Abstract: The invention relates to the area of protein determinations in homogeneous solution by means of antigen-mediated precipitation by antibodies or using latex materials coated with antibodies and subsequent optical measurement of the precipitation reaction by a nephelometric or turbidimetric measurement.

Abstract: The present invention relates to a flow cytometry assay for the determination of heparin-induced thrombocytopenia. This method (a) detects in a plasma sample the presence of anti-heparin antibodies which react with platelets in the presence of heparin to produce activated platelets, (b) quantitates by flow cytometry the presence of such activated platelets in the plasma sample, and (c) correlates the presence of activated platelets with a diagnosis of HIT for the patient. In addition, the flow cytometry assay of the invention is also useful in assessing the compatibility of a heparin-like molecule for use as an alternate therapy for patients with heparin-induced thrombocytopenia. In addition, the invention contemplates a mepacrine release assay with flow cytometry for the detection of heparin-induced thrombocytopenia and for the assessment of compatibility of heparin-like molecules in patients diagnosed with heparin-induced thrombocytopenia.

Abstract: The invention provides a fragment of C1q which is characterized in that a plurality of such fragments selectively binds immune complexes or aggregated immunoglobulins in the presence of monomeric immunoglobulin. The invention also provides a synthetic peptide comprising the sequence: ##STR1## or variants thereof capable of binding immunoglobulin. Like the C1q fragment, a plurality of the peptides can selectively bind immune complexes or aggregated immunoglobulins in the presence of monomeric immunoglobulin. As a result of this property, the fragments and peptides are well-adapted for removing immune complexes and aggregated immunoglobulins from fluids containing monomeric immunoglobulin, and for detecting or quantitating immune complexes in such fluids. The invention also provides a binding material for removing immune complexes or aggregated immunoglobulins from a fluid.

Abstract: An assay and method for screening newborns to determine risk of Sudden Infant Syndrome is described. The assay and method is based on the detection of elevated IgM-anti-IgG (MAG) levels in newborns' serum within the first year of birth. In particular, it has been discovered that elevated MAG levels indicate an increased risk of Sudden Infant Death Syndrome (SIDS).

Abstract: The present invention describes Urinary Tumor Associated Antigen (UTAA), its isolation and use in diagnostic assays. In particular, UTAA has been identified in samples from cancer patients, in some cases as part of an immune complex of UTAA and UTAA-specific immunoglobulin. Isolated UTAA also may be formulated as a pharmaceutical for production of antibodies or as a vaccine.

Abstract: The invention provides a fragment of C1q which is characterized in that a plurality of such fragments selectively binds immune complexes or aggregated immunoglobulins in the presence of monomeric immunoglobulin. The invention also provides a synthetic peptide comprising the sequence: ##STR1## or variants thereof capable of binding immunoglobulin. Like the C1q fragment, a plurality of the peptides can selectively bind immune complexes or aggregated immunoglobulins in the presence of monomeric immunoglobulin. As a result of this property, the fragments and peptides are well-adapted for removing immune complexes and aggregated immunoglobulins from fluids containing monomeric immunoglobulin, and for detecting or quantitating immune complexes in such fluids. The invention also provides a binding material for removing immune complexes or aggregated immunoglobulins from a fluid.

Abstract: The present invention relates to the field of cancer immunoassay. Specifically, a new immunoassay method for prostate specific antigen (PSA) is presented. Also presented is a complex which resembles a complex of PSA and .alpha.-antichymotrypsin (ACT) that can be used as a calibrator or control in an immunoassay for PSA. Further presented is a method for fractionating polyclonal antibodies, to PSA, into those which bind epitopes that are masked by the binding of PSA to ACT and those which do not bind such epitopes.

Abstract: An agent for the detection of peroxidase or of pseudoperoxidase activity, and its preparation and its use are described. The agent contains a tetraalkylbenzidine, a peroxide and buffer substances. The agent according to the invention has, as a peroxidase substrate, the advantage over previous tetraalkylbenzidine-containing substrates that it generates higher color signals.

Abstract: This invention provides a specific immunocapture ELISA for the quantitation of cancer procoagulant antibody complex (CPAC) in biological samples. In particular, this invention provides methods and techniques for specifically selecting and quantitatively measuring CPAC from a sample material using anti-CP antibodies followed by labeled anti-immunoglobulin antibodies. The amount of captured CPAC is then determined by measuring the amount of label in the captured CPAC.

