Abstract: A kit containing the reagents necessary for the qualitative or quantitative demonstration of epidermal growth factor receptor (EGFR) in formalin-fixed, paraffin-embedded tissue sections. A immunohistochemical staining procedure is employed which utilizes a primary monoclonal mouse antibody that selectively binds to EGFR. The primary antibodies bound to tissue antigens are detected using a peroxidase labeled polymer that is conjugated with secondary anti-mouse immunoglobulin antibodies. The enzymatic conversion of the subsequently applied chromogen results in formation of a visible reaction product at the site of the EGFR antigen. Following development of the chromogen, specimens may then be counterstained and coverslipped. Results are interpreted using a light microscope or other optical imaging device. The detection system is adapted for both manual and automated staining.

Abstract: The present invention involves a method for assaying a substance. The method of the present invention comprises contacting the substance with an assay agent comprising a catalytic agent to associate the substance with the catalytic agent, contacting the resulting associated substance with a label precursor capable of reacting catalytically with the catalytic agent to release the label, and detecting a mass label. The present invention also involves a kit for assaying a substance. The kit of the present invention comprises an assay agent comprising a catalytic agent, and a label precursor capable of reacting catalytically with the catalytic agent to release a mass label.

Abstract: Disclosed is a class of compounds referred to herein as effector compounds. Effector compounds are useful in connection with the modulation of an immune response. Modulation refers to the ability of the effector compounds of the present invention to either enhance (antigen supercharging) or inhibit (immunosuppressant activities) antigen presentation, depending upon the nature of the particular effector compound and the therapeutic context. Effector compounds include peptides, modified peptides and peptidomimetics. Also disclosed are methods for modulating presentation of an MHC class II restricted antigenic peptide to a T cell. Also disclosed are effector compounds demonstrated to act specifically on a human MHC class II allele. Also disclosed is a second class of compounds, referred to herein as immunomodulatory organic compounds.

Abstract: The invention relates to (1) pressure-mediated dissociation of an analyte complexed with an endogenous binding partner to enable detection of a complex formed from the analyte and an exogenous binding factor, (2) pressure-mediated association of an analyte and an exogenous binding partner to enable more rapid and/or more sensitive detection of an analyte, and (3) pressure-mediated association and dissociation of biomolecular complexes to enable separation of one biomolecule from a complex mixture. Pressure can be used to improve assays by dissociating endogenous analyte complexes and improving assay speed and sensitivity by associating the analyte molecules with exogenously supplied binding partners. Pressure can also be used to improve the separation of compounds from contaminated mixtures.

Abstract: The present invention is directed to the molecular characterization of the nuclear antigen recognized by atypical p-antineutrophil cytoplasmic antibodies (p-ANCA) in order to better diagnose patients with inflammatory bowel diseases such as ulcerative colitis (UC), and autoimmune liver diseases such as primary sclerosing cholangitis (PSC) and autoimmune hepatitis (AIH). Molecular characterization of the target antigen comprises preparing cytoplasmic and nuclear extracts of human neutrophils, human HL-60 and murine 32D myeloid cells. Proteins should then be resolved by 1 and 2 dimensional gel electrophoresis and reactive proteins can then be detected by immunoblotting with sera from individuals, making certain to have both normal and disease controls. Atypical p-ANCA should then be affinity purified against the reactive protein and investigated for their immunofluorescence pattern using confocal microscopy.

Abstract: Methods of detecting antibodies to one or more glycosphingolipid(s) of interest in a sample are disclosed which comprise using a solid-phase reactant having carbonyl groups attached thereon, and the glycosphingolipid(s) of interest linked to the solid-phase reactant by an amide bond between an amino group of the glycosphingolipid of interest and a carbonyl group attached to the solid-phase reactant. The methods of detecting antibodies to glycosphingolipid(s) of interest can be used in methods of diagnosing autoimmune diseases in an individual.

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: Described herein is an ELISA based assay for the detection of HCV infection. This new assay can detect HCV infection earlier than the currently used assays for the screening of blood for HCV infection by using a combination of HCV antigens and anti-core antibodies to capture HCV.

