Abstract: A method of assessing glycosylated haemoglobin in a sample, wherein the method comprises the steps of (a) contacting the sample with signal-forming molecules comprising a conjugate of one or more dihydroxyboryl residues or salts thereof, linked to a signal-forming label; (b) separating by selective precipitation from a homogenous solution, glycosylated and non-glycosylated haemoglobin and any molecules bound thereto, from the reaction mixture of step (a) above; and (c) assessing signal-forming molecules selected from the group consisting of signal-forming molecules which have bound to the separated haemoglobin, and non-haemoglobin bound signal-forming molecules. Steps (a) and (b) may be performed simultaneously or sequentially. The sample may optionally be haemolyzed to liberate any cell bound haemoglobin. The invention also comprises an analytical test kit for use in accordance with the method of the invention.

Abstract: A method for performing a diagnostic immunoassay by a solid phase separation. To a reaction mixture of a test sample and labeled antibody, which forms a complex of any analyte present in the test sample, is added a solid phase material having a compound capable of binding any excess labeled antibody. The solid phase material is chosen to rapidly settle whereby a solid and liquid phase is formed. The liquid phase can then be extracted to measure the amount of analyte-labeled antibody present therein.

Abstract: A method of monitoring the aggregation of cells in, for example, an immuno-agglutination assay, comprises promoting agglutination sonically in a capillary and inverting the capillary to cause agglutinated particles to settle at a meniscus. The granular appearance of agglutinated cells can be distinguished visually from the smooth distribution of non-aggregated cells.

Abstract: An immunoenzymatic method for the detection of anti-Plasmodium falciparum-sporozoite antibodies in a sample of human blood, which operates, in homogeneous phase, and under suitable conditions, with a synthetic polypeptidic antigen (P), a synthetic antigen-enzyme (P-E) conjugate, wherein said antigen is capable of specifically reacting with the anti-Plasmodium falciparum-sporozoite antibodies (Ab) possibly present in the sample, and an inert substance capable of quantitatively precipitating the antibody-synthetic antigen-enzyme complex (Ab-P-E).The method, due to its specificity, sensitivity, reproducibility and rapidity, is particularly useful in the epidemiological investigations into malaria and in the evaluation of the efficacy of an antimalarial vaccine.

Abstract: Rapid assays for analytes of interest in a fluid sample utilize a first conjugate of a labelled reactant that specifically binds to the analyte, and a second conjugate that binds to the analyte coupled to a polymer that has an affinity for a selected solid phase. The reaction components are incubated briefly, then contacted with the selected solid phase and the labelled components determined. Optional wash steps provide for enhanced sensitivity and specificity. When the analyte of interest is an antibody to HIV, the first reactant may be a synthetic, recombinant or native HIV antigen, and the second reactant may be protein A or an anti-immunoglobulin.

Abstract: Methods for determining the presence and/or concentration of an analyte in a biological fluid sample are disclosed. The methods generally include admixing in solution certain polymer/reactant and reporter/reactant conjugates along with the biological fluid sample suspected of containing the analyte, thereby forming ternary complexes. The separation of the complexes from the reaction mixture is achieved through the affinity of certain selected polymer compositions for various solid phases. Upon separation, the amount of reporter activity in the solution may be measured, and therefrom the presence and/or concentration of the analyte determined. Multiple analyses on a biological fluid sample suspected of containing one or more analytes may also be performed, using either a variety of different reporters or selected polymers having varied affinity for the solid phase.

Abstract: A method and apparatus for removing unreacted protein and unreacted antisera from a gel plate during immunofixation electrophoresis. The apparatus includes a pressure plate movable toward and away from a fixed base for exerting a desired force on the electrophoresis plate. A stop member limits the movement of the pressure plate toward the fixed base thus controlling the amount of pressure on the electrophoresis plate.

Abstract: A reaction kit is provided with a reaction zone of suitable cross-sectional area to aspirate a sample by capillarity and a transparent plate with a flat surface in at least part of the reaction zone, and a supporting base to incline the reaction zone at a specified angle. The reaction zone is normally a space formed by two opposite transparent plates and spacers inserted between these two transparent plates. A supporting base may be molded separately, the transparent plates and spacers being set on the base at the time of measurement, or alternatively the base may be molded integrally with at least one of the plates defining the reaction zone. Further, substances with specificity such as antigens or antibodies may be coated on a surface in the reaction zone.

