Test Papers Patents (Class 435/805)
  • Patent number: 9034657
    Abstract: A two step lateral flow assay method for identifying IgE antibodies in a sample comprises applying a sample to a sample port of a device, wherein the device is adapted to deliver the sample to a lateral flow matrix having a plurality of IgE antigen species immobilized at respective positions at a first location; allowing the sample to travel along the lateral flow matrix through the immobilized plurality of IgE antigen species to a second location downstream of the first location; and, after a predetermined period of time, applying liquid buffer to the lateral flow matrix to mobilize labeled reagent which is adapted to bind anti-IgE antibody and which is dried on the lateral flow matrix at a location upstream of the sample port delivery of the sample to the lateral flow matrix, and allowing labeled reagent mobilized by the liquid buffer to travel along the lateral flow matrix through the immobilized plurality of IgE antigen species and bind with any IgE antibody bound to the immobilized IgE antigen species, a
    Type: Grant
    Filed: December 8, 2010
    Date of Patent: May 19, 2015
    Assignee: Phadia AB
    Inventors: Gerd Rundström, Per Matsson, Paul Christopher
  • Patent number: 9005991
    Abstract: Devices and methods for testing a biological sample for an analyte of interest are provided that make use of a reaction chamber for receiving a reaction mixture, a housing positioned below the reaction chamber for receiving a test cassette, and a door that is positioned in the top portion of the housing. The door includes a ramp that extends downwardly into the housing such that biasing the ramp upwards opens the door into the cavity of the reaction chamber and places the reaction chamber in fluid communication with the insertion area to thereby allow the reaction mixture to flow onto a test cassette and allow for the determination of an amount of an analyte of interest.
    Type: Grant
    Filed: January 5, 2012
    Date of Patent: April 14, 2015
    Assignee: American Bio Medica Corporation
    Inventors: Douglas Casterlin, Larry Ferringo
  • Patent number: 8956859
    Abstract: A host antigen-specific antibody testing system and method. The a ternary complex of the antigen, a ligand-bound anti-host IgM, and a non-host anti-antigen IgG detector conjugate selectively form a quaternary complex with host antibodies, wherein the host antibodies and IgG compete for the antigen, and the IgM binds the host antibodies. The quaternary complex is retained by an immobilized IgM ligand binding agent, and any residual ternary is retained by a later encountered immobilized anti-non-host IgG. If sufficient host antibodies have a high affinity for the antigen, the complex is detected at the quaternary complex detection region based on the presence of the detector, and if there are insufficient high affinity host antibodies, the ternary complex migrates past the quaternary complex detection region and is retained and detected at a control region.
    Type: Grant
    Filed: August 15, 2011
    Date of Patent: February 17, 2015
    Assignee: Aviex Technologies LLC
    Inventor: David G. Bermudes
  • Patent number: 8900881
    Abstract: The present invention relates to a quantitative assay device and a method for the determination of an analyte, based on a test strip, which contains a porous test membrane allowing for capillary flow of the analyte and complexes of the analyte, a porous upstream membrane in fluid connection with the test membrane and a porous downstream membrane in fluid connection with the test membrane, wherein the test membrane contains two bands having deposited on there high and low concentrations of different calibrator agents and a test band capable of reacting with conjugated analyte complexes giving rise to a measurable signal.
    Type: Grant
    Filed: September 12, 2011
    Date of Patent: December 2, 2014
    Inventor: Jin Po Lee
  • Patent number: 8889424
    Abstract: A device and method for performing a point of care diagnostic test for detecting and quantifying at least one analyte in a biological sample (e.g., a body fluid). A device may include an immunoassay apparatus and a holder with an adjustable variable angle stage for positioning the immunoassay apparatus relative to a light source and a detector device so as to optimize the angle of incidence and angle of radiation to optimize an elastic light scattering signal from the immunoassay apparatus. The elastic light scattering signal may be used to quantify the amount of the analyte(s) of interest present in the sample. The device is based upon elastic light scattering, so the variation in the angle of incidence and angle of reflection are optimized to maximize signal generation due to elastic light scattering.
    Type: Grant
    Filed: September 12, 2012
    Date of Patent: November 18, 2014
    Inventors: Joel R. L. Ehrenkranz, Pamela J. Turbeville, Jeong-Yeol Yoon, David J. You
  • Patent number: 8883086
    Abstract: Disclosed herein are an apparatus and method for measuring biomedical data and a measurement strip. The apparatus includes a plurality of detection units arranged within a strip reception area on a plane and spaced apart from each other, a measurement type determination unit for determining whether reactive portions are present in areas of the measurement strip corresponding to the plurality of detection units based on detection results obtained by the detection units and determining a type of measurement based on results of the determination, a biomedical data measurement unit for activating part or all of the detection units according to the type of measurement determined by the measurement type determination unit, and measuring the biomedical data using the activated detection units, and an output unit for outputting the measured biomedical data to an outside.
