Abstract: The present invention relates to a treatment for myocardial infarction and blood clots within a patient, and more specifically to a therapy which enhances clot lysis comprising administering to a patient an antibody directed to &agr;2-antiplasmin crosslinked to fibrin (&agr;2AP-FX) which does not inhibit plasma &agr;2-antiplasmin (&agr;2AP). The invention also relates to a treatment for enhancing clot lysis comprising administering an antibody directed toward &agr;2-antiplasmin crosslinked to fibrin which does not inhibit plasma &agr;2AP together with a thrombolytic agent.

Abstract: A method is provided for preparing preservative-free allergen test solutions in a prepared sterile environment. A sterile environment is prepared by utilizing a disinfectant wipe and a sterile barrier field. An antigen is added to a diluent to form a solution of the antigen by dispersing or suspending the antigen in the diluent. The solution is subjected to triple filtration under specific and sequential conditions to provide consistent and preservative-free allergen test solutions. Shelf life is extended by storing the solution at a temperature below 5° F. or by lyophilizing the allergen test solution.

Abstract: Methods for assessing immunocompetence, cellular or humoral immunity, antigen exposure, or allergic conditions in an individual by accelerating diagnostic particles into a target skin site in the individual are provided.

Abstract: A method and also a device is proposed for identification of a substance, preferably comprising biochemical molecules. In a first step a probe and said substance will be brought into contact, afterwards in a second step the probe and said substance will be withdrawn from each other, while measuring the value of at least one physical parameter characterizing the interaction between said probe and said substance and comparing said measured value with a reference value for identification.

Abstract: In a competitive receptor binding assay for detecting TSH-receptor auto-antibodies in a biological sample, the sample is reacted in a reaction mixture which contains (i) a TSH-receptor or TSH-receptor preparation; (ii) a primary competitor, for example labelled TSH; and (iii) an agent for separating a complex composed of the TSH-receptor and the elements bound thereto of the reaction mixture from the liquid phase. According to the invention, the reaction is carried out in the presence of at least one monoclonal or polyclonal antibody specific against a partial peptide sequence of the TSH eceptor. This specific antibody is used to immobilize a complex of TSH-receptor and primary competitor and/or as secondary competitor for another part of the TSH-receptor auto-antibodies expected in a sample. The primary or secondary competitors are or can be selectively labelled.

Abstract: The present invention is directed to a panel of monoclonal antibodies (Mabs) specific for murine prion protein PrPc. These Mabs can be applied to immunoblotting, cell surface immunofluorescent staining and immunohistochemistry at light and electron microscopy. Additionally, these Mabs recognize both the normal (PrPc) and protease-resistant (PrPres) isoforms of PrP. Some Mabs are species restricted, while others react with PrP from a broad range of mammals including mice, humans, monkeys, cows, sheep, squirrels and hamsters. Moreover, several of the Mabs selectively recognize different PrP glycoforms as well as the metabolic fragments of PrPc. These newly generated PrPc antibodies are useful for exploring the biology of PrPc and to establish the diagnosis of prion diseases in both humans and animals.

Abstract: This invention discloses a method and composition for detecting the presence of class specific antibodies reactive with analytes such as bacteria, allergens, autoimmune antigens, viral proteins, and carbohydrates by lateral flow techniques. In one embodiment of the invention, a test sample obtained from bodily fluids reacts with a gold labeled antigen. The resulting complex travels across the membrane, and along the lateral flow strip. Red colored lines formed in specific locations along the test strip indicate the presence of class specific antibodies in the test specimen. In another embodiment of the invention, the lateral flow assay serves as an immunochromatographic screening test for the detection of allergen-specific IgE antibodies in human serum. Test sample reacts with gold labeled anti-IgE antibody. The resulting complex travels across the membrane where immobilized allergens capture the allergen specific IgE complex.

Abstract: Electrochemiluminescent-labels and enzyme substrates, which preferably are conjugated, are used in immunoassays and electrochemiluminescence is generated catalytically. In conventional electrochemiluminescence immunoassays, an anti-analyte antibody molecule can give rise to typically 6-8 electrochemiluminescence-active ruthenium atoms, while in the present invention, each enzyme-labeled anti-analyte molecule can give rise to thousands of electrochemiluminescence-active ruthenium atoms per second. An exemplary immunoassay is based on a catalytic process employing &bgr;-lactamase-conjugated anti-analytes which enzymatically hydrolyze electrochemiluminescent-labeled substrates, making them strongly electrochemiluminescent. The electrochemiluminescence signal generated by each anti-analyte molecule (i.e., each analyte molecule) is much greater than with the conventional method. Accordingly, greater sensitivity can be gained in the measurement of low concentrations of a given immunoassay analyte.

