# US 7,611,908 B2 · Method and apparatus for therapeutic drug monitoring using an acoustic device > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 7,611,908 B2 - Document ID: US7611908B2 - Status: Granted - Kind: B2 - Application number: 11/416,624 - Filed: 2006-05-02 - Published: 2009-06-11 - Granted: 2009-11-03 - Earliest claimed: 2005-05-02 - Assignees: BioScale, Inc. - Inventors: Michael Miller; Brett P. Masters; Mark Lundstrom; Alok Srivastava; Wayne U. Wang - Web page: https://patentgrep.com/patent/US7611908B2 ## CPC - G01N 29/4418: {with a model, e.g. best-fit, regression analysis} - 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} - G01N 29/022: {Fluid sensors based on microsensors, e.g. quartz crystal-microbalance [QCM], surface acoustic wave [SAW] devices, tuning forks, cantilevers, flexural plate wave [FPW] devices (microdevices per se B81B)} - G01N 29/036: by measuring frequency or resonance of acoustic waves - G01N 33/54313: {the carrier being characterised by its particulate form} - G01N 33/9493: {Immunosupressants} - B01L 2200/0647: Handling flowable solids, e.g. microscopic beads, cells, particles - B01L 2300/0681: Filter - B01L 2300/1822: using Peltier elements - B01L 2400/043: magnetic forces - B01L 2400/0487: fluid pressure, pneumatics - B82Y 15/00: Nanotechnology for interacting, sensing or actuating, e.g. quantum dots as markers in protein assays or molecular motors - B82Y 30/00: Nanotechnology for materials or surface science, e.g. nanocomposites - G01N 2291/0256: Adsorption, desorption, surface mass change, e.g. on biosensors - G01N 2291/02836: Flow rate, liquid level - G01N 2291/0427: Flexural waves, plate waves, e.g. Lamb waves, tuning fork, cantilever - G01N 2800/324: Coronary artery diseases, e.g. angina pectoris, myocardial infarction - 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 - B82Y: SPECIFIC USES OR APPLICATIONS OF NANOSTRUCTURES; MEASUREMENT OR ANALYSIS OF NANOSTRUCTURES; MANUFACTURE OR TREATMENT OF NANOSTRUCTURES ## Abstract Methods for therapeutic drug monitoring are provided. A plurality of particles, each of which is coated with a capture agent capable of binding a therapeutic drug of choice is combined with the sample to form a plurality of therapeutic drug-particle complexes. The system also includes a transport arrangement for transporting the sample and/or particles to the sensor surface, and optionally a magnetic field inducing structure constructed and arranged to establish a magnetic field at and adjacent to the sensor surface. The resonant sensor produces a signal corresponding to an amount of therapeutic drug-particle complexes that are bound to the sensor surface. ## Claims ### Claim 1 A method for detecting one or more immunosuppressants in a sample, the method comprising the steps of: a) introducing a fluid comprising a sample, a plurality of magnetic particles and a competitor molecule into a fluid chamber, said magnetic particles being coated with a first capture agent capable of binding an immunosuppressant, wherein at least one surface of the fluid chamber comprises a flexural plate wave device that has been coated with a second capture agent capable of binding to the competitor molecule, wherein the flexural plate wave device has a membrane that is capable of vibrating, and wherein the second capture agent is bound to the membrane; b) applying a retractable source of magnetic flux positioned external to the fluid chamber close to the membrane to create a significant magnetic field gradient to attract the magnetic particles in the fluid toward the membrane; c) monitoring a first signal output by the flexural plate wave device, wherein the first signal output is monitored in the presence of a magnetic flux; d) after removing the retractable source of magnetic flux, flowing a solution through the fluid chamber to remove magnetic particles not bound to the membrane; e) monitoring a second signal output by said flexural plate wave device, wherein the second signal output is monitored in the absence of the magnetic flux; and f) comparing the first and the second signal output to a control signal, thereby detecting the immunosuppressant. ### Claim 2 (depends on 1) The method of claim 1, further comprising adjusting dosage of said immunosuppressant administered to an individual based on the level of said drug in the sample. ### Claim 3 (depends on 1) The method of claim 1, wherein prior to being introduced into the fluid chamber, said plurality of magnetic particles has been exposed to the sample and to the competitor molecule. ### Claim 4 (depends on 1) The method of claim 1, wherein the competitor molecule comprises the immunosuppressant bound to a tag and the second capture agent is capable of binding to the tag. ### Claim 5 (depends on 4) The method of claim 4, wherein the tag is biotin. ### Claim 6 (depends on 1) The method of claim 1, wherein the competitor molecule comprises two or more immunosuppressant molecules bound to a carrier, and the second capture agent is capable of binding the immunosuppressant. ### Claim 7 (depends on 6) The method of claim 6, wherein the carrier is a selected from the group consisting of horseradish peroxidase and albumin. ### Claim 8 (depends on 1) The method of claim 1, wherein the sample is selected from the group consisting of blood, serum, plasma, cerebrospinal fluid, urine, saliva, and biopsy material. ### Claim 9 (depends on 1) The method of claim 1, wherein the immunosuppressant is selected from the group consisting of cyclosporine, tacrolimus, rapamycin, and mycophenolate mofetil. ### Claim 10 (depends on 1) The method of claim 1, wherein the control signal is obtained without the sample. ### Claim 11 (depends on 1) The method of claim 1, wherein the control signal is a standard curve. ### Claim 12 (depends on 1) The method of claim 1, wherein the second capture agent is indirectly bound to said surface. ### Claim 13 (depends on 12) The method of claim 12, wherein said surface is coated with a first member of a binding pair, and the second capture agent is bound to a second member of the binding pair. ### Claim 14 (depends on 13) The method of claim 13, wherein a first member of the binding pair is biotin. ### Claim 15 (depends on 1) The method of claim 1, wherein the first or the second capture agent is an antibody. ### Claim 16 (depends on 13) The method of claim 13, wherein a second member of the binding pair is a derivative of avidin. ### Claim 17 (depends on 1) The method of claim 1, wherein a fluid flows across the membrane during one or more of steps of a), b), c) and e).