    Type: Grant
    Filed: March 11, 2010
    Date of Patent: November 11, 2014
    Assignee: Infopia Co., Ltd.
    Inventors: Byeong-Woo Bae, Sung-Dong Lee, Byung-Hoon Kho, Ji-Eon Ryu, Jin-Kyeong Kim, Hyou-Arm Joung
  • Patent number: 8877515
    Abstract: It is an object of the present invention to provide a measurement kit for developing a first developing solution and a second developing solution from different directions to suppress background noise, and an immunochromatography kit. The present invention provides a measurement kit, which comprises a first developing member for supplying a first developing solution and a second developing member for supplying a second developing solution, wherein the developing direction of the first developing solution is allowed to intersect with the developing direction of the second developing solution, so that development is carried out by developing the first and second developing solutions in different developing directions, and a water absorbent portion is established on the downstream of each of the developing directions.
    Type: Grant
    Filed: July 7, 2011
    Date of Patent: November 4, 2014
    Assignee: FUJIFILM Corporation
    Inventors: Hiroyuki Chiku, Junichi Katada, Hideyuki Karaki, Hiroki Terada
  • Patent number: 8835182
    Abstract: The present invention provides an immunochromatographic device, which contains the following (a) and (b): (a) a first device part holding a first insoluble carrier used for developing a complex formed with an analyte and a labeling substance comprising a metal labeled with a first binding substance that can bind to the analyte and capturing the analyte and the labeling substance at a reaction portion containing a second binding substance that can bind to the analyte, and (b) a second device part holding a second insoluble carrier used for developing a liquid and a third insoluble carrier used for absorbing a liquid, in such a way that the first insoluble carrier does not come into contact with the second insoluble carrier and the third insoluble carrier.
    Type: Grant
    Filed: January 24, 2013
    Date of Patent: September 16, 2014
    Assignee: FUJIFILM Corporation
    Inventors: Junichi Katada, Hideyuki Karaki, Takayoshi Oyamada
  • Patent number: 8815609
    Abstract: A lateral flow device includes a sample compressor and a test strip comprising a diverting zone. The diverting zone, which may include a barrier and/or a gap or ditch, stops or impedes flow. Flow is reinitiated and diverted into an alternate plane by compression of a sample compressor. Flow returns to the original, lateral plane, at the end of the diverting zone.
    Type: Grant
    Filed: March 7, 2013
    Date of Patent: August 26, 2014
    Assignee: Rapid Pathogen Screening, Inc.
    Inventors: Uma Mahesh Babu, Robert P. Sambursky, Peter Condon, Robert W. VanDine
  • Patent number: 8802427
    Abstract: The present invention is related to a diagnostic test kit that assesses ovarian reserve by measuring Follicle Stimulating Hormone (FSH) in a liquid sample. The sample can be deposited on a first portion of the device for transport to a second portion of the device. The device can include a release medium formed of a first material and including a detectable label thereon and a capture medium, including a test site, in fluid communication with the release medium and formed of a second, different material.
    Type: Grant
    Filed: June 9, 2009
    Date of Patent: August 12, 2014
    Assignee: Church & Dwight Co., Inc.
    Inventors: Albert R. Nazareth, Timothy Snowden, Mary Beth Boyle, Shang Li
  • Patent number: 8722426
    Abstract: The present invention relates generally to an assay for detecting and differentiating multiple analytes, if present, in a single fluid sample, including devices and methods therefore.
    Type: Grant
    Filed: March 5, 2010
    Date of Patent: May 13, 2014
    Assignee: Quidel Corporation
    Inventors: Paul Lambotte, Michael Cerrito, Cecille Ramirez
  • Patent number: 8703504
    Abstract: A lateral flow, membrane-based assay device for detecting the presence or quantity of an analyte residing in a test sample is provided. The device utilizes phosphorescence to detect the signals generated by excited phosphorescent labels. The labels may have a long emission lifetime so that background interference from many sources, such as scattered light and autofluorescence, is practically eliminated during detection. In addition, the phosphorescent labels may be encapsulated within particles to shield the labels from quenchers, such as oxygen or water, which might disrupt the phosphorescent signal.
    Type: Grant
    Filed: September 4, 2013
    Date of Patent: April 22, 2014
    Assignee: Kimberly-Clark Worldwide, Inc.
    Inventor: Xuedong Song
  • Patent number: 8614101
    Abstract: Devices and methods incorporate lysis agents into a point-of-care testing device. The sample is loaded, and then the sample travels until it encounters a lysis agent. The lysis agent is preferably pre-loaded onto the collection device. In a preferred embodiment, the initially lysis agent is localized between the sample application zone and the conjugate zone. The lysis agent is preferably soluble or miscible in the sample transport liquid, and the lysis agent is solubilized and activated upon contact with the sample transport liquid. The sample transport liquid then contains both lysis agent in solution or suspension and sample components in suspension. Any lysis-susceptible components in a sample, then being exposed in suspension to the lysis agent, are themselves lysed in situ. The running buffer then carries the analyte, including any lysis-freed components, to the detection zone.
