Abstract: An analytical device for fluid samples includes a fluid sample well means connected to a sample initiation area in such a fashion that the assay will not commence unless sufficient sample is introduced into the sample well means to conduct the assay. Once sufficient sample has been deposited into the sample well means, the sample flows into an initiation area and the assay commences.

Abstract: A monoclonal antibody specifically reactive to hamster immunoglobulins, a hybridoma producing said monoclonal antibody, and an immunoassay utilizing said monoclonal antibody are provided. The monoclonal antibody is useful in an immunoassay as a secondary antibody to a hamster-derived primary antibody or antiserum raised against various antigens.

Abstract: A method for the rapid screening of a drug targeted to the V3 hypervariable loop of the human immunodeficiency virus type 1 or type 2 envelope glycoprotein gp 120 comprising measuring the inhibitory effect of the drug on the interaction between gp 120 (or an antigen comprising the V3 hypervariable loop of HIV 1 gp 120 or HIV 2 gp 120) and antibodies specific for the V3 hypervariable loop, and anti-HIV chemotherapy with drugs binding to the V3 hypervariable loop.

Abstract: Heme-containing proteins, such as cytochrome c, are useful in admixture with enzyme-labeled immunoreactants, such as peroxidase-labeled antibodies or fragments thereof. The heme-containing proteins and enzyme-labeled immunoreactants can be supplied in a buffered composition as part of a test kit. The buffered composition comprising the heme-containing protein and peroxidase-labeled immunoreactant excludes 4'-hydroxyacetanilide, which is a phenolic electron transfer agent. The composition can be used in immunoassays for detecting various immunologically reactive species, such as hCG, and chlamydial or gonococcal antigens.

Abstract: Terminal hair follicles of the human scalp in the anagen phase of growth are distinguished from non-terminal follicles or from terminal follicles in phases of growth other than anagen by the presence of L-fucose on the cell membranes of the infrainfundibular portion of suprabasal keratinocytes of the follicles. L-fucose can be detected by a lectin specific for it. Accordingly, a method for identifying terminal hair follicles in the anagen phase of growth in the human scalp comprises the steps of: (1) contacting the cell membrane of the infrainfundibular portion of suprabasal keratinocytes with a lectin capable of specifically binding L-fucose on the cell membrane of the infrainfundibular portion of the keratinocytes; and (2) identifying terminal hair follicles by determining the lectin bound, the lectin preferentially binding to terminal hair follicles in the anagen phase of growth as opposed to terminal hair follicles in phases of growth other than anagen or non-terminal hair follicles.

Abstract: Disclosed is a method for the screening of pathological condition in the intestinal tract of an animal or a human being, e.g., intestinal ischemia, necrotizing enterocolitis, inflammatory bowel disease and bowel graft rejection. The method assays elevated levels of lipid binding protein, more particularly intestinal fatty acid binding protein, in a biological sample obtained from the animal or human being. Serum or urine are preferred biological samples. Preferred methods employ an immunological assay such as a radioimmunoassay or an enzyme-linked immunosorbent assay for the detection of intestinal fatty acid binding proteins in the sample.

Abstract: Immunoadsorbent combinations for the detection and diagnosis of group B streptococcus polysaccharide antigen, comprising an insoluble carrier, a capture agent having an affinity for specifically binding to the trirhamnose epitope of group B streptococcus antigen and having the formula .alpha.-L-Rhap(1.fwdarw.2)-.alpha.-L-Rhap(1.fwdarw.2).alpha.-Rhap- 1- wherein Rhap is rhamnose, and an antigen marker agent having an affinity for binding to monorhamnose epitope of group B streptococcus polysaccharide antigen of formula .alpha.-L-Rhap-1- when the group B streptococcus polysaccharide is bound to the carrier. An immunoassay method test kit and polyclonal antibody are also described.

Abstract: Methods and compositions for membrane flow-through assays using substrate and enzyme conjugate is described. A preferred method of the present invention comprises providing E. coli alkaline phosphatase (ECAP) conjugate, with additional color enhancement provided by combining lithium salt with the substrate, calcium and/or magnesium salts with the conjugate, and polyalcohol polymers with the conjugate. Color development is further enhanced by spotting tetrazolium dyes, such as the Nitro Blue tetrazolium series, onto the membrane.

