has a thickness in the range of about 0.1 to 3 mm, more preferably a thickness of about 0.2 to 0.4 mm. Is within the range.

  Preferably, but not necessarily, the size of a single test system 70 for testing a single liquid analyte is substantially about 20 mm × 20 mm × 10 mm.

  As shown in FIG. 5B, the housing top 10 of the housing 60 preferably has an outer surface 46 on which the label 11 is marked. The label display 11 is preferably visible with the naked eye, followed by a bar code display 13 and / or a document display 15. In an embodiment that does not include the housing 60, the label display 60 may instead be written directly on the outer surface of the passage layer 12 (not shown). In any case, the label display 11 is marked on the outer surface by printing, bonding, or writing. Then, although not necessarily, preferably, a numbered bar code display 13 is provided for tracking each inspection system 70 and for other purposes such as quality control. Similarly, the document display 15 includes information and data regarding the disposable immunodiagnostic test system 70 and its intended use, eg, name of the intended test, expiration date, description, storage conditions, disposal instructions, and / or similar information. Is described. Furthermore, the label display 11 may be provided with a color code (not displayed) that identifies a specific type difference of the inspection system 70.

  As best seen in FIG. 5A, the inspection system 70 is not necessarily required, but is preferably assembled by inserting a combined inspection subassembly 50 into an empty housing 60. The housing hole 20 preferably communicates substantially vertically with the hole 24 in the base of the passage layer 12. The housing 60 is then preferably sealed at each open end with the housing end 36. As described above, the material forming the housing rim 36 may be the same or different sealant used in the subassembly peripheral sealing 34. As described above, the present disposable immunodiagnostic test system 70 (best seen in FIG. 5B) is not necessarily required, but is preferably fully assembled.

  FIGS. 2A through 4E show another preferred embodiment of the inspection system 70 and, like all drawings, for ease of reference, the different elements of the present invention will be described where possible, even if they are different. Similar reference numbers are used. The inspection system 70 embodiment shown in FIGS. 2A, 2B, 2C, and 3 is substantially separate in the upper and lower housing layers 10 and 18 from the pillow-type embodiment shown in FIGS. 5A and 5B. In many respects, this embodiment is the same as the embodiment discussed above.

  As best seen in all of the foregoing and in FIG. 2B, the housing hole 20 is substantially aligned with the passage layer hole 24 (the imaginary line “B” is generally shown in FIG. 2B).

  As best seen in FIG. 2C, the upper surface of the protein layer 14 is not necessarily required, but is preferably in contact with and substantially aligned with the inner edges 22 and 26 of the housing top 10 and the passage layer 12. It is the shape which forms the hollow part 58.

  FIGS. 2D to 2F illustrate another preferred embodiment of an inspection system 70 in which the passage layer 12 has a first hole 24a, a second hole 24b, and a control hole 24c. As best seen in FIG. 2F, the upper surface of the passage layer 12 is not necessarily required, but preferably has a shape that is substantially in contact with the inner edge 22 of the housing upper portion 10 and forms a substantially indented portion 56.

  According to a further encouraged embodiment of the present invention shown in FIGS. 6 and 7, the disposable immunodiagnostic test system 70 can comprise a plurality of test formats. In such an embodiment, the individual inspection system 70 may be perforated 38 in the housing so that the end user (not shown) can determine the number of inspection systems 70 required for a particular or intended purpose. There are some which are arranged side by side in a removable manner and / or are weakly connected. Each individual inspection system 70 shown in FIG. 6 effectively corresponds to any of the inspection systems of FIGS. 2A to 4E. Similarly, each individual inspection system 70 shown in FIG. 7 effectively corresponds to the inspection system shown in FIGS. 5A and 5B, respectively.

  As mentioned above, the various encouraged embodiments of the present testing system 70 shown in the figure are not necessarily required, but preferably each is employed to test for the presence of a marker protein in a liquid analyte (indication) Not). The liquid sample to be analyzed is a sample intended to be examined by the system 70, and this sample may or may not contain the marker protein to be examined. That is, the liquid analyte is a substance or component to be examined or analyzed, for example, a living body in which a liquid sample substrate, serum, plasma, sweat, urine sample, and / or tissue cell is embedded and / or suspended. Other aqueous extracts containing the substance can be mentioned. Preferably, but not necessarily, other analytes that can be tested using the system 70 include environmental samples, such as well water samples. Thus, the present test system 70 is preferably used to test for the presence of marker proteins originating from a broad class, eg, organisms, agriculture, animals, and / or the environment.

  As an example of agricultural applications, the presence or absence of various diseases of bananas, such as banana bructo mosaic virus (common banana disease in India, Philippines, Sri Lanka, etc.) and / or Abaca mosaic virus (in the Philippines) In order to detect common banana disease), an aqueous extract of seedlings or leaves can be examined with the system 70.

