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: A process for quantification of cell populations or subpopulations, by incubating a sample with labelled antibodies directed against characteristic surface antigens of the cell population to be quantified to form labelled antibody/antigen complexes. Standards with known, differing particle concentration and having comparable sedimentation behavior to the cells to be determined and further, carrying molecules which are directed against the labelled antibody or a part hereof are also incubated with the labelled antibodies. The cells of the sample solution, as well as the particles of the standard solution, are separated off from the excess labelled antibodies and the amount of the labelling is measured not only on the cells but also on the particles. By comparison of the measurement value from the sample with the measurement values from the standard solutions, there is ascertained the number of cells to be determined in the sample.

Abstract: The present invention is concerned with two novel monoclonal antibodies which define carbohydrate antigens associated with human non-small cell lung carcinomas ("NSCLC") and certain other human carcinomas. The antibodies bind to normal human cells to a much lesser degree than to tumor cells. The antibodies find use in diagnostic methods such as the detection of malignant cells associated with NSCLC and in therapeutic methods. The invention also comprises a method for determining the presence of a malignant condition in the lung of a subject. The method involves examining tissue from the subject for the presence of antigens which are Le.sup.x or Le.sup.y antigen or which have the characteristics of Le.sup.y and Le.sup.x.

Abstract: The invention relates to an immunological complex of two antibodies of a first animal species, e.g. mouse antibodies, which have been conjugated to form a cyclic tetramer with two monoclonal antibodies of a second animal species, e.g. rat monoclonal antibodies, directed against the Fc-fragment of the antibodies of the first animal species.Preferably, the complex is bifunctional, that is to say, that it contains two different antibodies of the first animal species, one of which is preferably directed to a detectable substance, such as an enzyme, e.g. peroxidase, and the other is directed to any desired antigen. A tetrameric complex of this kind may be used as a labelled antibody in immunoassays.Further, the invention relates to processes for preparing the complexes and for using the complexes in immunological reactions. Finally, the invention relates to drugs containing a complex according to the invention, as the complexes may be used to direct certain active principles to target cells.

Abstract: Sensitive detection techniques and compositions for such techniques are provided by employing fluorescent proteins having bilin prosthetic groups as labels. The bilin containing proteins can be conjugated to ligands or receptors for use in systems involving ligand-receptor binding for the analysis, detection or separation of ligands and receptors. Particularly, one or more of the bilin containing proteins may be used as labels in conjunction with each other or other fluorescers for defining subsets of naturally occurring aggregations e.g. cells.

Abstract: This invention provides a class of phycoerythrins useful in diagnostic and detection protocols wherein a fluorescent label is required. The unique spectral properties of the phycoerythrins described herein provide for increased sensitivity and alternative uses in assays employing them.

Abstract: Method and compositions including monoclonal antibodies to a serogroup-common antigen are provided for the detection and diagnosis of Legionella pneumophila. The monoclonal antibodies recognize a proteinaceous antigen of molecular weight 28,000-29,000 Daltons which is detected in at least serogroups 1 through 8 of Legionella pneumophila and is not detected in other common respiratory pathogens.

Abstract: A composition for therapeutic or diagnostic use in regard to pathogenic microorganisms, containing as an active constituent a structural element having the formula: ##STR1## wherein R.sub.1, R.sub.2, R.sub.3 and R.sub.4 are same or different and are hydrogen or an organic residue, for example lower alkyl, lower acyl, or a carbohydrate residue or an inorganic residue, such as sulphate or phosphate, and wherein OR.sub.1 is in .alpha.- or .beta.-configuration; a process for therapeutic treatment; a process for identification or quantification of the said structural element in native biological material; a process for purifying acceptor structures of bacteria; and a process for performing disinfection on surfaces.

