208results about "Reference solutions" patented technology

According to the standard solution and the determination method of the present invention, in a case where a voltage is applied by a drive voltage of a measurement apparatus to an electrode portion of a biosensor comprising an electrode portion including a counter electrode and a measuring electrode formed on an insulating substrate, and a reagent layer which reacts with a sample solution supplied to the electrode portion, and a current value which flows at the application is measured, thereby determining a substrate contained in the sample solution, a reducing substance is contained in the standard solution used for controlling a precision of measurement of the measurement apparatus. Therefore, when the standard solution is measured, a large change occurs in a current waveform between time t0 and t1 shown in FIG. 6 due to the reducing substance, thereby discriminating whether the analyte liquid being measured is the standard solution or the sample solution and easily identifying the kind of analyte liquid.

The invention is directed to novel methods of stabilizing blood compositions for use in the quality control of analytical techniques. The novel method comprises removing leucocytes from a blood composition to yield a depleted blood composition, stabilizing the leucocytes by treatment with an effective amount of a stabilizing agent comprising an aged transition metal solution, and then adding the resultant stabilized leucocytes to the depleted blood composition or a second blood component composition.

A quality control material is disclosed which is used to monitor the calibration or used for recalibration of instruments used to screen for interferents in serum or plasma specimens. In particular, the quality control material disclosed is used to monitor instrument calibrations or used for recalibration for instruments which assess the amount of hemolysis, turbidity, bilirubinemia and biliverdinemia, either separately, or any two, or any three, or all four simultaneously, in plasma or serum samples. The quality control material does not contain any blood products such as plasma lipids, bile pigments, or hemoglobin, is stable at room temperature, and is ready for use with up to four constituents.

A method of quality control to diagnose the cause of a malfunction of an instrument. The method uses measurements of the physical property of a sample to diagnose the cause of a malfunction of an instrument. The spatial position of a control product sample is analyzed. Alternatively, the spatial position of a statistically significant number of patient blood samples can be used. The method enables the monitoring of an instrument for problems associated with debris and noise caused by red cell lysis inefficiency; instrument reagents pump volume settings; instrument laser alignments; instrument gain settings; and flow noise caused by partial plugs, residual plugs or other flow problems. The method provides a more specific indication of the type and cause of an instrument malfunctioning than non specific flagging provided by prior art methods.

The invention relates to methods and corresponding arrays especially suited to correct for signal errors due to variations in sample preparation. Methods and compositions for performing quantitative array-based assays are provided. In the subject methods, both a reporter and an analyte is employed, where the reporter is characterized by binding selectively to an internal reference present on the array, i.e. at least a subset of, if not all of, the spots present on the array employed in the method contain an internal reference which can be bound by reporter.

A method of quality control to diagnose the cause of a malfunction of an instrument. The method uses measurements of the physical property of a sample to diagnose the cause of a malfunction of an instrument. The spatial position of a control product sample is analyzed. Alternatively, the spatial position of a statistically significant number of patient blood samples can be used. The method enables the monitoring of an instrument for problems associated with debris and noise caused by red cell lysis inefficiency; instrument reagents pump volume settings; instrument laser alignments; instrument gain settings; and flow noise caused by partial plugs, residual plugs or other flow problems. The method provides a more specific indication of the type and cause of an instrument malfunctioning than non specific flagging provided by prior art methods.

Methods of using a reference control composition containing a nucleated red blood cell component for measurement of nucleated red blood cells are disclosed. The nucleated red blood cell component is made of stabilized or processed nucleated blood cells which have impedance and optical properties simulating the impedance and optical properties of human nucleated red blood cells under a blood lysing condition as measured by a specific measurement. The methods include mixing the reference control composition with a lytic reagent, and analyzing the control sample mixture on a flow cytometric instrument by impedance, impedance and optical measurement, or DC impedance and a multi-dimensional measurement of light scatter, radio frequency and a second DC impedance; and reporting the simulated nucleated red blood cells in the reference control composition.

A method of making a reference control containing a nucleated red blood cell component includes providing a blood cell containing a nucleus; treating the blood cell with a treatment solution to alter a nucleus property from a natural value to a target value suitable for simulating nucleated red blood cells on a blood analyzer; and suspending treated blood cell in a suspension medium to form a reference control. The method also includes integrating the nucleated red blood cell component with white blood cell, red blood cell, platelet and reticulocyte components. Further disclosed is a cell treatment composition for altering a nucleus property, which includes a conditioning component, a lytic component for permeating cell membrane, and a fixing component for preserving the cell nucleus. Also disclosed is a method of using the reference control for measurement of nucleated red blood cells on a blood analyzer.

