MX2007005180A

MX2007005180A - Disposable immunodiagnostic test system.

Info

Publication number: MX2007005180A
Application number: MX2007005180A
Authority: MX
Inventors: Uma Mahesh Babu
Original assignee: Internat Bio Therapeutic Res I
Priority date: 2004-11-01
Filing date: 2005-11-01
Publication date: 2007-11-08
Also published as: BRPI0516894A; JP5364266B2; WO2006047869A1; AP2007004015A0; CA2585695A1; AU2005301045A1; ZA200704512B; JP2008518215A; CA2585695C; CN101133326B; AU2005301045B2; EP1815250A1; CN101133326A; EP1815250A4

Abstract

A disposable immunodiagnostic system tests for marker proteins in liquid sample analytes. It includes intimately contacting passage, protein, and absorbent layers. The passage layer is non-porous and has an aperture therethrough. The protein layer is porous and operatively enables immobilization of combinable proteins thereon, as well as passage of the analyte therethrough. The protein layer has an active surface area that is aligned with the passage layer aperture. The analyte is operatively introduced onto the protein layer through the passage layer aperture. In positive results, the marker proteins are operatively bound to the combinable proteins and immobilized relative to the protein layer. In negative results, the analyte operatively passes through the protein layer, and is absorbed by the absorbent layer. A housing may also be provided. The system is constructed of a combustible material that produces non-toxic by-products upon incineration, enabling ecologically responsible disposal after diagnostic use of the system.

Description

PROOF SYSTEM FOR DISPOSABLE IMMUNODIAGNOSIS FIELD OF THE INVENTION The invention relates to the field of test systems, equipment and devices for unodiagnostics, and more particularly to a disposable immunodiagnostic test system for testing the presence of marker proteins in a liquid sample analyte.

BACKGROUND OF THE INVENTION Several diagnostic test methods and equipment have been used in clinical settings, such as, for example, immunochromatographic assays, multi-immunoassay diagnostic systems that test the presence of antigens and / or antibodies, devices that analyze the sample of tests, and rapid immunoassay test strips. Other rapid assay test devices and methodologies may be known to a greater or lesser degree in the art, and these may be classified in a number of formats, depending on whether the sample being tested flows through the device, and possibly also depending on the manner and / or direction of any flow. For example, the test devices may have a dipstick, direct flow and / or lateral flow format.

There is, however, a continuing need for a test device that can provide faster and more accurate test results, which may not require the acquisition of additional specialized equipment or the additional training of already highly qualified test personnel, and / or that can authorize a simple analyte sample to be tested on a substantially contemporaneous basis for the presence of any plurality of infectious agents. There is likewise a need for a test system, equipment and / or immunodiagnostic device (which may, in the future, be referred to simply as a "immunodiagnostic test system") that is effective and simple to use, and can be administered rapidly . There is also a pressing need - one that has not been adequately addressed by prior devices - for a test system that could be used and / or easily arranged at the "point of care" and / or "in the field" (ie, outside). of traditional clinical settings either, for example, as part of a temporary auxiliary program, an emergency response project, in a temporary hospital and / or in a current field that tends to a crop of plants or a herd of affected livestock ). In addition, there is a need for a system of test that can be manufactured and / or assembled in the field and / or in an industrial facility that is specifically intended for that purpose. There is also a need for such a system that could also involve lower production and packaging costs. There is an additional need for a test system that can be selectively adaptable to provide any qualitative and / or quantitative results, depending on the preferences of the user and / or the nature of the test being conducted. Previously, the elimination of immunodiagnostic systems from the "point of care" may have presented a notable difficulty or problem for those workers who provide this service. In the past, such a device (which had been a potentially contaminated device following its 'use) would normally have been sent to a landfill for disposal, thus giving rise to a' multitude of environmental costs and problems, including the potential for , over time, contaminants from the device could seep out of the landfill and its surrounding regions. The disposal of the sanitary landfill of some currently commercialized immunodiagnostic test systems has so far been substantially required by the fact that such systems have been normally composed mainly of materials (such as plastic) that can not be burned or incinerated safely without generating noxious and / or toxic fumes. The elimination of test systems in sanitary landfills has also usually involved additional transport and disposal costs and efforts. Partly due to this last fact, field workers have been required to transport portable waste containers adapted to transport and safely control such potentially contaminated test systems. Such waste procedures may have involved sterile glassware, plastic utensils, laboratory tools and the like, as well as correspondingly strict handling and sterilization regimes. Accordingly, there is a permanent and extremely sensitive need for a test system that could be easily disposed of in an ecologically responsible, even simple manner, such as, for example, by incineration over an open fire. There is also a need for a test system that could be selectively adaptable to detect infections induced by viruses, fungi, bacteria and / or vectors, any or all of these tests are possibly performed using a simple sample. In addition to all of the above, there is a need for a test system that provides visually discernible test results and / or results within a relatively short period of time, such as, for example, in the span of sixty to ninety seconds. Accordingly, it is an object of the invention to obviate, mitigate and / or address one or more of the aforementioned needs, limitations and / or disadvantages associated with the prior art.

SUMMARY OF THE INVENTION In accordance with the present invention, a test system for immunodiagnostics is described for testing the presence of marker proteins in a liquid sample analyte. The test system includes a substantially planar pitch layer comprising a first material having a substantially non-porous structure that is formed to define at least one through opening. The test system also includes a protein or protein layer comprising a second material that is adapted to allow, in an operational configuration, substantial immobilization of combinable proteins therein. The protein layer has a substantially porous structure to allow a portion of the liquid sample analyte to pass substantially therethrough. The protein layer is in intimate contact with the protein layer for I will define an active surface area in the protein layer that is substantially adjacent to and substantially aligned with, the opening of the pass layer. The test system also includes an absorbent layer comprising a third material that allows absorption of at least a portion of the liquid sample analyte. The absorbent layer is in intimate contact with the protein layer. In the operative configuration, the combinable proteins are substantially immobilized in the protein layer as already mentioned, and the liquid sample analyte is introduced onto the protein layer through at least one opening of the passage layer. In a configuration of positive results, the marker proteins bind to the combinable proteins and are immobilized substantially in relation to the protein layer. In a configuration of negative results, at least a portion of the liquid sample analyte passes substantially through the protein layer. According to a further aspect of the invention, the first material, the second material and the third material are constructed of at least one combustible material that produces non-toxic by-products in the incineration. According to one aspect of a preferred embodiment of the invention, the test system may also preferably comprise a reagent which, in the configuration of positive results, is operatively linked to marker proteins that are substantially immobilized relative to the protein layer. According to one aspect of a preferred embodiment of the invention, the reagent may comprise a substance visually for labeling which operatively provides a colored indication of the configuration of positive results. According to one aspect of another preferred embodiment of the invention, the reagent may comprise a protein enzyme conjugate substance. In this embodiment, the test system may preferably further comprise an enzyme substrate substance that is operatively linked to the protein enzyme conjugate substance in the configuration of positive results, and which can preferably deploy a colored clue in the configuration of positive results . According to one aspect of a preferred embodiment of the invention, at least a visible portion of the active surface area may be visible through the opening of the passage layer. According to one aspect of a preferred embodiment of the invention, the test system may further preferably comprise at least one sealant substantially juxtaposed between the passage layer and the protein layer, and between the protein layer and the absorbent layer. According to a further aspect of a preferred embodiment of the invention, the visible portion of the active surface area may preferably comprise a first test surface area with the combinable proteins, which are preferably substantially immobilized therein in the operational configuration. The visible portion of the active surface area may also preferably comprise a procedural control surface area. The procedural control surface area can preferably be adapted to display a control reading both in the configuration of positive results and in the configuration of negative results, to operatively confirm that the test system has been used appropriately. According to a further aspect of a preferred embodiment of the invention, the test system may preferably further comprise a housing substantially encapsulating the passage layer, the protein layer, and the absorbent layer. A lower housing portion of the housing is in intimate contact with the absorbent layer. A top housing portion of the housing is in intimate contact with the passage layer. The accommodation portion top is formed to define at least one housing opening therein. The housing opening is substantially aligned in operative fluid communication relationship with at least one opening in the passage layer. According to a further aspect of a preferred embodiment of the invention, the housing can preferably be constructed of at least one aforementioned combustible material. According to one aspect of a preferred embodiment of the invention, the housing may preferably comprise a housing material having a substantially non-porous housing structure. According to one aspect of a preferred embodiment of the invention, at least one sealant can be juxtaposed preferably substantially between the upper housing portion and the passage layer, and between the lower housing portion and the absorbent layer. According to a further aspect of one of the preferred embodiments of the invention, the housing may preferably comprise an outer surface portion with at least one labeling mark marked thereon. The outer surface portion may preferably be provided in the upper housing portion.

