IP Library Granted Patent US 12,693,291
Granted Patent B2
US 12,693,291 · App. 17/225,605 · Granted Jul 28, 2026

Methods and devices for detecting MxA in a sample on a sample anaysis device

Inventors: Uma Mahesh Babu (Bradenton, FL); Robert P. Sambursky (Lakewood Ranch, FL)
Assignee: Rapid Pathogen Screening, Inc.
G01N33/54388G01N33/56911G01N33/56983B01L3/5023Y10T436/25125
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Quick Facts
Patent No.
US 12,693,291
App. No.
17/225,605
Filed
Apr 8, 2021
Granted
Jul 28, 2026
Kind
B2
Art Unit
1677
USPC
435/287.2
Abstract

Devices and methods incorporate mucolytic agents into a point-of-care testing device. The sample is loaded, and then the sample travels until it encounters one or more lysis agents and/or mucolytic agents. The mucolytic agent is preferably pre-loaded onto the collection device. In a preferred embodiment, the mucolytic agent is localized between the sample application zone and the conjugate zone. In embodiments with a sample compressor, one or more mucolytic agents may be pre-loaded and dried on the sample compressor, the sample collector, in various locations on the test strip, or in the running buffer.

Claims (21)

1 . A method for detecting MxA in a sample on a sample analysis device that includes a flow of an elution medium from an elution medium application zone to a detection zone, comprising:

a) transferring a blood sample that includes lymphocyte cells onto a sample application zone on the sample analysis device;

b) applying an elution medium that includes a lysis agent capable of lysing lymphocyte cells to the elution medium application zone, such that the elution medium, including the at least one lysis agent, flows through the sample application zone toward the detection zone to produce lysed lymphocyte cells, thereby releasing intracellular MxA present within the lymphocyte cells into the elution medium prior to reaching the detection zone;

c) reducing components of the lysed lymphocytes at a blocking zone of the sample analysis device that are larger than a pore size of a barrier at the blocking zone, wherein the blocking zone is positioned between the sample application zone and the detection zone; and

d) detecting the presence of MxA at the detection zone on the sample analysis device.

2 . The method of claim 1 , wherein a conjugate zone is located between the sample application zone and the detection zone.

3 . The method of claim 2 , wherein the blocking zone comprises pores that act as a barrier to slow or arrest lysed materials effectively larger than the pore size of the pores, wherein the blocking zone is positioned between the sample application zone and the conjugate zone.

4 . The method of claim 2 , wherein the blocking zone is positioned between the sample application zone and the conjugate zone.

5 . The method of claim 1 , wherein the sample is whole blood.

6 . The method of claim 1 , further comprising the step of detecting a presence of an extracellular protein at the detection zone.

7 . The method of claim 1 , wherein the sample analysis device is a lateral flow immunoassay device.

8 . The method of claim 1 , wherein the sample analysis device comprises a chromatography test strip.

9 . The method of claim 1 , wherein the blocking zone comprises pores that act as a barrier to slow or arrest lysed materials from the lysed lymphocyte cells effectively larger than the pore size of the barrier.

10 . The method of claim 1 , wherein the barrier is a physical barrier.

11 . The method of claim 1 , wherein erythrocytes of the blood sample are physically removed by the barrier to enhance selective lysis of leukocytes of the blood sample.

12 . The method of claim 1 , further comprising:

(i) exposing the MxA to a chemiluminescent detection reagent to form a detectable binding complex comprising the MxA coupled to the chemiluminescent detection reagent; and

(ii) detecting a chemiluminescence signal from the detectable binding complex, thereby determining the presence of MxA at the detection zone.

13 . The method of claim 1 , further comprising:

(i) exposing the MxA to a fluorescent or phosphorescent detection reagent to form a detectable binding complex comprising the MxA coupled to the fluorescent or the phosphorescent detection reagent; and

