Abstract: Retroviruses associated with Acquired Immune Deficiency Syndrome (AIDS), including Lymphadenopathy Associated Virus (LAV), are isolated from the sera of patients afflicted with Lymphadenopathy Syndrome (LAS) or AIDS. LAV is a Human Immunodeficiency Virus (HIV). Viral extract, structural proteins and other fractions of the retrovirus immunologically recognize the sera of such patients. Immunological reaction is used to detect antibodies that specifically bind to antigenic sites of the retrovirus in samples of body fluids from patients with AIDS or risk of AIDS. A kit for in vitro assay of LAS or AIDS is provided.

Abstract: Hybridomas secreting monoclonal antibody having specificity for and cytolytic against Trichomonas vaginalis are provided. The cytolytic monoclonal antibodies specific for T. vaginalis are useful in detecting the presence of T. vaginalis among a general population of micro-organisms found in a biological sample. Detection of the T. vaginalis is evaluated by observing cell lysis of T. vaginalis after contacting the cultured micro-organisms with the cytolytic monoclonal antibody specific for T. vaginalis. Therapeutic uses of the monoclonal antibody as an immunological anti-microbial reagent for the treatment of T. vaginalis infection are also disclosed.

Abstract: Early pregnancy can be determined by detection of a protein in milk, which protein is associated with the placental membrane. The protein is characterized by having an approximate molecular weight of 47,000 to 53,000 and an isoelectric point of from about 4.0-4.4.

Abstract: An agglutination immunoassay for antibody wherein antigen for sensitizing a solid particulate support is treated with detergent. The resultant antigen-sensitized support is resistant to self-agglutination.

Abstract: Compounds useful in a simultaneous multiple assay for analytes such as steroids, proteins, peptides, carbohydrates or drugs. The compound or compounds are prepared by labelling an individual analyte with a radioisotope through a chelating agent to form a coordinated compound. The assay uses one or more chelated labelled analytes with one or more labelled analytes wherein each radioisotope is different.

Abstract: A method of specimen treatment preparatory to conducting an immunoassay is disclosed whereby a microbial protein is solubilized by a detergent at elevated temperatures and in the presence of an alkali or alkaline earth metal ion. At elevated temperatures, the detergent is soluble. However, at lower temperatures, the presence of the metal ion renders the detergent insoluble so that it is prevented from interacting in the immunoassay procedure. A specific application is in the solubilization of the principal outer membrane protein of Chlamydia trachomatis.

Abstract: A preparation for the detection of chlamydial infections using lipopolysaccharide of Re-lipopolysaccharide mutants of gram-negative bacteria. The lipopolysaccharide preparation is used in the production of group-specific antibodies to chlamydiae for diagnostic purposes or for the demonstration of antibodies to chlamydial group antigen in specimens.

Abstract: A method and device for detecting an antigenic material in which the device comprises a test utensil having an indentation in which two reagent spots are placed, the first body being a dyed substrate having a coating of an antibody or antibody-like material thereon and the second of the two reagent spots comprising a dyed test-inert material or a dyed substrate with a coating of a normal animal serum, the dye employed in the second reagent spot having a different color than that employed in the first spot. When a liquid test sample is added to the indentation, the dyed substrate particles or components are suspended or solubilized, and the resulting suspension gives the appearance of a third color. A positive agglutination test is indicated by the formation of at least one spot having the color of the first dyed substrate against a background having the color of the second dyed substrate.

Abstract: A latex agglutination procedure for detecting and determining one of the participants in an antigen-antibody reaction, in which non-specific reactions are suppressed by additives, and an agent for carrying out this type of procedure are described.

Abstract: There is described an enzyme immunoassay for measuring the concentration of an analyte in a sample wherein the substrate for the enzyme forms at least a part of the sample. In a particular embodiment the sample comprises or consists of a milk sample and the enzyme is an enzyme capable of clotting milk. An example given of such an enzyme is chymosin. The assay described may be used to measure the concentration of progestagens or oestrogens in milk using the techniques of heterogeneous or homogeneous enzyme immunoassay. The results of such an assay give an indication of the fertility of a milk producing domestic animal (e.g. a cow) and may be used to diagnose pregnancy of such an animal. Particular compounds for use in the assay are described, as is a kit of reagents for use in the assay.

Abstract: The present invention relates to a method which eliminates centrifugation and decantation steps, to be performed in an automatic manner for carrying out specific binding assay tests, wherein liquid and solid phases are present.According to the invention, use is made of a specially designed device, consisting of a mixing reservoir into which is fitted snugly a mixer separator having a channel in the vertical axis of the mixer-separator. A rack holding a number of said mixing reservoirs containing the incubated reagents and analytes, capped with the mixer separators, is placed into a press-device designed to perform at a controlled rate a downward movement. The mixer separators are pushed downwards into the mixing reservoirs at a chosen rate for a preselected distance to complete the mass transport and separation operations. The separation devices are removed and either one of the separated phases can be measured in the desired analytical instrument for a quantitative or qualitative determination.