Abstract: The present invention provides an improved method for detection of panel reactive antibodies in serum of a subject against HLA class I antigens, which comprises the steps of adding serum from a subject to an array of microbeads, each microbead presenting HLA antigens from a cell population presenting the same HLA antigens; incubating the serum and microbeads for sufficient time for anti-HLA antibodies in the serum to bind to the HLA antigens presented on the microbeads; removing the serum components which do not specifically bind with the HLA antigens presented on the microbeads; incubating the microbeads with a labeled ligand capable of specifically binding with anti-HLA antibodies bound to said HLA antigens; removing the labeled ligand which is not bound to said HLA antigens; and detecting the presence of labeled ligand bound to said HLA antigens by flow cytometry.

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: A change in viral tropism occurs in many HIV positive individuals over time and can be indicated by a shift in coreceptor use from CCR5 to CXCR4. The shift in coreceptor use to CXCR4 has been shown to correlate with increased disease progression. In patients undergoing HAART, the predominant populations of virus can be shifted back to CCR5-mediated entry after the CXCR4-specific strains have emerged. The present invention relates to a diagnostic method to monitor coreceptor use in the treatment of human immunodeficiency virus (HIV) infection. The present invention further relates to a diagnostic method applied to HIV-positive individuals undergoing HAART to monitor the suppression of CXCR4 specific strains. The diagnostic methods can be used to assist in selecting antiretroviral therapy and to improve predictions of disease prognosis over time.

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: A process of preparing a pharmaceutical composition includes the steps of: a) obtaining isolated immunoglobulins from an animal; b) contacting the isolated immunoglobulins with a bacterial Fc-binding protein; c) collecting the immunoglobulins not bound to the bacterial Fc-binding protein; and d) adding a pharmaceutically acceptable carrier to the immunoglobulins not bound to the bacterial Fc-binding protein.

Abstract: This invention is directed toward methods and kits for the detection of antibodies associated with autoimmune disorders or infectious agents in an individual employing immunoretroid peptides derived from antigens associated with said disorders and agents.

Abstract: The present invention relates to a dermatomyositis-specific auto-antigen, a DNA encoding it and a process for the preparation thereof as well as its use.

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 genomic structure including the sequence of the intron/exon junctions is disclosed for KVLQT1 and KCNE1 which are genes associated with long QT syndrome. Additional sequence data for the two genes ARE also disclosed. Also disclosed are newly found mutations in KVLQT1 which result in long QT syndrome. The intron/exon junction sequence data allow for the design of primer pairs to amplify and sequence across all of the exons of the two genes. This can be used to screen persons for the presence of mutations which cause long QT syndrome. Assays can be performed to screen persons for the presence of mutations in either the DNA or proteins. The DNA and proteins may also be used in assays to screen for drugs which will be useful in treating or preventing the occurrence of long QT syndrome.

Abstract: The invention provides methods and materials related to the diagnosis of eosinophil degranulating conditions. Specifically, the invention provides methods and materials that involve visual types of analysis (e.g., microscopic analysis) that are used to determine the presence or absence of a horseshoe-shaped eosinophil granule structure within a mucus sample collected from a mammal. The presence of a horseshoe-shaped eosinophil granule structure within a patient's mucus indicates that the patient has an eosinophil degranulating condition. In addition, the invention provides methods and materials that involve immunological types of analysis (e.g., immunoassays) that are used to determine if a patient's mucus contains a tissue-damaging amount of eosinophil granule content that is outside the eosinophil granule and within the mucus.

Abstract: Methods and kits for simultaneously measuring both members of a binding pair are described.

Abstract: Allograft rejection is initiated by an immune response to donor major histocompatibility complex proteins. After allogeneic heart transplantation, de novo CD4+ T cell and B cell autoimmune responses to contractile proteins of cardiac muscle, e.g. cardiac myosin (CM), are elicited. The transplantation induced autoimmune response to cardiac myosin plays an significant role in cardiac transplant rejection. Methods are provided for diagnosis and therapy of graft rejection.

Abstract: Diagnosis of overt, subclinical or potential autoimmune adrenal disease, by contacting a sample of body fluid with: (i) at least one epitope region of 21-hydroxylase which epitope region is essential for binding monoclonal or polyclonal antibodies to 21-hydroxylase and/or autoantibodies to 21-hydroxylase; and (ii) monoclonal or polycolonal antibodies to 21-hydroxylase. The degree of binding of the autoantibodies present in the sample to the relevant epitope region is monitored.

