Abstract: A reagent vessel insert for a reagent vessel for a centrifuge and/or a pressure varying device includes an insert housing formed such that the reagent vessel insert is insertable in a reagent vessel for a centrifuge and/or for a pressure varying device. The reagent vessel insert also includes at least one agitating element arranged in at least one interior volume such that a place and/or position of the at least one agitating element is changeable with respect to the insert housing. The reagent vessel insert is configured such that at least one material filled into the at least one interior volume is agitatable and such that, during an adjustment, at least one subunit of the at least one agitating element contacting at least one holding structure, by which the at least one agitating element is held in at least one semi-stable place and/or at least one semi-stable position.

Abstract: A microfluidic device is provided for inducing the separation of constituent elements from a microfluidic sample by introducing phase changes in the microfluidic sample while contained in a microfluidic channel in the device. At least a portion of the microfluidic sample is frozen to cause fractional exclusion of the constituent element from the frozen portion of the microfluidic sample. Different portions of the microfluidic sample may be frozen in different sectors and at different times in order to cause movement in a desired direction of the separated constituent element. Portions of the microfluidic sample may be frozen in a sequential order of adjacent sectors within the microfluidic channel in order to cause sequential movement of the excluded constituent element toward one portion of the microfluidic channel. The frozen portion of the microfluidic sample is then thawed, wherein the separated constituent element remains substantially separated from the thawed, purified microfluidic sample.

Abstract: Provided are efficient, cost-effective and water tolerant methods (e.g., single-vial methods) for preparing fatty acid esters from organic matter, including: obtaining organic matter having at least one fat substituent, contacting the organic matter in a reaction mixture with a basic solution under conditions suitable to provide for hydrolytic release of monomeric fatty acids from the at least one fat substituent to provide a base-treated reaction mixture, and esterifying the monomeric fatty acids of the base-treated reaction mixture by acidification of the reaction mixture and treating in the presence of an organic alcohol to provide fatty acid esters. The methods optionally further include, prior to esterifying, neutralizing the base-treated reaction mixture to provide for neutralized fatty acids, separating the neutralized fatty acids from the neutralized reaction mixture, and dissolving the separated fatty acids in the esterification reaction mixture.

Abstract: A nucleic acid extraction kit, which enables the nucleic acid extraction operation to be accomplished safely without causing contamination, and in which the complex preparation of reagents and the disposal treatments that are performed before and after the nucleic acid extraction operation can be performed rapidly and simply, with the extraction performed in an automated manner. The nucleic acid extraction kit includes: a container including reagent wells that each store at least a reagent, a sample well into which a biological sample is introduced, a waste liquid well, and a collection well in which an extracted nucleic acid is collected, and an extraction filter cartridge equipped with an extraction filter for separating and extracting a nucleic acid from the biological sample, wherein the extraction filter cartridge is formed in a manner that enables the extraction filter cartridge to be supported on the waste liquid well and the collection well.

Abstract: This disclosure is directed to systems for separating a target analyte from a suspension. A suspension is added to a tube. A float is also added to the tube, and the tube, float, and suspension are centrifuged together, causing the constituent components of the suspension to separate into different layers along the axial length of the tube according to their specific gravities. The float has a specific gravity that positions the float at approximately the same level as a layer containing the target analyte, when the tube, float and sample are centrifuged. Prior to isolation, the material may be located between an outer surface of the float and an inner surface of the tube, or within a central bore that extends longitudinally through the float. The target analyte may then be drawn into a compartment within the float, thereby isolating the target analyte from the other suspension constituents.

Abstract: A collection device and a method for collecting a biological sample, particularly whole blood, includes a separating member to separate the whole blood into its components, and at least reagent positioned to selectively interact with a component of the separated sample. The reagent is able to selectively interact with the plasma/serum, and is prevented from contacting or interacting with the whole blood.

Abstract: A method and analytical device for collecting a sample volume containing at least one analyte of interest from a liquid analytical sample having contaminants disposed at or near the sample surface. The liquid analytical sample is provided. A first pipetting device comprising a first pipetting needle aspirates from an upper region of the liquid analytical sample a portion comprising the contaminants and discards the portion. The first needle is washed with washing liquid. A second pipetting device comprising a second pipetting needle, or a disposable pipetting tip, aspirates the sample volume from the liquid analytical sample after the first pipetting device discards the aspirated portion and discharges the sample volume for analysis. The second needle is washed with washing liquid or disposed of.

