Abstract: A sample holder includes a first member featuring a first retaining mechanism configured to retain a first substrate that includes a sample, a second member featuring a second retaining mechanism configured to retain a second substrate that includes a reagent medium, and an alignment mechanism connected to at least one of the first and second members, and configured to align the first and second members such that the sample contacts at least a portion of the reagent medium when the first and second members are aligned.

Abstract: The present invention is directed to a continuous affinity chromatography method and to an apparatus to be used in such method. The method allows the use of high operational velocity while maintaining high binding capacities.

Abstract: A method for generating and localizing a signal in a solid phase substrate detection system comprises applying a solution of target material to a substrate; binding the target with a specific affinity molecule having an attached label, the label comprising multiple signal precursor molecules; applying a carrier to the substrate, and treating the label to convert the signal precursor molecules to signal generating molecules. The carrier comprises solvent for the label and thickener for localizing the signal. The carrier may include developer that converts signal precursor molecules to signal generating molecules. Developer is not necessary if the signal precursor molecules are converted to signal generating molecules by e.g. temperature change, pH change, sonication, light irradiation, microwave heating. A test device for detecting target in a fluid sample, and a kit of parts for determining the presence of target in a fluid sample are also disclosed.

Abstract: Microfluidic devices and methods for using the same are provided. Aspects of the invention include microfluidic devices that include a separation medium and a pan-capture binding medium. The microfluidic devices are configured to subject a sample to two or more directionally distinct electric fields. Also provided are methods of using the devices as well as systems and kits that include the devices. The devices, systems and methods find use in a variety of different applications, including diagnostic and validation assays.

Abstract: The present invention relates to a method of detecting a target antibody, particularly a target autoantibody, in a sample, using a small molecule fluorophore-labelled target antigen, or a functional fragment, functional variant or functional derivative thereof that specifically binds to the target antibody. Detection is typically carried out using immunodiffusion or immunoelectrophoresis. The invention also relates to methods of diagnosing disease, particularly autoimmune disease, using small molecule fluorophore labelled target antigens and autoantigens. Small molecule fluorophore labelled target antigens, including autoantigens, are also disclosed, as are uses such.

Abstract: A biosensor combining the sensitivity of surface acoustic waves (SAW) generated at a frequency of 325 MHz with the specificity provided by antibodies and other ligands for the detection of viral agents. In a preferred embodiment, a lithium tantalate based SAW transducer with silicon dioxide waveguide sensor platform featuring three test and one reference delay lines was used to adsorb antibodies directed against Coxsackie virus B4 or the negative-stranded category A bioagent Sin Nombre virus (SNV). Rapid detection of increasing concentrations of viral particles was linear over a range of order of magnitude for both viruses, and the sensor's selectivity for its target was not compromised by the presence of confounding Herpes Simplex virus type 1 The biosensor was able to delect SNV at doses lower than the load of virus typically found in a human patient suffering from hantavirus cardiopulmonary syndrome (HCPS).

Abstract: The invention provides a device and method for the rapid identification of patients suspected of having thalassemia. The invention provides a test strip for the aqueous detection of thalassemia related proteins in whole blood. The test strip includes antibodies specific to the gamma 4, (?4) protein and provides easy visual discrimination between a positive result and a negative result. The invention can be used in remote or clinical settings.

Abstract: Multi-directional microfluidic devices and methods for using the same are provided. Aspects of the invention include microfluidic devices that are configured to subject a sample to two or more directionally distinct flow fields, and include a separation medium and a binding medium, where the binding medium is in fluid communication with the separation medium. Also provided are methods of using the devices as well as systems and kits that include the devices. The devices, systems and methods find use in a variety of different applications, including diagnostic and validation assays.

Abstract: The present invention is based on the discovery that a single nucleotide polymorphism (SNP) present the chitinase 3-like 1 gene (CHI3L1) encoding YKL-40 or a regulatory domain of the CHI3L1 gene, is associated with elevated YKL-40 levels, as well as an increased risk for developing a lung disorder, including asthma, bronchial hyperresponsivity, and/or reduced lung function.

Abstract: Apparatus and method employing gel electrophoresis and optical imaging techniques to measure the amount of biomaterial that attaches to specified locations on a detector slide and to determine the molecular weight of the molecules at those locations.

Abstract: The present invention relates generally to methods and compositions for analyzing test samples containing target analytes including proteins and nucleic acids. The invention uses a surface acoustic wave sensor in combination with a hydrogel to obtain an ultra sensitive non-fluorescent detection system.