Abstract: An array bundle is provided for creating multiple arrays for testing. The array bundle is adapted to be cut transversely to form a series of identical arrays of cells. In one embodiment, the array bundle is used in detecting predetermined components from sample mixtures.

Abstract: The subject invention pertains to methods and materials for accurately assessing the presence or absence of analytes of interest in samples, particularly in physiological samples. The subject invention involves utilizing a ligand binding domain (LBD) of a receptor to selectively capture the analyte target specific for that LBD. In one embodiment, the receptor is a protein or polypeptide. The ligand binding domain is allowed to react with a sample and the presence or amount of ligand (i.e., target analyte) bound by the LBD is determined. Suitable analytes include soluble analytes such as hormones, enzymes, lipoproteins, bacterial or viral antigens, immunoglobulines, lymphokines, cytokines, drugs, soluble cancer antigens, and the like. The methods of the present invention can be performed in both liquid-phase and solid-phase.

Abstract: The invention concerns a method for the determination of antigen-specific antibodies of the immunoglobulin M class in the presence of immunoglobulins of the G class and/or rheumatoid factors in body fluids by incubation with at least two different receptors R1 and R2 and optionally additional receptors wherein an essential component of R2 is a binding partner in a polymeric form and interference by IgG antibodies of the same antigen specificity is reduced by binding partners in a monomeric form; a reagent for determining an antigen-specific antibody of the immunoglobulin M class, as well as the use of binding partners in a monomeric form to reduce interference by IgG antibodies in the determination of antigen-specific IgM antibodies.

Abstract: The present invention relates to cells which have improved receptivity to viruses which are capable of infecting them. Receptivity to such viruses is improved by selecting cells from a population which express the receptor(s) that enable a virus to attach to the cell and gain entry into it. Any combination of viruses and host cell lines can be used. In a preferred embodiment, the present invention relates to improving receptivity or infectivity of a cell line which can be infected with an immunodeficiency virus, such as HIV-1.

Abstract: The present invention relates generally to a structure, on the surface of the support material of which structure molecular layers are immobilized so as to be electrically addressable, a method for the electrically addressable immobilization of molecules, a device for carrying out this method, and the use of this structure as a chemo- and/or biosensor, in particular as a multisensor system for chemical, biological, and physical assays, and for applications in the combinatorial synthesis on the boundary surface.

Abstract: A test method for IgA nephropathy involves determining antibody, which recognizes the core peptide of the hinge region in IgA1, in specimens. The method is a rapid and sample test method for IgA nephropathy having less emotional distress for the patients, low risk for peripheral hemorrhage of the kidney and reduced financial burden for the patients.

Abstract: The invention relates to a method for detecting antibodies from body fluids by means of an immune reaction with tissue transglutaminase (tTG), with tTG-containing compounds, the antigenic structures, immunoreactive sequences or analogues thereof. The method may be used in the diagnosis and therapy control of diseases associated with an immune reaction against tTG, tTG-containing compounds, the antigenic structures, immunoreactive sequences or analogues thereof. Therefore, the invention is also directed to the use of tTG and the above-mentioned substances in diagnosis and therapy control, preferably in the diagnosis and therapy control of chronically inflammatory diseases or autoimmune diseases, and more preferably, in the diagnosis and therapy control of sprue or coeliac disease.

Abstract: A C-reactive protein concentration level test and kit for on-site determination of C-reactive protein levels in biological samples is disclosed.

Abstract: Ligand-aminodextran-(phycobiliprotein or tandem dye) conjugates useful for detection of a desired target biological material by providing an enhanced fluorescent signal are described. Also described is a method for a single-measurement quantification of multiple populations of cells based upon the labeling of different pairs of cell populations, each pair containing mutually exclusive cell receptors which are expressed at substantially similar receptor densities with labeled ligands for each receptor. One cell population is labeled with a ligand capable of binding to a first cell surface receptor which ligand is directly conjugated to a fluorescent phycobiliprotein or tandem dye; and a second cell population is labeled with a ligand capable of binding to a second cell surface receptor, which ligand is cross-linked to an aminodextran to a fluorescent phycobiliprotein or tandem dye.

