WO2022035726A1

WO2022035726A1 - Systems and methods for a multi test strip utilization

Info

Publication number: WO2022035726A1
Application number: PCT/US2021/045148
Authority: WO
Inventors: David RABIDEAU; Kirk GOULET
Original assignee: Envirologix Inc.
Priority date: 2020-08-10
Filing date: 2021-08-09
Publication date: 2022-02-17
Also published as: AR123194A1

Abstract

The present invention features systems and methods suitable for coupling multiple test strips together within a single structure. The invention provides coupling multiple test strips in a configuration to facilitate rapid simultaneous testing for multiple different target agents, for example, simultaneously testing for multiple mycotoxins.

Description

SYSTEMS AND METHODS FOR A MULTI TEST STRIP UTILIZATION

CROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of the following U.S. Provisional Application No.: 63/063,572, filed August 10, 2020, the entire contents of which are incorporated herein by reference.

FIELD OF THE INVENTION

[0002] The present disclosure relates to systems and methods suitable for coupling multiple test strips together within a single structure. In particular, the present disclosure relates to systems and methods coupling multiple test strips in a configuration to facilitate rapid simultaneous testing for multiple different target agents, for example, simultaneously testing for multiple mycotoxins.

BACKGROUND

[0003] Generally, testing for in food sources is critical to ensure that food is safe for consumption by humans and/or animals. One example of food testing is testing for mycotoxins that may appear in the food chain through fungal infection of crops. Specifically, mycotoxins are toxic chemicals produced by fungi and molds that are especially threatening to grain and food crops. The adverse effects of mycotoxins on the health of animals and humans can range from acute poisoning to such long-term diseases as immune deficiency and even cancer. Mycotoxins’ ability to attach to mold spores, dust, or other flying particles allows them to appear anywhere within the agricultural products supply chain. Grain supplies are particularly susceptible, with contamination possible at any point between crop growth and grain storage.

[0004] Global changes to both climate and supply-chains are introducing new mycotoxins to both field and factory. These widely spread contaminants present an increased risk of toxicity not only on their own but through their biochemical interactions, which can greatly increase each mycotoxin’s toxicity. Such escalating factors have increased the risks associated with singlemycotoxin testing. Conventional protocols can miss the presence of untested toxins and also yield “safe” single readings well below the true toxicity that may be elevated by the interplay with other mycotoxins. SUMMARY

[0005] There is a need for improvements for providing simultaneous and consistent testing for multiple agents using test strips. For example, there is a specific need for quick and accurate testing of food for multiple different mycotoxins to ensure the healthy growth of humans, animals, and the grain-based businesses that support them. The present disclosure is directed toward further solutions to address this need, in addition to having other desirable characteristics. Specifically, the present disclosure provides systems and methods for rapid simultaneous testing of multiple different mycotoxins using an elongate structure designed to hold multiple test strips each designed to detect different mycotoxins.

[0006] In one aspect, the disclosure provides an apparatus for simultaneous testing for multiple agents within a sample. In some embodiments, the apparatus includes an elongate member with a first surface for receiving a plurality of test strips thereon; and at least one adhesive material designed for placement on the first surface and to adhere the plurality of test strips to the elongate member. In some embodiments, the surface includes a plurality of indicators for placement of the plurality of test strips. In some embodiments, the plurality of indicators includes spacing of about 14mm to 15mm between each of the plurality of test strips. In some embodiments, the elongate member is constructed from a polystyrene material or a paper material. In some embodiments, the at least one adhesive material is sized and shaped to overlap a proximal end of the plurality of test strips. In some embodiments, the elongate member is about 6mm to 10mm in width.

[0007] In another aspect, the disclosure provides an apparatus for simultaneous testing for multiple agents within a sample includes an elongate member with a plurality of recesses sized and shaped for receiving proximal portions of a plurality of test strips. In some embodiments, the elongate member includes: a first elongate member with a first plurality of recesses for receiving a first portion of the plurality of test strips; and a second elongate member with a second plurality of recesses for receiving a second portion of the plurality of test strips. In some embodiments, the first plurality of recesses includes a plurality of ridges extending a length of the first plurality of recesses; the second plurality of recesses includes a plurality of teeth positioned throughout the second plurality of recesses; and the plurality of ridges and plurality of teeth retain a proximal end of a test strip positioned within a combined first plurality of recesses and second plurality of recesses. In some embodiments, the plurality of recesses includes spacing of about 14mm to 15mm between each of the plurality of test strips positioned therein. In some embodiments, the elongate member is constructed from a paper material, metal material, plastic material, clear acrylic, polystyrene, or a combination thereof. In some embodiments, the elongate member is about 6mm to 10mm in width. In some embodiments, the plurality of test strips is 2, 3, 4, 5, 6, or more.

[0008] In yet another aspect, the present disclosure provides a system for simultaneous quantification of multiple agents within a sample. In some embodiments, the system includes any of the apparatus as disclosed herein; and a plurality of test strips each with a distal end and a proximal end, each of the plurality of test strips being designed to detect a different target agent. In some embodiments, the apparatus is coupled to proximal ends of each of the plurality of test strips extending substantially perpendicular to a length of the apparatus and substantially parallel to one another. In some embodiments, the plurality of test strips each include a reagent capable of specifically binding to the target agent. In some embodiments, the plurality of test strips each comprise a different bar code for quantifying the target agent detected by each of the plurality of test strips.

[0009] In some embodiments, the system further includes an electronic reader for scanning the bar code and quantifying agents detected by the plurality of test strips. In some embodiments, the system further includes an incubator comprising a plurality of openings to receive incubator tubes, each of the incubator tubes being designed for the insertion of a test sample and one of the plurality of test strips. In some embodiments, the plurality of test strips is 2, 3, 4, 5, 6, or more. In some embodiments, any of the systems as provided herein are for use in a method for simultaneous quantification of multiple mycotoxins within a sample.