Abstract: Novel magnetic assay methods and systems. According to a preferred embodiment, a chromatographic medium is provided that is designed to be contacted with a test solution having activated magnetic particles such that the solution flows bilaterally thereacross. A magnetic field, generated by a magnet or electromagnet, is selectively applied to the medium which causes the charged particles to become substantially bound at a site on the medium specified by the position of the magnet, to thus form a captured line or zone. In one preferred embodiment, the magnetic field is applied at the site on the medium at which the test solution is contacted. The assay is multi-configurable and can be modified to suit a particular immuno-separation procedure or application.

Abstract: A biochemical analysis instrument for multiple fluid analyses includes a housing. A sensor for sensing a reaction is disposed in the housing. An aperture is formed in the housing. A test tape housing area is formed in the housing, and the sensor is disposed to selectively move within the housing area; the aperture being formed to provide access to the tape housing area. A cassette is configured to be received within the tape housing area. The cassette includes a case. First and second chambers are formed in the case. A gap is formed in the case. The first chamber and second chamber are disposed at a respective side of the gap. A test tape disposed within the housing extends from the first chamber across the gap to the second chamber. The test tape includes a plurality of active zones disposed at predetermined spaced intervals along the tape for testing an analyte.

Abstract: This is a self-contained disposable thermal cycler device in which target sequence is amplified as the samples passes over a grid of alternating temperature and then at the completion of the reaction, the amplified material is captured by probes complementary to the targeted sequence. Since the device can be sealed and is disposable, it reduces the occurrence of cross contamination or specimen carry-over.

Abstract: A method for diagnosing a condition of a patient involves the steps of (a) adding one or more reagents to a test sample from a patient, the test samples comprising at least part of a blood sample from the patient, in order to cause formation of a complex comprising at least one acute phase protein and at least one human lipoprotein, while causing substantially no fiber polymerization; (b) measuring the formation of the complex over time so as to derive a time-dependent measurement profile, and (c) determining a slope and/or total change in the time-dependent measurement profile, so as to diagnose a condition of the patient. A greater formation of the complex is correlated to increased probability of death of the patient.

Abstract: The present invention pertains to the field of medicine and may be used for producing a specific antiserum as well as for carrying out immunological diagnoses of malignant tumours. This method for producing an antiserum involves sampling an embryo at the foetal stage from animals of a same genetic type so as to obtain a cell suspension. After immunization, this method involves sampling spleen cells from the animal, separating lymphocytes and immunizing the animal of the same genetic line using the lymphocyte suspension. An antiserum is then obtained and cells originating from healthy organs of the same animals are added to the antiserum. The mixture is finally decanted and the liquid located above the sediments is filtered. In order to carry out a diagnosis, the filtrate is added to the subject's blood and the results are obtained by immuno-fluorescence, by blood tests or using other methods of immunological diagnosis.

Abstract: The present invention relates to a systematic process for the creation of functionally organized, spatially patterned assemblies of polymer-microparticle composites including the AC electric field-mediated assembly of patterned, self-supporting organic (polymeric) films and organic-polymer-microparticle composites of tailored composition and morphology. The present invention further relates to the incorporation of said assemblies into other structures. The present invention also relates to the application of such functional assemblies in materials science and biology. Additional areas of application include sensors, catalysts, membranes, and micro-reactors, and miniaturized format for generation of multifunctional thin films. This invention also provides simple methods and apparatus for synthesizing thin films of tailored composition and morphology.

Abstract: The present invention relates to an immunogenic conjugate comprising a carrier molecule coupled to an autoinducer of a Gram negative bacteria. The immunogenic conjugate, when combined with a pharmaceutically acceptable carrier, forms a suitable vaccine for mammals to prevent infection by the Gram negative bacteria. The immunogenic conjugate is also used to raise and subsequently isolate antibodies or binding portions thereof which are capable of recognizing and binding to the autoinducer. The antibodies or binding portions thereof are utilized in a method of treating infections, a method of inhibiting autoinducer activity, and in diagnostic assays which detect the presence of autoinducers or autoinducer antagonists in fluid or tissue samples.

Abstract: A method for separating a chemical or biological compound present in a mixture of similar compounds by diffusion in a medium, the method comprising reacting the compounds of the mixture with a component (P) present in the medium to obtain products (Qi), wherein the reactions Ci+P?Qi are reversible and have kinetic constants k1 and k2, and applying to the medium a varying field to which the compounds are sensitive, wherein the period of the field and the concentration of component (P) in the medium are determined from the kinetic constants (k1,k2) of the compound (C) to be separated in order to establish resonance condition between said reactions and the field and for giving compound C an apparent diffusion coefficient (Da) in the medium that is maximum.

