Test Papers Patents (Class 435/805)
  • Patent number: 5334502
    Abstract: A method is provided 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. Color indication by dye markers and/or enzymatic activation of color indicators provides an indication that at least a predetermined amount of saliva has been applied to an absorbent and the enzymatic reaction indicates that saliva is contained in the sample collected.
    Type: Grant
    Filed: December 24, 1991
    Date of Patent: August 2, 1994
    Assignee: Osborn Laboratories, Inc.
    Inventor: Jangbir S. Sangha
  • Patent number: 5330715
    Abstract: A unitized multilayer dry reagent analytical chemistry test structure and device and method of fabricating such device is described. The device includes two or more contiguous layers of absorbent or porous paper or polymeric material, at least one of which is incorporated with a test reagent composition, the layers attached to each other with intermediate porous attachment layers by fusion bonding. When the device is contacted with the fluid being tested the attachment layers allow the free flow of such fluid from one layer to the next.
    Type: Grant
    Filed: December 30, 1992
    Date of Patent: July 19, 1994
    Assignee: Environmental Test Systems, Inc.
    Inventors: Kenneth A. Blake, James E. Christner, Leonard J. Lucchese, II
  • Patent number: 5310646
    Abstract: A method for screening a patient for mucopolysaccharidoses is provided in which sample urine absorbed onto a porous sheet and dried is extracted with water. 1,9-dimethylmethylene blue dye reagent in buffer is added to the aqueous extract to produce a test solution which is assessed spectrophotometrically for color change indicative of mucopolysaccharidoses. The invention is particularly applicable to rapid and reliable mass screening and diagnosis of newborn infants.
    Type: Grant
    Filed: December 9, 1991
    Date of Patent: May 10, 1994
    Assignee: Regents of the University of Minnesota
    Inventor: Chester B. Whitley
  • Patent number: 5304468
    Abstract: A method for determining the presence of an analyte in a fluid is described along with various components of an apparatus specifically designed to carry out the method. The method involves taking a reflectance reading from one surface of an inert porous matrix impregnated with a reagent that will interact with the analyte to produce a light-absorbing reaction product when the fluid being analyzed is applied to another surface and migrates through the matrix to the surface being read. Reflectance measurements are made at two separate wavelengths in order to eliminate interferences, and a timing circuit is triggered by an initial decrease in reflectance by the wetting of the surface whose reflectance is being measured by the fluid which passes through the inert matrix. Repeatability is insured by a normalization technique performed on the light source before each reading, and an alignment method operated on the reagent strip prior to emplacement on the apparatus.
    Type: Grant
    Filed: January 26, 1993
    Date of Patent: April 19, 1994
    Assignee: Lifescan, Inc.
    Inventors: Roger Phillips, Geoffery McGarraugh, Franklin A. Jurik, Raymond D. Underwood
  • Patent number: 5304467
    Abstract: A device for colorimetric assay of at least one component in a liquid sample, which device comprises a support, a reagent layer formed on a part of one surface of the support and a sample-receiving layer which covers at least a part of the reagent layer and at least a part of the support surface, with which the timing of application of a sample on the device is automatically detected with accuracy.
    Type: Grant
    Filed: December 18, 1991
    Date of Patent: April 19, 1994
    Assignee: Kyoto Daiichi Kagaku Co., Ltd.
    Inventors: Hisashi Sakamoto, Shigeki Yamada, Hiroshi Taniguchi
  • Patent number: 5302346
    Abstract: A test carrier for the determination of ions containing a test layer which has a liquid-resistant, organic phase which contains a hydrophobic polymer in a homogeneous mixture with a hydrophobic, organic liquid of low volatility and an ionophore, as well as a substance which changes its colour in the presence of the ion to be determined. The test carrier is characterized in that the test layer contains particles with an oil number of 80-200 and the ionophore is homogeneously dispersed in the hydrophobic, organic phase. A second test layer contains a buffer capable of maintaining the pH therein at a value of between 5-10.
    Type: Grant
    Filed: March 8, 1993
    Date of Patent: April 12, 1994
    Assignee: Boehringer Mannheim GmbH
    Inventors: Peter Vogel, Detlef Thym, Michael Fritz, Dan Mosoiu
  • Patent number: 5294540
    Abstract: A multilayer analytical element for quantitatively assaying ethanol comprising a tetrazolium salt, alcohol dehydrogenase, NAD.sup.+, and an electron transfer agent characterized in that the layer comprising the electron transfer agent also includes a polymer having recurring negatively charged groups and the NAD.sup.+ is in a different layer is disclosed.
    Type: Grant
    Filed: February 3, 1992
    Date of Patent: March 15, 1994
    Assignee: Eastman Kodak Company
    Inventors: Daniel S. Daniel, Karen L. Warren, James R. Schaeffer
  • Patent number: 5290514
    Abstract: A dry analysis element which gives a calibration curve having a constant blank value for every lot and can be used without the need of correction of the internal calibration curve memorized in an analyzer. The dry analysis element including a water-permeable layer which contains: a reagent composition capable of producing an optically detectable substance in the presence of a predetermined analyte in an aqueous sample; and a fogging agent selected from the group consisting of the optically detectable substance and a material which is detectable by the same method for detecting the optically detectable substance. Also provided is a process for preparing the analysis element.
