Abstract: Methods of detecting influenza, including differentiating between type and subtype are disclosed, for example to detect, type, and/or subtype an influenza infection. A sample suspected of containing a nucleic acid of an influenza virus, is screened for the presence or absence of that nucleic acid. The presence of the influenza virus nucleic acid indicates the presence of influenza virus. Determining whether the influenza virus nucleic acid is present in the sample can be accomplished by detecting hybridization between an influenza specific probe, influenza type specific probe, and/or subtype specific probe and an influenza nucleic acid. Probes and primers for the detection, typing and/or subtyping of influenza virus are also disclosed. Kits and arrays that contain the disclosed probes and/or primers also are disclosed.

Abstract: The present invention is related with the field of Biomedicine. It comprises the engineering of the Pertactin protein (Prn) and using it as part of bacterial vaccines, and more precisely, as part of acellular vaccines against Bordetella pertusis. The engineered Prn molecules comprise on their structure polimorfisms from different B. pertussis strains, and induce immune responses with protective capacity and opsonophagocytic activity when assayed as vaccines, higher than that generated by other pre-existing vaccines. The engineered Prn variants of the present invention are applicable in human and veterinary medicine.

Abstract: Antibodies specifically binding to c-Met protein, hybridoma cell lines, and compositions comprising the antibodies are disclosed herein. Methods of making and using the antibodies and compositions are also disclosed.

Abstract: A polynucleotide encoding a modified luciferase polypeptide. The modified luciferase polypeptide has at least 60% amino acid sequence identity to a wild-type Oplophorus luciferase and includes at least one amino acid substitution at a position corresponding to an amino acid in a wild-type Oplophorus luciferase of SEQ ID NO:1. The modified luciferase polypeptide has at least one of enhanced luminescence, enhanced signal stability, and enhanced protein stability relative to the wild-type Oplophorus luciferase.

Abstract: A lateral flow, membrane-based assay device for detecting the presence or quantity of an analyte residing in a test sample is provided. The device utilizes phosphorescence to detect the signals generated by excited phosphorescent labels. The labels may have a long emission lifetime so that background interference from many sources, such as scattered light and autofluorescence, is practically eliminated during detection. In addition, the phosphorescent labels may be encapsulated within particles to shield the labels from quenchers, such as oxygen or water, which might disrupt the phosphorescent signal.

Abstract: The present invention relates to nucleic acids, vectors and polypeptides that are suitable markers for detecting Streptococcus strains of the anginosus group, preferably for detecting Streptococcus anginosus and/or Streptococcus constellatus as well as for discriminating Streptococcus anginosus and/or Streptococcus constellatus from other streptococci. The present invention furthermore relates to these nucleic acids and polypeptides for use in the diagnosis and/or prognosis of infections with Streptococcus strains of the anginosus group. The present invention furthermore relates to methods utilizing these nucleic acids and polypeptides as well as to arrays and antibodies.

Abstract: The present invention discloses culture medium unit doses for cultivating microorganisms comprising at least two compositions, each composition packaged in a composition unit dose of a predetermined amount, said composition unit doses being used for combining one of each composition unit dose forming said culture medium unit dose. The composition unit doses being packaged separately and individually until a time said culture medium unit dose is to be prepared for use for cultivation of microorganisms, wherein said time one of each composition unit dose are combined thereby forming said culture medium unit dose. The invention also discloses a method of manufacturing the composition unit doses, and a kit for cultivating microorganisms, the kit comprising a combination of the composition unit doses.

Abstract: The present invention relates to novel lateral flow devices using two dimensional features, preferably, uniform two dimensional test and control features, and the methods for detecting an analyte using the lateral flow devices, and processes for making the lateral flow devices.

Abstract: Two cell lines, PICM-19H and PICM-19B, were derived from the bipotent ARS-PICM-19 pig liver stem cell line. The unipotent porcine stem cell line PICM-19H differentiates exclusively into hepatocytes and can be induced to express CYP450 enzymes. The growth rate and cell density in culture, morphological features, and hepatocyte detoxification functions, i.e., inducible CYP450 activity, ammonia clearance, and urea production of the PICM-19H cells were evaluated for their application in artificial liver devices. PICM-19H cells contain numerous mitochondria, Golgi apparatus, smooth and rough endoplasmic reticulum, vesicular bodies and occasional lipid vacuoles and display inducible CYP450 activity, clear ammonia, and produce urea in a glutamine-free medium. The data indicate that both cell lines, either together or alone, may be useful as the cellular substrate for an artificial liver device. The results demonstrate the potential for the use of PICM-19H cells in drug biotransformation and toxicity testing.

