Abstract: The present invention relates to a method of producing liposomes useful for encapsulating and delivering a wide variety of biologically active materials. The invention provides liposomes and a production method which is simple, feasible and inexpensive for the large-scale commercial manufacturing of liposomes and encapsulated materials. The method involves the formation of a liposome dispersion in the absence of an organic solvent or detergent, one or several cycles of freezing and thawing the liposomes, and dehydration of the liposome dispersion to form a lipid powder. When desired, the lipid powder is hydrated in the presence of the biologically active material whereby the material is encapsulated in reconstituted liposomes. The method can also include combining the liposome dispersion with a bulking agent prior to the dehydration and formation of the lipid powder. The addition of the bulking agent facilitates the handling of the lipid powder as well as its rapid dispersal upon hydration.

Abstract: Biological factors with enhanced biological activity are prepared by covalently linking a biomolecule to one or more chains of a synthetic polymer wherein the synthetic polymer is derived from the oxymethylene-oxyethylene part structure.

Abstract: The present invention relates to single and multiple layer collagen films that are useful for improved sustained release delivery of pharmaceuticals.

Abstract: Collagen-containing sponges comprising an absorbable gelatin sponge, collagen, and an active ingredient are disclosed as are methods of enhancing wound healing of external and internal wounds using such sponges.

Abstract: Assay reagents, devices, methods and kits used in the analysis of low molecular weight analytes which by themselves are too small or unable to bind to two specific binding members at the same time. The invention involves the use of an analyte-substitute reagent (ASR) comprising at least two components, the first of which is identical to or an analog of the analyte to be determined, while the second is an unrelated ligand for which an antibody or other specific binding member can be obtained or produced.

Abstract: The novel analytical devices and methods of the present invention involve dual pathway devices which provide for the confirmation of sandwich or competitive assay results. In a self-confirming sandwich assay, the labeled analyte complex becomes immobilized within a first pathway at an assay capture site to indicate the presence or amount of an analyte in the test sample. In a second pathway, a confirmatory reagent blocks the binding of the analyte or labeled analyte complex to a confirming assay site, thereby confirming that the presence of label in the assay capture site indicates a positive test sample. In a self-confirming competitive assay, a confirmed positive result is one in which the device displays a decrease in signal or no signal at the assay capture site, and the confirming assay site displays a detectable signal.

Abstract: The present invention involves an integrated double-ended needle and blood collection device assembly which is convenient to use, safely contained and ready for disposal after use. The device allows the user to expose and resheath potentially infectious needles without bringing the user's fingers or hands into close proximity with sharp or broken needle tips. After removing the needle from the patient, the needle is safely resheathed by retracting the needle into the device, thereby reducing the risks of accidental needle wounds and infection. The device also serves as a holder for blood collection tubes which can be easily inserted and removed for multiple sampling.

Abstract: A monoclonal antibody which specifically binds to HIV-2 gp36 antigen and does not specifically bind to HIV-1 antigens. The monoclonal antibody is useful in immunoassays as a capture reagent, as part of an indicator reagent, and/or as a positive control.

Abstract: A competitive immunoassay to measure Lp(a) levels semiquantitatively and identify individuals with elevated plasma Lp(a) protein levels (greater than 7 mg/dl) who have an increase risk for coronary artery disease. The assay is useful for monitoring the effectiveness of Lp(a)-lowering drugs. The assay provides a quick, reliable, easy to use and inexpensive method to measure plasma Lp(a) level with serum, plasma or whole blood.

Abstract: The present invention provides a metal ion scavenging procedure and antibody compositions for radioimmunoscintigraphy and cytotoxic radioimmunotherapy having chelator concentrations of greater than about 10.sup.-4 M which are optimized with respect to their metal binding capacity such that highly efficient labelling of the antibody is achieved in a simple one step procedure using readily available sources of radiometal ions.