Abstract: The invention provides a method for determining the presence of products of conception in a sample derived from the uterus during a D&C, or a therapeutic or spontaneous abortion, and comprises determining the presence in the sample of a fetal restricted antigen, which is found in products of conception but not found in significant amounts in maternal plasma or serum. Since the fetal restricted antigen is not present in significant quantities in maternal plasma or serum, the methods of this invention are reliable even when the sample is contaminated with maternal blood. One fetal restricted antigen is fetal fibronectin.In one embodiment of this invention, the sample is contacted with an insoluble support to which anti-(fetal restricted antigen) antibody is adhered, and the fetal restricted antigen binding to the support is determined.

Abstract: The present invention is directed to monoclonal antibodies, and hybridomas which produce them, which are preferentially reactive with glycated albumin and insignificantly reactive with other proteins, as well methods of using these monoclonal antibodies to detect glycated albumin.

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: This invention relates to a method for the immunoassay of ddI (2',3'-dideoxyinosine), also known as didanosine, in biological fluids such as serum, semen, plasma and urine, as well as other body fluids. The invention also includes (1) various novel analogs of ddI useful in preparing immunogens for antibodies to ddI and in preparing labeled ddI, (2) immunogens for antibodies to ddI, (3) antibodies to ddI, (4) labeled ddI analogs and (5) diagnostic test kits for the immunoassay.

Abstract: Receptors, characterized by the fact that they consist of the product obtained by affinity chromatography on a column coupled with 3 G8 antibodies or lectins or polyclonal anti-receptor FcR antibodies of a biological fluid of human origin, then by gel permeation. The spectrum of said product, electrophoresis acrylamide gel in reducing condition, comprising a major band corresponding to a molecular mass of between 72000 and 76000 daltons, and a number of minor bands. According to its purified form, the receptor consists of a glycoprotein with a molecular mass of between 72000 and 76000 daltons, recognized by ELISA and Western Blotting by the monoclonal anti-Leu 11b antibody. Application of said receptors to diagnosis and to follow-up treatment of diseases involving Fc receptors (infectious diseases, diseases of the autoimmune system, rejection of transplants, cancer and myeloma and AIDS), as well as to the study of human polymorphisms.

Abstract: Screening methods to obtain suitable antibodies for use in immunoassays for analytes not ordinarily susceptible to detection by this means involves in vitro screening of panels of cells secreting a representative selection of antibodies. An application of this method also permits the preparation of specific mimotopes which mimic the immunological activity of the desired analyte, which mimotopes can then be used as competitors in the immunoassay or can be used to immunize subject mammals in order to improve the specificity and affinity of the antibodies. Methods to identify a particular analyte by its pattern of binding strength to a panel of related antibodies and to match an arbitrary analyte with an immunoreactive member of a panel of candidate antibodies are also disclosed.

Abstract: Ligand reagents are disclosed which consist essentially of recombinant hyperglycosylated cytokines, expressed in yeast, which are purified and conjugated to various functional moieties, for example, biotin groups, via oligosaccharide residues.

Abstract: A two part peroxide/chromogen reagent for use in peroxidase labeled binding assays which is stable for at least about 24 hours is disclosed. The reagent is provided as two components, the first component preferably incorporating a peroxide dissolved in a first solvent, and the second component preferably having a chromogenic substance dissolved in a second solvent where the two components can be mixed within about 48 hours of colorimetric detection of an enzyme immunoassay.

Abstract: Immunopurification of Protease Nexin-2 and .beta. amyloid precursor protein is disclosed. Methods of detecting Protease Nexin-2 and the use of these methods in the diagnosis of Alzheimer's disease and other conditions are also disclosed. Additionally, pharmaceutical preparations including Protease Nexin-2 or modified forms thereof are disclosed. Medical uses for the pharmaceutical preparations are also disclosed.

Abstract: A rapid immunoassay device comprising a single porous membrane that serves as both a reagent support and a spent reagent reservoir is disclosed. The immunoassay device directs the flow of sample and reagents within the device in a manner that eliminates both lateral diffusion and backflow of reagents without the necessity of additional external means.

Abstract: An immunoenzymatic method for the detection of anti-Plasmodium falciparum-sporozoite antibodies in a sample of human blood, which operates, in homogeneous phase, and under suitable conditions, with a synthetic polypeptidic antigen (P), a synthetic antigen-enzyme (P-E) conjugate, wherein said antigen is capable of specifically reacting with the anti-Plasmodium falciparum-sporozoite antibodies (Ab) possibly present in the sample, and an inert substance capable of quantitatively precipitating the antibody-synthetic antigen-enzyme complex (Ab-P-E).The method, due to its specificity, sensitivity, reproducibility and rapidity, is particularly useful in the epidemiological investigations into malaria and in the evaluation of the efficacy of an antimalarial vaccine.

