Abstract: Methods for detecting His-tagged proteins using metal ion-chelating nitrilotriacetate (NTA) probes and polyacrylamide gel electrophoresis (PAGE) are disclosed. In one embodiment, the method includes using a metal ion-loaded NTA probe coupled to a UV-excitable fluorophore with visible emission and the presence of His-tagged proteins in the sample is determined by exposing the gel following PAGE, to a UV-light source with naked human eye or bench camera visualization. The metal ion-loaded NTA-containing chelator head can be coupled to a fluorophore that is not UV-excitable (i.e., with the majority of emission and excitation in the visible region of the electromagnetic spectrum. The method includes separating proteins in a sample using PAGE, contacting the gel following electrophoresis with a composition containing a metal ion-loaded NTA probe coupled to the fluorophore, to allow binding of the probe to the His-tagged proteins, and detecting the presence of the probe and therefore of the His-tagged proteins.

Abstract: Described herein are methods for treating rheumatoid arthritis by determining whether a subject having rheumatoid arthritis will respond to an anti-TNF-alpha therapy based on the number of innate and adaptive immune cells in a sample from the subject prior to treatment.

Abstract: The present invention relates to a method for determining the total amount and/or concentration of an analyte in the presence of a binding molecule as well as kits, compositions and uses relating thereto.

Abstract: Described herein are novel rapid and reliable methods of detection of extracellular vesicles and quantifying extracellular vesicle concentrations and absolute number from various sources, including raw cell harvest. The methods described herein comprise detection of intrinsic fluorescence of extracellular vesicles in biological samples. Extracellular vesicles analyzed by the methods of this application have a stereotypical elution profile distinct from known contaminants. The methods described herein are a significant improvement over the state of the art and fulfills an unmet need in the field of extracellular vesicle manufacturing and quality control.

Abstract: Compositions and methods are provided for diagnosis and/or prognosis of cardiovascular diseases or events in a subject. In some embodiments, the method includes measuring and comparing the level of particular proteins to other proteins. In other embodiments, the method includes comparison with clinical variable information.

Abstract: Disclosed herein are methods and compositions for the detection of biomarkers for cardiac diseases. Disclosed herein are sample collection devices comprising detection devices for heart failure. Disclosed herein are methods of detecting, monitoring, preventing, or treating heart failure.

Abstract: The present technology regards the utilization of CEACAM1 as a biomarker for cancer. In particular the present invention regards the detection and measurement of soluble CEACAM1 levels for the detection and diagnosis of melanoma.

Abstract: The invention relates to methods of diagnosing, prognosing, or monitoring or staging the progression of non-alcoholic fatty liver disease (NAFLD) using biomarkers. The invention also relates to a method of scoring to determine the severity of NAFLD, and a method of treating NAFLD.

Abstract: The present invention is directed to the discovery that RapI-GTP, Rac1-GTP and Flt3-L can be used as Biomarkers for the early detection of sepsis in patients suspected of a bacterial infection which presents as sepsis or is likely to produce sepsis. In particular, the present invention is directed to methods, assays and kits which may be used to distinguish sepsis (infection) from systematic inflammatory response caused by sterile inflammation in trauma patients. The method may be used to diagnose bacteria infection and/or sepsis and monitor therapy of a patient to allow modification of treatment and/or cessation of treatment.

Abstract: The present invention relates to compositions and methods use in designing immunoassay controls. In various aspects, the invention provides synthetic peptides comprising the sequence CPRRPYIL (SEQ ID NO: 1) or an analog thereof; ELAGLGFAELQC (SEQ ID NO: 4) or an analog thereof; and CDWRKNIDAL (SEQ ID NO: 8) or an analog thereof; specific binding reagents that bind to a CPRRPYIL (SEQ ID NO: 1), ELAGLGFAELQC (SEQ ID NO: 4) or CDWRKNIDAL (SEQ ID NO: 8) peptide; methods of producing such reagents; and assays utilizing such reagents to provide assay controls signals that are unrelated to the measurement of the analyte or analytes of interest in that no reagents used in the analyte assay(s) contribute to the control signal.

