Abstract: A method is disclosed for fabricating free-standing polymeric nanopillars or nanotubes with remarkably high aspect ratios. The nanopillars and nanotubes may be used, for example, in integrated microfluidic systems for rapid, automated, high-capacity analysis or separation of complex protein mixtures or their enzyme digest products. One embodiment, preferably fabricated entirely from polymer substrates, comprises a cell lysis unit; a solid-phase extraction unit with free-standing, polymeric nanostructures; a multi-dimensional electrophoretic separation unit with high peak capacity; a solid-phase nanoreactor for the proteolytic digestion of isolated proteins; and a chromatographic unit for the separation of peptide fragments from the digestion of proteins.

Abstract: The present disclosure provides an automated system and method for protein digestion, recovery, and analysis. The present disclosure also provides a buffer solution for use therein.

Abstract: A self-contained apparatus for isolating nucleic acid, cell lysates and cell suspensions from unprocessed samples apparatus, to be used with an instrument, includes at least one input, and: (i) a macrofluidic component, including a chamber for receiving an unprocessed sample from a collection device and at least one filled liquid purification reagent storage reservoir; and (ii) a microfluidic component in communication with the macrofluidic component through at least one microfluidic element, the microfluidic component further comprising at least one nucleic acid purification matrix; and (iii) at least one interface port to a drive mechanism on the instrument for driving said liquid purification reagent, through the microfluidic element and the nucleic acid purification matrix, wherein the only inputs to the apparatus are through the chamber and the interface port to the drive mechanism.

Abstract: The apparatus for analyzing a disease sample according to the present invention includes: a member for separating and quantitatively determining an amino acid stereoisomer in a biological material from a subject; a member for obtaining a disease state index value through a calculation by substituting the amount of the amino acid stereoisomer into a discriminant equation; and a member for outputting disease state information on the subject on the basis of the disease state index value. The method for analyzing a disease sample according to the present invention includes: a step of measuring the amount of amino acid stereoisomers in a biological material from a subject; a step of obtaining a disease state index value through a calculation by substituting the amount of the amino acid stereoisomers into a discriminant equation; and the like.

Abstract: Embodiments of the present invention are directed toward devices, systems, and method for conducting sandwich assays using sedimentation. In one example, a method includes generating complexes on a plurality of beads in a fluid sample, individual ones of the complexes comprising a capture agent, a target analyte, and a labeling agent. The plurality of beads including the complexes may be transported through a density media, wherein the density media has a density lower than a density of the beads and higher than a density of the fluid sample, and wherein the transporting occurs, at least in part, by sedimentation. Signal may be detected from the labeling agents of the complexes.

Abstract: A system and method for measuring at least one bioprocess parameter utilizes a barrier that separates an external sensor from a culture medium. The barrier allows analytes to diffuse in and out of the culture vessel, thereby allowing the bioprocess parameter to be measured non-invasively by the external sensor.

Abstract: A microfluidic device for glycan analysis includes a deglycosylation column comprising a glycosidase attached to a solid support; a tagging column comprising a reactive ester for reaction with an amino group, wherein the tagging column is arranged downstream of the deglycosylation column; an analytical column comprising a stationary phase capable of separating a derivatized glycan; and a plurality of inlet/outlet ports configured to connect with channels on a switching element to form flow paths.

Abstract: The invention concerns a method for isolating and purifying nucleic acids from a sample and a device that is suitable therefore.

Abstract: The present invention relates to a method of expressing an immunotoxin in Pichia pastoris strain mutated to toxin resistance comprising a) growing the Pichia pastoris in a growth medium comprising an enzymatic digest of protein and yeast extract and maintaining a dissolved oxygen concentration at 40% and above; and b) performing methanol induction with a limited methanol feed of 0.5-0.75 ml/min/IO L of initial volume during induction along with a continuous infusion of yeast extract at a temperature below 17.5° C., antifoaming agent supplied up to 0.07%, agitation reduced to 400 RPM, and the induction phase extended out to 163 h.

Abstract: Provided is a strip-assembled immunochromatographic disc, containing: a base, a lid engaged with the base and a draining piece disposed between the strips on the base and the lid, wherein a sampling opening is disposed on the lid directly facing to the draining piece, and the said sampling opening intercommunicates to a draining groove provided on the inner side of the lid which is formed by a plurality of draining channels; several strip stages are provided on the base with their location and number corresponding to those of the draining channels provided on the lid, and the edge of the draining piece laps to the sample pads of the strips carried on the stage adjacent to one end of the sampling opening. Also provided is a method of performing multiplexed immnochromatographic detection using the strip disc to accomplish the detection of multiple target analytes in one sample in an assay.