    Type: Grant
    Filed: July 14, 2009
    Date of Patent: December 24, 2013
    Assignee: Rapid Pathogen Screening, Inc.
    Inventors: Robert W. VanDine, Uma Mahesh Babu, Robert P. Sambursky
  • Patent number: 8603835
    Abstract: Test cells have a first sorbent strip with a sample receiving location and defining a first migration path, a distinct second sorbent strip which receives buffer solution and at least partially defines a second migration path distinct from and elongated relative to the first migration path, conjugate supported by the second strip, a test site located at a junction of the first and second strips and having an immobilized ligand-binding mechanism, and a divider which directs a first amount of the buffer to the first strip to move the sample to the test site and a second amount to the second strip to move the conjugate to the test site. The first and second migration paths have first and second lengths chosen so that ligand in the sample reaches the test site and binds to the immobilized ligand-binding mechanism prior to the conjugate reaching the test site.
    Type: Grant
    Filed: February 10, 2011
    Date of Patent: December 10, 2013
    Assignee: Chembio Diagnostic Systems, Inc.
    Inventor: Javanbakhsh Esfandiari
  • Patent number: 8557604
    Abstract: A lateral flow, membrane-based assay device for detecting the presence or quantity of an analyte residing in a test sample is provided. The device utilizes phosphorescence to detect the signals generated by excited phosphorescent labels. The labels may have a long emission lifetime so that background interference from many sources, such as scattered light and autofluorescence, is practically eliminated during detection. In addition, the phosphorescent labels may be encapsulated within particles to shield the labels from quenchers, such as oxygen or water, which might disrupt the phosphorescent signal.
    Type: Grant
    Filed: December 14, 2007
    Date of Patent: October 15, 2013
    Assignee: Kimberly-Clark Worldwide, Inc.
    Inventor: Xuedong Song
  • Patent number: 8486717
    Abstract: The present invention relates to novel lateral flow devices using two dimensional features, preferably, uniform two dimensional test and control features, and the methods for detecting an analyte using the lateral flow devices, and processes for making the lateral flow devices.
    Type: Grant
    Filed: January 4, 2012
    Date of Patent: July 16, 2013
    Assignee: Symbolics, LLC
    Inventors: Brendan O'Farrell, Thomas C. Tisone
  • Patent number: 8470608
    Abstract: The sensitivity of visually read lateral flow immunoassay tests is enhanced by adding a small quantity of fluorescing dye or fluorescing latex bead conjugates to the initial conjugate material. When the visible spectrum test line is visibly present, the test result is observed and recorded. However, in the case where the result is indeterminate, a light of an appropriate spectrum, such as a UV, visible, or infrared spectrum, is cast on the test line to excite and fluoresce the fluorescing latex beads which are bound in the test line in true positive tests to enhance the visible color at the test line.
    Type: Grant
    Filed: June 10, 2009
    Date of Patent: June 25, 2013
    Assignee: Rapid Pathogen Screening, Inc
    Inventors: Uma Mahesh Babu, Robert W. VanDine, Robert P. Sambursky, Ganga Kanaujia, Richard Rivas, Jr.
  • Patent number: 8455263
    Abstract: The present invention relates to an assay device and a method for using such for the quantitative determination of an analyte, based on a test strip, which contains a porous test membrane allowing for capillary flow of the analyte and complexes of the analyte, a porous upstream membrane in fluid connection with the test membrane and a porous downstream membrane in fluid connection with the test membrane, wherein the test membrane contains a test site having immobilized thereon a ligand capable of reacting with the analyte and binding such to the test site, and two standard band sites having immobilized thereon known high and low concentrations of a calibrator agent capable of reacting with a label conjugate and binding such to the standard sites, wherein the upstream membrane has a site for the application of a sample to be analyzed, and has a site downstream from the sample application site for depositing label conjugates capable of reacting with the analyte and label conjugates capable of reacting with the
    Type: Grant
    Filed: December 30, 2008
    Date of Patent: June 4, 2013
    Inventor: Jin Po Lee
  • Patent number: 8445293
    Abstract: The present invention includes methods and devices for preventing interfering substances from affecting the accuracy of a lateral flow immunoassay. In preferred embodiments, a test strip includes a capturing zone that includes at least one mobile capturing reagent that separates at least one interfering substance from the analyte. The capturing zone is preferably located upstream of the sample application zone. In some embodiments, the reagent/conjugate zone is also located upstream of the sample application zone. The capturing zone may be located upstream, downstream, or overlapping with the reagent/conjugate zone in these embodiments. In other preferred embodiments, one or more mobile capturing reagents are included in the elution medium/running buffer. In yet other embodiments, the capturing reagent is incorporated into a sample collection device of a sample collection system, preferably separate from the chromatographic test strip. A lysis zone is also included in some preferred embodiments.
