Abstract: Hepatitis GB Virus (HGBV) synthetic peptides useful for a variety of diagnostic and therapeutic applications, kits for using the HGBV nucleic acid or amino acid sequences and antibodies which specifically bind to HGBV. Also provided are methods for producing antibodies, polyclonal or monoclonal, from the HGBV peptides.

Abstract: Human P450 IID6 cytochrome-derived peptide fragments, anti peptide anti fragment antibodies and applications thereof in the diagnosis of autoimmune hepatitis and more especially in the differential diagnosis between autoimmune hepatitis and other chronic viral forms of hepatitis, such as hepatitis C or B. Said human P450 cytochrome peptide fragment contains at least one P450 IID6 cytochrome immunodominant epitope and consists of an amino acid sequence comprising from 3 to 70 amino acids. Said peptide binds specifically with anti-LKM auto-anitbodies produced in autoimmune hepatitis.

Abstract: Monoclonal antibodies are described which specifically bind to Hepatitis E Virus (HEV), and more particularly to HEV orf-2 antigen. Also provided are hybridoma cell lines which secrete these monoclonal antibodies, methods for using these monoclonal antibodies, and assay kits which contain these monoclonal antibodies.

Abstract: The invention concerns a process for the production of hapten-labelled peptides which is characterized in that (a) a peptide with the desired amino acid sequence is synthesized on a solid phase from amino acid derivatives whose reactive side groups are blocked by protecting groups wherein the protecting groups on primary amino side groups are selected in such a way that, if desired, they can be selectively cleaved off, (b) protecting groups are cleaved to form at least one free primary amino group, (c) a hapten-active ester derivative is coupled to the at least one free primary amino group of the peptide and (d) if desired protecting groups that still remain are cleaved off, the hapten being selected from the group comprising sterols, bile acids, sexual hormones, corticoids, cardenolides, cardenolide-glycosides, bufadienolides, steroid-sapogenines and steroid alkaloids.

Abstract: A solid phase method of detection or assay of the presence or amount in a serum or plasma sample of a target antibody specific to a cell surface antigen. The sample is contacted with an immobilised preparation of cells bearing the antigen and antibody bound thereto is detected or assayed by means of an indicator comprising a binding partner for the antibody bound to labelled latex particles.

Abstract: An aqueous composition suitable for use when performing immunological procedures. The composition includes at least one biological buffer, dithiothreitol (alternatively referred to herein as "DTT"), and ethylene glycol. The composition can also include at least one biological detergent, at least one source of positive and negative counterions, e.g., salt, and at least one viscosity modifier, e.g., sugar. The buffer also can include at least one preservative, such as sodium azide. The pH of the composition preferably ranges from about 6.4 to 7.2. A kit containing the composition is also disclosed.

Abstract: Monoclonal antibodies which specifically bind to either Hepatitis C Virus C-100 protein, Hepatitis C Virus 33C protein and Hepatitis C Virus CORE protein, and hybridomas which produce these monoclonal antibodies. Also provided are methods for using these monoclonal antibodies and assay kits containing these antibodies.

Abstract: A diagnostic reagent for hepatitis C, which detects an antibody induced by infection of hepatitis C virus, and comprises the second envelope protein or first non-structural protein which is encoded by the gene of hepatitis C virus and has a sugar chain. This invention also provide a method for detecting an anti-hepatitis C virus antibody. The use of the diagnostic reagent for hepatitis C according to the present invention makes highly sensitive diagnosis of hepatitis C possible.

Abstract: A diagnostic reagent for hepatitis C, which detects an antibody induced by infection of hepatitis C virus, comprising the second envelope protein or first non-structural protein which is encoded by the gene of hepatitis C virus and has a sugar chain. This invention also provides a method for detecting an anti-hepatitis C virus antibody. The use of the diagnostic reagent for hepatitis C according to the present invention makes highly sensitive diagnosis of hepatitis C possible.

Abstract: The present invention relates to novel linear and branched peptides specific for the diagnosis and prevention of hepatitis C virus (HCV) infection. More particularly, the present invention is directed to linear and branched synthetic peptides containing at least one antigenic site which is effective for detecting HCV-associated antibodies in patients using immunoassay techniques. In some cases, these peptides are also library peptides with degenerate amino acid positions. Preferred mixtures for detection of HCV antibodies are provided as well as a novel spliced peptide useful for blocking the non-specific reactivity of certain NS-3 conformational epitopes.