According to one aspect of the invention, the combinable proteins may preferably, but not necessarily, comprise proteins adapted to bind to fungal marker proteins, viral marker proteins, bacterial marker proteins, vector-induced marker proteins, plant marker proteins and / or native proteins biosynthesizable by substantially healthy cells in at least one liquid sample analyte and the same species that supplies the same. According to one aspect of one of the preferred embodiments of the invention, the visible portion of the active surface area can preferably also comprise a second test surface area. In the operational configuration, second combinable proteins are substantially immobilized in the second test surface area. In the configuration of positive results, the marker proteins bind to the second combinable proteins and are immobilized substantially in relation to the protein layer. According to a further aspect of this preferred embodiment of the invention, the visible portion of the active surface area can further preferably comprise a first additional test surface area and a second additional test surface area. In the operative configuration, proteins combinable are preferably, but not necessarily, substantially immobilized in each first test surface area and first additional test surface area. In the operational configuration, the second combinable proteins are preferably, but not necessarily, substantially immobilized in each second test surface area and the second additional test surface area. According to one aspect of a preferred embodiment of the invention, a substantially high concentration of the combinable proteins is substantially immobilized in the first additional test surface area relative to the concentration of the combinable proteins in the first test surface area . According to one aspect of a preferred embodiment of the invention, the first test surface area and the first additional test surface area can together preferably, but not necessarily theoretically, define a substantially substantial first test ring, with each first test surface area and the first test surface area theoretically located therein. Likewise, the second test surface area and the second additional test surface area can together preferably but not necessarily, theoretically defining a second substantially flat test ring, with each second test surface area and the second additional test surface area theoretically located therein. The second test ring can preferably, but not necessarily, substantially circumscribing the first test ring. Also, according to one aspect of a preferred embodiment of the invention, the first test ring may preferably, but not necessarily, substantially circumscribe the procedural control surface area. According to one aspect of one embodiment of the invention, at least one opening of the passage layer may preferably, but not necessarily, comprise at least two openings. An upper surface of the passage layer may preferably, but not necessarily be formed to define a concave portion substantially adjacent to at least two openings and substantially aligned with the housing opening. According to one aspect of another preferred embodiment of the invention, an upper surface of the protein layer may preferably, but not necessarily, be formed to define a concave portion. The concave portion is preferably, but not necessarily, substantially adjacent to the visible portion of the active surface area and substantially aligned with the opening of the through layer. Other advantages, aspects and features of the present invention, as well as methods of operation and functions of the related elements of the structure, and the combination of parts and manufacturing savings, will be more apparent in the consideration of the following detailed description and the claims annexed with reference to the attached drawings, the last of which are briefly described below.

BRIEF DESCRIPTION OF THE DRAWINGS The novel features which are believed to be characteristic of a test system for disposable immunodiagnosis according to the present invention, as to its structure, organization, use and method of use, together with additional objectives and advantages of it will be better understood from the following drawings in which at least one currently preferred embodiment of the invention will now be illustrated by way of example. It is expressly understood, however, that the drawings are not necessarily represented to scale and are for the purpose of illustration and description only. For these and other reasons, it should be appreciated that the drawings they are not intended as a definition of the limits of the invention. In the accompanying drawings: Figure 1A is a top front left perspective view of a preferred embodiment of an immunodiagnostic test system according to the invention; Figure IB is a top front left perspective view of the test system of the Figure IA, shown in an unsealed and exploded configuration with substantially aligned portions thereof shown in an imaginary profile; Figure 2A is a top front left perspective view of another preferred embodiment of a test system according to the invention including a housing; Figure 2B is a top front left perspective view of the test system of Figure 2A, shown in the unsealed and exploded configuration; Figure 2C is an enlarged view of the circled area 2C of Figure 3, which is discussed below; Figure 2D is a top front left perspective view of a different preferred embodiment of a test system according to the invention including a plurality of through layer openings; Figure 2E is a top front left perspective view of the test system of Figure 2D, shown in the unsealed and exploded configuration; Figure 2F is an enlarged view, similar to the Figure 2C, of the test system shown in Figure 2D; Figure 3 is a cross-sectional view of the test system of Figure 2A taken along line 3-3 of vision; Figure 4A is a top plan view of a further preferred embodiment of the test system according to the invention which is similar to that shown in Figure 2A; Figure 4B is a top plan view of the test system of Figure 2A; Figure 4C is a top plan view of a further even preferred embodiment of the test system according to the invention, which is similar to that shown in Figure 2A; Figure 4D is a top plan view of the test system of Figure 2D, showing the upper housing portion and the passage layer; Figure 4E is a top plan view of the test system of Figure 2D, showing the protein layer, with the housing and the layer openings of step shown in imaginary profile; Figure 5A is a top front left perspective view of yet another additional embodiment of the test system according to the invention, shown in a partially unsealed and exploded configuration; Figure 5B is a front left, top perspective view of the test system of Figure 5A; Figure 6 is a front left perspective view of a portion of yet another embodiment according to the invention, representing a plurality of frangible test systems, each similar to that shown in Figure 2A; and Figure 7 is a top front left perspective view of a portion of yet another embodiment according to the invention, representing a plurality of frangible test systems, each similar to that shown in Figure 2B.