Abstract: Compositions, methods of manufacture and methods of treatment for post-myocardial infarction are herein disclosed. In some embodiments, the composition includes at least two components. In one embodiment, a first component can include a first functionalized polymer and a substance having at least one cell adhesion site combined in a first buffer at a pH of approximately 6.5. A second component can include a second buffer in a pH of between about 7.5 and 9.0. A second functionalized polymer can be included in the first or second component. In some embodiments, the composition can include at least one cell type and/or at least one growth factor. In some embodiments, the composition(s) of the present invention can be delivered by a dual bore injection device to a treatment area, such as a post-myocardial infarct region.

Abstract: Compositions, methods of manufacture and methods of treatment for post-myocardial infarction are herein disclosed. In some embodiments, the composition includes at least two components. In one embodiment, a first component can include a first functionalized polymer and a substance having at least one cell adhesion site combined in a first buffer at a pH of approximately 6.5. A second component can include a second buffer in a pH of between about 7.5 and 9.0. A second functionalized polymer can be included in the first or second component. In some embodiments, the composition can include at least one cell type and/or at least one growth factor. In some embodiments, the composition(s) of the present invention can be delivered by a dual bore injection device to a treatment area, such as a post-myocardial infarct region.

Abstract: A method for detecting a predisposition to breast cancer in a subject is provided. The method includes detecting in a biological sample from the subject one or more polymorphisms in the sequence of CD44 gene. The presence of one or more polymorphisms in the sequence of CD44 gene indicates that the subject has a predisposition for developing breast cancer.

Abstract: Devices and methods for the detection of target molecules are disclosed. Devices and methods for detecting food-borne target molecules are also disclosed.

Abstract: The present invention provides molecules, including IgGs, non-IgG immunoglobulins, proteins and non-protein agents, that have increased in vivo half-lives due to the presence of an IgG constant domain, or a portion thereof that binds the FcRn, having one or more amino acid modifications that increase the affinity of the constant domain or fragment for FcRn. Such proteins and molecules with increased half-lives have the advantage that smaller amounts and or less frequent dosing is required in the therapeutic, prophylactic or diagnostic use of such molecules.

Abstract: The sensitivity of visually read lateral flow immunoassay tests is enhanced by adding a small quantity of fluorescing dye or fluorescing latex bead conjugates to the initial conjugate material. When the visible spectrum test line is visibly present, the test result is observed and recorded. However, in the case where the result is indeterminate, a light of an appropriate spectrum, such as a UV, visible, or infrared spectrum, is cast on the test line to excite and fluoresce the fluorescing latex beads which are bound in the test line in true positive tests to enhance the visible color at the test line.

Abstract: Described are methods of separating viable cells, apoptotic cells and dead cells and antibodies or use in such methods. The antibodies may also be used in treatment of inflammatory disease, cancer and in wound healing.

Abstract: The invention provides scFv antibodies and monoclonal antibodies that bind to and decrease an activity of Carbonic Anhydrase IX (G250). Also provided are methods of treating and/or preventing cancer, such as renal clear cell cancer. Also provided are methods of identifying a carbonic anhydrase IX (G250) protein. The invention additionally provides methods of modifying immune effector cells, and the immune effector cells modified thereby.

Abstract: The invention provides methods for identifying a HLA-B*0702-restricted cryptic epitope in an antigen, as well as methods for increasing the immunogenicity of HLA-B*0702-restricted cryptic epitopes. The HLA-B*0702-restricted cryptic epitopes and their cognate immunogenic epitopes are useful for stimulating an immune reaction against the cryptic epitopes in a subject. Accordingly, the invention further provides pharmaceutical compositions comprising a HLA-B*0702-restricted cryptic epitope or a cognate immunogenic epitope thereof, and vaccination kits comprising such epitopes. The novel materials of the invention are particularly useful for efficiently treating patients having an HLA-B*0702 phenotype.

