Abstract: The present invention relates to a method of qualifying ovarian cancer status in a subject comprising: (a) measuring at least one biomarker in a sample from the subject and (b) correlating the measurement with ovarian cancer status. The invention further relates to kits for qualifying ovarian cancer status in a subject.

Abstract: An immunoassay device has a housing defining a first opening for receiving a solution and a second opening through which a liquid sample is deposited, a strip of sorbent material having a test site with immobilized antigen or antibody for the ligand to be tested, and a filter for filtering the sample. The filter is located at the second opening and directly above the test site. The sorbent material defines a horizontal flow path in the housing for the solution from the first opening to the test site. In use, the sample is first applied via the filter to the test site, and then, after the ligand has been captured, a buffer added through the first opening is used to cause a secondary specific binder conjugated to a marker to migrate horizontally by capillary action to the test site where it can bind to the already captured ligand. This immunoassay offer several advantages over the traditional chromatographic immunoassays.

Abstract: An improved multi-layered diagnostic sanitary test strip for receiving a heterogenous fluid, such as whole blood, to test for presence and/or amount of a suspected analyte in the fluid by facilitating a color change in the strip corresponding to the amount of the analyte in the fluid, wherein the test strip includes fluid volume control dams to prevent spillage of the fluid from the strip and a chemical reagent solution that facilitates end-point testing.

Abstract: An in vitro method for the detection, determination of severity and monitoring and prognosis of neurodegenerative diseases is disclosed. The presence and/or concentration of the physiologically inactive proadrenomedullin (proADM) partial peptide, in particular, the midregional proADM partial peptide, is determined in a biological fluid of a patient who is suffering from a neurodegenerative disease or is suspected of having such a disease. Conclusions about the presence, course, severity or success of a treatment of the neurodegenerative disease are drawn on the basis of the presence and/or concentration of the specific partial peptide in the biological sample.

Abstract: Methods and apparatus for electronically addressing and interrogating microarrays are disclosed. The described microarrays include a plurality of features disposed on a substrate. Each of the features has a first electrode disposed on the substrate, a second electrode disposed on the substrate, and a probe disposed between the first electrode and second electrode. The substrate also includes addressing circuitry in operable relation to the features. Method of using the microarrays are also described.

Abstract: The present invention provides a method for confirming existence of a phosphoric acid monoester compound (peptide, saccharine and the like) and easily identifying the molecular weight thereof even among biological samples including a plurality of compounds, and an additive for a mass spectrometry used for the method. In the method according to the present invention, a complex compound exhibiting extremely high coordination ability to a phosphoric acid monoester group and configured of single kind of zinc isotopes is used to obtain a plurality of mass spectrum data, and then the data are compared.

Abstract: Specific and accurate immunoassay of tartrate resistant acid phosphatase 5b (TRACP 5b) in a specimen may be carried out by bonding TRACP 5b in the specimen to an antibody, subjecting the TRACP 5b bonded to the antibody to enzyme reaction with a 2-halo-4-nitrophenylphosphoric acid or a salt thereof, a substrate for TRACP 5b, and then assaying the enzymatic activity of TRACP 5b.

Abstract: Novel conjugates of docetaxel and novel docetaxel immunogens derived from the 7 and 10 positions of docetaxel and monoclonal antibodies generated by these docetaxel linked immunogens are useful in immunoassays for the quantification and monitoring of docetaxel in biological fluids.

Abstract: A method for identification and evaluation of the hydrogen storage capacity of materials is presented, the method comprising providing a plurality of materials, wherein the plurality of materials comprise an array of synthesized hydrides and analyzing hydrogen content in the plurality of materials.

Abstract: A non-continuous immunoassay device which includes two or more separated pads for immunoassay analysis, and is capable of controlling the migration speed of a mobile phase between the separated pads, and an immunoassay method using the same are disclosed. The immunoassay device includes a first pad receiving a mobile phase; a second pad which is spatially separated from the first pad by a predetermined distance, and to which the mobile phase migrates; an upper case for covering the upper parts of the first pad and the second pad; a lower case for covering the lower parts of the first pad and the second pad; and a connecting member which is formed on at least one of the upper case and the lower case, and located between the first pad and the second pad to form a passage for moving the liquid sample.

Abstract: The present invention pertains to the use of a peptide molecule consisting in a maturation product of SMR1 (Submandibular rat protein 1) of structural formula QHNPR, as well as the biologically active derivatives of the said peptide, for preventing or treating diseases associated with a mineral ion imbalance in a human or an animal body. More particularly, the present invention relates to the therapeutic use of the above-cited molecules for preventing or treating an hydro-mineral imbalance in organs and tissues such as kidney, bone, dental enamel, dental ivory, gut matrix, pancreas or glandular gastric mucosa. This invention also deals with therapeutic compositions comprising a pharmaceutically active amount of the above-described therapeutic molecules as well as with therapeutic methods using the said therapeutic compositions.