DETAILED DESCRIPTION OF THE INVENTION Referring now to Figures 1A, IB, 5A and 5B of the drawings, there is shown a preferred embodiment of a disposable immunodiagnostic test system 70, according to the invention, for testing the presence of marker proteins in a liquid sample analyte (not shown). As best seen in Figure 5A, one of the preferred embodiments of the test system 70 includes a combined test sub-assembly 50 and a housing 60. It is also noted that, as best seen in Figures IA and IB, the test system 70 may simply include the combined test sub-assembly 50, without the housing 60. With further reference to Figure IB, it will be noted that the combined test subassembly 50 includes a substantially flat pitch layer 12, a protein layer 14, and an absorbent layer 16, each of which is preferably constructed of a combustible material that produces non-toxic by-products in the incineration. For this reason, among others, the combined test sub-assembly 50 can be easily disposed of in an environmentally responsible manner, such as, for example, by incineration on an outdoor flame. As in the above, the passage layer 12 is substantially planar and has a through opening 24 which is defined by a corresponding internal edge 26 of the passage layer 12. Although the preferred embodiment shown in Figures IA, IB, 5A and 5B has a single opening 24 through the passage layer 12, the passage layers of other embodiments (see, for example, Figures 2D to 2F, which are discussed in additional detail later) they may be provided with more than one opening 24. The passage layer 12 has a substantially non-porous structure, so that it will preferably have a non-woven, non-fluffy, substantially impermeable nature. The through layer 12 may preferably, but not necessarily, be constructed from a densely packed paper material, such as cardboard. Other relatively rigid materials, such as, for example, tree bark and / or packed sheet materials, can also be used in the construction of the passage layer 12 according to the invention. In this way, either as a result of its densely packed nature preference, the inherent properties of its construction material or otherwise, the through layer 12 preferably provides a measure of stiffness to the test system 70. The passage layer 12 is preferably, but not necessarily, between about 0.2 and 10 millimeters thick, with an even more preferred thickness being substantially within the range of between about 2 and 4 millimeters. As best seen in Figures 1A and IB, the protein layer 14 is in intimate contact with the passage layer 12. The protein layer 14 has an active surface area 30 that is substantially adjacent to the opening 24 of the passage layer 12, and is substantially aligned with it (as generally indicated by the imaginary line "A" in Figure IB). As best seen in Figure IA, at least a portion 31 of the active surface area 30 is preferably visible through the opening 24. The protein layer 14 may preferably, but not necessarily, be constructed of nitrocellulose, nylon and / or or acetate and of course any other material in which the reactant and / or combinable proteins can be substantially bound or immobilized. It is thought, although it is not essential for the operation of the test system 70, that nitrocellulose is an effective protein binding material that can be used in the protein layer 14. Commercially available nitrocellulose membranes, suitable can be molded on a thin supporting paper backing and used in the protein layer 14 according to a preferred embodiment of the present invention. The protein layer 14 is preferably, but not necessarily, not more than about 5 millimeters thick, with an even more preferred thickness that is substantially within the range of between about 0.5 and 2.0 millimeters. The protein layer 14 has a substantially porous structure, meaning that it is preferably provided with a plurality of pores (not shown) therebetween. In the case of nitrocellulose membranes and some of the other preferred protein layer 14 materials, it is now believed, although it is not essential to the operation of the test system 70, that the provision of larger pores in the protein layer 14 will correspondingly produce capacity and / or binding abilities of inferior proteins. As discussed in further detail below, a protein layer 14 having lower protein binding capabilities can decrease the sensitivity of any test performed using system 70. A protein layer 14 of nitrocellulose will preferably, but not necessarily, have pore sizes. between about 0.1 microns and 25 microns in diameter, with an even more preferred diameter size that is substantially within the range of between about 0.4 and 2.0 microns. It is believed that the protein layers 14 have pores (not shown) that are substantially dimensioned with the above range can produce an improved protein binding capacity. As best in Figure IB, the absorbent layer 16 is in intimate contact with the passage layer 12. As its name suggests, the absorbent layer 16 is constructed of an absorbent material which is preferably adapted, depending on the nature of the test being carried out, to be incorporated or absorbed in at least a portion (more preferably, a portion in excess) of the liquid sample analyte to be treated. The absorbent layer 16 can be formed preferably from a spongy material, or of course from any other material capable of incorporating or absorbing at least a portion of the liquid sample analyte (not shown). For example, the absorbent layer 16 may be constructed of a paper towel and / or an acetate material. The absorbent layer 16 preferably, but not necessarily, between about 1 and 50 millimeters thick, with an even more preferred thickness that is substantially within the range of between about 5 and 20 millimeters. Preferably, the absorbent layer 16 will be adapted so that it can absorb and retain three times or more of the volume of the liquid sample analyte to be administered during a single test. As already mentioned, the absorbent layer 16 is in an intimate contact relationship with the protein layer 14, and the protein layer 14 is in an intimate contact relationship with the passage layer 12. Preferably, while not essential to the basic operation of the test system 70, the passage layer 12 and the protein layer 14 can be held together in an intimate contact relationship already mentioned with the aid of a sealant (not shown) which is juxtaposed substantially between them. Likewise, the protein layer 14 and the passage layer 16 can be maintained from preferably together in an intimate contact relationship with the aid thereof or a different sealant (not shown) that juxtaposes substantially between them. Suitable sealants according to the invention may preferably, but not necessarily, include glue and other adhesives, as well as the use of staples, seams and heat sealing methodologies and / or ultrasound, or in fact any other material or process that is suitable to ensure that the layers 12, 14, 16 are substantially maintained in an intimate contact relationship already mentioned with each other. It is contemplated that, for ease of manufacture, a conventional thermal sealant or glue intended for domestic use may be sufficient to provide sufficient sealing properties, according to the invention. As best in Figures 1A and 5A, the combined test sub-assembly 50 may also preferably include a peripheral sub-assembly seal 34. As shown in Figures IA and 5A, the peripheral sub-assembly seal 34 in a preferred embodiment of the test system 70 can securely attach peripheral edge portions of each of the layers 12, 14, 16. The peripheral seal 34 of sub-assembly can be constructed of the same or still a different sealant as that which is discussed above. For example, sealing 34 sub-assembly peripheral may consist of an adhesive material that may adhere to the peripheral edge portions of layers 12, 14, 16. In addition to the aforementioned sealants and sealing methodologies, peripheral sub-assembly seal 34 may be constructed alternatively of any material or of course in a form that provides physical compression of the layers 12, 14, 16 (possibly and substantially adjacent to their peripheral edge portions) to ensure that they remain in intimate contact with each other. For example, the peripheral sub-assembly seal 34 may consist of a fastening member (not shown) that couples the peripheral edge portion of the passage layer 12 and the absorbent layer 16 to apply a compressive force to the three layers 12. , 14, 16 in relation of intimate contact with each other. As best seen in Figures 5A and 5B, the housing 60 substantially encapsulates the passage layer 12, the protein layer 14, and the absorbent layer 16, since they may preferably be assembled together, but not necessarily to form the sub-assembly. 