Abstract: The present invention provides a method for determining sickle-cell zygosity in a subject. The method involves forming a first solution which includes a sample from the subject, a phosphate buffer, a detergent, and a reducing agent and subjecting the first solution to centrifugation to form a second solution and a supernatant; and taking a color reading of the supernatant and of the second solution; optionally filtering the second solution to form a filtrate and a precipitate, and optionally measuring the amount of the precipitation and the absorbance of the filtrate or taking a color reading of the filtrate.

Abstract: A method for collecting and processing biological samples (e.g., fecal samples) is disclosed. The method may include obtaining a system comprising a container, a collector, and a lid. Using the collector, a user may collect a sample. The sample may be inserted within the container. The lid may be secured and the container and sample contained therewithin may be transported to a testing facility. At the testing facility, the container may be used throughout the processing of the sample. Accordingly, the risk of cross-contamination may be reduced.

Abstract: Quantification of vitamin D2, vitamin D3, and the monohydroxy and diihydroxy metabolites of vitamin D2 and vitamin D3, can comprise labeling analytes with mass spectrometry (MS) tagging reagents and performing LC-MSMS analysis of the labeled analytes. The labeled analytes can include a labeled standard and can have distinct retention times on a reversed phase column, as well as distinct masses. Under high energy collisions, reporter groups can be generated. The intensity or the peak area detected for each reporter group can be used for quantitation. In some embodiments, a one-step tagging reagent is used that is a dienophile-containing, labeled Diels Alder reagent.

Abstract: A method of processing animal sperm cells that includes: collecting sperm cells from a male animal; sorting the sperm cells to obtain a quantity of sperm cells having a desired characteristic, the quantity of sorted sperm cells being contained in a first volume of fluid having a first concentration of sperm cells; and subjecting the sperm cells to concentration steps in which the concentration of the sperm cells is increased to a second concentration greater than the first concentration.

Abstract: This disclosure is directed to systems and methods for immunomagnetic separation of a target analyte of a suspension from the other component materials of the suspension. The system may be composed of a tube, a magnetizable float, and a magnet. The magnetizable float is configured to propagate or introduce a magnetic field. In one aspect, the magnet is included in the magnetizable float. In another aspect, the magnet is external to the magnetizable float. The system may also include a solution containing a particle to conjugate with the target analyte to form a target analyte-particle complex. The particle is capable of being attracted by the magnetic field or magnetic gradient introduced by the magnet. The target analyte-particle complex may be attracted to the magnetizable float.

Abstract: Devices and methods incorporate lysis agents into a point-of-care testing device. The sample is loaded, and then the sample travels until it encounters a lysis agent. The lysis agent is preferably pre-loaded onto the collection device. In a preferred embodiment, the initially lysis agent is localized between the sample application zone and the conjugate zone. The lysis agent is preferably soluble or miscible in the sample transport liquid, and the lysis agent is solubilized and activated upon contact with the sample transport liquid. The sample transport liquid then contains both lysis agent in solution or suspension and sample components in suspension. Any lysis-susceptible components in a sample, then being exposed in suspension to the lysis agent, are themselves lysed in situ. The running buffer then carries the analyte, including any lysis-freed components, to the detection zone.

Abstract: A microfluidic system for preparing a sample containing an analyte of interest is provided. The microfluidic system includes a microfluidic cartridge and a magnetic element. The microfluidic cartridge includes a number of reservoirs, an immobilizer, a number of microfluidic flow channels and a number of microvalves. The microfluidic channels are coupled with the reservoirs and the immobilizer. The microvalves are positioned along the microfluidic flow channels. The magnetic element is positioned with respect to the immobilizer. The magnetic element is configured to generate a magnetic field to magnetically immobilize the analyte of interest in the immobilizer. The immobilizer is configured to flow one or more reagents therethrough to react with the analyte of interest.