Abstract: A method of binding aggregated immunoglobulin or immune complexes comprising contacting them with modified forms of C-reactive protein. The method may be employed for diagnostic and therapeutic purposes and to deplete fluids of aggregated immunoglobulin or immune complexes. Further, a method of reducing the levels of immune complexes in a mammal comprising administering modified-CRP to the mammal, and a method of binding immunoglobulins comprising contacting them with modified C-reactive protein. Also, a method of binding aggregated immunoglobulin or immune complexes comprising contacting them with antibody to neo-CRP, and a method of modifying C-reactive protein. Finally, a test kit for detecting or quantitating immune complexes and a device for removing aggregated immunoglobulin or immune complexes from fluids are disclosed.

Abstract: An assay and method for screening newborns to determine risk of Sudden Infant Syndrome is described. The assay and method is based on the detection of elevated IgM-anti-IgG (MAG) levels in newborns' serum within the first year of birth. In particular, it has been discovered that elevated MAG levels indicate an increased risk of Sudden Infant Death Syndrome (SIDS).In a preferred embodiment of the invention, an ELISA is utilized in which a first binding agent having specific affinity for IgM is used to capture and separate IgM antibodies from the newborn's blood sample. A second binding agent having specific affinity for IgG which has been separated from the sample eluant by complexing with MAG, is then used in conjunction with an enzyme conjugate to indirectly determine the amount of MAG in the newborn's blood. The MAG level is then compared to a cut-off which is selected to separate out approximately 4% of the newborns which have the highest MAG levels.

Abstract: The amount of an analyte in a sample derived from a living sample is measured by reacting the analyte with an excess of a substance having affinity for the analyte, followed by separation of complex by high pressure liquid chromatography and measurement using a linear calibration curve representing the peak area values associated with known concentrations of analyte.

Abstract: As a carrier for binding of the antiphospholipid antibodies used for immunological diagnosis of antiphospholipid syndrome, a phospholipid-bound carrier treated with purified serum albumin and a surfactant is used. Thus, immunological diagnosis of antiphospholipid syndrome can be made with high accuracy. By using the fraction or protein obtained from animal serum or plasma, having the activity of enhancing the binding ability of the antibodies specifically present in the antiphospholipid syndrome to the phospholipid, immunological diagnosis of antiphospholipid syndrome can also be made more accurately, as compared to known diagnosis.

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: The invention relates to a latex agglutination method for the detection or determination of one partner of an antigen-antibody reaction, wherein, in order to suppress non-specific reactions, to, for example, Clq and rheumatoid factors the immunochemical reaction takes place in the presence of an immune complex which does not contain any antibody or antigen that is specific for one of the partners.

Abstract: Peptides are disclosed possessing some of the immunological properties of the peptide of the formula Gly-Gly-Arg-Leu or Lys-Lys-Thr-Glu, as well as application thereof for screening for certain autoimmune diseases.

Abstract: A method for determining total analyte concentration in a sample having both free and bound analyte is described. This method involves (a) disassociating immune complexes, (b) assaying for the concentration of free analyte, (c) assaying at least once for the concentration of free analyte in the sample wherein said sample contains a known quantity of analyte which has been added to the sample, and (d) determining total analyte concentration from the assayed concentrations obtained in steps (b) and (c).

Abstract: By allowing the mast cell enriched population of human conjunctival tissue cells to incubate for a minimum of about forty (40) hours post enzymatic digestion, the treatment window between spontaneous histamine release and anti-human IgE stimulated histamine release is increased. Culturing the human conjunctival tissue mast cells decreases the spontaneous release of histamine and increases the anti-IgE stimulated histamine release, greater than ten fold over spontaneous, at time points over forty (40) hours. This treatment window is sufficient to detect a compound's stabilizing or anti-allergic activity.

Abstract: The present invention provides a method for assaying a sample of cells for the presence of a cell surface antigen. More particularly, the present invention describes methods for detecting the presence of plasma and cell bound autoantibodies against cell surface antigens. In addition, the present invention provides a method of crossmatching donor platelets and transfusion recipients.

Abstract: An in vitro method of detecting a cell-mediated immune response to a specific antigen, comprising incubating a whole blood sample with the specific antigen and detecting the presence of gamma interferon released by sensitized lymphocytes in the whole blood sample as an indication of a cell-mediated immune response to the specific antigen.