Abstract: The present invention provides a method and automated system for the purification of polypeptides including the direct filtration of solutions containing the polypeptides after purification.

Abstract: Methods and microfluidic circuitry for inline injection of nucleic acids for capillary electrophoresis analysis are provided. According to various embodiments, microfabricated structures including affinity-based capture matrixes inline with separation channels are provided. The affinity-based capture matrixes provide inline sample plug formation and injection into a capillary electrophoresis channel. Also provided are methods and apparatuses for a microbead-based inline injection system for DNA sequencing.

Abstract: The invention provides devices and methods for isolating one or more sample components of a sample material following separation of the sample material into a plurality of sample components. A device includes a separation channel having a sample loading well. A low-conductivity buffer is disposed in the loading well, the buffer having a conductivity<0.2 mS/cm. In a method, a buffer is loaded into a loading well in fluid communication with a separation channel of a device. A sample material having a conductivity higher than that of the buffer is then loaded into the loading well such that the sample material is disposed beneath the buffer, the buffer disposed over and covering the sample material. The sample material is separated into a plurality of separated components in the separation channel, and a separated component is collected from a collection well disposed in a collection leg of the device.

Abstract: Removable cartridges are used on automated flow-through systems for the purpose of extracting and purifying genetic material from complex matrices. Different types of cartridges are paired with specific automated protocols to concentrate, extract, and purifying pathogenic or human genetic material. Their flow-through nature allows large quantities sample to be processed. Matrices may be filtered using size exclusion and/or affinity filters to concentrate the pathogen of interest. Lysed material is ultimately passed through a filter to remove the insoluble material before the soluble genetic material is delivered past a silica-like membrane that binds the genetic material, where it is washed, dried, and eluted. Cartridges are inserted into the housing areas of flow-through automated instruments, which are equipped with sensors to ensure proper placement and usage of the cartridges. Properly inserted cartridges create fluid- and air-tight seals with the flow lines of an automated instrument.

Abstract: Disclosed is a method for measuring thrombin generation in a whole blood sample. The whole blood sample may be applied forthwith, without prior processing. The blood cells and blood plasma in the whole blood sample are separated by (lateral) flow migration. Also disclosed is an assembly of a sample support and a device dedicated to measure thrombin generation in a whole blood sample. Advantageously, the sample support comprises a separator medium allowing separation of whole blood into blood cells and blood plasma by means of (lateral) flow migration.

Abstract: A unitary apparatus for isolating cells from adipose tissue including a lipid separation processor with a dispersing head equipped with a plurality of ports and a digestion chamber for dissociation of the constituent cells disposed in adipose tissue. The lipid separating apparatus is useful for the separation of lipids and adipocytes from a mixed cell population. A cell seeding chamber may be attached to the cell isolation apparatus. The components of the apparatus may be packaged in modular kit form.

Abstract: The bioreactor is for use in performing biological and/or biochemical reactions and includes a vessel, an agitator, a reaction assembly, and a harvesting outlet. The vessel of the bioreactor includes several ports including a mixing port, a reaction port, and a harvesting port. The agitator extends through the mixing port into the vessel while the harvesting outlet extends through the harvesting port and permits the withdrawal of reaction medium to another vessel. The reaction assembly extends through the reaction port into the vessel and has multiple components including a gas conduit adapted to introduce gas into a reaction medium in the vessel, a sampling device adapted to remove a portion of the reaction medium from the vessel without contamination of the remaining reaction medium, and an introduction conduit permitting the introduction of at least the reaction medium into the vessel.

Abstract: The invention relates generally to solid supports for chromatography. In specific embodiments the invention provides for solid supports suitable for affinity chromatography along with methods, systems and kits which use the same.

Abstract: A method and kit for assaying a cell sample for the presence of at least a threshold number of cells of a given type are disclosed. The kit includes an assay device having a sample chamber for receiving the cell sample and an elongate collection chamber containing a selected-density and/or viscosity medium and having along its length, a plurality of cell-collection regions, and particles which are capable of specific attachment to cells of the selected cell type, and which are effective, when attached to the cells, to increase the density or magnetic susceptibility of the cells. In operation, particle-bound cells and particles in the cell sample are drawn through the elongate collection chamber under the influence of a gravitational or selected centrifugal or magnetic-field force until the particle-bound cells and particles completely fill successive cell-collection regions in the collection chamber.

