Abstract: The invention relates to a heterogeneous immunoassay which is carried out using a multizoned test device. In particular, the invention involves the use of an inhibitor of a label which is used in the assay. The label which may be an enzyme, is attached to a receptor such as an antibody. The inhibitor is not acted upon by the label, but must be removed in order for a signal to be produced. Also described are test strips which can be used for the assay.

Abstract: The present invention provides an enhancer DNA segment, a gene fragment having (a) the enhancer DNA segment and (b) a structural gene such as human D, V and J gene, and a promoter. A hybrid DNA (1) having a phage DNA fragment from Charon 4A phage vector and human DNA fragments, a Charon 4A phage containing the hybrid DNA (1), a hybrid DNA (2) having a PBR322 fragment and human DNA fragment, a transformant of E. coli C600 strain transformed with the hybrid DNA (2), plasmid pSV2-H1G1 obtained by inserting a human DNA fragment into a vector pSV-2gpt, a transformant of E. coli MC 1000 strain transformed with the plasmid pSV2-H1G1 and a transformant of mouse myeloma cells J558L or NS-1 transformed with the plasmid pSV2-H1G1 are also provided.

Abstract: The invention provides an imaging immunoassay detection apparatus system and method capable of detecting multiple light emitting reactions from small volume samples simultaneously and quantifying the same.

Abstract: The present invention provides a process for the determination of a protein according to the fluorescence polarization immunoassay principle in a homogeneous system by simultaneous incubation of the sample solution witha) a peptide sequence, labelled with a fluorescing compound, of 6 to 14 amino acids, two of which are cysteine which form a disulphide bridge with one another, the sequence thereby corresponding to an epitope sequence of the protein to be determined, andb) an antibody which is specifically bindable not only with the protein but also with the peptide sequence and displays for the fluorescing peptide sequence of the protein and the native protein molar relative affinities which differ by a factor of at most 6, and measurement of the depolarization of polarized light passed through the incubated solution.

Abstract: A medical device, particularly a filter, cannula, catheter, or implant made of plastic or plastic-coated metal or glass for fixing disease-causing microorganisms, particularly viruses, bacteria, and fungi as well as pathogenic metabolic products, toxins, lipoid substances, and drugs, wherein the plastic surface is provided (firmly attached thereto or covalently bound therewith):a) homologous or monoclonal immunoglobulins, preferably those that have been afterpurified by affinity chromatography in the classes G1, G2, G3, and/or G4 and/or IGM, IGE, IGD and/or IGA and/or the F(ab)2 fragments thereof, preferably those that have been afterpurified by affinity chromatography, which are selectively active against the specific antigens or antigenic determinants of the respective disease-causing microorganisms, particularly viruses, bacteria, and fungi as well as pathogenic metabolic products, toxins, lipoid substances (e.g.

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 method for obtaining a substantially pure preparation of an enzyme-antibody conjugate having an enzyme component covalently coupled to a predetermined number of an antibody component where the molecular weight of the enzyme component is substantially greater than the molecular weight of the antibody component. The method involves the electrophoretic separation of the desired enzyme-antibody conjugate from an enzyme-antibody conjugate reaction mixture comprising, as separately migratable species, at least a free enzyme component and a poplulation of enzyme-antibody conjugates comprising one or more of the enzyme component convalently coupled to one or more of the antibody component. The resulting conjugate preparations are substantially pure and are therefore particularly useful as labeled reagents in immunometric assays.

Abstract: The present disclosure described an assay for screening monoclonal antibodies for their potential as highly cytotoxic immunotoxins. The assay involves treating cells with dilutions of the test antibody followed by a Fab fragment of a secondary antibody coupled to an A chain toxin ("indirect assay"). The cytotoxicity of the indirect assay is compared to that of the direct assay where the monoclonal antibody is coupled to an A chain toxin. Indirect and direct assays were carried out using 14 antibodies and a panel of 8 human and mouse cell types. The two assays showed virtually 100% correlation. The indirect assay, therefore, predicts the potency of a given monoclonal antibody to make an effective immunotoxin and should be useful in screening monoclonal antibodies for use as immunotoxins.

Abstract: The electrophoresis method of the present invention employs a media which contains uniformly dispersed liposomes of phospholipid, or combinations of phospholipid and neutral lipid, which contain chromogenic materials or dye precursers. After electrophoresis of a test sample, the liposomes are lysed and the chromogen or dye material released. The chromogen or dye can be any signal producing substance including a chromogenic agent, and enzyme, a fluorogenic agent, or a chemiluminescent agent, but a detectable signal occurs only where the staining material is in close proximity to specific enzymes, effectors, analytes, or other color-inducing agents which have migrated through the gel during electrophoresis.