50 combined test. The housing 60 may preferably include a top housing portion 10 and a bottom housing portion 18. The upper housing portion 10 and the lower housing portion 18 may preferably be, but not necessarily in contact relationship. intimate with the passage layer 12 and the absorbent layer 16 respectively. Preferably, the upper housing portion 10 and the passage layer 12 can be held together in aforementioned intimate contact relationship with the aid thereof or a different sealant (not shown) such as the one mentioned above, which sealant is substantially juxtaposed between them. . Also, the lower housing portion 18 and the absorbent layer 16 can preferably be held together in a above-mentioned intimate contact relationship with the aid thereof or even a different sealant (not shown) which juxtaposes substantially between them. As best seen in Figure 5B, the housing 60 may be further preferably provided with the housing edge portions 36 that are substantially contiguous with one or more peripheral edges of each of the upper and lower housing portions 10, 18. The receiving edge portion 36 in a preferred embodiment of the test system 70 can be fixedly coupled to the peripheral edge portions 34 of the combined test sub-assembly 50 (as shown in Figure 5B) and / or can couple the portions of peripheral edge of each of the layers 12, 14, 16 (as shown in Figures 2A, 2D and 3, and discussed in further detail below). The edge portion 36 of The housing may be constructed of the same or even a different sealant such as the one discussed above, including any of the alternative sealant materials, methodologies and / or forms mentioned above with reference to sub-assembly peripheral sealing 34, preferably to maintain the combined test sub-assembly 50 in intimate contact relationship with housing 60. As best seen in Figures 5A and 5B (and also as shown in Figures 2A, 2B, 2D and 3, where other preferred embodiments of the test system 70 are shown, as can be discussed in further detail below), the upper housing portion 10 is provided with a housing through aperture 20 which is defined by a corresponding internal edge 22 of the upper housing portion 10. The housing 60 is preferably constructed of substantially non-porous materials, meaning that they are preferably substantially impermeable, and / or of a non-absorbent and / or non-woven construction. All portions of the housing 60 are preferably constructed of materials that produce non-toxic byproducts in the incineration, to better ensure that the test system 70 can be disposed of in an environmentally responsible manner, such as, for example, by combustion. The paper is a preferred material which may be suitable for the construction of the housing 60. Other similar materials may also be used for the housing 60 according to the invention, and such materials could include cloth, nylon, silk and / or biodegradable membranes. Each of the upper and lower housing portions 10, 18 preferably, but not necessarily, be between about 0.1 and 3 millimeters thick, with an even more preferred thickness that is substantially in the range of between about 0.2 and 0.4 millimeters. Preferably, but not necessarily, the dimensions of a simple test system 70, adapted for testing a single liquid analyte sample will be substantially in the range of about 20 mm x 20 mm x 10 mm. As shown in Figure 5B, the upper housing portion 10 of the housing 60 preferably includes an outer surface portion 46 with labeling indicia 11 marked thereon. Preferably, labeling indicia 11 may be visible to the unaided eye, and may include sequentially numbered bar code indicia 13 and / or text indicia. In the modalities that do not include the housing 60, the labeling signs 60 can be marked alteratively or directly (not shown) in an outer surface portion of the passage layer 12. In any case, the labeling indicia 11 can be marked on the outer surface portion by way of printing, adhesion or being written. The sequentially numbered bar code indicia 13 may preferably, but not necessarily, be provided to allow tracking of each test system 70 and for other purposes, including, for example, quality control purposes. Similarly, text indicia 15 may include information and data about the immunodiagnostic test system 70 and its intended uses, such as, for example, the name of the intended test, expiration dates, instructions, storage conditions, instructions of elimination and / or similar. It will be further appreciated that the labeling indicia 11 may also consist of color coding (not shown) to identify each different type of specific test system 70. As best seen in Figure 5A, the test system 70 may be assembled preferably, but not necessarily, by inserting the combined test sub-assembly 50 into the hollow housing 60. The housing opening 20 may preferably be in a substantially vertical register with the underlying opening 24 in the passage layer 12. The housing 60 can more in front of preferably be sealed at each of the open ends with the housing edge portion 36. As mentioned, the material from which the receiving edge portion 36 is formed may or may not be the same sealing material as that used for the peripheral sub-assembly seal 34. In the aforementioned manner, the disposable immunodiagnostic test system 70 (as best seen in Figure 5B) may preferably, but not necessarily be completely assembled. Figures 2A to 4E represent alternate preferred embodiments of the test system 70 where, as in the case with all the drawings, similar reference numbers have been used to indicate similar elements of the present invention, where possible, in the various views for ease of reference. The embodiment of the test system 70 shown in Figures 2A, 2B, 2C and 3 is in a greater sense identical to that which has been discussed above, except that the upper and lower housing layers 10, 18 each consist of substantially flat and substantially more discrete layer portions than the same pillow-shaped embodiment shown in Figures 5A and 5B. You will appreciate all of the above, and how better observes in Figure 2B, that the housing opening 20 is substantially aligned with the passage layer opening 24 (as generally indicated by the imaginary "B" lines in Figure 2B). As best seen in Figure 2C, the upper surface of the protein layer 14 may preferably, but not necessarily, be formed to define a concave portion 58 that is substantially adjacent to, and substantially aligned with, the internal edges 22, 26 of the upper housing portion 10 and passage layer 12. With reference to Figures 2D to 2F, an alternative preferred embodiment of the test system 70 is shown, wherein the passage layer 12 is provided with first openings 24a, second openings 24b and a control through opening 24c. As best seen in Figure 2F, an upper surface of the passage layer 12 may preferably, but not necessarily be formed to define a concave portion 56 that is substantially adjacent to, and substantially aligned with, the inner edge 22 of the portion 10. of superior accommodation. According to still other preferred embodiments of the invention, which are shown in Figures 6 and 7 of the drawings, the test system 70 for disposable immunodiagnosis can be provided in a Multiple test format. In such embodiments, individual test systems 70 may be disposed in removably connected and / or frangible relationship side by side by means of tear-away receiving holes 38 that may be pulled off by an end user (not shown), who could determine the number of systems 70. of proof that are required for any particular or intended use. The individual test systems 70 shown in Figure 6 may each correspond substantially to those shown elsewhere in Figures 2A to 4E. Similarly, the individual test systems 70 shown in Figure 7 may each correspond substantially with those shown in Figures 5A and 5B. As mentioned above, the various preferred embodiments of the test system 70 shown in the drawings are preferably adapted, but not necessarily to test for the presence of marker proteins in a liquid sample analyte (not shown). The liquid sample analyte is the sample that is intended to be tested by system 70, whose sample may or may not contain the requested marker proteins. That is, the liquid sample analyte is the substance or constituent that is tested or tested, and includes, for example, liquid sample matrices, sera, plasma, transpiration, urine samples and / or other aqueous extracts containing body substances in which the tissue cells are integrated and / or suspended. Other analytes that may preferably, but not necessarily, be capable of testing when using system 70 could include environmental samples, such as, for example, groundwater samples. Accordingly, the test system 70 can preferably be adapted to test the presence of marker proteins from a broad class, including those of a biological, agricultural, veterinary and / or environmental origin. By way of example, in an agricultural application, the system 70 can be used, together with extracts of aqueous plants or leaves, to detect the presence of various diseases in banana plants, such as, for example, the leaf mosaic virus. of plantain (a common disease of the banana plant in areas such as India, the Philippines and Sri Lanka), and / or the abaca mosaic virus (a common disease of the banana plant in the Philippines). Similarly, in a veterinary environment, the system 70 can be used to detect the presence of various diseases in animals and / or domestic pets, such as dogs or cats. For example, system 70 could be used to detect the presence of disease of canine parasites and / or other diseases, such as, for example, leishmaniasis, parvoviral infections, and / or Lyme disease. By way of yet another example, the system 70 may preferably, but not necessarily, also be used to detect the presence of various environmental contaminants, such as, for example, gasoline additives such as tertiary methylbutyl ether. In the case of such gasoline additives, and although they can normally be used to benefit air quality by reducing automobile emissions, they can also problematically find their way to groundwater supplies that can ultimately be used for human consumption. By way of yet another example, the test system 70 can also be used to detect the presence of various diseases common to humans that can be caused by any number of pathogens. For example, the test system 70 of the present invention may be capable of being used to simultaneously detect the presence of causative agents associated with a number of diseases, such as cardiovascular diseases. In the case of cardiovascular diseases, the causative agents may include a large number of different pathogens, such as, for example, agents of viral, fungal and / or bacterial origin.