    Type: Grant
    Filed: September 29, 2009
    Date of Patent: May 21, 2013
    Assignee: Rapid Pathogen Screening, Inc.
    Inventors: Uma Mahesh Babu, Franz Aberl, Marcus Scheibenzuber, Robert P. Sambursky, Robert W. VanDine, Jose S. Sambursky
  • Patent number: 8431405
    Abstract: The present invention related to a pregnancy test device that can selectively detect hyperglycosylated human chorionic gonadotropin (hCG-H) in a liquid sample. The sample can be deposited on a proximal portion of the device for transport to a distal portion of the device. The device can include a release medium formed of a first material and including a detectable label thereon and a capture medium, including a capture site, in fluid communication with the release medium and formed of a second, different material. At least one of the release medium and the capture medium includes a binding member that exhibits a moderate to high affinity for hCG-H and is selectively or preferentially reactive with hCG-H.
    Type: Grant
    Filed: August 22, 2012
    Date of Patent: April 30, 2013
    Assignee: Church & Dwight Co., Inc.
    Inventors: Albert R. Nazareth, Timothy Snowden
  • Patent number: 8409526
    Abstract: The invention provides a method and article for storing genetic material or analytes from a biological sample by contacting said biological sample with a cellulose substrate comprising structural units of Formula I wherein X and Y are independently N—O-L-A or O, with the proviso that when Y is O, then X is N—O-L-A, and when X is O, then Y is N—O-L-A; L is a direct bond, an aliphatic radical, an aromatic radical, a cycloaliphatic radical, or a combination thereof; and A=COOH, SO3H, or a combination thereof. The invention also relates to a cellulose substrate comprising the structural units of Formula I, and a method of manufacturing the same.
    Type: Grant
    Filed: December 9, 2010
    Date of Patent: April 2, 2013
    Assignee: General Electric Company
    Inventors: Omayra Liz Padilla De Jesus, David Roger Moore, William Christopher Alberts
  • Patent number: 8404493
    Abstract: Methods for measuring the amount of two or more analytes of interest in a fluid sample, and kits useful in the methods, are disclosed. The methods involve determining a ratio of a detected amount of a single analyte of interest, to the sum of a detected amount of each of the analytes of interest plus a detected amount of a control, wherein the amount of each analyte of interest is directly or inversely related to the ratio for each analyte of interest.
    Type: Grant
    Filed: June 4, 2009
    Date of Patent: March 26, 2013
    Assignee: Response Biomedical Corporation
    Inventors: Whalley K. Fong, Paul C. Harris, Brian G. Richards
  • Patent number: 8394600
    Abstract: Compositions, methods and devices for the detection of anti-lipoidal antibodies and the diagnosis of disease, for example, syphilis, are described. In particular, a method for immobilizing a lipoidal antigen, comprising cardiolipin, lecithin, and cholesterol, on a solid support (such as a nitrocellulose membrane) is described. The ability to immobilize a lipoidal antigen on a membrane satisfies a long-felt need for a membrane-based assay for the detection of anti-lipoidal antibodies. Also described are immunoassay devices for concurrently performing treponemal and non-treponemal tests for syphilis.
    Type: Grant
    Filed: March 23, 2012
    Date of Patent: March 12, 2013
    Assignee: The United States of America as represented by the Secretary of the Department of Health and Human Services, Centers for Disease Control and Prevention
    Inventor: Arnold R. Castro
  • Patent number: 8389229
    Abstract: Compositions, methods and devices for the detection of anti-lipoidal antibodies and the diagnosis of disease, for example, syphilis, are described. In particular, a method for immobilizing a lipoidal antigen, comprising cardiolipin, lecithin, and cholesterol, on a solid support (such as a nitrocellulose membrane) is described. The ability to immobilize a lipoidal antigen on a membrane satisfies a long-felt need for membrane-based assay for the detection of anti-lipoidal antibodies. Also described are immunoassay devices for concurrently performing treponemal and non-treponemal tests for syphilis.
    Type: Grant
    Filed: March 15, 2012
    Date of Patent: March 5, 2013
    Assignee: The United States of America as Represented by the Secretary of the Department of Health and Human Services, Centers for Disease Control and Prevention
    Inventors: Arnold R. Castro, Robert W. George
  • Patent number: 8309366
    Abstract: Methods and devices for rapid lateral flow immunoassays to detect specific antibodies within a liquid sample while also validating the adequacy of the liquid sample for the presence of immunoglobulin and the integrity and immunoreactivity of the test reagents that detect the antibodies of interest, without requiring instrumentation. The methods and devices provide for delivery of a diluted liquid sample to a single location that simultaneously directs the liquid flow along two or more separate flow paths, one that serves as a positive control to confirm that all critical reagents of the test are immunoreactive, and that the sample being tested is adequate, and the other to detect specific antibodies if present.
