Abstract: A method for diagnosing the presence of hereditary spastic paraplegia (HSP) or predicting the risk of developing HSP in a human subject, comprising detecting the presence or absence of a defect in a gene encoding a polypeptide comprising the sequence of FIG. 9 (SEQ ID NO: 19), in a nucleic acid sample of the subject, whereby the detection of the defect is indicative that the subject has or is at risk of developing HSP.

Abstract: The invention relates to antibodies, including monoclonal and polyclonal, or fragments thereof, which discriminate between the histidine and tyrosine isoforms of Complement Factor H and to their use in diagnostic methods and therapeutic treatments relating to Complement Factor H mediated diseases.

Abstract: A device and method for detecting the presence of hemoglobin in a biological sample, more particularly, the presence of blood in a fecal sample as an indicator of upper or lower gastrointestinal tract bleeding.

Abstract: In one aspect the present invention provides a method for selecting a cell or cell colony which produces a polypeptide of interest, comprising a) providing a medium comprising cells and a detection agent, wherein the detection agent is associated with a detectable signal and the detection agent is capable of binding to the polypeptide of interest; b) providing a solid phase having a capture agent disposed thereon, wherein the capture agent is capable of binding to the polypeptide of interest; c) contacting the medium with the solid phase; d) detecting the signal associated with the detection agent; and e) selecting a cell or cell colony associated with the signal, wherein presence of the signal is indicative of a cell or cell colony which produces the polypeptide of interest.

Abstract: It is disclosed herein that antibodies specific for preproproteins or preproteins, which are synthesized by certain types of cells or tissues, can be used in immunohistochemistry assays to discriminate between the intracellular component of the protein (including the preproprotein, preprotein and/or proprotein forms of the protein) from the secreted component of the same protein. Accordingly, provided herein is an immunohistochemical method for specific detection of the intracellular form of a protein in a biological sample using an antibody specific for the preproprotein or preprotein form of the protein. In particular examples, the protein is albumin or an immunoglobulin light chain. Also disclosed herein are preproprotein-specific ore preprotein-specific antibodies that can be used to detect specific cell types, tissue lesions or other pathological foci and metastases by IHC. In particular, antibodies that specifically bind human preproalbumin, but do not bind the secreted form of albumin are disclosed.

Abstract: A liposomal composition, preferably a vaccine, comprising liposomes formed of liposome forming compounds, containing coentrapped polysaccharide antigen and T-cell dependent protein carrier, such as tetanus toxoid or diphtheria toxin modified to render it non-toxic. The invention is of use in the production of vaccines against Haemophilus influenzae, Streptococcus pneumoniae or Neisseria meningitidis.

Abstract: The present invention relates generally to the diagnosis of psychosis, schizophrenia and bipolar disorder, including psychotic bipolar disorder.

Abstract: The present invention provides an assay for detecting serum IgE antibody levels to cetuximab and to other proteins. The present invention further provides a method for predicting whether a subject will respond adversely to cetuximab treatment. The present further provides a method for detecting sensitivity to compounds comprising galactose-alpha-1,3-galactose.

Abstract: Sepsis is a complex, incompletely understood and often fatal disorder, typically accompanied by hypotension, that is considered to represent a dysregulated host response to an infection. Neurotensin (NT) is 13-amino-acid peptide that, among its multiple effects, induces hypotension. It is shown herein that plasma concentrations of NT are increased in humans with sepsis and in mice after caecal ligation and puncture (CLP), a model of sepsis. Mast cells can degrade NT through neurotensin receptor 1-and neurolysin-dependent mechanisms, diminishing the hypotensive effects of NT, reducing intraperitoneal NT concentrations, and improving survival. These findings show that mast cells can regulate NT concentrations, and identify NT as a biomarker and therapeutic target in sepsis.

Abstract: The present invention relates to novel monoclonal antibodies which may be used in the detection of Human Immunodeficiency Virus (HIV). These antibodies exhibit an unusually high degree of sensitivity, a remarkably broad range of specificity, and bind to novel shared, non-cross-reactive epitopes. In particular, the monoclonal antibodies of the present invention may be utilized to detect HIV-1 antigen and HIV-2 core antigen in a patient sample.

