Abstract: An immunoassay of a liquid biological specimen for a specific analyte is conducted by forming a test sample by contacting the specimen with: (1) a binding substance of a ligand, antiligand or receptor capable of binding the analyte and (2) a detector substance of a colloidal gold or silver labeled ligand or antiligand to form a test sample. The test sample is applied by flowing onto a defined zone of an insoluble porous support film having a pore size impassable to a complex formed between the analyte, if present, with the binding substance and the detector substance, but passable to the binding substance and detector substance while remaining uncomplexed in the absence of the desired analyte. If the analyte is present in the test specimen, the detector substance binds with the analyte and the binding substance to form a visually inspectable complex on the surface of the porous support film.

Abstract: The present application describes novel uses of ruthenium bipyridyls or palladium porphyrins as photo-activatable crosslinking agents. Crosslinking can be between any two molecules including peptides, proteins, or compounds. Crosslinking occurs in the presence of an electron donor such as ammonium persulfate, and requires only moderate intensity visible light. Crosslinking can be between peptides, polypeptides or lead candidate compounds to unknown target molecules. Reagents utilyzing ruthenium bipyridyls and palladium porphyrins crosslinkers for use in diagnostic and detection scenarios are also disclosed.

Abstract: A method is disclosed for obtaining and/or immunologically detecting an analyte contained in a gas phase by immunologically binding the analyte to a binding partner thereof contained in a gas- and liquid-permeable first carrier matrix. Said method is characterized in that a) the analyte-containing gas phase is brought into contact with the first carrier matrix (immune adsorber), b) the analyte is bound to the first binding partner which is contained in the first matrix and not bound to the matrix, and c) the complex of analyte and first binding partner and the free first binding partner are eluted from the first matrix, d) the eluted complex or the free first binding partner is determined as a measure for the amount of analyte present.

Abstract: Methods and compositions are described for the detection and quantitation of cardiac specific troponin I and troponin T in samples. Cardiac-specific troponin isoforms exist in various forms in the blood, including free and complexed forms. By selecting antibodies that are sensitive and/or insensitive to these various forms, the present invention can provide immunoassays that more accurately reflect the clinical state of an individual. These described methods and compositions can be used for providing indicators of myocardial infarction and other cardiac pathologies.

Abstract: Compositions and methods of use thereof for capture and detection of selected molecules are described. In one embodiment, a first composition includes a ligand component, such as an antibody coupled to a nucleic acid component. An a preferred embodiment, the nucleic acid is labeled with a fluorescent marker to facilitate detection. Another aspect of the invention is the ligand component bound to a solid support via a complementary nucleic acid component and a linker moiety. The method involves binding the target with the first composition in free solution, then binding the target to the solid support by means of both DNA hybridization and antibody-antigen affinity binding. Unbound molecules are washed away, and then the bound targets are detected by fluorescence detection. Vital stains can also be used to detect viable cells.

Abstract: An assay device, a fluid analyte sample separator device and methods for use of thereof for determining whether the integrity of a fluid analyte sample has been compromised and for contemporaneously assaying the sample for the presence or absence of multiple analytes, such as drugs of abuse. The device is composed of a housing having separate slots therein for insertion of one or more analyte test strips, one end of which protrudes from the housing, and one or more units of a sample integrity monitoring system. The device may be used in dipstick or cassette form. An analyte sample separator for division of sample and retention of uncontaminated sample for further testing is also provided. The analyte test strips and sample integrity monitoring system are replaceable, so that the panel of analytes and of sample condition parameters tested can be customized.

Abstract: The present invention is drawn to an immunoassay capable of the rapid detection of a variety of test substances that may be present in a test sample. One feature of the invention is that extraction or isolation of the test substance occurs simultaneously with the formation of the primary antigen-test substance complex. The primary antigen-test substance complex is then captured in a solid phase format having a plurality of interstitial spaces which facilitate rapid and efficient detection. The immunoassay of the present invention works over a wide range of environmental conditions and is simple enough to be used in the absence of laboratory facilities.