In such a test, system 70 could also be used to test the presence of antibodies for markers of healthy cells, such as, for example, the protein myosin which is found in cardiac muscles, and / or to any causative agents listed therein. The particular applications of the test system 70 which are discussed herein are merely intended to serve as examples of the test capabilities of the invention, and are not intended to limit the potential applications of the test system 70 and its varied uses together with several liquid sample analytes. Operationally, the protein layer 14 of the test device 70 will preferably have combinable proteins (not shown) attached to and / or immobilized substantially therein. Within the scope of the invention, the combinable proteins can adhere to a surface of the protein layer 14 and / or could be substantially integrated in the present. In fact, a wide variety of different ways of binding and / or annexing the combinable proteins to the protein layer 14 will preferably fall within the scope of the invention. The combinable proteins that are operably linked to the protein layer 14 of the test system 70 can preferably be selected specifically to correspond to the test being conducted and / or to ensure binding with the requested marker proteins that may be present in the analyte demonstrates particular liquid to be tested. For example, and without limitation, if the test system 70 is intended to test for the presence of HIV 1, then combinable proteins that are particularly well adapted to bind HIV 1 and / or their marker proteins could be substantially immobilized in the layer 14. protein Similarly, if the test system 70 is to be used to test Hepatitis C, then the combinable proteins that adapt particularly well to bind with Hepatitis C and / or its marker proteins could be substantially immobilized in the protein layer 14. As stated above, the test system 70 may preferably, but not necessarily be used to simultaneously detect the presence of causative agents for a wide number of diseases, including for example, agents of viral, fungal and / or bacterial origin, with proteins corresponding combivables immobilized in the protein layer 14 in such cases. That is, the combinable proteins may comprise proteins which are adapted to bind to fungal marker proteins, viral marker proteins, bacterial marker proteins and / or marker proteins induced by vector, as may be present in the tested liquid sample analyte. It can be seen that the protein layer 14 is a "reaction zone" of the test system 70. In an operational configuration according to the invention, the combinable proteins will be immobilized preferably substantially in the protein layer 14, and more preferably in the active surface area 30 and the visible portion 31 of the protein layer 14. According to the invention, the nitrocellulose or other protein layer 14 of the test system 70 can be provided preferably to the end user (not shown) with the combinable proteins already substantially immobilized therein. Alternatively, the combinable proteins can also be immobilized preferably in the protein layer 14 at or near the test time. In any case, and as mentioned above, the combinable proteins will preferably be those to which the requested marker proteins, if present in the tested sample liquid sample analyte, will fix such adhesion or binding. It is contemplated, although not essential to the operation of the system 70, that the combinable proteins can be immobilized preferably directly on the protein layer 14 in the vicinity of the active surface area 30, and more preferably in the visible portion 31 of the active surface area 30. The combinable proteins can be immobilized in the visible portion 31 of the active surface area 30 in any desired pattern, shape or design, even after the test system 70 has been fully assembled. For example, and without limitation, after assembly of the test system 70, combinable HIV 1 proteins could be immobilized preferably in the active surface area 30 in the visually discernible form of a "1" number (not shown), and Likewise proteins combinable with Hepatitis C could preferably be immobilized in them in the form of the letter "C". Of course, any other format could be used to satisfy the user and / or manufacturer of the test system 70. According to the invention, the combinable proteins can be substantially immobilized in the protein layer 14 by applying and / or depositing a combinable protein solution (not shown) on the active surface area 30 of the protein layer 14, such as, for example, ink jet spray, physically using a pipette, and / or touching the combinable protein solution over the designated area of the nitrocellulose membrane or other protein layer, so that the Combinable proteins could then be absorbed on the protein layer 14 by suction and / or capillary action. It should be appreciated therefore that, prior to the test, when the test system 70 is assembled in the operational configuration, combinable proteins for the detection of a plurality of different marker proteins in the liquid sample analyte can be selected and / or immobilized. preferably in any useful pattern in the protein layer 14, substantially in the region of the active surface area. With the combinable proteins substantially immobilized to the active surface area of the protein layer 14, the marker proteins (not shown) in the liquid sample analyte can be allowed, in some of the contemplated uses discussed below, to become substantially immobilized with relation to the protein layer 14. As best seen in Figures 4A and 4B, the active surface area 30 is preferably visible, by the user, through the housing opening 20 and the opening 24 in the through layer. In the embodiment shown in Figures 4A and 4b, the active surface area 30 includes a first test surface area 32 and a procedural control surface area 28. In the operational configuration, the combinable proteins immobilized in the protein layer 14 are substantially immobilized in the first test surface area 32. The process control surface area 28 is adapted to display a control reading in both a positive result configuration (as shown in Figures 4A and 4B) and in a negative result configuration (not shown) of the test system 70, to confirm preferably that it has been used, maneuvered and / or stored properly. More specifically, and as best seen in Figures 4A and 4B, if the test system 70 has been used, maneuvered and stored appropriately, a control reading can preferably be generated in and deployed from the procedural control surface area 28. The control reading may preferably, but not necessarily, take the form of a color or other indication that may correspond to a pattern of the combinable proteins that are operatively immobilized in the active surface area 30 of the protein layer 14, as discussed previously. The absence of a control reading in the procedural control surface area 28 could indicate that any test performed using the system 70 can be invalidated. It should be appreciated that, although the area 28 of procedural control surface does not need, strictly speaking, being present in the test system 70 according to the invention is preferably presented. If a simple type of qualitative marker protein test is to be performed using the system 70, the control surface area 28 may preferably, but not necessarily, be disposed in relation to the first test surface area 32 in the manner described in FIG. Figure 4A. Alternatively, if a quantitative marker protein test is to be performed using the system 70, the procedural control surface area 28 may preferably, but not necessarily, be located in a substantially central location of the active surface area 30, as shown in FIG. Figure 4B. In Figure 4B, the active surface area 30 may preferably comprise a first additional test surface area 32a. The same combinable proteins are preferably operatively immobilized both in the first test surface area 32 and in the first additional test surface area 32a, although preferably, but not necessarily, different concentrations. For example, a substantially higher concentration of combinable proteins can be substantially immobilized in the first additional test area 32a relative to a concentration of the combinable proteins in the first area 32 of test surface. Also, and as best seen in Figure 4C, if the user wishes to test the presence of multiple marker proteins in substantially the same time using a simple system 70, the procedural control surface area 28 may preferably, but not necessarily , located in a substantially central location of the active surface area 30. As shown in Figure 4C, the active surface area 30 may further include a second test surface area 33, with a second set of different combinable proteins (not shown) operatively immobilized therein. The second set of combinable proteins can be selected and / or preferably adapted to detect the presence of different marker proteins than those of the (first set of) combinable proteins. Likewise, the second set of combinable proteins can be immobilized in any useful pattern in the protein layer 14. In addition to the first test surface area 32, the first test surface area 32a, and the second test surface area 33, and as shown in Figure 4C, the active surface area 30 may also include a second 33rd test surface additional. The same