Abstract: A ratchet wrench includes a body, a driving unit, a control unit, a first rotary unit, a second rotary unit and a second connector. The body has a first recess and a restriction portion. The driving unit is connected to the working end of the body and is driven by the control unit to allow the wrench to be rotated clockwise or counter clockwise. The first rotary unit has a first rotary rod, a third toothed ring, a sleeve, a first clip, a second resilient member and a bead. The second rotary unit has a second rotary rod, two caps, a second resilient member, a third rotary rod and a handle. The second connector is located in the restriction portion. The second connector is located corresponding to the groove of the first rotary rod, so that the first rotary rod does not drop from the first recess.

Abstract: A two step lateral flow assay method for identifying IgE antibodies in a sample comprises applying a sample to a sample port of a device, wherein the device is adapted to deliver the sample to a lateral flow matrix having a plurality of IgE antigen species immobilized at respective positions at a first location; allowing the sample to travel along the lateral flow matrix through the immobilized plurality of IgE antigen species to a second location downstream of the first location; and, after a predetermined period of time, applying liquid buffer to the lateral flow matrix to mobilize labeled reagent which is adapted to bind anti-IgE antibody and which is dried on the lateral flow matrix at a location upstream of the sample port delivery of the sample to the lateral flow matrix, and allowing labeled reagent mobilized by the liquid buffer to travel along the lateral flow matrix through the immobilized plurality of IgE antigen species and bind with any IgE antibody bound to the immobilized IgE antigen species, a

Abstract: The invention relates to antibodies, including monoclonal and polyclonal, or fragments thereof, which discriminate between the histidine and tyrosine isoforms of Complement Factor H and to their use in diagnostic methods and therapeutic treatments relating to Complement Factor H mediated diseases.

Abstract: The invention concerns an internal standard used to quantitative analysis of the risk of humoral (i.e. vascular) transplant rejection. The internal standard consists of a stable composition of the C4d complement bound to a carrier consisting of erythrocytes or microparticles. The invention also concerns a method for analyzing in vitro the risk of humoral organ transplant rejection, which consists in determining the amount of component of C4d component fixed on the erythrocytes contained in a blood sample from a patient.

Abstract: Lateral flow assay devices and methods for detecting an analyte in a sample which comprises a plurality of nonspecific binding pair members are adapted for two step determinations.

Abstract: This disclosure teaches a method and composition for detecting the presence of class specific antibodies reactive with analytes such as bacteria, allergens, autoimmune antigens, viral proteins, haptens, and carbohydrates by lateral flow techniques. In one embodiment of the disclosure, a test sample is added to the test strip, which then migrates to the site of the immobilized allergens, thereby forming a first antibody IgE-allergen complex. A chase release buffer is added upstream to or from the site of the labeled anti-IgE antibodies, which is itself upstream from the sample site. The anti-IgE antibodies migrate downstream to the site of immobilized first complex, thereby forming a second complex indicating the presence of class specific IgE antibodies in the test specimen. In another embodiment of the disclosure, a liquid form of the labeled anti-IgE antibodies can be added to the test strip after the first complex has been formed.

Abstract: A method for identifying or monitoring SLE in an individual is provided. The method includes quantitating complement component C4d on the surfaces of platelets and comparing the amounts of C4d to reference levels of C4d on platelets of individuals without SLE and/or on platelets of the individual obtained at a different time. Kits for use in the above-described methods are provided along with computer readable media tangibly embodying executable instructions to perform the methods.

Abstract: The invention is related to methods of diagnosing inflammatory diseases or conditions by determining levels of components of the complement pathway on the surface of white blood cells.

Abstract: Methods for diagnosing and monitoring systemic lupus erythematosus (SLE) or scleroderma by determining, in a blood sample from the individual being diagnosed or monitored, complement component C4d deposited on surfaces of red blood cells in the sample, and optionally also determining complement receptor CR1 deposited on the red blood cell surfaces. For diagnosis this is compared with the quantity of C4d (and optionally CR1) present on red blood cells of normal individuals. For monitoring it is compared with a value in a sample or samples previously obtained from the individual patient. The comparison may be made with individual values for C4d and CR1 and/or with a ratio of the two found in normal individuals.

