Abstract: Compounds from biopolymers and effector substances which are linked via optically active amino acid derivatives, processes for the preparation thereof and the use thereof. The invention relates to compounds from biopolymers and effector substances which are linked with the aid of derivatives of optically active amino acids in which the amino group has been converted into a maleimido group and the carboxyl group into an active ester group.

Abstract: An assay and test kit of the determination of LKM-1 autoantibodies in test samples suspected of containing anti-LKM-1 autoantibodies. The method uses a solid phase which preferably is a microparticle. The method is standardized and can be performed in automated systems, allowing quantitation of the amount of anti-LKM antibody in test samples.

Abstract: Panels which consist of individual members, said members comprising proteins, wherein at least one of the members of the panel is a protein other than an immunoglobulin (Ig) or fragment thereof and wherein the presence of said non-Ig protein enriches the panel are described herein. These panels can be tested for reactivity with an analyte to create a profile. Such profiles can be used in pattern matching, analysis of samples and other analyses. Illustrated herein using such panels is a method to determine reactivity of a candidate compound with a target "receptor" which method does not require the physical presence of the receptor. By providing a formula for treating data obtained from a reference panel of this type which is predictive of reactivity with the target receptor, the compound to be tested can be physically assessed with respect to the reference panel, the formula applied, and reactivity with the actual target receptor may be predicted.

Abstract: Combinations, called matrices with memories, of matrix materials with remotely addressable or remotely programmable recording devices that contain at least one data storage unit are provided. The matrix materials are those that are used in as supports in solid phase chemical and biochemical syntheses, immunoassays and hybridization reactions. The data storage units are preferably non-volatile antifuse memories. By virtue of this combination, molecules and biological particles, such as phage and viral particles and cells, that are in proximity or in physical contact with the matrix combination can be labeled by programming the memory with identifying information and can be identified by retrieving the stored information. Combinations of matrix materials, memories, and linked molecules and biological materials are also provided.

Abstract: A cellulose binding domain (CBD) having a high affinity for crystalline cellulose and chitin is disclosed, along with methods for the molecular cloning and recombinant production thereof. Fusion products comprising the CBD and a second protein are likewise described. A wide range of applications are contemplated for both the CBD and the fusion products, including drug delivery, affinity separations, and diagnostic techniques.

Abstract: An immunodiagnostic reagent consists of magnetic balls covered with a substance binding specifically to a substance to be detected in suspension in a suitable liquid. The magnetic balls consist of an organic matrix enclosing a magnetic charge and having a magnetizable material mass/non-magnetizable material mass ratio between 60 and 70%.

Abstract: Methods and test kits are described which provide a reliable, sensitive and selective assessment of periodontal disease activity, peri-implantitis or HIV(+)-infection/AIDS-disease related periodontal diseases. The preferred methods and test kits are constructed to be easy and rapid chair-side tests. The method is based on the preparation and use of monoclonal antibodies which recognize the active mammalian matrix metalloproteinase-S (MMP-8) and is capable of differentiating between said active matrix metalloproteinase-8 and its inactive proform.

Abstract: A method of assaying bone collagen breakdown levels in a human subject useful to screen for the presence of bone resorption disorders. Also disclosed is a method for monitoring the progression and/or treatment response of a cancer condition which involves or has the potential to progress to a metastatic condition which involves abnormalities in bone resorption rates.

Abstract: A method for the analysis of DNA sequences and PCR products comprises the steps of constructing an oligonucleotide-labeled bead set, and labeled complementary probe, and exposing the bead set and probe to a DNA fragment or PCR product under hybridizing conditions and analyzing the combined sample/bead set by flow cytometry. Flow cytometric measurements are used to classify beads within an exposed bead set to determine the presence of identical or nonidentical sequences within the test sample. The inventive technology enables the rapid analysis of DNA sequences and detection of point mutations, deletions and/or inversions while also reducing the cost and time for performing genetic assays.

