Abstract: The present invention relates to methods of enriching for desired cell population from cell sources, such as body fluids, dispersed tissue specimens and cultured cells. In particular, the present invention relates to the use of a cell-trap centrifugation tube containing a specific density gradient solution adjusted to the specific density of a desired cell population to enrich for the desired cell from a cell source. The tube allows the desired cell population to be collected by decantation after centrifugation to minimize cell loss and maximize efficiency. In addition, the method can be further simplified by density-adjusted cell sorting which uses cell type-specific binding agents such as antibodies and lectins linked to carrier particles to impart a different density to the undesired populations in a more convenient manner. The rapid cell enrichment method described herein has a wide range of diagnostic and therapeutic applications.

Abstract: A method of screening for the presence of a periodontal disease condition is disclosed. The method involves obtaining an oral fluid sample from a human subject being tested, and determining the level of native free pyridinium crosslinks (free pyridinoline and/or free deoxypyridinoline) from the subject. An above-normal level of crosslinks, when compared with a predetermined level characteristic of normal subjects, is an indication of the presence of a periodontal disease condition.

Abstract: An allergen immunoassay method features the use of a combination of a) closely controlled 1) elevated temperatures for assay reactions, 2) low temperatures for reagents and samples, 3) times for assay steps and especially assay reaction times, 4) reagent concentrations, and 5) reagent amounts; b) the use of a fast and accurate method of sample preparation that removes dust and contaminants; c) the stabilization of samples to avoid auto- and antibody degradation and unwanted effects of sample contaminants; and d) the formation of a colored product to determine the amount of a specific allergen. This combination provides an assay that can be completed in a few hours while retaining the precision, accuracy, sensitivity and response curve of previous methods requiring much longer periods of time.

Abstract: Assays using receptor:reland complexes capable of releasing the reland in the presence of an analyte are described, wherein the reland does not detectably compete with analyte for binding to the receptor. The dissociation constant of the reland and the receptor is such that no appreciable release of reland occurs in the absence of analyte for the receptor. In a preferred embodiment, the association constant of the monomeric reland and the receptor is less than or equal to about 10.sup.5 M, preferably 10.sup.3 to 10.sup.5 M, most preferably 1% or less of the association constant of the analyte and receptor. In a preferred embodiment, the reland is labelled and the amount of analyte bound to the receptor is determined from the amount of labelled reland which is released.

Abstract: Methods of determining collagen degradation in vivo, by quantitating the concentration of a peptide in a body fluid, the peptide having the following structure: ##STR1## is hydroxylysyl pyridinoline or lysyl pyridinoline, and J is pyroglutamic acid or glutamine and (Leu) are optional leucines, are disclosed.

Abstract: A method of immunologically assaying intact human osteocalcin in a human assay sample is provided by using an antibody having an epitope in a region of an amino acid sequence 1 to 20 on the N-terminal side of human osteocalcinand an antibody having an epitope in a region of an amino acid sequence 36 to 49 on the C-terminal side of human osteocalcin. Furthermore, a method of immunologically assaying the total amount of human intact osteocalcin in a human assay sample is provided. A reagent and a kit therefor are also described, as well as a monclonal antibody and a polyclonal antibody used for the assay a process for producing these antibodies; and a process for use of these antibodies.

Abstract: A method is described for performing an affinity assay comprising contacting a sample to be assayed for the presence of an analyte with a dry reagent containing the analyte (hapten, antigen, antibody, receptor, or complementary polynucleotide) bound to a reaction cascade initiator, an antibody or other binding pair partner reactive with said analyte, and magnetic particles, to form an assay mixture in a reaction chamber, incubating the assay mixture, applying an oscillating or moving static magnetic field to the assay mixture, activating the reaction cascade initiator to initiate a reaction cascade, monitoring the response of the magnetic particles to the oscillating or moving static magnetic field to provide a time varying signal, and determining the analyte concentration of the sample by analysis of the time varying signal, as well as a kit for performing the assay and a diagnostic system for performing the assay.

Abstract: A method of recovering a first material, e.g. plasmid DNA, from a solution containing pre-precipitated second material, e.g. genomic DNA and cellular debris, by precipitating the first material in the presence of magnetically attractable beads which become non-specifically associated with the newly formed precipitate, using a magnet to draw down the beads and the newly formed precipitate, and removing the supernatant.

Abstract: Disclosed is an apparatus designed to be used for enriching specific cell types from cell mixtures. The apparatus includes a centrifugable device that includes a constriction defining a lower region and a defined cell separation medium. The constriction prevents mixing between the upper and lower portions of the device. Also disclosed are methods that use precisely defined cell separation media to isolate specific cells from cell mixtures, including CD34.sup.+ hematopoietic progenitor cells from blood or bone marrow, nucleated fetal cells from maternal blood, specific tumor cells, dendritic cells, natural killer cells, and natural suppressor cells from various body fluids, and for enrichment or depletion of T cell lymphocytes. Also disclosed is a density adjusted cell separation technique used to augment the above apparatus and enrichment methods. The apparatus and enrichment methods are useful in various diagnostic and therapeutic regimens.

Abstract: The invention pertains to dipstick immunoassay devices. The device comprises a base member and a single, combined sample contact zone and test zone, wherein the test zone incorporates the use of symbols to detect analytes in a sample of biological fluid. A first immunological component, an anti-immunoglobulin capable of binding to an enzyme-labeled antibody, is immobilized in a control indicia portion. A second immunological component, capable of specifically binding to a target analyte which is bound to the enzyme-labeled antibody to form a sandwich complex, is immobilized in a test indicia portion. The enzyme-labeled antibody produces a visual color differential between a control indicia portion and a non-indicia portion in the test zone upon contact with a substrate.