Abstract: A lateral flow testing device is provided for testing a biological fluid for the presence of methamphetamines. The device includes a substrate element such as a nitrocellulose strip, including an antibody zone and an immobilized drug conjugate zone for detecting presence of methamphetamines, and an on-board chemical reactant for preventing undesirable cross-reactivity to ephedrine and/or pseudoephedrine that may be present in the biological fluid being tested. Preferably, the on-board chemical reactant is sodium periodate. Methods for preparing test devices are provided including the step of striping a substrate sheet with a solution containing sodium periodate during manufacture of methamphetamine lateral flow test strips.

Abstract: The invention concerns a method for the immunological determination of an analyte in a sample using magnetic particles coated with the analyte to be determined or analyte-specific bonding partners and directly detectable non-magnetic particles coated with analyte-specific bonding partners or the analyte to be determined or using a non-magnetic substance which is indirectly detectable, and incubation of the reaction mixture. The method is characterized in that the magnetic particles are subsequently separated from the reaction mixture using a magnetic test strip and the analyte concentration is determined directly.

Abstract: A test device, system and method, the device composed of an elongated, toothbrush-shaped, transparent, plastic housing and a lateral-flow test strip for the detection of an analyte, such as a beta-lactam in milk, in the housing, the housing having an expansion cavity to receive expanded, liquid-contacted, absorbing material in the test strip, and to control lateral flow rate and times in the test strip.

Abstract: Hybridoma cell lines have been generated which produce and secrete monoclonal antibodies which selectively bind to 4,4′-dinitrocarbanilide (DNC), the active agent of nicarbazin. These hybridomas may be obtained by using as an immunization agent or immunogen, p-nitroaniline which has been conjugated to an immunogenic carrier. DNC in biological samples may be detected and quantified by contacting the sample with the antibodies to form a DNC/antibody immunocomplex when DNC is present, which immunocomplex may then be detected. The monoclonal antibodies also may be incorporated into kits for the detection and quantification of DNC and/or nicarbazin.

Abstract: A container for measurement of cell functions, for use in the determination of a physiologically active substance produced by blood cells, is constituted such that an amount of material capable of inducing production of the physiologically active substance, when extracted by collecting water of a volume equal to a liquid volume to be subjected to measurement, is controlled at a level insufficient to induce production of the physiologically active substance from the blood cells. A container for measurement of cell functions in which a material capable of inducing production of a physiologically active substance in blood when contacted with the blood is accommodated in such a condition as being contactable with blood, and in which an amount of the material capable of inducing production of the physiologically active substance in the container before use is limited to a level insufficient to influence a measured value of the physiologically active substance.

Abstract: Methods are disclosed for determining an analyte in a medium suspected of containing the analyte. One method comprises treating a medium suspected of containing an analyte under conditions such that the analyte, if present, causes a photosensitizer and a chemiluminescent compound to come into close proximity. The photosensitizer generates singlet oxygen and activates the chemiluminescent compound when it is in close proximity. The activated chemiluminescent compound subsequently produces light. The amount of light produced is related to the amount of analyte in the medium. Preferably, at least one of the photosensitizer and chemiluminescent compound is associated with a surface which is usually a suspendible particle, and a specific binding pair member is bound thereto. Compositions and kits are also disclosed.

Abstract: The present invention provides a method for the quantification and assessment of platelet activation in whole blood samples and monitoring of antiplatelet pharmacologic agents. The method for quantifying platelet activation includes exposing platelets to a physiological concentration of an agonist that activates some of the platelets, resulting in the formation of at least one binding site on the surface of the activated platelets, and measuring the activated platelets. The present invention provides a method of assessing specific components of platelet activation.

Abstract: This invention relates to a lateral flow immunochromatographic assay device without a plastic housing. The assay includes a sample receiving region, analyte detection region and end region all made of porous material and capable of lateral flow. The analyte detection region includes labeling reagents, a capture reagent and a control reagent. The back of the porous material is laminated with a semi-rigid material with adequate mechanical strength. The top is partially covered with a thin plastic material so as to leave a portion of the sample receiving region exposed for sample application.