Abstract: The invention provides compositions and methods of detecting binding of molecules to a biosensor. Compositions of the invention comprise a multiwell plate with an integrated biosensor and a membrane.

Abstract: Acoustic wave devices coated with a biolayer are described for the detection target bio-molecules. The acoustic wave device is connected in an oscillator circuit, and the frequency shift ?f resulting from a biomolecular event is recorded. Further described are the use of Rayleigh wave surface acoustic wave devices for vapor phase detection as well as quartz crystal microbalance devices for liquid phase measurements. A biofilm on the surface of the acoustic wave device comprises of a layer of antibodies raised against a specific target molecule or antigen. Signatures for detection events are presented in the form of frequency shifts ?f(t).

Abstract: A method and test device for differentiating between states of an analyte that can exist in different forms, such as follicle stimulating hormone (FSH). The method or test device uses a pair of specific binding agents, especially monoclonal antibodies, in two assays for the same analyte. The assays, applied to contemporaneous samples, differ from one another in format, one being a two step assay and the other being one step. A novel pair of anti-FSH monoclonal antibodies that can be used together in two such assays to differentiate pre-menopausal and post-menopausal FSH samples is disclosed.

Abstract: The invention relates generally to methods, systems, and devices for measuring the concentration of target analytes present in a biological system using a series of measurements obtained from a monitoring system and a Mixtures of Experts (MOE) algorithm. In one embodiment, the present invention describes a method for measuring blood glucose in a subject.

Abstract: An immunochemical assay device for determining the presence of NT-proBNP alone or conjunctively with Cardiac Troponin I comprising a base member, an array disposed on the base member, and at least one assay indicia zone. The array comprises (i) a reservoir pad to receive sample liquid, (ii) a wicking membrane, and (iii) at least one filter zone interposed between the wicking membrane and the reservoir pad. The filter zone being operable to permit passage of any specific immunocomplex to the wicking membrane while impeding passage of larger components.

Abstract: The invention provides haptens, immunogens comprising such haptens coupled to an antigenicity-conferring carrier material, conjugates comprising such haptens bonded to a labelling agent as well as, antibodies raised against such immunogens and capable of binding with ketamine and its primary metabolite, norketamine.

Abstract: The present invention relates to immobilized procainamide analogs, as well as to a method of making immobilized procainamide analogs. These immobilized analogs are prepared by activating the carboxyl group on a substituted p-benzoic acid derivative toward nucleophilic attack; reacting the activated benzoic acid derivative with a polyamine to produce the benzoic acid derivative of Formula 3: and binding the benzoic acid derivative of Formula 3 to a latex polymer having functional groups that react with aliphatic amino groups. A method of conducting an immunoassay using the immobilized procainamide analog Formula 3 is described, comprising the steps of preparing a solution comprising said immobilized procainamide analog; adding a sample suspected of containing procainamide to said solution; adding an anti-procainamide antibody to said solution and observing the rate of increase in solution turbidity following antibody addition.

Abstract: The amount of lipid associated sialoprotein (LSP) in body fluids such as cerebrospinal fluid, peritoneal fluid, pleural fluid, bronchial washings, saliva and sputum samples, may be determined by a method which may be automated, involving the following steps to be performed on the sample: adding a mixture of a chlorinated lower alkyl alcohol; centrifuging to yield a substantially clear upper phase; recovering the upper phase and adding to it a protein precipitating agent; mixing the resulting admixture; recovering the resulting precipitate; washing the precipitate with saline solution; centrifuging to recover the precipitate; dissolving the precipitate in water; mixing; adding to the resulting mixture an hydrolysis agent; heating; and determining the amount of lipid associated sialoprotein present by determining the optical density of the sample.

Abstract: This invention relates to the diagnosis and monitoring of ischemia, including but not limited to myocardial and cerebral ischemia, by measuring the concentration of molecules that do not originate from the ischemic tissue but whose concentration in the blood and other fluids changes as a consequence of the ischemic state.

Abstract: A method of making a derivatized aminoglycoside includes reacting an aminoglycoside with at least 2 equivalents of a divalent metal ion in an aprotic solvent to complex two neighboring amino group and hydroxyl group pairs; reacting the non-complexed amino groups with a protecting reagent to provide protecting groups; removing the divalent metal ion to provide two unprotected amino groups; reacting one of the unprotected amino groups with a reactive substance containing an linker, a carrier, or a label; and removing the protecting groups. This method can be used to produce novel compounds and reagents.