Abstract: DNA encoding for a voltage-gated, TTX-sensitive sodium channel is isolated. Also disclosed are polypeptide products of recombinant expression of these DNA sequences, expression vectors comprising the DNA sequences, and host cells transformed with these expression vectors. Other aspects of this invention are peptides whose sequences are based on the amino acid sequences deduced from these DNA sequences, antibodies specific for such proteins and peptides, procedures for detection and quantitation of such proteins, and nucleic acids related thereto. Another aspect of this invention is the use of this voltage-gated, tetrodotoxin-sensitive sodium channel as a therapeutic target for compounds.

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

Abstract: This invention discloses compositions of cyclodextrin polymers for carrying drugs and other active agents. Compositions are also disclosed of cyclodextrin polymer carriers that release drugs under controlled conditions. The invention also discloses compositions of cyclodextrin polymer carriers that are coupled to biorecognition molecules for targeting the delivery of drugs to their site of action.

Abstract: The invention relates to methods of determining the presence or amount of an analyte in a sample suspected of containing the analyte, said method comprising the steps of: (a) bringing together in an aqueous medium to form a mixture: (i) the sample; (ii) at least one specific binder for the analyte; (iii) a first binding agent coupled to either (1) exogenous analyte or (2) the specific binder for the analyte; (iv) a support comprising a second binding agent; b) adding an activator to the mixture, wherein the activator binds the first binding agent and the second binding agent of the support to immobilize the first binding agent; c)determining the amount of the analyte in the sample by detecting the immobilized first binding agent, the presence or amount thereof being related to the presence or amount of the analyte in the sample.

Abstract: A composition and method for detecting Crohn's disease include the use of serological testing as a rapid and simple way to diagnose Crohn's disease. The serological tests were based on the use of the two recombinant clones isolated from an M. paratuberculosis genomic library that expressed 35K and 36K MW antigens. Antigen p35 was isolated from Johne's disease sera (acid-fast bacilli form) and p36, from human CD sera (spheroplast form). The combined use of p35 and p36 recombinant antigens provides a highly specific and sensitive test to demonstrate the humoral immune response of CD patients to M. paratuberculosis. A serologic kit is disclosed including the composition including the combined p35 and p36 antigens. A treatment methodology utilizes antimycobacterial drugs, preferably upon patients prescreened for the presence of M para.

Abstract: Non-invasive methods are provided for obtaining biological samples of mammary fluid or mammary fluid components by administering oxytocin to a patient to stimulate expression of mammary fluid. During or after mammary fluid expression, a biological sample is collected in the form of whole mammary fluid, whole cells or cellular components, other selected liquid or solid fractions of the mammary fluid, purified or bulk proteins, glycoproteins, peptides, nucleotides or other desired Constituents of mammary fluid. Methods and kits are also provided for determining the presence or amount of a breast disease marker in biological samples of mammary fluid or mammary fluid components obtained according to the above sample collection methods. Also provided within the invention are novel breast pump and breast pump adapter devices which incorporate a solid phase sample collection medium integrated within the breast pump or adapter or otherwise fluidly connected therewith.

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 present invention includes a method to detect chronic pulmonary diseases of the airways associated with anti-Fc.sub..epsilon. R IgG autoantibodies. Preferred diseases to detect include atopic asthma and non-atopic asthma. The invention also includes methods to prescribe and monitor treatment for animals with such diseases. Also included are kits to detect disease as well as kits to prescribe or monitor treatment. The present invention also includes formulations to treat chronic pulmonary diseases of the airways associated with anti-Fc.sub..epsilon. R IgG autoantibodies. Preferred formulations include compounds that inhibit the ability of anti-Fc.sub..epsilon. R IgG autoantibodies in susceptible animals to bind to Fc.sub..epsilon. R-expressing cells. Also included are methods to treat such diseases.

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 present invention relates to the diagnosis of severe diseases based on the determination of the presence of AGE-IgG autoantibodies in patients and to a method of treatment thereof. More precisely, the invention relates to a method for the diagnosis of severe diseases in patients, which comprises the steps of: a) incubating a solid support coated with an AGE antibody with a biological sample from said patient for a time sufficient for an immunoreaction to occur; and b) determining the presence of AGE-IgG autoantibodies present in said sample; whereby the presence of AGE-IgG autoantibodies in said patient's sample is indicative of a severe disease. Such severe diseases which may be diagnosed in accordance with the present invention include Rheumatoid arthritis, atherosclerosis, amyloidosis, diabetes, Henoch Schonlein Purpura, Crohn's disease and Coeliac disease.

