81results about "Reference solutions" patented technology

A method of quality control of a specimen prepared from a sample, includes: (S1) setting, from a control index information (MII) in which a plurality of indexes for the specimen are respectively associated with control values corresponding to the plurality of indexes, at least one index to be used for quality control of the specimen; (S3) obtaining a feature value relating to the at least one index from image data of the specimen; and (S5) outputting quality control information of the specimen based on the feature value and a control value associated with the at least one index.

The present disclosure relates to synthetic controls useful, e.g. for immunohistochemistry (IHC), as well as kit and methods of manufacture and use related thereto. In some embodiments, the synthetic controls include a solid antigen / carrier protein gel comprising a purified antigen (e.g. at a known quantity) and a carrier protein such as an albumin protein (e.g. a serum albumin protein), an egg white protein or mixture of egg white proteins, gelatin, or polylysine. In some embodiments, the purified antigen is cross-linked to the carrier protein in the solid antigen / carrier protein gel.

An IROA Matrix of metabolite compounds is disclosed. Each of whose compounds has a molecular weight of 2000 AMU or less, and is present as first and second isotopomers that are equally present at two predetermined isotopomeric balances, and contain 2 to 10% of a first isotope, and 90 to 98% of a second isotope, respectively. A reagent pair for transforming a natural abundance mass spectral analysis metabolite sample into an IROA sample is also disclosed and comprises two reactively identical reagents that constitute first and second isotopomers containing 2 to 10% of a first isotope, and 90 to 98% of a second isotope, respectively. Each of the reagent pair contains the same reactive group that reacts with and bonds to a functional group of one or more compounds present in a composition of biologically-produced metabolite compounds. Methods of making and using the above and related materials are also disclosed.

Reagents are disclosed for use with potentiometric magnesium ion selective electrodes, along with kits containing same as well as methods of use thereof.

An IROA Matrix of metabolite compounds is disclosed. Each of whose compounds has a molecular weight of 2000 AMU or less, and is present as first and second isotopomers that are equally present at two predetermined isotopomeric balances, and contain 2 to 10% of a first isotope, and 90 to 98% of a second isotope, respectively. A reagent pair for transforming a natural abundance mass spectral analysis metabolite sample into an IROA sample is also disclosed and comprises two reactively identical reagents that constitute first and second isotopomers containing 2 to 10% of a first isotope, and 90 to 98% of a second isotope, respectively. Each of the reagent pair contains the same reactive group that reacts with and bonds to a functional group of one or more compounds present in a composition of biologically-produced metabolite compounds. Methods of making and using the above and related materials are also disclosed.

Provided herein are red blood cell control compositions containing one or more populations of lysable hydrogel particles having an impedance that is substantially similar to the impedance of a human red blood cell of average diameter; and a population of hemoglobin molecules or a population of dye molecules that have substantially similar absorbance as hemoglobin; wherein (i) and / or (ii) are present in an amount that corresponds to a normal blood sample or disease state, or (i) and (ii) are present at a ratio that corresponds to a normal blood sample or disease state.

A reference method for quantifying the total amount of NT-proBNP in a sample, independent of its degree of glycosylation, involving LC-MS / MS analysis of a sample that has been subjected to affinity purification and subsequent digestion.

A device for quantifying the concentration of at least one analyte in a liquid test sample, the device comprising: a receptacle or plurality of receptacles, each receptacle configured to hold a liquid sample wherein each receptacle independently comprises: a) a matrix solution, and b) an analyte standard solution comprising at least one analyte standard, wherein the at least one analyte standard corresponds to the at least one analyte being assayed; wherein the matrix solution is separated from the analyte standard solution in said receptacle or plurality of receptacles, and the matrix solution and the analyte standard solution are not in substantial admixture.