Abstract: The present invention relates to an assay device and a method for using such for the quantitative determination of an analyte, based on a test strip, which contains a porous test membrane allowing for capillary flow of the analyte and complexes of the analyte, a porous upstream membrane in fluid connection with the test membrane and a porous downstream membrane in fluid connection with the test membrane, wherein the test membrane contains a test site having immobilized thereon a ligand capable of reacting with the analyte and binding such to the test site, and two standard band sites having immobilized thereon known high and low concentrations of a calibrator agent capable of reacting with a label conjugate and binding such to the standard sites, wherein the upstream membrane has a site for the application of a sample to be analyzed, and has a site downstream from the sample application site for depositing label conjugates capable of reacting with the analyte and label conjugates capable of reacting with the

Abstract: Tube and float systems and methods for isolating, enumerating, and harvesting target materials of a suspension are described. In one aspect, a tube and float system includes a filter embedded in a tube cap. The filter enables the passage of fluids but prevents the passage of the target materials. The tube and float system can be used to isolate and enumerate the target materials by centrifuging the tube and float system with the suspension to trap the target materials between the float and inner wall of the tube. Fluids above and below the float are poured off and a second fluid can be introduced to the tube to re-suspend the trapped target material. The second fluid can be poured through the filter in the cap to trap the target material against the filter. The target material can be enumerated and analyzed.

Abstract: The present invention includes methods and devices for preventing interfering substances from affecting the accuracy of a lateral flow immunoassay. In preferred embodiments, a test strip includes a capturing zone that includes at least one mobile capturing reagent that separates at least one interfering substance from the analyte. The capturing zone is preferably located upstream of the sample application zone. In some embodiments, the reagent/conjugate zone is also located upstream of the sample application zone. The capturing zone may be located upstream, downstream, or overlapping with the reagent/conjugate zone in these embodiments. In other preferred embodiments, one or more mobile capturing reagents are included in the elution medium/running buffer. In yet other embodiments, the capturing reagent is incorporated into a sample collection device of a sample collection system, preferably separate from the chromatographic test strip. A lysis zone is also included in some preferred embodiments.

Abstract: Disclosed are antibodies and methods for detecting pregnancy in an animal. In certain aspects antibodies used binds immunologically to at least two PAGs selected from PAG4, PAG6, PAG9, PAG16, PAG17, PAG19, PAG20 and PAG21. Antibody encoding nucleic acids are also provided, as are kits, methods of use and additional antibody related compositions.

Abstract: Provided herein are compositions and methods for binding outgrowth endothelial cells (OEC). The compositions consist of peptide ligands capable of binding OEC with high affinity and specificity. The compositions of the invention include peptides set forth in SEQ ID NO: 1-38 and variants and derivatives thereof. Compositions also include the nucleotide sequences encoding the peptides of the invention. The compositions find use in methods for the isolation of OEC and for the recruitment and retention of OEC to sites of therapeutic interest. Methods for the identification and isolation of other peptides capable of binding OEC are also provided.

Abstract: The present invention provides an improved flat package of petri dishes and method of producing the same for prolonging shelf life and preservation of sterility of the petri dishes. The flat package is comprised of an optically clear, high-barrier, moisture-, gas- and microbial-resistant pouch. A plurality of petri dishes located adjacent one another are placed in an interior cavity of the pouch, after which the pouch is vacuum-packed, optionally flushed with an inert gas and then heat sealed. The placement and immobilization of the petri dishes in the pouch allow for prolonged shelf life and preservation of sterility, greatly reduced breakage rates, and enhanced visibility of the petri dishes by a user.

Abstract: Methods for measuring the amount of two or more analytes of interest in a fluid sample, and kits useful in the methods, are disclosed. The methods involve determining a ratio of a detected amount of a single analyte of interest, to the sum of a detected amount of each of the analytes of interest plus a detected amount of a control, wherein the amount of each analyte of interest is directly or inversely related to the ratio for each analyte of interest.

Abstract: A simple membrane assay method for detecting or quantitating an analyte in a specimen sample using an assay device equipped with a membrane bound with a capture-substance to capture the analyte, including the steps of filtering a specimen sample using a filter, dropping the filtrate onto said membrane and detecting the presence of the analyte in said specimen sample, as well as a simple membrane assay kit for detecting the presence of an analyte in a specimen sample, including (1) a filter tube, and (2) an assay device equipped with a membrane bound with a capture-substance to capture the analyte. The method or the kit can decrease the occurrence of false positivity and can provide a highly accurate detection of the analyte such as pathogen and antibody in a specimen collected in a medical scene or by an individual.

Abstract: The present invention includes but is not limited to a specimen collection device that includes a chamber capable of collecting a specimen, a specimen passage slot, a reservoir, a reservoir seal, and a test device. A sample or specimen added to the chamber flows through the specimen passage slot into the reservoir. Flow into the reservoir may be limited by the reservoir seal. The test device positioned within the reservoir detects the presence or concentration of an analyte within the sample or specimen.

