Abstract: The present invention concerns a method for assessing the risk of peptic ulcer by determining the presence and topographic phenotype of gastritis in an individual, by determining quantitatively the pepsinogen I and gastin-17 concentrations in a serum sample from the said individual, selecting a method-specific reference value and cut-off value for respective analyte, assessing the topography and phenotype of gastritis based on a comparison of the pepsinogen I and gastrin-17 concentrations so determined with their respective method-specific reference and cut-off values, and correlating the so assessed gastritis phenotype with the risk for peptic ulcer. Preferably also Helicobacter antibodies are determined in the sample.

Abstract: A method and kit for monitoring autoantibodies to thyroid stimulating hormone (TSH) receptor in a sample of body fluid, which employs the steps of: (i) incubating TSH receptor with a sample of body fluid; (ii) reacting the incubated sample of body fluid with at least one binding agent which is capable of binding to the TSH receptor in competitive reaction with TSH receptor autoantibodies (TRAb), or in a case where TSH receptor is complexed to labelled antibody, reacting the sample of body fluid with at least one binding agent which can bind to TRAb in such a way as not substantially to interfere with binding of the TRAb to the TSH receptor; and (iii) detecting bound TRAb in the reacted incubated sample of body fluid.

Abstract: The invention relates to novel fluorescence-based assays for protein kinases and phosphatases which can be used in high throughput screening. The methods of the invention utilize a competitive immunoassay to determine the amount of substrate that is phosphorylated or dephosphorylated during the course of a kinase or phosphatase reaction to yield a product, as well as the phosphorylating or dephosphorylating activity of a kinase or phosphatase.

Abstract: A disposable biosensor for testing a fluid sample including a laminated strip with a first and second end, a reference electrode embedded in the laminated strip proximate to the first end, at least one working electrode embedded in the laminated strip proximate to the first end and the reference electrode, an open path for receiving a fluid sample beginning from the first end and connecting to a vent spaced from the first end, the open path being sufficiently long to expose the reference electrode and the working electrode to the fluid sample, and conductive contacts located at the second end of the laminated strip. The laminated strip has a base layer with a conductive coating, a reagent holding layer, a channel forming layer and a cover having an inlet notch at the first end. The working electrode contains a reagent having an enzyme.

Abstract: The invention provides isolated nucleic acid and amino acid sequences of TL-&ggr;, antibodies to TL-&ggr;, methods of screening for TL-&ggr; modulators using biologically active TL-&ggr;, and kits for screening for TL-&ggr; modulators.

Abstract: Provided are novel complexes containing a crosslinked avidin, an analyzing method and analyzing reagents and kits whereby a compound to be analyzed can be quickly, conveniently and accurately analyzed while taking advantage of the avidin-biotin reaction. The complexes contain at least two homogeneous or heterogeneous biotin-introduced products and one crosslinked avidin sandwiched therebetween. In the analyzing method, the homogeneous or heterogeneous biotin-introduced products and the crosslinked avidin are used. The analyzing reagent contains the crosslinked avidin. The analyzing kit contains the crosslinked avidin and a biotinylating agent.

Abstract: Isolated and purified Staphylococcus thioredoxin reductases (TrxB) are provided. Polynucleotides encoding the TrxBs, vectors and host cells containing such polynucleotides are also provided. In addition, antibodies reactive with the TrxBs are provided, as are methods of isolating the TrxBs, as well as methods for producing recombinant TrxBs, using TrxBs for screening compounds for TrxB-modulating activity, and detecting Staphylococcus in a test sample.

Abstract: The present invention relates generally to lysosomal storage disorders and to diagnostic agents for their detection in humans and other animals. More particularly, the present invention is directed to the uses of the LSD markers Lamp-1, Lamp-2, Limp-II, 4-sulphatase, acid phosphatase (ACP), &bgr;-hexosaminidase or &agr;-mannosidase, amongst others as diagnotic agents for the detection of many lysosomal storage disorders.