Abstract: The claimed invention relates to a substrate for evaluating glycosidic enzymes comprising a fluorescein derivative of the general formula: ##STR1## wherein GlyX is a carbohydrate bonded to fluorescein by a glycosidic linkage;Y, which may be the same as GlyX or different, is an alkyl ether, an ester, or a glycosidically linked carbohydrate;R is a lipophilic residue containing from 1 to 21 carbon atoms; andL links the R residue to fluorescein.A preferred embodiment of the invention is a non-fluorescent substrate specifically hydrolyzable by a glycosidase inside a cell to yield, after greater than about 2 minutes, a fluorescent detection product excitable at between about 460 nm and 550 nm and with fluorescence observable at an emission wavelength longer than the excitation wavelength, which fluorescent detection product is retained inside a viable cell more than about 2 hours at greater than about 15.degree. C. and which is non-toxic to the cell.

Abstract: An apparatus for determining an analyte in a sample, as well as a method for carrying this out, are disclosed. The apparatus utilizes a first zone containing a labeled substance, and a second zone which permits separation of a mobile detectable moiety from unreacted reaction component. Detectable moiety is the product of reaction between reaction component and labeled substance.

Abstract: There is disclosed a process and a device for detecting and measuring (1) the amount of enzyme present as a detecting system following a nucleic acid hybridization reaction or immunoreaction; (2) the level and activity of free enzyme in a biological sample; (3) the level of enzyme from contaminating microorganisms present in a sample; and (4) enzymes from pure culture isolates for microbial identification and antimicrobial susceptibility testing.

Abstract: The new hybridoma cell lines RF-HBs-1, RF-HBs-2 and RF-HBs-4 each secrete a nonoclonal antibody to hepatitis B surface antigen. The production of the antibodies may be carried out in vitro by culturing one of the cell lines or in vivo by establishing one of the cell lines as an ascites tumour in a mouse and isolating antibodies from the ascites fluid or from the serum. The antibodies have therapeutic, preventative and diagnostic uses in respect of hepatitis B virus infections and can be used to purify hepatitis B surface antigen. The relative specificities of the three monoclonal antibodies make them particularly useful in radiometric assay techniques employing specific combinations of the antibodies in solid phase.

Abstract: The present invention relates to a method and associated agents for measuring the presence and amount of advanced glycosylation endproducts in cells and fluids. The methods take advantage of the existence of receptors and receptor complexes for AGEs and include receptor-containing ligands comprising whole mesangial and other cells, mesangial cellular fragments and protein extracts therefrom. Competitive assays, sandwich assays and assays involving AGE antisera are disclosed. Numerous diagnostic applications are defined and test kits are also contemplated.

Abstract: A microassay card for a includes an upper layer containing wells for receiving a liquid sample. A second layer of the card, beneath the first layer, includes a supporting surface bound to a reactive species. A third layer includes a superabsorbent support impregnated with an indicator. Typically, the indicator is a substrate for an enzyme, such as a reduced dye precursor and a source of hydrogen peroxide necessary for the action of the enzyme upon the substrate to cause a spectral change in the absorbent layer. By selecting the structure of the first and second layers, the card can be formatted for a displacement assay or a competitive assay. The microassay card of the present invention is particularly useful for drug testing.

Abstract: A method and kit are provided for determining levels in a biological sample of free IGF-I, IGF-II, or GH ligand that is normally associated in the sample with a binding protein. This method involves contacting the body fluid with an immobilized unlabeled capture reagent and incubating at 4.degree.-10.degree. C. for no greater than about 4 hours to bind the free ligand contained in the body fluid; separating the fluid from the immobilized capture reagent; and measuring the level of free ligand now bound to the capture reagent. This method is particularly useful to determine levels of free IGF-I in serum or plasma.

Abstract: The invention relates to DNA molecules coding for human CENP-B polypeptides. The invention provides DNA molecules comprising an epitopically functional part of the cDNA sequence of human CENP-B polypeptide. The inventBACKGROUND OF THE INVENTIONThis work was supported a Grant from the National Institutes of Health. The U.S. Government may retain certain rights in this invention.

Abstract: The present invention concerns a method to catalyze reporter deposition to improve detection or quantitation of an analyte in a sample by amplifying the detector signal which comprises reacting an analyte dependent enzyme activation system with a conjugate consisting of a detectably labeled substrate specific for the enzyme system, said conjugate reacts with the analyte dependent enzyme activation system to form an activated conjugate which deposits substantially wherever receptor for the activated conjugate is immobilized, said receptor not being reactive with the analyte dependent enzyme activation system. In another embodiment the invention concerns an assay for detecting or quantitating the presence or absence of an analyte in a sample using catalyzed reporter deposition to amplify the reporter signal.