  Similarly, in the animal field, the system 70 is used to detect the presence of various diseases in animals and / or indoor pets, such as dogs and cats. For example, the system 70 can detect the presence or absence of canine filamentous worms and / or other diseases, such as Leishmania disease, parvovirus infection, and / or Lyme disease.

  As another example, the system 70 is preferably not used, but is preferably used to detect the presence or absence of various environmental contaminants such as gasoline additives such as methyl tertiary butyl ether. While such gasoline additives are commonly used to reduce automobile exhaust and improve air quality, they have entered into groundwater sources and ultimately consumed by humans. .

  In yet another example, the test system 70 is also used to detect the presence or absence of common illnesses in various people caused by pathogenic bacteria. For example, the test system 70 of the present invention can be used to simultaneously detect the presence of causative agents associated with many illnesses, such as cardiovascular diseases. These causative agents include a wide variety of different pathogens, such as those from viruses, fungi, and / or bacteria. In such tests, the system 70 may be used to test for the presence of antibodies to healthy cell markers, such as the protein myosin found in heart muscle, and / or antibodies to the causative agents listed above.

  The particular application of the inspection system 70 discussed here is intended to be taken merely as an example of the inspection capability of the present invention, the potential application of the inspection system 70, and the various applications using different liquid analytes. It is not intended to limit use.

  To be effective, a binding protein is preferably bound and / or immobilized (not shown) on the protein layer 14 of the test system 70. Within the scope of the present invention, the binding protein is attached on and / or virtually embedded in the surface of the protein layer 14. Indeed, a wide variety of methods for binding and / or adding binding proteins to the protein layer 14 are preferably within the scope of the present invention.

  The binding protein that effectively binds to the protein layer 14 of the test system 70 preferably corresponds to the test to be performed and / or is the marker protein to be probed that may be present in the particular liquid analyte being tested. Select individually to ensure that they are combined. For example, but not limited to this example, when the test system 70 is used to test for the presence of HIV1, a binding protein particularly suitable for binding to HIV1 and / or its marker protein is present on the protein layer 14. Virtually fixed. Similarly, when testing system 70 is used for testing for hepatitis C, a binding protein that is particularly suitable for binding to hepatitis C and / or its marker protein is effectively immobilized on protein layer 14.

  As described above, the test system 70 is not necessarily required, but is preferably a corresponding binding protein immobilized on the protein layer 14 in such a case, which is a causative agent for many broad diseases, such as viruses, It can be used to simultaneously detect the presence of substances originating from fungi and / or bacteria. That is, the binding protein is a protein used to bind to a fungal marker protein, a viral marker protein, a bacterial marker protein, and / or a vector-derived marker protein that is considered to be present in the liquid analyte to be examined.

  The protein layer 14 is considered to be the “reaction zone” of the inspection system 70. In the effective configuration of the present invention, the binding protein is preferably substantially immobilized on the protein layer 14, more preferably on the visible portion 31 of the effective surface area 30 of the protein layer 14. In the present invention, the nitrocellulose or other protein layer 14 of the test system 70 is preferably provided to the end user, preferably with the binding protein already immobilized thereon (not shown). . Alternatively, the binding protein can be immobilized on the protein layer 14, preferably at the time of inspection or shortly before the inspection. In any case, as described above, the binding protein preferably serves to add the marker protein to be examined by adsorption or binding if the marker protein is present in the liquid analyte to be examined. is there.

  Although not essential to the function of the system 70, the binding protein is preferably directly immobilized on the protein layer 14 that is in full contact with the effective surface 30, more preferably on the visible portion 31 of the effective surface 30. . After the inspection system 70 is fully assembled, the bound protein is preferably on the protein layer 14 that is in full contact with the effective surface area 30, and more preferably on the visible portion 31 of the effective surface area 30. Fixed directly in pattern, shape, or design. For example, but not limited to this example, after assembly of the test system 70, the HIV1 binding protein is preferably fixed to the active surface area 30 in a visually identifiable form numbered “1” (indication) Similarly, the hepatitis C binding protein is preferably immobilized in the form of the letter “C”. Of course, other formats can be used as appropriate for the user and / or manufacturer of the inspection system 70.

  In accordance with the present invention, the protein layer 14 is effective, for example, by an inkjet spray, a physical method using a pipette, and / or a method in which a bound protein solution is brought into contact with a specified area of a nitrocellulose membrane or other protein layer 14. The binding protein is applied and / or deposited (not shown) on the surface area 30, and the binding protein is absorbed into the protein layer by absorption and / or capillary action to be substantially fixed on the protein layer 14.

  Therefore, prior to testing, at the stage where the testing system 70 is assembled into an effective configuration, preferably a binding protein that detects a plurality of different marker proteins in the liquid analyte is selected and / or a substantially effective surface area. Fix in a useful pattern on the protein layer 14 in 30 regions.

