Abstract: The present invention provides a method for the real-time continuous monitoring of a change or density and/or viscosity within a test sample. Such methods can be used to determine the occurrence of a chemical reaction within a test sample where the same causes and increase or decrease in the density and/or viscosity of the sample due to, for example, a gelation, precipitation or coagulation occurring within the test sample. There is further provided a multi-resonator apparatus for use in measuring the density and/or viscosity of a test sample in which the multi-beam resonator is immersed.

Abstract: The invention is directed to a method and a kit for calibrating a photoluminescence measurement system, in particular a fluorescence measurement system. The kit includes a number of fluorescence standards i and their corrected and certified fluorescence spectra Ii(?), whereby the fluorescence standards i are selected, so that their spectrally corrected fluorescence spectra Ii(?) cover a broad spectral range with high intensity. The standards are characterized by large half-widths FWHMi of their bands of at least 1400 cm?1. According to the method of the invention, partial correction functions Fi(?) are generated by forming the quotient of the measured fluorescence spectra Ji(?) and the corresponding corrected fluorescence spectra Ii(?), which are then combined to form a total correction function F(?) for a broad spectral range.

Abstract: The invention relates to a method of using high-mass matrix assisted laser desorption-ionization (MALDI) mass spectrometry for the quantitative analysis of the amount of aggregation (dimers, trimers or multimers) of antibodies or other therapeutic proteins in purified pharmaceutical samples or complex biological matrices, as well as to the use of this method for characterization of antibodies, drug development and quality control of therapeutic proteins, including automated high throughput applications.

Abstract: A blood analyzer configured to prevent an abnormal number of white blood cells caused by lipid particles or red blood cells of poor hemolysis from being output. The blood analyzer includes a system for obtaining a first white blood cell number and a system for obtaining a second white blood cell number. The analyzer also includes an output device for outputting the second white blood cell number, and a system for determining whether the second white blood cell number is abnormal. The output device is configured to output the first white blood cell number when the second white blood cell number has been determined to be abnormal.

Abstract: A system and a method for the automated pipetting of fluids are disclosed as well as a method for calibrating the system. A channel pump having at least one tip-sided port connected to a pipetting tip by a tip-sided pump conduit for generating a positive or negative pressure in the pipetting tip, and at least one reservoir-sided port connected to a system fluid reservoir by a reservoir-sided pump conduit is provided. The channel pump when operated at a nominal flow rate exhibits a fluid backflow caused by a pressure difference in the tip- and reservoir-sided pump conduits which results in an effective flow rate compared to the nominal flow rate. Such a pressure difference can be used to determine an extended pipetting period which extends a pipetting period of the channel pump operating at the nominal flow rate, and to calibrate the system.

Abstract: A diagnostic test kit that employs a lateral flow assay device and a plurality of assay reagents for detecting a test analyte within a test sample is disclosed. The assay reagents include detection probes that are capable of producing a detection signal representing the presence or quantity of the test analyte in the test sample. To further enhance detection accuracy, calibration probes are also used that are capable of producing a calibration signal representing the presence or quantity of a calibration analyte. The calibration signal may be utilized to calibrate the detection signal.

Abstract: A bio-threat simulant that includes a carrier and DNA encapsulated in the carrier. Also a method of making a simulant including the steps of providing a carrier and encapsulating DNA in the carrier to produce the bio-threat simulant.

Abstract: A simulant material for simulating hazardous materials is provided. The simulant material includes a quantity of at least one explosive material and at least one inert material. The simulant material is a non-explosive material and is in the form of a homogenous, flexible and non-particulated material. Also provided is a method for manufacturing such a simulant material.

Abstract: The present invention relates generally to the field of diagnostic screening and diagnostic assays. In particular, the present invention provides an improved, rapid, and efficient method of screening for antiphospholipid antibodies, such as lupus anticoagulants (LA). The invention also relates to a kit for screening plasma levels for antiphospholipid antibodies in subjects in need thereof, such as those at risk for or suffering from, inter alia, antiphospholipid syndrome (APS) and systemic lupus erythromatosus (SLE).

