Patents Assigned to Quidel
  • Publication number: 20060078986
    Abstract: The present invention provides analytical devices comprising primary and secondary flow paths. A secondary flow path is configured to allow for a portion of a liquid sample to enter the secondary flow path from a primary flow path and subsequently be drawn back into the primary flow path, thereby providing sequential delivery of a portion of the sample to downstream locations.
    Type: Application
    Filed: September 30, 2005
    Publication date: April 13, 2006
    Applicant: Quidel Corporation
    Inventors: Peter Ly, Rajesh Mehra, Catherine Pawlak, Romy Meris, Jan Pawlak
  • Publication number: 20050227371
    Abstract: The invention relates to devices for performing single step assays for the determination of the presence or absence of an analyte in a liquid sample, and methods of determining the presence or absence of such analytes using such devices. Devices disclosed comprise a labeled analyte-binding reagent reversibly-immobilized on a non-porous solid material, which solid material is in physical contact with a dry porous carrier bearing an immobilized analyte-binding reagent. Also provided are quantitative assay devices.
    Type: Application
    Filed: March 23, 2005
    Publication date: October 13, 2005
    Applicant: Quidel Corporation
    Inventor: Cem Gokhan
  • Patent number: 6924153
    Abstract: This invention provides solid phase specific binding lateral flow assay methods, devices and kits for quantitating high and low molecular weight analytes. The methods and devices of the invention employ labelled reagents which are either analyte analogs or complementary specific binding pair members for the analyte and a novel arrangement of capture zones comprising immobilized specific binding substances for either the analyte or the labelled reagent to effect bound from unbound labelled reagent as a function of analyte concentration. The capture zones are disposed on a non-bibulous matrix defining a flow path from a sample receiving zone to the capture zone. The devices of this invention also include multilane flow paths and multiple capture zones to quantitate analyte.
    Type: Grant
    Filed: March 6, 1997
    Date of Patent: August 2, 2005
    Assignee: Quidel Corporation
    Inventors: Hans Boehringer, Gerald Rowley, Allan Pronovost
  • Publication number: 20050070021
    Abstract: Laminated test devices in which positive results are detected by the appearance of a symbol on the surface of the device due to a color change in an indicator in the device are improved by placing the indicator lamina on one side of a light-transmissive substrate sheet and a pigment lamina on the other side, the indicator lamina forming the icon and the pigment lamina forming the background, the pigment being the color of the indicator prior to the color change. This arrangement reduces false positive readings by obscuring the outlines of the symbol prior to the color change. False negative readings are reduced by further changes in the arrangement of the laminae.
    Type: Application
    Filed: September 17, 2004
    Publication date: March 31, 2005
    Applicant: QUIDEL CORPORATION, a Delaware corporation
    Inventors: Paul Lawrence, Aulena Chaudhuri
  • Patent number: 6855561
    Abstract: A test device and method for determining the presence or absence of an analyte in a fluid sample, the test device including a support bearing a mark thereon, and a matrix defining an axial flow path. 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: September 10, 2001
    Date of Patent: February 15, 2005
    Assignee: Quidel Corporation
    Inventors: Jeremy Jerome, Mark Daquipa, Bruce Jacono, Hans Boehringer
  • Publication number: 20040072280
    Abstract: The release by trichomonads of a hydrolase that hydrolyzes a narrowly defined class of substrates at a low pH without interference from hydrolases that are unrelated to trichomoniasis is the basis for a selective diagnostic assay for trichomoniasis that measures hydrolysis of any of these substrates by vaginal fluid at a low pH. Selective assays for trichomoniasis are also obtained by removing particulate matter from a sample of vaginal fluid to extract a fraction devoid of particles greater than a selected size, and where desired, combining the extracted fraction with any of certain specified hydrolase inhibitors, then testing the fraction for enzymatic hydrolase activity. These qualities of trichomoniasis are the basis for a series of diagnostic tests and test devices that produce results that are detectable by visual and other means with a high degree of accuracy.
    Type: Application
    Filed: October 10, 2002
    Publication date: April 15, 2004
    Applicant: QUIDEL CORPORATION
    Inventors: Paul J. Lawrence, Mark A. Hughes, Aulena Chaudhuri, Terrence J. Andreasen
  • Patent number: 6716593
    Abstract: Disclosed is a method for measuring a level of pyridinoline and/or deoxypyridinoline in a sample. In the method, a non-hydrolyzed sample containing one or more peptide-bound collagen pyridinium crosslinks selected from the group consisting of pyridinoline, deoxypyridinoline, or both, is contacted with a protease reagent under conditions effective for the protease reagent to cleave the crosslinks from attached collagen amino acids and peptides, so that peptide-bound forms are converted to native, peptide-free pyridinoline and deoxypyridinoline. After proteolysis, the level(s) of native, peptide-free pyridinoline and/or deoxypyridinoline are measured. Preferably, proteolysis is effective to ensure that at least 80% of total pyridinium crosslinks are present as the native, peptide-free forms. The method is particularly useful in screening or monitoring collagen degradation activity. Kits and reagents for use in the method are also disclosed.