[0010] In one aspect, the present disclosure provides a method for simultaneous quantification of multiple agents within a sample. In some embodiments, the method includes selecting any of the systems as provided herein; applying the system to the sample; and quantifying the target agents detected by the system.

[0011] In another aspect, the present disclosure provides a method for simultaneous quantification of multiple agents within a sample including selecting a plurality of test strips, wherein each of the plurality of test strips is capable of detecting a target agent; coupling each of the plurality of test strips to any of the apparatus as provided herein, wherein the apparatus is sized and dimensioned to receive and couple to proximal ends of each of the plurality of test strips; applying the plurality of test strips, using the apparatus, to the sample; and quantifying the target agents detected by each of the plurality of test strips.

[0012] In some embodiments, the method further includes inserting the apparatus coupled to the plurality of test strips or the system into an electronic reader device. In some embodiments, the plurality of test strips each contain a different bar code, wherein the electronic reader device is capable of reading the bar code to quantify the target agents in the sample. In some embodiments, the method further includes inserting the sample into a plurality incubator tubes; inserting, using the elongate member, each of the plurality of test strips into separate incubator tubes for a predetermined period of time; and removing, using the apparatus, the plurality of test strips from the incubator tubes. In some embodiments, the predetermined period of time is 3-5 minutes. In some embodiments, the plurality of test strips is 2, 3, 4, 5, 6, or more. [0013] In some embodiments, the agent is a genetically modified organism or a mycotoxin. In some embodiments, the agent is a mycotoxin selected from the group consisting of Aflatoxin, Vomitoxin, Fumonisin, Zearalenone, T-2/HT-2 Toxin, and Ochratoxin A. In some embodiments, the sample is an agricultural sample. In some embodiments, the agricultural sample is a plant or food. In some embodiments, the agricultural sample is selected from the group consisting of cereal grains, oil seeds, forages, and co- or by-products thereof. In some embodiments, forages are selected from the group consisting of com, wheat, barley, cottonseed, sorghum, sugarcane, peanuts, canola, feed inputs, finished feed, soybean, rice, oats, rye, milo2228, alfalfa. In some embodiments, the co- or by-products are selected from the group consisting of hay, corn meal, corn germ meal, corn gluten, distillers grains (DDG and DDGS), cottonseed meal, peanut meal, wheat bran and midds, flour, rice bran, and barley protein meal. [0014] The description and examples herein illustrate embodiments of the present disclosure in detail. It is to be understood that this disclosure is not limited to the particular embodiments described herein and as such can vary. Those of skill in the art will recognize that there are numerous variations and modifications of this disclosure, which are encompassed within its scope.

[0015] The practice of some embodiments disclosed herein employ, unless otherwise indicated, conventional techniques of immunology, biochemistry, chemistry, molecular biology, microbiology, cell biology, genomics and recombinant DNA, which are within the skill of the art. See for example Sambrook and Green, Molecular Cloning: A Laboratory Manual, 4th Edition (2012); the series Current Protocols in Molecular Biology (F. M. Ausubel, et al. eds.); the series Methods In Enzymology (Academic Press, Inc.), PCR 2: A Practical Approach (M.J. MacPherson, B.D. Hames and G.R. Taylor eds. (1995)), Harlow and Lane, eds. (1988) Antibodies, A Laboratory Manual, and Culture of Animal Cells: A Manual of Basic Technique and Specialized Applications, 6th Edition (R.I. Freshney, ed. (2010)).

[0016] Although various features of the present disclosure can be described in the context of a single embodiment, the features can also be provided separately or in any suitable combination. Conversely, although the present disclosure can be described herein in the context of separate embodiments for clarity, the present disclosure can also be implemented in a single embodiment. The section headings used herein are for organizational purposes only and are not to be construed as limiting the subject matter described.

[0017] The features of the present disclosure are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the disclosure are utilized, and in view of the accompanying drawings as described herein below.

DEFINITIONS

[0018] Unless defined otherwise, all technical and scientific terms used herein have the meaning commonly understood by a person of ordinary skill in the art to which this invention belongs. The following references provide one of skill with a general definition of many of the terms used in this invention: Singleton et al., Dictionary of Microbiology and Molecular Biology (2nd ed. 1994); The Cambridge Dictionary of Science and Technology (Walker ed., 1988); The Glossary of Genetics, 5th Ed., R. Rieger et al. (eds.), Springer Verlag (1991); and Hale & Marham, The Harper Collins Dictionary of Biology (1991). As used herein, the following terms have the meanings ascribed to them below, unless specified otherwise.

[0019] By “agent” is meant any small molecule chemical compound, antibody, nucleic acid molecule, or polypeptide, or fragments thereof. In some embodiments, an agent is a genetically modified organism (GMO). In some embodiments, an agent is a mycotoxin.

[0020] In this disclosure, “comprises,” “comprising,” “containing” and “having” and the like can have the meaning ascribed to them in U.S. Patent law and can mean “includes,” “including,” and the like; “consisting essentially of’ or “consists essentially” likewise has the meaning ascribed in U.S. Patent law and the term is open-ended, allowing for the presence of more than that which is recited so long as basic or novel characteristics of that which is recited is not changed by the presence of more than that which is recited, but excludes prior art embodiments.

[0021] “Detect” refers to identifying the presence, absence or amount of an analyte (e.g., mycotoxin) to be detected.

[0022] By “mycotoxin” is meant a toxic compound that is naturally produced by organisms of the fungus kingdom, including molds. Nonlimiting examples of mycotoxins include Aflatoxin, Vomitoxin, Fumonisin, Zearalenone, T-2/HT-2 Toxin, and Ochratoxin A. [0023] By “specifically binds” is meant a compound or antibody that recognizes and binds an agent, such as a mycotoxin, but which does not substantially recognize and bind other molecules in a sample, for example, an agricultural sample (e.g., plant or food (e.g., com, grain). [0024] Ranges provided herein are understood to be shorthand for all of the values within the range. For example, a range of 1 to 50 is understood to include any number, combination of numbers, or sub-range from the group consisting 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50.