Abstract: A method is disclosed for determining whether a compound binds to a lipoprotein such as LDL or VLDL in a manner which will lower plasma cholesterol. The method provided includes assessing the ability of the compound to form a complex with the lipoprotein, and then determining whether the newly formed complex causes a change in the structure of apoB-100 that results in increased binding affinity to an LDL receptor.

Abstract: Methods are provided for diagnosing and/or characterizing chronic immune disease activity in a subject. In the subject methods, a sample is obtained from a subject suspected of having or known to have a chronic immune disease. The sample is then assayed for the presence of low molecular actin fragments. The assay results are used to diagnose the presence of chronic immune disease activity and/or characterize chronic immune disease activity in the subject, e.g. to confirm an initial chronic immune disease diagnosis, to determine the stage of the disease, to monitor disease progression, to predict disease attacks, and the like. Also provided by the subject invention are kits for practicing the methods.

Abstract: A sample separation apparatus including a porous, or rough, capillary column. The porous capillary column includes a matrix which defines pores, and may be formed from a material such as porous silicon. Alternatively, the capillary column may have a rough surface of hemispherical grain silicon. The capillary column is defined in a surface of a substrate, such as silicon. The sample separation apparatus may include a stationary phase or a capture substrate disposed on the surfaces thereof. The sample separation apparatus may also include a detector positioned proximate the capillary column. A variation of the sample separation apparatus includes an electrode proximate each end of the capillary column. The sample separation apparatus may be employed to effect various types of chromatographic separation, electrophoretic separation, and analyte identification.

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.

Abstract: The present invention relates to bioassay materials useful for the detection of toxic substances and, more particularly, to packaging materials for food and other products, along with methods for their manufacture and use. The invention provides a unique composite material capable of detecting and identifying multiple biological materials within a single package. The biological material identification system is designed for incorporation into existing types of flexible packaging material such as polyvinylchloride or polyolefin films, and its introduction into the existing packaging infrastructure will require little or no change to present systems or procedures.

Abstract: A testing apparatus 10 having an absorbent matrix 12, including a membrane 14 which contains a plurality of counter-ions 16. Chromionophore (or fluorionophore)s 18 and affinophores 22 compete to carry ions into the membrane 14 and neutralize the charge of the counter-ions 16. Biological recognition molecules 42 bind to a portion of the affinophores 22 and prevent them from entering the membrane 14, thereby allowing more chromionophore (or fluorionophore)s 18 to enter the membrane 14. The portion of affinophores 22 bound to the biological recognition molecules 42 is inversely proportional to the amount or concentration of analyte 40 occurring within the solution or medium 30. The result of this is that the color of the membrane-covered matrix changes in a manner related to the concentration of the analyte. One application of this apparatus is a strip test for prediction of ovulation.

Abstract: The present invention relates to diagnostic applications. For autoimmune diseases more particularly, it is demonstrated herein that individuals with SLE, APLA, MCDS and PSS have antibodies that are specific for SR proteins. Thus, in particular aspects the present invention provides methods and compositions for diagnosing autoimmune disease using SR proteins and antibodies to detect the presence of SR protein-specific antibodies in an individual suspected of having autoimmune disease, wherein the presence of such antibodies is indicative of said individual suffering from autoimmune disease.

Abstract: Surprisingly, the present inventors have discovered that thermal denaturation of prion protein facilitates its detection by immunological methods. Accordingly, the present invention provides methods for the preparation and thermal denaturation of samples for prion detection, comprising: homogenizing a candidate sample and heating said sample in a buffer, preferably one with properties that aid stabilization of the denatured form of the protein. The methods described in this disclosure can be used in the detection of PrPSc. Such detection is useful for the diagnosis of transmissible spongiform encephalopathies. This method can be used with immunoassays of various formats, including, but not limited to, dot blot and western blot assays, which utilize polyclonal antibodies, monoclonal antibodies, antibody fragments, receptors, natural and synthetic ligands and other entities.

Abstract: The invention relates to capillary electrophoretic methods for detecting ligands or hit compounds that can bind to a selected target at or above a selected binding strength. The method allows one to rank various ligands based on their relative affinity, i.e., the relative stability of the target/ligand complex during capillary electrophoresis under selected conditions. The method also enables selective detection of strong-to-moderate binding hit compounds, even in the presence of high concentrations of weaker, competitive hit compounds.

Abstract: The present invention relates to diagnostic applications. For autoimmune diseases more particularly, it is demonstrated herein that individuals with SLE, APLA, MCDS and PSS have antibodies that are specific for SR proteins. Thus, in particular aspects the present invention provides methods and compositions for diagnosing autoimmune disease using SR proteins and antibodies to detect the presence of SR protein-specific antibodies in an individual suspected of having autoimmune disease, wherein the presence of such antibodies is indicative of said individual suffering from autoimmune disease.