Abstract: An apparatus comprises: a first chromatographic column fluidically coupled to a source of sample and a source of a first chromatographic mobile phase solvent; a second chromatographic column fluidically coupled to the first column; a source of a second mobile phase solvent fluidically coupled between the first and second columns; and a detector, the first chromatographic column being configurable to receive, in a trapping step, the first solvent and sample and to retain a first portion of a plurality of analytes therein and to pass a second portion of the plurality of analytes therethrough, the second chromatographic column being configurable, in the trapping step, to receive the second portion of the plurality of analytes and the first and second solvents and to retain the second portion of the plurality of analytes therein, the detector being arranged to receive the second and first portions in respective first and second elution steps.

Abstract: Embodiments of the present techniques provide systems and methods for isolating particular classes of biological molecules, for example, proteins or nucleic acids, from mixtures of biological components. The methods use solutions that react with the biological molecules to enhance their adsorption by substrates, allowing contaminants to be washed away from the targeted molecules. Embodiments include automated systems that can be used to implement the technique with no or minimal intervention. Other embodiments include separation column technologies that may be used in the techniques.

Abstract: Methods and kits for diagnosis and prognosis using biomarkers comprising albumin-bound protein/peptide complex (ABPPC).

Abstract: Systems, kits, and methods for quantitation of metabolites of vitamin D by liquid chromatography-mass spectrometry (LC-MS). The systems, kits, and methods described herein stabilize and/or promote the formation of the protonated molecular ion ([M+H]+) for the vitamin D metabolites in the ionization source (e.g., electrospray ionization (“ESI”)). Formation of the molecular ion does not involve loss of a water molecule from the parent molecule. Subsequent fragmentation of the [M+H]+ ion yields product ions that are specific to each molecular ion. The systems, kits, and methods described herein provide for no compromise in specificity and provide for a significant increase in sensitivity relative to previously described methods.

Abstract: A micro channel for recovering nucleic acid from a biological sample treated with a chaotropic ion, include an integrated portion composed of silica micro beads having a pore size of from 6 to 29 nm is formed in the channel.

Abstract: Methods and systems for identification of microorganisms either after isolation from a culture or directly from a sample. The methods and systems are configured to identify microorganisms based on the characterization of proteins of the microorganisms via high-resolution/mass accuracy single-stage (MS) or multi-stage (MSn) mass spectrometry. Included herein are also discussion of targeted detection and evaluation of virulence factors, antibiotic resistance markers, antibiotic susceptibility markers, typing, or other characteristics using a method applicable to substantially all microorganisms and high-resolution/mass accuracy single-stage (MS) or multi-stage (MSn) mass spectrometry.

Abstract: A microfluidic device for glycan analysis includes a deglycosylation column comprising a glycosidase attached to a solid support; a tagging column comprising a reactive ester for reaction with an amino group, wherein the tagging column is arranged downstream of the deglycosylation column; an analytical column comprising a stationary phase capable of separating a derivatized glycan; and a plurality of inlet/outlet ports configured to connect with channels on a switching element to form flow paths.

Abstract: A multi-compartment resealable container for testing for the presence of micro-organisms is provided with or adapted to receive a sample in a first substantially rigid transparent compartment, a growth medium in a second compartment, and a sanitizer in a third compartment, the compartments being separated by foil seals, the second and third compartments have an associated plunger which when depressed causes serrated cutters to puncture the foil seal and allow the contents to be added to the liquid containing or comprising the sample.

Abstract: Microfluidic devices, assemblies, and systems are provided, as are methods of manipulating micro-sized samples of fluids. Microfluidic devices having a plurality of specialized processing features are also provided.

Abstract: The present invention relates to a device for detecting a fungal contamination in an internal environment, to the use thereof and also to a method for detecting a fungal contamination in an internal environment using such a device.

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 based on the discovery that drug resistance in microorganisms can be rapidly and accurately determined using mass spectrometry. A mass spectrum of an intact microorganism or one or more isolated biomarkers from the microorganism grown in drug containing, isotopically-labeled media is compared with a mass spectrum of the intact microorganism or one or more isolated biomarkers from the microorganism grown in non-labeled media without the drug present. Drug resistance is determined by predicting and detecting a characteristic mass shift of one or more biomarkers using algorithms. The characteristic mass shift is indicative that the microorganism is growing in the presence of the drug and incorporating the isotopic label into the one or more biomarkers, resulting in change in mass.