Abstract: The present invention provides antigenic peptides and polypeptides of hepatitis E virus. Also provided are mixtures of conjugated and unconjugated peptides of the present invention. Methods of detecting hepatitis E viral infection in a subject using the peptides and peptide mixtures of the present invention are also contemplated.

Abstract: The use of an antigen (or antibody) previously modified with a hapten makes the immunoassay of a trace component (analyte) on the basis of a change of turbidity or scattered light intensity caused by antigen-antibody reaction rapid and easy with high accuracy and high reproduction.

Abstract: Human antibodies that bind to woodchuck hepatitis virus core antigen are elevated in chronic hepatitis B patients in comparison to acute hepatitis B patients. Immunoassays for detection of the level of anti-WHV core antigen antibodies is used to distinguish chronic from acute hepatitis B patients.

Abstract: Combinations of HCV antigens that have a broader range of immunological reactivity than any single HCV antigen. The combinations consist of an antigen from the C domain of the HCV polyprotein, and at least one additional HCV antigen from either the NS3 domain, the NS4 domain, the S domain, or the NS5 domain, and are in the form of a fusion protein, a simple physical mixture, or the individual antigens commonly bound to a solid matrix.

Abstract: A family of cDNA sequences derived from hepatitis C virus (HCV) are provided. These sequences encode antigens which react immunologically with antibodies present in individuals with non-A non-B hepatitis (NANBH), but which are absent from individuals infected with hepatitis A virus, or hepatitis B virus, and also are absent in control individuals. The HCV cDNA sequences lack substantial homology to the sequences of hepatitis delta virus (HDV) and HBV. A comparison of the sequences of amino acids encoded in the HCV cDNA with the sequences of Flaviviruses indicates that HCV may be related to the Flaviviruses.The HCV cDNA sequences and the polypeptides encoded therein are useful as reagents for the detection and therapy of HCV. The reagents provided in the invention are also useful for the isolation of NANBH agent(s), for the propagation of these agents in tissue culture, and for the screening of antiviral agents for HCV.

Abstract: Combinations of HCV antigens that have a broader range of immunological reactivity than any single HCV antigen. The combinations consist of an antigen from the C domain of the HCV polyprotein, and at least one additional HCV antigen from either the NS3 domain, the NS4 domain, the S domain, or the NS5 domain, and are in the form of a fusion protein, a simple physical mixture, or the individual antigens commonly bound to a solid matrix.

Abstract: The invention is an improved immunoassay and method for detection of antibody to hepatitis B core antigen (anti-HBc). The improved assay comprises the addition of a reducing agent to decrease the number of false positive reactions in the assay.

Abstract: Antibodies are recovered and isolated from the sera of a number "n" of patients each of which have or have had the same given disease so that each of the "n" patients has, within a large number of different antibodies, some antibodies uniquely associated with the same disease of interest. The antibodies of a first patient are bound to a support surface. To carry out initial screening libraries of molecules are brought into contact with the bound antibodies of the first patient under conditions where binding will occur. Secondary screening is then carried out by extracting and labeling the antibodies of a second patient and using the labeled antibodies to probe the molecules (peptides) isolated in the initial screening. Many of the non-disease specific antibodies (of the second patient) will not bind to the molecules (peptides) of the isolated bacteriophage which bound to the antibodies of the first patient.

Abstract: Monoclonal antibodies are described which specifically bind to Hepatitis E Virus (HEV), and more particularly to HEV orf-3 antigen. Also provided are hybridoma cell lines which secrete these monoclonal antibodies, methods for using these monoclonal antibodies, and assay kits which contain these monoclonal antibodies.

Abstract: The invention relates to a DNA molecule, a polypeptide expressed by the molecule, their use in diagnosis and their methods of production. More particularly, the invention relates to a diagnostic DNA molecule, a diagnostic protein, diagnostic antibodies and protective antigen and antibodies for hepatitis C virus (HCV). The DNA molecule disclosed herein is characterized by the DNA molecule derived from the genome of an HCV, and codes for a polypeptide having the antigenicity of an HCV core antigen protein. The polypeptide may be used in the detection of HCV.