    Type: Grant
    Filed: October 9, 1992
    Date of Patent: March 1, 1994
    Assignee: Fuji Photo Film Co., Ltd.
    Inventors: Mitsutoshi Tanaka, Takaki Arai, Takeshi Igarashi, Kenichi Sawada
  • Patent number: 5286624
    Abstract: An integral multilayer analytical element for the determination of ammonia or an ammonia-producing substance comprising a light-transmissive liquid-impermeable support, an indicator layer containing an indicator which produces a detectable change by gaseous ammonia, a liquid permeation barrier layer, a reagent layer containing an alkaline buffer and optionally a reagent capable of reacting with a substance to produce ammonia and a spreading layer laminated in this order, which is improved by that the indicator layer contains a polyvinyl alkyl ether, and/or which is improved by that the surface of said support facing toward the indicator layer is undercoated with a polyvinyl alkyl ether, a hydroxyalkyl cellulose, an alkyl cellulose, polystyrene, a polyalkyl methacrylate, polyviriylidene chloride, polyvinyl alcohol or polyvinyl pyrrolidone, substantially not containing ammonia and ammonium ion.
    Type: Grant
    Filed: October 17, 1991
    Date of Patent: February 15, 1994
    Assignee: Fuji Photo Film Co., Ltd.
    Inventors: Kaoru Terashima, Toru Kitani, Toshihiro Mori, Tsuneo Kawase
  • Patent number: 5278046
    Abstract: An analytical composition comprising antibody conjugate, an indicator which is capable of providing a detectable condition in the presence of peroxidase and hydrogen peroxide assays performed using this composition are described.
    Type: Grant
    Filed: September 16, 1991
    Date of Patent: January 11, 1994
    Assignee: The Mead Corporation
    Inventors: Mark A. Johnson, Alexander R. Pokora
  • Patent number: 5272061
    Abstract: A dry analytical element for the determination of serum cholinesterase (CHE) activity is disclosed. The element analyses undiluted body fluids and employs butyrylthiocholine as the substrate for CHE. Butyrylthiocholine is hydrolyzed by serum cholinesterase and liberates butyric acid and thiocholine. The thiocholine liberated then reduces ferricyanide to ferrocyanide and the rate of change is measured by reflectance densitometry.
    Type: Grant
    Filed: September 20, 1991
    Date of Patent: December 21, 1993
    Assignee: Eastman Kodak Company
    Inventor: Stephen C. Hasselberg
  • Patent number: 5268054
    Abstract: Disclosed is a mounting structure incorporating an exposed micro-sample of a particulate dry solid of interest, including a discrete adhesive covered circular plastic disc having a uniform exposed mono-layer of the particulate solid adhered to the surface of the adhesive and a handle mounted to the opposite side of the disc to facilitate exposure and retrieval of the micro-sample to and from various reactive media. The disc, adhesive and handle portion mounting the disc are of transparent generally inert, polypropylene plastic and acrylic adhesive materials, which are chemically dissimiliar to and non-reactive with the particulate solid.
    Type: Grant
    Filed: March 4, 1992
    Date of Patent: December 7, 1993
    Inventor: Youssef G. Bakhos
  • Patent number: 5268269
    Abstract: The present invention provides a diagnostic agent for the enzymatic determination of cholesterol, wherein, besides the necessary enzymes, it contains a scleroprotein or a scleroprotein hydrolysate; said invention also provides a process for the production of a reagent film for the detection of cholesterol, as well as a test strip for the detection of cholesterol; and said invention is also concerned with the use of scleroproteins and scleroprotein hydrolysates for increasing the enzyme stability in diagnostic agents for the detection of cholesterol and for increasing the temperature-independence of the detection of cholesterol with diagnostic agents.
    Type: Grant
    Filed: January 14, 1991
    Date of Patent: December 7, 1993
    Assignee: Boehringer Mannheim GmbH
    Inventors: Anselm Rothe, Heino Eikmeier
  • Patent number: 5266497
    Abstract: An immunochromatography which comprises chromatographically moving a sample together with or followed by labelling fine particles in a chromatographic medium having at least one reaction site having immobilized thereat a reagent bindable to a substance to be detected in a sample, to contact the above sample and the labelling fine particles with the above reaction site, and detecting the substance to be detected by use of the phenomenon that when the above substance to be detected is present in the sample the labelling fine particles are specifically bound to the above immobilized reagent via the substance to be detected at the above reaction site, to thereby capture the substance to be detected on the chromatographic medium, characterized in that the above labelling fine particles are sensitized dyed particles obtained by sensitizing, with a material bindable to the above substance to be detected, labelling dyed particles obtained by dyeing latex particles of a synthetic high polymer, said labelling dyed part
    Type: Grant
    Filed: August 30, 1991
    Date of Patent: November 30, 1993
    Assignees: Japan Synthetic Rubber Co., Ltd., Rohto Pharmaceutical Co., Ltd.