Abstract: Compositions, methods and devices for the detection of anti-lipoidal antibodies and the diagnosis of disease, for example, syphilis, are described. In particular, a method for immobilizing a lipoidal antigen, comprising cardiolipin, lecithin, and cholesterol, on a solid support (such as a nitrocellulose membrane) is described. The ability to immobilize a lipoidal antigen on a membrane satisfies a long-felt need for a membrane-based assay for the detection of anti-lipoidal antibodies. Also described are immunoassay devices for concurrently performing treponemal and non-treponemal tests for syphilis.

Abstract: A home test kit for detecting fecal blood includes a scoop device for collecting a fecal sample, a luminescent for mixing with the sample, a hollow container for containing the sample, water and the luminescent, or luminol during use of the kit. A base may be provided for supporting the container during testing, and the container may include an integrally formed lid. Detection of the blood in the sample is possible because the luminescent undergoes a light-producing reaction that involves, as a reactant or catalyst, blood or blood components or products. The blood is thus visible, or glows in darkened surroundings. The kit is compact, easy to use, and formed from biodegradable material for easy disposal.

Abstract: Compositions, methods and devices for the detection of anti-lipoidal antibodies and the diagnosis of disease, for example, syphilis, are described. In particular, a method for immobilizing a lipoidal antigen, comprising cardiolipin, lecithin, and cholesterol, on a solid support (such as a nitrocellulose membrane) is described. The ability to immobilize a lipoidal antigen on a membrane satisfies a long-felt need for membrane-based assay for the detection of anti-lipoidal antibodies. Also described are immunoassay devices for concurrently performing treponemal and non-treponemal tests for syphilis.

Abstract: Disclosed are the cloning and expression of novel antigens in Babesia microti. The recombinant polypeptides are highly immunogenic. The polypeptides of the present invention provide the basis of a diagnostic assay that is sensitive, rapid and accurate using patient's sera. Also disclosed is an IgG and IgM ELISA using two novel recombinant antigens in the diagnosis of Babesia infection.

Abstract: The invention relates to a method for in vitro seriological diagnosis of Whipple's disease, whereby the bacteria responsible for the disease are isolated and established in a culture and brought into contact with the serum or biological fluid of an infected patient. The invention also relates to useful oligonucleotides with a probe and a primer for amplifying, sequencing and detecting the gene rpoB of the bacteria, Tropheryma whippelii.

Abstract: The present invention provides, in particular embodiments, for modified recombinant T cell receptor (TCR) ligands (RTLs) comprising a MHC class I or MHC class II component. The modified RTLs have redesigned surface features that preclude or reduce aggregation, wherein the modified molecules retain the ability to bind Ag-peptides, target antigen-specific T cells, inhibit T cell proliferation in an Ag-specific manner and have utility to treat, inter alia, autoimmune disease and other conditions mediated by antigen-specific T cells in vivo.

Abstract: The present invention provides improved tests for the detection of methicillin-resistant Staphylococcus aureus. The tests are particularly useful for eliminating false positive results due to the presence of a mixed bacterial population in patient samples.

Abstract: The invention provides methods to detect C. difficile in biological samples using real-time PCR. Primers and probes for the detection of C. difficile are provided by the invention. Articles of manufacture containing such primers and probes for detecting C. difficile are further provided by the invention.

Abstract: The invention concerns a method for increasing the dynamic measuring range of especially immunological test elements in particular immunological chromatography test strips that can be evaluated optically that are based on specific binding reactions. The invention enables the dynamic measuring range of test elements based on specific binding reagents, especially of immunological test elements to be shifted towards higher analyte concentrations without impairing the lower detection limit.

Abstract: A stable aqueous pharmaceutical formulation comprising a therapeutically effective amount of an antibody, polysorbate 80, a buffer which inhibits polysorbate oxidation is described along with methods of making the preparation. Also described are formulations with high antibody concentrations which maintain fixed volumes and which may be used on patients of variable weight.

Abstract: A guided structured testing kit which may include a test strip container, a test strip meter, a testing protocol advisor, and at least one of diagnostic test strip is presented. The diagnostic test strip includes a support element, a glucose reagent provided on the support element, and a glycemic context code provided on the support element. The glycemic context code can be machine-readable. The glycemic context code signals a glycemic context to a test strip meter, either upon insertion of the diagnostic test strip or by a user manually inputting the glycemic context into the test strip meter. A method for performing a guided structured test is also provided.