Abstract: A method for detecting the presence of antibody to FIV in a biological sample. The method includes the steps of providing a first antigen having a first epitope recognized by the antibody, the first antigen being detectable; contacting the first antigen with the sample under conditions under which the antibody can bind to the first antigen to form an immune complex; and detecting the immune complex. An ELISA test for FIV, using purified FIV antigen, is also described.

Abstract: An aqueous composition suitable for use when performing immunological procedures. The composition includes at least one biological buffer, dithiothreitol (alternatively referred to herein as "DTT"), and ethylene glycol. The composition can also include at least one biological detergent, at least one source of positive and negative counterions, e.g., salt, and at least one viscosity modifier, e.g., sugar. The buffer also can include at least one preservative, such as sodium azide. The pH of the composition preferably ranges from about 6.4 to 7.2. A kit containing the composition is also disclosed.

Abstract: Mammalian expression systems for the production of HCV E1-E2 fusion proteins. Such expression systems provide high yields of HCV proteins extracelluarly, and enable the development of diagnostic, vaccine and therapeutic reagents which contain glycosylated structural antigens and also allow for the isolation of the HCV etiological agent.

Abstract: A nucleic acid encoding a mosaic hepatitis E virus (HEV) polypeptide, consisting of the nucleotide sequence defined in the Sequence Listing as SEQ ID NO:1 is provided. A nucleic acid encoding epitopes 5, 6, 22, 23, 28 and 29 of hepatitis E virus and substantially lacking the nucleic acids intervening the epitope-coding nucleic acids in the native hepatitis E virus is also provided. An isolated nucleic acid that selectively hybridizes under stringent conditions with the mosaic polypeptide-encoding nucleic acid and has at least 70% sequence identity with SEQ ID NO:1 is provided. Also provided are such nucleic acids having at least 80%, 90% and 95% sequence identity. A polypeptide consisting essentially of the amino acid sequence defined in the Sequence Listing as SEQ ID NO:2 is provided.

Abstract: Cloning and expression vectors for hepatitis B HBxAg, cell cultures containing those vectors, polypeptides related to HBxAg, and diagnostic systems and methods for assaying for the presence of HBxAg and anti-HBxAg antibodies in a body sample are disclosed.

Abstract: Isolated complexes (which include basement membrane components), antibodies to such complexes or polypeptide constituents thereof, and methods for detecting such complexes or constituents are disclosed. Detection of such complexes in a biological sample by immunological and non-immunological methods allows the diagnosis of a variety of diseases, including cancers, collagen degenerative diseases, and hepatitis. Suitable biological samples include urine, cervical secretions, bronchial aspirates, sputum, saliva, feces, serum, synovial fluid, and cerebrospinal fluid.

Abstract: Methods and materials for producing hepatitis virus HBe antigenic proteins useful in immunoassays without the necessity of maintaining these proteins in denaturing environments are disclosed. Assay methods and materials utilizing these HBe proteins are also provided.

Abstract: Antibodies are recovered and isolated from the sera of a number "n" of patients each of which have or have had the same given disease so that each of the "n" patients has, within a large number of different antibodies, some antibodies uniquely associated with the same disease of interest. The antibodies of a first patient are bound to a support surface. To carry out initial screening libraries of molecules are brought into contact with the bound antibodies of the first patient under conditions where binding will occur. Secondary screening is then carried out by extracting and labeling the antibodies of a second patient and using the labeled antibodies to probe the molecules (peptides) isolated in the initial screening. Many of the non-disease specific antibodies (of the second patient) will not bind to the molecules (peptides) of the isolated bacteriophage which bound to the antibodies of the first patient.

Abstract: The invention concerns a virus solution which contains a detergent having the general formula I and serves to stabilize the virus solution as well as its production and use in heterogeneous immunoassays for the detection of antibodies against viruses.

Abstract: Reagents and methods for the detection of a marker which is associated with severe forms of hepatitis delta virus infection are described. A vaccine comprising immunogenically active HDAg' polypeptides is also described.