    Type: Grant
    Filed: December 23, 2011
    Date of Patent: November 13, 2012
    Inventor: Thomas M. Buchanan
  • Patent number: 8278109
    Abstract: The present invention related to a pregnancy test device that can selectively detect hyperglycosylated human chorionic gonadotropin (hCG-H) in a liquid sample. The sample can be deposited on a proximal portion of the device for transport to a distal portion of the device. The device can include a release medium formed of a first material and including a detectable label thereon and a capture medium, including a capture site, in fluid communication with the release medium and formed of a second, different material. At least one of the release medium and the capture medium includes a binding member that exhibits a moderate to high affinity for hCG-H and is selectively or preferentially reactive with hCG-H.
    Type: Grant
    Filed: February 12, 2010
    Date of Patent: October 2, 2012
    Assignee: Church & Dwight Co., Inc.
    Inventors: Albert R. Nazareth, Timothy Snowden
  • Patent number: 8268636
    Abstract: The invention comprises a device for detecting an analyte in a liquid sample deposited on a first portion of the device for transport to a second portion of the device that is in fluid contact with the first portion. In specific embodiments, the device comprises a labeled conjugate comprising a binding member reactive with a first epitope of the analyte and a label comprising a gold colloid, preferably having a mean particle size of 50 nm to 100 nm. In further embodiments, the device comprises a capture component comprising polymerized streptavidin. The diagnostic device is particularly useful in the preparation of pregnancy test kits.
    Type: Grant
    Filed: June 25, 2010
    Date of Patent: September 18, 2012
    Assignee: Church & Dwight Co., Inc.
    Inventors: Albert Nazareth, Timothy Snowden, Yea-shun Cheng
  • Patent number: 8222046
    Abstract: The present invention is directed to immunoassays for detecting one or more target analytes in a fluid sample wherein the detection reaction occurs on a solid support and involves an amplification system. In particular, the invention is directed to making and using a test device having at least one site for detecting the presence of at least one target analyte, wherein a conjugate comprising dextran-polystreptavidin is immobilized at the test site(s) as a capture reagent for a complex containing the target analyze.
    Type: Grant
    Filed: April 29, 2009
    Date of Patent: July 17, 2012
    Assignee: Remel, Inc.
    Inventors: Zong-Li Xia, Raymond Chan, Kelly Doan
  • Patent number: 8211711
    Abstract: The invention comprises a device for detecting an analyte in a liquid sample deposited on a first portion of the device for transport to a second portion of the device that is in fluid contact with the first portion. In specific embodiments, the device comprises a labeled conjugate comprising a binding member reactive with a first epitope of the analyte and a label comprising a gold colloid, preferably having a mean particle size of 50 nm to 100 nm. In further embodiments, the device comprises a capture component comprising polymerized streptavidin. The diagnostic device is particularly useful in the preparation of pregnancy test kits.
    Type: Grant
    Filed: June 25, 2010
    Date of Patent: July 3, 2012
    Assignee: Church & Dwight Co., Inc.
    Inventors: Albert Nazareth, Timothy Snowden, Yea-shun Cheng
  • Patent number: 8192943
    Abstract: Methods for quantitatively measuring the amount of an analyte of interest in a fluid sample, and kits useful in the methods, are disclosed. The methods comprise sandwich assays, and utilize an internal calibration reaction that closely mimics the reaction of test particles by the use of a two-step reaction.
    Type: Grant
    Filed: December 21, 2009
    Date of Patent: June 5, 2012
    Assignee: Response Biomedical Corporation
    Inventors: Paul C. Harris, Whalley K. Fong, Lynn Cloney
  • Patent number: 8168446
    Abstract: A diagnostic and testing apparatus and related methods for the use of the same are disclosed which derive and use antibodies to equine albumin and equine hemoglobin in testing apparatus, kits, and methods for detecting and localizing gastric and colonic ulcers or bleeding in horses. Fecal droppings from a horse to be tested are placed in a container together with a buffered liquid solution and mixed thoroughly, following which several drops of liquid from the container are placed into a test kit. Visual markers in the test kits signify the detection of the indicators equine hemoglobin and equine albumin, which are respectively indicative of the presence of gastric and/or colonic ulcers or bleeding.
    Type: Grant
    Filed: November 16, 2009
    Date of Patent: May 1, 2012
    Assignee: Freedom Health, LLC
    Inventors: Franklin L. Pellegrini, Scott D. Carter
  • Patent number: 8158438
    Abstract: The invention relates to a method for the determination of the concentration of a non-volatile analyte in an aqueous sample medium, with the use of an optical sensor which contains a luminescent dye and is calibrated at the user site by means of a single-point-calibration. To enable the user to completely dispense with all calibration media a luminescence measurement value is obtained at the user site with the sensor in contact with the aqueous or bloodlike sample medium, which value is referenced to the relative characteristic obtained at the factory site and to a measured dry calibration value obtained at the user site, the concentration of the non-volatile analyte being deduced from these data.