(ii) detecting a fluorescent signal or phosphorescent signal from the detectable binding complex, thereby determining the presence of MxA at the detection zone.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 9, 2021
From: BABU, UMA MAHESH; SAMBURSKY, ROBERT P.
To: RAPID PATHOGEN SCREENING, INC.
Reel/Frame 055878/0383 →
Continuity (18)
Continuation 15797915 · Oct 30, 2017
Continuation 14805708 · Jul 22, 2015
Division 13463126 · May 3, 2012
Continuation In Part 12502662 · Jul 14, 2009
Continuation In Part 12469207 · May 20, 2009
Continuation In Part 12481631 · Jun 10, 2009
Continuation In Part 12958454 · Dec 2, 2010
Provisional Application 61481907 · May 3, 2011
Provisional Application 61080879 · Jul 15, 2008
Provisional Application 61098935 · Sep 22, 2008
Provisional Application 61179059 · May 18, 2009
Provisional Application 61071833 · May 20, 2008
Provisional Application 61060258 · Jun 10, 2008
Provisional Application 61266641 · Dec 4, 2009
Provisional Application 61331966 · May 6, 2010
Provisional Application 61352093 · Jun 7, 2010
Provisional Application 61392981 · Oct 14, 2010
Related Publication 20210302419A1 · Sep 30, 2021
References Cited (90)
US 4094647A · Deutsch et al. · 1978 [cited by applicant]
US 4861711A · Friesen et al. · 1989 [cited by applicant]
US 4960691A · Gordon et al. · 1990 [cited by applicant]
US 5120643A · Ching et al. · 1992 [cited by applicant]
US 5229073A · Luo · 1993 [cited by examiner]
US 5496562A · Burgoyne · 1996 [cited by applicant]
US 5559041A · Kang et al. · 1996 [cited by applicant]
US 5607863A · Chandler · 1997 [cited by applicant]
US 5637469A · Wilding et al. · 1997 [cited by applicant]
US 5695949A · Galen et al. · 1997 [cited by applicant]
US 5698537A · Pruss · 1997 [cited by applicant]
US 5714341A · Thieme et al. · 1998 [cited by applicant]
US 5756126A · Burgoyne · 1998 [cited by applicant]
US 5807527A · Burgoyne · 1998 [cited by applicant]
US 5824268A · Bernstein et al. · 1998 [cited by applicant]
US 5869345A · Chandler · 1999 [cited by applicant]
US 5939252A · Lennon et al. · 1999 [cited by applicant]
US 5972386A · Burgoyne · 1999 [cited by applicant]
US 5985327A · Burgoyne · 1999 [cited by applicant]
US 6106779A · Buechler et al. · 2000 [cited by applicant]
US 6350578B1 · Stark et al. · 2002 [cited by applicant]
US 6358752B1 · Durst et al. · 2002 [cited by applicant]
US 6368876B1 · Huang et al. · 2002 [cited by applicant]
US 6514773B1 · Klein et al. · 2003 [cited by applicant]
US 6875619B2 · Blackburn · 2005 [cited by applicant]
US 7374950B2 · Kang et al. · 2008 [cited by applicant]
US 7379167B2 · Mawhirt et al. · 2008 [cited by applicant]
US 7393697B2 · Charlton · 2008 [cited by applicant]
US 7425302B2 · Piasio et al. · 2008 [cited by applicant]
US 7723124B2 · Aberl et al. · 2010 [cited by applicant]
US 7939342B2 · Song et al. · 2011 [cited by applicant]
US 8614101B2 · VanDine · 2013 [cited by examiner]
US 8962260B2 · Sambursky · 2015 [cited by examiner]
US 9372192B2 · Sambursky · 2016 [cited by examiner]
US 9910036B2 · Sambursky · 2018 [cited by examiner]
US 9933423B2 · Sambursky · 2018 [cited by examiner]
US 10408835B2 · Sambursky · 2019 [cited by examiner]
US 11002734B2 · Babu · 2021 [cited by examiner]
US 12078636B2 · Sambursky · 2024 [cited by examiner]
US 20030027866A1 · Johnson et al. · 2003 [cited by applicant]
US 20030104506A1 · Durst et al. · 2003 [cited by applicant]
US 20030186463A1 · Hudak et al. · 2003 [cited by applicant]
US 20040110167A1 · Gerdes et al. · 2004 [cited by applicant]
US 20040156037A1 · Mawhirt et al. · 2004 [cited by applicant]
US 20040241779A1 · Piasio et al. · 2004 [cited by applicant]
US 20050227223A1 · Miyawaki · 2005 [cited by applicant]
US 20050239056A1 · Piasio et al. · 2005 [cited by applicant]