Abstract: A protein substrate includes a base having micro-passages and reaction grooves, a polyethyleneimine (PEI) fixed on the base and a specific protein fixed on the PEI. The base is modified by plasma stripper to make the PEI bonded on the base. Mixed with tyrosinase, the specific protein can stably stick on the base due to the tyrosinase bonded with the PEI. By antigen-antibody bonding specificity, the invention can quickly detect antibody in a sample able to link with the specific protein. The specific antibody can be added with targeted biotin secondary antibody, targeted avidin-peroxidase, and color producing substrate able to react with the targeted avidin-peroxidase, such as tetramethylbenzidine or 3-(4-hydroxy)phenyl propionic acid (HPPA), so as to measure a specific antibody amount.

Abstract: A lateral flow test system together with methods for its use in the detection of one or more analytes, or components, of interest within a sample, such as a biological sample, is provided. The system comprises a liquid formulation of a gold conjugate and a lateral flow assay device that does not include a conjugate pad having conjugate dried thereon.

Abstract: Novel immuno-interactive fragments of the ?C portion of a mammalian inhibin ? subunit, together with their variants and derivatives, produce antigen-binding molecules that are interactive with the ?C portion, and which are chemically well defined and which can be produced in commercially significant quantities. The antigen-binding molecules of the invention can be used for the detection of a mammalian inhibin and for the treatment and/or prevention of conditions associated with aberrant levels of a mammalian inhibin.

Abstract: The present invention provides diagnostic methods for determining the risk of developing an autism spectrum disorder (ASD) in a fetus or child by detecting in a biological sample from the mother antibodies that bind to one or more biomarkers selected from the group consisting of lactate dehydrogenase (LDH), guanine deaminase (GDA), collapsin response mediator protein 1 (CRMP1), stress-induced phosphoprotein 1 (STIP1), alpha subunit of the barbed-end actin binding protein Cap Z (CAPZA2), Y Box Binding Protein 1 (YBX1), eukaryotic translation and elongation factor 1A1 (EEF1A1), microtubule-associated protein Tau (MAPT), dihydropyrimidinase-like protein 2 (DPYSL2), dynamin 1-like protein (DNM1L), radixin (RDX), moesin (MSN), and ezrin (EZR).

Abstract: It is disclosed herein that isolated lymphocytes, such as human B-cells and CD4+ T-cell can be used to determine an amount of lymphocyte-associated anthrax lethal toxin activity present. Methods of using isolated lymphocytes to identify anthrax therapeutic agents and to determine the efficacy of a potential anthrax therapeutic are disclosed. Methods are also provided for diagnosing and treating anthrax infections.

Abstract: The application discloses new biomarkers for hypertensive disorders of pregnancy and particularly preeclampsia; methods for the diagnosis, prediction, prognosis and/or monitoring said disorders based on measuring said biomarkers; and kits and devices for measuring said biomarker and/or performing said methods.

Abstract: Described herein are materials and methods for identifying subjects that would benefit from Notch-targeted therapy.

Abstract: The invention relates generally to gelsolin binding agents (e.g., antibodies) which can bind to gelsolin polypeptides. Gelsolin binding agents of the invention are useful, alone or in combination, to detect a gelsolin polypeptide (a.k.a., the target polypeptide) in a test sample as well as to purify native gelsolin proteins. Gelsolin binding agents are also useful to diagnose, a gelsolin related medical condition in subjects in need thereof. Kits to detect gelsolin in biological samples are provided by the present invention.

Abstract: Disclosed are an antigen protein of black-lip pearl oyster egg extract, an antibody specific thereto, and a method of quantitative assessment of the reproductive effort of black-lip pearl oyster using the antibody. The method accomplishes quantitative assessment of reproductive effort of black-lip pearl oysters easily and accurately. In addition, the method provides important information for the study of life cycles of black-lip pearl oysters, and allows efficient management of black-lip pearl oysters.

Abstract: A process and assay for determining the neurological condition in a subject is provided whereby the level of one or more neuroactive biomarkers is measured in a sample obtained from the subject. The processes and assay include measurement of multiple neuroactive biomarkers for synergistic determination of a neurological condition such as neurological damage due to injury, disease, contact with a compound, or other source.