Abstract: The present invention provides a probe for the detection of HIV 1 antigens, comprising anti-HIV 1 F(Ab').sub.2 fragments. The invention further provides an immunoassay with enhanced specificity.

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 provides for novel homogeneous immunoassay systems involving complement-mediated lysis of marker-encapsulating lipid vesicles (liposomes) for detection of analyte in a fluid sample. These systems do not require the separation of unbound antigens and/or antibody conjugates yet provide highly sensitive procedures for analyte detection. Liposomes containing a marker, are coupled to antibody fragments in a way which confers the liposomes with immunological specificity yet avoids sensitizing the liposomes to complement mediated lysis in the absence of analyte. Antibody sensitized liposomes (the first reagent) are sequentially incubated with an analyte-containing sample, and optionally "dummy" liposomes, which do not contain encapsulated marker, a second antibody (the second reagent), and finally with a complement source such as plasma. Complement is activated by the liposome-antibody-antigen-second antibody complex causing liposome lysis and a concomitant release of marker.

Abstract: The present invention provides an enzymatically-inactive, immunologically-active .beta.-galactosidase mutein, wherein, in the region between the amino acids 430 and 550, at least one amino acid of the natural sequence is changed to another amino acid and the enzymatic activity does not amount to more than 1%, referred to the native enzyme. The present invention also provides a process for the production of this mutein. Furthermore, the present invention is concerned with the use of this mutein in the immunological determination of serum proteins by the enzyme immunoassay principle.

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 and materials for preparing specific binding reagents with a multiplicity of relatively noninterfering label moieties are described. By spacing the labels at the surface of a specific reagent with bulking agent, increased sensitivity can be achieved without interference between individual labeling entities.

Abstract: A protein antigen related to the dihydro-pyridine-sensitive calcium channel is expressed at high levels by small cell carcinoma of the lung and neuroblastomas. The antigen serves as a marker which can be exploited for diagnosis and therapy of these tumors. Methods of diagnosis and therapy of small cell carcinoma of the lung and neuroblastomas employing monoclonal antibodies which are specific for the dihydropyridine-sensitive calcium channel are also described.

Abstract: A biological fluid from a first animal species (e.g. human serum) is assayed for an immunogen therein by mixing with the fluid (Ig-minus-Fc) fragments of an immunoglobulin from a second animal species (e.g. rabbit), the immunoglobulin being immunospecific to the immunogen or another component of the mixture whereby the immunogen can be determined. Interference can occur from reaction between first animal species antibodies and the said fragments, and in the method of the invention this interference is avoided or overcome, preferably by also including in the mixture different (Ig-minus-Fc) immunoglobulin fragments from the second animal species which react with said antibodies but not with said immunogen. These different fragments are preferably aggregated. The method of the invention is particularly applicable to particle agglutination assays.

Abstract: The present invention provides a process for the determination of an antibody by incubation with three different reagents R.sub.1, R.sub.2 and R.sub.3, of which R.sub.1 and R.sub.3 are present in liquid phase and are bindable with the antibody, R.sub.2 is present bound to a solid phase and is bindable with R.sub.1 and R.sub.3 carries a label, separation of the solid phase from the liquid phase and measurement of the label in the solid phase, wherein as R.sub.1 there is used a conjugate of a substance specifically recognized by the antibody to be determined and a reaction component of a specific binding system, as R.sub.3 there is used a conjugate of a substance specifically recognized by the antibody to be determined and a label and as R.sub.2 there is used the other binding component of the specific binding system.The present invention also provides a composition for the determination of an antibody, wherein it contains two different soluble reagents R.sub.1 and R.sub.

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 method and apparatus for conducting specific binding pair assays, such as immunoassays, is described. A porous membrane capable of non-bibulous lateral flow is used as assay substrate; a member of the binding pair is affixed in an indicator zone defined in the substrate. The sample is applied at a position distant from the indicator zone and permitted to flow laterally through the zone; any analyte in the sample is complexed by the affixed specific binding member, and detected. A novel method of detection employs entrapment of observable particle in the complex. Blood is a particularly preferred sample as the red blood cells can be used as the observable particles for detection of the complex.