Abstract: Immunoassays for the detection of everolimus are provided. Compounds for producing antibodies for everolimus, as well as antibodies produced therefrom, are also provided.

Abstract: The invention provides a hapten, an immunogen comprising the hapten coupled to an antigenicity-conferring carrier material, a conjugate comprising the hapten coupled to a labelling agent, as well as, antibodies raised against the aforementioned immunogen and capable of binding with MDMA.

Abstract: This invention relates to a method for the determination of substances using the evanescence field method. A cuvette, a microtiter well, a solution and a kit for application in a method according to the invention are disclosed. This method can in particular be used in the field of diagnostics and in analytical procedures.

Abstract: Artificial antibodies or antibody mimics are described. They consist of polymers that carry specific binding sites mimicking the properties of antibodies. There is also described a method for producing artificial antibodies, in which polymerisable monomers carrying functional groups and crosslinking monomers are polymerised in the presence of a print molecule and subsequently the print molecule is removed leaving specific binding sites complementary to the print molecules. There are also described methods for determination and isolation of organic molecules using the artificial antibodies as well as therapeutic and diagnostic methods using these antibodies.

Abstract: Novel conjugates of 5-fluoro-uracil and novel 5-fluoro-uracil immunogens and monoclonal antibodies generated by these immunogens which are useful in immunoassays for the quantification and monitoring of 5-fluoro-uracil in biological fluids.

Abstract: Provided are a method for easily detecting phosphorylated peptides, namely, proteins, in samples derived from living organisms or the like, a method for selectively adsorbing the phosphorylated peptides, and compounds that are highly coordinated to the phosphorylated peptides and usable in the methods. The complex compound is represented by the formula: wherein X is a linker moiety, and Y is a labeling group. The compound (I) is highly coordinated to a phosphorylated peptide, and has a labeling group. Accordingly, with use of the compound (I), the phosphorylated peptide can be easily identified.

Abstract: The present invention provides methods for determining a ratio of an amount of a glycated form of a protein to a total amount of the protein in a sample containing the glycated protein, the glycosylated protein, or the glycoprotein. The method incorporates lateral flow test strip or vertical flow test strip devices having negatively charged carboxyl or carboxylate groups and hydroxyboryl groups immobilized and interspersed on a solid support matrix. The solid support matrix may include derivatives of cellulose (e.g., carboxy cellulose) derivatized with carboxylic acid (e.g., carboxylate, carboxyl) groups and hydroxyboryl compounds including phenylboronic acid (e.g., phenylborate), aminophenylboronic acid, boric acid (e.g., borate), or other boronic acid (e.g., boronate) compounds. The present invention is usefi.il for monitoring glycation or glycosylation of hemoglobin or albumin for monitoring glycemic control (e.g., glycemia in diabetes).

Abstract: Compounds are disclosed comprising a moiety, such as a poly(amino acid), a non-poly(amino acid) label moiety, or a non-poly(amino acid) immunogenic carrier, linked to a sirolimus compound at position 26 or at position 32. Such sirolimus compounds comprising an immunogenic carrier can be employed to raise both polyclonal and monoclonal antibodies to the sirolimus compound. Polyclonal antibodies are also disclosed, which are raised against a compound wherein a moiety, such as a poly(amino acid), a non-poly(amino acid) label moiety, or a non-poly(amino acid) immunogenic carrier, is linked to a sirolimus compound at position 32. The above antibodies and sirolimus compounds comprising a label can be used in assays for the detection of sirolimus compounds.

Abstract: New derivatives of FK 506 are disclosed. These new derivatives and other derivatives that are useful for determining the levels of FK 506 in a sample are also provided as are assay procedures and kits for use in determining the levels of FK 506 or other macrophilin binding substances in blood, particularly un-extracted blood in the presence of specific binding proteins for FK 506.

Abstract: The invention concerns lactic acid bacteria strains capable of regulating the production of NO and inflammatory cytokines by enterocytes, depending on the inflammatory condition of said enterocytes. The strains can also be incorporated in food supplements such as fermented dairy products used for regulating inflammatory response and non-specific immunity.

Abstract: Methods and devices for electrochemical detection of a specific binding pair member utilizing a microsphere with an incorporated electroactive marker, wherein a member of the specific binding pair to be detected is bound, directly or through one or more intermediates, to the microsphere. Multiple specific binding pair members may be detected by use of electrochemically distinguishable electroactive markers. Microspheres with incorporated electroactive markers may include one or more functional groups for binding members of specific binding pairs, and are preferably insoluble in aqueous solvents but soluble in selected organic solvents.