Abstract: A sample preparation and analysis system (10). The system (10) includes a housing (16) with a sample preparation station (12) and a sample analysis station (14) positioned within the housing (16). The sample analysis station (14) is spaced away from the sample preparation station (12). A transport assembly (50) is configured to move at least one sample within the housing (16) and between the sample preparation station (12) and the sample analysis station (14).

Abstract: The invention provides a device and method for the rapid identification of patients suspected of having thalassemia. The invention provides a test strip for the aqueous detection of thalassemia related proteins in whole blood. The test strip includes antibodies specific to the gamma 4, (?4) protein and provides easy visual discrimination between a positive result and a negative result. The invention can be used in remote or clinical settings.

Abstract: A method for estimating molecular parameters in a sample comprising the following steps: passing the sample through a processing chain including a chromatography step; thereby obtaining a representative signal of molecular parameters as a function of at least one variable of the processing chain; and estimating the molecular parameters using a signal processing device by inverting a direct analytical model of said signal defined as a function of the molecular parameters and technical parameters of the processing chain. Moreover, the processing chain includes a step for multiple measurements of the same product from the chromatography step, the direct analytical model of said signal comprises modelling of this multiple measurement step, and this modelling requires at least one common characteristic of the signals obtained from these multiple measurements.

Abstract: A microchip including a fluid circuit formed by a groove of a first substrate and a surface of a second substrate is provided. The fluid circuit includes a fluid retaining reservoir for containing a fluid. The fluid retaining reservoir includes a fluid outlet or outflow channel for allowing the fluid to flow out, and a partition dividing the fluid retaining reservoir into a first region including a fluid inlet for injecting a fluid into the fluid retaining reservoir and a second region including the fluid outlet or outflow channel. The partition includes at least one communication gate for allowing communication between the first region and the second region.

Abstract: Methods and devices for the interfacing of microchips to various types of modules are disclosed. The technology disclosed can be used as sample preparation and analysis systems for various applications, such as DNA sequencing and genotyping, proteomics, pathogen detection, diagnostics and biodefense.

Abstract: Methods and systems for processing polynucleotides (e.g., DNA) are disclosed. A processing region includes one or more surfaces (e.g., particle surfaces) modified with ligands that regain polynucleotides under a first set of conditions (e.g., temperature and pH) and release the polynucleotides under a second set of conditions (e.g., higher temperature and/or more basic pH). The processing region can be used to, for example, concentrate polynucleotides of a sample and/or separate inhibitors of amplification reactions from the polynucleotides. Microfluidic devices with a processing region are disclosed.

Abstract: HPLC-based quality control systems to perform quality control testing on a radiopharmaceutical solution shortly after synthesis. An HPLC-based quality control system makes efficient use of sample volume and is compatible with a variety of radioisotopes and radiopharmaceutical compounds. In several embodiments, the automated nature of an HPLC-based quality control system allows for quality control tests to be conducted quickly and with minimal impact on user workflow. When used as part of an integrated PET biomarker radiopharmaceutical production system, the present general inventive concept permits a manufacturer to produce product and conduct quality control tests with lower per dose costs.

Abstract: Methods and devices for the interfacing of microchips to various types of modules are disclosed. The technology disclosed can be used as sample preparation and analysis systems for various applications, such as DNA sequencing and genotyping, proteomics, pathogen detection, diagnostics and biodefense.

Abstract: Methods and devices for the interfacing of microchips to various types of modules are disclosed. The technology disclosed can be used as sample preparation and analysis systems for various applications, such as DNA sequencing and genotyping, proteomics, pathogen detection, diagnostics and biodefense.

Abstract: Methods and apparatus for genome analysis are provided. A microfabricated structure including a microfluidic distribution channel is configured to distribute microreactor elements having copies of a sequencing template into a plurality of microfabricated thermal cycling chambers. A microreactor element may include a microcarrier element carrying the multiple copies of the sequencing template. The microcarrier element may comprise a microsphere. An autovalve at an exit port of a thermal cycling chamber, an optical scanner, or a timing arrangement may be used to ensure that only one microsphere will flow into one thermal cycling chamber wherein thermal cycling extension fragments are produced. The extension products are captured, purified, and concentrated in an integrated oligonucleotide gel capture chamber. A microfabricated component separation apparatus is used to analyze the purified extension fragments.

