Abstract: The invention relates to multiplex ligase chain reaction (LCR). Two or more putative target sequences are selected. For each one, a set of four probes is used simultaneously to amplify the putative sequence if it is present in the sample. Preferably, all the amplicons are labeled with a common label/hapten and, for each different target, with a unique label/hapten. The invention also relates to an immunochromatographic strip device and method employing a diagonal array of capture spots.

Abstract: Methods, devices, apparatus and kits for amplifying and detecting nucleic acid are provided. The apparatus is a one or two-tier thermal cycling device that operates in conjunction with a reaction/detection unit. A sample is loaded into a reaction chamber of the device which is then mated with a detection chamber to form the reaction/detection unit. A first heating element of the thermal cycling apparatus applies a desired temperature to the reaction/detection device to amplify target nucleic acid in the sample. The reaction mixture is then transferred to the detection chamber by the second heating element and amplified target nucleic acid is immobilized on a support in the detection chamber. Microprocessor control controls the heat applied by the second element independently of the heat applied by the first element. A detection system associated with the apparatus detects and analyzes the immobilized amplified nucleic acid target.

Abstract: A method and apparatus for collecting a binding member of interest from a liquid specimen utilizes a collection receptacle in which the specimen is deposited, with an affinity-filter media being place in communication with a discharge port in the collection receptacle and a transfer device for drawing specimen from the collection receptacle and through the filter for capturing the binding member of interest. The collection receptacle, affinity-filter media and carrier therefor and the transfer device may be supplied in kit form for use in a clinical environment. A hypobaric vessel may be used and the transfer device and this vessel may also serve as a disposal receptacle for the liquid specimen passed through the filter media.

Abstract: A set of contiguous and partially overlapping RNA sequences and polypeptides encoded thereby, designated as LU103 and transcribed from lung tissue is described. A fully sequenced clone representing the longest continuous sequence of LU103 is also disclosed. These sequences are useful for detecting, diagnosing, staging, monitoring, prognosticating, preventing or treating, or determining the predisposition of an individual to diseases and conditions of the lung such as lung cancer.

Abstract: The invention relates to multiplex ligase chain reaction (LCR). Two or more purative target sequences are selected. For each one, a set of four probes is used simultaneously to amplify the putative sequence if it is present in the sample. Preferably, all the amplicons are labeled with a common label/hapten and, for each different target, with a unique label/hapten. The invention also relates to an immunochromatographic strip device and method employing a diagonal array of capture spots.

Abstract: A waveguide binding assay method involves detecting the scattering of light directed into the waveguide, the scattering being the result of scattering labels specifically bound to the waveguide within the penetration depth of an evanescent wave. The waveguide may be transparent plastic or glass and the binding is typically by oligonucleotide hybridization or immunological capture. Light scattering labels include colloidal metals or non-metals, including gold, selenium and latex. A light absorbing member consisting of dye or concentrated particles may also be employed to enhance signal. Real-time binding and dissociation can be monitored visually or by video imaging, such as with a CCD camera and frame grabber software. Hybridization mismatches of as few as one base can be distinguished by real-time melting curves.

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 device and method for quantitative determination of an analyte in a biological sample utilizes a non-transparent support medium for retaining a chromatogenic reaction product with the medium being exposed to a source of light for transmitting therethrough a scattered, uniform response light signal which is collected at a photosensitive device whereby the amount of the analyte is correlated to the intensity of the response light signal. The response light signal may be converted to a time-duration signal proportional to light intensity to facilitate the quantitative determination.

Abstract: Methods, devices, apparatus and kits for amplifying and detecting nucleic acid are provided. The apparatus is a thermal cycling device that operates in conjunction with a reaction/detection unit. A sample is loaded into a reaction chamber of the device which is then sealably mated with a detection chamber to form a sealed reaction/detection unit that is virtually irreversibly closed. One or more heating elements of the thermal cycling apparatus applies a desired temperature to the reaction/detection device to amplify target nucleic acid in the sample. The reaction mixture is then transferred to the detection chamber and amplified target nucleic acid is immobilized on a support in the detection chamber. A detection system associated with the apparatus detects and analyzes the immobilized amplified nucleic acid target. Kits include the reaction/detection units and reagents for amplification.

Abstract: Methods and kits are provided for the quantitative determination of the presence of an enzyme analyte in a sample by determination of the rate of analyte catalyzed reaction on a chromatographic medium. The methods may be used to determine both steady state and non-steady state enzyme reaction kinetics and provide a physical record reflecting the same. In a preferred embodiment, an analyte enzyme in a sample to be analyzed is immobilized at a reaction site on a chromatographic medium, the chromatographic medium is contacted with a solution containing a substrate, the solution is transported on the chromatographic medium to the reaction site where the analyte enzyme catalyzes the reaction of the substrate to produce a detectable reaction product at a rate related to the amount of enzyme present, and the solution and reaction product are transported from the reaction site to a detection region formed by a length of the chromatographic medium downstream from the reaction site.