Abstract: The invention relates to a method of evaluating the immunological status of a subject comprising the steps of 1) determining the content of an antibody in a liquid sample from the subject using an immunoassay, wherein the reaction between the antibody of the sample and a ligand in the form of an antigen, an antibody or a hapten, the ligand being directed to the Fab region of the sample antibody, is carried out in the presence of other constituents of the sample to obtain a measurement 1, 2) determining the content of an antibody in the liquid sample using an immunoassay, wherein the reaction between the antibody of the sample and a ligand in the form of an antigen, an antibody or a hapten, the ligand being directed to the Fab region of the sample antibody, is carried out in the absence of other constituents of the sample to obtain a measurement 2, and 3) interrelating measurements 1 and 2 to express the interference and using the interference as a parameter for evaluating the immunological status of the subje

Abstract: This invention features methods and kits for identifying human urine samples for forensic purposes.

Abstract: A method for measuring the end point and for monitoring the real time kinetics of a bioaffinity reaction in biological fluids and suspensions, employing microparticles as bioaffinity binding solid phase, biospecific reagent labelled with a fluorescent label and a fluorescence detection system which is based on two-photon fluorescence excitation, contacting the analyte, the labelled reagent and the solid phase simultaneously, focusing a two-photon exciting laser beam into the reaction suspension and measuring the fluorescence signal emitted by the microparticles from one particle at a time when they randomly float through the focal volume of the laser beam. In this method the signal is monitored kinetically to obtain information about the analyte concentration before the reaction approaches the highest point of the response. Since the growth rate of the signal intensity is directly proportional to the analyte concentration, the analyte concentration can be predicted in the initial phase of the reaction.

Abstract: A homogeneous biospecific assay method for an analyte in solution or in a biological suspension, in which a biospecific reagent competitively binding an analyte and a ligand labeled with a fluorescent molecule, is reacted with and bound to a solid phase, and in which the free labeled ligand is extracted is excited with two-photon excitation by focusing a laser beam suitable for two-photon excitation into the sample volume; and the concentration of the analyte is calculated based on the photon emission contributed by the free labeled ligand.

Abstract: Methods and apparatuses are disclosed for detecting the presence of a test material in a test sample. The test sample is introduced into a test column which has at least two snares. One of the snares has a control capture material for detection of the presence of control. Each of other snares has a capture material specific to a corresponding test material for which detection being sought. The capture material will bind with the corresponding test material to form a bound material. The test column is then washed to remove materials which have not been bound to the capture materials. Finally, the presence of bound materials is detected on each of the snares. The method is useful for detection of a pathogen indicator in a test sample, particularly suitable for detection of DNA and RNA.

Abstract: The use of a peptide reagent for detecting the presence or absence of a primary Epstein-Barr virus infection in a patient by testing for IgM antibodies, recognizing said reagent, in a biological sample from the patient according to a per se known method based on the formation of at least one antigen-antibody complex, is disclosed. The reagent contains a peptide recognized by at least one antibody to a peptide having the sequence of formula (II): Leu Glu Ile Lys Arg Tyr Lys Asn Arg Val Ala Ser Arg Lys Cys Arg Ala Lys Phe Lys Gln. The reagent enables such a primary infection to be detected very early.

Abstract: A method for the detection of substances contained on textile fibers or other natural or synthetic polymers is disclosed. The contained substances are identified with immunochemical methods, where the immunochemical reaction can occur on the fiber or polymer. The method is especially suitable for the determination of substances that can act as allergens.

Abstract: The invention relates to a method for detecting antibodies from body fluids by means of an immune reaction with tissue transglutaminase (tTG), with tTG-containing compounds, the antigenic structures, immunoreactive sequences or analogues thereof. The method may be used in the diagnosis and therapy control of diseases associated with an immune reaction against tTG, tTG-containing compounds, the antigenic structures, immunoreactive sequences or analogues thereof. Therefore, the invention is also directed to the use of tTG and the above-mentioned substances in diagnosis and therapy control, preferably in the diagnosis and therapy control of chronically inflammatory diseases or autoimmune diseases, and more preferably, in the diagnosis and therapy control of sprue or coeliac disease.

