Abstract: Embodiments of the invention provide method and devices for predicting the likelihood of acute appendicitis without invasive exploratory medical procedures. Several protein biomarkers: leucine-rich ?-2-glycoprotein (LRG); S100-A8 (calgranulin); ?-1-acid glycoprotein 1 (ORM); plasminogen (PLG); mannan-binding lectin serine protease 2 (MASP2); zinc-?-2-glycoprotein (AZGP1); Apolipoprotein D (ApoD); and ?-1-antichymotrypsin (SERPINA3); are increased in the urine of patients with appendicitis. The method and devices comprise detecting the levels of these biomarkers and comparing with reference levels found in healthy individuals.

Abstract: Methods and kits are provided for assessing radiation injury and exposure in a subject. The methods comprise measuring the levels of at least two (2) protein biomarkers from different biological pathways and correlating the levels with an assessment of radiation injury and exposure. Additional use of peripheral blood cell counts and serum enzyme biomarkers, evaluated in the early time frame after a suspected radiation exposure, and use of integrated multiple parameter triage tools to enhance radiation exposure discrimination and assessment are also provided. The information obtained from such methods can be used by a clinician to accurately assess the extent of radiation injury/exposure in the subject, and thus will provide a valuable tool for determining treatment protocols on a subject by subject basis.

Abstract: Methods and compositions are described for the diagnosis of primary biliary cirrhosis. Novel autoantigens are described for use in assays which employ test samples from individuals.

Abstract: Hybridoma cell line 10G4 and monoclonal antibody against total aflatoxins produced by the hybridoma cell line 10G4. The hybridoma cell line 10G4 is used to produce the monoclonal antibody that binds specifically total aflatoxin B1, B2, G1 and G2. The titer of the mouse ascites antibody produced by the 10G4 treated mouse is determined through non-competitive enzyme-linked immunosorbent assay and the titer can reach up to 5.12×105. The monoclonal antibody against total aflatoxin B1, B2, G1 and G2 are used for better identification of aflatoxin B1, B2, G1 and G2 with good consistency. The 50% inhibitory concentrations (IC50) of the antibody against aflatoxin B1, B2, G1 and G2 are 2.09 ng/mL, 2.23 ng/mL, 2.19 ng/mL and 3.21 ng/mL respectively. The range of cross reaction rate for aflatoxin B1, B2, G1 and G2 is about 65.2%-100%. The antibody is used for quantitative measurement of total aflatoxin B1, B2, G1 and G2.

Abstract: A method for measuring immunoglobulin G-mediated complement activation, includes the following steps: a) preparing a sample A of immunoglobulin G and a sample B including natural serum, the natural serum optionally being diluted in a dilution buffer; b) mixing sample A with sample B at a ratio (amount of IgG in A in grams):(volume of natural serum in B in liters) of between and 75, at a temperature of between 2° C. and 6° C., and subsequently incubating the resulting reaction mixture at a temperature of between 35° C. and 40° C. for a period of between 30 minutes and 2 hours; c) cooling the reaction mixture obtained at the end of step b) to a temperature of between 0° C. and 4° C. in the presence of EDTA; and d) measuring the amount of C5a fragment in the cooled reaction mixture obtained in c).

Abstract: A method for measuring the amount of sialic acid in immunoglobulin G and immunoglobulin G anti-ds DNA antibodies is disclosed. The method for measuring the amount of sialic acid in immunoglobulin G in the present invention uses culture fluid, blood, plasma, or serum to directly measure the amount of sialic acid in immunoglobulin G. Also, using a mouse monoclonal antibody immunoglobulin G as a standard, which is diluted from 1000 ng/ml to 15.625 ng/ml in phosphate buffered saline (PBS), produces good results. The method for measuring the amount of sialic acid in immunoglobulin G anti-ds DNA antibodies has never been done and the present invention produces good results as well.

Abstract: A method is taught for the accurate determination of the premature rupture of membranes (PROM), defined as spontaneous rupture of membranes before the onset of uterine contractions. More specifically, a lateral flow assay strip tests for at least two antigens to greatly limit or eliminate the possibility of false negatives. A built in timer in the cassette holding the lateral flow assay further increases the accuracy of the test. A collection buffer vial with self-contained shipping and dropper caps and built in stand is also taught.

Abstract: The invention relates to an in vitro method for determining procalcitonin levels in plasma and urine as a diagnostic marker to identify patients with urinary tract infections, in vitro methods to perform said determination, a kit for the diagnosis of patients with urinary tract infections, and the usefulness of procalcitonin in the diagnosis urinary tract infections.