Abstract: A solid-phase extraction pipette (20) is provided for extracting substances comprising: a generally hollow body (29) having an inlet (21), a stem (22), and an elastic chamber (28); a first extraction media (27) arranged within the hollow body; and a first fit (24) contained within the hollow body and configured to prevent the first extraction media from exiting the body. The body may be made of a transparent material such as low density polyethylene. The chamber may be configured for movement from a first expanded form having a first volume to a second contracted form having a second volume less than the first volume.

Abstract: Provided are a carrier-enclosed transformable container, a carrier-enclosed transformable container processing apparatus, and a carrier-enclosed transformable container processing method about which a carrier to which various substances such as biogenic substances are bonded or bondable is held in a transformable container as the container to be in a substantially stationary state, thereby making it possible to make the handling of the carrier, measurement, and other treatments effective, speedy, and easy.

Abstract: The present invention relates to a method for the determination of polysorbate in a protein-containing sample. The method of the present invention involves the pretreatment of the sample by alkaline hydrolysis followed by colorimetric determination.

Abstract: The invention relates to a device and method for collecting blood whereby certain target components are isolated or removed from the blood sample at the time of collecting the blood, as well as methods for using such devices.

Abstract: The present invention relates to paper supports for neonatal screening that are used for the storage and further processing of biological materials. The invention is particularly concerned with paper supports which have at least one surface coated with a chemical that enhances the recovery of the biological material from the support. Methods of preparing and using the paper supports are also described.

Abstract: A handheld, small but accurate and reliable device for diagnostic NO measurements using a NO sensor, where the parameters governing the taking of the sample are different from the parameters optimal for the accuracy of said NO sensor I described. By temporarily storing a portion of the exhaled air, and feeding this to the sensor at a flow rate adapted to the NO sensor, the accuracy and sensitivity of a system/method involving NO sensors, in particular electrochemical NO sensors, can be increased. The method for diagnostic NO measurements comprises steps for controlling the inhalation of NO free air, as well as the exhalation, both by built-in means and by audible and/or visual feedback to the patient.

Abstract: A reaction unit containing a bottom part and a top part for pipetting a liquid, wherein the bottom part contains a reaction cavity with a permeable filter grid insert and the top part contains a reaction cavity which can be fixed on said bottom part and contains a cavity or covering for receiving a magnet.

Abstract: The present invention is concerned with the analysis of polar metabolites and provides methods for analyzing polar metabolites including extracting a biological sample with a extraction buffer containing a phase separator and a volatile neutral ammonium salt under conditions which allow for immediate disruption of cells in the biological sample, separating the polar metabolites in the extract by chromatography, and analyzing the separated polar metabolites. Moreover, a method for quenching a biological sample containing cellular material is contemplated.

Abstract: The present invention provides methods of evaluating CHO cells.

Abstract: The invention features devices and methods for the deterministic separation of particles. Exemplary methods include the enrichment of a sample in a desired particle or the alteration of a desired particle in the device. The devices and methods are advantageously employed to enrich for rare cells, e.g., fetal cells, present in a sample, e.g., maternal blood and rare cell components, e.g., fetal cell nuclei. The invention further provides a method for preferentially lysing cells of interest in a sample, e.g., to extract clinical information from a cellular component, e.g., a nucleus, of the cells of interest. In general, the method employs differential lysis between the cells of interest and other cells (e.g., other nucleated cells) in the sample.

Abstract: A method for desorption of a blood sample from a dried blood spot on a medical test sheet, for the purpose of biomedical analysis, comprises the steps of: interposing the test sheet inbetween first and second clamping heads; clamping the first and the second clamping heads onto the interposed test sheet; and flushing a desorption area of the clamped test sheet with a sample elution fluid. The clamping heads are transmitting compressive forces to parts of the test sheet. The compressive forces create an imprinted sealing area of the test sheet, which imprinted sealing area has a closed loop shape surrounding a desorption area of the test sheet. The desorption area is contained in a space enveloped by first and second outer surfaces of the first and second clamping heads, respectively, and sealed by the imprinted sealing area.