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 new circulating factor from the parathyroid gland of some hypertensive mammals have been isolated and characterized. Polyclonal and monoclonal antibodies raised against this factor are usable as a screen for the presence of the factor. The factor is involved in the control of calcium uptake in cells. Hypertensive mammals may be treated to lower mean blood pressure by administering a calcium channel blocking agent together with one or both of a calcium supplement and Vitamin D. The hypotensive effect of this combination is synergistic and the dose response is more predictable than the administration of any of these agents singly. The factor has a molecular weight of 3,000 to 4,000 Daltons.

Abstract: An immunoassay procedure is provided which exhibits increased specificity over current procedures. The procedure allows the differentiation of animals infected with Brucella abortus from animals vaccinated with Brucella abortus Strain 19. The invention employs unique monospecific monoclonal antibodies having particular affinity, specificity and binding characteristics directed to a B. abortus lipopolysaccharide antigen. The invention also concerns continuous hybrid cell lines for producing the unique monoclonal antibodies.

Abstract: A method for amplifying enzyme activity is disclosed. Enzyme amplification is achieved by covalently bonding enzyme to a supporting material via a molecular chain which is a substrate for the enzyme, then introducing a small amount of enzyme in the free state to this system, causing release of a large amount of bound enzyme. In an alternative embodiment, complementary enzymatically inactive fragments of an active enzyme, which fragments can recombine to form active enzyme, are covalently attached to separate support materials by a molecular chain material which is a substrate for the active enzyme, and these two fragment-supported conjugates are connected in series. Upon application of free enzyme or free complementary enzyme to one of these fragment-support conjugates, followed by application of the resulting product mixture to the second fragment-support conjugate, a large amount of free enzyme is ultimately produced.

Abstract: This invention provides monoclonal antibodies useful for the detection of Sclerotinia infection of plants. Hybridoma producing the antibodies as well as materials and kits for carrying out the detection of the organisms are also disclosed.

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: This invention is to a method for detecting an amphiphilic antigen in a biological sample suspected of containing the amphiphilic antigen, which method comprises providing in combination a hydrophilic solid support modified to have a hydrophobic surface and an assay medium suspected of containing an amphiphilic antigen, incubating the combination under conditions sufficient for the amphiphilic antigen to bind to the hydrophobic surface, and determining the presence or amount of the amphiphilic antigen bound to the hydrophobic surface.

Abstract: Disclosed are methods that permit the determination of both lipid moiety (LM) and apolipoprotein expressed epitope immunoreactivity (EEI) of intact isolated lipoprotein species. One format of the method isolates a lipoprotein species by means of a ligand binding to a solid phase, and quantitates thereafter the LM and/or the EEI. A complementary variant format provides for nonquantitative study of a constant number of lipoprotein particles exploring the sizes of the particles (LM) and scanning the apolipoprotein epitopes (EEI). Disclosed also is a method using lipid moiety dynamics (LMD) and expressed epitopes immunoreactivity dynamics (EEID) to explore the lipid loading and unloading of the lipoprotein species during a fast-feeding cycle. Both the LMD and EEID of lipoprotein particles may be performed as a panel, individual or in any combination. This can be used to detect abnormalities in lipid metabolism that precede the hyperlipidemias associated with cardiovascular disease.

Abstract: An improved method for detecting the presence of durg metabolites in the meconium of newborn infants is described. The method involves a single step extraction of the drug metabolites from meconium using a buffered aqueous solution containing methanol in an amount between about 10 and 30% by volume and buffered to a pH between 6 and 7 and then assaying the extract individually for the presence of the drug metabolites. The method is particularly useful for detection of cocaine, morphine, cannabinoid and amphetamine metabolites; however, any drug metabolite in the infant meconium can be tested if it is extracted by the solution from the meconium. Various assay methods are used for the drug metabolites in the solutions derived from the meconium, including immunoassays, fluorescent assays and mass spectroscopy. The method provides for early detection of drug presence in newborn infants which contribute to infant illness.

Abstract: A diagnostic element for detecting the presence of anti-dsDNA antibodies in a sample. The diagnostic element includes a support (e.g., a microcell), a coating of mBSA on the support, dsDNA antigens immobilized on the coating, and a blocking layer for blocking immobilization sites other than ones occupied by dsDNA antigens. A testing kit is also provided which includes a diagnostic element, a sample diluent, an antibody solution, and a label identifying solution.