Abstract: The invention relates to a method for measuring the level of a preselected analyte in a sample of blood of a human or animal patient by incubating the test sample with an antibody specific to the analyte to form an immunocomplex, which then interacts with the white blood cell fractions and result in the production of oxidants. Oxidants are detected using chemiluminescent reagents. The assay is performed on the sample and in addition includes a measurement of the oxidant production resulting from a maximal stimulatory dose of immunocomplexes, providing a ratio to indicate the level of analyte in the sample. The white blood cell oxidant response may be enhanced by the inclusion of certain agents such as zymosan.

Abstract: A method to produce arrays of compounds for concurrent testing is described. Two formats are described using porous rods or porous sheet materials. In one format, the compounds of the array are immobilized onto porous rod elements. In the second format, the compounds are immobilized as lines on a sheet of porous material. In both cases, a bundle is formed by radial compression of the rods or spiral wrapping of the sheet. A sheath is applied to the bundle, and arrays are cut as slabs. Each synthesis or application step to create an array element is used to fabricate multiple arrays. Relatively high-density arrays can be produced with current printing technologies. The method is particularly suited to mass production of arrays.

Abstract: Method and test kit for assaying in a sample an analyte which is a bloodgroup antigen present on erythrocytes or an antibody binding to such a bloodgroup antigen. To that end, the sample is treated with a reagent containing a binding partner for the analyte, so that a complex of bloodgroup antigen present on erythrocytes and antibody bound thereto is formed if the sample contains analyte. The analyte is a bloodgroup antigen present on erythrocytes, the analyte binding partner is an antibody capable of binding to the bloodgroup antigen and if the analyte is an antibody binding to a bloodgroup antigen, the analyte binding partner is the bloodgroup antigen present on erythrocytes. Erythrocytes, complex or non-complexed, are then separated from non-bound antibodies using a separation medium with a density higher than that of the liquid containing the antibodies but lower than the density of crythrocytes.

Abstract: The invention relates to a novel retrovirus isolated from patients in West Africa that is capable of causing lymphadenopathies and the acquired immune deficiency syndrome (AIDS). This virus, which was originally designated “LAV type II”, “LAV-II”, or “West African AIDS retrovirus”, has been subsequently renamed the human immunodeficiency virus type 2 (HIV-2). Two isolates were obtained, characterized, and designated HIV-2MIR and HIV-2ROD (C.N.C.M. deposit nos. I-502 and I-532, respectively). Radioimmunoprecipitation (RIPA) and Western blot analyses involving patient antisera identified viral proteins with molecular weights of 16 Kd (p16), 26 Kd (p26), 130-140 Kd (gp130-140), and 36 Kd (gp36). The claimed invention is directed toward kits for the detection of HIV-2 antigens comprising polyclonal and monoclonal antisera directed against these proteins.

Abstract: The invention describes quality control devices for assays that measure analytes in cells and tissue samples, and methods of use thereof. In particular, the quality control device comprises a matrix affixed with synthetic controls in different concentrations, or different synthetic controls. The quality control device can be adhered to a microscope slide and processed simultaneously with a tissue sample.

Abstract: Calibration of an assay by converting an analyzer's normal signal response through an arithmetic function prior to performing the curve fit, thereby improving the accuracy of the curve fit in a region of greatest diagnostic interest.

Abstract: The invention provides an IgE and antigen-specific screening assay for use in identifying agents which suppress the IgE mediated immune response to antigen. The assay is performed in vivo in animals which hyper respond to antigen by producing exaggerated levels of IgE. The animals are sensitized to an antigen during a specific window of sensitivity which closes a day after the animal has been treated to produce the IgE hyper responsive phenotype. The screening assay is performed in the animals by treating them with a candidate IgE suppressor agent in conjunction with further immunization made after closure of the window of sensitivity defined by the invention. Positive results (indicating that the candidate agent has IgE suppressive activity) are obtained in the assay through measurement of a decline in antigen-specific IgE in the animal following its treatment with the candidate agent.

Abstract: The present invention is directed to an Assay for high capacity screening of substances interfering with the attachment of human IgE to its high affinity receptor and/or of substances capable of detaching already bound IgE from this receptor and for the differential analysis between autoimmune disorders and classical allergies.