    Inventors: Senzo Imai, Yoshiko Kouda, Toru Nishihara, Masahiko Kinoshita
  • Patent number: 5266486
    Abstract: A method, a sensor and apparatus for detecting biological activities in a specimen, for example in a blood sample, are provided in which a sealable container is sealed with a culture medium therein into which the sample is introduced, metabolic processes are enhanced in the presence of microorganisms in the sample and changes taking place in the concentrations of the substances such to such processes are detected and monitored with an excitation and detection assembly assigned to concentration sensors, herein the form of optodes which are optically coupled to the excitation and detection assembly and thereby to an evaluation unit for determining concentration changes of the substances over time as indications of the presence of microorganisms.
    Type: Grant
    Filed: March 29, 1990
    Date of Patent: November 30, 1993
    Assignee: NVL Photronics Corporation
    Inventors: Robert Fraatz, Ewald Joebstl, Hellfried Karpf
  • Patent number: 5264181
    Abstract: A testing device for determining the presence of occult blood in fecal matter has a primary support sheet with several window openings therein for receiving fecal matter. Guaiac test paper positioned on top of the support sheet covers the window openings. A strip of flexible opaque material is folded in two over the test paper, and a portion of the flexible material forms a pull tab which extends outwardly and away from the support sheet. An absorbent pad impregnated with hydrogen peroxide/alcohol is secured on top of the layered strip material, and a seal wrap covers the layers of strip material and the absorbent pad. Pulling the tab away from the primary support sheet draws the absorbent pad under the layers of flexible material and across the test paper to thereby moisten the paper covering the window openings and react with the guaiac in the test paper to turn the paper blue when blood is present in the fecal matter.
    Type: Grant
    Filed: September 29, 1992
    Date of Patent: November 23, 1993
    Inventor: Robert Schreiber
  • Patent number: 5260195
    Abstract: Non-aqueous, polymeric reagent film compositions for use with analytical test devices of the dry chemistry type are described. The film compositions are prepared from an organic solution of a copolymer formed by interaction of at least two monomers wherein(a) the first monomer is a hydroxylated acrylate of the general formula ##STR1## where R1 is hydrogen or, more preferably, methyl, and R2 is a hydroxyalkyl group having from 1 to 5 carbon atoms, and(b) the second monomer is a neutral acrylate of the general formula ##STR2## where R1 is hydrogen or, more preferably, methyl, and R3 is a substituted or unsubstituted alkyl group having from 1 to 8 carbon atoms.Preferably, a third monomer is also included which is an amine-containing acrylate of the general formula ##STR3## where R1 is hydrogen or, more preferably, methyl, and R4 is a substituted or unsubstituted aminoalkyl or glycidyl group having from 1 to 5 carbon atoms or a surfactant polyethylene glycol group having from 10 to 30 carbon atoms.
    Type: Grant
    Filed: January 3, 1991
    Date of Patent: November 9, 1993
    Assignee: Boehringer Mannheim Corporation
    Inventors: Abol F. Azhar, Arthur M. Usmani, Anthony D. Burke, Jill DuBois-Bousamra, Eric R. Diebold, Myron C. Rapkin, Mark T. Skarstedt
  • Patent number: 5258163
    Abstract: Test carrier for the analysis of fluids with a frame (2) consisting of at least two parts surrounding a test field opening (6) and with a test field disposed in the test field opening (6). In order to provide such a test carrier with frame with which it is possible to assemble the test field out of several test layers manufactured separately from one another, it is proposed that the test field be designed as a test layer package (7) with test layers (10, 11, 12) resting loosely on one another, the frame (2) comprise two shaped pieces of plastics material, one of which serves as base part (4) and comprises a seat (16) for accommodating the test layers (10, 11, 12), while the other serves as lid part (3) and comprises a bearing surface (17) resting on the topmost layer (10) of the test layer package (7).
    Type: Grant
    Filed: October 13, 1992
    Date of Patent: November 2, 1993
    Assignee: Boehringer Mannheim GmbH
    Inventors: Manfred Krause, Bernd Klein, Gerhard Schindler, Peter Schafer, Siegfried Notzel
  • Patent number: 5246856
    Abstract: The invention relates to a specimen receptable (5) for a swabbing set, having reduced diameter swab compartment (3) at its lower end. When a swab device is inserted into the receptacle (5), and the upper end (6) of the receptacle is closed by a stopper (4) carried by the stick (1) of the swab device, the specimen-containing swab (2) is compressed by, and closely confined in, the compartment (3), to hinder the access of air to the specimen absorbed in the swab and thereby protect the specimen.
    Type: Grant
    Filed: July 24, 1991
    Date of Patent: September 21, 1993
    Assignee: Scan-Labs Ltd.
    Inventor: Knud Gaarslev
  • Patent number: 5246664
    Abstract: A water-disintegrable support paper material largely formed of fibrous carboxymethylcellulose or carboxyethylcellulose having a degree of etherification of 0.1 to 1.0 and a degree of base saturation of 20% or more. A solution or dispersion of that paper has a pH of 5.0 to 8.0. There is also disclosed a composition for forming a water-disintegrable coat for coating on the support, the composition being a mixture of (a) at least one water-insoluble resin capable of forming a film having a saturation hygroscopicity less than 15% at a 90% relative humidity, (b) at least one water-soluble resin capable of forming film having a saturation hygroscopicity of 15% or more at a 90% relative humidity, and (c) a solvent in which both the resins (a) and (b) can dissolve.