[0025] Unless specifically stated or obvious from context, as used herein, the term “or” is understood to be inclusive. Unless specifically stated or obvious from context, as used herein, the terms “a”, “an”, and “the” are understood to be singular or plural.

[0026] Unless specifically stated or obvious from context, as used herein, the term “about” is understood as within a range of normal tolerance in the art, for example within 2 standard deviations of the mean. About can be understood as within 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, 0.5%, 0.1%, 0.05%, or 0.01% of the stated value. Unless otherwise clear from context, all numerical values provided herein are modified by the term about.

BRIEF DESCRIPTION OF THE FIGURES

[0027] These and other characteristics of the present disclosure will be more fully understood by reference to the following detailed description in conjunction with the attached drawings, in which:

[0028] FIG. 1 is an example illustration of a test strip in accordance with the present disclosure;

[0029] FIG. 2A is an example illustration of an elongate member in accordance with the present disclosure;

[0030] FIGS. 2B and 2C are example illustrations of an elongate member combined with a plurality of test strips in accordance with the present disclosure;

[0031] FIGS. 3 A-3H are example illustrations of an elongate member in accordance with the present disclosure;

[0032] FIG. 31 is an example illustration of an elongate member combined with a plurality of test strips in accordance with the present disclosure;

[0033] FIGS. 4A and 4B are example illustrations of a combined elongate member and a plurality of test strips inserted into incubation tubes in accordance with the present disclosure; and [0034] FIGS. 5A and 5B are example illustrations of a testing device for use with a combined elongate member and a plurality of test strips inserted in accordance with the present disclosure; and

[0035] FIG. 6 is an example flow chart for use of the elongate member in accordance with the present disclosure.

DETAILED DESCRIPTION

[0036] An illustrative embodiment of the present disclosure relates to systems and methods coupling multiple test strips in a configuration to facilitate rapid simultaneous testing for multiple different target agents, for example, simultaneously testing for multiple mycotoxins. Specifically, an elongate member designed to couple with multiple mycotoxin test strips can be used to provide fast time to results by using a common extraction and sample dilution protocol. Having the individual test strips coupled to the elongate member provides a common structure that simplifies handling of multiple test strips to assist in speeding up testing. The combination of the elongate member with the plurality of test strips can be transported to an incubation system, and then to an electronic reader/scanning device to quantify any interactions experiences in the incubation system. Having multiple test strips on a single elongate member can also enable the scanning device to simultaneously capture data for each of the included test strips.

[0037] In one embodiment, the systems and methods of the present disclosure can be used for simplified and rapid on-site testing for agents (e.g., GMOs, mycotoxins) in agricultural products. Agricultural products include plant and food products and co- or by- products. Nonlimiting examples include (i) cereal grains, oil seeds, and forages (such as but not limited to com, wheat, barley, cottonseed, sorghum, sugarcane, peanuts, canola, feed inputs, finished feed, soybean, rice, oats, rye, milo, alfalfa); (ii) co- or by-products derived from the foregoing (such as hay, corn meal, com germ meal, corn gluten, distillers grains (DDG and DDGS), cottonseed meal, peanut meal, wheat bran and midds, flour, rice bran, barley protein meal); and (iii) other similar milled grains that are used as raw agriculture inputs.. Use of the present disclosure enables a combination of accuracy, speed, and protocol simplicity for testing multiple agents(e.g., GMOs, mycotoxins). Agents for testing using the systems and methods provided herein include genetically modified organisms and mycotoxins. Nonlimiting examples of mycotoxins include Aflatoxin, Vomitoxin, Fumonisin, Zearalenone, T-2/HT-2 Toxin, and Ochratoxin A.

[0038] The present disclosure provides an elongate member that enables multiple different test strips to be combined for use during a single test process for certain agent testing, such as mycotoxin testing (e.g., Aflatoxin, Vomitoxin, Fumonisin, Zearalenone, T-2/HT-2 Toxin, Ochratoxin A). For example, the elongate member of the present disclosure in combination with different test strips is particularly advantageous where the same protocol may be used to test for mycotoxins in agricultural products, such as grain or corn. By combining test strips designed for screening for multiple mycotoxins, the present disclosure reduces time and minimizes chances for operator error. The elongate member, having a plurality of test strips coupled thereto, can be inserted into an electronic reader all at once so that results can be captured in data logs and provided in reports for data recordation and source traceability. In some embodiments, the plurality of test strips include a unique bar code that does not interfere with the elongate member or the portion of the strip in contact with a sample. In some embodiments, the unique bar code is read by the electronic reader to log the test results and agent quantification data. Simplifying such test data can have additional benefits, for example, by testing for multiple mycotoxins and utilizing the trend analysis function, the electronic reader can provide data that enable a user to make informed decisions on what toxins to test for based on regional risks and what suppliers to closely monitor based on historical delivery quality. Toxin trends can be charted by type and supplier using the data management capabilities of the electronic reader. Additionally, by assessing total mycotoxin quality upstream and early in the harvest, the testing plan for the remainder of the harvest can be optimized to minimize the cost of testing while lowering the risk of sourcing unsuitable com. Additional benefits of the present disclosure include easier manufacturability, simpler assembly and simpler inventory management and thereby reducing production costs and production speeds. The elongate member of the present disclosure in combination with different test strips provides a lean, flexible and customizable way to produce single strips or combs in any combination and permutation without the need of creating more work-in-progress components.

