A dynamic axial compression column is disclosed herein. This dynamic axial column utilized external compression to prevent the creation of end plate space in the column. The dynamic axial column can include a tube defining a first opening, a second opening, and a lumen extending there between. The dynamic axial column can include a first end plate assembly sealing the first opening and movably extending at least partially into the lumen via the first opening, a second end plate assembly sealing the second opening, a plurality of rods extending along the outside of the tube and connecting the first end plate assembly and the second end plate assembly, and a first plurality of compression devices external to the tube and engaging one of the plurality of rods to bias the first end plate assembly towards the second end plate assembly.
B01D 15/22 - Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to the construction of the column
The invention(s) cover systems and methods for target detection in a multiplexed and rapid manner. Embodiments of the system can include: a base substrate; and an array of sample processing regions defined at a broad surface of the base substrate, wherein each of the array of sample processing regions includes: a set of microwell subarrays arranged in a gradient by volumetric capacity between an upstream end and a downstream end of each respective sample processing region, and a boundary separating each respective sample processing region from adjacent sample processing regions. The system can support methods, with example implementation by an automated platform, for returning preliminary results from a subset of microwells of the samples processing regions, as well as results pertaining to specific and non-specific amplification, for multiple targets of a sample.
A system, method, and platform for target detection, the system including: a base substrate; a set of sample processing regions defined at a broad surface of the substrate, wherein each of the set of sample processing regions includes: a set of microwell subarrays arranged in a gradient between an upstream end and a downstream end of each respective sample processing region, and a boundary separating each respective sample processing region from adjacent sample processing regions; and a cover substrate configured to mate with the base substrate in a coupled mode, the cover substrate comprising a network of venting channels aligned with the set of sample processing regions upon mating the base substrate with the cover substrate in the coupled mode, the network of venting channels providing gas exchange between the base substrate and an environment surrounding the microwell assembly. The invention(s) can be used for MPN assays.
C12M 1/34 - Measuring or testing with condition measuring or sensing means, e.g. colony counters
C12M 3/00 - Tissue, human, animal or plant cell, or virus culture apparatus
G01N 33/48 - Biological material, e.g. blood, urine; Haemocytometers
G01N 37/00 - INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES - Details not covered by any other group of this subclass
4.
APPARATUS, SYSTEM AND METHOD FOR MEASURING PROPERTIES OF A SAMPLE
A device (1) comprising an optical apparatus (2) for monitoring bacterial growth of a drug-dosed liquid biological sample. A sample container port for receiving a sample container (6), in use, is provided in the device, the sample container (6) having at least one detection chamber (20) for containing the drug-dosed sample. The optical apparatus (2) comprises a light source (22) configured to emit light along an incident beam axis that, in use, intersects with at least one detection chamber (20) of the sample container (6), and to illuminate the drug-dosed sample contained within the detection chamber (20). The optical apparatus (20) comprises a first photodetector (26) configured to receive light scattered by bacteria in the sample. The optical apparatus (2) comprises a light collection arrangement (24) configured to collect light exiting the detection chamber (20) that has been scattered in a forward direction by bacteria in the sample, in a range of scattering angles between about +/-4 and +/-20 degrees relative to the incident beam axis, and to direct the collected scattered light to the first photodetector (26); and prevent non-scattered light travelling parallel to the incident beam axis and exiting the detection chamber (20) from reaching the first photodetector (26). The optical apparatus (2) comprises at least one processor configured to: measure an intensity of the scattered light received by the first photodetector (26); determine a corresponding representative amount or concentration of bacteria present in the sample based on the intensity of the scattered light; repeat the measuring and determining steps at a series of pre-determined intervals to determine changes in the representative amount or concentration of bacteria present in the sample as a function of time; and determine a corresponding susceptibility of the bacteria in the sample to the respective drug.
A fluidic device (1) configured to drive movement of fluid under centrifugal force comprises a central region about a central rotational axis (X) of the device and a peripheral region extending radially outwards from the central region. A fluid reservoir (4) provided in the central region of the device receives a fluid sample and communicates with at least one fluidic system (6), which extends radially outwards from the fluid reservoir (4) into the peripheral region of the device. Each fluidic system (6) comprises a fluid analysis chamber (12) configured to retain a portion of a fluid sample for analysis. A fluidic channel arrangement (26) is configured to enable fluid communication between the fluid reservoir (4) and the fluid analysis chamber (12), and movement of the fluid sample through the fluidic channel arrangement is driven by the centrifugal force created by rotational motion of the device about the central rotational axis (X). A valve mechanism (8) is arranged between the fluid reservoir (4) and the analysis chamber (12) and is configured to prevent fluid flow through that portion of the fluidic channel arrangement (26) when the speed of rotation of the device is less than a predetermined value. A cut-out portion of the device (24) may help to correctly locate the fluidic device (1) within an assay apparatus. An apparatus for driving rotational motion of the fluidic device and a method for moving a fluid sample within the fluidic device are also described.