  Due to the binding protein virtually immobilized on the effective surface area 30 of the protein layer 14, the marker protein (not shown) of the liquid sample to be analyzed is effectively attached to the protein layer 14 for several assumed uses that will be discussed below. Can be fixed.

  As best seen in FIGS. 4A and 4B, the active surface area 30 is preferably viewable by the user through the housing hole 20 and the passage layer hole 24. In the embodiment shown in FIGS. 4A and 4B, the effective surface area 30 includes a first inspection surface area 32 and an inspection contrast surface area 28. The binding protein fixed to the protein layer 14 with an effective configuration is effectively fixed to the first inspection surface area 32. The test control surface area 28 is preferably properly used, handled, and / or stored in both a positive result configuration (shown in FIGS. 4A and 4B) and a negative result configuration (not shown) of the test system 70. Used to display control readings to confirm if done.

  More specifically, as shown in FIGS. 4A and 4B, when the inspection system 70 is properly used, handled, or stored, a control value is preferably generated and displayed in the test contrast area 28. The reference reading is not necessarily required, but is preferably a color or other indication corresponding to the pattern of binding protein effectively immobilized on the effective surface area 30 of the protein layer 14 as described above.

  The absence of a control reading in the test control plane area 28 preferably indicates that a test performed using the system 70 may be invalid. Strictly speaking, the inspection system 70 according to the present invention need not include the inspection contrast area 28, but is preferably provided.

  When the system 70 is used to perform a single qualitative marker protein test, the test control surface 28 is not necessarily required, but is preferably arranged in the first test surface area 32 by the method shown in FIG. 4A.

  Alternatively, when performing a quantitative marker protein test using the present system 70, the test control area 28 is not necessarily required, but is preferably located substantially in the center of the effective area 30 as shown in FIG. 4B. Let In FIG. 4B, the effective surface area 30 preferably further includes a supplementary first inspection surface 32a. Preferably, the same binding protein is not necessarily required, but is preferably immobilized effectively at different concentrations in the first test surface area 32 and the supplementary first test surface area 32a. For example, a binding protein having a substantially higher concentration than the binding protein in the first inspection surface area 32 is effectively fixed to the supplementary first inspection surface area 32a.

  Similarly, as best seen in FIG. 4C, if the user attempts to test for the presence of multiple marker proteins in effect using one system 70, the test contrast area 28 is not necessarily required, Preferably, the effective surface area 30 is located in the actual center. As shown in FIG. 4C, the effective surface area 30 can further include a second test surface area 33 that effectively fixes a second set of different binding proteins (not shown). The second set of binding proteins is preferably selected and / or employed to detect the presence of a marker protein that is different from the (first set) binding protein. Similarly, the second set of binding proteins can be immobilized on the protein layer 14 in a beneficial pattern.

  In addition to the first inspection surface area 32, the supplementary first inspection surface area 32a, and the second inspection surface area 33, as shown in FIG. 4C, the effective surface area 30 may include a supplementary second inspection surface 33a. . Although not necessarily required, preferably the same binding protein is preferably fixed at different concentrations, preferably in both the second test surface area 33 and the supplementary second test surface area 33a. For example, a binding protein having a concentration substantially higher than the binding protein concentration in the second test area 33 can be effectively fixed in the supplementary second test area 33a.

  As best seen in FIG. 4C, the first inspection surface area 32 and the supplementary first inspection surface area 32a are not necessarily required, but preferably preferably conceptually form a first inspection ring 40 that is both substantially planar. Yes. Each of the first inspection surface 32 and the supplementary first inspection surface 32a are not necessarily required, but are preferably conceptually located therein. In such a configuration, the test contrast area 28 is not necessarily required, but is preferably in effect within the area surrounded by the first test ring 40.

  The second inspection surface area 33 and the supplementary second inspection surface area 33a are also not necessarily required, but preferably both conceptually form a substantially planar second inspection ring. The second inspection surface area 33 and the supplementary second inspection surface area 33a are each not necessarily required, but are preferably conceptually located therein. As best seen in such an embodiment, and in FIG. 4C, the second test ring 42 is preferably not necessary, but preferably substantially surrounds the first test ring 40.

  Alternatively, the first inspection surface area 32, the supplementary first inspection surface area 32a, the second inspection surface area 33, the supplementary second inspection surface area 33a, and the inspection contrast surface area 28 are all in various configurations, for example, various Other concentric and / or non-concentric geometric shapes conceptually. Of course, other geometric shapes, for example, different concentric shapes are included.

  In another embodiment foreseen in the present invention, the first and / or second inspection surface areas 32, 33 may constitute similar surface areas. More specifically, the binding protein that is substantially immobilized on the first and / or second test surface areas 32, 33 is alive with species that supply the substantially healthy cells and / or the same of the liquid analyte. May be a unique protein to synthesize.

