Methods and apparatus for therapeutic drug monitoring using an acoustic device
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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.
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Citations
35 Claims
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1-15. -15. (canceled)
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16. A method for detecting one or more immunosuppressants in a sample, the method comprising the steps of:
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a) introducing a plurality of particles and a competitor molecule into a fluid chamber, said particles being coated with a first capture agent capable of binding an immunosuppressant, wherein at least one surface of the fluid chamber comprises an acoustic device that has been coated with a second capture agent capable of binding to the competitor molecule, and b) monitoring signal output by said acoustic device, thereby detecting the immunosuppressant.
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17. The method of claim 16, wherein the acoustic device is a flexural plate wave device.
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18. The method of claim 16, further comprising adjusting dosage of said immunosuppressant administered to an individual based on the level of said drug in the sample.
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19. The method of claim 16, wherein prior to being introduced into the fluid chamber, said plurality of particles has been exposed to the sample and to the competitor molecule.
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20. The method of claim 16, wherein the competitor molecule comprises the immunosuppressant bound to a tag and the second capture agent is capable of binding to the tag.
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21. The method of claim 20, wherein the tag is biotin.
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22. The method of claim 16, 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.
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23. The method of claim 22, wherein the carrier is a selected from the group consisting of horseradish peroxidase and albumin.
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24. The method of claim 16, wherein the particles are magnetic and further comprising creating a magnetic flux in proximity to the acoustic device to attract at least one of the plurality of magnetic particles toward the at least one surface.
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25. The method of claim 24, wherein the magnetic flux is removed prior to step b).
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26. The method of claim 16, wherein the sample is selected from the group consisting of blood, serum, plasma, cerebrospinal fluid, urine, saliva, and biopsy material.
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27. The method of claim 16, wherein the immunosuppressant is selected from the group consisting of cyclosporine, tacrolimus, rapamycin, and mycophenolate mofetil.
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28. The method of claim 16, further comprising comparing the signal output of b) to a control.
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29. The method of claim 28, wherein the control signal is obtained in the absence of sample.
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30. The method of claim 28, wherein the control signal is a standard curve.
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31. The method of claim 16, wherein the second capture agent is indirectly bound to said surface.
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32. The method of claim 31, 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.
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33. The method of claim 32, wherein a first member of the binding pair is biotin.
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34. The method of claim 16, wherein the first or second capture agent is an antibody.
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35. The method of claim 33, wherein a second member of the binding pair is a derivative of avidin.
Specification