Abstract: An immunochemical assay to determine the presence or concentration of antigen or antibodies in a fluid, comprising: (a) forming a ternary complex of a first labelled antibody or antigen, a second labelled antibody or antigen, and the antigen or antibody to be determined; and (b) detecting a signal produced in the presence of at least one substrate, by an interaction between said first label and said second label, enhanced by their proximity to each other bound to the antigenic substance.

Abstract: A fluorescence-labeled Fab' is produced by causing a fluorescent substance to react with a Fab', dialyzing the resultant reaction solution, allowing the dialyzate to stand at rest thereby effecting reversion of unconjugated Fab' into F(ab').sub.2 and giving rise to a reaction solution containing a fluorescence-labeled Fab' and F(ab').sub.2 and collecting the fluorescence-labeled Fab' from the reaction solution.

Abstract: A kit for compounding radiolabeled monoclonal antibodies or antibody fragments for in vivo cancer diagnosis and therapy, which provides reagents for: (1) the selection of monoclonal antibodies or antibody fragments which are specific to a tumor specimen; (2) compounding the selected antibodies with a radionuclide material; and (3) quality control testing of the resulting compound. In the method of the invention, multiple aliquots of tumor biopsy material are fixed onto separate test areas of an apparatus which permits reaction with a panel of various monoclonal antibodies or antibody fragments known to react with tumor associated antigens. If one or more of the antibodies or antibody fragments bind to the tumor specimen, the reagents and antibodies or antibody fragments contained in the kit are combined with an appropriate, commercially available radionuclide.

Abstract: A novel method for preparing soluble antibody fragment compositions having superior characteristics for targeted delivery when administered in vivo are disclosed. The antibody fragment compositions are characterized by substantially the same immunospecificity as the unconjugated antibody and aqueous solubility such that they are suitable for in vivo administration. Therapeutic and diagnostic methods utilizing the antibody fragment compositions are also disclosed.

Abstract: The present invention is concerned with novel monoclonal antibodies which bind to Interleukin-1.beta. and do not bind to Interleukin-1.beta.. The antibodies bind to Interleukin-1.beta. and block receptor binding and biological activity. The antibodies find use in, for example, diagnostic methods such as an assay for the detection of Interleukin-1.beta..

Abstract: The present invention provides a process for the determination of an antibody in human body fluids according to the immunoassay principle in which a sample containing the antibody to be determined is incubated with at least two different receptors R.sub.1 and R.sub.2, of which one receptor R.sub.1 carries an antigenic determinant specific for the antibody to be determined and one receptor R.sub.2 carries a label to form bound and unbound label, the part which contains the bound label is separated from the part which contains the unbound label and the label is measured in one of the two parts, wherein, for the control, instead of the sample, there is used a standard solution which contains a conjugate of a bindable non-human antibody or a Fab or F(ab').sub.2 fragment thereof which non-human component binds with a receptor R.sub.s which also binds to the antibody to be determined, and a human immunoglobulin or the Fc part thereof.

Abstract: A new marker for colorectal carcinoma has been discovered which is a glycoprotein having a molecular weight of approximately 160,000 daltons. Assay methods which can identify this marker are useful indetecting, diagnosing, and monitoring colorectal carcinoma, and in particular, carcinoma of the undifferentiated variety which heretofor were not readily detectible. For example, an assay which utilizes an antibody reacting to this glycoprotein marker is useful in a screening method for the detection and monitoring of colorectal carcinoma cells. Such an antibody can be included as part of a kit for screening a patient for colorectal carcinoma.

Abstract: A method for calibrating a flow cytometer or fluorescence microscope in terms of number of binding antibodies as a function of fluorescence intensity value measured on the flow cytometer or fluorescence microscope, and subsequent measuring of a sample to which the antibodies are bindable. Also disclosed is a microbead calibration kit for carrying out the calibration method of the invention. The disclosed calibration methodology provides a direct relationship between instrument response and numbers of binding antibodies, independent of the fluorochrome employed to label the samples being measured. The method has utility in monitoring the status of an antigenic cellular condition in which the number of antibodies binding to successively obtained cellular samples is determined, to establish the progressionary character of the antigenic cellular condition, in a host from which the cellular samples are taken.