Abstract: Methods and reagents are disclosed for conducting assays. Embodiments of the present methods and reagents are concerned with a solid support such as, for example, a particle. The support comprises a chemiluminescent composition that comprises a metal chelate. The present inventors observed that, when such support such as, e.g., particles, were employed in assays for the determination of an analyte, stability of signal output by the chemiluminescent composition associated with the particle was unacceptably reduced as compared to particles comprising other chemiluminescent compositions. In accordance with embodiments of the present invention, the stability of signal output from such particles is enhanced by including in a medium comprising the particles a sufficient amount of one or more stabilizing agents, which may be a chelating agent and/or a metal chelate such as, for example, the metal chelate that is associated with the particle.

Abstract: A method to determine specificity of ligand binding includes comparing a solid phase carrier first extract obtained by pre-treating a sample with a ligand-immobilized solid phase carrier and a solid phase carrier second extract obtained by treating the pretreated sample again with a ligand-immobilized solid phase carrier in terms of the proteins contained therein, and identifying a protein whose content is remarkably decreased in the second extract compared to the first extract, in order to solve 1) the problem of the solubility of subject ligand, 2) the problem of the non-specific protein-denaturing effect of the subject ligand added, and the like, in antagonism experiments in target search using an affinity resin.

Abstract: The invention concerns fluorescence standards, and in particular fluorescence standards for calibrating optical detectors. According to the invention, a fluorescent mineral or mixtures of minerals are employed for use as a fluorescence standard. The fluorescent mineral can be a naturally occurring mineral or a synthetically produced mineral. Preferred fluorescent minerals for use as fluorescence standards are corundum, fluorite, turquoise, amber, zircon, zoisite, iolite or cordierite, spinel, topaz, calcium fluorite, sphalerite or zincblende, calcite or calcspar, apatite, scheelite or calcium tungstate, willemite, feldspars, sodalite, a uranium mineral, a mineral containing Al3+, and in particular ruby and sapphire.

Abstract: A method or device for integrated dosing and intermixing of small amounts of liquid, has at least one dosing reservoir (3) connected to a reaction reservoir (1) via at least one joining structure (11) and entirely filled with a first liquid. The at least one joining structure (11) is preferably dimensioned such that surface tension of the first liquid prevents the first liquid from penetrating into the reaction reservoir (1) which is entirely filled with a second liquid contacting the first liquid on the joining structure (11). A flow pattern is created in or on the reaction reservoir (1) to thoroughly mix the two liquids.

Abstract: A measuring method and a measuring apparatus which can classify and count myeloblast more precisely without influence of other component in a sample including platelet aggregation in measurement of a blood sample with a flowcytometry, wherein damage is given to a cell membrane of erythrocyte and mature leukocyte contained in a hematological sample, a hemocyte in which a cell membrane is damaged is constricted, and this is dyeing-treated with a fluorescent dye which can stain a nucleic acid to obtain a sample, the sample is measured with a flowcytometer, and a cell contained in a first cell group containing myeloblast, which is specified based on forward scattered light information and side scattered light information, and contained in a second cell group containing myeloblast, which is specified based on forward scattered light information and fluorescent information, is counted as myeloblast.

Abstract: An apparatus for measuring immature platelets is described that includes (a) a sample preparation unit for preparing an assay sample by adding a reagent to a blood specimen; (b) a detection unit having a semiconductor laser light source for irradiating the assay sample with laser light, and a detector for detecting optical information emitted from particles within the assay sample irradiated by laser light; and (c) a controller for differentiating and counting immature platelets based on the detected optical information. A method for measuring immature platelets is also described.

Abstract: The present invention provides methods of calibrating a fluidic device useful for detecting an analyte of interest in a bodily fluid. The invention also provides methods for assessing the reliability of an assay for an analyte in a bodily fluid with the use of a fluidic device. Another aspect of the invention is a method for performing a trend analysis on the concentration of an analyte in a subject using a fluidic device.