US 20060160078A1 · Cardy et al. · 2006 [cited by applicant]
US 20060240569A1 · Goldenbaum et al. · 2006 [cited by applicant]
US 20070059682A1 · Aberl et al. · 2007 [cited by applicant]
US 20070141564A1 · Aberl et al. · 2007 [cited by applicant]
US 20070264629A1 · Holmes et al. · 2007 [cited by applicant]
US 20080085525A1 · Herwijnen · 2008 [cited by applicant]
US 20080199851A1 · Egan et al. · 2008 [cited by applicant]
US 20090011436A1 · Piasio et al. · 2009 [cited by applicant]
US 20090232702A1 · Wu et al. · 2009 [cited by applicant]
US 20100143891A1 · Aberl et al. · 2010 [cited by applicant]
US 20100279308A1 · Morrow et al. · 2010 [cited by applicant]
US 20100291536A1 · Viljoen et al. · 2010 [cited by applicant]
US 20100297611A1 · Sambursky et al. · 2010 [cited by applicant]
DE 19622503C2 · 1998 [cited by applicant]
EP 1489416A1 · 2004 [cited by applicant]
JP 2000502452A · 2000 [cited by applicant]
JP 2005017248A · 2005 [cited by applicant]
JP 2012503170A · 2012 [cited by applicant]
JP 2012503205A · 2012 [cited by applicant]
JP 2012181211A · 2012 [cited by applicant]
WO 9723781A1 · 1997 [cited by applicant]
WO 03073817A2 · 2003 [cited by applicant]
WO 2004076054A2 · 2004 [cited by applicant]
WO 2006115866A1 · 2006 [cited by applicant]
WO 2007070117A1 · 2007 [cited by applicant]
WO 2008014709A1 · 2008 [cited by applicant]
WO 2009044167A1 · 2009 [cited by applicant]
WO 2009152209A2 · 2009 [cited by applicant]
WO 2010009206A2 · 2010 [cited by applicant]
WO 2010033963A2 · 2010 [cited by applicant]
“FTA Nucleic Acid Collection, Storage and Purification,” Whatman website, http://whatman.com/products.aspx?PID=108. [cited by applicant]
Barnard, et al., “Development of an Oligonucleotide-Based SNP Detection Method on Lateral Flow Strips Using Hexapet Tags,” Point of Care, vol. 4, No. 3, pp. 108-118 (Sep. 2005). [cited by applicant]
Berezovski, et al., “Cell lysis inside the capillary facilitated by transverse diffusion of laminar flow profiles (TDLFP),” Anal Bioanal Chem (2007) 387:91-96. [cited by applicant]
Chieux V, Hober D, Harvey J, Lion G, Lucidarme D, Forzy G, Duhamel M, Cousin J, Ducoulombier H, Wattre P. The MxA protein levels in whole blood lysates of patients with various viral infections. J Virol Methods. 1998;70… [cited by applicant]
Extended European Search Report for application No. 09798691.3, European Patent Office, Feb. 10, 2012. [cited by applicant]
International Search Report and Written Opinion dated Mar. 12, 2010, International Application No. PCT/US2009/050653. [cited by applicant]
Karle, et al., “Application of FTA-based Technology for Sample Collection, Transport, Purification, and Storage of PCR-ready Plant DNA” (Nov. 2003). [cited by applicant]
O'Mahony, et al., “Integration of Bacteria Capture via Filtration and in Situ Lysis for Recovery of Plasmid DNA under Industry-Compatible Conditions,” Biotechnol. Prog. 2007, 23, pp. 895-903. [cited by applicant]
Sambursky et al., “The RPS Adeno Detector for Diagnosing Adenoviral Conjunctivitis”, Ophthalmology, vol. 113, No. 10, pp. 1758-1764 (Oct. 2006). [cited by applicant]
Sambursky, “510-K Summary of Safety and Effectiveness” (Sep. 14, 2005). [cited by applicant]
Uchio, et al., “Rapid Diagnosis of Adenoviral Conjunctivitis on Conjunctival Swabs by 10-Minute Immunochromatography,” Opthalmology, vol. 104, No. 8, Aug. 1997, pp. 1294-1299. [cited by applicant]
Udeh et al., “Cost Effectiveness of a Point-of-Care Test for Adenoviral Conjunctivitis”, The American Journal of the Medical ciences, vol. 336, No. 3, pp. 254-264 (Sep. 2008). [cited by applicant]
Reichert A. et al., “Polydiacetylene Liposomes Functionalized with Sialic Acid Bind and Colorimetrically Detect Influenza Virus,” Journal of the American Chemical Society, Jan. 1995, vol. 117 No. 2, p. 829-830. [cited by applicant]