# US 11,994,517 B2 · Analytical assay reaction cartridge containing magnetic capture beads and methods of production and use thereof > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,994,517 B2 - Document ID: US11994517B2 - Status: Granted - Kind: B2 - Application number: 18/000,944 - Filed: 2021-06-16 - Published: 2023-06-22 - Granted: 2024-05-28 - Earliest claimed: 2020-06-18 - Assignees: Siemens Healthcare Diagnostics Inc. - Applicants: Siemens Healthcare Diagnostics Inc. - Inventors: Aaron Kauffmann; Jon Stradinger - Web page: https://patentgrep.com/patent/US11994517B2 ## CPC - G01N 33/54326: {Magnetic particles} - G01N 33/54366: {Apparatus specially adapted for solid-phase testing} - B01L 3/502761: {specially adapted for handling suspended solids or molecules independently from the bulk fluid flow, e.g. for trapping or sorting beads or physically stretching molecules} - B03C 1/01: by addition of magnetic adjuvants - B03C 1/0332: {using permanent magnets} - B03C 1/288: {disposed at the outer circumference of a recipient} - B03C 1/30: Combinations with other devices, not otherwise provided for - G01N 15/042: {by centrifuging and investigating centrifugates (centrifuges per se B04B)} - G01N 15/05: in blood - G01N 33/54386: {Analytical elements} - G01N 33/6872: {Intracellular protein regulatory factors and their receptors, e.g. including ion channels} - B01L 2200/04: Exchange or ejection of cartridges, containers or reservoirs - B01L 2200/0668: Trapping microscopic beads - B01L 2200/16: Reagents, handling or storing thereof - B01L 2400/043: magnetic forces - B03C 2201/18: Magnetic separation whereby the particles are suspended in a liquid - B03C 2201/26: for use in medical or biological applications - G01N 2015/045: {by optical analysis} - G01N 2015/055: {for hematocrite determination} - G01N 2333/4737: C-reactive protein - 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 - B03C: MAGNETIC OR ELECTROSTATIC SEPARATION OF SOLID MATERIALS FROM SOLID MATERIALS OR FLUIDS; SEPARATION BY HIGH-VOLTAGE ELECTRIC FIELDS (separating isotopes B01D59/00; combinations of magnetic or electrostatic separation with separation of solids by other means B03B, B07B) ## Abstract Analytical assay reaction cartridges, kits containing same, and methods of production and use thereof are disclosed. These cartridges include a magnetic assembly that surrounds at least a portion of a sample read window on the cartridge. The cartridge also includes an analytical reagent positioned therewithin, wherein the analytical reagent comprises magnetic beads coated with at least one anti-red blood cell antibody. ## Claims ### Claim 1 An analytical assay reaction assembly, comprising: an analytical assay reaction cartridge having a housing that comprises a reaction chamber, an inlet for introducing a liquid test sample into the reaction chamber, and a sample read window formed through a portion of the reaction chamber, wherein the sample read window has a shape with an outer edge that surrounds the shape of the sample read window that extends through the portion of the reaction chamber; at least one solid analytical reagent, wherein the solid analytical reagent comprises magnetic beads coated with at least one anti-human red blood cell antibody, and wherein the solid analytical reagent is soluble in a liquid reagent; and a magnetic assembly comprising a permanent magnet; and wherein at least one contact point of the magnetic assembly is disposed substantially adjacent to at least one contact point on the outer edge of the sample read window of the analytical assay reaction cartridge. ### Claim 2 (depends on 1) The analytical assay reaction assembly of claim 1, wherein the magnetic assembly is attached to the analytical assay reaction cartridge. ### Claim 3 (depends on 1) The analytical assay reaction assembly of claim 1, further comprising a cartridge holder of a diagnostic instrument, wherein the cartridge holder is capable of receiving the analytical assay reaction cartridge, and wherein the magnetic assembly is attached to the cartridge holder such that the at least one contact point of the magnetic assembly is disposed substantially adjacent to the at least one contact point on the outer edge of the sample read window of the analytical assay reaction cartridge when the analytical assay reaction cartridge is disposed within the cartridge holder. ### Claim 4 (depends on 1) The analytical assay reaction assembly of claim 1, wherein the magnetic assembly further comprises an insulator member and at least one metal guide that connects the insulator member to the permanent magnet and extends through the insulator member to provide at least one metal contact point on the outer surface of the insulator member that forms the at least one contact point of the magnetic assembly and that is disposed substantially adjacent to the at least one contact point on the outer edge of the sample read window of the analytical assay reaction cartridge. ### Claim 5 (depends on 4) The analytical assay reaction assembly of claim 4, wherein the magnetic assembly is attached to the analytical assay reaction cartridge, whereby the at least one metal contact point of the magnetic assembly is attached to the at least one contact point on the outer edge of the sample read window of the analytical assay reaction cartridge. ### Claim 6 (depends on 4) The analytical assay reaction assembly of claim 4, wherein the magnetic assembly comprises at least two metal guides that connect the insulator member to the permanent magnet and that extend through the insulator member to provide at least two metal contact points on the outer surface of the insulator member, and wherein the at least two metal contact points are each disposed substantially adjacent to a contact point on the outer edge of the sample read window of the analytical assay reaction cartridge. ### Claim 7 (depends on 4) The analytical assay reaction assembly of claim 4, wherein the sample read window of the analytical assay reaction cartridge is quadrilateral in shape, and the magnetic assembly comprises two metal guides, wherein the two metal guides form two contact points of the magnetic assembly, wherein one contact point is disposed substantially adjacent or in contact with a contact point in an upper corner of the sample read window and the other contact point is disposed substantially adjacent or in contact with a contact point in an opposing lower corner of the sample read window. ### Claim 8 (depends on 1) The analytical assay reaction assembly of claim 1, wherein the at least one solid analytical