Patent
Oscillating immunoassay method and device
العنوان: | Oscillating immunoassay method and device |
---|---|
Patent Number: | 9,329,175 |
تاريخ النشر: | May 03, 2016 |
Appl. No: | 13/204172 |
Application Filed: | August 05, 2011 |
مستخلص: | The present invention provides apparatus and methods for the rapid determination of analytes in liquid samples by immunoassays incorporating magnetic capture of beads on a sensor capable of being used in the point-of-care diagnostic field. |
Inventors: | Miller, Cary James (Ottawa, CA); Campbell, John Lewis Emerson (Ottawa, CA) |
Assignees: | Abbott Point of Care Inc. (Princeton, NJ, US) |
Claim: | 1. A magnetic immunosensing device for detecting an analyte in a sample, comprising: a dry reagent comprising magnetically susceptible beads, wherein the dry reagent is present in the device as a coating on a sample entry port, a sample entry chamber, a sensing device or a conduit and further wherein the beads are coated with an antibody to the analyte in the sample; a sensing electrode on a substantially planar chip, wherein the electrode is positioned in a conduit for receiving the sample containing the analyte mixed with the beads; two magnetic zones positioned in the conduit; and an oscillating device for applying an oscillating magnetic field across the surface of the electrode to move the beads back and forth across the surface to attract the beads in the conduit substantially proximate to the electrode and to substantially retain the beads at the electrode surface; wherein said immunosensing device is adapted for receiving the sample and wherein the oscillating magnetic field oscillates in the direction of a capture motion of the beads. |
Claim: | 2. The device of claim 1 , wherein the beads comprise ferrite. |
Claim: | 3. The device of claim 1 , wherein the beads comprise magnetite (Fe 3 O 4). |
Claim: | 4. The device of claim 1 , wherein the beads comprise a magnetically susceptible core with a polymer coating. |
Claim: | 5. The device of claim 1 , wherein the beads have an average particle size of from 0.01 μm to 20 μm. |
Claim: | 6. The device of claim 1 , wherein the beads have an average particle size of from 0.1 μm to 5 μm. |
Claim: | 7. The device of claim 1 , wherein the beads have an average particle size of from 0.2 μm to 1.5 μm. |
Claim: | 8. The device of claim 1 , wherein the antibody is to a low-abundance analyte in the sample. |
Claim: | 9. The device of claim 1 , wherein the antibody is to an analyte selected from the group consisting of cardiac troponin I, troponin T, a troponin complex, human chorionic gonadotropin, BNP, creatine kinase, creatine kinase subunit M, creatine kinase subunit B, creatine kinase MB (CK-MB), proBNP, NT-proBNP, myoglobin, myosin light chain and modified fragments thereof. |
Claim: | 10. The device of claim 1 , wherein the antibody is to an analyte selected from the group consisting of beta-HCG, TSH, ultra hTSH II, TT3, TT4, FT3, FT4, myeloperoxidase, D-dimer, CRP, NGAL, PSA, LH, FSH, prolactin, progesterone, estradiol, DHEA-S, AFP, CA 125 II, CA 125, CA 15-3, CA 19-9, CA 19-9XR, CEA, thyroxine (T4), triiodothyronine (T3), T-uptake, Tg, anti-Tg, anti-TPO, ferritin, cortisol, insulin, HBsAg, HCV Ag/Ab combo, HCV core Ag, anti-HCV, AUSAB (anti-HBs), CORE, CORE-M, SHBG, iPTH, theophylline, sirolimus, tacrolimus, anti-HAV, anti-HAV IgM, HAVAB, HAVAB-M, HAVAB-M2.0, HAVAB-G, HAVAB 2.0, HAVAB 2.0 Quant, IgM, CMV IgM, CMV IgG, â-2-microglobulin, digitoxin, HBe, anti-HBe, HBeAg, HIV 1/2gO, HIV Ag/Ab combo, testosterone, SCC, vitamin B12, folate, syphilis, anti-HBc, rubella IgG, rubella IgM, homocysteine, MPO, cytomegalovirus (CMV) IgG Avidity, toxo IgG avidity, toxo IgG, toxo IgM, C-peptide, vitamin D, HTLV I/II, total âhCG, progesterone, estradrogen, prolactin, myoglobin, tPSA, fPSA, carbamazepine (CBZ), digoxin, gentamicin, NAPA, phenytoin, phenobarbital, valproic acid, vancomycin, procaine, quinidine, tobramycin, methamphetamine (METH), amphetamine (AMPH), barbiturates, benzodiazepine, cannabis, cocaine, methadone, opiates, PCP, acetaminophen, ethanol, salicylates, tricyclics, holoTc, anti-CCP, HbA1c, barbs-U and modified fragments thereof. |