Abstract: Skin prick test for the determination of the predisposition of an individual to develop marginal periodontitis, said kit comprising: (a) a first reagent containing a known quantity of a surface structure common to anaerobic Gram negative pathogens which is capable of triggering the inflammatory response associated with periodontitis and gingivitis; (b) second reagent containing an agonist to said individual; (c) a negative control; and (d) instructions for the use of said kit; and a method for such determination of predisposition.

Abstract: The invention is an improved single-step test device for detecting the presence of a pre-selected analyte in a urine stream. The device includes a hollow rectangular outer casing and an assay material disposed within co-joined upper and lower sections of the casing. The outer casing includes a urine inlet port; a viewing window in the upper section; at least the upper section consisting of transparent material; and may also include at least one drainage vent spaced about the urine inlet port. The assay material is a sorptive material including: a urine sample application region adjacent to, and in fluid communication with the urine inlet port; a capture region adjacent to the viewing window; and a fluid flow path for transporting a liquid sample between the urine sample application region and the analyte capture region. The flow of urine in the fluid path is observable through the transparent upper section for confirming a test is operative.

Abstract: A method of analyzing cells in a carrier solution comprises the following steps: (a) Introducing the carrier solution into a conduit having a surface portion (preferably a substantially flat surface portion). The carrier solution has the cells suspended therein. (b) Allowing the cells to settle on the surface portion, the surface portion including at least one imaging field. In an alternate embodiment, one or more discreet capture zones (e.g., formed from an affinity species immobilized on the substrate or a textured region on the substrate) are formed on the surface portion, and this step (b) comprises capturing the cells in the capture zone. (c) Sequentially interrogating a plurality of the cells in the imaging field with emitted light. (d) Processing resultant light from the imaging field. (e) Generating digital information for each of the plurality of cells from the resultant light. (f) Generating a response file for each of the plurality of cells from the digital information.

Abstract: The subject invention relates generally to immunoassays for detection of antibodies by use chemiluminescent compounds. More particularly, the subject invention relates to chemiluminescent immunoassays to detect antibodies wherein a precomplex mixture is created and a two-step assay is performed resulting in a greater signal.

Abstract: A device comprises a solid support and multiple immobilized agents for protein detection is described. The immobilized agents are mainly proteins, such as antibodies and recombinant proteins. The immobilized agents can be synthesized peptides or other small chemicals. Agents are individually deposited in a predetermined order, so that each of the agents can be identified by the specific position it occupies on the support. The immobilized agents on the solid support retain their protein binding capability and specificity. Methods employing the device are extremely powerful in screening protein expression patterns, protein posttranslational modifications and protein—protein interactions.

Abstract: The invention relates in part to the use of independent assay controls (IACs) for the optical communication between an assay device and an instrument in monitoring and performing assays, preferably immunoassays.

Abstract: The present invention provides a human prostate-specific kallikrein (HPSK) and polynucleotides which identify and encode HPSK. The invention also provides genetically engineered expression vectors and host cells comprising the nucleic acid sequences encoding HPSK and a method for producing HPSK. The invention also provides for agonists, antibodies, or antagonists specifically binding HPSK, and their use, in the prevention and treatment of diseases associated with the expression of HPSK. Additionally, the invention provides for the use of antisense molecules to polynucleotides encoding HPSK for the treatment of diseases associated with the expression of HPSK. The invention also provides diagnostic assays which utilize the polynucleotide, or fragments or the complement thereof, and antibodies specifically binding HPSK.

Abstract: Assay systems and specialized antibodies for the detection and quantitation of troponin I and troponin T in body fluids as an indicator of myocardial infarction. Since troponin I and T exist in various conformations in the blood, the ratios of the monomeric troponin I an T and the binary and ternary complexes, as well as which form of troponin present in the blood, may be related to the metabolic state of the heart. Disclosed is a system to determine the presence of a troponin form or a group of troponin forms in a sample of whole blood, serum or plasma. Disclosed is a stabilized composition of troponin; the stabilized composition can comprise a stabilized composition of troponin I, wherein the troponin I is oxidized, the troponin I can be unbound or the troponin I can be in a complex.