Abstract: The use of compounds that block complement component C5 or its active fragments C5a and/or C5b (such compounds collectively referred to as “C5 blockers”) to treat established joint inflammation (arthritis) is disclosed. Administration of such C5 blockers has been found to: 1) arrest and/or reduce inflammation in joints which are already inflamed, and 2) inhibit the spread of inflammation to unaffected joints.

Abstract: The present invention relates to an assay for free protein S comprising the addition of a ligand specific for free protein S to a biological fluid sample to form a protein S/ligand complex, and subsequent determination of the amount of the complex formed in the sample. The ligand specific for free protein S is comprised of the C4b binding protein (C4BP), or part thereof, or a compound comprising an amino acid residue sequence that binds specifically to the binding site for C4BP in protein S. The present invention further relates to antibodies specific for free protein S, which can be used as ligands in the assay of the invention, and with protein S related polypeptides, which can be used to produce such antibodies. In addition, the present invention is related to diagnostic test systems, suitable in kit form, comprising the present ligand and at least one further reagent required in the assay for free protein S.

Abstract: The invention provides methods and compositions for exploiting the discovery that members of the small integrin-binding ligand, n-linked glycoproteins family termed SIBLINGS bind to complement Factor H, and moreover that SIBLINGS proteins, such as BSP, exist in relatively acidic forms. The methods provided can be used to detect SIBLINGS proteins in samples from subjects that are suspected of having tumors or abnormal bone turnover. The invention also provides methods of using SIBLINGS proteins to protect cells from complement mediated lysis. Finally, the discovery allows for the creation of specific binding agents that facilitate the detection of SIBLINGS proteins when they are associated with Factor H.

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: The present invention is concerned with an assay for free protein S comprising addition of a ligand specific for free protein S to a biological fluid sample to form a protein S/ligand complex, and subsequent determination of the amount of said complex formed in the sample. The ligand specific for free protein S is comprised of the C4b binding protein (C4BP) or part thereof or a compound comprising an amino acid residue sequence that binds specifically to the binding site for C4BP in protein S. The present invention is further concerned with antibodies specific for free protein S, which can be used as ligands in the assay of the invention, and with protein S related polypeptides, which can be used to produce such antibodies. In addition, the present invention is related to diagnostic test systems, suitable in kit form, comprising the present ligand and at least one further reagent required in the assay for free protein S.

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: The present invention provides a method for quantifying the presence of extracellular LBP in body fluids including blood in a subject comprising conducting an LBP immunoassay on plasma obtained from said subject.

Abstract: The use of calcium salts, magnesium salts or combination thereof in immunochemical methods for the determination of an analyte in a sample. These salts increase the specificity of such determinations, in particular, the background signal being reduced by addition of these salts in solid phase immunochemical methods.

Abstract: Methods of screening for cancers or treating cancers or autoimmune disorders are disclosed. In an aspect of the present invention, the screening methods are based on the detection of complement C3 or C3 related protein, or a nucleic acid molecule encoding the same, found to be associated with the presence of cancer. Additional screening methods are based on the use of complement regulators Factor I or DAF, or complement receptors 1 or 3. Preferred embodiments to the methods include detection based on immunological properties, physical properties, enzymatic properties and combinations thereof, or detection of a nucleic acid molecule encoding antigen based on nucleic acid amplification.

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: A method for the determination of soluble fibrin in a body fluid of a species is described, entailing use of a binding partner which is bound to a solid phase, and of a labeled bioaffinity binding partner, for fibrin.

Abstract: A reagent composition comprising (a) liposomes encapsulating a marker therein, immobilizing a hapten on liposome membranes and having a size in the range of 100 to 500 nm in terms of mean particle size plus twice the standard derivation, and (b) an antibody to the hapten is effective for measuring human complement activity easily and precisely with excellent storage stability.