Abstract: Surfactants bound to a ligand and dissolved in a single phase aqueous solution form a precipitate when a multivalent antiligand is added to the solution. This invention can be used in an affinity precipitation test procedure (and kit) for detecting the presence or absence of a multivalent antiligand in a sample suspected of containing the multivalent antiligand, in an affinity precipitation inhibition test procedure (and kit) for detecting the presence or absence of a target ligand in a sample suspected of containing the target ligand, and in a process for separating a multivalent antiligand from a crude material containing the multivalent antiligand.

Abstract: A process for the removal of non-specific turbidities in the carrying out of determinations according to the immuno-assay principle, wherein an inorganic boron compound is added to the sample solution in combination with a buffer system.

Abstract: A method for the determination of the presence of free light chains (Bence Jones protein) in a unconcentrated and undiluted urine sample is provided in which the sample is reacted with an anti-free light chain antiserum reagent, where the presence of the free light chains is revealed by increase in turbidity of the reacted sample. By comparison with the turbidity of calibrators having predetermined concentrations reacted with anti-free light chain antiserum, a quantitative analysis of the amount of free light chains in the urine sample can be determined. A kit for performance of the analysis, including anti-free light chain antiserum reagent, calibrator, and reagent without antiserum, is also provided.

Abstract: Surfactants bound to a ligand and dissolved in a single phase aqueous solution form a precipitate when a multivalent antiligand is added to the solution. This invention can be used in an affinity precipitation test procedure (and kit) for detecting the presence or absence of a multivalent antiligand in a sample suspected of containing the multivalent antiligand, in an affinity precipitation inhibition test procedure (and kit) for detecting the presence or absence of a target ligand in a sample suspected of containing the target ligand, and in a process for separating a multivalent antiligand from a crude material containing the multivalent antiligand.

Abstract: Chemically synthesized polypeptides containing about 6 to 40 amino acid residues and having amino acid residue sequences that substantially correspond to the primary amino acid residue sequences of particular variable or hypervariable regions of immunoglobulins, when administered alone or as polymers or as conjugates bound to carriers, induce the production of anti-idiotype antibodies of predetermined specificities.

Abstract: A reaction apparatus with sample inlet channel of suitable cross-sectional area for aspirating a sample into the interior of the apparatus by capillarity, a recess provided on the inner wall of the sample inlet channel, and a transparent plate with a flat surface arranged opposite the recess. The recess has sloping walls, and may for example, have a conical or hemispherical form. The recess may moreover be a V-shaped or U-shaped groove. Further, the inner wall of the recess may be coated with antibodies or antigens.

Abstract: A substance-conjugated complement component C1q is provided. A substance such as signal emitting substances or cell function regulating substances is conjugated via a sulfur atom to at least one site of the component. The site is not involved in binding immunoglobulins. A marker-labelled complement component C1q is used for measuring a complement-binding antibody, an antigen, a neutralizing antibody or a substance produced internally of and at the surface of a cell or a microorganism by measuring the marker.

Abstract: A two site cross-reaction immunometric sandwich assay method for the detection and measurement of an analyte, such as creatine phospho-kinase-MB, in serum comprising the selection of two different antibodies each of which is specific to a different analyte but each of which will cross-react with the analyte of interest. The first antibody is reacted with the unknown sample utilizing a solid-phase to bind the first antibody. Separation of the solid and liquid portions of the first reaction is accomplished and the solid portion thereof is reacted with the second antibody which is tagged. The solid portion and liquid portion of the second reaction are separated and the solid portion is tested for the tag as an indication of the presence of said analyte. With particular reference to testing for creatine phospho-kinase-MB in human serum, the cross-reacting antibodies utilized are antibody to creatine phospho-kinase-BB and creatine phospho-kinase-MM.