Abstract: Novel conjugates of taxol and novel taxol immunogens derived from the 9 and 7 positions of taxol and monoclonal antibodies generated by these taxol linked immunogens are useful in immunoassays for the quantification and monitoring of taxol in biological fluids.

Abstract: The present invention provides a method for the detection of early renal disease in animals. The method includes the steps of (a) obtaining a sample from an animal to be tested and (b) determining the amount of albumin in the sample. An amount of albumin in the range of from 10 ?g/ml to about 300 ?g/ml indicates the presence of early renal disease. The present invention also provides antibodies to canine, feline and equine albumin which can be used to detect the presence of early renal disease.

Abstract: A biosensor includes a substrate with a receptive material layer of radiation-absorbing member (RAM)-tagged biomolecules disposed thereon. The receptive material is specific for an analyte of interest. A pattern of active and deactivated areas of the receptive material are defined in the receptive material layer by a masking process wherein areas are exposed through a mask with a light source to induce deactivation.

Abstract: Lidocaine analogs, latex particle-analog conjugates, and methods of making and using the same. The analogs have the formula: wherein Z comprises a nucleophilic group and optionally a protecting group; L is a linker; R1, R2, R3, R4, R5 are each independently H, a protecting group, or C1 to C6 alkyls, provided that R1 and R3 may form a six membered ring with the nitrogen and carbon atom to which R1 and R3 are attached; R6 and R7 are each independently H or C1 to C20 alkyls; and including salts thereof. The analogs are immobilized on latex particles and prepared for use in assays for lidocaine.

Abstract: The cholesterol derivative, represented by the following formula (1): wherein R represents a C3–C23 saturated or unsaturated aliphatic hydrocarbon residue having an optional substituent, and, to the cholesterol backbone, —OH, —CHO, —COOH, —OOH, or an epoxy group may be added, specifically binds to ?2-glycoprotein. By use of the derivative, ?2-glycoprotein or a similar substance can be assayed in a very practical manner. Through the assay, a disease can be detected in a very practical manner.

Abstract: Novel conjugates of busulfan and novel busulfan immunogens derived from ?-substituted derivatives of busulfan and antibodies generated by these busulfan linked immunogens are useful in immunoassays for the quantification and monitoring of busulfan in biological fluids.

Abstract: An immunochemical assay device for determining the presence of NT-proBNP alone or conjunctively with Cardiac Troponin I comprising a base member, an array disposed on the base member, and at least one assay indicia zone. The array comprises (i) a reservoir pad to receive sample liquid, (ii) a wicking membrane, and (iii) at least one filter zone interposed between the wicking membrane and the reservoir pad. The filter zone being operable to permit passage of any specific immunocomplex to the wicking membrane while impeding passage of larger components.

Abstract: Methods and compositions for detection of microbial contaminants in peritoneal dialysis solutions are provided. The methods and compositions employ modified bioburden testing and the detection of peptidoglycan. A novel cause of aseptic peritonitis is provided—aseptic peritonitis associated with gram positive microbial contamination of a dialysis solution. Peptidoglycan is a major component of a gram positive bacterial cell wall and thus can serve as a marker for gram positive bacteria. In this regard, testing for peptidoglycans can be utilized to effectively prevent peritonitis in patients that use the peritoneal dialysis solutions, such as peritoneal dialysis solutions that contain a glucose polymer including an icodextrin and the like.

Abstract: An immunochemical assay device for determining the presence of NT-proBNP alone or conjunctively with Cardiac Troponin I comprising a base member, an array disposed on the base member, and at least one assay indicia zone. The array comprises (i) a reservoir pad to receive sample liquid, (ii) a wicking membrane, and (iii) at least one filter zone interposed between the wicking membrane and the reservoir pad. The filter zone being operable to permit passage of any specific immunocomplex to the wicking membrane while impeding passage of larger components.

Abstract: Methods and compositions for detecting and characterizing target biomolecules using sensitizer-linked substrate molecules are disclosed.

Abstract: Methods, compositions and kits are disclosed. The methods are directed to determining the presence of one or more analytes in a sample suspected of containing any one of a plurality of the analytes. A combination is provided comprising in a medium (i) the sample, (ii) a binding partner for each of the analytes, (iii) for each of the analytes, a first reagent comprising a member of a signal producing system, a ligand and an analyte analog, and (iv) a second reagent comprising a binding partner for the ligand. The binding of the binding partner for the ligand is affected by the presence of an analyte and alters the amount of signal produced by the member of the signal producing system. The signal thus is modulated if one or more of the analytes are present in the sample. The amount of the signal is determined and is related to the presence of one or more of the analytes in the sample. The method may be homogeneous or heterogeneous.