Abstract: A surface-immobilized multilayer structure of a plurality of vesicles (2), the structure comprising at least one linker (4) immobilized onto the surface, the at least one linker (4) being bound to at least one other linker, which is attached to a vesicle, which optionally may have another linker (5) bound to another linker (5) attached to another vesicle (2), wherein the structure either comprises at least two vesicles (2) bound via linkers (5) to each other or at least two vesicles (2) bound via linkers (5) attached to the vesicles to one linker (4) immobilized onto the surface (1).

Abstract: The invention provides a cassette-based automated assay for homocysteine.

Abstract: A method is provided for detecting multiple analytes via their interactions with reagents. The analytes are immobilized on an analyte support and are divided into subdivisions by a blotting apparatus. Reagents are applied, each to a specific subdivision of the analyte support and binds to the analytes there.

Abstract: An object is to provide a biomarker specific to amyotrophic lateral sclerosis and a use thereof. Provided are a marker for amyotrophic lateral sclerosis containing a transmembrane glycoprotein nmb, and a method for detecting amyotrophic lateral sclerosis, which utilizes the marker, and the like.

Abstract: A method for dissociating avidin or streptavidin efficiently from a biotin derivative, thereby making it possible to isolate a target material efficiently under a mild condition in a short period, and a dissociation agent for use thereof, are provided. The method for dissociating avidin or streptavidin from a biotin derivative, includes mixing a combination of avidin or streptavidin with desthiobiotin with a water-soluble polymer to which biotin or a derivative thereof is bound.

Abstract: The present invention relates to a method for detecting the presence and/or concentration of the soluble BAG3 protein in an unknown biological sample and the assay is preferably carried by ELISA assay with antibodies, preferably monoclonal antibodies. The presence of said protein in a soluble form is associated with heart disease or with the presence of pancreatic tumors.

Abstract: The present invention pertains to the field of tools for ensuring manufacture of polypeptides and quality control. Specifically, it relates to a method for determining the amount of processed (active) neurotoxin polypeptides in a solution comprising processed neurotoxin polypeptides and partially processed or unprocessed neurotoxin polypeptides. The present invention further relates to a device for determining the amount of neurotoxin polypeptides and a kit adapted to carry out the method of the present invention.

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

Abstract: The invention relates to a novel antibody which binds to wild type (wt) Glutathione S-transferase Omega 1 (wtGSTO1) but not to mutant (mut) GSTO1 and methods and uses based on the antibody. The antibody is based on novel haptens and immunogens.

Abstract: An enzyme detection device (1) for detecting the presence, in a sample, of an enzyme capable of modifying a provided substrate (10). The device (1) comprises a substrate which has a modification region (14) that is sensitive to modification by the enzyme from an unmodified state to a modified state. The device (1) further comprises a substrate recognition molecule (16) which binds the modification region (14) in either the modified or the unmodified state. The modification region 14 of the substrate is preferentially bound by the substrate recognition molecule (16) as compared with the enzyme when mixed. The device further comprises a detectable label (18) coupled to the substrate recognition molecule (17).

Abstract: A method for diagnosing, or differentially diagnosing, interstitial cystitis (IC) involves detecting or measuring increased expression of a biomarker Endothelin 1 (ET-1) in a biological sample from a mammalian subject, particularly in the urine or urothelial tissue. An increased level of expression of ET-1 above the level of expression in the same sample of a healthy mammalian subject is an indication of a diagnosis of IC. Such diagnosis may further involve identify other clinical symptoms of IC. Additionally the method may use additional biomarkers, such as Hb-EFG, EGF, APF, IL-8, IL-6, and cGMP. Assay methods and diagnostic reagents and kits for such diagnosis are provided. Methods and compositions for treating IC by reducing the action, production or synthesis of ET-1 in the urine or urothelium and/or inhibiting its binding to its ETA and/or ETB receptors are also provided.

Abstract: Disclosed are a method for early, sensitively and reliably detecting and distinguishing intrahepatic cholangiocarcinoma in a malignant tumor occurring primarily in the liver in a simple way, and a kit thereof. In the method, a glycan biomarker consisting of a lectin WFA (Wisteria floribunda Agglutinin)-binding glycoprotein derived from intrahepatic cholangiocarcinoma is used as a cancer marker to detect intrahepatic cholangiocarcinoma by detecting the cancer marker in a test specimen. The method for detecting intrahepatic cholangiocarcinoma can clearly differentiate intrahepatic cholangiocarcinoma from hepatocellular carcinoma and enables early detection and determination with a performance clinically acceptable in terms of applicability, sensitivity and precision.