combinable proteins are preferably operatively immobilized both in the second test surface area 33 and in the second additional test surface area 33a, although preferably, although not necessarily, different concentrations. For example, a substantially high concentration of combinable proteins can be substantially immobilized in the second additional test area 33a relative to a concentration of the combinable proteins in the second test surface area 33. As best seen in Figure 4C, the first test surface area 32 and the first test surface area 32a may preferably, but not necessarily, theoretically define a first substantially planar test ring 40 together. Each first test surface area 32 and first test surface area 32a preferably, but not necessarily, are theoretically located therein. In such a configuration, the procedural control surface area 28 may preferably, but not necessarily, be substantially circumscribed within the first test ring 40. The second test surface area 33 and the second test surface area 33a may also preferably, but not necessarily, define together theoretically a second substantially flat test ring 42. Each second test surface area 33 and second additional test surface area 33a are preferably placed, but not necessarily, within it. In such embodiments, and as best seen in Figure 4C, the second test ring 42 may, but not necessarily, substantially circumscribe the first test ring 40. Alternatively, the first test surface area 32, the first additional test surface area 32a, the second test surface area 33, the second additional test surface area 33a and the procedural control surface area 28 may define together theoretically several configurations, such as for example, several other concentric and / or non-concentric geometric shapes. Of course, other geometric shapes may be formed, which may for example, comprise deferring a multiple number of concentric shapes. In another contemplated embodiment of the invention, the first and / or second test surface areas 32 and 33 may consist of mimic surface areas. More specifically, the combinable proteins substantially immobilized in the first and / or second test surface areas 32, 33 can be native proteins that are biosynthesizable by substantially healthy cells in the liquid sample analyte and / or a species that supplies it. The modality of the test system 70 shown in Figures 4D and 4E is perhaps meriting some additional explanation. In this embodiment, and as mentioned above (ie, generally corresponding to the discussion of Figures 2D to 2F above), the passage layer 12 is formed with first and second openings 24a, 24b and a control opening 24c through the same. As can best be appreciated from a consideration of Figures 2E and 4E, the first openings 24a substantially align "A" with the first test ring 40, the second openings 24b substantially align with the second test ring 42, and the control aperture 24c is substantially aligned with the procedural control surface area 28 in the protein layer 14. The use of the test system 70 will be described with reference to the various embodiments which are depicted in the drawings. It should, however, be appreciated, that the following discussion of use may also preferably, but not necessarily, generally apply to other modalities which are not illustrated, but which fall within the scope of the invention. In a typical test, and before applying and / or testing the liquid sample analyte, a first drop of wash buffer is preferably added to the test system 70 through the housing opening 20 of the upper housing portion 10, to wet the visible portion 31 of the surface area 30 active in the protein layer 14 and allowed to adsorb. The wash buffer will preferably act, but not necessarily as a blocker for any areas in the active surface area 30 where combinable proteins have not been immobilized, to provide an inactive protein wash binding area 44 (as observed in FIG. , for example, Figure 4A and 4B), thus avoiding preferably the indiscriminate annexation of the marker and / or other proteins of the liquid sample analyte therein. The liquid sample analyte can then preferably be introduced, using a pipette or the like, through the housing opening 20 of the test system 70. The housing opening 20 is in operative fluid communication with the passage layer opening 24, so that the liquid sample analyte can preferably be deposited on the active surface area 30 of the protein layer 14 through at least one opening 24 of layer 12 of passage. The liquid sample analyte can be operatively introduced through the housing opening 20 in an amount that is preference, although not necessarily sufficient to cover the visible portion. As mentioned above, the test system 70 of the present invention tests for the presence of marker proteins in the liquid sample analyte. In a configuration of positive results, and as best shown in Figures 4A to 4E, the use of the test system 70 will preferably reveal that the requested marker proteins actually occur in the liquid sample analyte. In the configuration of positive results, one or more marker proteins from the liquid sample analyte will preferably bind to the combinable proteins and will be immobilized substantially relative to the active surface area of the protein layer 14. In the case where the analyte contains both first and second requested marker proteins, and in the additional case that the active surface area 30 includes both first and second test area areas 32, 33, the first and second areas 32, 33 of test surface may preferably have the first and second marker proteins respectively linked thereto in the configuration of positive results. In the case where, as mentioned above, combinable proteins comprise native proteins substantially immobilized in the mimic surface area, in the configuration of positive results, the marker proteins can preferably bind to the native proteins and be immobilized substantially in relation to the protein layer. In contrast, in a configuration of negative results, the use of the test system 70 will not preferably reveal the presence of any of the marker proteins in the liquid sample analyte. In the configuration of negative results (not shown), at least a portion and preferably most and / or substantially all of the liquid sample analyte, will pass substantially through the protein layer 14, without binding to any of the immobilized combinable proteins. in the same. In any case, and either due in part to gravity or under the influence of another force (such as, for example, inert forces which can be created in a centrifuge), a portion of the liquid sample analyte can preferably be run through substantially vertical form through the test system 70, and / or through the protein layer 14, away from its entry point. Preferably, a sufficient amount of the liquid sample analyte will be introduced onto the protein layer 14 to ensure that any proteins requested markers which may be contained therein will be immobilized substantially in relation to the protein layer 14 (in a positive result configuration) or not (in a negative result configuration). The above-mentioned substantially porous structure of the protein layer 14 preferably allows a portion of the liquid sample analyte to pass therethrough. In the case of liquid sample analytes containing particulate matter (such as whole blood), which are lipemic, and / or which may require further clarification or amplification, they may not leak through porous sizes smaller than about 5 to 6 microns. in the protein layer 14, such liquid sample analytes may preferably, but not necessarily, be clarified and / or split before the test. Liquid sample analytes that can be tested without clarification and / or additional amplification may preferably include, for example, serum, plasma, urine, perspiration and / or exudates. Other aqueous extracts that can be clarified preferably by filtration and / or centrifugation can also form a part of the analyte which is tested using the test system 70. Later, a drop or other necessary amount of a reagent may be added, in one preferred amount covering the visible portion 31 of the active surface area 30. The reagent is selected in particular and / or adapted to operatively bind to any marker proteins that may have been substantially immobilized relative to the protein layer 14 in the configuration of positive results. In one embodiment of the invention, the reagent (not shown) may preferably comprise a visually labeled substance which, when specifically bound to any binding proteins fixed to the combinable protein that are immobilized in the protein layer 14, provides color clues that indicate and / or confirm that the test system 70 is in the configuration of positive results. The visually labeled substance (not shown) may comprise any one or more of a variety of substances, such as, for example, a radioactive isotope substance, a fluorescent substance, a UV-absorbing substance, and / or a colored substance. Visually colored colored substances may consist of a colloidal gold conjugate substance, a dyed latex counting substance and / or the like. Preferably, for analytes in amounts of nanogram to femtogram, amplifications by enzymatic conjugates may be necessary. The situations where amplifications by enzyme conjugates may be preferable, could include, for example, detection of IgE