Abstract: A method for detecting the presence in a human of an integral membrane calcium-binding protein associated with essential hypertension which comprises isolating tissue from a human, treating the tissue to obtain integral membrane proteins, contacting the proteins thus obtained with a first antibody molecule which binds to the integral membrane calcium binding protein to form an detectable protein-antibody complex, and detecting the complex so formed.Further, methods for quantitatively determining the amount of an integral membrane calcium-binding protein and the messenger RNA encoding said protein, diagnostic methods for identifying individuals predisposed to essential hypertension, and protein and messenger RNA associated with said hypertension.

Abstract: A method and reagent composition provide for the removal or blocking of serum interferences in liposome immunoassays. A carrier or liposome exhibiting at least one domain of phosphoryl ester groupings different from those of the marker liposome is introduced into the reaction mixture, whereby endogenous interfering species competitively bind to such carrier or liposome rather than to the marker liposome. Also, soluble phosphoryl ester groupings can be introduced into the reaction mixture which react with such endogenous species and further reduce serum interferences.

Abstract: Cell lines have been produced that secrete monoclonal antibodies capable of binding to the flagellar proteins of selected Pseudomonas aeruginosa strains. Some of these antibodies have been found to be protective against lethal challenges of P. aeruginosa. Pharmaceutical compositions containing these antibodies, which can be in combination with other monoclonal antibodies, blood plasma fractions and antimicrobial agents, and the prophylactic and therapeutic use of such compositions in the management of infections, are included.Prior to filing this application, the continuous transformed cell lines PaF4 IVE8, FA6 IIG5, 20H11, and 21B8, described herein, were deposited in the America Type Culture Collection and given the designations HB9129, HB9130, CRL 9300, and CRL 9301, respectively.

Abstract: The synthesis, composition and use of particles exemplified by microbeads of uniform size and character, with covalently bound biological molecules for biological simulation is disclosed.

Abstract: In passing labeled cells through a cell sorter, the improvement which comprises employing a labeled cell comprising a cell, an antibody specific to and bound to such cell, a nucleic acid fragment joined to said antibody, and a plurality of labels on said nucleic acid fragment. Because of the presence of multiple labels, the sensitivity of the separation of labeled cells is increased.

Abstract: A chemical agent is provided for significantly preventing or blocking non-specific staining or binding of an antibody specific for Terminal deoxynucleotidyl Transferase (TdT) during immunofluorescent or immunoperoxidase assay procedures. These procedures include both immunofluorescent and immunohistochemical staining of samples followed by flow cytometric and/or microscopic analysis, respectively. The invention is practiced by selective use of casein introduced into the assay procedures at an appropriate interval prior to analysis using a labelled or tagged monoclonal antibody specific to a TdT epitope. The casein utilized successfully was obtained from a large variety of sources and includes the use of a non-fat milk product.

Abstract: A late differentiation antigen (LDA.sub.1) expressed by activated helper cells is described. LDA.sub.1 is a membrane protein recognized by a monoclonal antibody produced by immunizing mice with an alloreactive human T cell clone with helper function. LDA.sub.1 is expressed by helper T cells optionally 9 days after activation. Anti-LDA.sub.1 monoclonal antibody blocks T cell enhancement of B-cell immunoglobulin production. Thus, LDA.sub.1 is associated with helper T cell effector function. Methods of diagnosis and therapy based upon LDA.sub.1 are also described.

Abstract: A method of testing a fluid sample for the presence of antibodies against a micro-organism, which comprises contacting the sample with fixed cells or fragments of cells infected with the micro-organism, and determining the presence of antibody bound to the cell-associated antigens, in which the determination is by virtue of a color change visible to the naked-eye at the site of the antibodies. For use in a testing method of this type, a test component comprises upper and lower layers, in which the upper layer has an array of apertures through which discrete areas on the lower layer are exposed, and in which the lower layer carries, in some at least of the discrete areas, fixed cells or cell fragments infected by a micro-organism.

Abstract: A method is described for the in vitro determination of hypersensitivity to an allergen. The method consists of adding the allergen to a sample containing basophilic leucocytes from the blood of a patient, and then measuring the amount of degranulation of the leucocytes. The allergen is added slowly and continuously, such that the threshold concentration needed to cause degranulation of sensitized leucocytes is reached sometime during the addition step and is present for a long enough period of time to allow degranulation to occur.