Abstract: A novel cDNA clone, 20E, has been isolated and characterized as encoding a previously unknown polypeptide antigen recognized by antibodies in the serum of certain patients with non-A non-B hepatitis (NANBH). The nucleic acid sequence is not represented in the genome of the Hepatitis C Virus (HCV). Neither is the nucleic acid sequence represented in the human genome. The data suggest that the RNA sequence corresponding to clone 20E is contained within the genome of an external infective agent other than HCV, and therefore may represent an additional etiologic agent or contributing factor to the development of NANBH in human patients. The 20E nucleic acid and corresponding polypeptide and respective variants thereof will be useful in a variety of procedures directed at prevention and diagnosis of NANBH.

Abstract: The present invention relates to a method for the detection in body fluids of antibodies to hepatitis C virus (HCV), also known as a non-A non-B hepatitis (NANBH) virus and to the diagnosis of NANBH by the use of a composition of synthetic peptides. Each of these peptides has an amino acid sequence corresponding to immunodominant regions of a fusion protein and a non-structural polypeptide of HCV, SOD/HCV C100 and a postulated HCV structural (core) protein. More specifically, the present invention is directed to the use of a group of synthetic peptides in a prescribed sequence or their analogues for the detection of antibodies to HCV in body fluids. The detection method includes an enzyme-linked immunosorbent assay (ELISA), and other forms of immunoassay procedures.

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

Abstract: This invention relates to a novel reagent and a method of using the reagent in an immunoassay to detect antigens, particularly antigens immunocomplexed with their corresponding or cross-reacting antibodies. In particular, this reagent and method increase the detection of human immunodeficiency virus HIV-1 p24 core antigen.

Abstract: A method for preparation in a large quantity of human serum albumin-sensitized sheep erythrocytes is described. The sensitized cells are useful for detecting Hepatitis B virus pre-S.sub.2 antigen. The method uses human serum albumin sensitized glutaraldehyde-fixed, sheep erythrocytes in the presence of chromium chloride.

Abstract: Monoclonal antibodies which specifically bind to Hepatitis C Virus (HCV) E2/NS1 antigen. Also provided are hybridoma cell lines which secrete these monoclonal antibodies, methods for using these monoclonal antibodies, and assay kits for assays which contain these monoclonal antibodies.

Abstract: The antigenic peptide represented by the following amino acid sequence (SEQ ID NO: 1) ##STR1## and a method of the detection of anti-HCV antibodies wherein the above peptide is brought into contact with a sample under the conditions that the peptide is bound to anti-HCV antibodies present in the sample to form an immunological complex and the formation of the immunological complex is measured to confirm the existence of the anti HCV antibodies in the sample. The method is highly specific and sensitive to anti-HCV antibodies.

Abstract: The enzyme alanine aminotransferase (ALT) is colorimetrically determined as the hydrogen peroxide obtained in the pyruvate hydrolysis reaction catalysed by the enzyme pyruvate oxidase which develops a colour read at 550 nm making use of a reagent composition buffered at pH comprised within 7.0 and 7.5 containing L-alanine, ketoglutaric acid, a source of inorganic phosphorous, the enzyme pyruvate oxidase, a system for revealing the hydrogen peroxide and optionally one or more co-factors which interact in the enzymatic reaction catalysed by the enzyme pyruvate oxidase. It is moreover described a method for the determination of the enzyme alanine aminotransferase making use of said reagent composition and of the surface antigen of the hepatitis B virus (HBsAg), by enzyme-immune assay, in the same serum specimen and in the same well of a microtitration plate.

Abstract: This invention relates to improved "sandwich" immunoassays for antibodies in body fluids of the type where antigen specific for the antibody to be detected is disposed on a solid support and binds antibody from the body fluid, from which the antibody bound to the solid support is detected by a labeled antigen to the antibody to be detected. The improvement comprises using antigens from heterologous cell sources.

Abstract: The new hybridoma cell lines RF-HBs-1, RF-HBs-2 and RF-HBs-4 each secrete a nonoclonal antibody to hepatitis B surface antigen. The production of the antibodies may be carried out in vitro by culturing one of the cell lines or in vivo by establishing one of the cell lines as an ascites tumour in a mouse and isolating antibodies from the ascites fluid or from the serum. The antibodies have therapeutic, preventative and diagnostic uses in respect of hepatitis B virus infections and can be used to purify hepatitis B surface antigen. The relative specificities of the three monoclonal antibodies make them particularly useful in radiometric assay techniques employing specific combinations of the antibodies in solid phase.