Abstract: The present invention relates to isolated and pure Toxoplasma gondii antigenic fragments, recombinant polypeptides, nucleic acids encoding them, primers and probes derived from the same, as well as the use of these polypeptides, nucleic acids, primers and probes in methods and kits for the diagnosis and prevention of T. gondii infection in mammals (humans and animals).

Abstract: The invention relates in part to methods and compositions for identifying the presence, measuring the amount, stabilizing, and facilitating recovery of troponin complexes or individual troponin isoforms in a sample.

Abstract: A method for combining magnetic and centrifugal extraction techniques in a manner that improves wash efficiency and reduces the relative disadvantages of stand alone magnetic or centrifugal systems is provided. Centrifugation occurs about the rotational axis of a generally circular container with generally vertical sides featuring an inward protruding physical feature designed to retain material that exceeds the density of supernatent liquid and that is bound to magnetic particles during the centrifugation. During centrifugation, an external magnetic field is applied about the rotational axis of the container such that magnetic lines of force penetrate the container in any desired location. The magnetic and centrifugal forces may be independently modulated or modulated in relative unison to suit the hydrodynamic characteristics of a given complex.

Abstract: A method for the detection or quantitation of a water-borne parasite, such as Cryptosporidia. The detection or quantitation is accomplished by an electrochemiluminescence assay comprising the steps of filtering water to obtain a sludge thought to contain the parasite or a fragment thereof; extracting a sample of said sludge in a extraction medium to form antigenic derivatives of said parasite; forming an assay mixture comprising a sample of said extracted sludge and an antibody specific to said antigenic derivative; incubating said assay mixture to permit binding of said antibody and said antigenic derivative; and conducting an electrochemiluminescence assay for the bound complex of antibody and antigenic derivative, thereby detecting or quantitating the Cryptosporidia in said water.

Abstract: A process for magnetic immunoseparation of cells, in particular bacteria, fetal cells, stock cells of bone marrow and circulating cancerous cells, of the type consisting in affixing the target cells on paramagnetic balls and in causing a magnetic field to act on a sample containing the affixed cells, the free cells and the surplus paramagnetic balls, in order to isolate the paramagnetic balls, in that the sample is caused to circulate in a tube the section of which is much less than the length over which the magnetic field is applied.

Abstract: SNAP-25 (synaptosomal associated protein) is purified from cerebrospinal or amniotic fluid for immunoassay and quantitation. Quantitation of these proteins is useful in the diagnosis and monitoring of brain disorders and diseases such as schizophrenia and Alzheimer's.

Abstract: A method and device are provided for the semi-quantitative and quantitative determination of an analyte in a sample. A non-competitive trap which can bind unreacted labelled receptor to analyte but has virtually no binding capabilities to receptor in the presence of analyte is used. Labelled receptor:analyte complex is trapped in a second trap. The relative amounts of unbound receptor in the non-competitive trap versus the amount of receptor:analyte complex in the second trap is a measure of the amount of analyte in the sample.

Abstract: The present invention concerns methods for masking inhomogeneity of a member of a specific binding pair (sbp) employed in a capillary electroseparation. The method comprises binding the sbp member to synthetic particles that become localized during capillary electroseparation. Also disclosed is one embodiment of the present invention, which is a method for conducting a capillary electroseparation specific binding assay. The method involves the electroseparation of a labeled first member of a specific binding pair that is bound in a complex from labeled first member that is not bound in the complex. The complex comprises the first member and a second member of a specific binding pair. A combination is provided comprising a sample suspected of containing an analyte, a labeled first member of a specific binding pair, and a second member of a specific binding pair under conditions for forming a complex between labeled first member and the second member.

Abstract: A method of detecting an antibody in a sample using a labelling compound and comprising the steps of mixing a ligand antigen, antibody or hapten bound to biotin with the sample; an antibody directed against the antibody to be detected bound to paramagnetic particles; and a chemiluminescent acridinium compound bound to avidin or streptavidin to form a solid phase complex; separating the solid phase from the liquid phase; and analyzing the separated solid phase for the presence of chemiluminescent complex.