Abstract: Novel bifunctional hydroxyphenylazobenzoic acid analogues (HABA-type and conjugates) and biotin analogues probiotin-type conjugates) useful as reagents in assays employing catalyzed reporter deposition are described as well as intermediates useful in synthesizing these compounds.

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: The invention provides a disposable device for collecting, transporting and storing semi-solid or liquid specimens prior to analysis. A sample of the collected specimen is removed from the device for analysis by means of a detachable transferring stick, one area of which is the sample collecting portion of the device and another area of which is an integral handle. The device also provides for the collection of a liquid sample drained from a defined volume of a semi-solid specimen through porous screen and collected on the detachable transferring stick. A sample of the specimen or liquid from it may be flushed from the stick for a qualitative or quantitative determination of analyte. The device is useful in collecting fecal specimens and detecting occult blood therein by a determination of hemoglobin in the specimen itself or in a liquid sample drained therefrom.

Abstract: For the detection of compounds containing carbohydrate the compound to be detected is reacted with a conjugate which contains a group which enables a specific binding to the substance to be detected and contains a hapten with a molecular weight from 300 to 1200, afterwards the complex formed is brought into contact with labelled antibodies directed against the hapten and the label is determined in a known way.

Abstract: The present invention provides a method for assaying basic fetoprotein in urine comprising an antigen-antibody reaction with the use of anti-basic fetoprotein antibodies, and an assay kit used for performing said method comprising a first anti-basic fetoprotein antibody, a marker second anti-basic fetoprotein antibody, a solid phase and a standard basic fetoprotein antigen, characterized in that the first antibody and the second antibody react with antigenic determinants different from each other.

Abstract: A water-insoluble immunoreactive reagent is prepared from a polymeric particle composed of a polymer derived from at least one ethylenically unsaturated polymerizable monomer having either pendant activated 2-substituted ethylsulfonyl or vinylsulfonyl groups. The interior of the particle is substantially free of detectable tracer material. The particle is covalently attached through the pendant groups to an immunological species which is capable of participating in an immunological reaction to complex with a corresponding receptor. This immunoreactive reagent can be incorporated in elements for use in immunoassays. In addition, they can be used in various immunological methods, including agglutination, sandwich and competitive binding assays where at least one immunological species is insolubilized.

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: 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: Monoclonal antibodies specific for the glycosylated lysine residue at position 525 in glycoalbumin and a method for producing such antibodies. The monoclonal antibodies are useful as reagents in immunoassays for the specific determination of glycoalbumin in human blood samples which is indicative of the severity of the diabetic condition. The monoclonal antibodies are secreted by hybridomas obtained by fusing a myeloma cell with a lymphocyte that has been taken from an animal, usually a mouse, immunized with a peptide immunogen and which produces antibody to the lysine 525 residue in glycoalbumin. The synthetic peptide immunogen comprises a peptide residue which includes an .epsilon.-amino glucosylated lysine and an adjacent amino acid sequence in which at least one of the amino acid units is in a position corresponding to the peptide sequence of human albumin adjacent to lysine 525, the glycosylated peptide residue being linked to an immunogenic carrier.

Abstract: The invention concerns a new protein of approximately 17 KD, with angiogenic activity, a process for isolating it from mammalian milk, therapeutic compositions containing it, a process for detecting and/or determining the content of mammalian angiogenins, their homologues and their fragments. Said protein, of bovine origin, has a sequence of 125 aminoacids, 81 of which are common to human angiogenin, and a molecular weight of approximately 17 KD, and is extracted from mammalian milk. Application to the detection of mammalian angiogenin.

Abstract: The present invention provides a process for the determination of an antibody by incubation with three different reagents R.sub.1, R.sub.2 and R.sub.3, of which R.sub. and R.sub.3 are present in liquid phase and are bindable with the antibody, R.sub.2 is present bound to a solid phase and is bindable with R.sub.1 and R.sub.3 carries a label, separation of the solid phase from the liquid phase and measurement of the label in the solid phase, wherein as R.sub.1 there is used a conjugate of a substance specifically recognized by the antibody to be determined and a reaction component of a specific binding system, as R.sub.3 there is used a conjugate of a substance specifically recognized by the antibody to be determined and a label and as R.sub.2 there used the other binding component of the specific binding system. The present invention also provides a composition for the determination of an antibody, wherein it contains two different soluble reagents R.sub.1 and R.sub.