Chemical apparatus and process disinfecting – deodorizing – preser – Analyzer – structured indicator – or manipulative laboratory... – Calorimeter
Reexamination Certificate
2001-04-04
2003-12-16
Alexander, Lyle A. (Department: 1743)
Chemical apparatus and process disinfecting, deodorizing, preser
Analyzer, structured indicator, or manipulative laboratory...
Calorimeter
C422S067000, C422S105000, C436S164000, C436S169000
Reexamination Certificate
active
06663831
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to a “one device” system and method for collecting, extracting, testing, and confirming various constituents in fluids. In particular, this system is suitable for detecting drugs of abuse in bodily fluids. In one embodiment, the system is used to collect a human's saliva, sweat, urine, blood or other bodily fluid sample to test and/or confirm for drugs of abuse. In a preferred embodiment, the bodily fluid is collected via a collection end of the device with an absorbent pad, a series of pressure heads inside the cap of the collection device forces the sample (as the collection end of the device passes through the pressure heads) into the core of an immunoassay system containing diagnostic strips for drug of abuse detection. The drug in the sample competes with a drug conjugate immobilized on a membrane support for limited antibody sites on colored micro-spheres. A colored line indicates the presence or absence of illegal drugs in the sample. Furthermore, a portion of the sample is retained in a confirmation sample retention well, which is seal from the outside allowing samples stored for further testing.
BACKGROUND OF THE INVENTION
A number of devices and methods are commonly available to collect, extract, or test for various constituents in fluids. However, these devices require separate collection, extraction and testing of the sample. This device is designed to combine these three key functions into one device. Generally, fluids include saliva, urine, blood, sweat or other bodily fluids. The constituents include the detection for the presence of drugs of abuse, toxins, alcohols, glucose, cholesterol, urea, antigen or antibody, etc.
DESCRIPTION OF THE PRIOR ART
U.S. Pat. No. 4,431,742 to Rosenblatt describes a radio-receptor assay for benzodiazpines in saliva which comprises measuring the diminution of attachment of a know quantity of radio labeled benzodiazepine to a receptor carrier in the presence of an unknown quantity of unlabeled benzodiazepine in a known amount of human saliva.
U.S. Pat. Nos. 5,339,829, 5,479,937, 5,573,009, and 5,830,410 to Thieme et al describe a device for obtaining oral fluid containing substances for testing that includes a syringe having a plunger at the end of which an absorbent pad is attached.
U. S. Pat. No. 5,714,341 to Thieme et al describes an improved method for determining the presence of an analyte in an oral fluid sample. A portion of the sample is mixed or contacted with a chromogenic substrate effective to produce a colored product upon reaction with &agr;-amylase present in the sample.
U.S. Pat. No. 5,736,322 to Goldstein describes a substitute oral fluid standard for testing, calibration, and standardization of devices and methods for collection, storage, and analysis or oral fluids. The oral fluid standard comprises a mucin and protease inhibitor.
U.S. Pat. No. 5,705,353 to Oh et al describes an assay for determining the presence of an analyte of interest in a test sample containing an interfering substance that interferes with the assay is disclosed. The assay comprises the steps of forming a reaction mixture by combining in an assay medium (i) an assay system containing components for detecting the analyte of interest, (ii) a test sample containing the analyte and an interfering substance, and (iii) an additional amount of the interfering substance in a quantity sufficient to substantially mask the effect of the interfering substance in the test sample.
U.S. Pat. No. 5,871,905 to Thieme et al describes the use and composition of materials which, when added to oral fluid samples, make such sample suitable for use with microparticle-based immunoassays. The method involves providing an oral fluid sample combined with a bile acid or salt to reduce the rate of occurrence of false positives in said oral fluid based immunoassays.
U.S. Pat. No. 3,915,639 to Friedenberg describes a drug abuse compounds that are quantitatively and semi-quantitatively detected by the use of an ion exchange dipstick in combination with a stain-producing reagent, and a stain-intensifying reagent which will intensify the coloring effect of the stain-producing reagent.