[0039] FIGS. 1 through 6, wherein like parts are designated by like reference numerals throughout, illustrate an example embodiment or embodiments of improved operation for using test strips for detecting mycotoxins in agricultural products, such as plant and food products, according to the present disclosure. Although the present disclosure will be described with reference to the example embodiment or embodiments illustrated in the figures, it should be understood that many alternative forms can embody the present disclosure. One of skill in the art will additionally appreciate different ways to alter the parameters of the embodiment(s) disclosed, such as the size, shape, or type of elements or materials, in a manner still in keeping with the spirit and scope of the present disclosure. [0040] Referring to FIG. 1, in some embodiments, testing can be performed using one or more specialized test strips 100. The testing strips 100 can be designed for quick testing of target agent(s) (e.g., GMO, mycotoxin) in a sample (e.g., agricultural sample (e.g., grain, corn). The test strips 100 can include any combination of test strips known in the art. For example, the test strips 100 can be the test strips discussed with respect to U.S. Patent No. 8,824,800, incorporated herein in its entirety. In some embodiments, the test strip 100 can be have a length extending from a proximal end 102 to a distal end 104, with the length being greater than a width of the test strip 100. Each of the test strips 100 can include a combination of a testing portion 106 and an identifying information portion(s).

[0041] In some embodiments, the test strips 100 can be used for the detection of mycotoxins in plant or other food products, such as corn or grain. To test for mycotoxins, the testing portion 106 can include a combination of reagents and/or assays that specifically binds to, attracts and/or reacts with a target agent when contacted with a sample containing that target agent. For example, the test strip 100 can include reagents and/or assays that can specifically bind to, attract and/or react with an agent, such as a GMO or mycotoxin (e.g., Aflatoxin, Vomitoxin, Fumonisin, Zearalenone, T-2/HT-2 Toxin, Ochratoxin A) when exposed to a sample including the target agent(s). The reagents and/or assays can be provided on the testing portion 106 of the test strip 100 using any combination of methods known in the art. For example, the reagents and/or assays can be a coating on testing portion 106 of the test strip 100. When the testing portion 106 of the test strip 100 comes into contact with a target agent, for example, a GMO or mycotoxin (e.g., Aflatoxin, Vomitoxin, Fumonisin, Zearalenone, T-2/HT-2 Toxin, Ochratoxin A), the testing portion 106 can be designed to react in a manner to provide feedback to a user.

[0042] In some embodiments, the feedback can be provided by inserting the test strip 100 and/or the testing region 106 into an electronic reader 500 for analysis. The electronic reader 500 can include any combination of devices designed to quantify a result of an interaction between the reagents and/or assays and any target agents present in a sample to which the testing portion 106 of the test strip 100 was exposed. For example, the test strips 100 can be inserted into an imaging device for analysis, as discussed with respect to U.S. Patent No. 8,824,800, incorporated herein in its entirety. As discussed in greater detail herein, the electronic reader 500 can scan the testing region 106 and quantify the amount of the target agent(s) based on the interaction (or lack thereof) with the reagents and/or assays on the testing portion 106. In some embodiments, the testing region 106 can provide human readable visualizations to indicate a presence of a target agent within a sample. For example, when the testing portion 106 has been exposed to an agent, such as a GMO or mycotoxin (e.g., Aflatoxin, Vomitoxin, Fumonisin, Zearalenone, T-2/HT-2 Toxin, Ochratoxin A), for a predetermined period of time e.g., 3-5 minutes), at least a portion of the testing portion 106 can change color and/or reveal a line or symbol to indicate the presence of the mycotoxin. If the testing portion 106 is not exposed to a target agent, then there may not be any visual indication that is provided. Any other combinations of test strip designs can be used without departing from the scope of the present disclosure.

[0043] In some embodiments, the test strip 100 can include any combination of a first information section 110 having a lot number, a second information section 112 having a machine-readable code, and a third information section 114 having a color coding. The lot number of the first information section 110 can include a lot number that indicates a particular batch or shipment in which the test strip 100 was pulled from. This lot number can be used to assist in tracking and documenting test strips 100 after manufacturing. The machine-readable code of the second information section 112 can include scannable code that provides information specific to the test strip 100. The machine-readable code can be scanned by an electronic reader 500 to obtain any combination of information related to the test strip 100. For example, the machine-readable code can include information to identify the specific test strip 100, the lot that the test strip originated, the toxin test type, etc. for that strip 100. The color coding of the third information section 110 can include a simple visual indicator for which test that the test strip is associated with. For example, the test strip 100 can have a yellow color coding for test strips 100 testing Zearalenone, a blue color coding for test strips 100 testing Aflatoxin, a purple color coding for test strips 100 testing Vomitoxin, an orange color coding for test strips 100 testing Fumonisin, etc. The color coding can provide a simple way for a user to quickly confirm that the proper test(s) is being administered.

[0044] Referring to FIGS. 2A, 2B, and 2C, in some embodiments, an elongate structure 200 can be provided to combine multiple test strips 100 together as a single component. The elongate structure 200 can be any combination of sizes and shapes capable of receiving and coupling to one or more test strips 100. In some embodiments, as depicted in FIG. 2A, the elongate member 200 can be a rectangular prism having a length greater than its width. For example, the elongate member 200 can have an overall length of about 40mm to 80mm, a width about 6mm to 10mm, and a thickness of about 1mm to 2mm.

[0045] In some embodiments, the elongate structure 200 can have a first surface 202 along its length for receiving a plurality of test strips 100 thereon. The first surface 202 can be a substantially flat surface in which the test strips 100 can be adhered to or the first surface 202 can include grooves sized and shaped to receive the test strips 100 for adhesion. In some embodiments, the first surface 202 can provide a plurality of indicators 204 identifying specific locations for placement of the proximal ends 102 of the plurality of test strips 100. The plurality of indicators 204 can include any combination of markings to indicate to a user where to place the test strips 100 for coupling to the elongate member 200. For example, the plurality of indicators 204 can be markings painted on the elongate member 200 or they can be raised or engraved portions of the elongate member 200, or a combination thereof. In some embodiments, the plurality of indicators 204 can be designed to provide a specific spacing between the test strips 100. The spacing can be designed such that the test strips 100 can be placed as a single unit into separate incubation tubes, as discussed in greater detail herein. For example, the spacing between the test strips 100 can be about 14mm to 15mm, preferably 14.80mm. In some embodiments, the spacing is 14.0 mm on center (O.C.).