Abstract: Systems and methods are described for measuring pH of low alkalinity samples. The present invention provides a sensor array comprising a plurality of pH indicators, each indicator having a different indicator concentration. A calibration function is generated by applying the sensor array to a sample solution having a known pH such that pH responses from each indicator are simultaneously recorded versus indicator concentration for each indicator. Once calibrated, the sensor array is applied to low alkalinity samples having unknown pH. Results from each pH indicator are then compared to the calibration function, and fitting functions are extrapolated to obtain the actual pH of the low alkalinity sample.

Abstract: A method for separating and purifying the active hematinic species (AHS) present in iron-saccharidic compositions, including AHS such as sodium ferric gluconate complex, ferric hydroxide-sucrose complex and ferric saccharate complex and others of similar form and function. The method separates the AHS from one or more excipients and, preferably, lyophilizes the separated AHS. Separation of the AHS permits its analytical quantification, further concentration, purification and/or lyophilization as well as preparation of new and useful products and pharmaceutical compositions, including those useful for the treatment of humans and animals.

Abstract: Provided are methods comprising the use of non-sugar organic compatible solutes for protection and preservation of the activity of biologically active molecules and conjugate labels. The methods are particularly adaptable for use in conjunction with immunoassays, such as for example, immunochromatographic test assays and may be incorporated into any test methodology wherein a dry test strip is used as a carrier for depositing, mobilizeable and/or immobilized biologically active molecules and/or conjugate labels.

Abstract: An analytical apparatus includes a sample-injection valve, a sample pump, at least two sources of standards, and a selection valve. The sample-injection valve has an output port in fluid communication with a LC column, and an input port in fluid communication with a mobile-phase supply line. The at least two sources of standards are associated with at least two pharmaceutical compounds. The selection valve fluidically and selectably connects the sample pump to the at least two sources of standards, to the sample-injection valve, and to at least two pharmaceutical-manufacturing process lines associated with the at least two pharmaceutical compounds. A method for controlling a pharmaceutical manufacturing process includes switching the selection valve to alternately and repeatedly sample the at least two sources of standards and material flowing through the at least two pharmaceutical-manufacturing process lines.

Abstract: An artificial test soil comprises particulate, hair, and fiber components, wherein said particulate component consists of mineral, food, and plant materials, so chosen and proportioned as to correlate to a typical soil found in the home. The test soil may be used to test cleaning products by application of a known amount thereof to a surface, cleaning of said surface, and determination of the amount of said soil removed from said surface.

Abstract: The invention relates to methods of isolating white blood cells (WBCs) from a sample, e.g., whole blood, using magnetic particles that specifically bind to WBCs and a series of specific steps and conditions. The methods can include one or more of decreasing the viscosity of the sample prior to WBC isolation, agitating the sample at specified frequencies, and/or using a sample container arranged such that all of the sample is placed in close proximity (e.g., within 5, 2, 1, or 0.5 mm) to the source of the magnetic field. The new methods provide for isolation of WBC preparations with high yield, purity, and viability. The methods are designed for compatibility with automation protocols for rapid processing of multiple samples.

Abstract: Aspects and embodiments of the present disclosure are directed to devices and methods for the containment and presentation of a control solution to a medical device. Such devices and methods can be directed to containers (e.g., containment and presentation devices) that include structures such as nested containment wells for maintaining a stabilized control solution. Embodiments can include an indicator, such as one to indicate status of a seal for a container and/or for a liquid inside such a container.

Abstract: A liquid reagent in which a methylene blue compound color former is stably stored in a liquid state; and a method of stabilizing a methylene blue compound color former in a liquid state. A methylene blue compound color former is stabilized by causing it to coexist with either a quaternary ammonium compound having a C12 or higher hydrocarbon chain or a salt thereof in a liquid medium. Examples of the methylene blue compound color former include 10-(carboxymethylaminocarbonyl)-3,7-bis(dimethylamino) phenothiazine.

Abstract: A dye binding method for protein analysis is disclosed. The method includes the steps of preparing an initial reference dye solution of unknown concentration from an initial reference dye concentrate and creating an electronic signal based upon the absorbance of the initial reference dye solution. Thereafter, an electronic signal is created based upon the absorbance of a dye filtrate solution prepared from the initial reference dye solution and an initial protein sample. The absorbance signals from the reference dye solution and the dye filtrate solution are sent to a processor that compares the respective absorbances and calculates the protein content of the protein sample based upon the difference between the absorbances.