Abstract: A method of detecting substances, if desired in biological fluids, by using detection reactions based on chemiluminescence, wherein a luminophore, preferably having an emission wavelength longer than about 500 nm, is raised from its non-excited state into an excited state by electron transfer due to the detection reaction, and subsequently the radiation emitted by the luminophore when falling back into its non-excited state is measured. The chemiluminescence reaction is based on the oxidative decomposition of optionally substituted oxalates or oxamides, the radiation emitted by the luminophore when falling back into its non-excited state is of longer wavelength than the nonspecific background radiation of the reaction. The luminophore can be accumulated prior to the chemiluminesence reaction. Nonspecific background radiation of the reaction can be quenched.

Abstract: An in vitro method of identifying or isolating fetal cells from a blood sample is described. Fetal nucleated erythrocytes or erythroblasts are identified by using an antibody or antibody fragment specific for embryonic hemoglobin or an embryonic hemoglobin chain. Once the fetal cells are identified, they can be treated to render the fetal nucleic acids or proteins available for identification or amplification. Detecting the occurrence or existence of selected fetal nucleic acids or proteins allows a quantitative or qualitative diagnostic or prenatal evaluation, including determining the sex of the fetus, determining chromosomal, single gene or protein abnormalities, and determining the presence or absence of particular genes, nucleic acid sequences or proteins.

Abstract: An allergen immunoassay method features the use of a combination of a) closely controlled 1) elevated temperatures for assay reactions, 2) low temperatures for reagents and samples, 3) times for assay steps and especially assay reaction times, 4) reagent concentrations, and 5) reagent amounts; b) the use of a fast and accurate method of sample preparation that removes dust and contaminants; c) the stabilization of samples to avoid auto- and antibody degradation and unwanted effects of sample contaminants; and d) the formation of a colored product to determine the amount of a specific allergen. This combination provides an assay that can be completed in a few hours while retaining the precision, accuracy, sensitivity and response curve of previous methods requiring much longer periods of time.

Abstract: An apparatus for placing at least one biological reagent at a plurality of locations on a substrate includes a stamp member onto which the at least one biological reagent is applied. The stamp member defines a plurality of transfer elements patterned to correspond to the plurality of locations. The stamp member contacts the substrate to transfer the at least one biological reagent from the plurality of transfer elements to the plurality of locations. The transfer elements can be defined by reservoirs or projected portions of the stamp member. A method of using said apparatus is also disclosed.

Abstract: In vitro methods of determining whether or not an individual has metastasized colorectal cancer cells are disclosed. In vitro methods of determining whether or not tumor cells are colorectal in origin are disclosed. In vitro kits for practicing the methods of the invention and to reagents and compositions useful to practice the methods, for example as components in such in vitro kits of the invention are provided. Methods of and kits and compositions for analyzing tissue samples from the colon tissue to evaluate the extent of metastasis of colorectal tumor cells are disclosed.

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: An apparatus and method for selectively attracting and inhibiting attraction of at least one predetermined molecule to a site in a molecular detection device utilizes a first electrode and a second electrode proximate to the site. The first electrode selectively generates a first electric field proximate to the site in response to a first signal applied thereto. The first electric field provides an attractive force to attract the at least one predetermined molecule toward the site. The second electrode selectively generates a second electric field proximate to the site in response to a second signal applied thereto. The second electric field selectively inhibits attraction of the at least one predetermined molecule toward the site by providing a repulsive force which dominates the attractive force provided by the first electric field.

Abstract: Methods of screening for colorectal cancer by measuring levels of HC gp-39 are provided. Methods of monitoring patients with colorectal cancer are also provided. In addition, kits for detection of HC gp-39 useful in screening for and monitoring of colorectal cancer in a patient are provided.

Abstract: Methods for the detection, monitoring and treatment of malignancies in which the HER-2/neu oncogene is associated are disclosed. Detection of specific T cell activation (e.g., by measuring the proliferation of T cells) in response to in vitro exposure to the HER-2/neu protein, or detection of immunocomplexes formed between the HER-2/neu protein and antibodies in body fluid, allows the diagnosis of the presence of a malignancy in which the HER-2/neu oncogene is associated. The present invention also discloses methods and compositions, including peptides, for treating such malignancies.