Abstract: An assay for photometrically detecting and/or quantitating the presence of an analyte in a sample in which the signal generated by a label associated with the analyte is photometrically detected in the presence of a suspended solid support.

Abstract: The present invention relates to methods of enriching breast tumor cells from a patient's body fluids. In particular, it relates to the use of a cell-trap centrifugation tube containing a specific density gradient solution adjusted to a specific density to enrich for breast tumor cells from a cell mixture. The tube allows the desired cell population to be collected by decantation after centrifugation to minimize cell loss and maximize efficiency. In addition, the method can be further simplified by density-adjusted cell sorting which uses cell type-specific binding agents such as antibodies and lectins linked to carrier particles to impart a different density to the non-tumor or tumor cell populations allowing the breast tumor cells to be separated from the non-tumor cells in a more convenient manner.

Abstract: The present invention relates to methods of enriching fetal cells from maternal body fluids. In particular, it relates to the use of a cell-trap centrifugation tube containing a gradient solution adjusted to a specific density to enrich for fetal nucleated red blood cells from maternal blood. The tube allows the desired cell population to be collected by decantation after centrifugation to minimize cell loss and maximize efficiency. In addition, the method can be further simplified by density-adjusted cell sorting which uses cell type-specific binding agents such as antibodies and lectins linked to carrier particles to impart a different density to undesired cell populations allowing the fetal cells to be separated during centrifugation in a more convenient manner. The rapid fetal cell enrichment method described herein has a wide range of applications, including but not limited to, gender determination and prenatal diagnosis of genetic diseases without the use of invasive procedures.

Abstract: This invention relates to a composition for use in a method for determining the presence or amount of an analyte in a sample comprising a labeled constituent consisting of an aqueous carbon sol which is stable in the absence of a stabilizing substance. The colloidal carbon particles have directly conjugated to their surface a binding component which specifically binds to the analyte and the resulting analyte/carbon particle complex is used as an indication of the presence or amount of analyte in the sample. The grade of carbon used satisfies the condition V>0 wherein V is a linear predictor value according to the formula V=-138.954-0.987.times.DBP+15,609.times.VC+3.994.times.PPD, wherein DBP is the dibutylphthalate adsorption in ml/100 g, as determined according to DIN 53601; VC is the volatile content in %, as determined according to DIN 53552; and PPD is the average primary particle diameter in nanometers.

Abstract: A dry, removable analytical element can be used to detect chemiluminescent signals produced from the reaction of peroxidase and a chemiluminescent detection system. The analytical element contains at least two layers, the outer layer being non-tacky and water-soluble or water-permeable, and used to contact a gel plate or transblotting membrane in which multiple analytes are located. The resulting signal can be recorded using a photosensitive element. Test kits include the various packaged components needed to use the analytical element for analyte detection. Within the element are critical amounts of oxidase and an oxidase substrate for highly sensitive analyte detection.

Abstract: A method is described for determining a hapten which method comprises (i) contacting the hapten with a binding partner of the hapten, whereby the hapten becomes bound to some of the binding partner, (ii) contacting the unbound binding partner with a secondary binding partner therefor, (iii) contacting the binding partner with an antibody which binds the binding partner which has bound thereto the hapten but which does not bind the binding partner which has bound thereto its secondary binding partner; and (iv) determining the amount of antibody bound to the binding partner. Kits for use in the method are also described.

Abstract: A method of detecting bone acidic glycoprotein-75 (BAG-75) antigen includes the steps incubating a serum or synovial fluid sample with anti-BAG antibody, reacting the incubated sample with a signal generating antibody to the anti-BAG-75 antibody, and detecting the signal as an indication of BAG-75 antigen in the serum. Antibodies for use in the test for detecting BAG-75 antigen in serum and synovial fluid samples includes BAG-75 #3-13 peptide anti-serum, anti-BAG-75 protein anti-serum, and monoclonal antibodies against the BAG-75 protein, the antibodies recognizing the 75,000 molecular weight BAG-75 precursor protein and the 50,000 molecular weight BAG-75 fragment in serum and synovial fluid. Molecular weight assignments are based upon electrophoretic mobilities under denaturing conditions.

Abstract: Methods for modulating the rates and dose responses of immunoassays through the incorporation of one or more detergents into the immunoassay reaction are disclosed. The methods are particularly suitable for automated immunoassay formats, especially with formats that use analyte-biotin bidentate reagents. The methods may be used to facilitate the detection of any desired, preselected pharmacological agent.

Abstract: Methods and devices are disclosed which are useful for collecting magnetic materials in either internally or externally generated magnetic gradient fields, followed by resuspension into solution with a simple manipulation of the magnetic device. The methods provide for removal of excess reagent, washing of magnetic material, and resuspension for analysis, among other uses. The methods are applicable to all types of biological material that are susceptible to magnetic labelling, including, for example, cells, viruses, proteins, hormones, and receptor-ligand complexes. Several devices are disclosed to take advantage of the method for cellular and immunoassay applications, including both internal and external devices. Both flow-through and static separators are disclosed.

Abstract: A method of assaying bone collagen degradation activity in a human subject. In the method, a human urine sample is reacted with an antibody which (i) is capable of reacting immunospecifically with pyridinium crosslinks selected from the group consisting of native free pyridinoline and native free deoxypyridinoline, and (ii) has a ratio of reactivity toward the selected pyridinium crosslinks and urinary pyridinium peptides larger than 1,000 daltons in molecular weight, of greater than about 5:1. An immunocomplex forms between the antibody reagent and the selected pyridinium crosslinks which are present in the sample, and the amount of immunocomplex is measured. Also disclosed are antibody reagents and kits which can be used in the method.