Abstract: The invention provides methods for quantitatively analyzing a plurality of analytes in a sample. Also described are general and specific internal standards useful in such analysis. In particular embodiments, these standards are described as useful in liquid chromatography/mass spectroscopy systems, which are also described herein. Moreover, in certain embodiments, the quantification methods of the present invention are useful in increasing the precision and/or accuracy of multiple analyte quantification for analytes contained in a single sample mixture using known analyte derivatives simultaneously analyzed, and compared to the unknown analytes.

Abstract: A sheath liquid for a particle analyzer used to analyze particles contained in a sample is described. The sheath liquid includes water and a refractive-index adjustment agent with glycerols and/or sulfate. A method for producing the sheath liquid and a method for analyzing particles using the sheath liquid are also described.

Abstract: Method as well a kit for the performance of the method for the investigation of biological samples from a mammal for at least one component, wherein the method includes the following steps: (a) Administering at least one marker substance to a mammal; (b) Waiting for a length of time which is sufficient for the at least one marker substance to reach the location of sample removal; (c) Removing a biological sample from the mammal; (d) Investigating the biological sample for the presence and/or amount of at least one marker substance or a derivative thereof; and, if the at least one marker substance or the derivative thereof is detectable in the biological sample; (e) Investigating the biological sample for an analyte.

Abstract: A calibration method for a flow cytometer with a multichannel detector module. During calibration, the fluorescence intensity data values for the different detector channels are used to calculate normalization factors needed to adjust subsequent data collected by each of the channels. By using a multichannel detector module, the results from the different flow cells can be reliably compared, so that multiple stages of flow cells can be arranged in series along a common flow path, for example to measure the same sample at defined time intervals.

Abstract: A method for identifying a product includes providing a solid body (10) fabricated from at least a molecularly imprinted polymer having molecular sized cavities (12) adapted to selectively receive and bind molecules (50) having a specific taggant molecular structure (51), the molecular sized cavities (12) disposed on a portion of an exterior surface (11) of the body (10), and applying to the surface of the body a composition containing indicator molecules (50) having a taggant moiety (51) at one end and a marking function group (53) tethered to the taggant moiety (51) by a molecular chain the taggant moieties (51) engaging and binding to the molecular sized cavities (12) so as to mark the portion of the surface (11) of the body (10) with the indicator molecules (50) bound thereto, the marking functional groups (53) rendering the marked portion of the surface (11) perceptible with or without detection instrumentation.

Abstract: The present invention provides a method for fast dispersing carbon nanotubes in an aqueous solution. In this method, the carbon nanotubes are added into an aqueous solution of a nontoxic surfactant, and then dispersed therein through ultrasonic oscillation. This uniform dispersion can maintain high stability for at least two months without aggregation, suspension or precipitation. This dispersion is suitable for calibrating concentration of the carbon nanotubes.

Abstract: Embodiments of the invention provide to apparatuses and media used in drug elution studies and methods for making and using them. One embodiment of the invention is a drug elution method that can be used for in-vitro studies of a matrix impregnated with a compound such as a drug blended polymer matrix. Such methods and materials can be used for example to assess and control the manufacturing process variability of drug eluting implantable devices such as cardiac leads.

Abstract: A reagent preparing device for preparing a reagent to be supplied to a measurement device for measuring a specimen, comprising: a first liquid storage unit for storing a first liquid; a reagent storage unit for storing a prepared reagent, including the first liquid and a second liquid different from the first liquid; a first liquid discarding unit for discarding the first liquid stored in the first liquid storage unit; and a controller configured for measuring an accumulated time of the first liquid in the first liquid storage unit; and controlling the first liquid discarding unit to discard the first liquid stored in the first liquid storage unit when the accumulated time reaches a predetermined time is disclosed. A specimen measuring device and a reagent preparing method are also disclosed.