Abstract: Antibodies that immunoreact with the hepatitis B virus HBxAg antigen and with HBxAg polypeptides, as well as diagnostic system and methods for assaying for the presence of HBxAg and anti-HBxAg antibodies in a body sample are disclosed.

Abstract: Non-A, Non-B Hepatitis Virus Genome RNA is disclosed along with cDNA and Virus Antigen Protein.

Abstract: The invention relates to assays utilizing microparticle separation. More particularly, the invention relates to microparticle assays used for confirmation of ligands in a biological sample.

Abstract: The present invention is directed to a method for detecting hepatic diseases which are associated with fibrosis by determining the level of human prolyl hydroxylase in a serum sample which comprises:(a) contacting a serum sample of a patient suspected of having said hepatic disease associated with fibrosis with a monoclonal antibody specific to the .beta.-subunit of human prolyl hydroxylase to form an antigen antibody complex bound on a solid support;(b) contacting said antigen antibody complex bound on said solid support with an enzyme-labeled monoclonal or enzyme-labeled polyclonal antibody specific to human prolyl hydroxylase to form an antibody antigen enzyme-labeled antibody complex; and(c) measuring the amount of enzyme activity of said bound antibody antigen enzyme-labeled antibody complex to determine the level of human prolyl hydroxylase present in said serum sample.

Abstract: A method for determining human prolyl hydroxylase by radioimmunoassay according to the sandwich method wherein a monoclonal antibody to human prolyl hydroxylase and polyclonal antibody to human prolyl hydroxylase are used, characterized in that a monoclonal antibody to human prolyl hydroxylase is used as at least one of the antibodies which are to be coated on a solid support and to be labeled with a radioactive element. This method is simple and operable with small amounts of samples and gives exact results. Thus, this method is useful for the diagnosis of hepatic diseases. A monoclonal antibody specific to the .beta.-subunit of human prolyl hydroxylase is used to test for the human prolyl hydroxylase.

Abstract: A solid phase immuno-assay system for assaying at least one analyte, in the form of a solid support having a plurality of receptors bound thereto. At least two of the receptors conjugate with the same analyte.A reaction container comprising a plurality of longitudinally arranged individual compartments, and a longitudinally extending single compartment.A card for assaying a plurality of samples for the same analyte, having a plurality of receptors for the analyte at different locations on the card.A method of performing an assay for the same analyte in more than one sample, by providing a receptor for the analyte at more than a single location on a solid substrate; exposing each of the receptors to different samples; and developing each of the receptor locations to indicate the presence of the analyte in each of the samples.

Abstract: Anti-hepatitis B virus surface protein (anti-HBS) antibody is adsorbed onto the surface of a substratum. Hepatitis B virus PreS2+S (PreS2+S) protein is then adsorbed onto the same surface through the interaction of the anti-HBS antibody with the "S" portion of the PreS2+S protein. The coated surface is then incubated concomitantly with the test sample and a radiolabelled antibody specific for the "PreS2" portion of the PreS2+S protein.

Abstract: An assay to detect the presence of live hepatitis viruses in vitro. Bone marrow cells of leukemic cell line cells are exposed to a body fluid or biological preparation to be tested and the cells are placed in suspension. When using bone marrow cells, growth factors to the bone marrow stem cells are added. It has been determined that presence of a live hepatitis virus suppresses the growth of colonies of the stem cells. Therefore, if the number of colonies growing in the mixture are less than that number present in a culture of cells exposed to a sample that has been determined to contain no live virus, live hepatitis virus is present in the sample tested. The assay is particularly useful to determine the presence of live hepatitis B virus in a vaccine.

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: The performance of double receptor, specific binding assays is improved by use of a receptor complex having the structureA.sub.BL (BL).sub.n A.sub.1wherein BL is a binding ligand, A.sub.BL is a receptor specific for binding ligand, A.sub.1 is a receptor, BL is covalently bonded to A.sub.1 and A.sub.BL is reversibly bonded to BL. Generally A.sub.BL is absorbed onto an insoluble surface and A.sub.1 is an antibody to the substance being assayed. The complex has particular utility in coated tube and rechargeable radioimmunoassay systems.