Abstract: The invention relates to a novel strain of severe acute respiratory syndrome (SARS)-associated coronavirus, resulting from a sample collected in Hanoi (Vietnam), reference number 031589, nucleic acid molecules originating from the genome of same, proteins and peptides coded by said nucleic acid molecules and, more specifically, protein N and the applications thereof, for example, as diagnostic reagents and/or as a vaccine.

Abstract: The present invention is in the field of autoimmunity. More specifically, the present invention relates to the detection of autoantibodies to domain 4 of beta 2-glycoprotein I (?2-GPI) as an indicator for atherosclerosis.

Abstract: We describe examples using aptamers for capturing and reporting the presence of a target, such as a pathogen. Examples described here include a set of aptamers that are specific to F. tularensisis. Other examples described here include an Aptamer-Linked Immobilized Sorbent Assay (ALISA) and dot blot assay. An example of a method provided here comprises: providing a set of DNA sequences that exhibit high binding affinity to target antigen, placing the DNA sequences in a sandwich aptamer-linked immobilized sorbent assay (ALISA), contacting the DNA sequences with a sample, and detecting whether the target is present in the sample. Some alternative implementations may include dot blots and different reporters. Quantum dot sandwich assays and quantum dot de-quenching reporters can be used.

Abstract: In a wide variety of human solid tumors, an aggressive, metastatic phenotype and poor clinical prognosis are associated with expression of the receptor tyrosine kinase Met. Disclosed herein are (a) a monoclonal antibody named Met4, which antibody is specific for Met, and (b) a hybridoma cell line that produces Met4. The Met4 antibody is particularly useful for detecting Met in formalin-fixed tissue. Methods of using the Met4 antibody for detection, diagnosis, prognosis, and evaluating therapeutic efficacy are provided.

Abstract: The present invention relates to a new isolate of Neospora caninum and to the extracts which may be produced therefrom. Said isolate presents a high degree of attenuation, which makes it suitable for the development of vaccines against neosporosis, and of diagnostic tests to detect infection by Neospora caninum in animals. It also describes pharmaceutical compositions wherein said isolate or extracts thereof are used for the prevention and treatment of the infections caused by Neospora caninum in animals.

Abstract: A method and composition for the diagnosis of and treatment of prostate cancer including a recombinant AKAP-4 tumor-associated antigen loaded antigen presenting cell that generates an AKAP-4 specific cytotoxic T lymphocyte specific for one or more prostate cancer cells.

Abstract: The invention relates to a method of diagnosing or monitoring schizophrenia or other psychotic disorder.

Abstract: The present invention relates to the use of soluble CD163 as a prognostic marker for the assessment of the risk for contracting a disorder, in particular for contracting diabetes and/or a liver disorder. The invention also relates to the use of CD163 as a prognostic marker for assessing lifetime expectancy.

Abstract: Use of FGF-2 and Anosmin-1 proteins to predict the histopathology of the lesions of a subject with a demyelinating disease of the central nervous system (CNS) by detecting the amount of such proteins in a sample of isolated biological fluid. Furthermore, the present invention relates to a method for the understanding of the histopathological features of the lesions of a subject with a CNS demyelinating disease a kit to carry out this method. Preferably, the CNS demyelinating disease is multiple sclerosis, and the biological fluid is cerebrospinal fluid (CSF).

Abstract: By detecting an antibody which immunologically reacts with amylase ?2-A in a sample, AIP or FT1DM is examined or the possibility of developing FT1DM is determined. For instance, detection of this antibody is carried out by an immunological method using an antigen which immunologically reacts with this antibody. The antigen is preferably a partial fragment containing the amino acid sequence of amino acid numbers 299 to 511 of human amylase ?2-A (SEQ ID NO: 1).

Abstract: The present invention provides Tumor Endothelial Marker 5? (TEM5?) polypeptides and nucleic acid molecules encoding the same. The invention also provides selective binding agents, vectors, host cells, and methods for producing TEM5? polypeptides. The invention further provides pharmaceutical compositions and methods for the diagnosis, treatment, amelioration, or prevention of diseases, disorders, and conditions associated with TEM5? polypeptides.