Abstract: A biosensor system determines analyte concentration from an output signal generated by an oxidation/reduction reaction of the analyte. The biosensor system adjusts a correlation for determining analyte concentrations from output signals at one temperature to determining analyte concentrations from output signals at other temperatures. The temperature-adjusted correlation between analyte concentrations and output signals at a reference temperature may be used to determine analyte concentrations from output signals at a sample temperature.

Abstract: The present invention is to present a sample analyzer comprising: a reagent container holder; a measurement unit; and an information processing unit configured to perform operations comprising: controlling the measurement unit so as to start the successive measurement of the plurality of samples; determining whether or not to switch from the first reagent container to the second reagent container while performing the successive measurement by using the reagent contained in the first reagent container; controlling the measurement unit so as to suspend a start of aspiration of a next sample, to measure a quality control measurement sample prepared from the reagent contained in the second reagent container, when determined to switch from the first reagent container to the second reagent container; and controlling the measurement unit so as to start the aspiration of the next sample when an analysis result of the quality control measurement sample meets a predetermined condition.

Abstract: Methods and apparatuses are provided for creation of discrete corrosion defects with a wide range of diameter to depth aspect ratios for painted test standards. Also provided are methods for use of those test standards to characterize the corrosion under paint detection threshold, statistical reliability, and accuracy of NDI and/or NDT techniques including but not limited to flash thermography, ultrasonic testing, eddy current testing, microwave testing, shearography, and infrared testing.

Abstract: The invention concerns a method which consists in determining ageing an ageing index of a blood bag (11, 62), to determine whether the blood bag is or not suitable for transfusion to a patient. The ageing index is calculated by connecting a silicon chip provided with a loop antenna integral with the blood bag (11, 62) with an electronic communication device (2, 8, 17, 12, 20, 24), itself equipped with a loop antenna, connected to a computer (9, 13) containing appropriate computing software elements. Said ageing index is regularly calculated at the blood transfusion center (16) from the sample (1), until it is removed from storage (7) to be sent to the health-care institution (18) and to the operating theatre (19).

Abstract: Methods and apparatus are provided for assaying cell samples, which may be living cells, using probes labeled with composite organic-inorganic nanoparticles (COINs) and microspheres with COINs embedded within a polymer matrix to which the probe moiety is attached. COINs intrinsically produce SERS signals upon laser irradiation, making COIN-labeled probes particularly suitable in a variety of methods for assaying cells, including biological molecules that may be contained on or within cells, most of which are not inherently Raman-active. The invention provides variations of the sandwich immunoassay employing both specific and degenerate binding, methods for reverse phase assay of tissue samples and cell microstructures, in solution displacement and competition assays, and the like. Systems and chips useful for practicing the invention assays are also provided.

Abstract: The invention provides among other things methods and kits based on assaying for cardiac troponin autoantibodies, either in conjunction with an assay for cardiac troponin and/or as an independent indicator of cardiac pathology, such as myocarditis, cardiomyopathy, and/or ischemic heart disease. Assay methods of the invention can be employed among other things to identify cardiac pathology, or risk thereof, in subjects who have an autoimmune disease or who are related to an individual with an autoimmune disease. In particular embodiments, the invention also provides a method of determining whether a subject having, or at risk for, a cardiac pathology is a candidate for immunosuppressive therapy or immunoabsorption therapy. The invention also provides kits and kit components that are useful for performing the methods of the invention.

Abstract: A method of producing microbead populations that mimics the fluorescence intensity profile distribution of fluorescent biological cells so that they may be used a standard for flow cytometry.

Abstract: The invention provides a method to efficiently express high levels of a recombinant untagged NT-proBNP for use as a calibrator in NT-proBNP immunoassays.

Abstract: An object of the present invention is to quantitate with good accuracy, furthermore, quantitate absolutely, one or a plurality of biological molecules in a sample such as a tissue, a biological fluid, a cell, a cell organ or protein complex. By adding a metabolically isotope labeled biological molecule as an internal standard substance and measuring with a mass spectrometer, quantitating with good accuracy one or a plurality of target molecules in a sample has become possible. In addition, by performing waveform separation processing during mass analysis, a highly accurate quantitative analysis method of mass analysis is provided.