Abstract: Compounds and methods are disclosed for reversibly aggregating particles suspended in a liquid medium. The method comprises combining the liquid medium containing the particles with a polyionic polymer capable of aggregating the particles under conditions suitable for such aggregation. Thereafter, the particles are contacted with a chemical reagent capable of cleaving the polyionic polymer under conditions sufficient to reverse the aggregation. Optionally, magnetic particles are added to the liquid medium in the present method under conditions for non-specific binding and the medium including the aggregates is subjected to a magnetic field gradient to separate the aggregates from the medium. The compounds of the present invention are polyions. The aggregation of the particles is reversible upon contact with chemical agents which cleave at least some of the bonds within the polyionic polymer.

Abstract: A test kit useful for the determination of Streptococcus A antigen comprises: (i) an immunoreactive reagent comprising either Streptococcus A antigen or antibodies attached to water-insoluble particles, (ii) a substrate having thereon a dried, binder-free coating of a first extraction reagent, (iii) an aqueous solution of a second extraction reagent, and (iv) a neutralizing solution. Both extraction reagents combine to provide nitrous acid. In addition, an extraction device includes a water-insoluble container having affixed therein the first extraction reagent and an applicator means for collecting and depositing a biological specimen within the container. The extraction device and test kit are useful to the determination of Streptococcus A antigen in a biological specimen.

Abstract: A number of naturally occurring antibodies to human erythrocyte surface antigens are capable of combining with their specific antigens (for example, Rhesus factor), but are not capable of producing visible hemagglutination. Also, the sensitivity of many diagnostic methods, such as in human blood typing, depends upon cell agglutination.The present invention provides liposome-protein conjugates, especially useful for hemagglutination assays, having an enhanced agglutination capacity with respect to antibody from which the conjugates are derived.

Abstract: Monoclonal antibodies are produced which specifically bind to human ovarian cancer cells. These antibodies are conjugated to Pseudomonas exotoxin in order to produce an immunotoxin suitable for the chemotherapeutic treatment of human ovarian cancer.

Abstract: A non-enzymatic method of immunohistochemical staining uses a bound electron transfer agent to achieve amplification of antibody binding to specific antigens of interest in a histology or cytology specimen. A preferred embodiment uses a bound phenazine, which is reduced with a soluble reducing agent, and which in turn reduces a tetrazolium salt, to precipitate a formazan dye at the site of primary antibody binding to the antigen of interest. Reagents and kits for use in the method are also provided.

Abstract: The invention is directed to a method for the diagnosis of a malady in a subject by observing a degree of reaction between all blood cells: red blood cells, leukocytes and platelets; in the subject's blood with a foreign entity having a predetermined relationship with the malady being diagnosed. The test includes comparing amounts and sizes of red blood cells, leukocytes and/or platelets in a control sample and at least one test sample. The test sample includes a portion of the subject's blood and the foreign entity being tested.

Abstract: Specific binding members are provided for binding to lymphocytic cell surface receptors, which receptors are involved in the activation of a cell from the G.sub.0 state into the cell division cycle to proliferate. The cell surface receptors are further characterized by binding to envelope proteins of neoplasia-causing retroviruses, and/or to intact retroviral particles.

Abstract: An antibody reactive with activated human platelets, and substantially unreactive with resting human platelets, with the azurophilic granules of monocytes, and with granulocytes.

Abstract: Disclosed herein is a method for examining cells, comprising subjecting the cells to an antigen-antibody reaction treatment, then measuring a pattern of the electrophoretic mobility of the cells and comparing the electrophoretic property of the cells under examination with the electrophoretic property of standard cells.

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: Methods and compositions are provided for identifying patients suffering from neoplastic diseases such as breast cancer. It has been found that neoplastic epithelial cells, including neoplastic mammary epithelial cells, release a particular N-terminal blocked, soluble cytokeratin into circulation. The presence of this cytokeratin is diagnostic of neoplastic disease.