Abstract: Disclosed is a glycoprotein, carcinoma orosomucoid-related antigen, (CORA), which has a binding affinity for carcinoembryonic antigen (CEA). This glycoprotein is a marker for carcinoma, and can be characteried by having a molecular weight of about 46,000-50,000 daltons, an isoelectric point of about 3.0-3.5, a carbohydrate content of about 25-35% by weight, reactivity with antisera raised thereto, and substantially no reactivity with antisera raised to nonspecific cross-reacting antigen (NCA) or to CEA. Also disclosed are a hybridoma which produces a monoclonal antibody to CORA, the monoclonal antibody to CORA, and a device, kit, and method for detecting and monitoring carcinoma.

Abstract: Monoclonal antibodies to angiotensin II and the continuous hybrid monoclonal cell lines for their production are provided. These antibodies are useful in the diagnosis and treatment of angiotensin II-induced hypertension.

Abstract: A method of selectively suppressing the immune system and conferring immunotolerance against a specific antigen by interferring with the L3T4 differentiation antigens on helper T cells is described. Simultaneous administration of a binding moiety specific for the L3T4-equivalent in the subject species and a specific antigen or administration of the antigen subsequent to the binding moiety for L3T4-equivalent within the time required for T-cell recovery results in a diminished ability of the subject to respond immunologically to the antigen, whether or not the subject has been exposed previously to the antigen.

Abstract: A monoclonal antibody is disclosed capable of specifically reacting with the human mesothelial cell but not with other normal cells and human tumor cells, and therefore applicable in diagnosis of cancers.

Abstract: This invention relates to apparatus useful in determining a component or components of a test sample, as well as methods using these apparatus. Of particular interest are apparatus and methods which involve formation and determination of quarternary complexes.

Abstract: Antigens, immunogens, inocula, antibodies, receptors, diagnostic methods and systems relating to tuberculosis mycobacteria are disclosed. Each of the compounds, compositions, methods or systems contains about 40 residues, or an antibody containing site that immunoreacts with such a polypeptide. The polypeptide includes the thirteen or fourteen amino acid reside sequence (AlaLysValAsnIleLysProLeuGluAspLysIleCys) or (CysAlaLysValAsnIleLysproLeuGluAspLysIleCys). When linked to a carrier and introduced in an effective amount into a mammalian host, the polypeptide is capable of inducing production of antibodies that immunoreact with an antigen to a tuberculous mycobacterium.

Abstract: Fluorescent compounds which are conjugates of a biologically active moiety and an arylidene dye moiety. The compounds have a large Stokes shift and are useful in applications such as biological diagnostic elements.

Abstract: The present invention provides a process for the quantitative determination of a polyvalent antigen by incubation with three different receptors of which the first (R1) and the third (R3) are present in liquid phase and are bindable with the antigen, the second receptor (R2) is present in solid phase and is bindable with receptor (R1), and receptor (R3) carries a label and does not cross-react with (R1) and (R2), separation of the solid phase from the liquid phase and measurement of the label in one of the phases, wherein a first receptor (R1) is used which consists of at least two antibody molecules or antibody molecule fragments bound with one another, at least one of which binds specifically with the antigen to be determined.

Abstract: The present disclosure is directed to methods for the preparation of immunoadsorption matrices having IgG molecules adsorbed thereto in a preferred configuration, i.e., adsorbed to the matrix by their (Fc) rather than F(ab) portions. IgG molecules, are selected such that the F(ab) portion of the IgG fraction adsorbed has a more acidic or basic net isoelectric point or pI range than the F(c) end of the molecule, depending on the characteristics of the adsorption surface. For negatively charged surfaces, IgG molecules having relatively alkaline F(c) portions are selected. For positively charged surfaces, IgG with relatively acidic F(c) portions are selected. Additional selection criteria include pI fractionation to provide fractions having well defined pI characteristics as defined by "non-overlap" or "pI range" of F(c) and F(ab) portions pI's. Methods disclosed are particularly well suited to the preparation of colloidal gold immunostains.

Abstract: For the determination of a reaction partner of an immunological reaction according to the principle of immunoassay, the reaction partner to be determined is brought into contact with a marked specific receptor R.sub.1 and at least 1 unmarked receptor R.sub.2, one of the unmarked receptors R.sub.2 being bonded on a solid phase by a binding-capable substance R.sub.3. In order to determine the sample blank value, the unmarked receptor R.sub.2, which is bonded by the receptor fixed on the solid phase, is then replaced by another unmarked receptor R'.sub.2 which does not react with the reaction partner of R.sub.2 to be determined.