Abstract: A sample preparation device is disclosed. The sample preparation device includes a housing defining a passage way between a first opening and a second opening; and a sample filter occupying a section of said passage way. The sample filter contains a monolith adsorbent that specifically binds to nucleic acids. Also disclosed are sample filters containing glass frit is coated with an capture agent that binds specifically to an analyte of interest, sample filters containing a hydrophilic matrix with impregnated chemicals that lyses cell membranes, a cartridge base and an integrated sample preparation cartridge.

Abstract: Hemoglobin in a sample solution is quickly and reliably denatured; at the same time, quick and accurate measurement of hemoglobin and a hemoglobin derivative is realized. In a method for measuring hemoglobin and a hemoglobin derivative, and a reagent composition, a measurement kit, an analysis device, and an analysis system used in the method, a sample solution containing a blood component is treated with a nonionic surfactant, an oxidizing agent, and a metal salt to denature hemoglobin in the sample solution to measure the hemoglobin, and thereafter the amount of a hemoglobin derivative in the sample is measured by an immunological method using an antibody specifically binding to a denatured site of the denatured hemoglobin derivative.

Abstract: A structure for controlling fluid flow from a sample receiving pad into a lateral flow assay test strip, including: a lateral flow assay test strip; a sample pad abutting the lateral flow assay test strip; a pinch wall positioned to direct fluid flow from the sample pad to the lateral flow assay test strip; a top support structure positioned on top of the test strip; and a bottom support structure positioned underneath the test strip, wherein each of the top and bottom support structures comprise a plurality of separate spaced-apart support ribs positioned along the length of the test strip.

Abstract: Provided are methods and compositions for isolating and detecting rare cells from a biological sample containing other types of cells, particularly including debulking that uses a microfabricated filter for filtering samples. The enriched rare cells can be used in a downstream process such as identification, characterization or growth in culture, or in other ways. Also included is a method of determining tumor aggressiveness or the number or proportion of cancer cells in the enriched sample by detecting telomerase activity, nucleic acid or expression after enrichment of rare cells. Also provided is an efficient, rapid method to specifically remove red and white blood cells from a biological sample containing at least one of the cell types, leading to enrichment of rare target cells including circulating tumor (CTC), stromal, mesenchymal, endothelial, fetal, stem, or non-hematopoietic cells et cetera from a blood sample.

Abstract: The invention discloses a method of prenatal diagnosis comprising the step of isolating exosomes from an isolated fluid, wherein the exosomes are identified by biomarker detection. Furthermore, the invention discloses the isolation of exosomes from an isolated fluid and the use of a biomarker, particularly CD24 to isolate exosomes from an isolated fluid.

Abstract: The invention provides enzymatic methods for direct determination of percentage of glycated hemoglobin in blood samples without the need of a separated measurement of total hemoglobin content in blood samples. The methods utilizes one or two different types of oxidizing agents which selectively oxidize low-molecular weight reducing substances and high-molecular weight (mainly hemoglobin) reducing substances in blood samples, coupled with enzymatic reactions catalyzed by proteases, fructosyl amino acid oxidase. The amount of hydrogen peroxide generated in the reaction is measured for determination of percentage of glycated hemoglobin in blood samples. The invention provides kits for performing the methods of the invention.

Abstract: A method for measuring glycated hemoglobin includes hemolyzing a blood sample with a hemolysate; reacting the hemolyzed blood sample with bead conjugates in which beads are conjugated with glycated hemoglobin binding materials; measuring the amount of total hemoglobin in the reacted blood sample; isolating normal hemoglobin from the glycated hemoglobin conjugated with the bead conjugates; measuring the amount of glycated hemoglobin isolated from the normal hemoglobin; and determining the percentage of the glycated hemoglobin in the blood sample on the basis of the measured amounts of total hemoglobin and glycated hemoglobin. The isolation of normal hemoglobin is performed by absorbing the normal hemoglobin using an absorption pad that is a porous pad having pores, each of which has a size greater than the size of the normal hemoglobin and smaller than the size of the bead.

Abstract: The invention relates to the detection of DHA and EPA. In a particular aspect, the invention relates to methods for detecting DHA and EPA by mass spectrometry.