  The embodiment of the inspection system 70 shown in FIGS. 4D and 4E is probably worth supplemental explanation. As in this embodiment, and as described above (ie, generally corresponding to the discussion of FIGS. 2D-2F above), the passage layer 12 has first and second holes 24a and 24b therethrough and a control hole 24c. . As best seen in the discussion of FIGS. 2E and 4E, the first hole 24a is effectively “A” on the protein layer 14 and the second hole 24b is effectively second on the first inspection ring 40. On the inspection ring 42, the control hole 24 c is practically aligned with the inspection control surface area 28.

  The use of this inspection system 70 will be described with reference to various embodiments shown in the figures. However, the following discussion regarding use is not necessarily required, but should preferably be considered as generally applicable to other embodiments not shown in the figures, but within the scope of the present invention.

  Prior to a typical test and application and / or test of a liquid analyte, preferably the first drop of wash buffer is added from the housing hole 20 of the housing top 10 to the test system 70 and the protein layer. Visible portions 31 of the 14 effective surface areas 30 are moistened and absorbed. A wash buffer is not necessarily required, but preferably acts as a blocking agent in the area of the effective area 30 where the binding protein is not immobilized to form an inactive protein wash binding region 44 (see, eg, FIG. 4A). 4B), preferably to prevent indiscriminately fixing here markers and / or other proteins of the liquid analyte.

  The liquid analyte can be injected from the housing hole 20 of the test system 70, preferably using a pipette or similar instrument. The housing hole 20 is an effective liquid communication path leading to the passage layer hole 24, and the liquid analyte preferably reaches the effective surface area 30 of the protein layer 14 from at least one hole 24 of the passage layer 12. . A liquid sample to be analyzed is not necessarily required, but preferably the amount to sufficiently cover the visible portion 31 is effectively injected from the housing hole 20.

  As described above, the inspection system 70 of the present invention inspects the presence of the marker protein in the liquid analysis sample. In the configuration of positive results, as best seen in FIGS. 4A to 4E, the use of this test system 70 preferably reveals that the marker protein to be tested is actually present in the liquid analyte. In a positive result configuration, one or more marker proteins of the liquid sample to be analyzed are preferably bound to the binding protein and effectively immobilized on the effective surface area 30 of the protein layer 14.

  When the sample to be analyzed includes the first and second test target marker proteins and the effective surface area 30 has the first and second test surface areas 32 and 33, the first and second test surfaces 32 and 33 are Preferably, the first and second marker proteins can be individually bound in a positive result configuration.

  As previously mentioned, if the binding protein is a native protein that is virtually immobilized in a similar area, the marker protein preferably binds to this native protein in a positive result configuration and is effectively a protein. Fixed to the layer.

  Conversely, using test system 70 in a negative result configuration preferably does not reveal that the marker protein to be tested is actually present in the liquid analyte. In a negative result configuration (not shown), at least a portion of the liquid analyte, and preferably most and / or virtually all, the protein layer 14 is not immobilized on the immobilized binding protein. Pass over.

  In any case, due to the effects of gravity or another force (eg, the inertial force created by the centrifuge), a portion of the liquid analyte sample preferably flows from the test system 70 substantially vertically. And / or spread from the injection point to the protein layer 14.

  Preferably, the marker protein to be tested contained in the liquid analyte is effectively fixed on the protein layer 14 (configuration of positive results) or guaranteed not to be fixed (configuration of negative results), A sufficient amount of liquid sample to be analyzed is injected into the protein layer 14.

  Since the protein layer 14 described above is actually a porous structure, a part of the liquid sample to be analyzed passes therethrough. When liquid analytes (eg, whole blood), lipemia, and / or liquid analytes that require further clarification or amplification may not pass through the pores of the protein layer 14 that are less than 5-6 microns Although not necessary, preferably the sample is clarified and / or disassembled prior to inspection. Liquid analytes that can be examined without clarification and / or amplification preferably include, for example, serum, plasma, urine, sweat, and / or exudates. Preferably, other aqueous extracts that are clarified by filtration and / or centrifugation are also considered part of the sample to be analyzed using the test system 70.

  Next, preferably a drop of reagent, or other required amount, is added and the recommended amount is that which covers the visible portion 31 of the effective surface 30. This reagent is particularly selected and / or employed because it effectively binds to a marker protein that is effectively immobilized to the protein layer 14 in a positive result configuration.

  In the embodiment of the present invention, this reagent (not shown) is preferably configured so that the test system 70 has a positive result when the marker protein specifically binds to the binding protein immobilized on the protein layer 14. It is a visual marker that provides a color indication to indicate and / or confirm. This visual labeling material (not shown) includes one or more different materials, such as radioactive isotopes, fluorescent materials, UV absorbing materials, and / or colored materials. Colored visual labeling materials include colloidal gold complexes, dyed latex beads, and / or similar materials.