Abstract: A waveguide binding assay method involves detecting the scattering of light directed into the waveguide, the scattering being the result of scattering labels specifically bound to the waveguide within the penetration depth of an evanescent wave. The waveguide may be transparent plastic or glass and the binding is typically by oligonucleotide hybridization or immunological capture. Light scattering labels include colloidal metals or non-metals, including gold, selenium and latex. A light absorbing member consisting of dye or concentrated particles may also be employed to enhance signal. Real-time binding and dissociation can be monitored visually or by video imaging, such as with a CCD camera and frame grabber software. Hybridization mismatches of as few as one base can be distinguished by real-time melting curves.

Abstract: The present invention relates to improved specific binding assay methods, kits and devices utilizing chromatographically mobile specific binding reagents labelled with colloidal particles. Specific binding reagents labelled with colloidal particles such as gold and selenium may be subjected to rapid chromatographic solvent transport on chromatographic media by means of selected solvents and chromatographic transport facilitating agents. Further, impregnation of solid substrate materials with labile protein materials including colloidal particle and enzyme labelled reagents in the presence of meta-soluble proteins provides for the rapid resolubilization of such materials which have been dried onto such substrate materials.

Abstract: A method and apparatus for collecting a cell sample from a liquid specimen utilizes a collection receptacle in which the specimen is deposited, with a filter media being place in communication with a discharge port in the collection receptacle and a transfer device for drawing specimen from the collection receptacle and through the filter for capturing the cellular component of the specimen on the filter media for defining a cell sample for analysis. The collection receptacle, filter media and carrier therefor and the transfer device may be supplied in kit form for use in a clinical environment. A hypobaric vessel may be used and the transfer device and this vessel may also serve as a disposal receptacle for the liquid specimen passed through the filter media.

Abstract: New devices and kits for solid-phase immuno-assays comprising a solid porous support, preferably in the form of a sheet, where antigens or immuno-globulins or both of them are bound by direct application in any suitable geometry, e.g. as an assay of dots or lines. Such porous supports are suitable for effecting an unlimited number of antibody-antigen reactions simultaneously and in one operation.

Abstract: Methods, devices, apparatus and kits for amplifying and detecting nucleic acid are provided. The apparatus is a two-tier thermal cycling device that operates in conjunction with a reaction/detection unit. A sample is loaded into a reaction chamber of the device which is then mated with a detection chamber to form the reaction detection unit. A first heating element of the thermal cycling apparatus applies a desired temperature to the reaction/detection device to amplify target nucleic acid in the sample. The reaction mixture is then transferred to the detection chamber by the second heating element and amplified target nucleic acid is immobilized on a support in the detection chamber. A detection system associated with the apparatus detects and analyzes the immobilized amplified nucleic acid target.

Abstract: The present invention relates to methods and test strips for performing nucleic acid hybridizations on a porous chromatographic material having the capacity for rapid chromatographic solvent transport of non-immobilized reagents and reactive solution components by means of a selected chromatographic solvent. The strip includes a first end or contact site, at which chromatographic solvent transport begins, a second end, at which chromatographic solvent transport ends, and at least one zone positioned between the first and second ends. The zone is impregnated with a capture nucleotide sequence which is immobilized against solvent transport and which is capable of hybridization with a complementary nucleotide sequence or probe so as to render it immobilized in the capture zone. The strip may further include a probe zone between the first end and the capture zone, wherein a labeled probe is impregnated such that it is mobilized by the solvent and transported to the capture zone where hybridization can occur.

Abstract: The present invention relates to improved specific binding assay methods, kits and devices utilizing chromatographically mobile specific binding reagents labelled with colloidal particles. Specific binding reagents labelled with colloidal particles such as gold and selenium may be subjected to rapid chromatographic solvent transport on chromatographic media by means of selected solvents and chromatographic transport facilitating agents. Further, impregnation of solid substrate materials with labile protein materials including colloidal particle and enzyme labelled reagents in the presence of meta-soluble proteins provides for the rapid resolubilization of such materials which have been dried onto such substrate materials.

Abstract: A test strip for analysis of analytes such as antigens, antibodies or polynucleotides employs a chromatographic medium and a solvent capable of transporting reagents and/or sample. Reagents are selected and disposed on the medium such that a labeled (first) reagent arrives at the detection (third) zone only after analyte is immobilized there and non-reactive sample componets have been transported beyond the detection zone. This sequential arrival is accomplished by the relative mobility of the reagent or sample; or by the site relationship of the zones. Preferably, the site relationship of the sample (second) zone and the label (first) zone is such that a plurality of pathways guide the sample and labeled reagent and any subsequent reagents to the detection zone in the recited order. Single and multiple pathway devices are disclosed.

Abstract: The present invention relates to improved specific binding assay devices comprising a chromatographic medium including a reaction site at which a specific binding reagent is immobilized, a sample application well located adjacent to the chromatographic medium and offset upstream from the reaction site, and a liquid absorption blotter offset downstream from the reaction site.

Abstract: A new specific antibody to 5'-terminal mono-, di- or triphosphorylated (2'-5')adenyl-adenoisine oligonucleotides and a method of producing it have been found. The antibody can be used for the quantitative analysis of the oligonucleotides mentioned above in any one of the well known methods of immunological analysis.