Abstract: The present invention relates to antibodies, binding portions thereof, or probes that bind specifically to glucosyltransferase enzymes, and uses of these agents for detecting glucosyltransferase enzyme(s) in a sample and for diagnosing predisposition of a human child to early childhood caries. The present invention also relates to a kit for detecting a glucosyltransferase enzyme in an oral sample from an animal.

Abstract: The present disclosure provides methods of diagnosing chronic heart failure in patients by detecting the presence and amounts of biomarkers of heart failure in samples from the patients. Such biomarkers may be used to develop a more accurate prognosis for a patient with heart failure, or to accurately diagnose a patient suspected of having heart failure.

Abstract: The application discloses MCAM as a new biomarker for acute heart failure; methods for predicting, diagnosing, prognosticating and/or monitoring acute heart failure based on measuring said biomarker; and kits and devices for measuring said biomarker and/or performing said methods.

Abstract: The present invention provides a method for detecting or diagnosing in vitro Alzheimer's disease, or memory and/or cognitive disorders, using a human biological sample and the inactivation of STAT3 protein as an indication, and a method for screening for a therapeutic drug for Alzheimer's disease or memory and/or cognitive disorders, using the activation of STAT3 protein as an indication.

Abstract: There is a constant need for increased sensitivity of antibody-based assays as well as a need for high affinity antibodies. Higher affinity molecules such as antibodies increase the specificity and sensitivity of assays. Both increased sensitivity and higher affinity can be achieved when multiple copies of a binding molecule are coupled to a flexible backbone. According to one embodiment of the invention, multiple copies of a detection molecule, such as, for example, an antibody or antibody fragment, are covalently linked to a high molecular weight water soluble polymer creates multivalent antibody constructs. The affinity or avidity increases markedly as multivalency increases and also, multiple copies of a signal molecule can be similarly added to the polymer. Thus, the construct comprises multiple copies of detection and signal molecules on a high molecular weight, water soluble, flexible polymer.

Abstract: The disclosed invention relates to monoclonal antibodies (MAbs) which recognize human fatty acid synthase (hFAS) and are distinct from previously known anti-hFAS antibodies. Compositions, devices and kits comprising the MAbs are provided along with methods of using the MAbs in a variety of applications.

Abstract: The present invention relates to a new method to determine the presence of antibodies to a pathogen in a serological sample using a new detection reagent which comprises at least two and preferably at least four copies of an antigen from the pathogen and a detectable marker. The present invention also relates to a new detection reagent which consists of at least two and preferably at least four antigenic peptides in a complex with a detectable marker via interacting multimerization domains upon both the antigenic peptides and detectable marker.

Abstract: A method, composition and system respond to ionizing radiation to adjust biological activity. In some approaches the ionizing radiation is X-ray or extreme ultraviolet radiation that produces luminescent responses that induce biologically active responses.

Abstract: The present invention relates to a method for diagnosing a cardiovascular or cancer disease by detecting IGFBP-4 (Insulin-like Growth Factor Binding Protein-4) fragments in a patient sample. Antibodies specifically recognizing novel epitopes originated by enzyme-dependent cleavage of IGFBP-4 are also disclosed.

Abstract: Microfluidic methods and devices for heterogeneous binding and agglutination assays are disclosed, with improvements relating to mixing and to reagent and sample manipulation in systems designed for safe handling of clinical test samples.

Abstract: The present invention provides methods and compositions for identifying compounds which modulate cellular glycosylation. The invention further provides methods for treating subjects suffering from or at risk of developing a glycosylation associated disorder.

Abstract: The invention provides a method for diagnosing amyotrophic lateral sclerosis (ALS) in a subject, a method for assessing the effectiveness of a drug in treating ALS, and a method for determining the site of onset of ALS in a subject. Each method comprises (a) obtaining a sample from the subject, (b) analyzing the proteins in the sample by mass spectroscopy, and (c) determining a mass spectral profile for the sample. In some embodiments, the method comprises comparing the mass spectral profile of the sample to the mass spectral profile of a positive or a negative standard.