    Type: Grant
    Filed: May 20, 1991
    Date of Patent: September 21, 1993
    Assignee: Dai Nippon Insatsu Kabushiki Kaisha
    Inventors: Ryohei Nagata, Tskeshi Saito, Tetsuya Fujiwara, Motohiro Oka, Masanao Watanabe
  • Patent number: 5244630
    Abstract: A disposable device suitable for performing automated solid-phase diagnostic assays which employs microparticles to complex an analyte and where the microparticle complex becomes retained and immobilized on a fibrous matrix such that the presence of analyte on the microparticles can be detached by optical means.
    Type: Grant
    Filed: October 23, 1989
    Date of Patent: September 14, 1993
    Assignee: Abbott Laboratories
    Inventors: Omar S. Khalil, Charles F. Hanna, Denise G. Huff, Thomas F. Zurek
  • Patent number: 5240844
    Abstract: A test card incorporates a colorimetric indicator test to determine the presence of a minute amount of a specific substance in a liquid medium. The test card includes top and bottom sheets adhesively secured to an intermediate frame member which, together with the top and bottom sheets, defines a filter chamber having a flat filter therein which incorporates a test portion. The test portion of the filter has a binding substrate to which antibodies of the specific substance have been bound. This binding substrate is in communication with a test port. In the method of the invention a substance to be tested is administered through the test port and contains an unknown amount of antigen. After the sample is administered an aqueous solution of enzyme labelled antigen is administered and, subsequently, a liquid substrate is added to cause a color change in the filter below the test port inversely proportional to the amount of antigen contained in the sample administered at the test port.
    Type: Grant
    Filed: March 14, 1988
    Date of Patent: August 31, 1993
    Inventors: Siong I. Wie, Arden A. Kelton
  • Patent number: 5238809
    Abstract: For optical determination of the catalytic enzyme activity of a sample by means of enzyme reactants which are split under the influence of the enzyme to be measured, the enzyme reactant is placed at the end of an optical fiber and brought into contact with the sample to be determined. The measurements are carried out by observing the rate of change in spectral characteristics of the enzyme reactant, or its reaction products, resulting from the enzyme reaction. The method permits measurements of undiluted blood and in-vivo determinations of enzyme activities.
    Type: Grant
    Filed: June 4, 1991
    Date of Patent: August 24, 1993
    Assignee: AVL Medical Instruments AG
    Inventor: Otto S. Wolfbeis
  • Patent number: 5223220
    Abstract: In response to an express need for an immunoassay device with universal applicability, which further promotes the goals of inventory reduction and simplified, less costly manufacture, a container for holding materials used in conjunction with an immunoassay, having a housing with an inside, an outside, and a top, wherein the top is provided with a plurality of apertures communicating with the inside of the housing, and a thin web of opaque material applied over the top of the housing covering at least one but not all of the apertures.
    Type: Grant
    Filed: July 20, 1992
    Date of Patent: June 29, 1993
    Assignee: Pacific Biotech, Inc.
    Inventors: Eugene Fan, Sinfu Tzeng, Fon-Chiu M. Chen, Ching Huang, Dou-Mei Wang, Theresa Popejoy
  • Patent number: 5223403
    Abstract: A colorimetric assay system for diagnosing periodontal disease utilizes a chromogenic test substance for measuring proteolytic activity in a specimen such as subgingival plaque which may contain suspected periodontopathogenic bacteria. The chromogenic test substance comprises a peptide substrate which is hydrolyzable by proteolytic enzymes in the plaque specimen to release a chromophore. Detection of a color change in the test substance indicates whether such proteolytic activity is present. In a specific illustrative embodiment, the chromogenic test substance comprises N-benzoyl-DL-arginine-2-naphthylamide (BANA) or benzoyl-DL-arginine-p-nitroanilide (BAPNA). In the case of BANA, for example, the chromophore, .beta.-naphthylamide, is detected by the addition of a color developer, such as fast garnet. The development of a red-orange color is interpreted to indicate the presence of periodontal disease associated with anaerobic periodontopathogens, such as B. gingivalis, T. denticola, and B.
    Type: Grant
    Filed: March 15, 1990
    Date of Patent: June 29, 1993
    Assignee: University of Michigan
    Inventors: Walter J. Loesche, Salam A. Syed, Barbara E. Laughon
  • Patent number: 5219762
    Abstract: A method for measuring target substance contained in a liquid sample is disclosed. The measurement is carried out by using a device having at least one reaction area comprising a solid phase, and the liquid sample is applied onto the reaction area through a porous member to allow for a reaction of predetermined volume of the liquid sample on the reaction area. A device used for such measurement is also disclosed. A device comprises a body having at least one reaction area comprising a solid phase, and a porous member disposed on or above the reaction area. The porous member allows for the liquid sample to be permeated therethrough.
    Type: Grant
    Filed: December 20, 1989
    Date of Patent: June 15, 1993
    Assignee: Mochida Pharmaceutical Co., Ltd.