Abstract: Immunoassays for complement components, complement activation products or, preferably both, can be used to determine an acceptable level of anticomplement activity (AC) in plasma derived biologically active products intended for infusion into a mammal. In one application an ELISA for complement components (CC) such as C1q, C1r or C1s can be used to determine AC in an IgM-enriched immune serum globulin (ISG). In another application, an immunoassay for complement activation products (CAP) is used for a similar determination. In yet a preferred third application, assays for both a CC (such as measuring a decreasing amount of C1r) and a CAP (such as measuring an increasing amount of C4a) are used to assess the relative AC (and safety) of a biologically active, therapeutic preparation.

Abstract: Human C3a Receptor polypeptides and DNA (RNA) encoding such C3a Receptor and a procedure for producing such polypeptides by recombinant techniques is disclosed. Also disclosed are methods for utilizing such C3a Receptor for the treatment of inflammatory and auto-immune disorders, among others. Antagonists against such C3a Receptor and their use as a therapeutic to treat inflammatory and auto-immune disorders, among others, are also disclosed. Also disclosed are diagnostic assays for detecting diseases related to mutations in the nucleic acid sequences and altered concentrations of the polypeptides. Also disclosed are diagnostic assays for detecting mutations in the polynucleotides encoding the C3a Receptor and for detecting altered levels of the polypeptide in a host.

Abstract: A reagent composition comprising (a) liposomes encapsulating a marker therein, immobilizing a hapten on liposome membranes and having a size in the range of 100 to 500 nm in terms of mean particle size plus twice the standard derivation, and (b) an antibody to the hapten is effective for measuring human complement activity easily and precisely with excellent storage stability.

Abstract: A novel technique is disclosed for the prevention of false positive reactions in immunological testing which are caused by interference of C.sub.1 and C.sub.1q. The method is based on heating a sample of a body fluid at a temperature of 59.degree.-64.degree. C. in the presence of a particular neutral salt. A method for screening for rheumatoid factor is also disclosed.

Abstract: The present invention provides a method for the differential diagnosis of bacterial meningitis in an individual in need of such diagnosis, comprising the steps of: measuring the levels of complement C3 and complement factor B in the cerebrospinal fluid of the individual; and determining whether that individual has bacterial menigitis based on the levels of complement C3 and complement factor B in the cerebrospinal fluid of that individual. Also provided is a method for the differential diagnosis of bacterial menigitis in an individual in need of such diagnosis, comprising the steps of: measuring the levels of complement factor B in a sample from the individual; and determining whether that individual has bacterial menigitis based on the levels of complement factor B in the sample from that individual.

Abstract: A composition and methods for use thereof relating to polypeptides having the ability to act as an inhibitor of complement C5b-9 complex activity. The compositions contain an 18 kDa protein found on the surface of human erythrocytes, a 37 kDa protein found on the surface of human platelets, a 37 kDa protein found on the surface of human endothelial cells, active derivatives or fragments thereof which act to inhibit the activity of C5b-9, anti-idiotypic antibodies mimicking the action of the inhibitor proteins or antibodies against C7 or C9 which block the formation of the C5b-9 complex. The compositions can be used in vitro to inhibit C5b-9 related stimulatory responses of platelets and vascular endothelium of perfused organs and tissues, thereby preventing the C5b-9 initiated cell necrosis or stimulated secretion of proteolytic enzymes and the exposure of the procoagulant membrane receptors during collection and in vitro storage.