Abstract: Methods of preparing glucitollysinehemoglobin from a sample of glucohemoglobin containing stable and labile glucohemoglobins and for assaying for the presence of stable glucohemoglobin are disclosed, as is a diagnostic assay system useful for carrying out the methods.

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: F(ab) fragments are isolated from an antibody containing source by contacting the antibody containing source with a papain-polyacrylamide matrix to produce F(ab) and F(c) fragments which are then passed through an antigen-polyacrylamide gel capable of attracting the F(ab) fragments. F(ab).sub.2 fragments are obtained by contacting the antibody containing source with a pepsin-polyacrylamide matrix to produce F(ab).sub.2 and F(c) fragments which are then passed through an antigen-polyacrylamide gel capable of attracting the F(ab).sub.2 fragments. IgG antibodies are obtained by passing an antibody containing source through an antigen-polyacrylamide gel. These processes can be used to purifiy a wide variety of antibodies which can be used as therapeutic agents and as diagnostic agents. Antivenins produced by these processes have substantially reduced foreign protein levels and hence are less likely to produce immunogenic reactions.

Abstract: Methods are provided for detecting and determining the amount in a sample of an antigenic determinant from an antigen receptor derived and released from a T cell or NK cell. Methods are also provided for detecting and determining the amount in a sample of an antigenic determinant from a complex of at least a portion of an antigen receptor derived from and released from a T cell or NK cell and a protein complex. These methods form the bases for methods of diagnosing and monitoring in a subject a disease characterized by the presence or an amount different from a normal subject of one of these antigenic determinants in a body fluid. A soluble antigen receptor or complex thereof derived from a T cell or a NK cell but free of such T cell or NK cell is also provided.

Abstract: This invention teaches a process for preparing a conjugate useful in enzyme immunoassays, and the conjugate produced by the process. The process involves oxidizing an enzyme containing a carbohydrate portion, such as peroxidase, with periodic acid or an alkali metal salt thereof in an aqueous medium followed by reduction with sodium borohydride. The oxidation and reduction step may be carried out either before or after the enzyme is coupled to the immunologically effective component of the conjugate.

Abstract: Human-nonhuman heterohybridomas capable of expressing IgM type antibodies can be screened to select hybridomas expressing IgM antibodies comprising human J chain components. Method comprises contacting separate samples of IgM antibodies (or IgM J chain components) from a given cell line with anti-human J chain antibodies and anti-non-human J chain antibodies to determine which antibody complexes with the J chain component of the samples, thereby identifying and permitting the early selection of a heterohybridoma expressing IgM having a human J chain component.

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: Methods and reagents for attaching radionuclide metal ions to antibody fragments are disclosed. A coupling agent is employed which contains a maleimidyl group linked, through a divalent organic moiety, to a group capable of forming a chelate complex with the radionuclide metal ion. Antibody fragments labeled with radionuclide metal ions by the disclosed procedure are useful for in vivo diagnostic or therapeutic applications.

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: A method of detecting the presence and/or amount (concentration) of an analyte in a sample is provided by forming a reaction medium containing (1) a sample; (2) a plurality of particles having a binding pair member bound to their surfaces; and (3) a monovalent complementary partner to the binding pair member to which is bound an analyte mimic or analyte binding partner; and detecting the presence or amount of agglutination of the particles in the reaction medium. In some cases a polyvalent receptor capable of binding to the analyte (and to the analyte mimic, if present) is also present in the reaction medium.

Abstract: A method for immunological assay of IgM antibodies against at least one said antigen in a liquid sample containing at least IgM and IgG antibodies, such as a biological fluid, comprising reaction of said liquid sample and of antibodies against IgG, and addition to the so obtained reaction product of the said antigen bound to finely divided particles and of a free said antigen, the amount of IgM being inversely proportional to the amount of unagglutinated finely divided particles.

Abstract: Process for the production of an immune-reactive, porous carrier material for heterogeneous immunological analysis by application to a carrier material of a solution of a receptor and of a component precipitating this immunologically, incubation of the carrier material impregnated with these solutions for the immune precipitation, optional washing and subsequent drying of the impregnated carrier material, wherein the concentrations of the receptor and of the component are so chosen that, in the case of the impregnation, their molar ratio is greater than the ratio defined by the Heidelberger maximum. Also a carrier material for heterogeneous, immunological analysis, wherein it contains a receptor and an immunologically precipitating component in a molar ratio which is greater than the ratio defined by the Heidelbeger maximum.