# US 11,906,513 B2 · Immunochromatographic test piece for extracting and measuring sugar chain antigen, which is capable of controlling development of specimen > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,906,513 B2 - Document ID: US11906513B2 - Status: Granted - Kind: B2 - Application number: 16/492,427 - Filed: 2018-03-14 - Published: 2020-02-06 - Granted: 2024-02-20 - Earliest claimed: 2017-03-14 - Assignees: Denka Company Limited - Applicants: Denka Company Limited - Inventors: Daisuke Kato; Shino Muramatsu; Tomohiro Hattori - Web page: https://patentgrep.com/patent/US11906513B2 ## CPC - G01N 33/54388: {based on lateral flow} - B01L 3/5023: {with a sample being transported to, and subsequently stored in an absorbent for analysis} - G01N 33/5308: {for analytes not provided for elsewhere, e.g. nucleic acids, uric acid, worms, mites} - G01N 33/543: with an insoluble carrier for immobilising immunochemicals - G01N 33/66: involving blood sugars, e.g. galactose - B01L 2200/16: Reagents, handling or storing thereof - B01L 2300/0825: Test strips - G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q) - B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE ## Abstract It is an object of the present invention to provide a method or an immunochromatographic test piece, which controls a speed or a direction of development of a specimen on the immunochromatographic test piece, so that a treatment with an acid reagent, nitrite, and a neutralizing reagent is properly controlled. The present invention provides an immunochromatographic test piece for extracting and measuring a sugar chain antigen in a specimen, the immunochromatographic test piece having a neutralizing region impregnated with a neutralizing reagent upstream of a label region, and further having a solid acid reagent or nitrite region impregnated with a solid acid reagent, or with nitrite, upstream of the neutralizing region, wherein a resin-made sheet is sandwiched between the solid acid reagent or nitrite region the neutralizing region so as to suppress the movement of a reagent or the movement of a specimen solution between the regions. ## Claims ### Claim 1 An immunochromatographic test piece for extracting and measuring a sugar chain antigen in a specimen, the immunochromatographic test piece comprising: a single specimen adding port in a sample pad to which a specimen mixed with nitrite or an acid solution is added, wherein the sample pad is a site located most upstream of the immunochromatographic test piece; a label region comprising a labeled antibody obtained by labeling an antibody against the sugar chain antigen; and a detection region on which the antibody against the sugar chain antigen is immobilized, wherein an antibody-sugar chain antigen-labeled antibody complex is formed in the detection region to measure the sugar chain antigen, and the immunochromatographic test piece having a neutralizing reagent region impregnated with a neutralizing reagent, and further having a solid acid reagent region impregnated with a solid acid reagent when the specimen mixed with the nitrite is used, or a nitrite region impregnated with nitrite when the specimen mixed with the acid solution is used, the neutralizing reagent region being present upstream of the label region, and the solid acid reagent region or nitrite region being present upstream of the neutralizing reagent region, wherein a single flow channel of a continuous lateral flow is formed, and wherein a resin-made sheet is sandwiched between the solid acid reagent region or the nitrite region and the neutralizing reagent region such that the solid acid reagent region or the nitrite region and the neutralizing reagent region come into partial contact with each other, and the resin-made sheet suppresses the movement of a reagent or the movement of a specimen solution between the regions. ### Claim 2 (depends on 1) The immunochromatographic test piece according to claim 1, wherein the solid acid reagent region or the nitrite region is present on the sample pad. ### Claim 3 (depends on 2) The immunochromatographic test piece according to claim 2, wherein the sample pad is present above the resin-made sheet, and wherein the resin-made sheet is located above the neutralizing reagent region, the label region, and the detection region. ### Claim 4 (depends on 1) The immunochromatographic test piece according to claim 1, wherein the solid acid reagent is selected from the group consisting of malonic acid, malic acid, maleic acid, citric acid, and tartaric acid. ### Claim 5 (depends on 1) The immunochromatographic test piece according to claim 1, wherein the neutralizing reagent is tris(hydroxymethyl)aminomethane or sodium hydroxide. ### Claim 6 (depends on 1) The immunochromatographic test piece according to claim 1, wherein the antibody against the sugar chain antigen is an antibody against the sugar chain antigen of protozoa, fungi, bacteria, mycoplasma, rickettsia, chlamydia, or virus. ### Claim 7 (depends on 1) A method of measuring a sugar chain antigen in a specimen according to an immunochromatography method using the immunochromatographic test piece according to claim 1, the method comprising mixing the specimen with a nitrous acid solution when the immunochromatographic test piece has a region impregnated with a solid acid reagent, or mixing the specimen with an acid solution when the immunochromatographic test piece has a region impregnated with nitrite, and adding the mixture to a sample pad of the immunochromatographic test piece, wherein in the immunochromatography method, the sugar chain antigen is extracted from the specimen by the action of nitrous acid generated through a reaction of the nitrite with the solid acid reagent in the region impregnated with the solid acid reagent or the region impregnated with the nitrite, the acid solution containing the sugar chain antigen is neutralized in a region impregnated with a neutralizing reagent, and an antibody-sugar chain antigen-labeled antibody complex is formed in a detection region, and wherein a speed or a direction of development of the specimen on the immunochromatographic test piece is controlled, so that a treatment with the acid reagent, the nitrite, and the neutralizing reagent is controlled.