Abstract: A two site cross-reaction immunometric sandwich assay method for the detection and measurement of an analyte, such as creatine phospho-kinase-MB, in serum comprising the selection of two different antibodies each of which is specific to a different analyte but each of which will cross-react with the analyte of interest. The first antibody is reacted with the unknown sample utilizing a solid-phase to bind the first antibody. Separation of the solid and liquid portions of the first reaction is accomplished and the solid portion thereof is reacted with the second antibody which is tagged. The solid portion and liquid portion of the second reaction are separated and the solid portion is tested for the tag as an indication of the presence of said analyte. With particular reference to testiong for creatine phospho-kinase-MB in human serum, the cross-reacting antibodies utilized are antibody to creatine phospho-kinase-BB and creatine phospho-kinase-MM.

Abstract: Compositions and methods are disclosed for multiple simultaneous assays of different analytes using radioactive labeled antibodies to the analytes, at least one portion of the assay being an immunoradiometric assay in which there is employed a metal isotope label, e.g., .sup.57 Co, attached to an antibody to the analyte through a chelator, e.g., ethylenediaminetetraacetic acid. Multiple simultaneous immunoradiometric assays can be performed by this method, as can multiple simultaneous assays in which one portion of the assay is an immunoradiometric assay and another portion or portions involve one or more other radioassay techniques.

Abstract: The present invention relates to systems and methods used to assay for particular complement component fragments. The invention can be used to determine the amount of a particular complement component fragment in a sample. The fragment can be fluid phase or bound to an immune complex. Generally, specific binding agents, such as antibodies, directed to the complement component fragments and immune complexes are used in the assay.

Abstract: Methods are disclosed for detecting an antigen in a biological sample. The methods involve providing in combination a solid support, which is substantially free of specific binding proteins, and a medium comprising an antigen from the sample and an antibody for the antigen. The combination is incubated under conditions sufficient for the antibody when bound to the antigen to bind to the support. The presence or amount of antibody on the support or in the medium is determined and is related to the presence of antigen in the sample. The methods have particular application to the detection of gram-negative bacteria.

Abstract: A test system and procedure for quantitatively assaying biological material for a target immunological substance by means of immunochemical binding of immune complexes, comprising the target substance and its immunospecific conjugate, to insolubilized non-immunospecific factor, such as Clq. A sample of biological material suspected of containing the target substance is introduced into the test system including pre-determined amounts of the target substance and its immunospecific conjugate forming immune complexes having a known degree of chemical binding to the non-immunospecific factor. The amount of target substance present in the test sample is determined according to the deviation from the known degree of immunochemical binding caused by the addition of the sample to the test system, by reference to a standard curve.

Abstract: Methods for delivering substances into, removing substances from, or reacting substances with a selected environment utilizing polymer gels or coatings characterized by a critical solution temperature (CST) are disclosed. The CST as well as the pore structure, pore size, pore distribution, and absorbing capacity of the gel may be selectively controlled. The substances may be physically or chemically immobilized within the polymer gels. In addition, a method for altering the surface wettability of CST polymers is also disclosed.

Abstract: Hybridomally produced monoclonal IgM antibodies having high affinity are useful for the immunoassay and purification of viral antigens.

Abstract: Materials can be screened for carcinogenic properties by administering them to test animals and assaying biological tissue, preferably plasma, for the presence of a 60K cancer-associated phosphoprotein. The test is applicable to a wide range of chemically-diverse carcinogens and is not restricted to carcinogens having one particular mode of action.

Abstract: A process for producing monoclonal antibodies specific to carcinoembryonic antigen (CEA), comprising immunizing a mammal with a first CEA to produce cells capable of producing antibodies, collecting the cells from the mammal, fusing the collected cells with the cells of a line of myeloma of another mammal, selecting the thus-obtained hybridoma cells on the basis of their capacity to produce antibodies reactive with said first CEA, subjecting the thus-selected hybridoma cells to cloning, selecting the thus-obtained monoclones on the basis of the reactivities of monoclonal antibodies produced by them with at least one antigen selected from CEAs other than said first CEA and CEA-related antigens of normal adult human origin, culturing the thus-obtained monoclones and recovering the desired monoclonal antibodies from the spent culture. The selection may preferably be effected by radioimmunoassay using a marker antigen labelled with a radioactive substance.