Abstract: Endothelial cells are detected in a blood sample by enriching the endothelial cells from the blood sample followed by performing on the enriched endothelial cells an immunoassay capable of detecting antigens expressed by the endothelial cells. The immunoassay is capable of detecting antigen expressed from 300 endothelial cells per milliliter of blood. The method can be used for assaying mature circulating endothelial cells or circulating endothelial progenitor cells.

Abstract: The present invention provides a method for diagnosing cancer, predicting a disease outcome or response to therapy in a patient sample. The method involves isolating a circulating tumor cell (CTC), for example, a viable CTC, from a sample using a parylene microfilter device comprising a membrane filter having or consisting of a parylene substrate, which has an array of holes with a predetermined shape and size; and detecting and quantifying telomerase activity in blood circulating tumor cells. The invention further provides methods of using cells live-captured in various applications.

Abstract: Subpopulations of spore-like cells expressing specific cell surface and gene expression markers are provided. In one embodiment, the cells express at least one cell surface or gene expression marker selected from the group consisting of Oct4, nanog, Zfp296, cripto, Gdf3, UtF1, Ecat1, Esg1, Sox2, Pax6, nestin, SCA-1, CD29, CD34, CD90, B1 integrin, cKit, SP-C, CC10, SF1, DAX1, and SCG10. Also provided are methods for purifying a subpopulation of spore-like cells of interest from a population of spore-like cells, and methods for inducing differentiation of the isolated spore-like cells into cells of endodermal, mesodermal or ectodermal origin. The spore-like cells can be used to generate cells originating from all three germ layers and can be used to treat a patient who has a deficiency of functional cells in any of a wide variety of tissues, including the retina, intestine, bladder, kidney, liver, lung, nervous system, or endocrine system.

Abstract: A method and tube for separating a sample. The tube is configured to separate agglomerated or clumped material or other sample components having over a particular size from other smaller size portions of the sample. For example, blood clots may be separated from serum of a blood sample. The tube includes a chamber with a closed bottom and a sidewall extending upwardly from the bottom, and a sample inlet branch coupled to the chamber. A slit is positioned between the chamber and the sample inlet branch so that after a sample is placed into the sample inlet branch, a portion of the sample having a size smaller than the slit (e.g., liquid material) passes through the slit and into the chamber, and material in the sample having a size larger than the slit remains in the sample inlet branch.

Abstract: The methods of the disclosure provide fluorescence-based assays for calcineurin activity, especially in isolated T cells. The methods include the stimulation of the T cells with agents that specifically target the TCR with or without influencing co-stimulatory pathways. One TCR agonist is monoclonal antibodies specific for CD3, which more precisely distinguish the inducible activity of calcineurin than does an alternative method targeting the T cell receptor (CD3) combined with CD28 costimulation. This method more accurately distinguishes between the measured level of calcineurin activity of T cells from immunosuppressed transplant recipients and normal individuals, and thus has improved diagnostic accuracy with respect to the response of an individual to immunosuppressant therapy following an organ transplant.

Abstract: The disclosure relates to a process and related article for functionalizing a porous membrane by contacting the membrane with a polyacid polymer at low pH to stably adsorb a polyacid layer on the membrane pore surface. The resulting functionalized membrane is characterized by a high density of free acid groups, resulting in a higher specific capacity for its intended application. The process allows functionalization of porous membranes in a very simple, one-step process. Such functional membranes may find multiple uses, including rapid, selective binding of proteins for their purification or immobilization.

Abstract: The present invention concerns a monoclonal antibody and corresponding hybridoma cells and antigens suitable for isolating fetal cells from maternal blood. The inventive monoclonal antibody reacts with a surface antigen present on fetal red blood cells including their nucleated precursor cells, but not with surface antigens on adult erythroid cell.

Abstract: Disclosed is a method for separating immunomagnetic bead labeled particulates. A carrier board is formed with at least one flow channel structure, which includes an inner reservoir, an outer reservoir, and at least one micro flow channel in communication with the inner reservoir and the outer reservoir. The method includes labeling target particulates with immunomagnetic bead, introducing a sample fluid into the inner reservoir, and applying a magnetic force and a driving force, wherein the driving force drives the particulates not labeled with immunomagnetic bead to flow through the micro flow channel to the outer reservoir, while the magnetic force attracts the particulates labeled with the immunomagnetic bead to retain in the inner reservoir. The driving force may be centrifugal force, pressure, or surface tension.