reagent is positioned within the reaction chamber of the analytical assay reaction cartridge. ### Claim 9 (depends on 8) The analytical assay reaction assembly of claim 8, wherein the solid analytical reagent is attached to a portion of the reaction chamber of the housing. ### Claim 10 (depends on 1) The analytical assay reaction assembly of claim 1, wherein the permanent magnet of the magnetic assembly is selected from the group consisting of a neodymium magnet, an actuated electromagnet, an alnico magnet, and a ferrite magnet. ### Claim 11 (depends on 1) The analytical assay reaction assembly of claim 1, wherein the permanent magnet comprises a cylindrical neodymium magnet that has a diameter in a range of from about 0.1 cm to about 5 cm, and wherein the magnetic beads of the solid analytical reagent have a diameter of about 0.1 μm to about 5 μm. ### Claim 12 (depends on 1) The analytical assay reaction assembly of claim 1, further comprising a second solid analytical reagent utilized in an assay for an analyte, wherein the solid analytical reagent is soluble in a liquid reagent. ### Claim 13 (depends on 12) The analytical assay reaction assembly of claim 12, wherein the second solid analytical reagent is positioned within the reaction chamber of the analytical assay reaction cartridge. ### Claim 14 (depends on 12) The analytical assay reaction assembly of claim 12, wherein the second solid analytical reagent comprises beads coated with at least one anti-CRP (C-Reactive Protein) antibody. ### Claim 15 (depends on 1) The analytical assay reaction assembly of claim 1, wherein the analytical assay reaction cartridge further comprises a flange extending from the housing. ### Claim 16 (depends on 1) The analytical assay reaction assembly of claim 1, further comprising: a reagent tray disposed and retained within the housing of the analytical assay reaction cartridge, the reagent tray having a cavity formed therein in which a predetermined volume of liquid reagent is disposed, the reagent tray having a flexible cover removably attached thereto that seals the liquid reagent within the cavity, wherein the flexible cover has a tab portion for releasing the liquid reagent into the reaction chamber of the housing, and wherein the solid analytical reagent is soluble in the liquid reagent; and a capillary holder at least partially inserted into the inlet of the analytical assay reaction cartridge. ### Claim 17 (depends on 16) A method for performing at least one analytical reaction to determine the presence of an analyte in a liquid test sample using the analytical assay reaction assembly of claim 16, the method comprising the steps of: (a) contacting the capillary holder with a liquid test sample, whereby a portion of the liquid test sample is drawn into a capillary of the capillary holder; (b) disposing the capillary holder within at least a portion of the inlet of the analytical assay reaction cartridge to thereby introduce the liquid test sample into the reaction chamber of the analytical assay reaction cartridge; (c) positioning the analytical assay reaction cartridge within a cartridge holder of a diagnostic assay instrument, wherein the predetermined volume of liquid reagent is released from the reagent tray into the reaction chamber prior to, simultaneously with, or following insertion of the cartridge within the diagnostic assay instrument, whereby the liquid reagent mixes with the liquid test sample and the solid analytical reagent to form a reaction mixture in the reaction chamber; and (d) measuring a detectable response in the reaction mixture through the sample read window of the cartridge to determine the presence of at least one analyte in the liquid test sample. ### Claim 18 (depends on 17) The method of claim 17, wherein in step (c), the liquid reagent is released from the reagent tray into the reaction chamber by pulling the tab portion of the flexible cover of the analytical assay reaction cartridge. ### Claim 19 (depends on 17) The method of claim 17, further comprising the step of rocking the analytical assay reaction cartridge following step (c) and prior to step (d), wherein the rocking is sufficient to allow the magnetic beads of the analytical reagent to pass by and accumulate over the magnetic assembly. ### Claim 20 (depends on 17) The method of claim 17, wherein the magnetic assembly is attached to the analytical assay reaction cartridge. ### Claim 21 (depends on 17) The method of claim 17, wherein the magnetic assembly is attached to the cartridge holder such that the at least one metal contact point of the magnetic assembly is disposed substantially adjacent to the at least one contact point on the outer edge of the sample read window of the analytical assay reaction cartridge. ### Claim 22 (depends on 17) The method of claim 17, wherein the magnetic assembly further comprises an insulator member and at least one metal guide that connects the insulator member to the permanent magnet and extends through the insulator member to provide at least one metal contact point on the outer surface of the insulator member that forms the at least one contact point of the magnetic assembly and that is disposed substantially adjacent to the at least one contact point on the outer edge of the sample read window of the analytical assay reaction cartridge. ### Claim 23 (depends on 22) The method of claim 22, wherein the magnetic assembly is attached to the analytical assay reaction cartridge, whereby the at least one metal contact point of the magnetic assembly is attached to the at least one contact point on the outer edge of the sample read window of the analytical assay reaction cartridge. ### Claim 24 (depends on 22) The method of claim 22, wherein the magnetic assembly comprises at least two metal guides that connect the insulator member to the permanent magnet and that extend through the insulator member to provide at least two metal contact points on the outer surface of the insulator member, and wherein the at least two metal contact points are each disposed substantially adjacent to a contact point on the outer edge of the sample read window of the analytical assay reaction cartridge. ### Claim 25 (depends on 17) The method of claim 17, wherein the permanent magnet of the magnetic assembly comprises a cylindrical neodymium magnet. ### Claim 26 (depends on 25) The method of claim 25, wherein the cylindrical neodymium magnet has a diameter in a range of from about 0.1 cm to about 5 cm, and wherein the magnetic beads of the solid analytical reagent have a diameter of about 0.1 μm to about 5 μm.