Abstract: A method for determining the quantity of an antibody in a sample, the method having the steps of: (1) providing a labelled antigen to the antibody; (2) contacting the labelled antigen with the sample in solution to form a labelled antigen-antibody complex; (3) providing an agent for precipitating the complex; (4) mixing the solution containing the labelled antigen-antibody complex with the precipitating agent to produce a precipitate and a supernatant; the supernatant containing labelled antigen and the precipitate containing the labelled antigen-antibody complex and uncomplexed labelled antigen; and (5) measuring the quantity of label in the precipitate or the supernatant in a manner substantially independent of the amount of uncomplexed labelled antigen in the precipitate.

Abstract: An in vitro diagnostic method for determining the presence of nerve growth factor receptor bearing tumors is disclosed which comprises determining the presence of an elevated level of a truncated nerve growth factor receptor in a sample of a body fluid from a patient afflicted with such tumor.

Abstract: Immunoassay methods and compositions are disclosed for the detection of analytes in fluid samples. The disclosure provides conjugates of analytes or reactants with polymerizable organic monomers. Specific binding reactions between reactants are detected by means of resporter/reactant conjugates. Free and specifically-bound reporter/reactant conjugates are separated by a polymerization reaction which renders the polymerized monomers insolule.

Abstract: The present invention provides a process for the preparation of an immuno-reactive, porous carrier material by application of a solution of a first reaction component of an immuno-reaction and of a solution of a second component of an immuno-reaction coprecipitating therewith, incubation of the carrier material impregnated with the solutions for the immuno-precipitation, optional washing and subsequent drying of the impregnated carrier material, wherein a solution of both components of the immuno-reaction is prepared, which solution contains an inhibitor for the immuno-precipitation, the carrier material is impregnated with this solution and then the immuno-precipitation is initiated by removal of the inhibitor or by removal of the inhibiting action.

Abstract: An assay for 1,25-dihydroxy vitamin D is disclosed. One aspect of the invention involves adding pig receptor protein, radiolabeled, 1,25-dihydroxy vitamin D and biotinylated antibody capable of binding to the receptor to untreated blood serum. In performing a competitive binding assay, vitamin D transport protein, DBP, acts as a screen to minimize interference from related metabolites. A kit and an assay are disclosed.

Abstract: A method for performing a diagnostic immunoassay by solid phase separation for digoxin. To a reaction mixture of a test sample and labeled anti-digoxin antibody, which forms a complex of any digoxin present in the test sample, is added a solid phase material having an immobilized ouabain triacetate derivative compound capable of binding any excess labeled antibody. The solid phase material is chosen to rapidly settle whereby a solid and liquid phase is formed. The liquid phase can then be extracted to measure the amount of digoxin-labeled antibody present therein. Ouabain triacetate derivative compounds possess sufficient affinity for anti-digoxin antibodies, and are therefore useful in a solid phase separation based digoxin immunoassay for settling out such antibodies without contributing to undesired background interference.

Abstract: An immunoassay in which a thermally induced phase separation is used to effect the separation of specifically bound reactants from free reactants is disclosed. A first reactant is conjugated to a temperature-sensitive polymer to form a polymer/reactant conjugate, and a second reactant is conjugated to a reporter to form a reporter/reactant conjugate. The polymer/reactant, reporter/reactant, and biological fluid samples suspected of containing the analyte are admixed in solution at a temperature other than that at which the polymer will precipitate. Specific binding is allowed to occur, thereby forming a ternary complex. The salt concentration of the adjusted solution is then adjusted to a concentration sufficient to cause the complex to precipitate from the solution, the amount of reporter activity in the precipitated complex or in the solution measured and the presence and/or concentration of the analyte therefrom determined.

Abstract: The method of measuring circulating antigens or antibodies by using a ligand labeled specific antigen or ligand labeled specific antibody chemically attached to a soluble matrix or backbone, a differently labeled anti-antigen or anti-antibody and a solid phase anti-ligand directed at the ligand attached to the specific antigen or specific antibody. This is achieved by either one or two analytical schemes:(a) Reacting a patient sample with a ligand labeled specific antigen or a ligand labeled specific antibody in the liquid phase in the presence of a differently labeled specific anti-antigen or labeled specific anti-antibody. This immunological complex is reacted with an immobilized anti-ligand on a solid support which is directed against the ligand attached to the specific antigen or antibody through the liquid matrix. Subsequently the solid phase is washed and checked for the label on the anti-antigen or anti-antibody which is directly proportional to the concentration of specific antigen or antibody.