Abstract: A ferromagnetic thin-film based magnetic field detection system used for detecting the presence of selected molecular species. A magnetic field sensor supported on a substrate has a binding molecule layer positioned on a side thereof capable of selectively binding to the selected molecular species. The magnetic field sensor can be substantially covered by an electrical insulating layer having a recess therein adjacent to the sensor in which the binding molecule layer is provided. An electrical interconnection conductor can be supported on the substrate at least in part between the sensor and the substrate, and is electrically connected to the sensor. The magnetic field sensor can be provided in a bridge circuit, and can be formed by a number of interconnected individual sensors.

Abstract: Method for screening the risk for gastric cancer using, in combination, the determination of serum pepsinogen I, gastrin-17 and the supporting determination of Helicobacter pylori antibodies from blood serum, in order to detect either atrophy of the corpus area, atrophy of the antrum area or atrophy of the mucosa of the whole stomach as well as a causative Helicobacter pylori infection, whereby the risk for gastric cancer can be evaluated and the necessary gastroscopy and follow-up can be planned.

Abstract: A process for the preparation of a pure form of protein, wherein the protein is protease activating blood clotting factor VII, the proenzyme for the protease, or a mixture of both the-protease and the proenzyme, is described. The protein is obtained from biological fluids or through genetic engineering and is isolated by anion- and/or cation-exchange chromatography at a pH below the isoelectric point of the protein to be isolated, or by a combination of anion- or cation-exchange chromatography with a chromatography process and/or fractional precipitation at pH between 2.5 and 9.0.

Abstract: The present invention discloses a method for the measurement of hydride using a chemiluminescent compound. The preferred chemiluminescent molecule is an acridinium compound. The source of hydride for the reduction of acridinium compound may be of chemical or biochemical origin, or the result of enzymatic catalysis. The chemical source of hydride, for example, might be metal hydrides, such as NaBH4. A biochemical source of hydride might be that derived from NADH, or NADPH, while an enzymatic source would be the class of oxidoreductases termed dehydrogenases which convert NADH or NADPH from NAD or NADP. There are numerous potential applications for acridinium compounds as chemiluminescent indicators of hydride. Any applied tests or diagnostic assays, in which hydride is either present at the onset of or generated through the course of a reaction, would benefit from the present invention.

Abstract: A test piece for use in biological analyses includes a plurality of different known specific binding substances disposed in predetermined positions on a substrate. The specific binding substances are disposed on a plurality of surfaces provided by the substrate and arranged in the direction of thickness of the substrate.

Abstract: This invention relates to methods and compositions for monitoring the interaction of binding partners as a function of the addition or subtraction of a phosphate group to or from one of the binding partners by a protein kinase or phosphatase.

Abstract: A method and apparatus for extracting, identifying, and manipulating proteins or peptides from a solution uses paramagnetic beads having a coating with an affinity for the target component. In one embodiment, paramagnetic beads coated with C18 are used to adsorb proteins and peptides. The beads can be used to purify, immobilize and assay antibodies. By cycling the beads, many times greater molar amount of binding partner may be separated from a solution. A magnetic probe is used to capture the beads and transfer the beads to selected processing stages.

Abstract: The invention provides multifunctional fusion constructs which are rapidly incorporated into a macromolecular structure such as a phycobilisome such that the fusion proteins are separated from one another and unable to self-associate. The invention provides methods and compositions for displaying a functional polypeptide domain on an oligomeric phycobiliprotein, including fusion proteins comprising a functional displayed domain and a functional phycobiliprotein domain incorporated in a functional oligomeric phycobiliprotein. The fusion proteins provide novel specific labeling reagents.