    Type: Grant
    Filed: July 4, 2006
    Date of Patent: April 17, 2012
    Assignee: Roche Diagnostics Operations, Inc.
    Inventors: Marco Jean-Pierre Leiner, James Kenneth Tusa
  • Patent number: 8114610
    Abstract: The present invention relates to a diagnostic method for the detection of small quantities of amniotic fluid in the vagina. More specifically, the invention relates to the detection of PAMG-1 in the vagina using anti-PAMG-1 antibodies.
    Type: Grant
    Filed: March 11, 2010
    Date of Patent: February 14, 2012
    Assignee: N-Dia, Inc.
    Inventors: Boris Fuks, Dmitrii Dmitrievich Petrunin, Evgeny I. Zaraisky, Marina Nikolayevna Boltovskaya, Svetlana Vladimirovna Nazimova, Nelly Andronikovna Starosvetskaya, Alexandr Konstantinov, Margarita Igorevna Marshiskaia
  • Patent number: 8101429
    Abstract: This invention is directed to a lateral flow assay for detecting the presence of an analyte in a liquid test sample. The lateral flow assay represents an improvement in the ability to accurately and with high fidelity to detect the presence or absence of a target analyte in a liquid sample, in part, by encompassing a reference region of immobilized, non-diffusible analyte that allows for detection of any factors that interfere with the interaction and binding of the analyte to the labeled capture reagent. Any influences on the interaction and binding of the analyte that is free in solution in the liquid test sample to its complementary labeled reagent will be encountered in parallel in the binding between the immobilized analyte in reference region to the labeled reagent as it diffuses through the reference region. In one embodiment, the lateral flow assay of the invention is a urine-based human Chorionic Gonadotropin (hCG) assay.
    Type: Grant
    Filed: June 3, 2004
    Date of Patent: January 24, 2012
    Assignee: Siemens Healthcare Diagnostics Inc.
    Inventors: Gary H. Krauth, David J. Ledden
  • Patent number: 8030091
    Abstract: A test device and method for determining the presence or absence of one or more analytes in a fluid sample, the test device including a support or member bearing a mark thereon, and a matrix or member containing a capture zone. In operation, an observation area in the test device becomes transparent, thereby allowing the user to view a mark that is present on a support that is disposed beneath the observation area. Typically, the mark on the underlying support is configured as a minus (?) sign. In the absence of analyte in the sample, the test device presents a negative result as a minus (?) signal. In the presence of analyte in the sample, however, the mark operates in concert with a perpendicular test line on the observation area to present a positive result as a plus (+) signal that is visible to the user.
    Type: Grant
    Filed: April 14, 2009
    Date of Patent: October 4, 2011
    Assignee: Quidel Corporation
    Inventors: Jeremy Jerome, Mark Daquipa, Bruce Jacono, Hans Boehringer, Paul Lambotte, Paul J. Lawrence
  • Patent number: 8003407
    Abstract: The present invention relates to a lateral flow assay and system, including a test strip, for detection and quantification of analytes in samples, such as samples containing cells and fluid. In general, according to the present invention, a test strip for a lateral flow assay for detection of at least one analyte in a sample comprises: (1) a chromatographic strip, a sample filter, a fluid-impermeable barrier, and means for providing a mobilizable detectable agent that is capable of binding to the at least one analyte or to the capture agent after capturing the analyte to the chromatographic strip such that the mobilizable detectable agent migrates through the chromatographic strip and contacts sample that has passed through the sample filter and also has migrated through the chromatographic strip. The test strip allows detection with or without quantitation of an analyte in a sample containing whole cells.
    Type: Grant
    Filed: July 29, 2005
    Date of Patent: August 23, 2011
    Assignee: Relia Diagnostic Systems, LLC
    Inventors: Siliang Zhou, William Rutter, Ning Liu
  • Patent number: 7993935
    Abstract: A test strip for immunochromatography comprising a sample receiving member, a label holding member, and a chromatography membrane is described. The chromatography membrane has a first detection zone and a second detection zone. The second detection zone is formed by utilizing a blocking material and the second substance. A method for producing above the test strip is also described.
    Type: Grant
    Filed: January 5, 2006
    Date of Patent: August 9, 2011
    Assignee: Sysmex Corporation
    Inventors: Haruki Yamaguchi, Takehiro Hasegawa, Takeshi Imoarai
  • Patent number: 7993283
    Abstract: A method and apparatus for non-invasive analysis of saliva includes a user friendly lolli-pop like apparatus that is self contained and provides the user with a method to obtain saliva by sucking or licking on the pop head, the saliva activates a color change reaction on the apparatus that results in a color visual response that can be compared to a color coded alphanumeric gauge for analysis in monitoring health conditions and concerns.