    Inventors: Tomoaki Katamine, Hiroshi Sato, Ei Mochida
  • Patent number: 5217874
    Abstract: A test sheet for the determination of the presence of a substance having peroxidase-like activity in a throw-in-the-bowl fecal occult blood test, includes a specimen test area and a positive control area. The test area has deposited thereon a test ink having at least one oxygen donor reagent and a chromogen reagent capable of being oxidized by the oxygen donor in the presence of blood or a substance having peroxidase-like activity, to provide a visually observable change of color. The test ink also includes a water soluble polymer for immobilizing the chromogen and oxygen donor. The positive control area has deposited thereon the test ink and a substance having the peroxidase-like activity.
    Type: Grant
    Filed: May 9, 1991
    Date of Patent: June 8, 1993
    Assignee: Helena Laboratories Corporation
    Inventors: Philip A. Guadagno, Janine P. Burrows
  • Patent number: 5217905
    Abstract: A device for the rapid qualitative and quantitative determination of the presence of a reactive ligand in a fluid.This device comprises a first reaction zone in which there is an at least temporarily impermeable membrane designed to receive a sample of test fluid and to be associated with at least one labeled reagent; a second reaction zone which is bounded on the one hand by the said membrane and on the other by a second at least temporarily impermeable membrane comprising a solid phase containing a reference reagent; and a third reaction zone which contains means for developing the reaction.A method for the rapid qualitative and quantitative determination of the presence of a reactive ligand in a fluid.Applications to the detection of the presence, in a biological fluid, of antibodies or antigens in particular.
    Type: Grant
    Filed: July 18, 1988
    Date of Patent: June 8, 1993
    Assignees: Compagnie Oris Industrie S.A., Cistest
    Inventors: Joseph Marchand, Jacques Toledano
  • Patent number: 5215713
    Abstract: Test kit 10 for determining an analyte in a pasty sample, in particular in stool. It contains a capillary-active fluid transport section 11 which leads from an eluant application zone 12 via a sample application zone 14 to an eluate reception zone 15, together with analysis section containing reagents which react with the analyte and include a component producing a test signal. Improved reliability of the analysis with simplicity of manufacture and ease of handling is achieved by the fact that the fluid transport path 11 between the eluant feed zone 12 and the sample field 23 is formed as a delay section 13. The sample application zone 14 is provided with a sample layer 16a with a sample field 23 for the application of the sample.
    Type: Grant
    Filed: July 9, 1991
    Date of Patent: June 1, 1993
    Assignee: Boehringer Mannheim GmbH
    Inventor: Joachim Steinbiss
  • Patent number: 5215899
    Abstract: Specific nucleic acid sequences are amplified through the use of a hairpin probe which, upon hybridization with and ligation to, a target sequence is capable of being transcribed. The probe comprises a single stranded self-complementary sequence which, under hybridizing conditions, forms a hairpin structure having a functional promoter region, and further comprises a single stranded probe sequence extending from the 3' end of the hairpin sequence. Upon hybridization with a target sequence complementary to the probe sequence and ligation of the 3' end of the hybridized target sequence to the 5' end of the hairpin probe, the target sequence is rendered transcribable in the presence of a suitable RNA polymerase and appropriate ribonucleoside triphosphate (rNTPs).
    Type: Grant
    Filed: August 23, 1990
    Date of Patent: June 1, 1993
    Assignee: Miles Inc.
    Inventor: Nanibhushan Dattagupta
  • Patent number: 5212066
    Abstract: Disclosed is a novel diagnostic reagent system for the detection of hydroperoxides or substances which react with peroxidatively active substances resulting in the liberation of hydroperoxides which reagent system comprises a chromogenic oxidation indicator and a peroxidase or a peroxidatively active substance, together with an inhibitor of color generation selected from the group of 1,4-disubstituted semicarbazides, thiosemicarbazides and 1,5-disubstituted carbazides as inhibitors of color generation. By inhibiting the generation of color formed by oxidation of the chromogenic indicator, the indicator's usefulness in discriminating between varying concentrations of analyte is enhanced.
    Type: Grant
    Filed: November 14, 1991
    Date of Patent: May 18, 1993
    Assignee: Miles Inc.
    Inventors: James P. Albarella, Todd K. Cast, David W. Michaels, Wallace G. Strycker
  • Patent number: 5211914
    Abstract: The invention concerns a test carrier for the determination of ions containing a test layer which has a liquid-resistant, organic phase which contains a hydrophobic polymer in a homogeneous mixture with a hydrophobic, organic liquid of low volatility and an ionophore, as well as a substance which changes its colour in the presence of the ion to be determined. The test carrier is characterized in that the test layer contains particles with an oil number of 80-200 and the ionophore is homogeneously dispersed in the hydrophobic, organic phase.
    Type: Grant
    Filed: May 10, 1991
    Date of Patent: May 18, 1993
    Assignee: Boehringer Mannheim GmbH
    Inventors: Peter Vogel, Detlef Thym, Michael Fritz, Dan Mosoiu
  • Patent number: 5210015
    Abstract: The present invention is directed to a process of detecting a target nucleic acid using labeled oligonucleotides. This process uses the 5' to 3' nuclease activity of a nucleic acid polymerase to cleave annealed labeled oligonucleotide from hybridized duplexes and release labeled oligonucleotide fragments for detection. This process is easily incorporated into a PCR amplification assay.
    Type: Grant
    Filed: August 6, 1990
    Date of Patent: May 11, 1993
    Assignee: Hoffman-La Roche Inc.