[0046] In some embodiments, an adhesive material 206 can be used to couple the plurality of test strips 100 to the elongate member 200. The adhesive material 206 can include any combination of materials with sufficient bonding power to hold the test strip 100 in place. For example, the adhesive material 206 can be a glue, epoxy, Pressure Sensitive Adhesive (PSA), single/double sided tape, etc. In some embodiments, the adhesive material 206 can be a layer designed for placement onto the test strips 100 and the first surface 202. In some embodiments, the adhesive material 206 can be sized and shaped to cover a limited area of the test strips 100, such as the proximal end 102 of the plurality of test strips 100. In some embodiments, the adhesive material is 6.0mm to 10.0mm. For example, the adhesive material 206 can be sized and shaped such that at least the second information section 112 and the third information section 114 are not overlapped or covered by the adhesive material 206. These dimensions can be used so that the machine-readable code in the second information section 112 is not obstructed. In some embodiments, the adhesive material 206 can be substantially transparent.

[0047] Referring to FIG. 2B, in some embodiments, when a plurality of test strips 100 are coupled to the elongate member 200 a combined structure that is capable of simultaneous testing for multiple agents within a sample is provided. In some embodiments, 2, 3, 4, 5, 6, or more test strips may be coupled to the elongate member. In some embodiments, 4 test strips are coupled to the elongate member. The combined structure can resemble a comb shape with the test strips 100 extending from the elongate member 200. Referring to FIG. 2C, in some embodiments, an applicator tool 208 can be used to assist in the coupling of the test strips 100 to the elongate member 200. The applicator tool 208 can be designed apply an initially substantially flat adhesive material 206 to the contour of the combined test strips 100 and elongate member 200. By rolling the applicator tool 208 over the adhesive material 206, while in place on the both the first surface 202 of the elongate member 200 as well as the surface of the proximal ends 102 of the test strips 100, it can securely bond the three components together. In some embodiments, the applicator tool 208 can be designed with a plurality of teeth and gaps that correspond to the depth of the test strips 100 (e.g., gap sizes) as well as the spacing between the test strips 100 (e.g., teeth sizes) to press the adhesive material 206 into the comers between the test strips 100 and the first surface 202. Using the applicator tool 208 in this manner can securely bond the adhesive material 206 to both the elongate member 200 and the test strips 100 while full wrapping around the test strips 100.

[0048] Referring to FIGS. 3A-3I in some embodiments, the elongate structure 200 can be designed with a plurality of recesses 210 sized and shaped for receiving proximal ends 102 of a plurality of test strips 100. FIG. 3 A shows an example isometric view of a structure of the elongate member 200 having a plurality of recesses 210 positioned within one side of the elongate member 200. In some embodiments, each of the plurality of recesses 210 can be sized and shaped to receive the proximal ends 102 of the test strips 100. For example, the proximal end 102 of the test strip 100 shown in FIG. 1 is substantially rectangular, therefore, the recesses 210 in the elongate member of FIGS. 3A-3I are substantially rectangular in shape.

[0049] FIG. 3B shows an example front side view of a structure of the elongate member 200 having a plurality of recesses 210 therein. FIG. 3C shows an example bottom side view of a structure of the elongate member 200 having the plurality of recesses 210. FIG. 3D shows an example end side view of a structure of the elongate member 200. The dotted lines in FIG. 3B and solid lines in FIG. 3C show an example front side view shape and bottom side view shape of the plurality of recesses 210, respectively, created within the elongate member 200. Although FIGS. 3B and 3C show four recesses 210, the elongate member 200 can be designed with any number of recesses 210 without departing from the scope of the present disclosure. The inclusion of more or less recesses may impact an overall length of the elongate member. For example, the elongate member 200 having four recesses 210 can have an overall length of about 50mm to 70mm, a with about 6mm to 10mm, and a thickness of about 1mm to 2mm.

[0050] In some embodiments, a predefined spacing can be provided between each of the plurality of recesses 210 to enable the test strips 100 to be spaced according to a particular testing arrangement. The spacing can be designed such that the test strips 100 can be placed as a single unit into separate incubation tubes, as discussed in greater detail herein. For example, the plurality of recesses 210 can have a spacing of about 14mm and 15mm, preferably 14.80mm. Using this spacing may enable the test strips 100 placed within the recesses 210 to be spaced such that they can be moved as a unit and simultaneously placed into separate testing tubes, as discussed in greater with respect to FIGS. 4 A and 4B.

[0051] In some embodiments, the depth of the recesses 210 can be sized and shaped to cover a limited area of the test strips 100, such as the proximal end 102 of the plurality of test strips 100. For example, the recesses 210 can have a depth such that at least the second information section 112 and the third information section 114 are not overlapped or covered by the elongate member 200. These dimensions can be used so that the machine-readable code in the second information section 112 is not obstructed. In some embodiments, at least a portion of the elongate member 200 can be substantially transparent such that any information on the proximal portion 102 of the test strip 100 within the elongate member 200 (e.g., within a recess 210) can be visually read by a user. For example, at least one side of the elongate member 200 can be substantially transparent, the elongate member 200 can include substantially transparent windows over plurality of recesses 210 (i.e., such as the area outlined in FIG. 3B), the entire elongate member 200 can be transparent, or a combination thereof.

[0052] Referring to FIG. 3D, the elongate member 200 can have sufficient thickness to fully surround the proximal ends 102 of the test strips 100 residing in the recesses 210. For example, the elongate member 200 can be about 6mm to 10mm in width to accommodate test strips of about 6.1mm to 9.9 in width.