Abstract: This invention pertains to a method of detecting, in a sample obtained from an individual, anti-heparin antibodies which inhibit the formation of the heparin accelerated antithrombin III-thrombin complex. In the present method, the presence of such anti-heparin antibodies are detected directly (by detecting the presence of anti-heparin antibodies themselves) or indirectly (by detecting the presence or formation of the heparin accelerated antithrombin III-thrombin complex). In one embodiment of the present method, antibodies which react with or interfere with the heparin pentasaccharide which binds antithrombin III in such a manner that binding to antithrombin III is inhibited are detected. In a specific embodiment of the present method, the anti-heparin antibody detected is one which reacts with or interferes with the disaccharide UA-2S/GlcNs-6 present in residues IV and V of the heparin pentasaccharide that binds antithrombin III.

Abstract: Disclosed is a process for preparing a C1-esterase inhibitor concentrate, of human plasma origin, comprising 2 separations by chromatography on ion exchanger gels of tentacular type.

Abstract: Methods for detecting and isolating acrosome-reacted sperm and complement receptor-bearing oocytes using the complement component C3, fragments, or variants thereof, antibodies to a complement receptor, or antibodies to C3, are disclosed. These methods have application in the assessment of fertility, in the preparation of sperm or oocytes for in vitro fertilization or for gamete intrafallopian tube transfer, in promoting or inhibiting fertilization in vitro and in vivo, and in diagnosing and treating infertility.

Abstract: Complement immunoassay using liposomes is improved by pretreatment of a sample solution before determination of analyte comprising acidifying or alkalinizing the sample solution, followed by changing the pH to about neutral so as to remove influences caused by interfering substances present in the sample.

Abstract: The present invention relates to a method of determining the presence of an antigen, particularly the HLA-B.sub.27 antigen, at the surface of cells, particularly lymphocytes, by combining the sensitivity of a cytotoxicity test, particularly a lymphotoxicity test, combined to a fluororescence detection, particularly, by using propidium iodide. The claimed method does not involve any purification of lymphocytes from a blood sample. The erythrocytes contained in the test blood sample are lysed after the immune reaction and complement action is completed. Moreover, the formation of the immune complexes, the complement fixation and reaction and the staining of the cells may take place at the same time in the test tube. This method is therefore very simple and very fast to execute. The facility of reading the positive cells is also an advantage to the claimed method over and above the methods using dyes like eosin or trypan blue, because of the direct visualization of colored cells as positive cells.

Abstract: Detectably labelled annexines and compositions thereof are disclosed. Also disclosed are methods for diagnosing a disruption or activation of the hemostatic system or a prothrombotic state in an individual suspected of having a hemostatic disorder, by contacting the blood of said individual with an annexine, and detecting whether an annexine-platelet complex is formed.

Abstract: New devices and kits for solid-phase immuno-assays comprising a solid porous support, preferably in the form of a sheet, where antigens or immuno-globulins or both of them are bound by direct application in any suitable geometry, e.g. as an assay of dots or lines. Such porous supports are suitable for effecting an unlimited number of antibody-antigen reactions simultaneously and in one operation.

Abstract: Methods for detecting and isolating acrosome-reacted sperm and complement receptor-bearing oocytes using the complement component C3, fragments, or variants thereof, antibodies to a complement receptor, or antibodies to C3, are disclosed. These methods have application in the assessment of fertility, in the preparation of sperm or oocytes for in vitro fertilization or for gamete intrafallopian tube transfer, in promoting or inhibiting fertilization in vitro and in vivo, and in diagnosing and treating infertility.

Abstract: An assay for activated factor VII (factor VIIa) has been developed using truncated tissue factor (tTF), a soluble mutant form of (tTF) that retains the cofactor function of TF toward factor VIIa. Unlike full-length TF, however, tTF appears not to support the conversion of factor VII to VIIa. As a result, the tTF assay for factor VIIa is free from interference from factor VII in the plasma and is therefore specific for factor VIIa. The assay is much simpler than existing assays, because it is a single-stage clotting assay performed almost identically to a prothrombin time assay. It is also considerably more sensitive than current assays for factor VIIa in plasma. Since the tTF assay is calibrated against a factor VIIa standard, it yields an absolute concentration of factor VIIa in ng/ml.