Abstract: Immunoassays, assay methods, antibodies and methods of producing antibodies for the detection of fibroblast growth factor-23 (FGF-23). The immunoassay and assay method preferably comprise a non-competitive, sandwich-type assay utilizing a first bound antibody having affinity to a first site of the FGF-23 molecule, and a second, labeled antibody having an affinity for a second site present upon the FGF-23 molecule. The antibodies and methods of generating the same include administering antigenic peptide fragments of the FGF-23 molecule, monitoring the antibody titre produced thereby, extracting and selecting antibodies from the antisera having a specificity for the desired antigenic region of FGF-23, and purifying same. The antibodies may be incorporated into the immunoassay of the present invention or utilized for a variety of assay-type purposes for the detection of FGF-23.

Abstract: This invention relates to a method of assaying pyrrole-containing biological compounds and chemical compositions that can be used in the method. The method involves contacting a biological compound with one of: a) a bound or bindable derivatizing agent which forms a reaction product with the biological compound, followed by exposure to a detectable molecule which forms a complex with the reaction product; or b) a derivatizing agent which forms a reaction product with the biological compound, followed by exposure to a bound binding agent specific to the biological compound in the reaction product; or c) a binding agent specific to the biological compound, followed by exposure to a derivatizing agent which forms a reaction product with the biological compound, and determining the amount of bound biological compound. There is also provided a method of preparing an antigen.

Abstract: An enhanced diffraction based biosensor system and method are provided for detecting an analyte of interest in a test medium. The system incorporates at least one additional detection tag substance with the analyte of interest, the tag emitting a measurable parameter that is different from optical diffraction characteristics of the analyte. The biosensor may be a “fluoroptical” system wherein the detection tag is a fluorescence emitting substance, including fluorescent-labeled diffraction enhancing elements. The enhanced diffraction biosensor system may determine the presence of analytes in biological fluids both qualitatively and quantitatively.

Abstract: A method for the detection or quantitation of an analyte in a biological sample is disclosed. The method comprises the steps of selecting a biological sample suspected of containing a target analyte and binding the target analyte in the sample to a binding partner conjugated to an acridinium compound, wherein the acridinium compound comprises an acridinium nucleus having an electron-donating substituent directly attached to the acridinium nucleus at the C2 position. Chemiluminescent acridinium compounds useful in the method have emission maxima close to or in the near infrared (NIR) region (>590 nm). These chemiluminescent acridinium compounds when used in conjunction with short wavelength-emitting acridinium esters (with emission maxima below 450 nm) can be highly useful labels for the simultaneous detection of multiple target analytes in a single assay.

Abstract: A method for assessing aspirin resistance and relative risk of a cardiovascular event in a patient taking aspirin is provided. The concentration of 11-dehydro-thromboxane B2 in a urine sample is measured and compared to a set of standardized quartile concentrations. A concentration of urinary 11-dehydro-thromboxane B2 that falls within the second, third, or fourth quartile is indicative of aspirin resistance and an elevated risk of a recurrent cardiovascular event.

Abstract: An IgG1 ? monoclonal antibody to the immunosuppressive drug tacrolimus has improved properties. In particular, this monoclonal antibody, designated 1H6, has reduced cross-reactivity to several tacrolimus metabolites. This antibody is suitable for performance of immunoassays such as homogeneous immunoassays to detect or determine the presence or concentration of tacrolimus in samples such as blood samples. The invention further includes derivatives of tacrolimus derivatized at a non-binding portion of the molecule useful in immunizing antibody-producing animals and in producing such monoclonal antibodies, as well as labeled derivatives of tacrolimus useful as tacrolimus analogues in such assays. The invention further includes immunoassay methods for the detection of tacrolimus and test kits useful in performing such immunoassays.

Abstract: The invention provides methods and compositions for azide tagging of biomolecules. In one embodiment of the invention, proteins are tagged by metabolic incorporation of prenylated azido-analog substrates. Examples of such analogs are azido farnesyl diphosphate and azido farnesyl alcohol. The azido moiety in the resulting modified proteins provides an affinity tag, which can be chemoselectively captured by an azide-specific conjugation reaction, such as the Staudinger reaction, using a phosphine capture reagent. When the capture agent is biotinylated, the resulting conjugates can be detected and affinity-purified by streptavidin-linked- HRP and streptavidin-conjugated agarose beads, respectively. The invention allows detection and isolation of proteins with high yield, high specificity, and low contamination without harsh treatment of proteins.