Abstract: A method of determining the concentration of IgG antibodies in the biological fluids of mammals. The assay may be performed in a lateral flow cassette or dipstick format where dehydrated immobilized reagents are spaced along a membrane. A sample of a mammalian biological fluid is exposed first to an IgG complexing agent to yield a conjugate. The conjugate then moves along the membrane and is exposed to a standard mammalian IgG applied to the membrane at a test position. Binding of the IgG is indicated by a color change at the test position on the membrane. A control reagent of dehydrated anti-IgG complexing agent may be applied to the membrane at the control position spaced downstream from the test position. Interaction of the IgG complexing agent with the anti-IgG complexing agent forms a visible line at the control position on the membrane.

Abstract: Methods aiding in the diagnosis of certain immune-mediated, motor-sensory polyneuropathies, both chronic and acute, by assessing the amount of antibodies to heparan sulfate glycosaminoglycan, either acetylated or non-acetylated, in a test sample, are disclosed, as are kits that can be used in the methods.

Abstract: The invention consists of oligonucleotides which inhibit the immunostimulatory activity of ISS-ODN (immunostimulatory sequence oligodeoxynucleotides) as well as methods for their identification and use. The oligonucleotides of the invention are useful in controlling therapeutically intended ISS-ODN adjuvant activity as well as undesired ISS-ODN activity exerted by recombinant expression vectors, such as those used for gene therapy and gene immunization. The oligonucleotides of the invention also have anti-inflammatory activity useful in reducing inflammation in response to infection of a host with ISS-ODN containing microbes, in controlling autoimmune disease and in boosting host Th2 type immune responses to an antigen. The invention also encompasses pharmaceutically useful conjugates of the oligonucleotides of the invention (including conjugate partners such as antigens and antibodies).

Abstract: The present invention relates to monoclonal antibodies that are specific for the protein thymidylate synthase, and hybridomas producing these monoclonal antibodies. The invention further relates to methods of detection and diagnostic kits to test for the presence of thymidylate synthase. The invention also relates to the use of the monoclonal antibodies in determining the presence of colon carcinoma cells.

Abstract: The present invention provides a highly sensitive method of diagnosing inflammatory bowel disease (IBD) in an individual. The method includes the steps of isolating a sample from the individual; determining by non-histological means whether the sample is positive for anti-neutrophil cytoplasmic antibodies (ANCA); determining whether the sample is positive for anti-Saccharomyces cerevisiae immunoglobulin A (ASCA-IgA); determining whether the sample is positive for anti-Saccharomyces cerevisiae immunoglobulin G (ASCA-IgG); and diagnosing the individual as having IBD when the sample is positive for ANCA, ASCA-IgA or ASCA-IgG, and diagnosing the individual as not having IBD when the sample is negative for ANCA, ASCA-IgA and ASCA-IgG, provided that the method does not include histological analysis of neutrophils.

Abstract: The invention relates to a method for quantitating the level of a preselected analyte in a sample of blood of a human or animal patient by incubating the test sample with an antibody specific to the analyte to form an immunocomplex, which then interacts with the white blood cell fractions and result in the production of oxidants. Oxidants are detected using chemiluminescent reagents. In addition, the white blood cell oxidant response may be enhanced by the inclusion of certain agents such as opsonized zymosan. As part of the assay, separate blood samples are also maximally stimulated with a maximal stimulatory amount of exogenously-added antigen, and corresponding antibody, to form immunocomplexes, to provide a response factor used in the quantitation of analyte.

Abstract: The invention relates to a method for detecting specific target-cells in a simple and time saving way, using paramagnetic particles, antibodies recognizing the Fc portions of target-cell associating antibodies and target-cell associating antibodies directed to specific antigen determinants in the target-cell membranes. Incubation of the cell suspension with a mild detergent and/or second set of antibodies or antibody fragments, prelabeled or not with fluorescent agents, metallocolloids, radioisotopes, biotincomplexes or certain enzymes allowing visualization, with dramatically increase the specificity of the method. The method can further be used for isolation of the target-cells by magnetic field application and kit for performing the method according to the invention is described.

Abstract: This invention provides a method, a reagent, and a kit for detecting herpesvirus-specific IgM antibodies indicative of recent infection while preventing detection of low levels of herpesvirus-specific IgM antibodies present in individuals of low risk. The invention also provides a reagent for use in detecting herpesvirus-specific IgM antibodies indicative of recent infection while preventing detection of low levels of herpesvirus-specific IgM antibodies present in individuals of low risk.