Abstract: The present invention provides a method capable of simultaneous processing of plural test samples for the receptor binding property of a chemical substance, which does not require immobilization of the receptor or a special device, and a reagent to be used for this method. That is a method for assaying the receptor binding property of an assay target substance is provided, the method comprising the steps of (a) competitively reacting a known concentration of a ligand and the assay target substance with a known concentration of the receptor in a solution, (b) measuring, without physically removing the ligand bound with the receptor prior to the assay, the amount of a free ligand in the solution using one or more antibodies against the ligand, and (c) determining the receptor binding property of the assay target substance using the amount of the free ligand as an index.

Abstract: Families of compositions are provided as labels, referred to as eTag reporters for attaching to polymeric compounds and assaying based on release of the eTag reporters from the polymeric compound and separation and detection. For oligonucleotides, the eTag reporters are synthesized at the end of the oligonucleotide by using phosphite or phosphate chemistry, whereby mass-modifying regions, charge-modifying regions and detectable regions are added sequentially to produce the eTag labeled reporters. By using small building blocks and varying their combination large numbers of different eTag reporters can be readily produced attached to a binding compound specific for the target compound of interest for identification. Protocols are used that release the eTag reporter when the target compound is present in the sample.

Abstract: A method for detecting mutated alleles in an excess of wild type alleles in a sample by isolating sample DNA; amplifying a target DNA sequence; and separating mutated DNA sequences from wild type DNA sequences by virtue of the preferential binding of the wild type sequences to carrier-bound complementary oligonucleotides. The amplification and separation steps may be iterated through one or more additional cycles to enhance sensitivity.

Abstract: A rapid, non-invasive, semi-quantitative immunoassay of saliva has been developed to aid in the diagnosis of diseases, e.g., using saliva to detect subjects actively or previously infected with Mycobacterium tuberculosis, a causative organism of tuberculosis. The semi-quantitative assay comprises spotting disease-related antigens on the surface of a solid substrate; contacting the solid substrate with a saliva sample which, in positive subjects, contains primary antibodies to the disease-related antigens; contacting the primary antibodies with a label capable of being detected; and detecting and reading the label whereby exposure to the antigens is determined. The device for conducting these assays is a frame or support which holds a solid substrate capable of immobilizing the antigens of interest while permitting drainage of other materials or fluids away from the immobilized antigens.

Abstract: The present invention relates to toxins that specifically bind to GPI anchored proteins. More specifically, the present invention encompasses the uses of such toxins to detect the presence or absence of GPI anchored proteins. In one embodiment the present invention can be used to detect the presence of paroxysmal nocturnal hemoglobinuria.

Abstract: The invention concerns a process for diagnosis of an HIV infection by means of an immunoassay using the specific detection of the p24 antigen of HIV1, HIV1-Sub0 and/or the p26 antigen of HIV2, at least one antibody against the env region of HIV1, HIV1-Sub0 and/or of HIV2 and at least one antibody against the pol and/or gag region of HIV1, HIV1-Sub0 and/or HIV2, reagent kits and test strips suitable for diagnostic procedure as well as monoclonal antibodies against p24 and their use.

Abstract: An improved method of performing immunohistochemical staining on a tissue sample to determine the presence of cytoplasmic tumor marker Metallopanstimulin in cells in the tissue sample. The method consists of generally of collecting the tissue sample; fixing the tissue sample in a manner that preserves the Metallopanstimulin in the cytoplasm of the tissue cells; embedding the sample in paraffin; deparaffinizing the tissue; heating the sample to expose antigenic sites; incubating the slide with a stain blocking agent; incubating the tissue with a primary anti-Peptide A antibody having an affinity for the N-terminal portion of the Metallopanstimulin; incubating the sample with chromogen stain; rinsing the sample; dipping the slide in a counterstain; mounting the slide for reading. Materials for performing the above steps are provided in a convenient, reasonably priced kit.

Abstract: A molecule suitable for use as an indicator of free iron levels in a biological sample, the molecule including an iron binding moeity and a signal generating moeity, wherein an intensity of the signal generated by the signal generating moeity is related to an amount of the iron bound by the iron binding moeity.