Abstract: A device and method for detecting the presence of hemoglobin in a biological sample, more particularly, the presence of blood in a fecal sample as an indicator of upper or lower gastrointestinal tract bleeding.

Abstract: Monoclonal antibodies, or antigen-binding fragments thereof, that bind to ERG, and more specifically, to an epitope formed by amino acids 42-66 of ERG3 are disclosed. The monoclonal antibodies can be non-human antibodies (e.g., rabbit or mouse) or humanized monoclonal antibodies having the CDR regions derived from those non-human antibodies. In other embodiments, the monoclonal antibodies are chimeric, having the light and heavy chain variable regions of a non-human ERG anti-body. Methods of using the antibodies to detect ERG, or fusion proteins comprising all or part of an ERG polypeptide, such as an ERG polypeptide encoded by a TMPRSS2/ERG, SLC45A3/ERG, or NDRG1/ERG fusion transcript, are also provided, including methods of detecting ERG or ERG fusion events in a clinical setting.

Abstract: The present invention relates to a method for the in vitro diagnosis of colorectal cancer by determining the presence of the Prodefensin-A6 tumour marker in a biological sample taken from a patient suspected of having colorectal cancer, it being possible for said method to be used both in early diagnosis, screening, therapeutic follow-up and prognosis, and in relapse diagnosis in relation to colorectal cancer.

Abstract: A method for determining the risk of an individual of suffering from inflammation, opportunistic infection or disruption of immunoglobulin metabolism, comprising (a) determining the level of fragmentation or modification of Fc function of immunoglobulins in a sample taken from the individual and (b) determining thereby the risk of inflammation, impaired immune response or opportunistic infection. The invention also provides the use of a trypsin inhibitor in the manufacture of a medicament for use in the treatment or prevention of a disorder associated with elevated trypsin activity which is correlated with IgG fragmentation or modification.

Abstract: The invention refers to the design, synthesis and evaluation of 6 synthetic oligopeptides, that have not been previously described, designed from the T and B epitopes of allergens of group I of intradomiciliary mites of the species Dermatophagoides pteronyssinus, Dermatophagoides farinae and Blomia tropicalis, which can be used in the immunomodulation of individuals having immunocompetent systems and in the production of IgY polyclonal antibodies. The invention relates to a first method for obtaining a composition of IgY polyclonal antibodies that can be used as a diagnostic reagent having low cost and high reactivity in respect of intradomiciliary mites, and a second method for the detection of mite allergens, using the IgY antibody composition developed in the first method. The invention further relates to the composition of the IgY polyclonal antibodies.

Abstract: A specific and sensitive in vitro ELISA assay and diagnostic test kit is disclosed for determining levels of NT-proBNP protein in a variety of bodily fluids, non-limiting examples of which are blood, serum, plasma, urine and the like. The NT-proBNP ELISA assay test employs the sandwich ELISA technique to measure circulating NT-proBNP in human plasma. In order to obtain antibodies with specific binding properties for targeted amino acid sequences within human proBNP, recombinant human proBNP (or rhproBNP) was expressed and purified for use as an immunogen. Polyclonal antibodies (PAb) to specific amino acid sequences were subsequently purified from goat serum by sequential affinity purification. Monoclonal antibodies were raised against specific polypeptides. Recombinant human NT-proBNP (or rhNT-proBNP) was expressed and purified in order to obtain material for use in calibration of a quantitative method for measurement of human NT-proBNP.

Abstract: Kit and method for the pre mortem in vitro detection of Alzheimer's disease The invention relates to a detection kit for Alzheimer's disease based on the vitro identification of the presence of biomarkers in the remains normally discarded after crystalline lens surgery. The kit can be used for the pre mortem detection of the disease, even before the appearance of clinical symptoms. Among the available biomarkers, the biomarker of choice is beta-amyloid peptide, for which several methods of sample processing and labelling for the presence of the biomarker may be used. Embodied in the invention is also the use of the crystalline lens remains discarded during surgery, often cataract surgery, to prepare a method for the in vitro pre mortem detection of Alzheimer's disease.