    Type: Grant
    Filed: January 7, 2000
    Date of Patent: April 6, 2004
    Assignee: Quidel Corporation
    Inventors: Simon P. Robins, Jeffrey D. Brady
  • Patent number: 6706539
    Abstract: One-step enzyme immunoassays in which enzyme-antibody conjugate or label and enzyme substrate are separated until separation of bound and free enzyme conjugate or label is complete. This separation is accomplished by using variable flow paths, immobilization of substrate at the test line, placement of substrate in a sac or association with a particle label, enzyme product chemical capture, delay zone dissolution and protected enzyme substrates.
    Type: Grant
    Filed: August 29, 2001
    Date of Patent: March 16, 2004
    Assignee: Quidel Corporation
    Inventors: Alan M. Nelson, Jan W. Pawlak, Allan D. Pronovost
  • Patent number: 6656744
    Abstract: The efficiency and accuracy of one-step lateral flow assays can be improved by employing more efficient binding between participants in labeling and capture. Thus, in addition to analyte/anti-analyte interactions, specific binding is achieved through members of an irrelevant specific binding pair. Also included within the invention is a format wherein unlabeled competitor for analyte serves as a gatekeeper in the capture zone, competing with analyte for labeled anti-analyte, which analyte will be captured in a detecting portion of a capture zone.
    Type: Grant
    Filed: February 22, 2000
    Date of Patent: December 2, 2003
    Assignee: Quidel Corporation
    Inventors: Allan D. Pronovost, Hans Boehringer, Ya-Chen Hsu
  • Publication number: 20030157699
    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: Application
    Filed: September 10, 2002
    Publication date: August 21, 2003
    Applicant: Quidel Corporation
    Inventors: Jeremy Jerome, Mark Daquipa, Bruce Jacono, Hans Boehringer, Paul Lambotte, Paul J. Lawrence
  • Patent number: 6306642
    Abstract: One-step enzyme immunoassays in which enzyme-antibody conjugate or label and enzyme substrate are separated until separation of bound and free enzyme conjugate or label is complete. This separation is accomplished by using variable flow paths, immobilization of substrate at the test line, placement of substrate in a sac or association with a particle label, enzyme product chemical capture, delay zone dissolution and protected enzyme substrates.
    Type: Grant
    Filed: November 24, 1997
    Date of Patent: October 23, 2001
    Assignee: Quidel Corporation
    Inventors: Alan M. Nelson, Jan W. Pawlak, Allan D. Pronovost
  • Patent number: 5939331
    Abstract: A method and device for detecting the presence, absence or amount of an analyte in a whole blood sample is disclosed. The device comprises four zones, a sample receiving zone, a labeling zone, a capture zone and an absorbent zone. The sample receiving zone contains an irreversibly immobilized reagent that allows for removal of substantially all red blood cells from the whole blood sample. Flow through the device is via capillary migration and all of the dissolved or dispersed components in the sample flow at substantially equal rates and with relatively unimpaired flow through the device. The method involves the use of the device for detection of analyte in a whole blood sample.
    Type: Grant
    Filed: May 21, 1993
    Date of Patent: August 17, 1999
    Assignee: Quidel Corporation
    Inventors: John Burd, Steven Miller, Gerald Rowley, Allan Pronovost
  • Patent number: 5846751
    Abstract: A sensitive and specific antigen preparation for the detection of Helicobacter pylori in biological samples is disclosed. The preparation uses a range of antigens derived from size exclusion chromatography of detergent-solubilized H. pylori cells. Serological assays such as ELISA, latex agglutination, and rapid EIA assays utilizing the improved antigen preparation, and a kit for use in these serological assays are also disclosed.
    Type: Grant
    Filed: June 7, 1995
    Date of Patent: December 8, 1998
    Assignee: Quidel Corporation
    Inventors: Allan David Pronovost, Jan Waclaw Pawlak, Kristy S. Condon
  • Patent number: 5814455
    Abstract: A sensitive and specific antigen preparation for the detection of Helicobacter pylori in biological samples is disclosed. The preparation uses a range of antigens derived from size exclusion chromatography of detergent-solubilized H. pylori cells. Serological assays such as ELISA, latex agglutination, and rapid EIA assays utilizing the improved antigen preparation, and a kit for use in these serological assays are also disclosed.
    Type: Grant
    Filed: August 18, 1994
    Date of Patent: September 29, 1998
    Assignee: Quidel Corporation
    Inventors: Allan David Pronovost, Jan Waclaw Pawlak, Kristy S. Condon
  • Patent number: 5804452
    Abstract: The present invention provides devices and methods for the detection of creatinine in biological fluids using lateral flow methodologies. The invention is particularly useful in providing one step creatinine assays for correcting urinary steroid hormone assays.
