# US 9,753,032 B2 · Method for pretreating specimen and method for assaying biological substance > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 9,753,032 B2 - Document ID: US9753032B2 - Status: Granted - Kind: B2 - Application number: 14/874,154 - Filed: 2015-10-02 - Published: 2016-01-28 - Granted: 2017-09-05 - Earliest claimed: 2008-12-25 - Assignees: Universal Bio Research Co., Ltd. - Applicants: Universal Bio Research Co., Ltd. - Inventors: Hideji Tajima - Web page: https://patentgrep.com/patent/US9753032B2 ## CPC - G01N 33/54386: {Analytical elements} - B01L 3/508: {Rigid containers without fluid transport within} - B01L 3/52: {Containers specially adapted for storing or dispensing a reagent (B01L3/02 takes precedence; storing or dispensing test elements G01N33/4875; automated reagent dispensing G01N35/1002)} - C12Q 1/6804: Nucleic acid analysis using immunogens (immunoassay G01N33/53) - G01N 33/54326: {Magnetic particles} - G01N 33/54393: {Improving reaction conditions or stability, e.g. by coating or irradiation of surface, by reduction of non-specific binding, by promotion of specific binding} - G01N 35/026: {having blocks or racks of reaction cells or cuvettes} - B01L 2200/10: Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept - B01L 2300/0636: Integrated biosensor, microarrays - G01N 35/1009: {Characterised by arrangements for controlling the aspiration or dispense of liquids} - Y10T 436/143333: Saccharide [e.g., DNA, etc.] - Y10T 436/25125: Digestion or removing interfering materials - 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 - C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES - Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION ## Abstract This invention relates to an assay device and a method for pretreating a specimen containing a biologically-relevant substance and then assaying the biologically-relevant substance. Biologically-relevant substances used in the assay method include microorganisms, cells, viruses, nucleic acids, polysaccharides, proteins (including antigens, antibodies, chromoproteins, and enzymes), peptides, nucleic acids, and small molecules. This pretreatment method removes contaminants from the biologically-relevant substances using supports such as magnetic particles, gels, resins, membranes, and solid-phased reagents. Therefore, in the assay method the following steps are generally carried out (i) a pretreatment step of treating a specimen using one or more first supports and then one or more second supports, and (ii) the assay step carried out after the pretreatment step. In particular, the pretreatment method reduces false positives and false negatives in the assay. ## Claims ### Claim 1 A biologically-relevant substance assay device, comprising: (a) a specimen holding portion in which a specimen is held; (b) a first holding portion in which trapping particles for trapping a biologically-relevant substance from the specimen are held; (c) a second holding portion in which a reagent for detecting the biologically-relevant substance is held; (d) a dispensing mechanism for dispensing the specimen or the biologically-relevant substance; and (e) a light-irradiating mechanism for irradiating an irradiating light for letting the biologically-relevant substance fluoresce, and a detecting mechanism for receiving the fluorescence from the biologically-relevant substance to detect the biologically-relevant substance, wherein the light irradiating mechanism includes a light-irradiating optical fiber irradiating the irradiating light downwardly from a nozzle unit of the dispensing mechanism, the light-irradiating optical fiber is extended inside of the nozzle unit of the dispensing mechanism along the nozzle unit. ### Claim 2 (depends on 1) The biologically-relevant substance assay device according to claim 1, wherein the light-irradiating optical fiber is integrated into the nozzle unit. ### Claim 3 (depends on 1) The biologically-relevant substance assay device according to claim 1, wherein the nozzle unit includes a pumping opening, and the light-irradiating optical fiber is disposed outside of the pumping opening. ### Claim 4 (depends on 1) The biologically-relevant substance assay device according to claim 1, wherein the detecting mechanism includes a light-receiving optical fiber for receiving the fluorescence, and the light-receiving optical fiber is extended along the nozzle unit. ### Claim 5 (depends on 4) The biologically-relevant substance assay device according to claim 4, wherein the light-receiving optical fiber is disposed outside of the nozzle unit. ### Claim 6 (depends on 4) The biologically-relevant substance assay device according to claim 4, wherein the detecting mechanism includes a lens for receiving the fluorescence and sending the fluorescence to the light-receiving optical fiber. ### Claim 7 (depends on 6) The biologically-relevant substance assay device according to claim 6, wherein the lens faces a well for detection. ### Claim 8 (depends on 1) The biologically-relevant substance assay device according to claim 1, wherein the trapping particles are magnetic particles. ### Claim 9 (depends on 1) The biologically-relevant substance assay device according to claim 1, wherein the magnetic particles are held in a dispensing chip of the nozzle unit. ### Claim 10 (depends on 1) The biologically-relevant substance assay device according to claim 1, wherein the specimen holding portion, the first holding portion and the second holding portion are arranged in an approximate straight line. ### Claim 11 (depends on 1) The biologically-relevant substance assay device according to claim 1, wherein, the biologically-relevant substance is a nucleic acid, and the reagent for detecting comprises a reagent for nucleic acid amplification using a PCR method or an isothermal amplification method and a reagent for detecting an amplified product. ### Claim 12 (depends on 1) The biologically-relevant substance assay device according to claim 1, wherein the reagent for detecting the biologically-relevant substance is a freeze-dried reagent for detecting. ### Claim 13 (depends on 1) The biologically-relevant substance assay device according to claim 1, wherein the first and second holding portions are formed into a cartridge.