Disclosed herein are embodiments of a method for calibrating a group of analyzer units, each analyzer unit of the group of analyzer units configured for determining an amount of an analyte in plasma of a whole-blood sample. The method comprises: providing a plurality of calibration whole-blood samples, the plurality of calibration whole-blood samples including calibration whole-blood samples having respective hematocrit levels, for each calibration whole-blood sample of the plurality of calibration whole-blood samples: measuring a hematocrit measurement value indicative of the hematocrit level of said calibration whole-blood sample, measuring a whole-blood measurement value indicative of an amount of the analyte in the calibration whole-blood sample using at least one calibration analyzer unit of said group of analyzer units, measuring a plasma measurement value indicative of an amount of the analyte in plasma of said calibration whole-blood sample, and computing a ratio between the whole-blood measurement value and the plasma measurement value; generating a nonlinear functional relationship between the computed ratios and the corresponding hematocrit measurement values by curve fitting of a nonlinear function parametrized by one or more calibration parameters, the curve fitting resulting in respective parameter values of the one or more calibration parameters; storing a representation of the fitted nonlinear function in each analyzer unit of the group of analyzer units to allow each analyzer unit of the group of analyzer units to compute a hematocrit correction factor.

The present disclosure provides a peptide library comprising stable isotope-labeled (SIL) peptides, wherein the peptides comprise or consist of the sequences according to Table A, Table B, or Table C.

Disclosed is a method of diagnosing multiple sclerosis (MS), wherein a blood sample from a patient is incubated with a DNA-replication associated (REP) protein. The present invention relates to a DNA-replication-associated (Rep) protein for use in the diagnosis of multiple sclerosis (MS), wherein (a) Aan increased amount of Rep protein or fragments thereof in the sample as compared to an amount in a control sample; or an increased amount of anti-Rep protein antibodies with antigen in a sample from a subject as compared to an amount in a control sample correlates with a diagnosis of MS, wherein the Rep protein is MSBI1 Rep or MSBI2 Rep.

An in-vitro diagnostic (IVD) analyzer (200) comprising at least one sensor (212) located in a flow-through sensor path (211) of detecting unit and requiring at least one oxygenated calibration fluid (221', 222') for calibration is herein disclosed. The IVD analyzer (200) further comprises a fluid-supply unit (220) comprising at least one deoxygenated calibration fluid (221, 222), a fluid-selection valve (230) and at least one oxygenation tubing (215, 216) having two ends connected to the fluid-selection valve (230) as a loop, wherein the oxygenation tubing (215, 216) comprises oxygen-permeable walls, and wherein the IVD analyzer (200) further comprises a pump (240) and a controller (250) configured to control the pump (240) and the fluid-selection valve (230) for transporting deoxygenated calibration fluid (221, 222) into the oxygenation tubing (215, 216), to wait a predetermined time required for oxygenation of the deoxygenated calibration fluid (221, 222) via oxygen uptake from ambient air through the tubing walls, and to transport the thereby obtained oxygenated calibration fluid (221', 222') into the sensor path (211) for calibration of the at least one sensor (212). A respective automatic method of calibrating at least one sensor (212) is herein also disclosed.

Disclosed herein are methods, devices and kits suitable for high throughput screenings of extracellular pyridine nucleotide levels, such as NAD+ levels which are suitable for monitoring pyridine nucleotide induced slowdown of not only pathogenesis of multiple systemic diseases but also aging. In particular, assaying methods quantifying extracellular pyridine nucleotide(s), such as NAD+, in the low micromolar to the low nanomolar range in a sample that may have been subjected to long term storage are disclosed using a two-step enzymatic cycling reaction employing an oxidoreductase such as alcohol dehydrogenase. A modified revised simulated body fluid is also disclosed that is employed as a standard matrix to optimise enzymatic activity, linearity and / or sensitivity of the methods, devices and kits.

Disclosed herein is an in vitro diagnostic (IVD) analyzer (200) comprising at least one sensor (212) disposed in a flow-through sensor path (211) of a detection unit and requiring at least one oxygenated calibration fluid (221', 222') for calibration. The IVD analyzer (200) further comprises a fluid supply unit (220) containing at least one deoxygenated calibration fluid (221, 222), a fluid selection valve (230), and at least one oxygenation tube (215, 216) having two ends connected to the fluid selection valve (230) as a loop, the oxygenation tube (215, 216) having an oxygen-permeable wall, and the IVD analyzer (200) comprises a pump (240) and a flow path (240) for supplying the deoxygenated calibration fluid (221, 222) to the oxygenated calibration fluid. and a controller (250) configured to control the pump (240) and the fluid selection valve (230) to transfer the deoxygenated calibration fluid (221, 222) into the tubing (215, 216), wait a predetermined time required for oxygenation of the deoxygenated calibration fluid (221, 222) via uptake of oxygen from ambient air through the walls of the tubing, and transfer the resulting oxygenated calibration fluid (221′, 222′) to the sensor path (211) for calibration of the at least one sensor (212). Respective automatic methods for calibrating the at least one sensor (212) are also disclosed herein.