Abstract: The present invention provides a systematic and practical approach for the identification of candidate agents able to inhibit ubiquitin-mediated degradation of a cell-cycle regulatory protein, such as cyclins. One aspect of the present invention relates to a method for identifying an inhibitor of ubiquitin-mediated proteolysis of a cell-cycle regulatory protein by (i) providing a ubiquitin-conjugating system that includes the regulatory protein and ubiquitin under conditions which promote the ubiquitination of the target protein, and (ii) measuring the level of ubiquitination of the subject protein brought about by the system in the presence and absence of a candidate agent. A decrease in the level of ubiquitin conjugation is indicative of an inhibitory activity for the candidate agent.

Abstract: A chemiluminescent assay method, compositions, kits and chemiluminescent acridan compounds are described which use a two-step chemiluminescent reaction process. The reaction involves an acridan compound, preferably a derivative of an N-alkylacridan-9-carboxylic acid, which undergoes a reaction with a peroxide compound, a peroxidase enzyme and an enhancer under conditions of time, temperature and pH which permit the accumulation of an intermediate compound, which is subsequently induced to produce a burst of light by raising the pH. The result is generation of very high intensity light from the reaction. The peroxidase enzyme is present alone or linked to a member of a specific binding pair in an immunoassay, DNA probe assay or other assay where the hydrolytic enzyme is bound to a reporter molecule. The method is particularly amenable to automated assays because of the separation of the incubation and light generating steps.

Abstract: The present invention provides a general purpose specific binding assay method which has the advantages of highly accurate and quick measurements which exclude the effects of various factors that decrease reliability of the measured values, such as non-specific reactants in test samples, assay conditions and inactivation and the like changes in the activity of reagents. The present invention is further drawn to a specific binding assay device suitable for the practice thereof.

Abstract: The subject invention concerns a novel polynucleotide sequence cloned from emm2.2 gene of a Group A streptococcus, Type II strain which codes for an IgA-binding protein, ML2.2. The subject invention further concerns the novel IgA-binding protein. A process for producing the protein is given. The invention also concerns the protein in an immunoadsorbent and as a tracer for use in measuring and purifying IgA. Kits are given comprising the immunoadsorbent and the tracer form of the protein.

Abstract: The present invention relates to a method for the diagnosis of male infertility which comprises the steps of a) determining the amount of P34H in a sperm sample; and b) comparing the determined amount of step (a) with a fertile control sample. The present invention also relates to a kit for the diagnosis of male infertility which comprises an anti-P34H antibody enzyme-labeled, an enzyme substrate and a fertile control sample.

Abstract: The invention relates to a method of detection, a sensor and a test-kit which find application in immunological detection (e.g., immunoassay). The invention provides, inter alia, a method of detection, suitable for use in immunological detection of an entity, which method includes the use of a secondary species (as defined in the specification), the use of a first detectable species, and the use of a second detectable species. The method may include, for example, the use of a primary species, a secondary species, a first detectable species and a second detectable species. The primary species may be, for example, an antibody or a ligand. The secondary species may be, for example, an auxiliary species such as an auxiliary binder or an auxiliary ligand, or a species which has a part which is an auxiliary function. The entity to be detected may be an analyte species as such or may be an entity which carries or includes analytes species.

Abstract: The present invention provides: a labelled .beta.-amyloid peptide or active fragment; a composition including the labelled .beta.-amyloid peptide or active fragment thereof and a pharmaceutical carrier; a method for identifying active fragments of .beta.-amyloid peptide; a method for labelling the .beta.-amyloid peptide or an active fragment thereof; methods of using the labelled peptide or peptide fragment for detecting or monitoring Alzheimer's disease in a patient; and methods for screening agents that enhance or inhibit .beta.-amyloid aggregation or deposition onto tissue or other amyloid substance, such as silk.

Abstract: A method and device for determining the presence of an analyte in a sample suspected of containing the analyte is disclosed. The method involves contacting a test solution containing the sample and a first member of a specific binding pair with an end portion of a strip of bibulous material capable of being traversed by the test solution through capillary action. The first member of a specific binding pair is capable of binding the analyte. The strip contains a second member of a specific binding pair integral therewith for concentrating and non-diffusively binding the first sbp member at a small situs on the strip separated from the end portion of the strip. The detectible signal is produced in relation to the presence of the analyte in the test solution. The test solution passes through the situs as the test solution traverses the bibulous material.