[0053] Continuing with FIGS. 3B and 3C and referring to FIGS. 3E and 3F, regardless of the shape of the test strip 102 and the plurality of recesses 210, the plurality of recesses 210 can be sized and shaped to receive the proximal ends 102 of the test strips 100 and hold the test strips 100 in place. FIGS. 3E and 3F show cross-sectional end views of the elongate member 200 provided in FIGS. 3A-3D. To hold the test strips 100 within the recesses 210, the recesses 210 can include combination of coupling mechanisms to fixedly or removeable attach the test strips 100 to the elongate member 200. For example, the test strips 100 can be held within the recesses 210 using a friction fit, a mechanical coupling, an adhesive, welding, etc. or a combination thereof. Depending on the design of the coupling mechanism, once inserted into a recess 210, a test strip 100 can be permanently fixed to the elongate member 200 or it can be removable coupled. When using a permanent coupling, the elongate member 200 may be disposable while when using a removable coupling, the elongate member 200 may be reusable with replacement test strips 100.

[0054] In some embodiments, each of the plurality of recesses 210 can each include a plurality of ridges 212 extending a length of the first plurality of recesses 210 and a plurality of teeth 214 positioned throughout the plurality of recesses 210 to create a secure mechanical coupling mechanism. The combination of the plurality of ridges 212 and plurality of teeth 214 can be designed to retain the proximal end 102 of a test strip 100 positioned within the combined first plurality of recesses 210a and second plurality of recesses 210b. Although two different forms of coupling structures (e.g., ridges and teeth) are discussed, the recesses 210 could also include the same type of coupling structures could be used, for example, having ridges on both sides of the recesses 210. Similarly, different recesses 210 could have different coupling structures for coupling different types of test strips 100.

[0055] Referring to FIGS. 3G and 3H, in some embodiments, the elongate member 200 can be constructed by combining two pieces together. In the two-part construction, the elongate member 200 can have a first elongate member 200a having a first plurality of recesses 210a for receiving a first portion of the plurality of test strips 100 and a second elongate member 200b having a second plurality of recesses 210b for receiving a second portion of the plurality of test strips 100. When the first elongate member 200a and the second elongate member 200b are coupled together, for example using a mechanical coupling connection (e.g., clips), an overall structure of the elongate member 200 is created. In some embodiments, the first plurality of recesses can include a plurality of ridges 212 extending a length of the first plurality of recesses 210a and the second plurality of recesses 210b can include a plurality of teeth 214 positioned throughout the second plurality of recesses 210b. The combination of the plurality of ridges 212 and plurality of teeth 214 can be designed to retain the proximal end 102 of a test strip 100 positioned within the combined first plurality of recesses 210a and second plurality of recesses 210b.

[0056] When the first elongate member 200a is coupled with the second elongate member 200b, the elongate member 200 as shown in FIGS. 3A-3F can be created. The first elongate member 200a and the second elongate member 200b can be coupled together using any combination of methods known in the art. For example, the first elongate member 200a and the second elongate member 200b can be coupled together using a mechanical fit, using an adhesive, by a welding process, etc.

[0057] In some embodiments, at least one of the first elongate member 200a and the second elongate member 200b is substantially transparent such that any information on the proximal portion 102 of the test strip 100 within the elongate member 200 (e.g., within combined recess 210a, 210b) can be visually read by a user.

[0058] Referring to FIG. 31, in some embodiments, regardless of the design of the elongate member 200 having a plurality of recesses 210, when a plurality of test strips 100 are coupled to the elongate member 200 a combined structure that is capable of simultaneous testing for multiple agents within a sample is provided. The combined structure can resemble a comb shape with the test strips 100 extending from the elongate member 200.

[0059] Regardless of design of the elongate member 200 as discussed with respect to FIGS. 2A-3I, the elongate member 200 can be constructed using any combination of materials using any combination of manufacturing methods known in the art. For example, the elongate member 200 can be constructed from a paper material, metal material, plastic material, clear acrylic, polystyrene, or a combination thereof. The elongate member 200 should be constructed from materials with sufficient rigidity to hold and maintain a desired shape when multiple test strips 100 are coupled to the elongate member 200. A manufacturing process can be selected based on the type of materials, the type of construction (e.g., one-piece vs two-piece construction), and parameters of the structure of the elongate member 200. For example, the elongate member 200 can be constructed using injection molding, three-dimensional printing, stamp pressing, etc. or a combination thereof.

[0060] Referring to FIGS. 4A and 4B, in some embodiments, the combined plurality of test strips 100 and elongate member 200 structure (as shown in FIGS. 2B and 31) can be used to easily move and place the plurality of test strips 100 into desired locations. In one example, the combined structure can be used to move and place the plurality of test strips 100 into a row of incubator tubes 402 within an incubator or incubator block 400. For example, the structure discussed with respect to FIGS. 2A-2C can be placed in incubator tube 402 within a block 400, as shown in FIG. 4A. Similarly, the structure discussed with respect to FIGS. 3 A-3I can be placed in incubator tubes 402 within a block 400, as shown in FIG. 4A. In some embodiments, the incubator and/or incubator block 400 can include a plurality of openings to receive incubator tubes 402, each of the incubator tubes 402 being designed for the insertion of a test sample and one of the plurality of test strips 100. The spacing provided by the elongate member 200 enables the plurality of test strips 100 to be separated appropriately such that each test strip 100 can be inserted into separate incubation tubes 402. This process can be completely performed by only having to move the single comb like structure, reducing the need to individually move separate test strips when testing for multiple target agents (e.g., GMOs, mycotoxins).