Abstract: The present invention is directed to methods of detecting viable epithelial cells in a sample. The method includes isolating the sample comprising cells from a patient and culturing the cells for a time sufficient for an epithelial cell-specific marker to be released from the cells. The marker includes a substantially full-length cytokeratin. The method further includes detecting the released marker. Detection of the marker indicates the presence of disseminated epithelial cells. Methods are also directed to identifying disseminated epithelial tumor cells.

Abstract: A fluid cartridge, comprising a channel layer within which at least one circumferentially sealed fluid channel is formed, the channel layer comprising a substrate and an elastic layer fixedly arranged on the substrate, wherein the substrate has a rigidity being greater than that of the elastic layer, and wherein the at least one fluid channel is defined on at least one side thereof by the elastic layer.

Abstract: A multidimensional chemical separation and analysis system is described including a prototyping platform and modular microfluidic components capable of rapid and convenient assembly, alteration and disassembly of numerous candidate separation systems. Partial or total computer control of the separation system is possible. Single or multiple alternative processing trains can be tested, optimized and/or run in parallel. Examples related to the separation and analysis of human bodily fluids are given.

Abstract: A method for discovering pharmacologically active substances from natural products at high speed, including: obtaining an activity profile by testing pharmacological activity of a plurality of samples; obtaining mass profiles based on mass spectra resulting from analysis of the samples by mass spectrometry; and determining molecular weight of pharmacologically active substances by comparing and analyzing the activity profile and the mass profile. The method allows fast discovery of pharmacologically active substances by performing high resolution mass spectrometry for numerous components included in an extract sample of natural products and comparing with the activity test data. The information about the intensity of the activity of the pharmacologically active substances of the natural products allows effective utilization of the natural products.

Abstract: A method for determining the amount of a chemical species in a sample, in particular the amount of weak acid dissociable cyanide or total cyanide in a sample, and an apparatus for performing said method. The method comprises the steps of: i) treating the sample to liberate the chemical species into a gaseous stream; ii) directing the gaseous stream to a scrubber; iii) absorbing the chemical species into a scrubber solution; and iv) determining the amount of chemical species absorbed into the scrubber solution, wherein any remaining chemical species not absorbed into the scrubber solution is directed or recirculated to the scrubber in the gaseous stream and step iii) is repeated to increase absorption of the chemical species prior to performing step iv).

Abstract: This invention relates, inter alia, to detecting and/or measuring succinylacetone and one or more additional biological analytes using mass spectrometry, e.g., tandem mass spectrometry, by derivatizing succinylacetone in a sample by contacting the sample with an extraction solution comprising a C1-3 linear or branched chain monoalcohol and a strong base selected from the group consisting of hydrazine, a modified hydrazine, and hydroxylamine.

Abstract: A magnetic separation plate for use in methods employing magnetic particles, said magnetic separation plate comprising a support plate and magnetic pins in a predetermined geometrical arrangement, said magnetic pins having a fastening portion, an intermediate portion and a separation portion and being fastened to said support plate at their fastening portion, wherein said magnetic pins are individually displaceable at their separation portion. The invention further provides a method for the separation of magnetic particles using the separation plate.

Abstract: When an atomic absorption spectrophotometer (AAS) or inductively coupled plasma (ICP) is used, samples must be introduced in a liquid state. Thus, sample decomposition by acids must be performed. Methods for decomposing samples using beakers or microwaves have caused several problems such as loss of volatile elements, excessive use of acids, emission of harmful gases, limitation of sample capacity and amount, and inconvenience of cleaning up. However, the present invention can treat many samples with one acid injection through gas condensation by both heating of a reaction container and air cooling of a collection pipe, wherein the reaction container is made of fluororesin (Teflon) or quartz. Also, if there are many samples, the samples can be treated at once. Furthermore, since the present invention can treat the samples with a conventional heating plate, the invention can be used at inexpensive costs.

Abstract: Provided are methods and compositions for reducing or eliminating pH excursions in cation and anion exchange chromatography.