Abstract: Monoclonal antibody which lyses human natural killer (NK) cells in vitro in the presence of complement and which cells having a molecular weight of about 200-220 KD, as determined by SDS-PAGE electrophoresis on a 10% polyacrylamide gel.

Abstract: Disclosed is a method for detection for serum antibody and/or microbial surface antigen by radial partition immunoassay. The method of this invention is applicable to (a) the evaluation of a clinical specimen for identification of a microorganism; (b) antimicrobial sensitivity assays for determination of an efficacious antibiotic for use against a specific microorganism; (c) a semi-quantitative determination of viral surface antigen; and, (d) a quantitative method for the determination of the presence of serum antibodies to microbial antigens. In each of the foregoing applications, the analyte of interest can be immobilized within a porous matrix (solid phase) by simple pipetting of the sample onto the prepared matrix. Appropriate reagents are subsequently applied to the matrix to effect immunochemical interaction of a labeled binding material to the surface antigen (or antibody) of the analyte of interest. The portion of the matrix within which such interaction takes place is termed the "reaction zone".

Abstract: A method is provided for determining the presence in a sample of a member of a specific binding pair ("sbp member") consisting of ligand and its homologous receptor. The sample is combined in an aqueous medium with (1) a complementary sbp member wherein at least the sbp member or the complementary sbp member is bound to the surface of a cell and (2) a fuorescent agent capable of being incorporated into the cell. The presence of the sbp member is indicated by a change in fluorescence of the unseparated cell suspension as a result of agglutination of the cells.The present invention has particular application to blood typing, for example, for the determination of the presence of blood group antigens A, B, AB, O, and D (Rh.sub.o) and antibodies to such antigens.

Abstract: A method and composition for detecting analyte moieties by means of a signalling moiety capable of aggrandizement are disclosed. The signalling moiety can be attached to or not attached to the analyte moiety/analyte-specific moiety complex. The signalling moiety can be viable or non-viable. The methods disclosed herein provide a sensitive assay for the detection of a wide range of different analyte moieties.

Abstract: A method is devised to assay and diagnose common varied immunodeficiency syndrome. This syndrome is subdivided or subset into at least four separate groups of B-cell deficiencies based on a patients peripheral blood B-cell proliferative and/or differentiative response to various stimulatory factors alone or in combination. CVI diagnosis and therapy are aided by this invention.

Abstract: Detection of an identified human carcinoma tumor antigen in a pathological sample by means of a labelled monoclonal antibody specific to the determinant site on the antigen is enhanced and/or accelerated at an earlier development stage than heretofore achieved by removing a carbohydrate steric hindrance for monoclonal antibody availability to bind the antigen of the tumor for which it is specific. The carbohydrate steric hindrance for monoclonal binding to the antigen is identified as sialic acid. The method of the invention involves selective removal of sialic acid from the antigen's determinant site by enzymatic digestion using neuraminidase.

Abstract: Actinobacillus actinomycetemcomitans has frequently been implicated in juvenile periodontitis. The present monoclonal antibodies are specific to Actinobacillus actinomycetemcomitans. The present monoclonal antibodies are typically employed as reagents which include an inert carrier, preferably a liquid, such as buffered saline solution and a preservative. The carrier compositions are suitably selected to provide for the proper dispersal of bacteria, and to preserve the integrity of antigens and supplemental structures. The selection of the proper carrier is especially important in the detection in mixtures which include bacteria which produce large amounts of autolyltic enzymes such as B. gingivalis. The monoclonal antibodies of the present invention are useful in clinical testing and differentiating antigens in the gingival or subgingival sera.