The present invention relates to a sealed pouch containing a reference fluid for the calibration or quality control of a sensor element for measuring a body fluid parameter. The bag includes a peripheral wall of a first layered material. The bag further includes an access port formed by an opening in the first layered material, the opening being sealed by a cover of a second layered material, the second layered material being more resistant to oxidation by the reference fluid than the first layered material.

Embodiments described herein generally relate to systems and methods for processing mass spectrometry samples. Aspects of the disclosure include systems and methods for processing samples. Additionally, embodiments of the disclosure can also include systems and methods for sample analysis. Various embodiments include data analysis systems and methods for comparing data across samples and sample runs. Data analysis systems can run normalization methods for normalizing raw abundance mass spectrometry data. In some aspects, the normalized data can be used as input for predictive models.

An IROA Matrix of metabolite compounds is disclosed. Each of whose compounds has a molecular weight of 2000 AMU or less, and is present as first and second isotopomers that are equally present at two predetermined isotopomeric balances, and contain 2 to 10% of a first isotope, and 90 to 98% of a second isotope, respectively. A reagent pair for transforming a natural abundance mass spectral analysis metabolite sample into an IROA sample is also disclosed and comprises two reactively identical reagents that constitute first and second isotopomers containing 2 to 10% of a first isotope, and 90 to 98% of a second isotope, respectively. Each of the reagent pair contains the same reactive group that reacts with and bonds to a functional group of one or more compounds present in a composition of biologically-produced metabolite compounds. Methods of making and using the above and related materials are also disclosed.

The disclosure features calibration fluids that include a plurality of beads, such as cellulose, silica, poly(methyl-methacrylate) (PMMA), melamine, cross-linked agarose, polyvinylacetate (PVA), and / or polystyrene beads, where the beads are sized and colored to represent at least one type of blood cell; and a carrier fluid, that can include a polymer or polymerizing matrix, e.g., a water-soluble resin, e.g., an acrylic or polyurethane water-soluble resin or a starch or a cellulose, serum, and / or one or more or sugars. The disclosure also features methods of using the calibration fluids to calibrate automated sample preparation systems, such as automated hematology analyzer systems, e.g., image-based hematology analyzer systems.

The present invention relates to a method for determining an analyte in a sample by mass spectrometry (MS), the method comprising: (a) mixing a predetermined amount of an internal calibrator with the sample, the internal calibrator comprising a predetermined amount of at least two non-identical isotopologues of an analyte, (b) determining MS signals of ions generated from the analyte (analyte signal) and from the at least two isotopologues (isotopologue signal), (c) providing a calibration based on the analyte signal and the isotopologue signal determined in step (b), and (d) determining the analyte based on the calibration provided in step (c).Furthermore, the present invention relates to devices, systems and uses related thereto.

This invention describes a method for preparation of stable hematology reference materials by producing synthetic hydrogel blood cell surrogates, which mimic human blood components in size, morphology, performance and functionality when analyzed using an automated hematology analyzer employing multiple detection technologies. Different hydrogel particles can be combined and mixed to prepare multi-parameter and multi-level hematology reference materials, which could be used for calibration, linearity verification, proficiency evaluation, and routine performance monitoring of modern automated hematology analyzers. These hydrogel particles can also be combined with processed and stabilized human blood components to prepare the reference materials of this invention.

A method that evaluates metastatic behavior, apoptotic behavior, and / or cancer therapy response efficiency. The method has steps. The method has steps and some of those steps are: Providing a first cell culture having cancer cells and a second cell culture. There is no physical contact between the first cell culture and the second cell culture. Co-culturing the first cell culture and the second cell culture having no physical contact therebetween under a mutual headspace. Determining concentrations of VOCs in the mutual headspace. Comparing the concentrations of the VOCs in the mutual headspace to the concentrations of VOCs in a control sample. Identifying a set of VOCs indicative of cell-to-cell signaling in cancer cells in the mutual headspace wherein the VOCs have concentrations that are significantly different as compared to the control sample. And evaluating metastatic behavior, apoptotic behavior, and / or cancer therapy response efficiency using the set of VOCs identified above.

