Abstract: Diagnostic assays are provided comprising complementary enzyme fragments of .beta.-galactosidase, where one of the fragments is bound to a support and the other fragment is conjugated to an immunologically cross-reactive epitope of the analyte or complementary to an analyte receptor. Binding to the receptor allows for discrimination between complexed enzyme fragment conjugate and uncomplexed enzyme fragment conjugate. The assay medium is then allowed to wick onto a support to which the complementary fragment is substantially uniformly bound in the detection region. The support is then developed, where color formation from the substrate in the detection region is used as a measure of the presence of analyte in the sample.

Abstract: A method for detecting the onset or presence of Lyme disease in a mammal, which comprises isolating a biological sample from the mammal, isolating from said biological sample any circulating immune complexes suspected to contain antibody reactive to Borrelia burgdorferi, dissociating the immune complexes so isolated, and examining the dissociated immune complexes for the presence of antibody. The present method offers a simple and reliable means for detecting Borrelia antibodies. Test kits and related methodology are also disclosed.

Abstract: A test kit useful for the determination of an immunological ligand includes a labeled receptor for that ligand, a specific wash solution and a test device. The wash solution is buffered to a pH of from about 5 to about 9 and contains at least 0.01 weight percent of a compound having a dodecyl sulfate anion and an alkali metal or ammonium cation. One such compound is sodium dodecyl sulfate. The test device has several test wells, and in each well there is a microporous membrane. A receptor for the ligand of interest is immobilized in one test well. The kit is particularly useful for measuring human chorionic gonadotropin as an early indicator of pregnancy.

Abstract: The present invention is directed to in vitro and in vivo immunodiagnosis and immunotherapy using monoclonal antibodies reactive with difucosyl blood group antigens Y-6 and B-7-2.

Abstract: A buffered aqueous composition is useful simultaneously as a wash solution and a dye-providing composition in specific binding assays involving enzyme-labeled specific binding reagents. The wash composition includes a dye-providing composition, a buffer and an organic solvent having a certain molecular weight and water-solubility. Another useful composition includes a particulate substrate having avidin attached thereto, and a peroxidase reducing agent. Either composition can be provided in a diagnostic test kit, and can be used to detect a specific binding ligand in assays.

Abstract: A method for diagnosing hepatic carcinoma, which is characterized by enzyme-immunologically measuring the amount of collagenase inhibitor present in sera, plasmas of synovial fluids by way of a sandwich assay wherein two different monoclonal antibodies which specifically bind to different antigenic determinants of the collagenase inhibitor are used, and comparing the measured amount with that for normal subjects.

Abstract: Substantially pure modified .beta..sub.2 -microglobulin (m.beta..sub.2 m) of the formula I ##STR1## wherein R.sub.1 is 24-amino acid residue, with the sequence Ile-Gln-Arg-Thr-Pro-Lys-Ile-Gln-Val-Tyr-Ser-Arg-His-Pro-Ala-Glu-Asn-Gly-Ly s-Ser-Asn-Phe-Leu-Asn, R.sub.2 is a 30-amino acid residue with the sequence Tyr-Val-Ser-Gly-Phe-His-Pro-Ser-Asp-Ile-Glu-Val-Asp-Leu-Leu-Lys-Asn-Gly-Gl u-Arg-Ile-Gly-Lys-Val-Glu-His-Ser-Asp-Leu-Ser, R.sub.3 is a 20-amino acid residue with the sequence Trp-Ser-Phe-Tyr-Leu-Leu-Tyr-Tyr-Glu-Phe-Thr-Pro-Thr-Glu-Lys-Asp-Glu-Tyr-Al a, R.sub.4 is a 19-amino acid residue with the sequence Arg-Val-Asn-His-Val-Thr-Leu-Ser-Gln-Pro-Lys-Ile-Val-Lys-Trp-Asp-Arg-Asp-Me t, X is Phe, Phe-Ser, or Phe-Ser-Lys, and Y is Asp, Lys-Asp, or Ser-Lys-Asp is disclosed. The presence of the protein in body fluids is a diagnostic and/or prognostic marker for the development of a variety of disorders such as different types of cancer and diseases involving the immune system. Also disclosed are specific anti-m.

Abstract: Monoclonal antibodies against complement regulatory protein sgp 120 are provided.

Abstract: Immunodiagnostic assays for the detection and determination of mastitis and sub-chemical mastitis comprise capturing neutrophils or fragments or soluble products thereof in a milk sample on an insolubilized form of a corresponding antibody, optionally using conditions whereby the cells in the milk sample are lysed. Monoclonal antibodies are provided which can be used in said assays and which are specific to neutrophils.

Abstract: A method for determining the adequacy of a cervical or urethral test specimen collected for an immunological assay to detect the presence of Chlamydia trachomatis. Cells present in the specimen are disrupted to expose a substance present in or on C. triachomatis that is detectable by immunological reaction. In order to determine if the test specimen contains an adequate amount of the cervical or urethral cell type that serves as a host cell for C. trachomatis, the disrupted specimen is also reacted with an immunological reagent that produces a detectable complex upon specific binding with a substance present in or on columnar epithelial cells. The present invention therefore provides a control reaction that verifies the adequacy of the collected test specimen and thereby increases the confidence that a negative test result for the presence of Chlamydia indicates the absence of a C. trachomatis infection in the patient.