Abstract: A method of detecting chlamydia in a extracellular sample is provided which comprises contacting the sample with an idiotypic antibody to GLXA to form an immunocomplex and detecting the immunocomplex.

Abstract: Herein disclosed are methods for prenatally assessing risks of a pregnancy being affected by Down syndrome by testing maternal urine samples for levels of urinary gonadotropin peptide (UGP) elevated above normal. The methods employ immunoassays that are highly specific for UGP and have molar cross-reactivities of less than about 10% with intact hCG, with .beta.-subunit hCG, and with .alpha.-subunit hCG. The immunoassay methods of this invention are useful to test first trimester maternal urine samples. Among other benefits, first trimester prenatal screening provides the opportunity to terminate the pregnancy at an early gestational age, in the case of an unfavorable outcome.

Abstract: Seed lysine is detected by an immunoassay in which anti-EF antibody binds seed protein. Seed EF concentration is highly correlated with seed lysine content.

Abstract: A method for determining the concentration of the free fraction of an active compound, present in a biological fluid, in the presence of natural binders, the free and bound fractions of the active compound being in mutual equilibrium, bya) contacting a sample of the fluid with an unlabeled antibody,b) separating the sample from the unlabeled antibody,c) incubating the unlabeled antibody with a labeled substance (tracer) for cross-reaction with the antibody andd) measuring the amount of the tracer which is or is not bound to the antibody and calculating from this the concentration of the free fraction of the active compound,wherein the quantity of the unlabeled antibody and/or its affinity for the active compound are so small that they do not substantially effect the equilibrium between the free and bound fractions of the active compound, and the affinity of the tracer for the antibody is substantially higher or substantially lower than that of the active compound itself, and a test kit suitable for this metho

Abstract: The present invention relates generally to the field of human genetics. Specifically, the present invention relates to methods and materials used to isolate and detect a human breast and ovarian cancer predisposing gene (BRCA1), some mutant alleles of which cause susceptibility to cancer, in particular breast and ovarian cancer. More specifically, the invention relates to germline mutations in the BRCA1 gene and their use in the diagnosis of predisposition to breast and ovarian cancer. The present invention further relates to somatic mutations in the BRCA1 gene in human breast and ovarian cancer and their use in the diagnosis and prognosis of human breast and ovarian cancer. Additionally, the invention relates to somatic mutations in the BRCA1 gene in other human cancers and their use in the diagnosis and prognosis of human cancers. The invention also relates to the therapy of human cancers which have a mutation in the BRCA1 gene, including gene therapy, protein replacement therapy and protein mimetics.

Abstract: The present invention relates to a method for diagnosing prostatic adenocarcinoma (CAP) in a male human patient without requiring a biopsy. The total prostate specific antigen (PSA) level in the blood or serum of the patient is measured. If the patient has a total PSA level of between 2.5 ng/ml and 20.0 ng/ml, then the free PSA level in the blood or serum of the patient is measured. The proportion of free PSA to total PSA is calculated. If this proportion is less than about 7%, then the patient is diagnosed as having CAP. The present method can also be used on patients that have a total PSA of at least 10.1 ng/ml, but have also had a negative prostate biopsy.

Abstract: This invention discloses the incorporation of a peptide QRQYGDVFKGD (SEQ ID NO:1) from glycoprotein gE of Varicella zoster virus into a protein or polypeptide sequence for immunoisolation, immunopurification and immunodetection.

Abstract: Assays using receptor:reland complexes capable of releasing the reland in the presence of an analyte are described, wherein the reland does not detectably compete with analyte for binding to the receptor. The dissociation constant of the reland and the receptor is such that no appreciable release of reland occurs in the absence of analyte for the receptor. In a preferred embodiment, the association constant of the monomeric reland and the receptor is less than or equal to about 10.sup.5 M, preferably 10.sup.3 to 10.sup.5 M, most preferably 1% or less of the association constant of the analyte and receptor. In a preferred embodiment, the reland is labelled and the amount of analyte bound to the receptor is determined from the amount of labelled reland which is released.

Abstract: A rapid, sensitive in situ hybridization assay is provided which will detect as few as 1-5 copies of target biopolymer per cell and may be accomplished in 2-4 hours. There is provided a quantitative assay which may be used to diagnose and monitor treatment of diseases.