Abstract: A microorganism testing device includes a measurement chip having a specimen container; a reaction container for mixing a specimen and a dyeing reagent; a bacteria detection portion irradiated with excitation light; a detection liquid waste container a solution flow path which connects the specimen container, the reaction container and the bacteria detection portion, and ventilation ports which are connected to the specimen container, the reaction container and the detection liquid waste container, through a air flow path and is connected to a chip connecting tube. Bacteria are detected in the bacteria detection portion by switching of the states of the containers between a sealed state and a state open to the atmospheric pressure, by moving the specimen to the reaction container to mix and stir the specimen and the dyeing reagent, and by moving of the liquid mixture to the detection liquid waste container.

Abstract: Described herein is an analyte detection device and method related to a portable instrument suitable for point-of-care analyses. In some embodiments, a portable instrument may include a disposable cartridge, an optical detector, a sample collection device and/or sample reservoir, reagent delivery systems, fluid delivery systems, one or more channels, and/or waste reservoirs. Use of a portable instrument may reduce the hazard to an operator by reducing an operator's contact with a sample for analysis. The device is capable of obtaining diagnostic information using cellular- and/or particle-based analyses and may be used in conjunction with membrane- and/or particle-based analysis cartridges. Analytes, including proteins and cells and/or microbes may be detected using the membrane and/or particle based analysis system.

Abstract: Cartridges for the isolation of a biological sample and downstream biological assays on the sample are provided. In one embodiment, a nucleic acid sample is isolated from a biological sample and the nucleic acid sample is amplified, for example by the polymerase chain reaction. The cartridges provided herein can also be used for the isolation of non-nucleic acid samples, for example proteins, and to perform downstream reactions on the proteins, for example, binding assays. Instruments for carrying out the downstream biological assays and for detecting the results of the assays are also provided.

Abstract: A hydrodynamic filter includes a first portion, and a second portion which is spaced apart from and faces the first portion. The first portion includes a plurality of protrusions protruding in a first direction, and the second portion includes a plurality of protrusions protruding in a second direction opposite to the first direction. A filtering apparatus including a body which includes a plurality of the hydrodynamic filters and filters a fluid including target molecules, an inlet portion in connection with the body, and an outlet portion in connection with the body.

Abstract: A method and kit for assaying a cell sample for the presence of at least a threshold number of cells of a given type are disclosed. The kit includes an assay device having a sample chamber for receiving the cell sample and an elongate collection chamber containing a selected-density and/or viscosity medium and having along its length, a plurality of cell-collection regions, and particles which are capable of specific attachment to cells of the selected cell type, and which are effective, when attached to the cells, to increase the density or magnetic susceptibility of the cells. In operation, particle-bound cells and particles in the cell sample are drawn through the elongate collection chamber under the influence of a gravitational or selected centrifugal or magnetic-field force until the particle-bound cells and particles completely fill successive cell-collection regions in the collection chamber.

Abstract: A method for analyzing chemicals includes fractionating a complex sample into at least two sample portions that each include portions of two polypeptides though in different concentration ratios, digesting and performing LC/MS on each of the sample portions, and associating precursor ions observed via LC/MS with their corresponding polypeptide in response to LC/MS-provided intensity data. A set of precursor-ions that has substantially similar intensity ratios in both sample portions is determined to be associated with the same polypeptide.

Abstract: Methods and devices for isolating nucleic acids from a mixture containing such nucleic acids and extraneous matter are provided. In one embodiment, the method of the invention comprises passing the mixture through a glass frit under conditions effective to separate the nucleic acids from the extraneous matter. In a more specific embodiment, the glass frit is a sintered glass fit.

Abstract: Methods and devices for isolating nucleic acids from a mixture containing such nucleic acids and extraneous matter are provided. In one embodiment, the method of the invention comprises passing the mixture through a glass frit under conditions effective to separate the nucleic acids from the extraneous matter. In a more specific embodiment, the glass frit is a sintered glass frit.

Abstract: A system and method for measuring at least one bioprocess parameter utilizes a barrier that separates an external sensor from a culture medium. The barrier allows analytes to diffuse in and out of the culture vessel, thereby allowing the bioprocess parameter to be measured non-invasively by the external sensor.