[0061] Referring to FIGS. 5 A and 5B, in some embodiments, the combined plurality of test strips 100 and elongate member 200 structure (as shown in FIGS. 2B and 31) can be used to easily move and place the plurality of test strips 100 from one location to another during a testing process. Continuing the above example, the combined structure can be used to remove the plurality of test strips 100 from the incubator tubes 402 for placement into an electronic reader 500. In some embodiments, the elongate member 200, with a plurality of test strips 100 coupled thereto, can be moved and stored in a variety of orientations. For example, the combined structure can be placed in a substantially vertical orientation when in the incubator tubes 402 and rotated to a substantially horizontal orientation when inserted into the electronic reader 500, as shown in FIGS. 5A and 5B. This process can be completely performed by only having to move the single comb like structure, reducing the need to individually move separate test strips when testing for multiple target agents (e.g., GMOs, mycotoxins).

[0062] In some embodiments, with the combined elongate member 200 and plurality of test strips 100 in the electronic reader 500, strip information (e.g., lot number, machine readable information, color coding, etc.) and test information can be read by the electronic reader 500. For example, the combined structure can be placed within the electronic reader 500 such that the information off each of the plurality of test strips 100 and quantifying agents interacting with or specifically binding to reagents on the second 112 on the testing portion 106 of each of the plurality of test strips 100 can be tested simultaneously.

[0063] In some embodiments, the plurality of test strips 100 and elongate member 200 can be provided as part of a system or kit for performing target testing of multiple agents within a sample. For example, the kit can include the plurality of test strips 100, elongate member 200, a plurality of incubation tubes 402, an incubator and/or incubator block 400, and an electronic reader 500. In some embodiments, the plurality of test strips 100 can be provided as a one or more packs designed for testing different target agents, for example different GMOs or mycotoxins. In some embodiments, the plurality of test strips is designed to test for multiple mycotoxins. In some embodiments, the mycotoxins are selected from one or more of Aflatoxin, Vomitoxin, Fumonisin, Zearalenone, T-2/HT-2 Toxin, Ochratoxin A. The different test strips can be selected and combined with the elongate member 200 in any combination of target agent testing.

[0064] In operation, simultaneous testing for multiple agents within a sample. For example, the present disclosure can be used for simultaneous testing of multiple different mycotoxins within grain and food crops. FIG. 6 shows an exemplary flow chart depicting implementation of the present disclosure. Specifically, FIG. 6 depicts an exemplary flow chart showing an example process 600 using the elongate member 200 for simultaneous testing using a plurality of test strips 100, as discussed with respect to FIGS. 1-5B. At step 601, a user can select a an elongate member 200 that has been pre-coupled to a plurality of test strips 100 having the same or different reagents to test for a desired selection of target agents.

[0065] Alternatively, at step 602, a user can select a plurality of test strips 100 having the same or different reagents to test for a desired selection of target agents. At step 604, the user can couple the selected test strips 100 from step 602 to an elongate member 200. For example, the user can affix the test strips 100 to a surface 202 of the elongate member 200, as discussed with respect to FIGS. 2A-2C or can insert the proximal ends 102 of the test strips 100 into the recesses 210 within the elongate member 200, as discussed with respect to 3A-3I. For elongate designs with a plurality of recesses 210 the user can use either a one-piece design or a two-piece design. For the one-piece design, the user can push strips into recesses 210 of the elongate member 200 and for the two-piece design, the user can place strips and snap top and bottom elongate members 200a, 200b together to form the elongate member 200. The test strips 100 can be fixedly or removably coupled to the elongate member 200.

[0066] The test strips in each of step 601 or 602 can include one or more agents, for example one or more mycotoxins. In some embodiments, the mycotoxin is selected from one or more of Aflatoxin, Vomitoxin, Fumonisin, Zearalenone, T-2/HT-2 Toxin, and Ochratoxin A. [0067] At step 606, the user can prepare and insert a sample for testing into a plurality incubator tubes 402. For example, the user can blend, crush, extract (e.g., using a common water-based extraction), crush, etc. plant or food-based crops (e.g., corn or grain) into a sample for testing and pour the sample into each of the incubator tubes 402. At step 608, the user can simultaneously insert, using the combined elongate member 200 and plurality of test strips, each of the plurality of test strips into separate incubator tubes 402 for a predetermined period of time (e.g., about 3-5 minutes). For example, the user can hold the elongate member 200 and position the plurality of test strips over the plurality of prepared incubator tubes 402 and insert the test strips 100 into the tubes 402 for an incubation period.

[0068] At step 610, the user can remove, using the elongate member 200, the plurality of test strips 100 from the incubator tubes 402 and insert, using the elongate member 200, the plurality of test strips 100 into an electronic reader 500 for quantifying interactions between the different reagents on the plurality of test strips and the sample within the test incubator tubes 402. The electronic reader 500 can perform any combination of information gathering/recording and analysis known in the art. For example, the test strips 100 and the electronic reader 500 can be used as part of the quantitative analysis process discussed with respect to U.S. Patent No. 8,824,800 incorporated herein in its entirety.

[0069] Numerous modifications and alternative embodiments of the present disclosure will be apparent to those skilled in the art in view of the foregoing description. Accordingly, this description is to be construed as illustrative only and is for the purpose of teaching those skilled in the art the best mode for carrying out the present disclosure. Details of the structure may vary substantially without departing from the spirit of the present disclosure, and exclusive use of all modifications that come within the scope of the appended claims is reserved. Within this specification embodiments have been described in a way which enables a clear and concise specification to be written, but it is intended and will be appreciated that embodiments may be variously combined or separated without parting from the invention. It is intended that the present disclosure be limited only to the extent required by the appended claims and the applicable rules of law.

[0070] It is also to be understood that the following claims are to cover all generic and specific features of the invention described herein, and all statements of the scope of the invention which, as a matter of language, might be said to fall therebetween.