    Inventors: David H. Gelfand, Pamela M. Holland, Randall K. Saiki, Robert M. Watson
  • Patent number: 5202233
    Abstract: A process for the detection of substances with hydrolase activity in a sample by mixing the sample with a hydrolase substrate and an oxidizing agent, and the evaluating the resultant color intensity, wherein, as hydrolase substrate, there is used at least one compound of the formula ##STR1## in which R.sup.1 is hydrogen or an alkoxy radical,R.sup.2 is hydrogen or halogen, an amino group or an alkoxy or aralkoxy radical,R.sup.3, R.sup.4, R.sup.5 and R.sup.6, which can be the same or different, are hydrogen, halogen, carboxyl, a carbamoyl group, sulpho, an amino groups alkyl, an alkoxy radical, aralkoxy, alkylcarbonyl or alkoxycarbonyl, andX is a glycosyl, phosphate or acyl residue.Optionally R.sup.2 and R.sup.3, R.sup.3 and R.sup.4, R.sup.4 and R.sup.5, and R.sup.5 and R.sup.6 can be joined to form a ring system. At least one of R.sup.1 and R.sup.2 must be hydrogen and at least one of R.sup.1, R.sup.2 and R.sup.3 must not be hydrogen. Compounds in which X is .beta.-galactosyl are new.
    Type: Grant
    Filed: January 3, 1992
    Date of Patent: April 13, 1993
    Assignee: Boehringer Mannheim GmbH
    Inventors: Rupert Herrmann, Hans-Joachim Guder, Werner Guthlein, Manfred Kuhr, Johann Berger, Harvey Buck
  • Patent number: 5200321
    Abstract: A microassay card for a includes an upper layer containing wells for receiving a liquid sample. A second layer of the card, beneath the first layer, includes a supporting surface bound to a reactive species. A third layer includes a superabsorbent support impregnated with an indicator. Typically, the indicator is a substrate for an enzyme, such as a reduced dye precursor and a source of hydrogen peroxide necessary for the action of the enzyme upon the substrate to cause a spectral change in the absorbent layer. By selecting the structure of the first and second layers, the card can be formatted for a displacement assay or a competitive assay. The microassay card of the present invention is particularly useful for drug testing.
    Type: Grant
    Filed: September 7, 1990
    Date of Patent: April 6, 1993
    Assignee: The United States of America as represented by the Secretary of the Navy
    Inventor: David A. Kidwell
  • Patent number: 5196305
    Abstract: Methods for amplifying and detecting a predetermined target nucleic acid in a biological specimen are accomplished even where there is a mismatch in a single position between a primer and the target nucleic acid. The mismatch is located at or near the 3' end of the primer. Such a mismatch is overcome using a primer having a nucleotide with a thymine base at the position of the mismatch. The use of such primers is most likely to prime the target and form primer extension products. This method is particularly useful for detection of a nucleic acid sequence which is not fully known, or where there is considerable heterogeneity in DNA target from patient samples.
    Type: Grant
    Filed: September 12, 1989
    Date of Patent: March 23, 1993
    Assignee: Eastman Kodak Company
    Inventors: John B. Findlay, Lynn Bergmeyer
  • Patent number: 5196314
    Abstract: A process for the determination of substrate or enzyme activities by the use of a redox reaction as a measurement reaction is carried out in the presence of one or more additionally added tetrazolium salts to remove disturbing substances. The tetrazolium salts have the formula ##STR1## in which R.sup.1 is a hydrogen atom, a carboxyl group or an alkyl, phenyl, nitrophenyl, dinitrophenyl, carboxyl-substituted phenyl or trialkylammoniumphenyl radical, R.sup.2 is a phenyl, nitrophenyl, biphenylyl or naphthyl radical, R.sup.3 is a phenyl, carboxyl-substituted phenyl, carboxyl-substituted hydroxyphenyl or dimethylthiazolyl radical, and A.sup..crclbar. is a monovalent anion. The formazanes formed by reaction with reducing substances do not absorb light at all, or absorb light only to a negligible extent, at the measurement wavelength of the redox reaction.New compounds included within the structural formula are those in which R.sup.
    Type: Grant
    Filed: February 26, 1991
    Date of Patent: March 23, 1993
    Assignee: Boehringer Mannheim GmbH
    Inventors: Michael-Harold Town, Joachim Siedel, Joachim Ziegenhorn
  • Patent number: 5188966
    Abstract: Test carrier for analyzing a sample fluid with several test layers which form a sample fluid transport path and contain a reagent system which reacts with the sample fluid to produce a detectable signal. The test carrier includes a reservoir layer of absorbent material, a detection layer arranged in the fluid transport path downstream the reservoir layer, in which a detectable signal is formed, and a separating layer arranged between the reservoir layer and the detection layer. The separating layer makes a two-step process possible. Fluid contact between the reservoir layer and the detection layer arises only with pressure loading of the layer assembly of the reservoir layer, separating layer and detection layer. A more uniform optical detection signal, and consequently better accuracy, can be achieved because the separating layer is made up of a hydrophilic material, wich is in the form of a lattice-shaped structure, in which the mean width of the lattice openings is more than 0.