Abstract: This invention describes monoclonal antibodies that suppress thyrotropin receptor constitutive activity and methods of using the antibodies to treat thyroid related diseases; particularly hyperthyroidism and thyroid cancer.

Abstract: Compositions and kits for inhibiting an allergic response against an allergenic protein are disclosed. The compositions comprise a eukaryotic cell expression vector containing nucleotide sequences encoding an allergenic protein or a polypeptide that comprises an antigenic epitope of said allergenic protein; and an allergenic protein or a polypeptide that comprises an antigenic epitope of the allergenic protein. The kits comprise a first container which comprises a eukaryotic cell expression vector containing nucleotide sequences encoding an allergenic protein or a polypeptide that comprises an antigenic epitope of the allergenic protein and a second container which comprises an allergenic protein or a polypeptide that comprises an antigenic epitope of said allergenic protein.

Abstract: The invention provides for a urinary monitoring device to monitor for the presence or absence of markers indicative of a urinary tract infection (UTI). The invention also provides for methods of using such a device.

Abstract: Provided herein are immunoreactive peptides which can selectively bind Ehrlichia-specific anti-p120 or anti-p140 antibodies. Methods and kits utilizing the immunoreactive peptides are also provided. The immunoreactive peptides may be utilized, e.g., for determining whether or not a subject is infected with Ehrlichia chaffeensis or Ehrlichia canis. In certain embodiments, the immunoreactive peptides may be utilized in an ELISA or lateral flow assay.

Abstract: The present invention discloses to culture medium unit doses for cultivating microorganisms comprising at least two compositions, each composition packaged in a composition unit dose of a predetermined amount, said composition unit doses being used for combining one of each composition unit dose forming said culture medium unit dose. The composition unit doses being packaged separately and individually until a time said culture medium unit dose is to be prepared for use for cultivation of microorganisms, wherein said time one of each composition unit dose are combined thereby forming said culture medium unit dose. The invention also discloses a method of manufacturing the composition unit doses, and a kit for cultivating microorganisms, the kit comprising a combination of the composition unit doses.

Abstract: Methods and devices for rapid lateral flow immunoassays to detect specific antibodies within a liquid sample while also validating the adequacy of the liquid sample for the presence of immunoglobulin and the integrity and immunoreactivity of the test reagents that detect the antibodies of interest, without requiring instrumentation. The methods and devices provide for delivery of a diluted liquid sample to a single location that simultaneously directs the liquid flow along two or more separate flow paths, one that serves as a positive control to confirm that all critical reagents of the test are immunoreactive, and that the sample being tested is adequate, and the other to detect specific antibodies if present.

Abstract: The invention involves assays, diagnostics, kits, and assay components for determining levels of K41-glycated CD59 in subjects. Treatments for subjects based upon levels of K41-glycated CD59 also are provided.

Abstract: The present disclosure describes recombinant and synthetic polypeptides of Bartonella henselae and related methods and kits for the detection of antibodies specific for Bartonella henselae. The 17-kDa polypeptides, methods and kits are useful in the detection of recent and/or ongoing infections with Bartonella henselae, which can be useful in the diagnosis of Cat Scratch Disease (CSD).

Abstract: Provided is an assay device and kit for detecting the presence or amount of an analyte of interest.

Abstract: The invention comprises a device for detecting an analyte in a liquid sample deposited on a first portion of the device for transport to a second portion of the device that is in fluid contact with the first portion. In specific embodiments, the device comprises a labeled conjugate comprising a binding member reactive with a first epitope of the analyte and a label comprising a gold colloid, preferably having a mean particle size of 50 nm to 100 nm. In further embodiments, the device comprises a capture component comprising polymerized streptavidin. The diagnostic device is particularly useful in the preparation of pregnancy test kits.

Abstract: The present invention relates to a nucleic acid molecule comprising a 5? portion of an intestinal lactase-phlorizine hydrolase (LPH) gene contributing to or indicative of the adult-type hypolactasia. The present invention further relates to methods for testing for the presence of or predisposition to adult-type hypolactasia that are based on the analysis of an SNP contained in the above recited nucleic acid molecule. Additionally, the present invention relates to diagnostic composition and kit useful in the detection of the presence of or predisposition to adult-type hypolactasia.

Abstract: The invention relates to high affinity human monoclonal antibodies, particularly those directed against isotypic determinants of immunoglobulin E (IgE), as well as direct equivalents and derivatives of these antibodies. These antibodies bind to their respective target with an affinity at least 100 fold greater than the original parent antibody. These antibodies are useful for diagnostics, prophylaxis and treatment of disease.