Abstract: The invention is a method for measuring a hapten poorly soluble in aqueous solution in a sample which includes the steps of reacting the hapten with an antibody specific for the hapten; and comparing the result of the reaction of the hapten and the antibody with the result of the reaction of the antibody and a water-soluble conjugate of the hapten and a water-soluble macromolecule having a molecular weight greater than about 1,000.

Abstract: This invention relates to the identification of verocytotoxin receptors of the formula:X--O--Y(R) (I)wherein Y is sphingosine, hydroxylated sphinogosine or saturated sphingosine,wherein X is selected from said group and optionally a polysaccharide linking X to the --O--Y(R) group, andwherein R is H, or a fatty acid and R is linked to the amine moiety of the sphingosine,in combination with an assay component and their use in novel receptor-binding assays for the detection and quantitation of verocytotoxins.

Abstract: Monoclonal antibodies binding Mycoplasma genitalium more strongly than Mycoplasma pneumoniae, Mycoplasma hominis, Mycoplasma orale, Mycoplasma salivarium and Acholeplasm laidlawii are described herein. These monoclonal antibodies are utilized in immunoassays directed toward the detection of M. genitalium infections. Hybridomas producing the above-described monoclonal antibodies have been created and isolated. These monoclonal antibodies are directed toward M. genitalium antigens. Certain antibodies bind protein antigens, while others bind lipid antigens. In one case a particular antibody apparently has binding affinity for both protein and lipid antigens of M. genitalium.

Abstract: An assay method and compositions are provided for determining the presence of an analyte in a sample. The analyte is a member of an immunological pair (mip) comprising ligand and receptor. By providing a first measurement surface capable of specifically binding a labelled reagent in an amount depending upon the presence of analyte in the sample and a second calibration surface capable of binding a second labelled reagent in a manner unaffected by the presence of analyte in the sample, calibration of individual tests can be accomplished simultaneously with the performance of the test itself. A signal producing system includes an enzyme, a catalyst usually bonded to a mip which defines the first labeled reagent for binding to the measurement surface and the same catalyst conjugated to a ligand capable of binding to the calibration surface. Preferably, both labeled reagents have the same composition and the calibration surface includes anti-(first catalyst).

Abstract: A method of quantitation of human pulmonary surfactant characterized by determining the quantity of human pulmonary surfactant in the test sample according to the immunological method by use of the primary monoclonal antibodies which recognize the human pulmonary surfactant apoproteins and the labeled secondary monoclonal antibodies which recognize said apoproteins but bind to a part of the antigen which is different from the one to which the primary monoclonal antibodies bind, and a reagent kit to be used for the quantitation.

Abstract: Highly sensitive reagent for colorimetrically determining N-acetyl-.beta.-D-glucosaminidase (NAGase) activity by the continuous method, comprising sodio-3,3'-dichlorophenolsulfonphthaleinyl N-acetyl-.beta.-D-glucosaminide and a buffer, with which renal dysfunction can be diagnosed precisely, quickly, and easily.

Abstract: Immunoreagents for the release, non-specific capture and detection of lipopolysaccharides (LPS) that may be diagnostic for microorganisms causative for, among other things, Chlamydia trachomatis or Chlamydia psittaci are described.

Abstract: Herpes simplex viral antigen can be readily determined by contacting a specimen containing Herpes simplex virus of herpes simplex viral-infected cells with polymeric particles which have a surface area of from about 0.1 to about 600 m.sup.2 /g. Within a few minutes of this contact, antigen which is bound to the particles is contacted with antibodies thereto so as to form an immunological complex on the particles. Bound complex is separated from uncomplexed materials, and the presence of the complex is then appropriately determined. A kit for determining herpes comprises the particles described above, a disposable test device having a microporous membrane and antibodies to herpes simplex viral antigen.

Abstract: Diagnosis of Lyme disease by immunoassay for anti-Borrelia burgdorferi antibodies in the serum of a patient includes adsorption of crossreactive antibodies in the serum with antigen of Acinetobacter calcoaceticus or Treponema phagedensis prior to binding of anti-Borrelia antibodies to Borrelia burgdorferi antigen absorbed onto a solid support. The preferred assay is a flow-through assay using a porous membrane as the support and a dye-loaded liposome conjugated to a goat antihuman antibody for detection. The invention includes a kit of materials for performing the assay.

Abstract: Erroneous-positive results free method for the detection of moulds in foodstuffs and in human and animal body fluids with the aid of an immunological determination of the extracellular polysaccharide (EPS) produced by the mould; this method is characterized in that (a) an immunological determination of the EPS produced by the mould is carried out and, in the case of a positive result, subsequently (b) an immunological determination is carried out in the presence of a synthetically prepared epitope of the EPS investigated and the EPS investigated itself.