Abstract: The invention relates to the use of recombinant/semi-synthetic nucleosomes carrying histone and/or DNA modifications as a reference standard for quantification of covalently modified (on the histone proteins or wrapping DNA), variant, or mutant nucleosomes (collectively “modified nucleosomes” or “nucleosome modifications”) from a biological sample. The invention further relates to methods of using the assay to accurately quantify single or combinatorial nucleosome modifications as biomarkers of disease.

Abstract: The present invention relates to a system, device, and method for the high throughput multiplexed detection of a wide number of compounds. The invention comprises of a microwell array coupled to a capture agent array to form a plurality of interfaces between a microwell and a set of immobilized capture agents. The set of capture agents comprises a plurality of distinguishable features, with each feature corresponding to the detection of a particular compound of interest. In certain embodiments, each microwell is configured to contain a single cell. The invention is therefore capable of performing a high throughput analysis of single cell profiles, including profiles of secreted compounds.

Abstract: The present invention concerns the field of diagnostic assays for prenatal diagnosis of preeclampsia. In particular, it relates to a method for diagnosing whether a pregnant subject is not at risk for preeclampsia within a short window of time comprising a) determining the amount of at least one angiogenesis biomarker selected from the group consisting of sFlt-1, Endoglin and PlGF in a sample of said subject, and b) comparing the amount with a reference, whereby a subject being not at risk for developing preeclampsia within a short period of time is diagnosed if the amount is identical or decreased compared to the reference in the cases of sFlt-1 and Endoglin and identical or increased in the case of PlGF, wherein said reference allows for making the diagnosis with a negative predictive value of at least about 98%. Further contemplates are devices and kits for carrying out said method.

Abstract: An object of the present invention is to elucidate the cause of degradation of the reliability of detecting causative bacteria of environmental mastitis such as Escherichia coli, Klebsiella bacteria, Streptococcus bacteria, and CNS, and to provide a highly reliable detection means. Another object of the present invention is to provide a highly reliable detection means based on the immunochromatographic method, which enables quicker determination compared with the cultivation-based method, and a diagnosis kit using it.

Abstract: The invention relates to methods of assessing a patient's risk of developing Progressive multifocal leukoencephalopathy (PML).

Abstract: The present disclosure relates to an aglycosylated antibody-producing transgenic mouse and the use of an aglycosylated antibody produced therefrom. When the transgenic mouse of the present disclosure is used, it is possible to easily produce aglycosylated antibodies against various target antigens, and to precisely diagnose disease by detecting a glycoprotein biomarker using the produced aglycosylated antibody.

Abstract: This disclosure provides a method for determining male fertility status. The method comprises determining GM1 localization patterns following induced sperm capacitation, identifying the percentage of various patterns, particularly the ratio of [(AA+APM)/total number of GM1 localization patterns] and determining if the percentage of certain GM1 localization patterns in response to induced capacitation is altered. Based on the change in the percentage of localization patterns of certain patterns in response to induced capacitation, alone or in combination with other sperm attributes, male fertility status can be identified.

Abstract: Assays and methods for diagnosing and treating autoimmune diseases. Particularly, the invention provides methods for differential diagnosis of specific autoimmune diseases, including autoimmune rheumatic disorders.

Abstract: The present invention relates novel cells and their use in methods for determining the antibody-dependent cell-mediated cytotoxicity (ADCC) or antibody-dependent cell-mediated phagocytosis (ADCP) in a sample.

Abstract: The present invention inter alia provides a method, and use thereof, of diagnosing and/or predicting atherosclerosis or CVD by detecting the lipid concentrations or lipid ratios of a biological sample and comparing it to a control and has identified specific lipid markers that are more specific and sensitive in detecting and predicting atherosclerosis and CVD than currently utilized clinical markers. Also provided is an antibody towards said lipids, and the use thereof for predicting, diagnosing, preventing and/or treating atherosclerosis or CVD. The invention additionally relates to kits comprising lipids and/or an antibody thereto, for use in the prediction and/or diagnosis of atherosclerosis or CVD.