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: The present invention is directed to antibodies, in particular monoclonal antibodies, of porcine somatotropin (pST). When these antibodies are administered together with pST, the growth of vertebrates is greater than that achieved with the administration of pST alone. The invention is also directed to an increase in the growth of vertebrates which persists over long periods when an antibody to a somatotropin is administered together with such somatotropin.

Abstract: Immunoassay methods and apparatus are provided which utilize flow cytometry, coated latex microspheres, and labelled antibodies, to simultaneously detect the presence and amount of several antigens or antibodies in a sample. Microspheres can be sized by forward angle light scatter (FALS) or electronic volume. By combining FALS and fluorescence, it is practical to use beads of several different sizes, colors or shapes, each bead coated with a different protein or antibody, for the simultaneous detection of multiple analytes in a sample. Available auto-sampling systems make it even more appealing in this regard. In accordance with one embodiment, highly purified RNP. Sm, SS-A, SS-B and Scl-70 antigens are bound to 4, 5, 6, 7 and 10 .mu.m latex beads, respectively and stabilized for extended shelflife. Diluted patient serum is placed into test tubes containing a mixture of the five antigen coated beads and incubated. If an antibody is present for a specific antigen, it will bind to that specific bead.

Abstract: The invention relates to a method for staging sepsis in a patient by concurrently measuring in a sample of the patient's blood four parameters which are indicative of the stage of sepsis: 1) the level of microbial product level in the blood; 2) the level of tumor necrosis factor (TNF) response reserve; 3) the maximum oxidant production by neutrophils, and 4) the responsiveness of the patient's neutrophils to immunocomplexes. Based on determining the stage of sepsis, appropriate treatment for the patient may be identified.

Abstract: The present invention is generally directed to the analysis of biological samples. More particularly, the present invention is directed to automated sample analysis for paraproteins using immunosubtraction, capillary electrophoresis and Fourier transformation analysis.

Abstract: The present invention discloses methods for detecting antibodies to HAV 3C proteinase. These methods can distinguish an individual with a natural infection from one who has been vaccinated with an inactivated vaccine and are thus of utility in the diagnosis of hepatitis A in situations in which vaccination is widespread.

Abstract: The invention provides improved immunoassay techniques for detecting the presence of analytes in a liquid sample. The present immunoassay methods utilize anti-allotypic monoclonal antibodies as capture reagents for primary binding proteins specific for the analytes of interest. The monoclonal antibodies are highly specific for the allotypic determinants present on the primary binding protein. The use of anti-allotypic monoclonal antibodies as capture reagents provides improved levels of specificity and accuracy of the immunoassay, in part because interference from endogenous immunoglobulins in the sample is significantly reduced. The invention further provides anti-allotypic monoclonal antibodies.

Abstract: A method of determining affinity and kinetic properties for the solution interaction between an analyte and a binding partner therefor, which method comprises: (a) mixing a solution of said analyte with a solution of said binding partner, contacting the resulting reaction solution with (i) immobilised binding partner, or analogue, for said analyte, and/or (ii) immobilised analyte, or analogue, and monitoring the binding of said analyte and/or binding partner in said reaction solution to the respective immobilised species to determine the variation with time of the concentration of free analyte and/or binding partner in said solution; and/or (b) contacting a solution of the reaction complex of said analyte and a binding partner therefor with (i) immobilised binding partner, or analogue, and/or (ii) immobilised analyte, or analogue, and monitoring the binding of said analyte and/or binding partner in said reaction complex solution to the respective immobilised species to determine the variation with time of the

Abstract: A novel surface exposed protein of Haemophilus influenzae or related Haemophilus species is described. The protein named protein D is an Ig receptor for human IgD and has an apparent molecular weight of 42,000. Protein D can be detected in all of 116 encapsulated and non-encapsulated isolates of H. influenzae studied. The protein from all strains shows in addition to the same apparent molecular weight immunogenic similarities since protein D from all strains interacts with three different mouse monoclonal antibodies and monoclonal human IgD. A method for purification of protein D is described. Cloning of the protein D gene from H. influenzae in E. coli is described as well as the nucleotide sequence and the deduced amino acid sequence.