Abstract: A method of performing an assay to determine whether a patient has been exposed to or infected by Borrelia burgdorferi is disclosed which comprises collecting serum from the patient; preparing a sample mixture comprising a portion of the patient's serum and an inoculum of viable Borrelia burgdorferi organisms; incubating the sample mixture; determining the number of viable organisms remaining in the sample mixture after incubation; and comparing the number with the quantity of viable organisms remaining in a control. An assay kit is also disclosed which is useful for determining whether a patient has been exposed to or infected by Borrelia burgdorferi. The kit contains reagents necessary to practice the assay method disclosed herein. In its broadest form, the kit comprises an inoculum of viable Borrelia burgdorferi organisms. The kit can also contain an aliquot of normal serum, an aliquot of BSK medium and/or an aliquot of complement. Other reagents, tubes and other materials can also be included in the kits.

Abstract: Novel cell lines, receptors and monoclonal antibodies prepared therefrom that are specific for the human HLA-B27 antigen are provided. The monoclonal antibodies are useful in diagnosis and therapy, particularly with respect to certain rheumatoid disorders.

Abstract: The invention relates to a method of detecting gram-negative bacterial endotoxin using antibody capture combined with amoebocyte lysate chromogenic detection. The method is highly sensitive and rapid and may be used for detection of specific endotoxin. In a particular application, picogram levels of Haemophilus influenzae type b endotoxin are detected in plasma taken from previously infected mammals. In another particular application, the method is applied to the detection and diagnosis of disease, through the detection of endotoxin from disease-causing organisms. A specific example is the diagnosis of chancroid through the detection of endotoxin from H. ducreyi.

Abstract: A combination of reagents including (i) a first liquid containing (a) first microcapsules having an analyte immobilized on surfaces thereof and containing a marker therein and (b) microcapsules encapsulating an antibody and having different capsule walls from said first analyte immobilized microcapsules with respect to susceptibility to a capsule wall lysin, and (ii) a second liquid containing complement is suitable for immunoassay based on complement-dependent immune lysis of microcapsules.

Abstract: A process for covalently bonding biopolymer, such as protein, to an organic polymer surface coated with hydrophilic nonionic polymer having groups reactive with the biopolymer and having a cloud point in the reaction medium that is at least 5.degree. C. above the temperature at which the coated organic polymer surface is to be used, which comprises reacting biopolymer with the surface in an aqueous reaction medium, at a temperature not less than 5.degree. C. below the cloud point; but not above a temperature at which the biopolymer is deleteriously affected, and preferably not above about 100.degree. C., the product comprises a biopolymer immobilized on a hydrophilic solid surface having a nonionic polymer and a hydrophilic layer, coupled thereto via biopolymer-reactive groups of the nonionic polymer, and accordingly has low spontaneous adsorption of proteins and other biopolymers through electrostatic attraction and/or hydrophobic interaction.

Abstract: A procedure for finding and identifying red cell antibodies by means of the solid-phase method, comprising contacting erythrocytes having selected antigen patterns with sera or plasmas that are to be tested for antibodies and transferred along with a polyspecific anti-human globulin reagent onto a substrate coated with protein A or protein G, thereby to transfer the detection or identification cells or, in the case of autocontrols, inherent cells.

Abstract: The present invention relates to an in vitro method to determine the safety of modified hemoglobin blood substitutes for human subjects prior to their clinical usages, wherein the method is based on complement activation reaction from adding modified hemoglobin blood substitutes to a human plasma sample and comprises the steps of: a) obtaining at least one plasma sample from at least one human subject by i) taking a blood sample and immediately centrifugating; and ii) separating the centrifuged blood sample of step i) and retaining the supernatant plasma; b) mixing the plasma of step ii) with the modified hemoglobin blood substitutes or control-ringer in a weight/volume ratio of about 4:1; c) incubating for a time sufficient to allow for a complement activation reaction to occur; d) adding the product of step c) to an appropriate volume of saline in an EDTA tube; and e) analyzing the degree of complement activation by analysis of the product of step d); thereby determining the safety of the modified hemoglobi

Abstract: The invention relates to a method of detecting gram-negative bacterial endotoxin using antibody capture combined with amoebocyte lysate chromogenic detection. The method is highly sensitive and rapid and may be used for detection of specific endotoxin. In a particular application, picogram levels of Haemophilus influenzae are detected in plasma taken from previously infected mammals.