  Preferably, when analyzing nanogram to femtogram quantities, it may be necessary to amplify with an enzyme complex. Situations where amplification by enzyme complexes is encouraged include, for example, IgE detection for allergy diagnosis, and / or drug abuse, industrial and environmental pollutants, plant diseases, hormones, cancer markers, arthritis markers, and / or the like Detection of these substances.

  When these amounts and / or other amounts of analyte are used, the aforementioned reagent may be a protein enzyme complex (not shown). Like other reagents used in accordance with the present invention, the protein-enzyme complex is selected and / or selected to effectively bind to a marker protein that is effectively immobilized to the protein layer 14, particularly in a positive result configuration. Adopted.

  At this point, preferably a drop of the same or different wash buffer is added to the active area 30 to wash away unbound material, although not necessarily required. At this point, the washing buffer is absorbed by the protein layer 14.

  In the situation where the aforementioned reagent contains a protein-enzyme complex, an enzyme substrate (not shown) can be preferably added. Then leave it for an appropriate time, perhaps on the order of about 10-60 seconds, during which time a positive result provides an opportunity for the enzyme substrate to bind effectively to the protein-enzyme complex. Both the protein-enzyme complex and the enzyme substrate are selected and / or employed to effectively indicate a color indication that the test system 70 is positively configured and / or confirm. In this embodiment of the present inspection system 70, preferably a drop of additional wash buffer is added from the housing hole 20 and injected into the inspection system 70 through a substantially vertical hole away from the injection point, as described above. Thus, after penetrating multiple layers of the inspection system, the results are read.

  All materials considered to have an excess marker protein that is not fixed (eg, by adhesion or binding) on the protein layer 14 due to the binding protein already fixed to the protein layer 14 is not necessarily required, but preferably , It passes through the protein layer 14 and is finally captured, trapped and / or absorbed by the absorption layer 16.

  Thereafter, a few drops of additional wash buffer are required and / or preferably added to sharpen the background of the visible portion 31 of the crude protein 14 to read a clearer test result. it can.

  In summary, and generally speaking, a liquid analyte (not shown) is preferably injected over the protein layer 14 through at least one hole 24 in the passage layer 12 of the combined test subassembly 50. . The liquid sample to be analyzed passes through the protein layer 14 under the influence of gravity or other forces and is effectively injected into the absorption layer 16.

  The disposable immunodiagnostic test system 70 can be disposed of after use, preferably after drying, by environmentally responsible methods such as incineration.

  Although not essential to the basic function of the present inspection system 70, it is generally considered that when the passage layer 12 is denser and more impermeable, lateral diffusion of the added liquid analyte is less likely to occur.

  When the inspection system 70 is assembled so that the passage layer 12 and the housing hole 24 are substantially aligned in a line as indicated by “B”, the liquid sample to be analyzed enters the inspection system 70 during use.

  Although not necessary for the present invention, the housing top 10, layers 12, 14, 16, and / or housing bottom 18 of the inspection system 70 are preferably assembled in close contact with each other and / or the inspection system 70. It is believed that it should be assembled as a loose fitting relationship to enhance completeness. Further, although not essential to the present invention, the inspection system 70 is such that the assembled layers are in close enough relationship that the added liquid sample enters the interior from a point away from the entrance of the inspection system 70, and gravity And / or other similar forces are considered to work effectively as long as they are effectively passing vertically.

  In addition, although not essential to the basic function of the present inspection system 70, the various analytes 10, 12, 14, 16, 18 are brought into close contact with each other and the gaps and / or ends are sealed, so that the liquid analyte can be introduced. Preferably, excess sample is absorbed by the absorbent layer 16, flowing substantially vertically from a point away from and / or passing through one or more of the layers 12, 14, 16 of the present inspection system 70. It is generally considered.

  A method of testing the presence of a plurality of marker proteins from a single liquid analyte using the single test system 70 is considered to be a significant advantage. As an advantage, when multiple inspection systems require separate inspections, there are almost four corresponding inspections and a corresponding control is required, so the multiple inspection system preferably has a short overall execution time. Therefore, it is considered that the cost for the material is small.

  The use of the inspection system 70 is preferably simple, quick to use, very accurate and effective, without the need to purchase additional specialized equipment or supplemental training to already highly qualified inspection staff. Test results can be obtained quickly. As described above, with this system, it is preferable that a single analyte sample having a plurality of causative substances can be examined substantially simultaneously. The test system 70 is preferably used in clinical, therapeutic settings, and / or sites. In fact, the inspection system 70 is preferably manufactured and / or assembled in the field and / or specially designed manufacturing plant, which preferably results in low manufacturing and packaging costs. The test system 70 can preferably be used selectively to obtain quantitative and / or qualitative results, depending on user preference and / or the nature of the test being performed.

