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  Method of processing and testing powdered samples using immunochromatographic strip testsUSPTO Application #: 20080108087Title: Method of processing and testing powdered samples using immunochromatographic strip tests Abstract: A method and kit for processing and testing powdered samples are provided herein. The powdered sample is combined with a fluid to produce a slurry or liquid suspension, and the slurry is contacted with an immunochromatographic test strip containing detectable reagents that are immunoreactive with an analyte to be detected in the sample. The method is particularly useful for the analysis of agricultural products or crops, such as the identification of recombinant grains. (end of abstract) Agent: John S. Pratt, Esq Kilpatrick Stockton, LLP - Atlanta, GA, US Inventors: Tara Ann Kennedy, Alan Bruce McQuillin USPTO Applicaton #: 20080108087 - Class: 435007100 (USPTO) Related Patent Categories: Chemistry: Molecular Biology And Microbiology, Measuring Or Testing Process Involving Enzymes Or Micro-organisms; Composition Or Test Strip Therefore; Processes Of Forming Such Composition Or Test Strip, Involving Antigen-antibody Binding, Specific Binding Protein Assay Or Specific Ligand-receptor Binding Assay The Patent Description & Claims data below is from USPTO Patent Application 20080108087. Brief Patent Description - Full Patent Description - Patent Application Claims
FIELD OF THE INVENTION [0001] This relates to the field of immunology and more specifically relates to a method for the analysis of a powdered sample. BACKGROUND OF THE INVENTION [0002] Many situations exist in which it is important to have rapid, reliable, inexpensive tests that can be run by untrained individuals in the field, home, or other non-laboratory setting. Immunoassays have many of these characteristics. One type of immunoassay, referred to as an immunochromatographic or lateral flow strip test, has been successfully developed into `one-step` tests and employed for on-site analysis. The over-the-counter home pregnancy test is an example of a simple, one-step immunochromatographic strip test. [0003] Immunoassays have been used to detect substances in many different kinds of samples in many different markets, including the agriculture market. Modern biotechnology methods are being used to genetically modify plants. These genetically modified plants, and the seeds, grain and food derived from them all may contain novel or recombinant proteins. It is important to determine the presence of such proteins for regulatory, environmental, safety, and world trade issues. Very large amounts of grain and seed are harvested, transported, mixed, stored, distributed and traded throughout the world, and it is important to have tests that can detect these novel proteins in order to address these issues. It is desirable to have a rapid, simple and inexpensive method that can be used to test grain samples at many points along the distribution channel including trucks, elevators, barges, ships, etc. A strip test is ideally suited for this purpose. For example, recently, an immunochromatographic strip test (strip test or lateral flow device, LFD) that detects a specific protein in genetically modified soybeans was developed. [0004] Strip tests are comprised of multiple porous components, membranes and filters, through which liquid sample is drawn by capillary action. Analyte in the sample reacts with the test reagents contained within the test strip as it traverses the length of the strip. To detect an analyte (such as a protein or mycotoxin) in grain or seed (e.g., corn, soybean, rice, wheat, etc.), it is necessary to grind the grain into a powder and then extract the protein from the powder with a liquid that is then separated from the solid material and assayed using the test. To achieve the highest sensitivity test possible, it is important to extract as much of the analyte from the grain as feasible. This requires that the grain be ground to a fine powder to facilitate efficient extraction. However, very fine particulate matter suspended in the liquid sample clogs the pores of the strip test components causing the strip to run slowly, erratically or not at all. Additional steps or test components employed to remove the particulates only serve to complicate the testing process and increase the cost of the test and time-to-result. [0005] What is needed is a means for preparing and testing a finely ground powdered sample that maximizes extraction efficiency, sensitivity, speed and reliability of the strip test while minimizing the complexity and cost. SUMMARY OF THE INVENTION [0006] A method and kit for processing and testing powdered samples are provided herein. The powdered sample is combined with a fluid to produce a slurry or liquid suspension, and the slurry is contacted with an immunochromatographic test strip containing detectable reagents that are immunoreactive with an analyte to be detected in the sample. The method is particularly useful for the analysis of agricultural products, crops, or food fractions, such as the identification of recombinant grains. [0007] It is therefore an object of the present invention to provide a rapid, reliable, and inexpensive method for analyzing an analyte in powdered samples using an immunoassay. [0008] It is a further object of the present invention to provide an immunoassay method for the detection of analyte in a sample that is simple, portable and user-friendly and can be utilized successfully by non-scientific personnel in the laboratory and the field. [0009] It is a further object of the present invention to provide an immunoassay device and method for the detection of analyte in a sample without requiring precise sample or reagent measurements. [0010] It is a further object of the present invention to provide an immunoassay method for the detection of analyte in a powdered sample that provides results that are accurate and reproducible. [0011] These and other objects of the present invention will become apparent after reading the following detailed description of the disclosed embodiments and the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS [0012] FIG. 1 is a table showing chromatographic strip test results for the analysis of corn kernels using the method described herein. DETAILED DESCRIPTION OF THE DISCLOSED EMBODIMENTS [0013] A method for the detection of analyte in a sample using an immunochromatographic strip test is described herein. In accordance with the method, the sample is provided in powdered form or is processed from a solid or semi-solid sample such as a slice, granule, seed, grain, particle, or the like, to produce a powder. The powdered sample is then mixed with a fluid, such as an aqueous solution, to form a slurry or liquid suspension. The slurry is then contacted with an immunochromatographic strip. [0014] The method and kit are useful for the detection of a wide variety of analytes including, but not limited to, agricultural products, biological and environmental contaminants or additives, industrial chemicals, toxins (particularly mycotoxins), and biological analytes, such as antigenic determinants of proteins, polysaccharides, glycoproteins, lipoproteins, nucleic acids and hormones, of organisms such as viruses, bacteria, fungi, parasites, plants and animals, including large and small molecules, polymers and haptens. The method is particularly useful for the identification or quantification of proteins or peptides in genetically modified plants or recombinant agricultural products, such as grains. For example, the method is useful for the detection of the Bacillus thuringiensis Cry1Ab or Cry1Ac proteins in genetically modified plants, such as corn, as described below in the examples. DEFINITIONS [0015] The terms "a", "an" and "the" as used herein are defined to mean "one or more" and include the plural unless the context is inappropriate. [0016] The term "analyte" refers to a drug, hormone, chemical, toxin, compound, receptor, nucleic acid molecule or other molecule and fragments thereof to be measured by the method described herein. Sample Processing Method Development [0017] During the development of an immunochromatographic strip test to detect the Bacillus thuringiensis Cry1Ab protein in genetically enhanced corn kernels, great difficulty was encountered in achieving the sensitivity and time-to-result specifications that are required of the commercial product. Data demonstrated that increasing grinding time of the corn kernels increased extraction efficiency and test sensitivity. However, the more finely ground particles in the liquid sample caused the test to flow too slowly. Continue reading... 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