Abstract: A linearity control system includes a series of linearity control compositions, each thereof includes white blood cell analogs and stabilized red blood cells in a suspension medium. The concentration of the white blood cell analogs in the series of control compositions increases from 0.2×103 to 800×103 analogs per microliter, and the concentration of the white blood cell analogs in at least one control composition is greater than 120×103 analogs per microliter. The stabilized red blood cells facilitate mono-dispersion of the white blood cell analogs in the suspension medium by gently mixing. The control compositions further include platelet analogs, or additionally include reticulocyte and/or nucleated red blood cell analogs. The linearity control system allows the verification of the reportable measurement range and linearity of the measurements of hematology analyzers for white blood cells, red blood cells and platelets in extended concentration ranges.

Abstract: Disclosed are embodiments of a containment device having a flexible first layer and a flexible second layer sealed together to form a hermetically sealed reservoir. The surface area of contact between the first and the second layers can define a frame about the perimeter of the reservoir. The containment device can also include a porous pad located within the reservoir, and a liquid control solution configured to mimic a physiological fluid contained within the porous pad within the reservoir. The containment device can include a third flexible layer presenting a liquid holding surface for a user. A portion of the first and/or second layers can function as a frangible seal that is configured to be torn away by a user.

Abstract: The present invention pertains to a method for verifying usability of a test element on the basis of the relation of at least one control parameter measurable from the blank test field of a test element to a standard value for the at least one control parameter. In one embodiment, the method comprises determining the deviation between a first ratio calculated from a blank-field reference value measured for the control parameter and a first standard value, and a second ratio calculated from a blank-field control value and the first standard value, and rejecting a test element if the deviation is not within a predetermined tolerance range for the deviation.

Abstract: The invention concerns a method for automatically differentiating between a sample liquid and a control liquid especially within the context of analytical measuring systems, wherein the presence of a special property of the control liquid and/or at least two criteria are used for the differentiation. In addition the invention concerns appropriate control liquids that are suitable for the new method.

Abstract: There is provided a method for preparing an analytical standard used for microbeam X-ray fluorescence analysis which includes: a mixing step in which an element is added to a base material, and the base material and the element are mixed by stirring to obtain a mixed solution; a deaeration step in which the mixed solution is deaerated; a freeze step in which the mixed solution is slowly frozen; and a cutting step in which a thin section is cut out from the frozen mixed solution. In order to surely remove bubbles from the mixed solution, the deaeration step may contain a stationary step in which the mixed solution is allowed to stand still at room temperature; or the stationary step includes a removal step in which gas contained in the mixed solution which is allowed to stand still is removed with a suction apparatus.

Abstract: The present invention provides a reference solution for use in instruments that determine hematocrit levels in biological samples by measuring the resistance and/or conductivity of the biological samples. A reference solution according to the invention achieves conductivities representative of known hematocrit levels in blood, while maintaining tolerable levels of interference with the measurement of other analytes in the reference solution.

Abstract: A method is provided for determining the severity of appendicitis in a patient that includes testing a blood, serum or plasma sample from the patient for the quantity of MRP8/14 in the sample and comparing it with the quantity of MRP8/14 present in standard samples correlated with an appendicitis severity scoring system. A histologically-based appendicitis severity scoring system is also provided. Immunoassays and kits for performing the appendicitis assays of this invention are also provided, as are standard samples and data correlating MRP8/14 quantities present in patient samples to histologically-based appendicitis severity grades. The methods and immunoassay devices and kits of this invention are useful for managing the treatment of patients presenting with appendicitis symptoms.

Abstract: A urine analysis system includes a urinary particle analyzer and a computer. The urinary particle analyzer has a measuring unit that measures a cast concentration from the urine and an electric conductivity sensor that measures the electric conductivity of the urine. The computer has a function of correcting the cast concentration measured by the measuring unit on the basis of the electric conductivity of the urine measured by the electric conductivity sensor and a function of outputting the corrected cast concentration.