Abstract: A method for assaying bone resorption rates which consists of quantitating the concentration of peptide fragments derived from bone collagen, found in a body fluid is disclosed. The method includes immunometric assay, fluorometric assay and electrochemical titration. The structure of specific peptide fragments having 3-hydroxypyridinium cross-links found in urine of Paget's disease patients and procedures for making monoclonal antibodies is described.

Abstract: A device for performing an enzyme-labelled binding assay comprises an absorbent material and a developing solution, wherein the absorbent material is provided with a plurality of reagent zones including an indicator reagent zone, and is capable of transporting the developing solution by capillary action sequentially through each reagent zone, and wherein the indicator reagent zone includes a reagent capable, directly or indirectly, of immobilizing an enzyme-labelled reagent in an amount dependent upon the assay result, characterized in that the developing solution includes a signal producing substrate for the enzyme. The substrate moves slower through the absorbent material than the enzyme-labelled reagent or any compound of the enzyme-labelled reagent formed in the assay. The absorbent material is suitably in the form of an elongate strip provided with transverse reagent zones. The device is useful form performing immunoassays including immunometric assays and dual analyte assays.

Abstract: A diagnostic test, and a device for conducting the test, for assessing whether patient chest pain is cardiac in origin and for differentiating between unstable angina and myocardial infarction as a cause of patient chest pain is described. The diagnostic test comprises simultaneously detecting at least three selected cardiac markers with the use of at least three different monoclonal or polyclonal antibody pairs, each member of which is complementary to a different marker, which is released by heart muscle at varying stages after the onset of chest pain and is indicative of the cause of the chest pain.

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: An apparatus and method provide automated collection and transfer of particles from a liquid suspension to a glass slide for visual examination. A magnet is positioned adjacent to a solution which contains particles tagged with magnetic beads, for example cells, so that the magnetic particles flow toward the magnet and collect against a collection surface positioned between the particles and the magnet. A transfer mechanism applies a selected pressure to a second side of the collection surface for transferring collected cells to a viewing slide. The apparatus includes a device for dispersing the liquid suspension of particles prior to the collection process and for collecting particles against the collection surface with a spatial distribution advantageous for visual examination. The transfer operation maintains this spatial distribution.

Abstract: The present invention provides for a method for preparing antibodies that specifically detect the type IV collagen .alpha.5 chain that is defective in various basement membrane disorders such as in X chromosome-linked Alport's syndrome. The invention further provides for the use of such antibodies to detect the .alpha.5(IV) collagen chain in solutions and other human tissue specimens using immunological methods comprised of antibodies specific for said protein. Along this line, the invention relates to the use of the specific antibodies to examine the presence or absence of the .alpha.5(IV) collagen chain in the tissues, e.g. skin or kidneys, etc. of patients with renal failure, possibly due to Alport's syndrome. In addition, a further object of the present invention is to provide compositions, comprising both labeled and unlabeled peptides containing sequences from the .alpha.

Abstract: Monoclonal antibodies highly specific for human bone alkaline phosphatase, especially in the presence of human liver alkaline phosphatase, and their use in assays for human bone alkaline phosphatase are disclosed. A kit using the antibodies in an assay for human bone alkaline phosphatase is also disclosed.

Abstract: A method of monitoring markers of bone metabolism by continuously collecting a body fluid sample containing bone loss markers therein and analyzing the components of the body fluids for the markers of bone metabolism.

Abstract: The present invention provides a method for determining the presence of a class of an antibody in a biological sample. In this method, a first reagent including insoluble particles having an antigen to the antibody immobilized on the surface thereof, and a second reagent including insoluble magnetic particles having immobilized on the surface thereof a substance particularly reactive to a specific immunoglobulin class, is reacted with the sample under conditions to promote agglutination of the first and second reagents with the antibody. The unreacted second reagent and the agglutinate are separated from the unreacted first reagent by application of a magnetic field. Then the amount of unreacted first reagent is determined.

Abstract: A separation procedure for separating a selected desired or undesired population from a biological sample utilizing relatively heavy, dense particles and gravity sedimentation. The particles have one or more reactants bound thereto which are specific to and will bind with the selected population. The particles preferably are mixed with the sample by repeatedly causing the particles to settle through a substantial portion of the sample to bind to the selected population. The particles with the bound selected population then are allowed to preferentially settle in the sample and the supernatant including the non-selected population is separated from the particles with the selected population bound thereto. The particles can be heated for sterilization and endotoxin removal.