Abstract: A method of detecting an antibody in a sample using a labelling compound and comprising the steps of mixing a ligand antigen, antibody or hapten bound to biotin with the sample; an antibody directed against the antibody to be detected bound to paramagnetic particles; and a chemiluminescent acridinium compound bound to avidin or streptavidin to form a solid phase complex; separating the solid phase from the liquid phase; and analyzing the separated solid phase for the presence of chemiluminescent complex.

Abstract: This invention discloses methods for preparing compositions of cyclodextrin polymers for carrying drugs and other active agents. Methods are also disclosed for preparing cyclodextrin polymer carriers that release drugs under controlled conditions. The invention also discloses methods for preparing compositions of cyclodextrin polymer carriers that are coupled to biorecognition molecules for targeting the delivery of drugs to their site of action.The advantages of the water soluble (or colloidal) cyclodextrin polymer carrier are:(1) Drugs can be used that are designed for efficacy without conjugation requirements.(2) It will allow the use of drugs designed solely for efficacy without regard for solubility.(3) Unmodified drugs can be delivered as macromolecules and released within the cell.(4) Drugs can be targeted by coupling the carrier to biorecognition molecules.(5) Synthesis methods are independent of the drug to facilitate multiple drug therapies.

Abstract: The subject invention pertains to the identification of peptides useful in the detection and treatment of Wegener's granulomatosis.

Abstract: An antibody specific for a target analyte is purified by affinity chromatography on a substrate bearing a low-affinity analogue of the target analyte. The antibody is displaced from the substrate by contact with a second analogue of intermediate affinity, which remains complexed with the antibody. This complex can be used in a conventional assay for the target analyte, which displaces the intermediate-affinity analogue. The complexed antibody is rendered more storage-stable because the second analogue protects the antibody binding reagion.

Abstract: The invention relates to an immunochemical method for the detection and determination of rheumatoid factors using immune complexes as specific binding partners as well as to the preparation of reagents that are suitable for these methods.

Abstract: This invention relates to antibodies or fragments thereof that can be used as indicators of apoptosis. More specifically, this invention relates to antibodies and fragments thereof that selectively bind GP46, a protein whose levels increase significantly upon induction of apoptosis. This invention also relates to the hybridomas that produce anti-GP46 monoclonal antibodies. This invention also discloses a method of detecting cell death by apoptosis in vitro or in vivo by detecting and quantifying GP46 present in biological samples, comprising contacting the sample with the antibodies or fragments to form GP46 immunocomplexes, which may then be detected by the use of known methods. This detection method is useful for research into apoptosis and research relating to diseases in which apoptosis is involved. This method could also be used to diagnose the extent of damage caused by a particular disease or to evaluate the efficacy of drug treatments.

Abstract: The present invention provides a chimeric polypeptide comprising an epitope of GAD65 protein and a structural region comprising a polypeptide of the GAD family, wherein the chimeric polypeptide is a more specific diagnostic for insulin dependent diabetes mellitus than intact GAD65 and produces fewer false positives than intact GAD65. The invention further provides a method of screening a subject for risk of developing IDDM, comprising contacting the chimeric polypeptide of claim 1 with a biological sample containing antibodies from the subject and detecting binding between an antibody in the biological sample and the chimeric polypeptide, the detection of binding indicating the subject is at risk of developing IDDM.

Abstract: An improved method for detecting even low titer HLA antibodies in proposed organ transplant recipients employs flow cytometry crossmatching (FCXM) on pronase-treated B-cells and T-cells of the donor. Two-color FCXM is preferably employed. The peripheral blood lymphocytes, after pronase digestion, are maintained under conditions to suppress Fcy R receptor regeneration, combined with sera of the proposed transplant recipient, and tested against control sera, using fluorescent reporting complexing agents. Use of pronase digested lymphocytes permits the assay to distinguish between normal or irrelevant IgG B cell binding and immunologically important HLA antibody binding.