U.S. Pat. No. 4,231,923 to Miller et al describes an assay method for opioid activity comprising the steps of (a) incubating together an opiate receptor material, a radio-iodinated structural analogue of leucine-enkephalin or methionine-eukephalin, and a liquid sample; (b) measuring the percentage inhibition of the binding of the radio-iodinated compound to the opiate receptor material; and (c) determining the opioid activity of the liquid sample using the percentage inhibition measurement.
U.S. Pat. No. 4,997,771 to Barnett et al describes a method for determining the BZ-1 receptor activity of a test sample or a potential anxiolytic drug.
U.S. Pat. No. 5,073,340 to Covington et al describes a test device for use in determining analyte wherein binder is supported on a solid support in admixture with a marker whereby the presence and location of binder on the support can be determined prior to the assay.
U.S. Pat. No. 5,075,078 to Osikowicz et al describes an improved chromatographic strip binding assay devices provided for determining the presence or amount of an analyte present in a patient sample.
U.S. Pat. No. 5,079,141 to Niskanen et al describes an invention that comprises a pre-filled and pre-sealed apparatus for carrying out chemical, particularly immuno-chemical, analyses in non-laboratory environments.
U.S. Pat. No. 5,101,015 to Brynes et al describes a fluorescence polarization immunoassay (FPIA) for detecting the presence of one or more amphetamine-class analytes in a test sample.
U.S. Pat. No. 5,140,161 to Hillman et al describes methods and devices involving at least one chamber, at least one capillary, and at least one reagent involved in a system providing for a detectable signal.
U.S. Pat. No. 5,238,652 to Sun et al describes an analytical test device for competition assay for particular non-protein antigens, such as antigens representing drugs of abuse.
U.S. Pat. No. 5,244,815 to Guirguis describes a method and device for testing for the presence of substances such as drugs in body fluids while simultaneously positively identifying the test substance.
U.S. Pat. No. 5,304,479 to Lin et al describes a derivatives of phencyclidine provided as precursors for conjugating to antigenic proteins for the preparation of antibodies which bind to phencyclidine or conjugation to enzymes for use as reagents in immunoassays.
U.S. Pat. No. 5,583,003 to Hillyard et al relates to a reagent and a method for detecting an antigen, antibody or other analyte in a sample, such as human or animal blood, by an agglutination assay.
U.S. Pat. No. 5,022,409 to Goldstein et al describes an invention concerning the collection of immunoglobulins from the oral cavity for immunological testing.
U.S. Pat. No. 5,260,031 to Seymour describes a saliva sampling device includes a holder, a saliva collector and an indicator.
U.S. Pat. No. 5,334,502 to Sangha describes a method for rapidly determining during a saliva specimen collection procedure the presence of an amount of saliva, and for verifying that the sample obtained is in fact saliva.
U.S. Pat. No. 5,968,746 to Schneider describes a method and apparatus for the preservation of a saliva sample for use in subsequent quantitative chemical assays.
U.S. Pat. No. 6,022,326 to Tatum et al describes a method and device for automatic or semi-automatic collection of saliva has a mouthpiece on a wand.
U.S. Pat. No. 4,774,192 to Terminiello et al describes a dry chemistry reagent system, kit and method for detection of an analyte such as glucose, cholesterol, urea, antigen or antibody.
U.S. Pat. No. 5,260,194 to Olson describes a method and device for determining the presence of analyte in a sample suspected of containing the analyte.
U.S. Pat. No. 5,656,448 to Kang et al describes an invention pertains to dipstick immunoassay devices.
U.S. Pat. No. 4,843,377 to Fuller et al describes a remote confinement or home arrest s
Alexander Lyle A.
Forefront Diagnostics, Inc.
Knobbe Martens Olson & Bear LLP
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