Abstract: The property of phagocyte cells to show chemiluminescence when activated by certain chemical or immunological agents is used for a qualitative and quantitative analysis of such agents in biological fluids. A variety of factors such as opsonizing anti-bodies, complement, inhibitors, membrane-specific anti-bodies, and their antigens, membrane-specific lectins, lymphokines, endotoxins, toxic substances and others can be analyzed in this way. The new method finds application in the biotechnical, clinical, immunological and pharmacological fields, with a special preference for toxicological screening of pharmaceuticals. The phagocyte cells needed for the analysis can be derived from a continuous phagocyte cell line and a method of producing such a cell line is provided.

Abstract: A viral lysis immunoassay system and method. The system includes hemolytic particles carrying non-viral, anti-analyte molecules, lysable target cells which are devoid of surface molecules capable of binding to endogenous viral surface molecules, and foreign binding molecules added to the target cells. The binding molecules, which may be either analyte molecules or analyte-related molecules attached to the target cell surfaces, function to bind the particles to the cells, to initiate cell lysis and the release of encapsulated reporter molecules from the cells. The analyte to be assayed may be one adapted to bridge the virus particles to analyte-related molecules carried on the cell surfaces, or one which competes with target-cell molecules for binding to the particle anti-analyte molecules.

Abstract: A method is provided for recognizing and diagnosing diseases or conditions associated with immune system dysfunction and loss of integration of brain function, particularly a subset of Alzheimer's disease, and for the in vitro testing to determine efficacy of possible therapeutic agents. The method involves measurement of immunological parameters on peripheral blood immunocytes.

Abstract: A reagent for use in solid phase immunoassay diagnostics comprises a matrix of non-active hybridoma cells embedded with its self-produced, covalently bound, actively presented monoclonal antibodies.The solid phase reagent according to the invention is prepared by incubating in vitro a culture medium containing active hybridoma cells capable of producing monoclonal antibodies, allowing the formation of antibodies to proceed, separating and washing said cells, resuspending the cells in a buffer solution, adding to the resulting suspension an inactivator substance capable of converting active hybridoma cells into the non-active state.

Abstract: A method for identifying and enumerating cells of a subclass of blood cells in relation to cells of another subclass of blood cells is provided. In the method a first subclass of blood cells is selectively tagged by incubating an aliquot of a blood sample with a first tagging agent. A second subclass of blood cells is selectively tagged by incubating the aliquot with a second tagging agent. The aliquot is then passed, without lysing of any subclasses of blood cells which are not of interest, substantially a cell at a time through an area of optical stimulation for the tagging agents. Light emitted by the tagging agents is detected, the detection being limited by gating to a threshold value related to a predetermined intensity of light by one of the tagging agents. Cells of the subclass are differentiated based on occurrence of emitted light from the tagging agents.

Abstract: The invention relates to a process for producing a fucosyl antigen charcterized in that an oligosaccharide contaning an .alpha.-fucoyransoyl-(1.fwdarw.3)-, -(1.fwdarw.4)- or -(1.fwdarw.6)-galactoyransoyl group and serving as a hapten is reacted wtih a carrier protein to obtain a carbohydrate antigen and to a process for producing from the antigen an antibody having specific reactivity with cells of cancers of the digestive system, especially human colon carcinoma cells, and murine teratocarcinoma cells.The invention also relates to a method of determining a cancer associated crabohydrate linkage with use of such antibody capable of specifically recognizing specific carbohydrate linkage and to a cancer diagnosing kit containing the antibody.

Abstract: Method to detect and/or determine the presence of cancer cells in mammals, including humans, and to monitor the progress of treatment for cancer. A human protein marker, the assay-marker, has been ascertained of the molecular weight 70,000-74,000, which is secreted by cancer cells at levels 10-fold or greater than that observed with normal cells. An assay is described where the assay-marker or an antigenically analogous protein, the analog-marker, is used to prepare antibodies to the assay-marker. The antibodies are then reacted with blood or serum samples to determine the level of the assay-marker in the sample. Thus, the assay essentially comprises (1) providing an antibody to the protein described above (2) reacting the antibody of step 1 with the sample to be tested and (3) measuring the level of the reacted antibody to detect and/or determine the presence and/or quantity of cancer cells.