Abstract: Diagnostic assays wherein sera from a patient suspected of having an ill defined autoimmune rheumatic disease is reacted with antigens specific to the human immunodeficiency virus (HIV) core proteins (gag protein products p24 or p17) and envelope proteins env (protein products gp41 and gp160). Immunoreactivity is determined by the formation of an antibody-antigen complex as observed in a Western immunoblot assay. The degree of cross reactivity to the 4 individual proteins is determined, and with this information, a specific and more accurate diagnosis of the disease is made. Once a more accurate diagnosis is determined, the clinician may then proceed with prescribing a therapeutic regimen better suited for the specific patient.

Abstract: The present invention provides polypeptides composing epitopes of human centromere protein B, genes encoding therefor, plasmids or phages containing the genes, transformants obtained by introducing the plasmids or phages containing the genes, a method for producing the human centromere antigen polypeptide using the transformant, and a method for detecting anti-centromere antibody using the human centromere antigen polypeptide. Analysis of the above-mentioned epitope was accomplished using CENP-B gene obtained from a cDNA library prepared using mRNAs isolated from Jurkat cells. The present invention allows the production of the human centromere protein B epitope region in a large quantity, which in turn allows the detection of human anti-centromere antibody readily and precisely using the peptide obtained. Furthermore, it becomes possible to make a precise classification of the disease type of a patient having human anti-centromere antibody by determinations using each of the epitopes.

Abstract: For the determination of antibodies based on an immunoassay technique by incubation with at least three receptors R.sub.1, R.sub.2 and R.sub.3 which are present dissolved in a liquid phase and of which R.sub.1 is an antigen which is capable of being specifically bound to the antibody to be determined, R.sub.2 mediates the binding to the solid phase and R.sub.3 carries a label, separation of the complex which forms from the solution by binding to a solid phase and measurement of the label in one of the phases, a conjugate is used as the receptor R.sub.2 composed of a receptor capable of specific binding to R.sub.1 and a substance S.sub.1, which can be specifically bound, and a conjugate of a receptor which can specifically bind to R.sub.1 and a label is used as R.sub.3, wherein the immobilization of the complex which forms is mediated by binding to a component of the solid phase which can specifically bind S.sub.1.

Abstract: The invention provides for methods and compositions to detect the presence of anti-HLA antibodies, HLA antigen or preformed HLA-containing immune complexes in biological samples. The complement protein Clq is bound to a solid substrate, then mixed with a biological sample containing immune complexes. The immune complexes are preformed, or formed by adding HLA antigens to a biological sample containing antibodies to HLA, or alternatively, by combining a biological sample containing HLA antigens with defined antibodies to HLA. The immune complexes bind to Clq, and are then detected by the addition of a labeled reagent.

Abstract: Reactivity between alloantigen and alloantigen-specific ligand, such as HLA and anti-HLA antibody, is detectable in a sample by separating from the sample a portion of a targeted class of ligands (including such ligands complexed with alloantigen) and measuring the amount of alloantigen in such complex containing fractions. In another embodiment of the invention, reactivity between a plurality of samples is detected by measuring soluble alloantigen in at least first and second biological samples and in a mixture of the samples. Since the formation of alloantigen immune-complexes in the mixture alters the physical and immunological behavior of soluble alloantigen, a divergence between the measured and expected concentration of the mixture indicates reactivity.

Abstract: Receptors are disclosed that are antibodies that exhibit a binding affinity for an immune complex of a monoepitopic antigen and an antibody for such antigen that is substantially greater than the binding affinity for the monoepitopic antigen or the antibody for the monoepitopic antigen apart from the immune complex. In one embodiment the receptors are antibodies prepared against an affinity-labeled complex of an antigen and an antibody for the antigen. Normally, the monoepitopic antigen has a molecular weight less than 1500 and is an organic compound. The antibodies of the present invention find use in a method for determining a monoepitopic antigen in a sample suspected of containing such antigen. The method comprises forming an immune sandwich complex comprising the monoepitopic antigen or an analog thereof, a first monoclonal antibody that binds to the monoepitopic antigen, and a second monoclonal antibody that is an antibody of the present invention and detecting the immune sandwich complex.