    Type: Grant
    Filed: February 12, 1991
    Date of Patent: February 23, 1993
    Assignee: Boehringer Mannheim GmbH
    Inventors: Heino Eikmeier, Anselm Rothe
  • Patent number: 5183742
    Abstract: A test device having the following meritorious effects is obtained in accordance with the present invention by using at least one composition selected from the group consisting of ink compositions for detecting glucose, for detecting protein, for detecting urobilinogen, and for detecting occult blood in a body fluid, and for detecting the pH thereof:a) The test device is stable during storage in atmospheric air for a long period of time, presenting no discoloration phenomenon;b) The test device has high sensitivity coupled with excellent measurement performance;c) The regions for detecting glucose and the other body fluid ingredients and the pH can be formed directly on the surface of the test device by printing, allowing the test device to be formed by mass production and the process steps to be reduced; andd) The ink compositions for detecting glucose, etc. are stable, and can be handled easily.
    Type: Grant
    Filed: May 8, 1989
    Date of Patent: February 2, 1993
    Assignee: Dai Nippon Insatsu Kabushiki Kaisha
    Inventors: Kouichi Omoto, Takeshi Miyazaki
  • Patent number: 5183741
    Abstract: An integral multilayer element for chemical analysis utilizing an oxidase enzyme reaction system is prepared having in the following order:(a) a porous spreading layer;(b) an oxygen-permeable, protein-impermeable light-blocking layer;(c) an oxidase-containing layer;(d) an indicator layer containing peroxidase and a hydrogen peroxide indicator showing detectable change in the presence of peroxidase and hydrogen peroxide; and(e) a water-impermeable, light-transmissive support. The oxidase in the oxidase-containing layer is preferably glucose oxidase to provide a multilayer element for glucose determination. This multilayer element shortens the analytical time, widens the measurable concentration range of the analyte and improves accuracy.
    Type: Grant
    Filed: October 22, 1990
    Date of Patent: February 2, 1993
    Assignee: Fuji Photo Film Co., Ltd.
    Inventors: Fuminori Arai, Harumi Katsuyama
  • Patent number: 5182191
    Abstract: The invention provides a disposable device for collecting, transporting and storing semi-solid or liquid specimens prior to analysis. A sample of the collected specimen is removed from the device for analysis by means of a detachable transferring stick, one area of which is the sample collecting portion of the device and another area of which is an integral handle. The device also provides for the collection of a liquid sample drained from a defined volume of a semi-solid specimen through porous screen and collected on the detachable transferring stick. A sample of the specimen or liquid from it may be flushed from the stick for a qualitative or quantitative determination of analyte. The device is useful in collecting fecal specimens and detecting occult blood therein by a determination of hemoglobin in the specimen itself or in a liquid sample drained therefrom.
    Type: Grant
    Filed: September 21, 1989
    Date of Patent: January 26, 1993
    Assignee: Pacific Biotech, Inc.
    Inventors: Eugene Fan, Fon-Chiu M. Chen, Michael W. Milner, Leslie J. Rehg
  • Patent number: 5178831
    Abstract: A device for testing body fluids includes (a) a test reagent layer (1) formed on a substrate (5) and containing a test reagent, the tone of which changes according to the content of a test-objective material in a solution to be tested, and (b) a tone layer for criterion (3) formed on the substrate (5) and having a color formed by a dye or the like. The tone layer is used in order to judge the hue of the resulting color of the test reagent layer, wherein both the test layer (1) and the tone layer (3) have the property of absorbing the solution to be tested, and the hue of the resulting color of the test reagent layer and the hue of the tone layer can be compared by their wet colors, thereby affording a highly precise body fluid test.
    Type: Grant
    Filed: August 15, 1991
    Date of Patent: January 12, 1993
    Assignee: Dai Nippon Insatsu Kab Ushiki Kaisha
    Inventors: Kazuyuki Sakota, Junichi Kondo, Masanao Watanabe
  • Patent number: 5179005
    Abstract: A method for determining the presence of an analyte in a fluid is described along with various components of an apparatus specifically designed to carry out the method. The method involves taking a reflectance reading from one surface of an inert porous matrix impregnated with a reagent that will interact with the analyte to produce a light-absorbing reaction product when the fluid being analyzed is applied to another surface and migrates through the matrix to the surface being read. Reflectance measurements are made at two separate wavelengths in order to eliminate interferences, and a timing circuit is triggered by an initial decrease in reflectance by the wetting of the surface whose reflectance is being measured by the fluid which passes through the inert matrix. Repeatability is insured by a normalization technique performed on the light source before each reading, and an alignment method operated on the reagent strip prior to emplacement on the apparatus.
    Type: Grant
    Filed: April 28, 1988
    Date of Patent: January 12, 1993
    Assignee: LifeScan, Inc.
    Inventors: Roger Phillips, Geoffery McGarraugh, Franklin A. Jurik, Raymond D. Underwood
  • Patent number: 5175089
    Abstract: The present invention concerns a method of quantitatively determining the amount of bacterial endotoxin present in a periodontal pocket of a subject. The method comprises:a) obtaining a sample from the periodontal pocket of the subject;b) contacting the sample with an amebocyte lysate under conditions so as to activate an enzyme capable of cleaving a bond between an arginyl group and a nitrogen-containing group;c) contacting the activated enzyme with a substrate comprising an arginyl group and a suitable nitrogen-containing group bound to the arginyl group so as to form an amine;d) treating the resulting amine to produce a detectable product; ande) quantitatively determining the amount of product formed and thereby the amount of bacterial endotoxins present in the periodontal pocket.