Abstract: Removal of abundant proteins from a sample enhances detection and resolution of less abundant proteins in the sample such as in two-dimensional gel electrophoresis. The removal is accomplished by immunosubtraction of several high abundance, interfering or contaminating proteins simultaneously.

Abstract: A method for detecting or assaying one constituting member in a specific binding pair, for example, the antigen in an antigen/antibody pair, by utilizing specific binding such as binding between an antigen and an antibody, together with redox reaction for detecting a label, wherein an oxygen micro-electrode with a sensing surface area of 1 mm2 or less is used; and an apparatus to which the method is applicable. According to the method and by using the apparatus, redox reaction for assaying the label can be completed in such a short time as several minutes. Therefore, an inexpensive disposable apparatus for household use can be realized.

Abstract: The present invention relates to bioassay materials useful for the detection of toxic substances and, more particularly, to packaging materials for food and other products, along with methods for their manufacture and use. The invention provides a unique composite material capable of detecting and identifying multiple biological materials within a single package. The biological material identification system is designed for incorporation into existing types of flexible packaging material such as polyvinylchloride or polyolefin films, and its introduction into the existing packaging infrastructure will require little or no change to present systems or procedures.

Abstract: The present invention relates to bioassay materials useful for the detection of toxic substances and, more particularly, to packaging materials for food and other products, along with methods for their manufacture and use. The invention provides a unique composite material capable of detecting and identifying multiple biological materials within a single package. The biological material identification system is designed for incorporation into existing types of flexible packaging material such as polyvinylchloride or polyolefin films, and its introduction into the existing packaging infrastructure will require little or no change to present systems or procedures.

Abstract: The present invention provides methods of detecting and/or characterizing the viral vector particle content of a medium. A medium is provided and contacted with an excitation energy such that, if a viral vector particle is in the medium, an electron associated with the intrinsically fluorogenic portion of the viral vector particle will be raised to an excited energy state. The excited electron is permitted to emit radiation having an emission wavelength which is detected. The viral vector particle content of the medium then can be evaluated by comparing the detected emission wavelength with a standard signal. For example, the number of viral vector particles in a medium can be quantified by comparing the detected wavelength and its corresponding intensity to a standard signal. Similar methods for evaluating the adenoviral vector particle content of a medium and the intrinsically fluorogenic adenoviral structural protein content of a medium are provided.

Abstract: The present invention provides a method to characterize, optimize, and control the quality and production of hydrogel media. Additionally, the present invention provides a method for determining the size, size distribution, and spatial distribution of the pores of a porous substrate. More particularly, the invention provides a method for determining the size, size distribution, and spatial distribution of the pores of a polymeric hydrogel-based substrate.

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.

Abstract: A testing apparatus 10 having an absorbent matrix 12, including a membrane 14 which contains a plurality of counter-ions 16. Chromionophore (or fluorionophore)s 18 and affinophores 22 compete to carry ions into the membrane 14 and neutralize the charge of the counter-ions 16. Biological recognition molecules 42 bind to a portion of the affinophores 22 and prevent them from entering the membrane 14, thereby allowing more chromionophore (or fluorionophore)s 18 to enter the membrane 14. The portion of affinophores 22 bound to the biological recognition molecules 42 is inversely proportional to the amount or concentration of analyte 40 occurring within the solution or medium 30. The result of this is that the color of the membrane-covered matrix changes in a manner related to the concentration of the analyte. One application of this apparatus is a strip test for prediction of ovulation.

Abstract: The invention relates to a method for purifying and concentrating AAV-2 and antigen portions thereof. AAV-2 or antigen portions thereof are bonded to an activated chromatographic material on which antibodies are linked, said antibodies being directed against AAV-2. Afterwards, elution using a solution containing 0.5 to 4.5 M MgCl2 is carried out. The invention also relates to a kit for implementing said method.

Abstract: The slope lines of the peak lines are determined for a reference specimen and a test specimen and then compared with one another to analyze peak lines independently of the background. Preferably a minimum amplitude of a slope line is established with a threshold specimen so that fluctuations with a smaller amplitude can be disregarded. This method is suitable especially for automatic analysis of blot strips.

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: The present invention relates to bioassay materials useful for the detection of toxic substances and, more particularly, to packaging materials for food and other products, along with methods for their manufacture and use. The invention provides a unique composite material capable of detecting and identifying multiple biological materials within a single package. The biological material identification system is designed for incorporation into existing types of flexible packaging material such as polyolefin films, and its introduction into the existing packaging infrastructure will require little or no change to present systems or procedures.