Abstract: A heterogeneous specific binding assay method for determining the amount of a suspected analyte in an aqueous test medium wherein a reaction mixture is formed by combining the test medium with assay reagents including a labeled reagent, an immobilizable component, and a binding substance which causes the immobilizable component to precipitate. Free and bound species of the labeled reagent are formed as a function of the amount of the analyte in the test medium. One of the free and bound species of the labeled reagent is immobilized by binding of the immobilizable component with the binding substance. The immobilized labeled reagent is seperated from labeled reagent which has not been immobilized, and the amount of label in the labeled reagent in one of the separated fractions is determined and related to the amount of analyte in the test medium.

Abstract: A method of visualizing individual submicroscopic metal particles by subjecting said particles to bright field or epi-polarization microscopy and enhancing the contrast of the image so obtained by electronic means.

Abstract: Methods and compounds are disclosed for determining the presence, amount of, or association between substances of interest in samples suspected of containing same. The methods are based on the polymerization-induced separation of specifically-bound, reporter-labeled recognition reactants from free, reporter-labeled recognition reactants. The methods described are applicable to any substance for which suitable recognition reactants exist or can be made and are not limited by considerations such as chemical composition or molecular size.

Abstract: A method for assaying complement fragment C.sub.3 a, C.sub.4 a or C.sub.5 a or the des-Arg derivative thereof in a biological sample which comprises combining equal volumes of the biological sample and a solution of 0.8 to 1.6% of an acridine derivative selected from the group consisting of acrinol, acriflavine, acriflavine hydrochloride, and aminacrine, incubating the mixture for about one minute to 2 hour at about 25.degree. C., recovering the supernatant from the resultant precipitate, incubating the supernatant with a known amount of a labeled complement fragment selected from C.sub.3 a, C.sub.4 a or C.sub.

Abstract: A method and reagent kit means are provided for assay of a selected antigen such as hCG or CEA in an aliquot of body fluid. The method comprises the steps of constituting the aliquot in a mixture comprising tracer (which may be an enzyme tracer or a radioactive tracer) conjugated with monoclonal antibody, and separate immobilized monoclonal antibody, incubating the mixture to enable separation of a solid phase antigen antibody conjugate in sandwich relation, and measuring the tracer content and corresponding antigen content of the aqueous phase or the solid phase. The antibody (conjugated and/or immobilized) comprises multiple monoclonal antibodies from different cell lines so that the specificity of the assay is enhanced, and the possibility of unrecognized antigen fragments is reduced.

Abstract: To determine whether a patient will react adversely when injected intravenously with an iodine-containing contrast media, a sample of the patient's whole blood, whole blood depleted of red blood cells or plasma is treated to activate complement, and the level of at least one product resulting from complement activation is quantified and compared to the level of that product obtained in patients of known reactivity to radiographic contrast media.

Abstract: Immunoassay methods and compositions are disclosed for the detection of one or more analytes in fluid samples. The disclosure provides conjugates of analytes or reactants with polymerizable organic monomers. Specific binding reactions between reactants are detected by means of reporter/reactant conjugates. Free and specifically-bound reporter/reactant conjugates are separated by a polymerization reaction which renders the polymerized monomers insoluble.

Abstract: The invention relates to a method of testing for the presence of cancer. An antibody is produced which contains antibodies specific to a modified nucleoside component. The antibody is admixed with a body fluid drawn from a subject mammal. An immunoassay is performed on the admixture to quantify an amount of cancer associated nucleoside present in the fluid and reactive with the antibody.

Abstract: A substituted aldosterone of the formula: ##STR1## wherein either one of R.sup.1 and R.sup.2 is hydrogen and the other is --S(CH.sub.2).sub.m COR.sup.3 or --OCO(CH.sub.2).sub.n COR.sup.3, provided that when R.sup.1 is hydrogen, R.sup.2 is --S(CH.sub.2).sub.m COR.sup.3 or --OCO(CH.sub.2).sub.n COR.sup.3 and when R.sup.2 is hydrogen, R.sup.1 is --S(CH.sub.2).sub.m COR.sup.3 ; m being an integer from 1 to 3, n being an integer from 1 to 5 and R.sup.3 being hydroxyl, lower alkoxy or a residue of tyramine, tyrosine lower alkyl ester, histamine, histidine, 7-aminoheptanoyltyrosine lower alkyl ester or .beta.-D-galactosidase as optionally iodinated, or its (18-20)-acetal 20,21-ketonide, which is useful as the reagent in determination of aldosterones by radioimmunoassay or enzyme immunoassay.