Abstract: The present invention relates to analytical devices for determining the presence or amount of an analyte in a test sample. The analytical devices comprise an inlet port, a vent, a channel, and an array of structures. The structures have immobilized reagent covalently or non-covalently attached to the surface of the structures. The immobilized reagent captures analyte in the test sample where it is detected by a detection system. The present invention also provides methods and reagents for performing assays utilizing the analytical devices of the present invention. The present invention also provides methods of manufacturing the analytical devices of the present invention.

Abstract: A method of determining immunological cross reactivity between Candida and human tissue or food antigens. Tissue antigen preparations or food extracts are analyzed by electrophoresis. Cross reacting antigens are identified by immunoblotting using anti-Candida antisera.

Abstract: An antigen capture method, and an antigen capture assay diagnostic kit, for detecting the presence or concentration of HIV in a biological sample without interference from antigen-antibody immune complexes is provided. The lysate of a biological sample obtained from an animal is contacted with a detectable mount of an antibody specifically reactive with the nucleocapsid p7 antigen or an immunoreactive fragment of the p7 antigen for a time and under conditions sufficient for p7 antigen contained in the lysate to form a p7-antibody complex. The presence or concentration of this p7-antibody complex is determined to detect or quantitate the presence of HIV in the biological sample. Uses of this assay and method include detecting the presence of HIV infection in an infant born to an HIV-infected mother, monitoring the progression of HIV infection, and evaluating the effectiveness of an anti-HIV treatment administered to an animal, such as a human.

Abstract: In a method of analyzing a body fluid sample for the presence of an analyte indicative of a physiological condition, comprising the steps of contacting the body fluid sample with an immunological binding partner which binds to the analyte, detecting binding of the immunological binding partner to the analyte, and correlating any detected binding to the physiological condition, the improvement comprising contacting the body fluid sample with an immunological binding partner which binds to ##STR1## wherein ##STR2## is hydroxylysyl pyridinoline or lysyl pyridinoline, and correlating any detected binding to degradation of type II collagen in vivo.

Abstract: A diagnostic method for detecting a base pair mismatch in a DNA duplex, comprising the steps of contacting at least one strand of a first DNA molecule with the complementary strand of a second DNA molecule under conditions such that base pairing occurs contacting a DNA duplex potentially containing a base pair mismatch with a mispair recognition protein under conditions suitable for the protein to form a specific complex only with the DNA duplex having a base pair mismatch, and not with a DNA duplex lacking a base pair mismatch, and detecting any complex as a measure of the presence of a base pair mismatch in the DNA duplex.

Abstract: The present invention relates to a sandwich immunoassay for rapidly and readily measuring N-peptide using two kinds of monoclonal antibodies recognizing different portions of the N-peptide. The method for measuring N-peptide or a precursor thereof includes the steps of: incubating a mixture containing a sample and a first monoclonal antibody recognizing a portion of N-peptide; adding a labelled second monoclonal antibody recognizing a portion of N-peptide to the mixture, followed by further incubation; and detecting the resulting antigen-antibody complex in the mixture. Alternatively, the method includes the steps of: incubating a mixture containing a sample, a first monoclonal antibody recognizing a portion of N-peptide, and a labelled second monoclonal antibody recognizing another portion of N-peptide; and detecting the resulting antigen-antibody complex.

Abstract: The present invention describes Urinary Tumor Associated Antigen (UTAA), its isolation and use in diagnostic assays. In particular, UTAA has been identified in samples from cancer patients, in some cases as part of an immune complex of UTAA and UTAA-specific immunoglobulin. Isolated UTAA also may be formulated as a pharmaceutical for production of antibodies or as a vaccine.

Abstract: The invention provides a method for the purification of a mammalian thymidine kinase 1. Also provided is a purified mammalian TK1, obtained from Raji cells, that is stable in the absence of stabilizing agents, has a molecular weight of approximately 100 kD and exhibits enzyme activity associated with the native 100 kD tetrameric species of TK1 but not the monomeric subunit. This purified TK1 was used to prepare a monoclonal antibody which inhibited TK1 enzyme activity. This anti-TK1 monoclonal antibody was used in methods for the diagnosis of cancer and for predicting the recurrence of cancer.