Abstract: A novel signal amplification system for immunoassays that minimizes non-specific signals is disclosed. Immunoassay methods, reagents and test kits are described for obtaining immunoassays of enhanced sensitivity. The reagents include antibody-variant DNA conjugates, wherein the variant DNA is a substrate for an RNA-dependent RNA polymerase, such as, QB replicase. Immunoassay methods to detect, or to detect and quantitate, analyte in test samples comprise transcribing the variant DNA of said antibody-DNA conjugates that are bound to analyte, to RNA, and replicating the RNA transcripts, wherein the presence or quantity of variant RNA replication products can be correlated with the presence or quantity of analyte in the test samples. Further, methods are provided to detect, or to detect and quantitate, simultaneously two or more analytes in a test sample.

Abstract: This disclosure relates to novel antibodies specific to the recently discovered receptor to human interleukin 12 (IL-12R). The antibodies to IL-12R, most preferably, the monoclonal antibodies to that protein, are useful in determining the status of the human immune system and as diagnostic reagents or potential therapeutic reagents for conditions involving imbalances in IL-12 levels or cell types sensitive to IL-12 activation.Further aspects of the disclosure relate to methods of producing and purifying such novel antibodies and hybridoma cell lines capable of their production. Another aspect of the disclosure relates to an immunoprecipitation assay for the detection of solubilized IL-12R which employs, in a preferred embodiment, monoclonal antibodies to the receptor of the present invention covalently bound to Protein G-Sepharose resin.

Abstract: The present invention relates to the use of insoluble forms of recombinant proteins in a flow cytometric immunofluorescence assay for the detection of given antibodies.

Abstract: A test device, system and method, the device composed of an elongated, toothbrush-shaped, transparent, plastic housing and a lateral-flow test strip for the detection of an analyte, such as a beta-lactam in milk, in the housing, the housing having an expansion cavity to receive expanded, liquid-contacted, absorbing material in the test strip, and to control lateral flow rate and times in the test strip.

Abstract: An immunoassay is provided which is selective for an analyte over immunologically related substances which may be present in a sample to be tested. The presence of the analyte is detected using a first binding substance, typically an antibody, in the presence of a second binding substance, typically another antibody. The first binding substance recognizes an epitope which is characteristic of the analyte and cross-reacts with a related epitope on the cross-binding substance. The second binding substance preferentially binds the common epitope on the cross-binding substance, thus reducing non-specific binding of the first binding substance.

Abstract: Isolated mammalian nucleic acid molecules encoding receptor protein tyrosine kinases expressed in primitive hematopoietic cells and not expressed in mature hematopoietic cells are provided. Also included are the receptors encoded by such nucleic acid molecules; the nucleic acid molecules encoding receptor protein tyrosine kinases having the sequences shown in FIG. 1a (murine flk-2), FIG. 1b (human flk-2) and FIG. 2 (murine flk-1); the receptor protein tyrosine kinases having the amino acid sequences shown in FIG. 1a, FIG. 1b and FIG. 2; ligands for the receptors; nucleic acid sequences that encode the ligands; and methods of stimulating the proliferation and/or differentiation of primitive mammalian hematopoietic stem cells comprising contacting the stem cells with a ligand that binds to a receptor protein tyrosine kinase expressed in primitive mammalian hematopoietic cells and not expressed in mature hematopoietic cells.

Abstract: Use of an anti-cardiolipin antibody, anti-lipoprotein antibody or anti-.beta.2-glycoprotein I antibody together with an immobilized antibody thereof enables to accurately assay for a complex of .beta.2-glycoprotein I and an oxidized lipoprotein in a blood sample, according to a sandwich immunoassay. Thus, the oxidized lipoprotein in blood can be detected, whereby diagnosis of arteriosclerotic disease is enabled.

Abstract: The present invention includes novel rubella assays employing a Rubella virus capture reagent and a solid phase material containing a reaction site comprising a polymeric cation substance. A test sample suspected of containing Rubella antibody may be contacted with the capture reagent to form a capture reagent/analyte complex. The complex is then contacted to the positively charged solid phase to attract, attach, and immobilize the capture reagent/analyte complex.