  The inspection system 70 can be easily disposed of in a simple and environmentally responsible manner, such as incineration, in addition to all of the above descriptions. As described above, the test system 70 can preferably be selectively employed to detect viruses, fungi, bacteria, and / or vector-induced infections. The present inspection system 70 can preferably obtain visually identifiable test results and / or can obtain results in a relatively short period of time.

  Of course, other modifications or improvements may be incorporated into the design and manufacture of the examples in accordance with the disposable immunoassay system 70 without departing from the spirit and scope of the present invention. For example, but not limited to this example, the housing 60 and / or the various layers 12, 14, 16 of the present inspection system 70 may have various geometric shapes, such as squares, rectangles, circles, and / or It can be made spherical.

  Similarly, the present inspection system 70 can have a plurality of inspection surface areas (not shown) in addition to the first and second inspection surface areas 32 and 33 described above. In such an embodiment, the visible portion 31 of the effective surface area 30 is further comprised of a plurality of supplemental inspection surface areas, which can be combined to form various geometric shapes.

  In addition, the upper surface of the passage layer and the protein layers 12 and 14 form the recessed portions 56 and 58, respectively, while the passage layer and the protein layers 12 and 14 may also have a convex shape or other similar shapes, respectively.

  Further, the label display 11 is written on the housing upper part 10 or the passage layer 12 by a method not limited to printing, sticking, writing or the like.

  Although the above description describes only one housing hole 20, each inspection system 70 may have a plurality of housing holes (not shown).

  In addition, the units of the disposable immunodiagnostic test system are lined up in “multipacks” or other detachable or weak connections that the end user may desire (typically as shown in FIGS. 6 and 7). Other than a side-by-side cutable format).

  Similarly, the disposable immunodiagnostic test system 70 is assembled without the housing top 10 and in such an embodiment at least the passage layer 12 (possibly labeled on the outer surface 11), the protein layer 14, It is assumed that the absorbent layer 16, the housing lower portion 18, and the housing side surface 36 are constituted.

  Similarly, the housing lower portion 18 may be omitted, in which case the disposable immunodiagnostic test system 70 is at least provided in the housing upper portion 10, the passage layer 12 (the housing hole 20 being substantially perpendicular to the hole 24 of the passage layer 12). The protein layer 14, the absorbent layer 16, and the housing side surface 36.

  In addition, the test system 70 is sometimes described as a flow-through format rapid assay test, while it may be made in a side-flow format.

  The test system 70 discussed above is preferably a cost-effective immunodiagnostic test system that can be discarded and can be used to detect one or more marker proteins in a liquid analyte or substrate. It seems that it is preferable to carry out using a single liquid analyte, and since the present invention can detect a plurality of marker proteins in one test, it is preferable that a result is obtained in a shorter time.

  While the present invention appears to be used primarily as an immunodiagnostic system, various marker proteins and tissue fold solutions, plant extracts, seed extracts, soil extracts, and / or water and other aqueous extractions May be manufactured for use in detecting other materials present in the liquid.

  As described above, the disposable immunodiagnostic test system 70 according to the present invention is preferably environmentally responsible and can be disposed of by inexpensive methods such as incineration, combustion, and the like.

  The disposable immunodiagnostic test system 70 is preferably considered to be less expensive to manufacture and dispose of than other analytical test instruments currently in use.

It is the figure which looked at the upper front from one encouragement example of the disposable immunodiagnostic test system by the present invention from the left side. FIG. 1A is an exploded view of the inspection system as viewed from the left side, with the sealing portion removed, and the portions that are virtually aligned in a row are indicated by imaginary lines. Another top view of the preferred embodiment of the inspection system according to the invention, seen from the left side, includes a housing. It is the exploded view which removed the sealing part of FIG. 2A which looked at the upper front of the inspection system from the left side. FIG. 3 is an enlarged view of the circled region 2C in FIG. 3 and will be discussed in detail below. The top front view of the different preferred embodiments of the inspection system according to the invention as seen from the left, with a plurality of holes in the passage layer. It is the figure which looked at the upper front of the inspection system of Drawing 2D from the left, and is the exploded view which removed the sealing part. 2C is an enlarged view of the inspection system shown in FIG. 2D, similar to FIG. 2C. 3 is a cross-sectional view of the inspection system taken along line 3-3 in FIG. 2A. FIG. Fig. 2 is a top plan view of a further encouraged embodiment of an inspection system according to the present invention, similar to the diagram shown in Fig. 2A. FIG. 2B is a top plan view of the inspection system of FIG. 2A. Fig. 2 is a top plan view of a further encouraged embodiment of an inspection system according to the present invention, similar to the diagram shown in Fig. 2A. 2D is a top view of the inspection system of FIG. 2D showing the housing top and the passage layer. FIG. 2D is a top view of the inspection system of FIG. It is the figure which looked at the upper front of another Example of the inspection system by this invention from the left side, and is the exploded view which removed the sealing part partially. It is the figure which looked at the upper front of the inspection system of Drawing 5A from the left side. FIG. 4 is a top view of a part of another embodiment according to the present invention as seen from the left side, each showing a plurality of inspection systems similar to FIG. FIG. 6 is a top view of a portion of a further embodiment of the present invention as viewed from the left side, with a plurality of inspection systems each similar to FIG. 2B being weakly connected.