This invention describes a method for preparation of stable hematology reference materials by producing synthetic hydrogel blood cell surrogates, which mimic human blood components in size, morphology, performance and functionality when analyzed using an automated hematology analyzer employing multiple detection technologies. Different hydrogel particles can be combined and mixed to prepare multi-parameter and multi-level hematology reference materials, which could be used for calibration, linearity verification, proficiency evaluation, and routine performance monitoring of modern automated hematology analyzers. These hydrogel particles can also be combined with processed and stabilized human blood components to prepare the reference materials of this invention.
G06F 3/0484 - Interaction techniques based on graphical user interfaces [GUI] for the control of specific functions or operations, e.g. selecting or manipulating an object, an image or a displayed text element, setting a parameter value or selecting a range
7.
SAMPLE PROCESSING BARCODED BEAD COMPOSITION, METHOD, MANUFACTURING, AND SYSTEM
An embodiment of a composition for target material separation includes: a body and one or more molecules coupled to the body and structured for functionalization of the composition. In embodiments, each of the one or more molecules can include one or more of: a linker region; a polymerase chain reaction (PCR) segment or oligo binding region; one or more barcode region(s); a unique molecule identifier; a preparation-facilitating segment; an active segment; and a molecular scissor or cleavage region, wherein various regions can be coupled together in order to provide functionality to the composition. The invention(s) also cover manufacturing of the composition and various applications of use, in the context of target material capture (e.g., from single cells or other biological material).
C08J 3/16 - Powdering or granulating by coagulating dispersions
C08L 33/02 - Homopolymers or copolymers of acids; Metal or ammonium salts thereof
C08L 65/00 - Compositions of macromolecular compounds obtained by reactions forming a carbon-to-carbon link in the main chain; Compositions of derivatives of such polymers
A system and method for target material retrieval and processing, the system comprising: an adaptor configured to interface with a capture region of a capture substrate for capturing particles in single-particle format within a set of wells, wherein the adaptor comprises a first region configured to interface with the capture region, a second region, and a cavity extending from the first region to the second region; and a support structure coupled to the adaptor and providing a set of operation modes for movement of the adaptor relative to the capture substrate. The system enables methods for magnetic and/or other force-based methods of retrieval of target material (e.g., derived from single cells).
A system and method for automated single cell capture and processing is described, where the system includes a deck supporting and positioning a set of sample processing elements (including an integrated imaging subsystem); a gantry for actuating tools for interactions with the set of sample processing elements supported by the deck; and a base supporting various processing subsystems and a control subsystems in communication with the processing subsystems. The system can automatically execute workflows associated with single cell processing, including antibody detection, other protein detection, mRNA detection, and/or other applications associated with spatial transcriptomics.
C12Q 1/6865 - Promoter-based amplification, e.g. nucleic acid sequence-based amplification [NASBA], self-sustained sequence replication [3SR] or transcription-based amplification system [TAS]
C12M 1/34 - Measuring or testing with condition measuring or sensing means, e.g. colony counters
C12Q 1/70 - Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving virus or bacteriophage
A system and method for automated single cell capture and processing is described, where the system includes a deck supporting and positioning a set of sample processing elements; a gantry for actuating tools for interactions with the set of sample processing elements supported by the deck; and a base supporting various processing subsystems and a control subsystems in communication with the processing subsystems. The system can automatically execute workflows associated with single cell processing, including mRNA capture, cDNA synthesis, protein-associated assays, and library preparation, for next generation sequencing.
A system and method for target material capture, the method comprising: receiving a set of target cells into an array of wells defined at a surface plane of a substrate; receiving a set of particles into the array of wells, thereby co-capturing the set of target cells and the set of particles; achieving a desired state for the array of wells upon receiving a washing fluid into a cavity in communication with the array of wells; receiving a lysis buffer into the cavity; receiving a partitioning fluid into the cavity, thereby displacing the lysis buffer from the cavity and partitioning each of the array of wells from adjacent wells, at the surface plane; and retaining intercellular material of the set of target cells, individually with the set of particles within the array of wells.
C12Q 1/6883 - Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material
C12Q 1/6811 - Selection methods for production or design of target specific oligonucleotides or binding molecules
C12Q 1/6816 - Hybridisation assays characterised by the detection means
C12Q 1/6827 - Hybridisation assays for detection of mutation or polymorphism
A system and method for isolating and analyzing single cells, wherein the system includes: an array of wells defined at a substrate, each well including an open surface and a well cavity configured to capture cells in one of a single-cell format and single-cluster format, and a fluid delivery module including a fluid reservoir superior to the array of wells through which fluid flow is controlled along a fluid path in a direction parallel to the broad face of the substrate; and wherein the method includes: distributing a population of cells and a population of non-cell particles across the array of wells through the fluid reservoir to increase capture efficiency of individual cell-particle pairs within the array of wells, and processing the captured cell-particle pairs at the set of wells.