Abstract: Hybrid-myeloma cells which produce monoclonal antibody specific to the .beta. subunit of human chorionic gonadotropin and methods of use of the monoclonal antibody.

Abstract: In a particle agglutination assay for an antigen (Ag), there is included in the mixture a limited amount of a substance which binds univalently with a proportion of the Ag present, that Ag which is so bound being unable then to cause agglutination of the particles. In this way, unusually large concentrations of Ag can be assayed in that a proportion of the Ag is bound to the univalent substance and the particle agglutination assay is in effect conducted on the smaller amount of Ag still remaining free in solution.

Abstract: Early pregnancy can be determined by detection of a protein in serum, which protein is associated with the placental membrane. The protein is characterized by having an approximate molecular weight of 47,000 to 53,000 and an isoelectric point of from about 4.0-4.4.

Abstract: A method and reagent system for detecting pregnancy in a mammal at an early stage by detecting enhanced activation of blood platelets.

Abstract: An immunoassay and kit for determining a viral antigen, such as herpes simplex. In one embodiment, the antigen is immunocaptured by an insoluble matrix presenting IgG antibody against the viral antigen. The matrix resulting is subsequently contacted by biotin labeled monoclonal IgM antibody and labeled avidin.

Abstract: This invention relates to the detection of antibodies in sera of AIDS and pre-AIDS patients and describes the biochemical and immunological analysis of antigens associated with the virus HTLV-III Human T-Cell Leukemia Virus. It is shown that antigens associated with the infection of human cells by this virus are specifically recognized by antibodies from AIDS patients. Specifically, HTLV-III isolated from AIDS patients and transmitted by cocultivation with an HT cell line is specifically detected by antibodies from human sera taken from AIDS patients. The method of detection of antibodies preferred is a strip radioimmunoassay (RIA) based on the Western Blot technique or an ELISA (an enzyme-linked immunosorbent assay) or an indirect immunofluorescence assay.

Abstract: In an enzyme immunoassay, when a specific antibody produced by contacting a peptide essential to the formation of a specific antibody to a peptide antigen, a freeze-dried material of .beta.-D-galactosidase-enzyme conjugate or a peptide-enzyme conjugate prepared by coupling a labeling enzyme with a peptide of the general formula:H-R.sub.1 -Pro-Ser-Asp-Thr-Pro-Ile-Leu-Pro-Gln-OHwherein R.sub.1 is a peptide fragment consisting of 1 to 14 amino acid residues including Gly in the 14-position of the peptide Ala.sup.1 -Pro.sup.2 -Pro.sup.3 -Pro.sup.4 -Ser.sup.5 -Leu.sup.6 -Pro.sup.7 -Ser.sup.8 -Pro.sup.9 -Ser.sup.10 -Arg.sup.11 -Leu.sup.12 -Pro.sup.13 -Gly.sup.14 is used, a high reproducibility of the result of the enzyme immunoassay is obtained.

Abstract: Mixtures of monoclonal antibodies which contain effective assaying amounts of each of at least two monoclonal antibodies that bind to different antigenic sites on the antigen and are capable under appropriate conditions of binding simultaneously to an antigen are useful in enhanced sensitivity assays for the antigen. By utilizing such mixtures in diagnostic assays for important antigens such as the polypeptide human chorionic gonadotropin enhanced sensitivity can be achieved as compared with assays employing individual monoclonal antibodies.

Abstract: Hybridoma tumor cell line A.T.C.C. No. HB8116. An anti-H-Y antigen monoclonal antibody substance, "Hyclonalan," produced by said cell line. Use of Hyclonalan in immunoselection methodology.

Abstract: There is described an assay for determining the relative concentrations of two antigenic solutes in a sample. The assay involves a first antibody to the first antigenic solute, a second antibody to the second antigenic solute and a ligand molecule having substituents to which the first and second antibodies may bind. The second antibody is immobilized upon a solid phase support and the other components are in solution. The components are mixed with a sample containing the antigenic solutes causing competition between the ligand molecule and each of the antigenic solutes for binding to the first and second antibodies. In the situation where there is a relatively higher concentration of the first antigenic solute to the second antigenic solute in the sample, a significant number of the ligand molecules become attached to the solid phase via the second antibody yet are capable of binding to a labelled antibody having the same specificity as the first antibody.

Abstract: Method and kit for pregnancy detection adapted for self-performance. Urine to be tested is contacted with a lectin substrate being lectin bound to a solid support and capable of binding HCG. After separation of the lectin substrate from the urine the substrate is contacted with a liquid color reagent comprising a colored carrier material and anti-HCG antibodies bound thereto. If after separation of the colored reagent from the substrate the latter remains colored, the subject is pregnant, while lack of color indicates non-pregnancy. A preferred color reagent comprises killed and stained Staphylococci bacteria. There is also provided a kit for self-performance of the method comprising at least one column packed with a lectin substrate and adapted for the controlled passage of liquid therethrough, and a color reagent.