Claims

CLAIMS What is claimed is:

1. An apparatus for simultaneous testing for multiple agents within a sample, the apparatus comprising: an elongate member comprising a first surface for receiving a plurality of test strips thereon; and at least one adhesive material designed for placement on the first surface and to adhere the plurality of test strips to the elongate member.

2. The apparatus of claim 1, wherein the surface comprises a plurality of indicators for placement of the plurality of test strips.

3. The apparatus of claim 1 or 2, wherein the plurality of indicators comprises spacing of about 14mm to 15mm between each of the plurality of test strips.

4. The apparatus of any one of claims 1-3, wherein the elongate member is constructed from a polystyrene material or a paper material.

5. The apparatus of any one of claims 1-4, wherein the at least one adhesive material is sized and shaped to overlap a proximal end of the plurality of test strips.

6. The apparatus of any one of claims 1-5, wherein the elongate member is about 6mm to 10mm in width.

7. An apparatus for simultaneous testing for multiple agents within a sample, the apparatus comprising an elongate member comprising a plurality of recesses sized and shaped for receiving proximal portions of a plurality of test strips.

8. The apparatus of claim 7, wherein the elongate member comprises: a first elongate member comprising a first plurality of recesses for receiving a first portion of the plurality of test strips; and a second elongate member comprising a second plurality of recesses for receiving a second portion of the plurality of test strips.

9. The apparatus of claim 8, wherein: the first plurality of recesses comprises a plurality of ridges extending a length of the first plurality of recesses; the second plurality of recesses comprises a plurality of teeth positioned throughout the second plurality of recesses; and the plurality of ridges and plurality of teeth retain a proximal end of a test strip positioned within a combined first plurality of recesses and second plurality of recesses.

10. The apparatus of any one of claims 7-9, wherein the plurality of recesses comprises spacing of about 14mm to 15mm between each of the plurality of test strips positioned therein.

11. The apparatus of any one of claims 7-10, wherein the elongate member is constructed from a paper material, metal material, plastic material, clear acrylic, polystyrene, or a combination thereof.

12. The apparatus of any one of claims 7-11, wherein the elongate member is about 6mm to 10mm in width.

13. The apparatus of any one of claims 1-12, wherein the plurality of test strips is 2, 3, 4, 5, 6, or more.

14. A system for simultaneous quantification of multiple agents within a sample, the system comprising: an apparatus of any one of claims 1-13; and a plurality of test strips each comprising a distal end and a proximal end, each of the plurality of test strips being designed to detect a different target agent; wherein the apparatus is coupled to proximal ends of each of the plurality of test strips extending substantially perpendicular to a length of the apparatus and substantially parallel to one another.

15. The system of claim 14, wherein the plurality of test strips each comprise a reagent capable of specifically binding to the target agent.

16. The system of claim 14 or 15, wherein the plurality of test strips each comprise a different bar code for quantifying the target agent detected by each of the plurality of test strips.

17. The system of claim 16, further comprising an electronic reader for scanning the bar code and quantifying agents detected by the plurality of test strips.

18. The system of claim 17, further comprising an incubator comprising a plurality of openings to receive incubator tubes, each of the incubator tubes being designed for the insertion of a test sample and one of the plurality of test strips.

19. The system of any one of claims 14-18, wherein the plurality of test strips is 2, 3, 4, 5, 6, or more.

20. The system of any one of claims 14-19 for use in a method for simultaneous quantification of multiple mycotoxins within a sample.

21. A method for simultaneous quantification of multiple agents within a sample, the method comprising: selecting a system of any one of claims 14-16; applying the system to the sample; and quantifying the target agents detected by the system.

22. A method for simultaneous quantification of multiple agents within a sample, the method comprising: selecting a plurality of test strips, wherein each of the plurality of test strips is capable of detecting a target agent; coupling each of the plurality of test strips to an apparatus of any one of claims 1-12, wherein the apparatus is sized and dimensioned to receive and couple to proximal ends of each of the plurality of test strips; applying the plurality of test strips, using the apparatus, to the sample; and quantifying the target agents detected by each of the plurality of test strips.

23. The method of claim 21 or 22, further comprising inserting the apparatus coupled to the plurality of test strips or the system into an electronic reader device.

24. The method of claim 23, wherein the plurality of test strips each contain a different bar code, wherein the electronic reader device is capable of reading the bar code to quantify the target agents in the sample.

25. The method of any one of claims 21-24, further comprising inserting the sample into a plurality incubator tubes; inserting, using the elongate member, each of the plurality of test strips into separate incubator tubes for a predetermined period of time; and removing, using the apparatus, the plurality of test strips from the incubator tubes.

26. The method of any one of claims 21-25, wherein the agent is a genetically modified organism or a mycotoxin.

27. The method of any one of claims 20-26, wherein the agent is a mycotoxin selected from the group consisting of Aflatoxin, Vomitoxin, Fumonisin, Zearalenone, T-2/HT-2 Toxin, and Ochratoxin A.

28. The method of any one of claims 20-27, wherein the sample is an agricultural sample.

29. The method of claim 28, wherein the agricultural sample is a plant or food.

30. The method claim 28 or 29, wherein the agricultural sample is selected from the group consisting of cereal grains, oil seeds, forages, and co- or by-products thereof.

31. The method of claim 30, wherein forages are selected from the group consisting of corn, wheat, barley, cottonseed, sorghum, sugarcane, peanuts, canola, feed inputs, finished feed, soybean, rice, oats, rye, milo2228, alfalfa.

32. The method of claim 30, wherein the co- or by-products are selected from the group consisting of hay, corn meal, corn germ meal, corn gluten, distillers grains (DDG and DDGS), cottonseed meal, peanut meal, wheat bran and midds, flour, rice bran, and barley protein meal.

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33. The method of any one of claims 20-32, wherein the plurality of test strips is 2, 3, 4, 5, 6, or more.

34. The method of claim 5, wherein the predetermined period of time is 3-5 minutes.

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