Abstract: The present invention provides an improved method for detection of panel reactive antibodies in serum of a subject against HLA class I antigens, which comprises the steps of adding serum from a subject to an array of microbeads, each microbead presenting HLA antigens from a cell population presenting the same HLA antigens; incubating the serum and microbeads for sufficient time for anti-HLA antibodies in the serum to bind to the HLA antigens presented on the microbeads; removing the serum components which do not specifically bind with the HLA antigens presented on the microbeads; incubating the microbeads with a labeled ligand capable of specifically binding with anti-HLA antibodies bound to said HLA antigens; removing the labeled ligand which is not bound to said HLA antigens; and detecting the presence of labeled ligand bound to said HLA antigens by flow cytometry.

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

Abstract: The invention provides a fragment of C1q which is characterized in that a plurality of such fragments selectively binds immune complexes or aggregated immunoglobulins in the presence of monomeric immunoglobulin. The invention also provides a synthetic peptide comprising the sequence:Leu Glu Gln Gly Glu Asn Val Phe Leu Gln Ala Thr 1 5 10 ?SEQ ID NO 2!or variants thereof capable of binding immunoglobulin. Like the C1q fragment, a plurality of the peptides can selectively bind immune complexes or aggregated immunoglobulins in the presence of monomeric immunoglobulin. As a result of this property, the fragments and peptides are well-adapted for removing immune complexes and aggregated immunoglobulins from fluids containing monomeric immunoglobulin, and for detecting or quantitating immune complexes in such fluids. The invention also provides a binding material for removing immune complexes or aggregated immunoglobulins from a fluid.

Abstract: The present invention relates to nucleotide sequences of FHIT genes and amino acid sequences of their encoded proteins, as well as derivatives and analogs thereof, and antibodies thereto. The FHIT gene sequence is mutated in diseases involving cell overproliferation, particularly malignancies of the digestive tract. The present invention further relates to the use of FHIT genes and their encoded proteins as diagnostic and therapeutic reagents for the detection and treatment of disease states associated with cell overproliferation.

Abstract: Disclosed is a class of compounds referred to herein as effector compounds. Effector compounds are useful in connection with the modulation of an immune response. Modulation refers to the ability of the effector compounds of the present invention to either enhance (antigen supercharging) or inhibit (immunosuppressant activities) antigen presentation, depending upon the nature of the particular effector compound and the therapeutic context. Effector compounds include peptides, modified peptides and peptidomimetics. Also disclosed are methods for modulating presentation of an MHC class II restricted antigenic peptide to a T cell. Also disclosed are effector compounds demonstrated to act specifically on a human MHC class II allele. Also disclosed is a second class of compounds, referred to herein as immunomodulatory organic compounds.

Abstract: Use of an anti-cardiolipin antibody, anti-lipoprotein antibody or anti-.beta.2-glycoprotein I antibody together with an immobilized antibody thereof enables to accurately assay for a complex of .beta.2-glycoprotein I and an oxidized lipoprotein in a blood sample, according to a sandwich immunoassay. Thus, the oxidized lipoprotein in blood can be detected, whereby diagnosis of arteriosclerotic disease is enabled.

Abstract: A method and composition are provided for treatment of disorders involving immunological dysfunction. The invention comprises the administration of a low level of ribonucleotide polymerase protein or a derivative thereof to a human or animal with an immune dysfunction disorder.

Abstract: A method and composition are provided for treatment of disorders involving immunological dysfunction. The invention comprises the administration of a low level of ribonucleotide polymerase protein or a derivative thereof to a human or animal with an immune dysfunction disorder.

Abstract: Non-invasive methods and kits are provided for obtaining biological samples of mammary fluid or mammary fluid components by administering oxytocin or an oxytocin analogue to a mammalian patient to stimulate expression of mammary fluid. The oxytocin is preferably administered intranasally and causes myoepithelial contraction of target alveolar-ductal tissues of the breast. During or after mammary fluid expression, a biological sample is collected in the form of whole mammary fluid, whole cells or cellular components, other selected liquid or solid fractions of the mammary fluid, purified or bulk proteins, glycoproteins, peptides, nucleotides or other desired constituents of mammary fluid. Methods and kits are also provided for determining the presence or amount of a breast disease marker in biological samples of mammary fluid or mammary fluid components.

Abstract: The present invention relates to a method and assay device for detecting small analytes. The results of the assay can be directly read from the device, which is a lateral flow device.

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