Abstract: The present invention relates to a novel TFPI-3 protein which is a member of the tissue factor protease inhibitor family. In particular, isolated nucleic acid molecules are provided encoding human TFPI-3 proteins. TFPI-3 polypeptides are also provided as are vectors, host cells and recombinant methods for producing the same. The invention further relates to screening methods for identifying agonists and antagonists of TFPI-3 activity. Also provided are diagnostic methods for detecting hemostasis system-related disorders and therapeutic methods for treating hemostatis system-related disorders.

Abstract: A method for the multiplexed diagnostic and genetic analysis of enzymes, DNA fragments, antibodies, and other biomolecules comprises the steps of constructing an appropriately labeled beadset, exposing the beadset to a clinical sample, and analyzing the combined sample/beadset by flow cytometry. Flow cytometric measurements are used to classify, in real-time, beads within an exposed beadset and textual explanations, based on the accumulated data obtained during real-time analysis, are generated for the user. The inventive technology enables the simultaneous, and automated, detection and interpretation of multiple biomolecules or DNA sequences in real-time while also reducing the cost of performing diagnostic and genetic assays.

Abstract: A method for detecting cancer in a patient. The method comprises the steps of introducing labeled antibodies or labeled AFP to a biological sample of the patient so the labeled antibodies or labeled AFP will react with the AFP receptor binding sites in the biological sample. Next there is the step of identifying AFP receptor binding sites in the biological material which are reacted with the labeled antibodies or labeled AFP to determine the presence of cancer.

Abstract: This invention provides methods of regulating contraction of a subject's heart and of treating heart failure and cardiac arrhythmia. This invention also provides methods of obtaining compounds that bind to, and activate or inhibit the activation of a type 2 ryanodine (RyR2) receptor, and methods for screening for compounds that alleviate heart disease.

Abstract: Methods for detecting parasites, such as Cryptosporidium parvum, in turbid and non-turbid samples by solubilizing molecular markers or antigens of the parasite. The molecular markers are solubilized by incubating a sample containing the parasite with a solubilization buffer and detecting the solubilized antigens by electrochemiluminescence. The solubilization buffer contains one or more detergents alone or in combination with one or more denaturing agents in a buffered solution. The methods are an improvement over existing immunofluorescence assays for C. parvum because the methods described herein are quantitative, reproducible, have high sensitivity, are not labor-intensive, require only minimal sample processing, and avoid being adversely affected by sample turbidity. In addition, by using a electrochemiluminescence assay, microscopy is not required.

Abstract: Multilayered porous materials are formed by coating a porous substrate with a metal and adsorbing an organic layer comprising a recognition moiety onto the metal film. The recognition moiety interacts with an analyte of interest allowing for its detection, purification, etc. Suitable recognition moieties can be selected from a range of species including, small molecules, polymers and biomolecules and the like. The novel porous materials of the invention can be utilized in an array of methods including, ion-exchange, ion-selective ion-exchange, assays, affinity dialysis, size exclusion dialysis and the like.

Abstract: A test piece for use in biological analyses includes a plurality of different known specific binding substances disposed in predetermined positions on a substrate. The specific binding substances are disposed on a plurality of surfaces provided by the substrate and arranged in the direction of thickness of the substrate.

Abstract: Growth differentiation factor Lefty-1 polypeptide and polynucleotides are provided herein. Also disclosed are diagnostic and therapeutic methods of using the Lefty-1 polypeptide and polynucleotide sequences.

Abstract: Compounds and methods are provided for use in purification of CD34+ cells and specific surface antigens thereof. The present invention discloses methods for releasing CD34+ cells, as well as compounds having a carbohydrate epitope of the CD34 surface antigen, from an affinity matrix, using carbohydrates having the structure: Neu5Ac&agr;2-3Gal&bgr;1-4(X) wherein (X) is GlcNAc, or a monosaccharide or a cyclohexane derivative that is structurally similar to GlcNAc.