To provide reliable positive and negative IHC controls that are highly sensitive, specific, and adaptable to a wide range of targets, including targets for which no suitable biological controls exist.SOLUTION: Synthetic controls include a solid antigen / carrier protein gel comprising purified antigen (e.g., in a known amount) and a carrier protein, such as a serum albumin protein (e.g., a serum albumin protein), an egg white protein or a mixture of egg white proteins, gelatin, or polylysine. In some embodiments, the purified antigen is cross-linked to a carrier protein in a solid antigen / carrier protein gel.SELECTED DRAWING: Figure 3-1

The present invention provides a quality control solution and its use. Said quality control solution includes a buffer, a polymer, EDTA or a salt thereof, a preservative, a blood simulated dye and an analyte, said polymer being selected from PEG 2000~ 6000, propylene glycol, glycerol, or a combination thereof. The quality control solution of the present invention can be for performing quality control of at least one analyte. It does not require refrigeration, freezing or lyophilization, can be placed at room temperature, is relatively convenient to use and can be used in fields of immunological detection, biochemical detection and electrochemical detection.

The present invention addresses the problem of providing: a calibrator for measuring the activity or concentration of alkaline phosphatase contained in extracellular vesicles in a sample; and a measurement method using the calibrator. An activity value or concentration of an alkaline phosphatase contained in an extracellular vesicle in a sample is obtained using a calibrator containing a polypeptide molecule having a series of amino acid sequences including an amino acid sequence of the alkaline phosphatase and an amino acid sequence of a membrane protein present on the surface of the extracellular vesicle. Therefore, the above problem is solved.

Inline classification of a biological specimen including mammalian cells can include generating an alternating current (AC) electrical stimulus to an electrode structure. The electrode structure can be electrically coupled with a flow cell. A response, elicited by the electrical stimulus, can be received when a model specimen class traverses the flow cell. Using the received response, a corresponding impedance parameter value can be determined, the value indicative of a specified biophysical characteristic corresponding to the model specimen class. The first impedance parameter can be translated to a value corresponding to the specified biophysical characteristic.

To provide a calibrator used for measuring activity or concentration of alkaline phosphatase contained in an extracellular vesicle in a sample, and a measurement method using the calibrator. To solve the above problem, by acquiring an activity value or concentration of alkaline phosphatase contained in an extracellular vesicle in a sample using a calibrator containing a polypeptide molecule having a series of amino acid sequences including an amino acid sequence of alkaline phosphatase and an amino acid sequence of a membrane protein present on a surface of the extracellular vesicle.

A composition comprising a plurality of hydrogel particles, the plurality of hydrogel particles having substantially the same diameter, but each subclass of particles from the plurality of hydrogel particles having a different associated value of one or more passive optical properties that can be deconvoluted using cytometry instrumentation. Each hydrogel particle from the plurality of hydrogel particles can be functionalized with a different biochemical or chemical target from a set of targets. A method for preparing hydrogel particles includes forming droplets and polymerizing the droplets, optionally with functionalization.

Methods of identifying a compound, such as a test compound, and applications thereof are provided. For example, methods of identifying a compound that preferentially affects, increases, or decreases a level of association of a macromolecule with one or more target condensates or methods of identifying a compound that preferentially causes a macromolecule to associate or disassociate with one or more target condensates are provided. Additionally, methods of designing and / or identifying and / or making a compound, or portion thereof, with a desired characteristic are provided.

The invention relates to a preparation method of a bovine whole blood freeze-dried quality control product for metal element detection. The preparation method comprises the following steps: firstly, separating to obtain plasma and blood cells; then obtaining a uniform blood cell solution without precipitation from the obtained blood cells; respectively detecting the substrate values of the plasma solution and the blood cell solution; then preparing standard substance solutions, calculating the volume of the standard substance solutions needing to be added into each metal element, and mixing the required standard substance solutions together to obtain a mixed standard substance solution; adding purified water to dilute the mixed standard substance solution, and adding alkali to adjust pH; uniformly mixing the mixed standard substance solution with plasma, adding the blood cell solution, and uniformly mixing to obtain a solution before freeze-drying; and finally, sub-packaging and pre-freezing the solution before freeze-drying, and performing vacuum freeze-drying to obtain the bovine whole blood quality control freeze-dried powder. The preparation process is simple and easy to operate, the standardization of the production process is easy to realize, and the uniformity and stability of the quality control product are more effectively improved.