Claim: | 11. The device of claim 1 , wherein the oscillating device comprises a coil. |
Claim: | 12. The device of claim 1 , wherein the oscillating device comprises a fixed magnet on a mobile platform. |
Claim: | 13. The device of claim 1 , wherein the electrode is microfabricated. |
Claim: | 14. The device of claim 1 , wherein the electrode is amperometric. |
Claim: | 15. The device of claim 1 , wherein the electrode is a gold microarray. |
Claim: | 16. The device of claim 1 , wherein the conduit has a height of about 0.2 mm to about 5 mm and a width of about 0.2 mm to about 5 mm. |
Claim: | 17. The device of claim 1 , wherein the conduit has a uniform cross-sectional area. |
Claim: | 18. The device of claim 1 , wherein the conduit has a non-uniform cross-sectional area. |
Claim: | 19. The device of claim 1 , further comprising a reference sensor. |
Claim: | 20. The device of claim 1 , further comprising one or more differently-labeled magnetically susceptible beads. |
Claim: | 21. The device of claim 1 , further comprising a second sensing electrode. |
Patent References Cited: | 4230685 October 1980 Senyei et al. 4554088 November 1985 Whitehead et al. 4628037 December 1986 Chagnon et al. 4849340 July 1989 Oberhardt 4945045 July 1990 Forrest et al. 4978610 December 1990 Forrest et al. 5143630 September 1992 Rolchigo 5149630 September 1992 Forrest et al. 5200051 April 1993 Cozzette et al. 5422621 June 1995 Gambino et al. 5554339 September 1996 Cozzette et al. 5587102 December 1996 Stern et al. 5821399 October 1998 Zelin 5843329 December 1998 Deetz 5998224 December 1999 Rohr et al. 6231760 May 2001 Siddiqi 6294342 September 2001 Rohr et al. 6325973 December 2001 Leland et al. 6764859 July 2004 Kreuwel et al. 7106051 September 2006 Prins et al. 7223438 May 2007 Mirkin et al. 7419821 September 2008 Davis et al. 7572355 August 2009 Arumugam 7682833 March 2010 Miller et al. 7723099 May 2010 Miller et al. 8084272 December 2011 Campbell et al. 2002/0039667 April 2002 Takaya et al. 2003/0012693 January 2003 Otillar et al. 2003/0040129 February 2003 Shah 2003/0170881 September 2003 Davis et al. 2004/0009614 January 2004 Ahn et al. 2004/0210289 October 2004 Wang et al. 2005/0054078 March 2005 Miller et al. 2006/0257854 November 2006 McDevitt et al. 2008/0035579 February 2008 Lee et al. 2008/0160634 July 2008 Su et al. 2008/0187472 August 2008 Ahn et al. 2009/0001983 January 2009 Wittkowski 2009/0068757 March 2009 Lehmann et al. 2009/0148847 June 2009 Kokoris et al. 2009/0191401 July 2009 Deetz 2010/0009456 January 2010 Prins et al. 2010/0140146 June 2010 Markov et al. 2010/0248273 September 2010 Campbell et al. 2011/0071044 March 2011 Horiuchi 2011/0117580 May 2011 Campbell et al. 2011/0117581 May 2011 Campbell et al. 2011/0150705 June 2011 Doyle et al. 2011/0306070 December 2011 Campbell et al. 2012/0031773 February 2012 Miller et al. 2012/0034633 February 2012 Miller et al. 2012/0034684 February 2012 Campbell et al. 2012/0295302 November 2012 Lamish et al. WO 00/51814 September 2000 WO 01/87458 November 2001 |
Other References: | U.S. Appl. No. 61/288,189, filed Dec. 18, 2009, Doyle, et al. cited by applicant Laurell et al., Methods in Enzymology, vol. 73, “Electroimmunoassay”, Academic Press, New York, 339, 340, 346-348 (1981). cited by applicant M. J. Green (1987) Philos. Trans. R. Soc. Lond. B. Biol. Sci. 316:135-142. cited by applicant Bruls et al., Lab Chip 9, 3504-3510 (2009). cited by applicant Dittmer et al., Clin Chim. Acta (2010), doi:10.1016/J.cca.2010.03.001. cited by applicant International Search Report and Written Opinion mailed on Oct. 7, 2011 in corresponding International Application No. PCT/US2011/046761filed on Aug. 5, 2011 (11 pages). cited by applicant Rossier, et al., “Plasma Etched Polymer Microelectrochemical Systems,” Lab Chip, 2002, 2, pp. 145-150. cited by applicant Rossier, et al., Journal of Laboratory Automation, Dec. 2008, vol. 13, No. 6, pp. 322-329. cited by applicant Ramanujan, “Magnetic Particles