Abstract: This invention is directed to a vaccine for the prevention of disease caused by Bordetella pertussis which comprises the pertussis antigens filamentous hemagglutinin, detoxified lymphocytosis promoting factor and a 69 kilodalton outer membrane protein, where said antigens are individually purified prior to being combined to form the vaccine. The invention is further directed to pertussis vaccines where the antigens are combined in any ratio, including ratios not possible in whole cell or co-purified acellular pertussis vaccines. The pertussis antigens may be further combined with other individually purified pertussis antigens, pertussis structural components, adjuvants, stabilizers and non-pertussis vaccine components.

Abstract: A light emitting method of an acridinium ester, comprising reacting said acridinium ester and a superoxide anion, and a method of detecting a substance to be examined, comprising detecting a light emitted by reacting a superoxide anion with an acridinium ester used as a label are described. It is possible to carry out the reaction not under strongly alkaline conditions but around the neutral point and to generate strong luminescence which is stable over a long period of time.

Abstract: Antibodies having binding affinity for free IGFBP-1, biological compositions including antibodies having binding affinity for free IGFBP-1, kits for detecting free IGFBP-1 using the antibodies, and cell lines for producing the antibodies are provided. Also provided are devices and methods for detecting free IGFBP-1 and a rupture in a fetal membrane based on the presence of amniotic fluid in a vaginal secretion, as indicated by the presence of free IGFBP-1 in the vaginal secretion. The antibodies that are provided may be characterized by their ability to selectively recognize those IGFBP-1 molecules which are free of IGF-1 and IGF-2, i.e., antibodies which have a binding affinity for free IGFBP-1 that is greater than a binding affinity of the antibody to bound IGFBP-1. These antibodies may also be characterized by their competition with IGF-1 and IGF-2 for binding to IGFBP-1.

Abstract: The present invention is directed to protamine-reactive, IgM antibodies, and their uses in prognosis, diagnosis, and therapy. In a specific embodiment, the invention relates to low affinity binding, protamine-reactive serum IgM antibodies. In particular, such antibodies can recognize a sequence comprising four arginyl residues, including a triplet, within a six amino acid residue sequence. Such antibodies may be natural antibodies (i.e., not induced). A low affinity subset of serum protamine-reactive IgM antibodies may be assayed for prognosis or diagnosis of AIDS. Such antibodies are detectable in sera of normal subjects and HIV-infected individuals who subsequently exhibit a significant period of latency, but are absent or deficient in sera of individuals diagnosed with AIDS and sera of HIV infected individuals, who though asymptomatic at the time of the sampling, proceed to AIDS within a relatively short time.

Abstract: A method for determining a cell surface antigen comprising(a) immobilizing an antibody specific for the cell surface antigen to be determined on a solid phase;(b) immobilizing sample cell suspected of containing said cell surface antigen with the solid-phase antibody to bind the cell surface antigen and antibody;(c) the solid phase is washed after incubation; and(d) the presence of the cell surface antigen is detected by means of a property inherent to the cell by cellular enzymatic activity.

Abstract: An oligopeptide having an amino acid sequenceGlu Pro Gly Asn Ser Glu Ile Leu Pro Thr Leu Lysand variants thereof; immunogenic conjugates obtained therefrom; antibodies produced by means of said conjugates and which specifically recognize human plasma glutathione peroxidase (pl.GPx); methods for assaying human plasma glutathione peroxidase (pl.GPx); and assaying kits. The invention is useful in the medical diagnosis, treatment and monitoring of pathologic conditions induced by a variation in pl.GPx, for example, hepatic tumors, acute rejection of renal or hepatic graft, renal insufficiency and selenium deficiency.

Abstract: Methods are provided for determining in biological material the presence or amount human cyclin E polypeptide and/or cyclin E:cell division kinase complexes.

Abstract: Disclosed are a composition and method for determining the levels of specific immune responsiveness to a glycoprotein in an individual being treated therewith by (i) contacting a body fluid sample obtained from the individual prior to glycoprotein treatment with glycoprotein that has been modified to have an oxidized carbohydrate portion; (ii) contacting a body fluid sample obtained from the individual subsequent to glycoprotein treatment with the glycoprotein that has been modified to have an oxidized carbohydrate portion; and (iii) observing the degree of difference in the specific immune response to the oxidized glycoprotein in the pre- and post-treatment samples.

