127results about "Reference solutions" patented technology

The invention provides a quality control solution and application thereof, the quality control solution comprises a buffer solution, a polymer, EDTA (Ethylene Diamine Tetraacetic Acid) or a salt thereof, a preservative, a blood simulation dye and an analyte, and the polymer is selected from PEG (Polyethylene Glycol) 2000-6000, propylene glycol, glycerol or a combination thereof. The quality control liquid provided by the invention can be used for quality control of at least one analyte; the kit does not need refrigeration, freezing or freeze-drying, can be placed at room temperature, is convenient to use, and can be used in the fields of immunodetection, biochemical detection and electrochemical detection.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the strain of coronavirus that causes coronavirus disease 2019 (COVID-19), the respiratory illness responsible for the COVID-19 pandemic. Antibodies produced from an immune response against SARS-CoV-2 are used to analyze prior exposure to the virus. The present invention provides methods for detecting antibodies in response to SARS-CoV-2 infection in a single multiplex immunoassay.

Provided herein are red blood cell control compositions comprising 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.

To provide a method for stabilizing hemoglobin A2 and hemoglobin F, which is capable of stabilizing hemoglobin A2 and hemoglobin F in a hemoglobin solution; a method of producing a hemoglobin solution; and a hemoglobin solution.SOLUTION: The present invention provides methods for stabilizing hemoglobin A2 and hemoglobin F, methods of producing a hemoglobin solution, and a hemoglobin solution, the methods including preparing a solution containing a buffer, sucrose, and hemoglobin, wherein the solution has a pH of from 6.0 to 9.6, the concentration of the buffer in the solution is from 5 to 150 mM, the concentration of the hemoglobin in the solution is from 5 to 20 g / L, and the hemoglobin contains at least hemoglobin A2 and hemoglobin F.SELECTED DRAWING: None

A method of producing a solution containing hemoglobin A2 and a method of producing a hemoglobin precision control substance, the methods including contacting a solution containing hemoglobin and having a pH of from 7.8 to 9.5 with an anion exchanger, are provided.

To provide a method of producing a solution containing hemoglobin A2, which enables preparation of a hemoglobin A2-rich solution from an easily available blood sample, a method of producing a solution containing hemoglobin A2 and hemoglobin F, and a method of producing a hemoglobin quality control material.SOLUTION: Provided herein are: a method of producing a solution containing hemoglobin A2, the method comprising bringing a hemoglobin-containing solution with a pH of 7.8 to 9.5 into contact with an anion exchanger; and a method of producing a hemoglobin quality control material.SELECTED DRAWING: None

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.

Included is the steps of providing a plurality of standard solutions containing amyloid β-related peptide and a surfactant and having different concentrations of the amyloid β-related peptide; mixing a solution containing internal standard peptide with each of the plurality of standard solutions; performing immunoprecipitation and mass spectrometry on a plurality of calibration curve solutions; standardizing signal intensity (A) in the amyloid β-related peptide with the signal intensity (B) in the internal standard peptide for each of the plurality of calibration curve solutions; and calculating a regression equation of a calibration curve based on a plurality of normalized intensities and the concentration of the amyloid β-related peptide.

Fluorescent viral particles, including viral particles and a fluorescent dye conjugated to the viral particles, are used for viral contaminant removal testing as part of viral clearance evaluation for biological medical product preparation processes. The conjugated fluorescent dye adds only marginally to viral particle size, but provides versatility both for rapid screening of alternative viral removal approaches during process development and for final process validation, as the fluorescent viral particles have fluorescent activity throughout the viral clearance evaluation process, permitting rapid and consistent quantification of initial test solutions, resulting purified solutions, and intermediate solutions of interest at any point during processing under evaluation.

A process for preparation of in-house liquid photostable bilirubin control material from left over human serum samples of all genders and all age groups included whose total bilirubin concentration is within the range between ≥3mg / dl (≥0.2mmol / l) to ≤20mg / dl (≤1.1mmol / l) in each sample. Each sample is pretested by rapid kits for HIV I / II, HbsAg, Anti-HCV prior pooling, while excluding haemolysed, lipemic(turbid) and insufficient samples. Pooling is done in a falcon tube and baseline mean is established after twenty consecutive pre-runs for total bilirubin concentration estimated by diazo method in the pooled serum. The pool is transferred in a generic amber vial(s) which has a polypropylene stopper and a polypropylene screw cap. This amber vial(s) is shielded within aluminium packet with zip lock which has a silica gel packet (not exceeding 2gms) enclosed inside the aluminium packet with zip lock. This complete unit is stored in fridge door at a fixed temperature range 2-8°c. The endogenous bilirubin control material prepared with this method has very less amount of variation and is said to be stable for its utility in a clinical laboratory as a internal quality control material.

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.

Disclosed herein is an in vitro diagnostic (IVD) analyzer (200) comprising at least one sensor (212) located 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) comprising at least one deoxygenated calibration fluid (221, 222); a fluid selection valve (230); the IVD analyzer (200) comprises a fluid selector valve (230), and at least one oxygenation conduit (215, 216) having two ends connected as a loop with the fluid selector valve (230), where the oxygenation conduit (215, 216) comprises an oxygen permeable wall, and where the IVD analyzer (200) further comprises a pump (240) and a controller (250), the controller is configured to control the pump (240) and the fluid selection valve (230) to deliver a deoxygenated calibration fluid (221, 222) into the oxygenation conduit (215, 216), wait for a predetermined time required for oxygenation of the deoxygenated calibration fluid (221, 222) via oxygen uptake from ambient air through the conduit wall, and inject the oxygenated calibration fluid (221 ', 222' ') thus obtained into the oxygenation conduit (215, 216). 222 ') into the sensor path (211) for the calibration of the at least one sensor (212). A corresponding automated method of calibrating at least one sensor (212) is also disclosed herein.

Methods for determining protein and / or peptide concentration or molecular parameter, such as the extinction coefficient, and uses 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.

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.

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

In one embodiment, a method for performing rapid compensation in a flow cytometry experiment is provided. The method includes the following steps: generating an initial spillover matrix by using a plurality of single-stained compensation controls; passing a sample through a flow cytometer; generating a measured sample event vector by measuring the fluorescence of a plurality of cells passing through the flow cytometer; generating a compensated sample event vector by using the initial spillover matrix and the measured sample event vector; generating an adjusted spillover matrix by fine-tuning the initial spillover matrix; and calculating a re-compensated event vector by using the adjusted spillover matrix and the measured sample event vector.

Epileptic seizures, NES, NS, PNES or NEE are difficult to diagnose and are often difficult to distinguish from several conditions with similar presentations, and therefore, diagnosis of seizures is often a long, expensive, and unreliable process. This invention provides biomarkers for identifying and monitoring seizures and epilepsy, ES, NES, NS, PNES or NEE assays for measuring and assessing biomarker concentration, predictive models based on biomarkers and computational systems for diagnosing, monitoring and predicting therapeutic efficacy associated with seizures and epilepsy, ES, NES, NS, PNES or NEE in all clinical and healthcare settings. Diagnostic and treatment methods, systems, kits, and predictive models provided herein, provide quantitative and / or qualitative assessment in order to allow patients to proceed immediately to diagnostic and / or treatment protocols, and assess therapeutic treatment effectiveness.

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.

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.

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.