Abstract: A carboxyterminal propeptide of type I procollagen free from type III procollagen carboxyterminal propeptide can be used to produce an antibody which is specific for carboxyterminal propeptide of type I procollagen and which has no affinity for the type III procollagen carboxyterminal propeptide. This antibody can be used to assay more accurately the propeptide which is a measure of the rate of production of type I procollagen and useful in diagnosing and monitoring e.g. bone diseases.

Abstract: A disposable diagnostic device and method of its use are provided. The device comprises a housing containing first and second flow paths orthogonal to each other. The first flow path commences at a sample addition port and continues through a transport channel which feeds sample to an incubation area by means of capillary flow. The incubation area comprises a signal producing system and is underneath an optically-clear window. The first flow path terminates in a top waste reservoir which receives sample and wash fluid. The second flow path begins on one side of the incubation area at an inlet port over a side reagent reservoir. Liquid flows along the second flow path from the side reagent reservoir across the incubation area into the side waste reservoir. The incubation area may comprise agitation means for homogenous dispersion of reagent into liquid.

Abstract: Pterin derivatives having the general formula I ##STR1## wherein R.sub.1 represents a group --(CHOH).sub.2 --CH.sub.3 or --(CHOH).sub.2 --CH.sub.2 OH,R.sub.2 and R.sub.3 are not the same and represent either hydrogen or the group --(CH.sub.2).sub.3 CONH(CH.sub.2).sub.4 --NH--R.sub.4, wherein R.sub.4 represents hydrogen or a usual label group for immunoassays or usual coating/support materials for solid phase immunoassays or immunogenic groups for the preparation of antibodiesare useful for the preparation of sensitive immunoassays for the determination of neopterin and biopterin.

Abstract: The invention relates to a method of measuring antigens or antibodies in biological fluids in appropriately designed reaction cells in an automated analytical apparatus. The method includes the steps of contacting, in the reaction cell, the biological fluid with antibodies specific for a desired analyte antigen, which antibodies are coated on magnetic particulate carrier, under conditions such that binding of the antibody to the desired analyte antigen occurs, and detecting the presence or absence of an immunocomplex formed between the antibody and the desired analyte antigen. The automated analytical apparatus includes a closed circuit transfer path having means for transferring cells around the entire transfer path, and a thermostating period for each analysis to be performed with the automated analytical apparatus. The transfer path includes a loading station, a reagent delivery station, a mixing and washing station, a separating station and a discharging station.

Abstract: A rapid and accurate test kit is discussed for the detection of antibodies to HIV in saliva. The identification of antibodies to HIV in the saliva of seropositive individuals is shown using a test kit that requires no special machinery or skill and can be conducted by a single person in the privacy of their own home.

Abstract: A method of easily detecting the occurrence of colorectal cancer in the absence of occult blood is provided by measuring decay accelerating factor (DAF) molecules which are synthesized by colorectal cancer cells and present in feces. The method includes reacting an anti-DAF antibody with a supernatant of a fecal solution and measuring an amount of the antibody which has bonded to DAF molecules by an antigen-antibody reaction with the DAF molecules in the supernatant.

Abstract: Disclosed herein are receptors for pathogenic or opportunistic microorganisms, methods of obtaining such reeptors, and methods of using such receptors for diagnostic or pharmaceutical purposes. The receptor comprises a substantially pure compound selected from the group consisting of GalB1-4GlcNAcB1-3GalB1-4GlcB1-1-X(R), GalB1-3GlcNAcB1-3GalB1-4GlcB1-1-X(R), GlcNAcB1-3GalB1-4GlcB1-1-X(R), GalB1-4GlcNAcB1-3GalB1-4Glc, GalB1-3GlcNAcB1-3GalB1-4Glc, GlcNAcB1-3GalB1-4Glc, GalB1-4GlcNAcB1-3Gal, and GalB1-3-GlcNAcB1-3Gal wherein X is sphingosine, hydroxylated sphingosine, or saturated sphingosine and R is H or an N-acyl fatty acid derivative of X such that X(R) is a ceramide.