Claims (60)

A disposable immunodiagnostic test system for testing the presence of a marker protein in a liquid analyte,
a) a substantially planar pass-through layer comprising a first material of a substantially non-porous structure in a shape through which at least one hole penetrates;
b) a protein layer having an effective configuration, including a second material used to substantially immobilize the binding protein, and having a virtually porous structure through which a portion of the liquid analyte can be effectively passed. The protein layer is in intimate contact with the passage layer, substantially in contact with the hole in the passage layer, and forms an effective surface area on the protein layer that is substantially aligned;
c) including a third material capable of absorbing at least a part of the liquid sample to be analyzed, and including an absorption layer in close contact with the protein layer;
In an effective configuration, as described above, the binding protein is effectively immobilized on the protein layer, and the liquid sample to be analyzed is injected into the protein layer from at least one hole of the passage layer, In the positive result configuration, the marker protein binds to the binding protein and is practically fixed to the protein layer, and in the negative result configuration, at least a portion of the liquid sample to be analyzed passes through the protein layer.
The inspection system.   The inspection system of claim 1, wherein the first material, the second material, and the third material are comprised of at least one combustible material that produces a non-toxic byproduct upon incineration.   The test system according to claim 2, further comprising a reagent, wherein the reagent effectively binds to the marker protein and effectively fixes the marker protein to the protein layer in the positive result configuration.   The test system according to claim 3, wherein the reagent includes a visual labeling substance, and the substance provides an effective color display in the configuration of the positive result.   The inspection system of claim 4, wherein the visual labeling material comprises dyed latex beads.   The inspection system of claim 4, wherein the visual marker material comprises a gold colloid complex.   The inspection system according to claim 4, wherein the visual marker includes a carbon colloid complex.   The test system according to claim 3, wherein the reagent includes a protein enzyme complex, and the test system further includes an enzyme substrate that effectively binds to the protein enzyme complex in the configuration of the positive result.   The test system according to claim 8, wherein the enzyme substrate has an effective color display in the configuration of the positive result.   The inspection system according to claim 2, wherein at least a visible part of the effective surface area is visible from the hole in the passage layer.   The test system according to claim 10, wherein in the positive result configuration, a part of the liquid sample to be analyzed substantially passes through the protein layer.   The inspection system according to claim 10, wherein at least one sealant is inserted between the passage layer and the protein layer and between the protein layer and the absorption layer.   The visible portion of the effective surface area includes a first test surface area, and the binding protein is effectively fixed to the first test surface area with the above-described effective configuration. Inspection system.   The visible portion of the effective surface area further includes a test control surface area; the test control surface area by displaying control readings in both the positive result configuration described above and the negative result configuration described above. 14. The inspection system according to claim 13, which is used to effectively confirm that the inspection system is properly used.   15. The inspection system of claim 14, wherein the inspection contrast area is further used to effectively verify that the inspection system has been properly handled and stored.   15. The inspection system of claim 14, wherein the passage layer is effectively in the range of about 0.2 mm to about 10 mm thick.   The inspection system of claim 16, wherein the passage layer effectively ranges in thickness from about 2 mm to 4 mm.   The inspection system of claim 14, wherein the first material comprises a dense compressed paper material.   The inspection system of claim 18, wherein the paper material is cardboard.   The inspection system of claim 14, wherein the first material comprises a bark material.   The inspection system of claim 14, wherein the first material comprises compressed plant material.   15. The inspection system according to claim 14, wherein the protein layer is substantially about 5 mm or less in thickness.   23. The inspection system of claim 22, wherein the protein layer is substantially in the range of about 0.5 mm to about 2 mm thick.   15. The inspection system of claim 14, wherein the second material has a perforated shape, each of the holes effectively having a diameter in the range of about 0.1 microns to about 25 microns.   25. The inspection system of claim 24, wherein the diameter of the hole is effectively in the range of about 0.4 microns to about 2.0 microns.   The inspection system of claim 14, wherein the second material comprises a nitrocellulose material.   The inspection system of claim 14, wherein the second material comprises an acetate material.   The inspection system of claim 14, wherein the second material comprises a nylon material.   The inspection system of claim 14, wherein the absorbent layer effectively ranges from about 1 mm to about 50 mm in thickness.   The inspection system of claim 14, wherein the third material comprises a sponge material.   32. The inspection system of claim 30, wherein the sponge material comprises a paper towel material.   32. The inspection system of claim 30, wherein the sponge material comprises an acetate material.   