    Type: Grant
    Filed: July 15, 1988
    Date of Patent: December 29, 1992
    Assignee: The Trustees of Columbia University in the City of New York
    Inventors: Daniel H. Fine, Spyros Vratsanos
  • Patent number: 5173261
    Abstract: Test carrier for the analysis of fluids with a test field (7) held in a frame (2), in which the frame (2) comprises a top part (3) and a base part (4) and at least the top part (3) comprises a test field opening (6) through which a sample fluid can be applied to the surface (7a) of the test field. Simplified handling and improved analytical reliability are achieved by the fact that the base part (4) comprises a seat (16) for the test field (7) which is surrounded by positioning elements (15) which are higher than the test field (7). The test field opening (6) is greater than the test field (7), so that the rim (18) of the test field is visible. The top part (3) comprises pressure tongues resting on the surface (7a) of the test field (7) and projecting into the test field opening (7).
    Type: Grant
    Filed: December 12, 1991
    Date of Patent: December 22, 1992
    Assignee: Boehringer Mannheim GmbH
    Inventors: Manfred Krause, Gerhard Schindler
  • Patent number: 5171529
    Abstract: A testing device for determining the presence of occult blood in fecal matter has a primary support sheet with several window openings therein for receiving fecal matter. Guaiac test paper positioned on top of the support sheet covers the window openings. A strip of flexible opaque material is folded in two over the test paper, and a portion of the flexible material forms a pull tab which extends outwardly and away from the support sheet. An absorbent pad impregnated with hydrogen peroxide/alcohol is secured on top of the layered strip material, and a seal wrap covers the layers of strip material and the absorbent pad. Pulling the tab away from the primary support sheet draws the absorbent pad under the layers of flexible material and across the test paper to thereby moisten the paper covering the window openings and react with the guaiac in the test paper to turn the paper blue when blood is present in the fecal matter.
    Type: Grant
    Filed: January 24, 1992
    Date of Patent: December 15, 1992
    Inventor: Robert Schreiber
  • Patent number: 5171528
    Abstract: The specification discloses a fecal occult blood test device capable of determining whether the blood found during the test originated in the upper or lower gastrointestinal track. A fecal sample is applied to a test medium charged to be differentially attractive to blood components originating in the upper and lower gastrointestinal track respectively. A solvent is applied to the test specimen to cause differential migration of the blood components and an indicator is then applied to indicate the presence of the blood components, if any.
    Type: Grant
    Filed: August 5, 1991
    Date of Patent: December 15, 1992
    Inventors: Stephen C. Wardlaw, Robert A. Levine
  • Patent number: 5164294
    Abstract: Methods are disclosed for conducting assays. One such method comprises providing in combination a first bibulous member zone ("first zone") and a liquid medium containing a component. The first zone has non-diffusively bound thereto a reagent interreactive with the component. Conditions are selected wherein the liquid medium and at least a portion of the component contained therein traverse all of the first zone and migrate by capillary migration into a second bibulous member zone ("second zone"). The second zone is of a different composition than the first zone and is incapable of specifically binding the component except when an analyte is to be detected and the method further includes causing a reagent to become bound to the first bibulous member zone in relation to the amount of analyte present.
    Type: Grant
    Filed: July 7, 1989
    Date of Patent: November 17, 1992
    Assignee: Syntex (U.S.A.) Inc.
    Inventors: Carl N. Skold, Armen B. Shanafelt, Vartan Ghazarossian, Edwin F. Ullman
  • Patent number: RE34312
    Abstract: The present invention provides a process for the determination of an antibody by incubation with three different reagents R.sub.1, R.sub.2 and R.sub.3, of which R.sub. and R.sub.3 are present in liquid phase and are bindable with the antibody, R.sub.2 is present bound to a solid phase and is bindable with R.sub.1 and R.sub.3 carries a label, separation of the solid phase from the liquid phase and measurement of the label in the solid phase, wherein as R.sub.1 there is used a conjugate of a substance specifically recognized by the antibody to be determined and a reaction component of a specific binding system, as R.sub.3 there is used a conjugate of a substance specifically recognized by the antibody to be determined and a label and as R.sub.2 there used the other binding component of the specific binding system. The present invention also provides a composition for the determination of an antibody, wherein it contains two different soluble reagents R.sub.1 and R.sub.
    Type: Grant
    Filed: November 21, 1991
    Date of Patent: July 13, 1993
    Assignee: Boehringer Mannheim GmbH
    Inventors: Thomas Geiger, Wolf D. Engel, Urban Schmitt, Eberhard Maurer, Wolfgang Rudinger, Rolf Deeg
  • Patent number: RE34405
    Abstract: Methods and compositions are provided for concentrating particles in a minute area on a solid surface. The method permits the detection of small amounts of analytes by providing for an observable signal in relation to the concentration of particles in the area.
    Type: Grant
    Filed: November 12, 1987
    Date of Patent: October 12, 1993
    Assignee: Abbott Laboratories
    Inventors: Dennis R. Gould, Robert F. Zuk