A blood test tool with which blood in a dried state can be held without denaturation. In the blood test tool wherein a card made of filter paper is impregnated with the blood and then the blood is held in a dried state, a carboxylic acid such as citric acid is added to the part for holding blood. Thus, the carboxylic acid exerts an effect of preventing the blood in the dried state from denaturation. It is preferable to add a non-reducing sugar (sucrose, etc.), an anticoagulant (EDTA, etc.) and an antioxidant (glutathione, etc.) together with the carboxylic acid. This blood test tool can be produced by impregnating a filter paper card with a solution containing citric acid, etc. dissolved therein and then air-drying.

Standard reference materials and related methods are described for quality testing and calibration of instruments used for the qualitative and quantitative determination of hemoglobin and glycated hemoglobin as well as other analytes of interest in animal tissue samples. The reference solutions of the disclosure utilize a synthetic cruor in combination with an Hb peptide chain.

The present invention is drawn to a hematology control made from particles a particle having a biopolymer attached to a surface of the particle. The particle simulates a component of a blood sample, such as a reticulocyte or nucleated red blood cell component of a blood cell sample in a flow cytometer or hematology analysis instrument. The present invention is further drawn to methods of making and using the hematology control.

The invention generally relates to the field of immunoassays. In particular, the invention relates to use of a calibrator material to calibrate immunoassays for autoantibodies.

A reference control for cell by cell analysis on flow cytometric analyzers contains cellular analogs made of permeated blood cells containing therein aggregated intracellular proteins and preserved antigenic sites thereof, having cellular membrane permeable to antibodies and a suspension medium. The reference control is frozen after being prepared and thawed prior to use. The cellular analogs further contain a fluorescence marker therein. Further disclosed are a method of making the reference control and a method using the reference control, as an internal or stand-alone control, for measurements of cellular hemoglobin and cellular hemoglobin variant of a blood sample.

The present invention provides a method of monitoring calibration of a spectrophotometric apparatus that comprises one or more than one calibration algorithm for one or more than one analyte. This method comprises measuring absorbance of a quality control material with the apparatus to obtain a measurement, where the quality control material exhibits an absorbance spectra characterized as having a negative slope for a continuous spectral segment from about 5 nm to about 400 nm in length, or a wavelength there between, and where the spectral segment includes a principal calibration wavelength for the one or more than one analyte. The method then involves calculating one or more than one concentration values from the measurement using the one or more than one calibration algorithms, followed by comparing the one or more than one concentration values with an assigned value given to the quality control material for each of the one or more than one analytes. In this way one or more than one calibration algorithm of the apparatus may be monitored. A reagentless method for determining the concentration of one or more than one analyte in a sample in a spectrophotometric apparatus comprising one or more than one primary calibration algorithm is also disclosed. The present invention also provides to a method for selecting one or more than one substance as a quality control material for monitoring one or more than one primary calibration algorithm on a spectrophotometric apparatus. The present invention includes a quality control material for mimicking two or more than two analytes comprising, one or more than one substances having a combined absorption spectrum exhibiting a negative slope for a continuous spectral segment of from about 5 nm to 400 nm in length, or a wavelength there between, in a portion of an absorption spectrum, including one or more than one principal calibration wavelengths, for the two or more than two analytes.

A control composition, and method of preparing a control composition, that includes stabilized, mammalian granulocytes having altered physical properties so that the granulocytes function as a human lymphocyte analogs when used on an automated blood cell analyzer.

The invention provides populations of molecules that are prepared as, or treated to become, homogeneous for one or more molecular characteristics. In an aspect, the invention relates to molecular weight standards that may be used to determine the molecular weight or apparent molecular weight of uncharacterized molecules, such as proteins and nucleic acids, as well as in other applications. In one aspect, the molecular weight standards are pre-stained.

The invention provides a preparation method of a quality control material of glycosylated hemoglobin, comprising the following steps: collecting a blood sample of a nondiabetic patient, performing centrifugation and plasmapheresis to obtain red blood cells; adding red blood cell preserving fluid to the red blood cells to obtain a red blood cell sample; adding the red blood cell sample slowly into separating fluid and centrifuging to obtain separated red blood cells, wherein red blood cells adaptive to the cell separation fluid are dispersed in the cell separation fluid of each density; separately charging the separated red blood cells into different test tubes, adding physiological saline to each test tube to obtain a red blood cell suspension, regulating the hemoglobin concentration of the red blood cell suspensions to 120g/L, and screening out red blood cell suspensions with the HbA1c value of 3-5% to obtain the quality control material of glycosylated hemoglobin. The invention also provides the quality control material. The preparation method provided by the invention can perform mass production of low-value quality control materials of glycosylated hemoglobin.

The invention relates a method of quantifying CD64 and CD163 expression in leukocytes and, specifically to a kit for use with a flow cytometer including a suspension of quantitative fluorescent microbead standards, fluorescent labeled antibodies directed to CD64 and CD163, and analytical software. The software is used to take information on the microbead suspension and fluorescent labeled antibodies from a flow cytometer and analyse data, smooth curves, calculate new parameters, provide quality control measures and notify of expiration of the assay system.