Abstract: Soluble HLA cross-matches are determined by providing for antibodies or ligand bound to a solid substrate specific for at least one HLA allele and detecting complexes between either donor or recipient HLA antigens and recipient or donor antibodies, respectively, or reference HLA and patient antibodies, particularly IgG antibodies. Conveniently, anti-human immunoglobulin (Ig), particularly human IgG, conjugates are employed where the anti-human Ig is conjugated with a label capable of providing a detectable signal to permit detection of human anti-HLA bound to said solid substrate.

Abstract: A method of binding aggregated immunoglobulin or immune complexes comprising contacting them with serum amyloid P component ("SAP"). The invention also comprises methods of using SAP to detect or quantitate immune complexes and to deplete fluids of aggregated immunoglobulin or immune complexes for diagnostic or therapeutic purposes. Also provided is a test kit comprising SAP for detecting or quantitating immune complexes and a device for removing aggregated immunoglobulin or immune complexes from fluids.

Abstract: A method for detecting the onset or presence of Lyme disease in a mammal, which comprises isolating a biological sample from the mammal, isolating from said biological sample any circulating immune complexes suspected to contain antibody reactive to Borrelia burgdorferi, dissociating the immune complexes so isolated, and examining the dissociated immune complexes for the presence of antibody. The present method offers a simple and reliable means for detecting Borrelia antibodies. Test kits and related methodology are also disclosed.

Abstract: The present invention provides a method for assaying a sample of cells for the presence of a cell surface antigen. More particularly, the present invention describes methods for detecting the presence of plasma and cell bound autoantibodies against cell surface antigens. In addition, the present invention provides a method of crossmatching donor platelets and transfusion recipients.

Abstract: Utilizing mouse monoclonal antibodies which recognize Rodgers 1 and Chido 1 epitopes carried on the C4A and C4B molecules, and heat aggregated IgG to activate C1, an immunoassay was developed for the quantitation of complement components, including total C4, C4A and C4B. Interassay variation was 12.4%, 11.5% and 10.8%, respectively. The immunoassay was compared to the quantitation of total C4 by radial immunodiffusion by testing 103 random white controls and gave a Pearson's product moment correlation coefficient of 0.81. Three genetic total C4 deficient individuals were nonreactive in all three assays. This activated assay is specific, reproducible and superior to existing methods for the quantitation of C4A and C4B and detection of the heterozygous C4 null states.

Abstract: A method for the diagnosis of IgA nephropathy using a specific binding reaction comprising the steps:a) preparing a substrate capable of binding fibronectin or IgAb) contacting the substrate resulting from step a) with a sample of body fluid drawn from a patient subject to diagnosis to bind any fibronectin-IgA-complex present in said sample to the substrate, andc) determining the presence of complex bound to the substrate using the reaction between the exposed part of such bound complex and a corresponding antibody thereto; anda diagnostic kit for use in such diagnosis.

Abstract: To diagnose diseases in patients, a protein complex, RhC, is prepared from horse serum by precipitating a white powder from the serum at a pH of 5.5 and processing to remove lipids at a pH of 8.2 using Tris-HCl as the buffer. It includes two components associated together to provide a molecular weight of 280,000 and having characteristics of a rheumatoid factor and a Clq-like subcomponent of the complement. The protein complex is incubated with human serum or plasma and then precipitated by dialysis against a high pH buffer (0.05M Tris-HCl pH 8.2). When precipitated, it co-precipitates the immune complexes from the human blood serum without substantial monomeric immunoglobulin to quantitatively isolate immune complexes from serum. Immunological assays then determine how much immune complex and what kind were in the serum.

Abstract: A novel immunoassay techniques is provided which is useful in the detection and determination of antibodies to antigens. Antibodies of all classes to a given antigen or the specific subclass of immunoglobulin to a specified antigen can be detected. A conjugate of labelled antibody and specific antigen is used as the third reagent in a sandwich assay.

Abstract: A reagent for measuring immune complexes fixed with an anti-C3 antibody Facb fragment. By using the reagent, immune complexes existing in the blood serum or body fluid are quantitatively measured.

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: A secondary antibody capable of stabilizing the binding of a small molecule to its binding protein is described which secondary antibody is capable of binding said binding protein in the presence of an in the absence of the small molecule but is not capable of binding said small molecule in the absence of binding protein. Such antibodies may be obtained by forming a complex between a small molecule and its binding protein, using the complex to raise antibodies and selecting the antibodies. The antibodies may be used in competitive assays in which it is desired to improve the binding of a small molecule or labelled small molecule to its binding protein.