Abstract: An immunoassay of a specimen of a serum or the like to determine the composition of immune complexes, includes producing on a plastic base a layer of a non-proteinaceous, non-ionic polymer which will adhere to the plastic base and has the capability of adsorbing immune complexes of the specimen, placing a specimen on the layer and treating the layer to produce an indication of the composition of the immune complexes. The polymer may be polyethylene glycol, dextran, polyvinyl chloride, a polymeric polyol or an adduct of polyethylene glycol or mixtures thereof. Washing with conventional solutions, addition of monoclonal and/or polyclonal antibodies coupled with an enzyme and addition of a substrate reactive therewith to determine the antigen component, are similar to the ELISA test, with color measurement as by spectrophotometer. Or, the addition of anti IgG-I.sup.125 and measurement by a scintillation counter may be used. Addition of IgG, IgA, IgE, IgG.sub.

Abstract: This invention describes a process for immuno-chemical quantitative determination of immunologically active substances. The method involves a first incubation of a sample containing the active substance with a labelled binder, which contains an antibody or antibody fragment. After complexing has taken place, solid phase bound active substance identical to the substance being quantitatively determined is added. The solid phase bound substance binds with free binder, and the solid and liquid phases are separated. A second antibody which is specific either to antibody or the solid phase antibody-substance complex is then added to the liquid phase. This second antibody is non cross-reactive with individual complex components. The amount of labelled first antibody bound to second antibody is then determined.

Abstract: The invention relates to techniques for isolating from a mixed population of cells disired living cells either producing and releasing a particular product or having a characteristic molecule on their surface. The isolation techniques depend upon the localized interaction between the product (or molecule) and other agents added to the system such that distinguishable conditions can be caused to occur (or not occur) only in the immediate vicinity of desired cells which produced and released the product or which contain the molecule on their surface.

Abstract: An antigen/antibody precipitate is obtained, using monoclonal antibodies, the monoclonal antibodies (samples I or II or III or IV) being selected so as to be specific to two distinct antigenic binding sites (L or C 2 or C 3) on a protein (IgG) in a sample under test. The proportions of sub-populations of immunoglobulins (IgG kappa, IgG lambda) in a sample is determined by reacting the sample with a combination of antibodies (II and IV) both of which are specific to the heavy chains (H) of both sub-populations (IgG kappa, IgG lambda) and reacting the sample with an antibody combination (I and II) specific to said heavy chain (H) and to an antigenic determinant expressed by only one (IgG kappa) of the sub-populations.

Abstract: A method for assaying circulating immune complexes comprisescontacting the circulating immune complexes in solution in serum with a staphylococcal protein-A linked to a detectable label, whereby a CIC-protein-A-label complex is formed,selectively precipitating the CIC-SPA-label complex by contacting the complex with polyethylene glycol,separating the precipitated CIC-SPA-label complex from the serum,measuring the quantity of the label in the precipitated CIC-protein-A-label complexcomparing the measured quantity of label with at least one standard prepared by subjecting a solution containing a known amount of CIC or functional equivalent material to the same assay. The method requires only a single precipitation step and in a preferred embodiment the formation of the CIC-SPA-label complex may be formed in a single step.

Abstract: Several novel hybridoma cell lines, ATCC #HB-8510, 8511, 8512, 8513, 8514, 8515, 8516, and 8517 produce monoclonal antibody to an antigen, peptidoglycan, which is a normal structural component of neREFERENCE TO GOVERNMENTThe invention described herein was supported by National Institutes of Health grants DE-03487 and DE-05160.

Abstract: The present invention concerns an autologous precipitating antibody and the gp70 pigment-associated antigen on melanoma cells which it recognizes. The antibody is useful in detecting pigmented melanoma cells in excised specimen, serum or urine.

Abstract: Methods for the isolation and purification of an antigen, named NB/70K, from human ovarian carcinomas and radioimmunoassays for the detection of ovarian carcinomas, as well as an antibody specific for NB/70K.