Abstract: Recombinant E. coli clones which cell surface-express Legionella pneumophila antigens, a method for utilizing these clones for the detection of Legionella antibodies in a clinical sample, and a method for isolation of mono-specific anti-Legionella antibodies are disclosed. The recombinant clones are produced by ligating fragmented Legionella DNA to pBR322 which is then used to transform the appropriate E. coli host. Clones that cell surface-express individual Legionella antigens are selected by screening cellularly intact clones using anti-Legionella antibodies to probe for cell surface expression. An enzyme-linked immunosorbant assay (ELISA) is disclosed which utilizes the Legionella antigen-expressing clones to detect anti-Legionella antibodies.

Abstract: A method of distinguishing multiple subpopulations of cells from a single sample of cells of a variety of types comprises labeling particles with two or more marking agents. These particles are marked in a plurality of different pre-selected ratios of the agents ranging between zero percent and one hundred percent of each agent. Each such agent has distinguishing, quantifiable marking characteristics. The differently labeled particles are mixed with cells suspected of having specific receptors for the differently labeled particles. Each cell is analyzed to determine the ratio of any two identifiable marking characteristics associated with each cell so that is can be classified in a subpopulation category if its ratio of marking characteristics is related to one of the pre-selected ratios of marking agents.An apparatus for carrying out the above-described method is also within the purview of the present invention.

Abstract: Drug-induced thrombocytopenia can be detected via the use of an enzyme-linked immunospecific assay.

Abstract: A novel method for the diagnosis of Acquired Immune Deficiency Syndrome (A.I.D.S.) is disclosed, involving the use of immunocytoadherence (rosette inhibition) techniques. The method is based on the discovery that the lymphocytes of A.I.D.S. patients are unusually resistant to antithymocyte serum, and that the plasma of A.I.D.S. patients is capable of conferring this resistance to normal lymphocytes. Accordingly, the diagnostic method involves performing rosette inhibition tests on the patient's lymphocytes or on lymphocytes from a healthy donor after treatment with the patient's plasma. Any observable lessening of inhibition in comparison with a control is related to the presence of A.I.D.S.

Abstract: Methods are provided for rapidly determining a number of parameters in a few determinations. Particularly, the method is applicable to blood typing, determining the blood type as to the ABO and Rh type, as well as the determination of isoantibodies to the antigens. The method employs fluorescent particles having a plurality of fluorescers, where the presence or absence of light emission of a particular wavelength can be determined.

Abstract: A method for determining one or more antigens in a sample by immunological reaction between the antigen and antibodies directed specifically against the antigen in the presence of a liquid, said antibodies being bound to the surface of minute particles which are insoluble in the liquid in which the reaction is effected, the reaction leading to an agglutination which indicates the presence of the antigen in the sample. The antibodies are specifically fixed to a polypeptide which is derived from microorganisms and which can bind the Fc-part of the antibodies and the polypeptide is bound to the surface of the minute particles.

Abstract: An in vitro assay procedure for the detection of non-genotoxic substances is provided which utilizes a prepared cell culture whose cytoskeleton constituents are structurally identifiable as microtubules, intermediate filaments and microfilaments. The procedure combines the test sample with the cultured cells and detects a presence of epigenetic substances by identifying structural changes in the cytoskeletal constituents in comparison to normal control cells. The assay method is rapid, accurate, reproducible, and has been demonstrated to identify toxic substances which have not been previously detected by presently known bacterial and/or mammalian cell mutagenic assay systems.

Abstract: A diagnostic method and reagents for monitoring the efficacy of therapeutic treatment using the phenomenon of capping of cell membrane receptors, and is useful for relating receptor capping to clinical responses to therapy in patients with diseases, disorders, or malignancies involving cells that possess receptors. Therapeutic efficacy is determined by detecting receptors for activated substances, e.g., the third component of complement (C3), on cells having receptors therefor on the cell membrane surface, e.g., human lymphocytes, by the binding of an activated receptor substance, preferably labeled with a fluorescent or radioactive marker.