Abstract: Colorimetric detection of bindable substances such as antibodies and antigens using chromogens of improved sensitivity and stability. The chromogens take the form of activated solutions containing tetramethylbenzidine or water soluble derivatives of tetramethylbenzidine. Such chromogens are of particular use in home testing applications for detection of antigens such as human chorionic gonadotropin, human luteinizing hormone, and gonococcus bacteria, as well as the detection of antibodies for these substances.

Abstract: The present disclosure relates to a solid phase immunoassay for the detection of Chlamydia trachomatis antigens in a clinical specimen, wherein the Chlamydia trachomatis antigens to be determined are coated or adsorbed on the solid phase.

Abstract: In a method for immunochemical assay of human chorionic gonadotropin involving use of an antibody immobilized on a carrier, an antigen and an antibody to which a labeling agent has been attached, when the antibody supported on the carrier and the antibody coupled to a labeling agent are different antibodies which are not overlapping in antigen-determining site and one of said different antibodies is specifically reactive to human chorionic gonadotropin, a high reproducibility of the result of the immunochemical assay is obtained.

Abstract: The present invention relates to a novel method for the quantitative determination of PEP (progestagen-associated endometrial protein) in a body fluid by radioimmunoassay. The technique is useful in monitoring the function of the human endometrium.

Abstract: A method for direct serum assay of steroid hormones wherein the competition from binding protein, having an affinity for complexing with the steroid hormones, is significantly eliminated by adding to the serum an artificial compound which has a greater or equal affinity for the binding protein than do the steroid hormones, and which is not immuno-reactive with the steroid hormones. Because the compound is artificial, it is non-contaminating. Levonorgestrel and norethindrone as such compounds are disclosed.

Abstract: This invention relates to a highly-sensitive mini-iodinated radioactive hormone tracer which has both initial low iodine-to-hormone molar ratios and low specific activity. This invention also relates to methods for preparing and using such tracers in a radio-immunoassay which takes much less time than used heretofore and to a method of preparing said tracers.

Abstract: The present invention relates to a method which eliminates centrifugation and decantation steps, to be performed in an automatic manner for carrying out specific binding assay tests, wherein liquid and solid phases are present.According to the invention, use is made of a specially designed device, consisting of a mixing reservoir into which is fitted snugly a mixer separator having a channel in the vertical axis of the mixer-separator. A rack holding a number of said mixing reservoirs containing the incubated reagents and analytes, capped with the mixer separators, is placed into a press-device designed to perform at a controlled rate a downward movement. The mixer separators are pushed downwards into the mixing reservoirs at a chosen rate for a preselected distance to complete the mass transport and separation operations. The separation devices are removed and either one of the separated phases can be measured in the desired analytical instrument for a quantitative or qualitative determination.

Abstract: The present invention relates to a new technique and device for mass transfer of one or more components from one liquid phase to another liquid phase, involving a physical separation of said two phases.According to the new technique, the mass transfer and physical separation are carried out in the same device. The device consists of a mixing-reservoir into which is fitted snugly a mixer-separator, having a channel in the vertical axis of the mixer-separator. The two substantially immiscible liquid solutions are introduced into the mixing reservoir, the phases are thoroughly mixed, by moving the mixer-separator in and out the mixing reservoir. After the spontaneous separation into an upper and lower phase, the upper phase is removed by pushing in the mixer-separator said upper phase being accumulated in a collecting container.

Abstract: A method is provided for determining the concentration of pregnanediol glucuronide (PG) in a woman's urine which is characterized by utilization of the reagent 20.alpha.-hydroxy-4-pregnen-3-one (20-.alpha. reagent) in a form in which it reacts with antibodies binding to PG. The method is adaptable to a visual color indication test which can be performed by the woman herself as well as by laboratory analysis. The method can be used to define the period in which conception can occur, to define a post-ovulation safe period in which conception is prevented, and as an early pregnancy indicator.

Abstract: Latex agglutination test methods and kits. Employing dyed latex polymer particles and adding a water-soluble, non-latex polymer particle absorbing dye contrasting in color to the dyed latex polymer particles produces a reaction mixture that changes color when agglutination occurs. Direct and indirect latex agglutination tests are contemplated which are useful in detecting disease states or physiological states such as pregnancy.

Abstract: Process for the preparation of test reagents comprising antigens or antibodies adsorbed on a surface, for example, the surface of synthetic or natural polymer particles in which the test material to be adsorbed is dissolved in a solvent in contact with the adsorbing surface and precipitated by the addition of a liquid which is miscible with the solvent, but does not dissolve the test material.