in allergy diagnosis, and / or detection for drug abuse, industrial and environmental contaminants, plant diseases, hormones, cancer markers, arthritis markers and / or similar. In the case where these and / or other amounts of analytes are to be used, the aforementioned reagent may comprise a protein enzyme conjugate substance (not shown). As with the other reagents used according to the invention, the protein enzyme conjugate is selected and / or adapted particularly to be operably linked to any proteins that may have been immobilized substantially relative to the protein layer 14 in the configuration of positive results. . At that point, an additional drop of the same or different wash buffer can then be added preferably to the active surface area 30 for preferably, but not necessarily to clean any unbound material with water. At this point, the wash buffer can be allowed to adsorb on the protein layer 14. In situations where the aforementioned reagent comprises an enzyme conjugated substance protein, an enzyme substrate substance (not shown) can then be added preferably. Later, the user will wait for an appropriate period of time to pass, possibly in the order of approximately 10 to 60 seconds, during which period the enzyme substrate substance will produce an opportunity to operatively bind to the protein enzyme conjugate in the configuration of results positive The protein enzyme conjugate substance and the enzyme substrate substance are selected together and / or adapted to operatively display color indicia indicating and / or confirming that the test system 70 is in the configuration of positive results. In this embodiment of the test system 70 ', an additional drop of the wash buffer can then be added preferably through the housing opening 20, and it is allowed to cross substantially vertically away from its point of entry into the system 70 of test and through multiple layers of the test system, as mentioned above, before the results are read. All materials, possibly including any excess marker proteins, which do not become immobilized relative to the protein layer 14 by annexation (eg, by adhesion or binding) to the combinable proteins that are already immobilized therein can be preferably, but not necessarily, crossing through the protein layer 14 that is finally captured, trapped and / or absorbed by the absorbent layer 16. Additional drops of wash buffer may be later required and / or preferably applied to clean the background of the visible portion 31 of the protein layer 14 to provide more unambiguous test result readings. To recapitulate, and generally speaking, a liquid sample analyte (not shown) can be introduced preferably over the protein layer 14 through at least one opening 24 the passage layer 12 of the combined test sub-assembly 50. Either under the influence of gravity or some other force, the liquid sample analyte passes through the protein layer 15 and subsequently into the absorbent layer 16. After the test system 70 for disposable immunodiagnosis has been used, it may preferably be allowed to dry, after being disposed of in an ecologically responsible manner, such as, for example, by incineration. It is generally thought, although not essential to the basic operation of the test system 70, that the denser and more impermeable the passage layer 12, the lower the probability of lateral diffusion of sample analytes. added liquids. When the test system 70 is assembled, with the housing opening 24 substantially aligned "B" with the passage layer 12, the liquid sample analyte is allowed, in use to cross through the test system 70. Although not essential to the invention, it is believed that the upper housing portion 10, the layers 12, 14, 16 and / or the lower housing portion 18 of the test system 70 should preferably be assembled in close contact with each other, and / or in non-loose fitting relationship, to provide the test system 70 with improved integrity. It is further believed, although not essential to the invention, that the test system 70 can operate effectively as long as the assembled layers are placed in sufficient intimate contact ratio to cause the liquid sample analyte to aggregate to cross far from its point of entry. in the test system 70 and vertically substantially between them, under the influence of gravity and / or other similar force. It is also generally thought, although not essential to the basic operation of the test system 70, that an intimate contact relationship of the various layers 10, 12, 14, 16, 18, and the use of interstitial and / or peripheral sealing allows the liquid sample analyte to cross substantially vertically away from its point of entry, and / or crossing one or more layers 12, 14, 16 of the test system 70, with any excess that is preferably absorbed by the absorbent layer 16. The substantially contemporaneous test of a single liquid sample analyte for the presence of multiple marker proteins, using a simple test system 70, can offer remarkable advantages. These advantages may preferably include a faster total administration time, and a lower cost of materials, when compared to the corresponding administration of four or a similar number of separate tests that may otherwise be required in multiple test systems, together with corresponding controls. The use of the test system 70 will preferably be simple to use and quick to administer and to provide fast and highly accurate and effective test results, without requiring the acquisition of additional specialized equipment or the additional training of highly qualified test personnel. As mentioned above, their use also preferably allows a simple analyte sample to be tested on a substantially contemporaneous basis for the presence of any of a plurality of causative agents. The test system 70 can preferably be used in a clinical environment, at the point of care, and / or in the field. In fact, the test system 70 can be manufactured and / or assembled preferably in the field and / or in the industrial facility that is specifically intended for that purpose, and as such, preferably also involves lower production and packing costs. The test system 70 is preferably selectively adaptable to provide qualitative and / or quantitative results, depending on the preferences and / or the nature of the user of the test being conducted. In addition to all of the above, the test system 70 can easily be disposed of preferably in a simple, ecologically responsible manner, such as, for example, by incineration during outdoor fire. As mentioned above, the test system 70 can be selectively adaptable to detect viral, fungal, bacterial and / or vector-induced infections. Finally, the test system 70 preferably provides visually discernible test results and / or results within a relatively short period of time. Of course, other modifications and alterations can be used for the design and manufacture of modalities according to the test system 70 for disposable immunodiagnosis without departing from the spirit and scope of the invention. For example, and without limitation, the housing 60 and / or the various layers 12, 14, 16 of the test system 70 can be configured in various geometric shapes, such as, for example, in square, rectangular, circular and / or spherical shapes. Similarly, the test system 70 can be provided with a plurality of test surface areas (not shown) away from the first and second test areas 32, 33 which are described above. In such embodiments, the visible portion 31 of the active surface area 30 could further comprise a plurality of additional surface areas which can, in combination, also be configured in various geometric shapes. In addition, although upper step surfaces and protein layers 12, 14 can be formed to define their respective concave portions 56, 58, the passage and the protein layers 12, 14 can each define respective convex portions, or otherwise as well. In addition, the labeling mark 11 may be marked on the upper housing portion 10 or the passage layer 12 in a manner that is not restricted for printing, adhering or writing thereto. Furthermore, although the above description only describes the presence of a housing opening 20, multiple respective housing openings (not shown) can be presented for each test system 70. In addition, the units of the disposable immunodiagnostic test system may be arranged in "multiple packs" or in any other removably connected or frangible relationship that may be desired by the end user (i.e., except in the removably connected relationship format, side by side , representative shown in Figures 6 and 7). Similarly, the disposable immunodiagnostic test system 70 can be assembled without an upper housing portion 10, and in such embodiments, would comprise at least the passage layer 12 (possibly with certain labeling indicia 11 marked on its outer surface), the protein layer 14, the absorbent layer 16, the lower housing portion 18, and the housing side portions 36. Also, only the lower housing portion 18 can be removed, so that the disposable immunodiagnostic test system 70 would then comprise at least the upper housing portion 10, the passage layer 12 (assuring that the housing opening 20 aligns in substantial vertical register with the opening 24 in the passage layer 12), the protein layer 14, the absorbent layer 16, and the housing portions 36.