for Biomedical Applicatoins,” Chapter 17, Biomedical Materials, Springer, NY, 2009. cited by applicant Kuhn, et al., “Developing Multiplexed Assays for Troponin I and Interleukin-33 in Plasma by Peptide Immunoaffinity Enrichment and Targeted Mass Spectrometry,” Clinical Chemistry, vol. 55, No. 6, pp. 1108-1117, 2009. cited by applicant Estes et al., “On chip cell separator using magnetic bead-based enrichment depletion of various surface markers”, Biomed Microdevices (2009), 11: 509-515. cited by applicant Peng, Z-C, et al., “A Bead-Based Electrochemical Biosensor with Integrated magnetic Manipulation for Controllable Sample Preconcentration,” Solid-State Sensors, Actuators and Microsystems Conference, 2009. Transducers (2009): 1802-1805. cited by applicant Berti et al., “Microfluidic-based electrochemical genosensor coupled to magnetic beads for hybridization detection”, vol. 77, No. 3, Jan. 15, 2009, pp. 971-978. cited by applicant International Search Report and Written Opinion for PCT/US2011/046753 dated Dec. 30, 2011. cited by applicant International Search Report and Written Opinion for PCT/US2011/046757 mailed Oct. 12, 2011. cited by applicant International Search Report and Written Opinion for PCT/US2011/046758 mailed Oct. 7, 2011. cited by applicant International Preliminary Report on Patentability and Written Opinion mailed Feb. 5, 2013 in corresponding International Application No. PCT/US2011/046761. cited by applicant Final Office Action mailed on Oct. 15, 2015 for U.S. Appl. No. 13/204,094, 57 pages. cited by applicant Notice of Allowance mailed on Sep. 29, 2015 for U.S. Appl. No. 13/204,121, 8 pages. cited by applicant Non-Final Office Action mailed on Sep. 18, 2015 for U.S. Appl. No. 13/204,109, 36 pages. cited by applicant Office Action for corresponding U.S. Appl. No. 13/204,121 dated Oct. 22, 2014. cited by applicant Office Action for U.S. Appl. No. 13/204,094 dated Mar. 28, 2013. cited by applicant Response to Office Action dated Mar. 28, 2013 for U.S. Appl. No. 13/204,094, filed Jun. 28, 2013. cited by applicant Final Office Action for U.S. Appl. No. 13/204,094 dated Jul. 24, 2013. cited by applicant Response to Final Office Action dated Jul. 24, 2013 for U.S. Appl. No. 13/204,094, filed Oct. 16, 2013. cited by applicant Office Action for U.S. Appl. No. 13/204,109 dated Jun. 11, 2013. cited by applicant K&J Magnetics, kjmagnetics.com, neodymium cylinder magnets, D22-N52. cited by applicant Response to Office Action dated Jun. 11, 2013 for U.S. Appl. No. 13/204,109, filed Oct. 11, 2013. cited by applicant Final Office Action for U.S. Appl. No. 13/204,109 dated Jun. 18, 2014. cited by applicant Response to Final Office Action dated Jun. 18, 2014 for U.S. Appl. No. 13/204,109, filed Aug. 28, 2014. cited by applicant Office Action for U.S. Appl. No. 13/204,121 dated Nov. 9, 2012. cited by applicant Response to Office Action dated Nov. 9, 2012 for U.S. Appl. No. 13/204,121, filed Feb. 11, 2013. cited by applicant Office Action for U.S. Appl. No. 13/204,121 dated Apr. 24, 2013. cited by applicant Response to Office Action dated Apr. 24, 2013 for U.S. Appl. No. 13/204,121, filed Jul. 24, 2013. cited by applicant Final Office Action for U.S. Appl. No. 13/204,121, dated Nov. 1, 2013. cited by applicant Response to Final Office Action dated Nov. 1, 2013 for U.S. Appl. No. 13/204,121, filed Jan. 31, 2014. cited by applicant United States Patent and Trademark Office, Office Action, U.S. Appl. No. 13/204,121 dated May 20, 2015. cited by applicant United States Patent and Trademark Office, Office Action, U.S. Appl. No. 13/204,094 dated Jan. 29, 2015. cited by applicant European Patent Office, Communication Pursuant to Article 94(3) EPC, European Application No. 11748815.5 dated Jun. 16, 2015. cited by applicant European Patent Office, Communication pursuant to Article 94(3) EPC, European Application No. 11748815.5 dated Jan. 30, 2015. cited by applicant |
Assistant Examiner: | Do, Pensee |
Primary Examiner: | Shibuya, Mark |
رقم الانضمام: | edspgr.09329175 |
قاعدة البيانات: | USPTO Patent Grants |
الوصف غير متاح. |