Abstract: A standard material for measuring immune complexes which is prepared by chemically binding immunoglobulin and/or its fragment with a complement and/or its derivative through the medium of a bifunctional reagent. By using the standard material, the standard curve which is used for measuring immune complexes existing in the blood is obtained.

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: A method of detecting Toxoplasma infection and distinguishing acute infection from chronic infection is provided, comprising the steps of combining a sample suspected of containing antibodies to Toxoplasma antigens with a acute-phase-specific antigen reactive with an antibody specific for an acetone-treated Toxoplasma antigen under conditions favorable for formation of antigen-antibody complex, and detecting formation of the complex.

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: Novel and improved methods for diagnosis, prognosis, prophylaxis and therapy of viral infections are described. The novel methods employ a virus, viral antigen or fragment thereof in which "perturbation" of an oligosaccharide moiety renders the virus, viral antigen or fragment thereof more specifically recognizable or reactive with neutralizing antibody. As described, "perturbation" of an oligosaccharide moiety encompasses any modification that (1) alters the chemical or physical structure of a carbohydrate residue that is naturally present; (2) that removes, wholly or in part, a carbohydrate residue; and/or (3) that prevents or alters addition of a carbohydrate residue. A variety of methods for oligosaccharide "perpetuation" are also described.

Abstract: A secondary monoclonal antibody against a complex of a molecule of molecular weight less than 5000 and a binding protein against said molecule which secondary monoclonal antibody is not an antibody against molecule or against its binding protein.

Abstract: The invention involves polyclonal antibodies reactive with a complex of a hapten and its binding protein, wherein the antibodies are unreactive with the free hapten or free binding protein. The antibodies are useful in assays of the hapten or the binding protein.

Abstract: Procedure to be performed in conjunction with protein blotting or nucleic acid blotting wherein the matrix to which said components have been transferred is contacted with reagent and wash solutions in a rotary drum.

Abstract: Chronic immune thrombocytopenic purpura is due to platelet destruction by circulating anti-platelet antibody. Although autoantibodies against the platelet glycoprotein IIb/IIIa complex and glycoprotein Ib have been demonstrated using various methods, practical assays for detection of platelet-associated or plasma autoantibodies have not been available. I studied 44 patients with chronic immune thrombocytopenic purpura where platelet-associated and plasma autoantibodies against the glycoprotein IIb/IIIa complex and glycoprotein Ib were measured using a newly developed immunobead assay and a previously reported microtiter well assay. Platelet-associated autoantibody was detected using the immunobead assay in nine of 11 patients (81.8%; seven with anti-GPIIb/IIIa, two with anti-GPIb). Plasma autoantibodies were noted in 28 of 44 patients (63.6%; 19 with anti-GPIIb/IIIa, seven with anti-GPIb and two with both).

Abstract: A method of assaying biologically active substances by the competitive method or by the sandwich technique, characterized in that fine particles having a diameter of 0.03 to 3 .mu.m are used in the labelling agent.

Abstract: To diagnose diseases in patients, a protein complex, RhC, is prepared from horse serum by precipitating a white powder from the serum at a pH of 5.5 and processing to remove lipids at a pH of 8.2 using Tris-HCl as the buffer. It includes two components associated together to provide a molecular weight of 280,000 and having characteristics of a rheumatoid factor and a Clq-like subcomponent of the complement. The protein complex is incubated with human serum or plasma and then precipitated by dialysis against a high pH buffer (0.05 M Tris-HCl pH 8.2). When precipitated, it co-precipitates the immune complexes from the human blood serum without substantial monomeric immunoglobulin to quantitatively isolate immune complexes from serum. Immunological assays then determine how much immune complex and what kind were in the serum.

Abstract: Method of determining changes occurring in articular cartilage. The method involves (a) quantifying proteoglycan monomer and/or antigenic fragments thereof in a synovial fluid sample and (b) correlating the values thus obtained with progressive destructions in the articular cartilage appertaining to that sample fluid.

Abstract: The use of immunologically non-specific peptide linked amino acids containing compounds that are capable of immobilizing circulating immune complexes for the purpose of detection or removal from serum or blood, such compounds including oligopeptides, modified oligopeptides, polypeptides, modified polypeptides, proteins, modified proteins, and in particular glycosylated polypeptides and proteins.