Abstract: A method and compositions for the detection and/or quantification of an analyte through the use of a plurality of labeled probes, with two or more said probes targeted to different regions of said analyte. In specific embodiments, the labels are separately distinguishable, and/or are present at different specific activities on the labels.

Abstract: This invention provides new fluorescent molecules useful for detection of target entities. In particular, it relates to fluorescent adducts comprising an apoprotein and a bilin.

Abstract: Receptors are disclosed that are antibodies that exhibit a binding affinity for an immune complex of a monoepitopic antigen and an antibody for such antigen that is substantially greater than the binding affinity for the monoepitopic antigen or the antibody for the monoepitopic antigen apart from the immune complex. Normally, the monoepitopic antigen has a molecular weight less than 1500 and is an organic compound. The antibodies of the present invention find use in a method for determining a monoepitopic antigen in a sample suspected of containing such antigen. The method comprises forming an immune sandwich complex comprising the monoepitopic antigen or an analog thereof, a first monoclonal antibody that binds to the monoepitopic antigen, and a second monoclonal antibody that is an antibody of the present invention and detecting the immune sandwich complex.

Abstract: The disclosed nucleic acid primer sets, used in combination with quantitative amplification (PCR) of tissue cDNA, can indicate the presence of specific proteases in a tissue sample. The detected proteases are themselves specifically overexpressed in certain cancers, and their presence may serve for early detection of associated ovarian and other malignancies, and for the design of interactive therapies for cancer treatment.

Abstract: This invention relates to monoclonal antibodies that recognize modified &bgr;-tubulin isotypes, methods of using such antibodies to detect modified &bgr;-tubulin isotypes, methods of using such antibodies to monitor &bgr;-tubulin modifying agents administered to a patient, methods of using such antibodies to isolate modified &bgr;-tubulin, and methods of detecting the anti-modified &bgr;-tubulin antibodies.

Abstract: The invention features a monoclonal antibodies specific for human type I alveolar cells or for human type II alveolar cells. The invention also features methods of detecting lung injury in a subject using these monoclonal antibodies.

Abstract: Multilayered particulate materials are formed by coating a particulate substrate with a metal and adsorbing an organic layer comprising a recognition moiety onto the metal film. The recognition moiety interacts with an analyte of interest allowing for its detection, purification, etc. Suitable recognition moieties can be selected from a range of species including, small molecules, polymers and biomolecules and the like. The novel particulate materials of the invention can be utilized in an array of methods including, ion-exchange, ion-selective ion-exchange, assays, affinity dialysis, size exclusion dialysis, as supports in solid phase synthesis, combinatorial synthesis and screening of compound libraries and the like.

Abstract: The invention relates to the development of a method for assaying an antigen which is associated with disorders caused by mental stress in a human body fluid by way of an immunoassay technique which utilizes an antibody against a mental stress related protein having the following properties or a fragment thereof: (1) having a molecular weight of about 14 kDa (measured by SDS-PAGE); and (2) having the N-terminal partial sequence represented by SEQ ID NO: 1; and a kit for diagnosing disorders caused by mental stress which contains the above-mentioned antibody or a fragment thereof. Thus, the accumulation of mental stress can be easily estimated and judged and the results can be applied to the diagnosis of disorders caused by mental stress.

Abstract: A heterogeneous binding assay for an analyte in a fluid sample is developed, which uses a green fluorescent protein (GFP) label. A ligand-GFP conjugate has a specific binding affinity for an anti-ligand immobilized on a support. The anti-ligand also has a specific binding affinity for the analyte. Competition between the analyte and ligand-GFP conjugate for binding sites on the anti-ligand permits an assay for an unknown amount of the analyte. Preferred specific binding pairs for use in the assay are biotin:avidin, and a selected antibody and its antigen. A preferred assay employing an antibody and its antigen is illustrated for a fusion protein containing GFP and an antigenic determinant. Picomolar amounts of analyte can be detected. The mutant of GFP that contains a six-histidine tail to facilitate purification on an immobilized metal affinity column is chemically modified to incorporate biotin moieties.