    Type: Grant
    Filed: March 4, 2009
    Date of Patent: August 9, 2011
    Assignee: Pop Test LLC
    Inventor: Randice Lisa Altschul
  • Patent number: 7989217
    Abstract: The subject invention is an immunoassay for the semi-quantitative test kit for determination of human chrionic gonadtropin (hCG) in fluid sample (such as urine) as an aid in the diagnosis of a certain stage of pregnancy. The test device includes five strips having each having a dipping end or sample ends where sample can be applied. Results are indicated by coloration of two bands across a clear area of the strips, one band being coated with a reagent such as hCG antigens and the other with a reagent such as goat/rabbit polyclonal antibody gold conjugate. The combination of color indications on the bands provides the test results.
    Type: Grant
    Filed: March 29, 2007
    Date of Patent: August 2, 2011
    Assignee: AmeriTek USA, Inc.
    Inventors: Hsiao-Ching Yee, Kuo-Ching Yee, Hsian-Pei Yee
  • Patent number: 7972872
    Abstract: This invention provides an immunochromatography detection apparatus exhibiting excellent convenience, sensitivity, and specificity, a detection method therefore, a kit using the same, and a method for producing such apparatus and kit, by constructing a solid-phase support, on which the conditions for the reaction wherein an analyte specifically binds to a labeled reagent containing a ligand that specifically binds to the analyte and those for the reaction wherein a capture reagent specifically binds to a complex of the analyte and the labeled reagent in the immunochromatography detection method are continuously optimized, and the pretreated specimens are optimized for such reactions.
    Type: Grant
    Filed: June 7, 2005
    Date of Patent: July 5, 2011
    Assignee: Denka Seiken Co., Ltd.
    Inventors: Ryo Shida, Hiromi Ito
  • Patent number: 7910381
    Abstract: A chromatographic specific binding assay strip device, comprising: a non-permeable platform strip; a permeable membrane testing strip positioned on top of said non-permeable platform strip, with the testing strip comprising at least one capture reagent site containing a capture reagent for at least one specific analyte, a sample receiving pad positioned on top of and at a proximal end of the non-permeable platform strip, with the sample receiving pad having contact with a proximal end of said permeable membrane testing strip, a reservoir pad positioned on top of and at a distal end of said non-permeable membrane testing strip, with the reservoir pad having contact with a proximal end of said permeable membrane test strip; a supporting strip attached to and extending from the proximal end of said non-permeable platform strip; and a conjugate pad positioned on said supporting strip, said conjugate pad comprising a semi-permeable membrane containing a colorant conjugate.
    Type: Grant
    Filed: March 5, 2008
    Date of Patent: March 22, 2011
    Assignee: BioAssay Works
    Inventors: Glen Ford, Leslie Kirkegaard
  • Patent number: 7906317
    Abstract: The present invention discloses an apparatus for thin-layer cell smear preparation and in-situ hybridization, comprising at least one positioning device and a sealing device. The positioning device comprises at least one first opening. When the positioning device is set on a carrier device, the wall of the first opening and the carrier device form a cavity. The cavity is used to accommodate a cell suspension. The sealing device is provided on the positioning device for sealing the cavity to form an enclosed space.
    Type: Grant
    Filed: October 21, 2007
    Date of Patent: March 15, 2011
    Assignee: King Car Food Industrial Co., Ltd.
    Inventors: Bor-Heng Lee, Chiu-Cho Yan, Ying-Chih Wang, Ching-Yu Lin
  • Patent number: 7879612
    Abstract: Provided are methods comprising the use of non-sugar organic compatible solutes for protection and preservation of the activity of biologically active molecules and conjugate labels. The methods are particularly adaptable for use in conjunction with immunoassays, such as for example, immunochromatographic test assays and may be incorporated into any test methodology wherein a dry test strip is used as a carrier for depositing, mobilizeable and/or immobilized biologically active molecules and/or conjugate labels.
    Type: Grant
    Filed: December 27, 2007
    Date of Patent: February 1, 2011
    Inventors: William J. Palin, Alan H. Davis, Roger N. Piasio, Erik R. Piasio, Bruce C. Reinemann
  • Patent number: 7879597
    Abstract: The systems of the invention include test cells with a first sorbent material defining a first flow path for a solution, a second sorbent material defining a second flow path distinct from the first flow path for a sample, and a test site with immobilized antigens or antibodies or other ligand binding molecules such as aptamers, nucleic acids, etc. located at the junction of the first and second sorbent materials for identifying one or more ligands. The first and second sorbent strips touch each other at the test site location. The test cell may be used to test for pregnancy, HIV (including different HIV antigens or peptides), tuberculosis, prion, urin-analysis/drug, cardiac markers, cancer markers, Chagas, Chlamydia, dental bacteria (SM/LC), influenza A, influenza B, adenovirus, rotavirus, strep A, other bacteria or viruses, etc., and veterinary applications such as CPV, FIV, FeLV, heartworm, etc., although it is not limited to those applications.