Abstract: The present invention discloses novel immunogens, antibodies prepared from such immunogens, and labeled reagents useful in immunoassays for the detection and quantification of testosterone in a test sample. Also disclosed are immunoassays using these reagents and methods for synthesizing these reagents. The immunoassays are preferably microparticle enzyme immunoassays (MEIAs) and fluorescence polarization immunoassays (FPIAs). Further disclosed are novel starting materials for making the above novel immunogens and labeled reagents. Methods for making the novel immunogens and labeled reagents from the novel starting materials are also disclosed.

Abstract: The present invention provides methods for separating ligands from binding proteins. The methods include acidic separation and size separation. The methods of the present invention are particularly useful for separating insulin-like growth factors from insulin-like growth factor binding proteins.

Abstract: This invention relates to identification of a new key marker namely 9-O-Acetylated sialoglycoconjugate with the help of a known 9-O acetylsialic acid binding lectin, Achatinin-H useful for the diagnosis of visceral leishmaniasis, by a rapid, accurate haemagglutination assay.

Abstract: The present invention provides a method for targeting boron atoms to tumor cells in a patient. The method comprises the steps of:(A) administering a targeting composition comprising a conjugate of a first member of a binding pair and an antibody, wherein the antibody selectively binds to antigens produced by or associated with the tumor cells, and allowing the conjugate to localize at said tumor cells;(B) optionally, administering a clearing composition, and allowing the clearing composition to clear non-localized conjugate from circulation;(C) administering a boron-containing compound comprising a conjugate comprising a complementary member of said binding pair and boron atoms, and allowing the compound to localize at the tumor cells. The method may further comprise the step of irradiating the boron atoms of the boron compound, thereby effecting BNCT of the tumor cells. Compositions and kits for carrying out the method also are provided.

Abstract: A conjugate of at least two binding sites that bind specifically to the analyte-specific binding region of the receptor that is used for detection in a test, wherein the binding sites are linked by at least one soluble carrier substance and the conjugate is a product of a synthetic or recombinant production, dissolved in an aqueous solution in an exactly known amount is particularly suitable as a stable calibrator in a test for the detection of an analyte.

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: An in vitro immunoassay to detect and quantitate soluble crosslinked and non-crosslinked DesAABB fibrin polymers in a sample from a subject. The assay can be used to support a diagnosis of, to evaluate, and to monitor, in a mammalian subject, a thrombotic event, including, but not limited to, myocardial infarction, pulmonary embolism, stroke and deep vein thrombosis.

Abstract: The present invention provides methods for determining the concentration of analytes in liquid samples in which the amount of binding agent having binding sites specific for a given analyte in the liquid sample is immobilized in a test zone on a solid support, the binding agent being divided into an array of spatially separated locations in the test zone. The concentration of the analyte is obtained by back-titrating the occupied binding agent with a developing agent having a marker and integrating the signal from each location in the array. The present invention also provides a method for determining a value representative of a fraction of binding sites of the binding agent which are occupied by the analyte, comprising immobilizing the specific binding agent on a solid support, wherein the specific binding agent used for the fractional occupancy is present in an amount less than 0.

Abstract: The invention relates to in vitro detection of human pancreatitis-associated protein (hPAP) for the purpose of screening for cystic fibrosis. hPAP is quantitated in a biological sample, preferably blood, and a high value is indicative of pancreatic dysfunction. Immunoassays as rapid, reliable methods for hPAP quantitation are provided as are antibodies for use in the assays and hybridomas for production of monoclonal antibodies preferred for use in the assays.

Abstract: An assay, and kit, for the quantitation of cardiac troponin I in human biological fluid is provided. The assay involves a sandwich assay employing an antibody specific for cardiac troponin I as one binding partner for cardiac troponin I and troponin C as the other binding partner for cardiac troponin I.

Abstract: Disclosed is a method of diagnosing sepsis in a human infant. The method includes detecting an increase in the expression of leukocyte cell surface antigens in a blood sample from an infant at risk for developing sepsis.

Abstract: A novel enzyme sandwich immunoassay cassette comprising a microporous membrane support having coated thereon:(a) a conductive metal layer; and(b) a capture antibody layer over the conductive metal layer.