Abstract: Homogeneous immunoassays and enzyme-substrate assays which use capillary electrophoresis and fluoescent detection systems are described. The method is useful for detecting and/or quantitating the concentration of analytes in a sample.

Abstract: The invention provides phospholipid coated particles capable of specifically binding antiphospholipid antibodies and a method for preparing such particles. Methods are also provided for determining antiphospholipid antibodies in a serum or plasma. Also provided are methods for isolating antiphospholipid antibodies from a fluid and for raising specific antiphospholipid antibodies.

Abstract: Improvements in the existing procedures and materials for conduct of high gradient magnetic separation (HGMS) are disclosed. Superior superparamagnetic particles, optionally coated with a polysaccharide or other, usually organic, materials can be prepared in uniform compositions with homogeneous magnetizations. The coating can conveniently be conjugated to a specific binding moiety complementary to a biological material whose purification or separation is desired. In addition, plastic coated matrices which form superior magnetic gradient-intensifying supports are disclosed, along with improved methods and apparatus to conduct HGMS.

Abstract: The invention discloses monoclonal antibodies which bind specifically to Type II collagen, but not to its peptides, or vice versa. Also disclosed are the methods of preparing hybridomas for production of these antibodies; the assays which utilize these antibodies to detect or quantify Type II collagen and/or its peptides in a solution (e.g., body fluid, culture medium, and tissue extract); and assay kits containing these antibodies.

Abstract: Methods and devices are provided for separation of magnetic particles and/or magnetic-associated substances from non-magnetic associated substances and media. The methods are specifically applicable to biological separation, and utilize a phase phenomenon arising from mutual interactions between suspended magnetic particles and interactions with the suspension medium. The phenomenon is exploited to produce and maintain a distinct, structured phase of magnetic particles, or ferrophase, within a multi-phase liquid system. A ferrophase is established within a separation chamber prior to introducing therein a test sample containing the target substances to be separated. The formation of a ferrophase is used to transport target substances from regions of relatively low magnetic field gradient to regions of relatively high magnetic field gradient within a high-gradient magnetic separation apparatus.

Abstract: An antibody raised to type I collagen carboxyterminal cross-linked telopeptide isolated from decalcified human or animal bone, may be used in an assay to determine the concentration of liberated carboxyterminal telopeptide region of the type I collagen molecule in a sample. When the sample is a body fluid such as serum or urine the degradation product measured is resistant to further degradation, since it contains a multivalent intermolecular cross-link, and can thus be found in the body fluid. The assay may be used to assess the degradation of type I collagen, the major organic constituent of bone matrix.

Abstract: A method is disclosed for separating a substance from a liquid medium. The method comprises combining the liquid medium containing the substance with magnetic particles under conditions for non-specific chemical binding of the magnetic particles. Thereafter, the medium is subjected to a magnetic field gradient to separate the particles from the medium. The preferred non-specific binding is achieved as the result of charge interactions between the particles usually by means of a polyionic reagent. The method of the invention has particular application to the separation of cells and microorganisms from aqueous suspensions and also to the determination of an analyte in a sample suspected of containing the analyte. The analyte is a member of a specific binding pair (sbp). The sample is combined in an assay medium with magnetic particles and a sbp member complementary to the analyte.

Abstract: The present invention is directed to a method for regulating formation of a complex of a plasminogen activator, its receptor and one of its inhibitors. More specifically, this method involves contacting a target cell having a plasminogen activator receptor with a compound which interacts with a component of the complex such that a change in target cell cytoskeletal stiffness results.

Abstract: This invention relates to a method for determining the presence or amount of an analyte in a sample comprising contacting the sample with 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 method for assaying for the presence of analyte in a sample based on differential binding affinity involves detecting dissociation of a complex of receptor and ligand in the presence of analyte. The receptor binds the analyte with high affinity and with the ligand with low affinity. The receptor-ligand complex may be formed in situ or may be preformed. In the presence of free analyte, the receptor releases from the receptor-ligand complex and binds free analyte. Release of the receptor-ligand complex is detectable. A kit for performing release assays to detect the presence of analyte is also provided.