And a housing that substantially encloses the passage layer, the protein layer, and the absorption layer, wherein the lower portion of the housing is in close contact with the absorption layer, the upper portion of the housing is in close contact with the passage layer, and the upper portion of the housing is at least 15. The inspection system of claim 14, wherein the housing hole is shaped to penetrate and the housing hole is effectively aligned in a row so that the working liquid can pass through the holes of the at least one passage layer.   34. The inspection system of claim 33, wherein the housing is composed of at least one combustible material.   35. The inspection system of claim 34, wherein the housing includes a housing material that results in a substantially non-porous housing structure.   36. The inspection system of claim 35, wherein the housing upper portion and the housing lower portion are each substantially non-porous housing structures.   34. The inspection system of claim 33, wherein at least one sealant is effectively inserted between the housing top and the passage layer and between the housing bottom and the absorbent layer.   34. The inspection system of claim 33, wherein a visible portion of the effective area is visible from the housing hole.   34. The inspection system of claim 33, wherein at least one of the passage layer and the housing has an outer surface marked with at least one label.   40. The inspection system of claim 39, wherein the housing includes the outer surface.   41. The inspection system of claim 40, wherein the outer surface is attached to the top of the housing.   40. The inspection system of claim 39, wherein the label display includes a bar code display.   40. The inspection system of claim 39, wherein the label marker includes a text display.   34. The inspection system of claim 33, wherein the upper housing layer and the lower housing layer each have a thickness in the range of about 0.1 mm to about 3 mm.   45. The inspection system of claim 44, wherein the upper housing layer and the lower housing layer each have a thickness ranging from about 0.2 mm to about 0.4 mm.   The test system according to claim 13, wherein the binding protein includes a protein used for binding a fungal marker protein.   The test system according to claim 13, wherein the binding protein includes a protein used for binding a viral marker protein.   The test system according to claim 13, wherein the binding protein includes a protein used for binding a bacterial marker protein.   The test system according to claim 13, wherein the binding protein includes a protein used for binding a vector-derived marker protein.   14. The inspection system according to claim 13, wherein the binding protein includes a protein used for binding a plant marker protein.   The visible portion of the effective surface area includes a supplementary first surface area, and the binding protein is effectively fixed to the first test surface area and the supplementary first test surface area with the above-described effective configuration. The inspection system according to claim 14.   52. The inspection system of claim 51, wherein the supplementary first inspection surface area has a binding protein that is substantially higher in concentration than the binding protein concentration of the first inspection surface area.   Both the first inspection surface area and the supplementary first inspection surface area conceptually form a substantially flat first inspection ring, in which the first inspection surface area and the supplementary first inspection surface area 52. The inspection system of claim 51, wherein each is conceptually contained.   54. The inspection system of claim 53, wherein the first inspection ring effectively surrounds the inspection contrast area.   The visible portion of the effective surface area further includes a second surface area, and with the effective configuration described above, the second binding protein is effectively fixed to the second test surface area, with the positive result configuration described above. The test system according to claim 13, wherein the marker protein binds to the second binding protein and is practically immobilized on the protein layer.   The visible portion of the effective surface area further includes the supplementary first test surface area and the supplementary second test surface area, wherein the binding protein has the first test surface area and the 56. The inspection system of claim 55, each substantially fixed to a supplementary first inspection surface area, and wherein the second binding protein is substantially fixed to each of the second inspection surface area and the supplemental second inspection surface area. .   Both the first inspection surface area and the supplementary first inspection surface area conceptually form a substantially flat first inspection ring, in which the first inspection surface area and the supplementary first inspection surface area Each of the second inspection surface area and the supplementary second inspection surface area together form a second inspection ring which is conceptually a substantially flat surface, in which the second inspection surface is formed. 57. The inspection system of claim 56, wherein the area and the supplemental second inspection surface area each conceptually include; the second inspection ring substantially surrounds the first inspection ring.   The second test surface area includes a similar surface area, wherein the second binding protein contains at least one substantially healthy cell of the liquid analyte and a unique protein biosynthesized by a species supplying the same. In the effective configuration, the intrinsic protein is practically fixed to the similar area, and in the positive result configuration, the marker protein binds to the intrinsic protein and is practically fixed to the protein layer. 56. The inspection system of claim 55.   At least one hole in the passage layer includes at least two holes, the upper surface of the passage layer forms a recess that is substantially in contact with the at least two holes, and the protrusion is substantially in contact with the at least two holes. 34. The inspection system of claim 33, substantially in line with the outer housing hole. The inspection of claim 14, wherein the top surface of the protein layer forms a recess, the recess substantially contacting a visible portion of the effective surface area and substantially in line with the hole in the passage layer. system.

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