    Type: Grant
    Filed: April 27, 1995
    Date of Patent: September 8, 1998
    Assignee: Quidel Corporation
    Inventors: Alan Pronovost, Jan Pawlak
  • Patent number: 5786220
    Abstract: Methods and devices for distinguishing between normal and abnormal pregnancies are provided. The methods rely on determining the concentration of progesterone or progesterone metabolite in a patient sample, where a concentration above a threshold value is indicative of a normal pregnancy. Preferably, the concentration of hCG is determined simultaneously, where an hCG concentration above a threshold value provides confirmation that the individual being tested is pregnant. An exemplary test device comprises a lateral flow membrane having zones for capturing label in response to the progesterone and hCG concentrations, respectively. Visible label is accumulated when the hCG concentration exceeds the threshold value but is absent when the progesterone concentration exceeds the threshold value.
    Type: Grant
    Filed: April 28, 1995
    Date of Patent: July 28, 1998
    Assignee: Quidel Corporation
    Inventors: Allan D. Pronovost, Theodore T. Lee
  • Patent number: 5783401
    Abstract: A device for detecting the presence of substances, particularly biological materials, contained in a liquid sample is formed of a series of layers of film materials. A first film has a cut-out which forms an upper reservoir for receiving the liquid sample. A first reagent is provided in the upper reservoir capable of reacting with a substance possibly contained in the liquid sample. A first membrane is situated at the base of the upper reservoir and is made of a material which is temporarily impermeable so that the liquid sample is temporarily retained in the upper reservoir in contact with the first reagent, but after awhile the membrane becomes permeable and allows the liquid to pass. A second film has a cut-out which forms a median reservoir positioned for receiving the liquid passing through the first membrane. A second reagent is provided in the median reservoir capable of reacting with a predetermined substance.
    Type: Grant
    Filed: July 1, 1994
    Date of Patent: July 21, 1998
    Assignee: Quidel Corporation
    Inventor: Jacques Toledano
  • Patent number: 5773234
    Abstract: A lateral flow assay device for detecting the presence of Chlamydia antigen in patient's samples comprises a flow matrix including a labelling zone and a capture zone. Labelling complex comprising antibodies specific for an epitope on the lipopolysaccharide antigen of Chlamydia is present within the labelling zone. Immobilized antibody specific for the same or another epitope of the lipopolysaccharide antigen of Chlamydia is located in the capture zone. The sample containing the Chlamydia antigen will flow first through the labelling zone, where it complexes with the labelling complex, and then to the capture zone, where it is captured by the immobilized antibody. Chlamydia antigen may be extracted from a patient sample, such as a endocervical swab, by first extracting the antigen in a strong base followed by neutralization with a zwitterionic detergent and a blocking protein present in a zwitterionic buffer.
    Type: Grant
    Filed: August 7, 1995
    Date of Patent: June 30, 1998
    Assignee: Quidel Corporation
    Inventors: Allan D. Pronovost, Robert E. Klepper, Catherine Pawlak
  • Patent number: 5770460
    Abstract: A particularly efficient design for a nonbibulous lateral flow one step assay for an analyte in a biological sample is disclosed. In the improved device of the invention, three zones which are in nonbibulous lateral flow contact are employed: a sample receiving zone, a labeling zone, and a capture zone. The sample containing analyte is carried through the labeling zone and interacts with an assay label comprising visible moieties, preferably particles, which are coupled to specific binding reagent for analyte or to a competitor with analyte for a capture reagent. The flow continues into the capture zone where the visible moieties to which analyte or competitor are coupled are captured. Excess fluid is absorbed into an absorbent zone in contact with the capture zone. A positive result is obtained by visualizing the visible moieties in the capture zone.
    Type: Grant
    Filed: June 7, 1995
    Date of Patent: June 23, 1998
    Assignee: Quidel Corporation
    Inventors: Catherine Pawlak, Allan D. Pronovost, Keren Goins
  • Patent number: 5766961
    Abstract: A particularly efficient design for a nonbibulous lateral flow one step assay for an analyte in a biological sample is disclosed. In the improved device of the invention, three zones which are in nonbibulous lateral flow contact are employed: a sample receiving zone, a labeling zone, and a capture zone. The sample containing analyte is carried through the labeling zone and interacts with an assay label comprising visible moieties, preferably particles, which are coupled to specific binding reagent for analyte or to a competitor with analyte for a capture reagent. The flow continues into the capture zone where the visible moieties to which analyte or competitor are coupled are captured. Excess fluid is absorbed into an absorbent zone in contact with the capture zone. A positive result is obtained by visualizing the visible moieties in the capture zone.
    Type: Grant
    Filed: November 23, 1993
    Date of Patent: June 16, 1998
    Assignee: Quidel Corporation
    Inventors: Catherine Pawlak, Allan D. Pronovost, Keren Goins