Abstract: A patient's health may be diagnosed by centrifuging blood samples in a transparent tube, which tube contains one or more bodies or groups of bodies such as floats, inserts, liposomes, or plastic beads of different densities. Each density-defined body carries analyte-capture binding materials such as antigens or antibodies, which are specific to an epitope, or other specific high affinity binding site on a target analyte which target analyte may be in the blood or other sample being tested; and the level of which analyte is indicative of the patient's health. At least one labeled binding material which is also specific to an epitope, or other specific high affinity binding site on the target analyte is added to the sample so as to form labeled binding material/analyte/body complexes in the sample.

Abstract: Assays and antibodies are disclosed for the detection and quantitation of cardiac specific troponin I and troponin T in body fluids as an indicator of myocardial infarction. Since troponin I and T exist in various conformations in the blood, the ratios of the monomeric troponin I and T and the binary and ternary complexes may be related to the metabolic state of the heart. More specifically, immunoassays for determining the presence or amount of free, binary and ternary complexes of troponin I and T are claimed.

Abstract: The assay reagent and kit of the present invention suppress non-specific binding of a labeled substance onto a solid phase, and can assay one or more species of antibodies or one or more species of antigens by means of a single reagent in a simple manner. The assay method involves reacting immunological ligands in a test sample with the assay reagent which contains a combination of components (A) and (B), thereby forming complexes, which complexes are captured onto the independently and separately present Solid phases (C), to assay the label contained in the complexes.

Abstract: Two or more analytes having the same action, or having different actions in spite of their similar structures, or two or more analytes having the same action and the same detectable chemical characteristics, in samples derived from living bodies, etc., can be measured rapidly and easily by forming one or more complexes with one or more affinity substances, separating the complexes by using high pressure liquid chromatography, followed by measurement of the amount of an affinity substance or one of the analytes.

Abstract: The novel analytical devices and methods of the present invention involve a semiquantitative specific binding assay method for the detection of the presence of at least a predetermined minimum concentration of an analyte in the test sample. A calibration reagent is present at a concentration sufficient to inhibit the formation of a detectable analyte complex unless a predetermined minimum concentration of analyte is present in the test sample.

Abstract: A patient's health may be diagnosed by centrifuging blood samples in a transparent tube, which tube contains one or more bodies or groups of bodies such as floats, inserts, liposomes, or plastic beads of different densities. Each density-defined body carries analyte-capture binding materials such as antigens or antibodies, which are specific to an epitope, or other specific high affinity binding site on a target analyte which target analyte may be in the blood or other sample being tested; and the level of which analyte is indicative of the patient's health. At least one labeled binding material which is also specific to an epitope, or other specific high affinity binding site on the target analyte is added to the sample so as to form labeled binding material/analyte/body complexes in the sample.

Abstract: Binding assays are effected by introducing a specific binding reagent through a top absorbant membrane in parallel contact with a main absorbant membrane. By providing a parallel flow of liquid in the two membranes, and by controlling the flow of the diluted reagent from the top absorbant membrane into the main absorbant membrane, a controlled, uniform dilution of the reagent is obtained, leading to more accurate assay results.

Abstract: The present invention provides a method of diagnosing caprine arthritis-encephalitis virus infection (CAEV) in a human sample suspected of being infected with CAEV.

Abstract: Method for producing a protein having the same IgG specificity as protein G from group G Streptococci, strain G148. The invention also relates to a recombinant DNA molecule coding for said protein, and to microorganisms containing this recombinant DNA molecule. The invention also relates to a recombinant DNA molecule coding for a protein having the IgG binding specificity of both protein G and protein A.

Abstract: A solid diagnostic device for the quantitative determination of substances of biological affinity in biological fluids is described. A process is also described in which the biological fluid is brought into contact with a specific functional sector of the device, the fluid migrates through several functional sectors situated beside one another and containing suitable reagent components, and one or more substances of biological affinity are detected in such functional sectors which contain, for each substance to be detected, at least one combination partner of biological affinity, attached to a solid phase.