    Type: Grant
    Filed: March 10, 2006
    Date of Patent: February 1, 2011
    Assignee: Chembio Diagnostic Systems, Inc.
    Inventor: Javanbakhsh Esfandiari
  • Patent number: 7879623
    Abstract: The present invention provides an apparatus for fluid sample collection and analyte testing, including a sample receiving member and at least one membrane test strip, and optionally a sample retention member, fingerprint acquisition pad, and/or fluid collector. It also provides a fluid collection apparatus having an absorbent material, compression element, and closure element, and optionally a lid that allows the apparatus to be used in conjunction with a fluid container. Also provided are methods of collecting, testing, and retaining a fluid sample and verifying the identity of one or more individuals associated with the sample, such as the test subject, test administrator, and/or witnesses.
    Type: Grant
    Filed: February 11, 2008
    Date of Patent: February 1, 2011
    Inventor: Raouf A. Guirguis
  • Patent number: 7863057
    Abstract: Embodiments described herein include methods and assays for detecting an analyte in a sample using a plurality of control zone capture agents. Some embodiments include detection of multiple analytes in a sample utilizing a plurality of analyte binders and a control zone containing multiple control zone capture agents. In some embodiments, the multiple control zone capture agents capture a plurality of binders within one control zone. Test results are determined by comparison of the control zone signal to a test zone signal.
    Type: Grant
    Filed: July 8, 2008
    Date of Patent: January 4, 2011
    Assignee: Charm Sciences, Inc.
    Inventors: Steven J. Saul, Robert J. Markovsky, David W. Douglas
  • Patent number: 7858396
    Abstract: A lateral flow test strip for the analysis of a sample featuring numerous capture zones arranged in an array such that each capture zone is substantially equidistant from the sample containing area. The sample does not pass through another capture zone to reach any one of the other capture zones. The capture zones are preferably arranged in a linear array perpendicular to the flow of the sample through the lateral flow test strip. The lateral flow test strip allows for an increased number of simultaneous analyses of numerous analytes from one sample to occur on one lateral flow test strip.
    Type: Grant
    Filed: October 31, 2006
    Date of Patent: December 28, 2010
    Assignee: Orasure Technologies, Inc.
    Inventors: Paul L.A.M. Corstjens, Keith Kardos, R. Sam Niedbala, Hans J. Tanke, Michel Zuiderwijk, Hans H. Feindt, Vijay K. Mokkapati, Jess Aaron Kimball
  • Patent number: 7829347
    Abstract: A diagnostic test kit that provides an integrated system for accurately detecting a test analyte over a broad range of possible concentrations is provided. One feature of the integrated system is that it is capable of indicating whether an analyte is within the “hook effect” region. Based on this indication, a technique may be selected for correlating a measured signal intensity to an analyte concentration or range of concentrations. For example, when it is determined that the test sample falls outside the “hook effect” region, the analyte concentration may be determined using one portion of a dose response curve. On the other hand, when it is determined that the test sample falls within the “hook effect” concentration, the analyte concentration may be determined using another portion of the dose response curve. Alternatively, the sample may simply be diluted for re-performing the assay.
    Type: Grant
    Filed: August 31, 2005
    Date of Patent: November 9, 2010
    Assignee: Kimberly-Clark Worldwide, Inc.
    Inventor: Xuedong Song
  • Patent number: 7824344
    Abstract: A method and apparatus for non-invasive analysis of saliva includes a user friendly lolli-pop like apparatus that is self contained and provides the user with a method to stimulate saliva by sucking on the pop head. The saliva activates a color change reaction on the apparatus that results in a visual response that can be compared to a user gauge for analysis in monitoring health conditions and concerns.
    Type: Grant
    Filed: July 18, 2008
    Date of Patent: November 2, 2010
    Assignee: Pop Test LLC
    Inventor: Randice Lisa Altschul
  • Patent number: 7803633
    Abstract: A screening device for performing an immunoassay test to detect the presence of a compound in a body fluid. The device includes a holder for removably receiving a membrane to which the fluid has been applied. Light is directed to the membrane. A photodetector measures the concentration of the light reflected back from the membrane. Specifically, the concentrations of reflected light from a control zone and a test zone are measured. Signals representative of the measured light concentrations are applied to a processor. If a specified concentration of predetermined light from a control zone on the membrane is detected, the processor considers the test to be successful. In the test is successful, the processor, based upon the measured concentration of reflected light from the test zone, generates data representative of the presence of the compound.
    Type: Grant
    Filed: April 30, 2008
    Date of Patent: September 28, 2010
    Assignee: Cozart Bioscience Limited
    Inventors: Robin James Spivey, Christopher William Hand, Dene Baldwin, Osborn Pierce Jones