In addition, although the test system 70 may sometimes have been described in the foregoing, as a rapid test test in a direct flow format, it may be constructed in its place in a lateral flow format as well. The test systems 70 discussed above are preferably discarded and profitable immunodiagnostic test systems that are usable for the detection of one or more marker proteins in an analyte or liquid sample matrix. Since the present invention can be used to test multiple marker proteins in a single test, as it can be preferably administered through the use of a single liquid sample analyte, there is preferably a reduced waiting time before the results can be obtained. Although the present invention is contemplated to be used primarily as an immunodiagnostic system, it may also be manufactured for use in the detection of various marker proteins and other such proteins as may be present in tissue culture fluids, plant extracts, seed extracts, extracts of soil and / or water and other aqueous extracts. As mentioned above, the test system 70 for disposable immunodiagnosis according to the The present invention can preferably be disposed of in an ecologically responsible and inexpensive manner such as, for example, by incineration or combustion in an open fire. The test system 70 for disposable immunodiagnosis may preferably have lower production and disposal costs associated with it, compared to other analyte test devices that may be currently available.

Claims

NOVELTY OF THE INVENTION Having described the present invention, it is considered as a novelty and therefore the property described in the following claims is claimed as property. CLAIMS 1. A test system for disposable nodiagnostics to test the presence of marker proteins in a liquid sample analyte, the test system is characterized in that it comprises: a) a substantially flat passage layer comprising a first material having a structure substantially non-porous which is formed to define at least one through opening; b) a protein layer comprising a second material that is adapted to allow in an operative configuration, the substantial bilization of proteins combined therein, with the protein layer having a substantially porous structure that allows a portion of the liquid sample analyte to be passes substantially through it, and with the protein layer in intimate contact with the passage layer to define an active surface area in the protein layer that is substantially adjacent to, and substantially aligned with, the opening of the pass layer; Y c) an absorbent layer comprised of a third material that allows the absorption of at least a portion of the liquid sample analyte, with the absorbent layer in intimate contact with the protein layer; wherein, in the operative configuration, the combinable proteins are substantially bilized in the protein layer as mentioned above, and the liquid sample analyte is introduced onto the protein layer through at least one opening of the passage layer, so that in a configuration of positive results, the marker proteins bind to the combinable proteins and are bilized substantially in relation to the protein layer, and so that in a configuration of negative results, at least a portion of the liquid sample analyte passes substantially through the protein layer. The test system according to claim 1, characterized in that the first material, the second material and the third material are constructed of at least one combustible material that produces non-toxic by-products in the incineration. 3. The test system according to claim 2, characterized in that it also comprises a reagent, wherein, in the configuration of positive results, the reagent is operatively linked to the labeling proteins that are substantially bilized in relation to the "protein layer" 4. The test system according to claim 3, characterized in that the reagent comprises a visually labeled substance that operatively provides a color clue to the configuration of positive results. The test system according to claim 4, characterized in that the visually labeled substance comprises dyed latex beads 6. The test system according to claim 4, characterized in that the visually labeled substance comprises a conjugated substance of gold The test system according to claim 4, characterized in that the visually labeled substance comprises a colloidal carbon conjugate 8. The test system according to claim 3, characterized in that the reagent comprises a conjugated substance of protein enzyme , with the test system further comprises an enzyme substrate substance which is operatively linked to the conjugate substance of the protein enzyme in the configuration of positive results. 9. The test system according to claim 8, characterized in that the configuration of positive results, the enzyme substrate substance operationally displays a color clue. The test system according to claim 2, characterized in that at least a visible portion of the active surface area is visible through the opening of the through layer. 11. The test system according to claim 10, characterized in that the configuration of positive results, a portion of the liquid sample analyte passes substantially through the protein layer. The test system according to claim 10, characterized in that it further comprises at least one sealant substantially juxtaposed between the passage layer and the protein layer, and between the protein layer and the absorbent layer. The test system according to claim 10, characterized in that the visible portion of the active surface area comprises a first test surface area.; and wherein the operational configuration, the combinable proteins are substantially immobilized in the first test surface area. 14. The test system according to claim 13, characterized in that the visible portion of the active surface area further comprises a procedural control surface area; and wherein the procedural control surface area is adapted to display a control reading both in the configuration of positive results and in the configuration of negative results to operatively confirm that the test system has been used properly. The test system according to claim 14, characterized in that the procedural control surface area is further adapted to operatively confirm that the test system has been properly maneuvered and stored. 16. The test system according to claim 14, characterized in that the passage layer is substantially between about 0.2 mm and about 10 mm thick. The test system according to claim 16, characterized in that the passage layer is substantially between approximately 2 mm and approximately 4 mm thick. The test system according to claim 14, characterized in that the first material comprises a densely packed paper material. 19. The test system according to claim 18, characterized in that the material of Paper is a cardboard material. 20. The test system according to claim 14, characterized in that the first material comprises a tree bark material. 21. The test system according to claim 14, characterized in that the first material comprises a packed sheet material. 22. The test system according to claim 14, characterized in that the protein layer is substantially no greater than about 5 mm thick. 23. The test system according to claim 22, characterized in that the protein layer is substantially between about 0.5 mm and about 2 mm thick. 24. The test system according to claim 14, characterized in that the second material is formed to define pores therebetween, with each of the pores having a pore diameter substantially between about 0.1 microns and about 25 microns. 25. The test system according to claim 24, characterized in that the pore diameter is substantially between about 0.4 microns and about 2.0 microns. 26. The test system in accordance with the claim 14, characterized in that the second material comprises a nitrocellulose material. 27. The test system according to claim 14, characterized in that the second material comprises an acetate material. 28. The test system according to claim 14, characterized in that the second material comprises a nylon material. 29. The test system according to claim 14, characterized in that the absorbent layer is substantially between about 1 mm and about 50 mm thick. 30. The test system according to claim 14, characterized in that the third material comprises a spongy material. 31. The test system according to claim 20, characterized in that the spongy material comprises a paper towel material. 32. The test system according to claim 30, characterized in that the spongy material comprises an acetate material. 33. The test system according to claim 14, characterized in that it comprises a housing substantially encapsulating the passage layer, the protein layer, and the absorbent layer, with a portion of lower housing housing that is in intimate contact with the absorbent layer and a housing portion of the housing that is in intimate contact with the passage layer, with the upper housing portion being formed to define at least one opening accommodation intern, with the housing opening substantially aligning in fluid operational communication relationship with at least one opening in the passage layer. 34. The test system according to claim 33, characterized in that the housing is constructed of at least one combustible material. 35. The test system according to claim 34, characterized in that the housing is comprised of a housing material having a substantially non-porous housing structure. 36. The test system according to claim 35, characterized in that each upper housing portion and the lower housing portion has a substantially non-porous housing structure. 37. The test system according to claim 33, characterized in that at least one sealant is juxtaposed substantially between the upper housing portion and the passage layer, and between the portion of lower housing and the absorbent layer. 38. The test system according to claim 33, characterized in that the visible portion of the active surface area is visible through the housing opening. 39. The test system according to claim 33, characterized in that at least one passage layer and the housing comprises an outer surface portion with at least one labeling mark marked therein. 40. The test system according to claim 39, characterized in that the housing comprises the outer surface portion. 41. The test system according to claim 40, characterized in that the outer surface portion is provided in the upper housing portion. 42. The test system according to claim 39, characterized in that the labeling indicia comprises a bar code indicia. 43. The test system according to claim 39, characterized in that the labeling indicia comprises a text indicium. 44. The test system according to claim 33, characterized in that the layer of The upper housing and the lower housing layer are each substantially between about 0.1 and about 3 mm thick. 45. The test system according to claim 44, characterized in that the upper receiving layer and the lower receiving layer are each between approximately 0.2 mm and approximately 0.4 mm thick. 46. The test system according to claim 13, characterized in that the combinable proteins comprise proteins adapted to bind to fungal marker proteins. 47. The test system according to claim 13, characterized in that the combinable proteins comprise proteins adapted to bind to viral marker proteins. 48. The test system according to claim 13, characterized in that the combinable proteins comprise adapted proteins that bind to bacterial marker proteins. 49. The test system according to claim 13, characterized in that the combinable proteins comprise adapted proteins that bind to vector-induced marker proteins. 50. The test system in accordance with the claim 13, characterized in that the combinable proteins comprise proteins adapted to bind to plant marker proteins. 51. The test system according to claim 14, characterized in that the visible portion of the active surface area comprises a first additional surface area; and wherein in operable configuration, the combinable proteins are substantially immobilized on each first test surface area and the first additional test surface area. 52. The test system according to claim 51, characterized in that a substantially high concentration of combinable proteins is substantially immobilized in the first additional test surface area relative to a concentration of combinable proteins of the first test surface area . 53. The test system according to claim 51, characterized in that the first test surface area and the first test surface area theoretically together define a first flat test ring, with each first test surface area and The first additional test surface area is theoretically located therein. 54. The test system in accordance with the claim 53, characterized in that the first test ring substantially circumscribes the procedural control surface area. 55. The test system according to claim 13, characterized in that the visible portion of the active surface area further comprises a second test surface area.; and wherein in the operational configuration, second combinable proteins are substantially immobilized in the second test surface area so that in the configuration of positive results, the marker proteins bind to second combinable proteins and are substantially immobilized relative to the protein layer. 56. The test system according to claim 55, characterized in that the visible portion of the active surface area further comprises a first additional test surface area and a second additional test surface area; and wherein in the operational configuration, the combinable proteins are immobilized substantially on each first test surface area and the first additional test surface area, and the second combinable proteins are substantially immobilized on each second test surface area and the second Additional test surface area. 57. The test system according to claim 56, characterized in that the first test surface area and the first additional test surface area theoretically together define a first substantially flat test ring, with each first test surface area and the first test surface area first additional test surface area theoretically located therein; wherein the second test surface area and the second additional test surface area together theoretically define a second substantially planar test ring, with each second test surface area and the second additional test surface area theoretically located within the test surface. same; and wherein the second test ring substantially circumscribes the first test ring. 58. The test system according to claim 55, characterized in that the second test surface area comprises a mimic surface area, wherein the second combinable proteins comprise native proteins biosynthesizable by substantially healthy cells in at least one sample analyte liquid and a species that builds it; wherein the operative configuration, the native proteins are immobilized substantially in mimic surface area, so that in the configuration of positive results, the marker proteins bind to native proteins and are immobilized substantially in relation to the protein layer. 59. The test system according to claim 33, characterized in that at least one opening of the passage layer comprises at least two openings, and wherein an upper surface of the passage layer is formed to define a substantially adjacent concave portion. at least two openings and substantially align with the housing opening. 60. The test system according to claim 14, characterized in that an upper surface of the protein layer is formed to define a concave portion, with the concave portion substantially adjacent to the visible portion of the active surface area and substantially aligned with opening of the passage layer.