Abstract: Methods for the biochemical and immunohistochemical detection of cell apoptosis are described. The methods utilize the detection and measurement of polypeptide fragments generated during apoptosis. Conditions associated with apoptosis may be detected by the methods of this invention. Methods are also presented for the screening of potential therapeutic compounds which inhibit or stimulate apoptosis. Kits for detection of apoptosis and diagnosis of diseases are also provided.

Abstract: A testing apparatus 10 having an absorbent matrix 12, including a membrane 14 which contains a plurality of counter-ions 16. Chromoionophore (or fluorionophore)s 18 and affinophores 22 compete to carry ions into the membrane 14 and neutralize the charge of the counter-ions 16. Biological recognition molecules 42 bind to a portion of the affinophores 22 and prevent them from entering the membrane 14, thereby allowing more chromoionophore (or fluorionophore)s 18 to enter the membrane 14. The portion of affinophores 22 bound to the biological recognition molecules 42 is inversely proportional to the amount or concentration of analyte 40 occurring within the solution or medium 30. The result of this is that the color of the membrane-covered matrix changes in a manner related to the concentration of the analyte. One application of this apparatus is a strip test for prediction of ovulation.

Abstract: Disclosed is a test cell and a method for detection of a preselected ligand in a liquid sample such as a body fluid. The test cell includes an elongate outer casing which houses an interior permeable material capable of transporting an aqueous solution and defining a sample inlet, a test volume, and a reservoir volume. The reservoir volume is disposed in a section of the test cell spaced apart from the inlet and is filled with sorbent material. The reservoir acts to receive liquid transported along a flow path defined by the permeable material and extending from the inlet and through the test volume. In the test volume is a test site which includes a first protein having a binding site specific to a first epitope of the ligand immobilized in fluid communication with the flow path. The test site can be observed through a window of the casing.

Abstract: A solid phase system for use in ligand-receptor assays, particularly immunoassays using monoclonal antibodies, is disclosed. The solid phase system comprises a porous matrix in which microspheres, bound with a receptor capable of capturing a target ligand, are entrapped. Preferably, the microspheres are entrapped within a discrete zone or zones of the porous matrix.

Abstract: A cellulose binding domain (CBD) having a high affinity for crystalline cellulose and chitin is disclosed, along with methods for the molecular cloning and recombinant production thereof. Fusion products comprising the CBD and a second protein are likewise described. A wide range of applications are contemplated for both the CBD and the fusion products, including drug delivery, affinity separations, and diagnostic techniques.

Abstract: Analytes can be detected from among closely related substances by reacting the analyte in a test sample with a labeled binding agent which specifically binds to the analyte to form a complex. The labeled binding agent is supplied in excess, and the complex is identified through a time window relative to the detection of the excess unbound agent. The complex and labeled binding agent are isolated on a separation media and identified by the differential rate of migration.

Abstract: A method of detecting malignant tumors and determining their mass includes withdrawing fresh blood and/or serum samples from the patient. The blood or serum sample is then stabilized. The tumor determination is obtained from a shift in the ratio of at least one of the IgG subclasses to the sum of the IgG subclasses, relative to the normal ratio in the samples.

Abstract: Disclosed is a test cell and a method for detection of a preselected ligand in a liquid sample such as a body fluid. The test cell includes an elongate outer casing which houses an interior permeable material capable of transporting an aqueous solution and defining a sample inlet, a test volume, and a reservoir volume. The reservoir volume is disposed in a section of the test cell spaced apart from the inlet and is filled with sorbent material. The reservoir acts to receive liquid transported along a flow path defined by the permeable material and extending from the inlet and through the test volume. In the test volume is a test site which includes a first protein having a binding site specific to a first epitope of the ligand immobilized in fluid communication with the flow path. The test site can be observed through a window of the casing.

Abstract: An analytical test device useful for example in pregnancy testing, comprises a hollow casing (500) constructed of moisture-impervious solid material, such as plastics materials, containing a dry porous carrier (510) which communicates indirectly with the exterior of the casing via a bibulous sample receiving member (506) which protrudes from the casing such that a liquid test sample can be applied to the receiving member and permeate therefrom to the porous carrier, the carrier containing in a first zone a labelled specific binding reagent is freely mobile within the porous carrier when in the moist state, wherein the mobility is facilitated by a material comprising a sugar, in an amount effective to reduce interaction between the test strip and the labelled reagent, and in a second zone spatially distinct from the first zone unlabelled specific binding reagent for the same analyte which unlabelled reagent is permanently immobilised on the carrier material and is therefore not mobile in the moist state, the t