Abstract: An improved chromatographic device and method for quantitating the activity of an enzyme utilizes a bibulous test strip as the stationary phase, an aqueous solution as the mobile phase, and a chromophore as the indicator. The enzyme activity is quantitated by transforming a substantially depletable amount of a chromogenic substrate from soluble chromogen to insoluble chromophore as the mobile phase advances, whereupon the insoluble chromophore becomes immobilized on the test strip to produce a column of color. The length and/or the intensity of the column of color are related to the activity of the enzyme. The present invention is useful for the direct determination of enzyme-analytes and for the indirect determination of analytes which can be coupled to an enzyme.

Abstract: The invention relates to assays utilizing microparticle separation. More particularly, the invention relates to microparticle assays used for confirmation of ligands in a biological sample.

Abstract: The present invention provides a metal ion scavenging procedure and antibody compositions for radioimmunoscintigraphy and cytotoxic radioimmunotherapy having chelator concentrations of greater than about 10.sup.-4 M which are optimized with respect to their metal binding capacity such that highly efficient labelling of the antibody is achieved in a simple one step procedure using readily available sources of radiometal ions.

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 for producing a binding assay device composed of antigens on a cellulose nitrate, cellulose nitrate/acetate or similar solid phase is described. The method involves applying to a solid phase a small amount of an allergen composition, or a pretreated allergen composition, containing a certain concentration of allergen and drying the solution. The device is used by contacting a patient test sample to the immobilized allergen and determining whether or not the test sample contains IgE antibodies for the allergen.

Abstract: The present invention involves an integrated double-ended needle and blood collection device assembly which is convenient to use, safely contained and ready for disposal after use. The device allows the user to expose and resheath potentially infectious needles without bringing the user's fingers or hands into close proximity with sharp or broken needle tips. After removing the needle from the patient, the needle is safely resheathed by retracting the needle into the device, thereby reducing the risks of accidental needle wounds and infection. The device also serves as a holder for blood collection tubes which can be easily inserted and removed for multiple sampling.

Abstract: Improved chromatographic strip binding assay devices are provided for determining the presence or amount of an analyte present in a patient sample. Assay label reagents interact with capture reagents immobilized in a testing region on the strip substrate to generate a visually detectable image indicative of the test result. The test result images include a minus sign (-) to indicate a negative test result for analyte which image is generated if the suspect analyte is absent in the patient sample and a plus sign (+) to indicate a positive test result for analyte which image is generated if the suspect analyte is present or is present at a pre-determined concentration in the patient sample. The immobilized capture reagents responsible for the location and configuration of the test result images are applied to the strip at an angled orientation with respect to the fluid flow direction of the strip to ensure that sharp substantially complete test result images are formed during performance of the assay.

Abstract: A device and method for permitting the separation of plasma or serum from whole blood. The device comprises a matrix of hydrophilic sintered porous material to which at least one red blood cell agglutinating agent has been applied. According to a first method of using the device, a sample of whole blood is applied to a first end of the matrix and the red blood cells within the sample come in contact with the agglutinating agents present in the matrix. The blood cells agglutinate, and are entrapped in the interstices of the matrix, while substantially blood-cell-free serum or plasma accumulates near the outlet of the device. A filter means in liquid receiving relationship with the matrix functions to wick the serum of plasma from the matrix.According to an alternative aspect of the invention, a filter means in liquid receiving relationship with the outlet of the matrix functions to retain any blood cells which pass through the matrix as the filter means wicks the plasma or serum from the matrix.

Abstract: The invention is a novel immunoassay method for detection of the immunoglobulin IgA.sub.1 with O-linked oligosaccharides lacking sialic acid in fluid samples, such as blood, serum and plasma. Particuarly, the invention is an immunoassay method which extracts total IgA from fluid samples by reaction with an immobilized anti-IgA antibody, and then detects only the IgA.sub.1 fraction with labeled peanut agglutinin.

Abstract: The present invention provides linear, cyclic and trifurcate tri- and tetramine backbone multidentate chelating agents based on the 8-hydroxyquinoline chelating unit. The chelating agents may optionally be substituted with a substate reactive moiety and antibody-metal ion conjugates may be produced for in vivo diagnostic and therapeutic methods.