Abstract: Methods for identifying individuals at increased risk of diabetes are disclosed. The methods disclosed utilize the discovery of the DQw3.2 variant, which identifies a specific allelic polymorphism at a sinle gene locus. One preferred method utilizes a labeled probe to detect the DQw3.2 allele. This method involves estimating the size of the hybridizable DNA fragment generated by a specific restriction endonuclease and therefrom determining the presence of the allele. A second preferred method involves the serologic detection of the DQw3.2 allele. Within this method, immunocomplexes formed between two different MAb's and separate portions of a cell collection are detected and the presence or absence of the allele determined.

Abstract: A method of immunologically determining free human protein S in an assay sample, which comprises contacting a primary antibody fixed to an insoluble solid carrier and a labelled secondary antibody with the assay sample, the primary and secondary antibodies having the property of binding to different epitopes of free human protein S, and one of the primary and secondary antibodies being a monoclonal antibody having the property of not binding to a complex of the human protein S and human complement cofactor C4b-binding protein (C4bp) but specifically binding to the free human protein S.

Abstract: Utilizing mouse monoclonal antibodies which recognize Rodgers 1 and Chido 1 epitopes carried on the C4A and C4B molecules, and heat aggregated IgG to activate C1, an immunoassay was developed for the quantitation of complement components, including total C4, C4A and C4B. Interassay variation was 12.4%, 11.5% and 10.8%, respectively. The immunoassay was compared to the quantitation of total C4 by radial immunodiffusion by testing 103 random white controls and gave a Pearson's product moment correlation coefficient of 0.81. Three genetic total C4 deficient individuals were nonreactive in all three assays. This activated assay is specific, reproducible and superior to existing methods for the quantitation of C4A and C4B and detection of the heterozygous C4 null states.

Abstract: A liposome immunoassay comprising the steps of reacting an analyte antigen, a liposome bearing antibody comprising a first antibody to the analyte antigen and a liposome encapsulating a marker therein linked to the antibody, and a second antibody to the analyte antigen to form an antigen-antibody complex, releasing the marker from the liposome in an amount depending on an amount of the analyte antigen in the presence of a complement, and measuring the released marker to determine the analyte antigen, characterized in using a third antibody capable of binding directly or indirectly to the second antibody and having an ability to activate the complement; andA kit for liposome immunoassay comprising at least one of; (1) an liposome bearing antibody comprising a first antibody to an analyte antigen and liposome encapsulating a marker therein linked to the antibody; (2) a second antibody to the analyte antigen; (3) a third antibody capable of binding directly or indirectly to the second antibody and having an abil

Abstract: A method for evaluating the potential immunogenicity of a protein derived from recombinant DNA technology. The method involves injecting an animal with the recombinant protein and then isolating antiserum from the animal. The antiserum is depleted of antibodies to a reference protein, i.e., a plasma derived protein, by adsorbing the antiserum against the reference protein. The adsorbed antiserum is then blotted against the recombinant protein, to see if any antibodies were produced which recognize the recombinant protein, but did not recognize the plasma-derived protein during adsorption.

Abstract: Microcapsule-reagents are prepared by previously reacting at least a part of an antigen or antibody attached to microcapsules encapsulating a labeling substance with an antibody or antigen which is specifically reactive therewith, and then the reagent thus prepared is reacted with a sample containing an antigen or antibody in the presence of a complement, whereby highly sensitive immunoassay of the antigen or antibody in the sample can be realized even when the antigen or antibody attached to the microcapsules has a lowered activity or has only low reactivity with the antibody or antigen in the sample.