Abstract: Method for screening for a modulator of a biomolecule by comparing growth of a first microbe having an altered biomolecule with a second microbe having a normal biomolecule. The first and second microbes are grown in contact with a potential modulator in a growth medium.

Abstract: Immunoassays for measuring type II collagen (cartilage) resorption in vivo employ either one or two antibodies. A first antibody binds to EKGPDP (SEQ ID NO:2) but not to EKGPDPLQ (SEQ ID NO:10), where the K symbols refer to lysine or preferably to cross-linking 3-hydroxypyridinium residues. Measurement of analyte binding to the first antibody in serum provides an indication of unmineralized cartilage resorption in vivo. A second antibody binds to EKGPDPLQ (SEQ ID NO:10) but not to EKGPDP (SEQ ID NO:2). Measurement of analyte binding to the second antibody in serum provides an indication of mineralized cartilage resorption in vivo. An indication of total (unmineralized and mineralized) cartilage resorption in vivo is provided by either measurement of analyte binding to the first antibody in urine, or by measurement of the total analyte binding to the first and second antibodies in serum.

Abstract: The present invention provides a human glutathione s-transferase (HGST) and polynucleotides which identify and encode HGST. The invention also provides genetically engineered expression vectors and host cells comprising the nucleic acid sequences encoding HGST and a method for producing HGST. The invention also provides for agonists, antibodies, or antagonists specifically binding HGST, and their use, in the prevention and treatment of cancer and other diseases associated with the expression of HGST. Additionally, the invention provides for the use of antisense molecules to polynucleotides encoding HGST for the treatment of cancer and other diseases associated with the expression of HGST. The invention also provides diagnostic assays which utilize the polynucleotide, or fragments or the complement thereof, and antibodies specifically binding HGST.

Abstract: Disclosed is an assay for an analyte in a fluid test sample such as urine which involves combining the fluid test sample with a reagent system comprising an apo-peroxidase, a redox dye, a peroxide and a metal porphyrin which is bound to an analyte/analyte specific binding partner which complex has a combined molecular weight of at least about 180 K Daltons. When this conjugate interacts with analyte in the fluid test sample, a portion of the specific binding partner is dissociated from the complex thereby enabling the metal porphyrin to reconstitute with the apo-peroxidase. The reconstituted peroxidase can interact with the peroxide and redox dye to provide a colored response to analyte in the fluid test sample.

Abstract: The invention relates to methods for identifying antimicrobial agents which inhibit bacterial toxin membrane pore formation and for treating diseases where bacterial protein toxins that form pores in membranes are virulence agents. The invention involves screening for small molecule agents which inhibit membrane pore formation by bacterial protein toxins. The invention is also a method for treating bacterial infection by inhibiting membrane pore formation by bacterial toxin using agents that inhibit membrane pore formation by bacterial toxins. The methods of the invention are also applicable for developing antiviral agents that treat viral infection where exposure of hydrophobic sites of proteins is associated with infection.

Abstract: A method and compositions for the detection and/or quantification of an analyte through the use of a plurality of labeled probes, with two or more said probes targeted to different regions of said analyte. In specific embodiments, the labels are separately distinguishable, and/or are present at different specific activities on the labels.

Abstract: The invention concerns a method for detecting a hormone or antihormone resistance in cancers. The invention is intended for use in medicine, biology and the pharmaceutical industry. The aim of the invention is to consistently improve the use of antihormones in the treatment of cancer so that unnecessary treatment can be avoided as much as possible. The aim is to develop a method which can be used to identify the type of cancer before corresponding antihormone treatment is given. This aim is achieved by measuring the immune reactivity of the hormone receptors of cancers.