Methods are provided for end users of diagnostic measurement procedures to prepare quality controls having desired analyte recoveries, estimate recoveries of quality controls already prepared, and compare estimated and measured recoveries. To prepare a quality control containing a particular analyte, a desired recovery of a measurement procedure for the analyte can be scaled by a correlation factor to obtain a target nominal concentration of the analyte in the quality control. Alternatively, the nominal concentration of an analyte in a quality control can be scaled by a correlation factor to obtain a predicted recovery of a measurement procedure for the analyte. The correlation factors can be based on recovery data previously obtained using the measurement procedure and optionally one or more reference procedures, and can be calculated using regression analysis of these data. Each quality control can be prepared by dissolving a number of solid beads containing the analyte(s) of interest in a volume of base matrix.
G01N 37/00 - INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES - Details not covered by any other group of this subclass
G01N 33/48 - Biological material, e.g. blood, urine; Haemocytometers
15.
STABILIZATION OF LABILE ANALYTES IN REFERENCE MATERIALS
Provided herein are assay control materials comprising stable analytes and lyophilized unstable analytes, and methods of making and using the same. Provided herein are stable multianalyte quality control materials for monitoring the performance of various diagnostic testing methodologies in clinical laboratories. The presently described multianalyte control materials address the problem of unstable control solutions, can quickly and easily be prepared at the point of use, and can meet the quality control needs of a lab with regards to the stability of analytes.
The present invention provides a method for determining whether a subject is suffering from celiac disease by contacting a sample of bodily fluid from the subject, with an antigen formed from a hexamer of a gliadin fusion protein immobilized on a solid support. The gliadin fusion protein of the antigen includes a recombinant deamidated gliadin linked to a tag such as Glutathione-S transferase (GST) protein. The antigen is prepared by immobilizing the gliadin fusion protein on the solid support. The antigen can further include tissue Transglutaminase (tTG) cross-linked to the gliadin fusion protein. When tTG is present, the tTG and recombinant deamidated gliadin are mixed together prior to immobilization to the solid phase.
Solid beads each containing a selected quantity of analyte are combined and a liquid base matrix that contains attributes of a biological fluid that is to be assayed, together constitute a kit from which a laboratory technician can, at the point of use, prepare a liquid control for a particular analyte, and preferably a series of such controls at different levels of the same analyte customized for a particular assay.
The present invention proposes a method for optimizing a quality control strategy for rapid release results. An embodiment of the invention includes generating a set of candidate quality control rules and for each candidate rule, computing a maximum number of patient specimens that can be tested between quality control events while keeping the expected number of correctible unacceptable results below a predetermined correctible maximum and keeping the expected number of final unacceptable results below a predetermined final maximum. Furthermore a quality control utilization rate can be computed based on the number of patient specimens tested between each quality control event and the number of reference samples tested at each quality control event. The candidate rule for which the best quality control utilization rate may be selected along with the corresponding number of patients to be tested between each quality control as the optimum quality control strategy.
G06Q 10/0639 - Performance analysis of employees; Performance analysis of enterprise or organisation operations
G16H 10/40 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
G16H 40/20 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
19.
SYSTEM AND METHOD FOR DETERMINING AN OPTIMUM QC STRATEGY FOR IMMEDIATE RELEASE RESULTS
The present invention proposes a method for optimizing a quality control strategy for rapid release results. An embodiment of the invention includes generating a set of candidate quality control rules and for each candidate rule, computing a maximum number of patient specimens that can be tested between quality control events while keeping the expected number of correctible unacceptable results below a predetermined correctible maximum and keeping the expected number of final unacceptable results below a predetermined final maximum. Furthermore a quality control utilization rate can be computed based on the number of patient specimens tested between each quality control event and the number of reference samples tested at each quality control event. The candidate rule for which the best quality control utilization rate may be selected along with the corresponding number of patients to be tested between each quality control as the optimum quality control strategy.
G06Q 10/04 - Forecasting or optimisation specially adapted for administrative or management purposes, e.g. linear programming or "cutting stock problem"
G16H 10/40 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
G16H 40/20 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
20.
FLUORESCENCE SCANNING HEAD WITH MULTIBAND DETECTION
In a scanning system for the detection and discrimination of a plurality of targets in each of a plurality of samples, one or more multiband fluorescence detection channels each of which contains a single multiband emission filter and a single detector replaces multiple detection components in scanning heads of the prior art. In certam embodiments, a single multi-emitter light source is used as well, to illuminate each sample with excitation light at a variety of distinct wavelengths in succession.
A method of establishing statistically valid assay means and ranges for quality control materials, used to qualify medical testing machines, utilizes tests on a new lot of quality control material to establish an assay mean, and uses data from a database of historical test results to establish an assay range. The system may estimate the variability of test results from prior lot data, and then compute the limits of the assay range such that a new test on a new lot of the quality control material will be expected to fall within the range with a specified probability. Because historical data is used to estimate the test variability, the number of new tests required to specify a statistically valid mean and range may be dramatically reduced, as compared with establishing the mean and range based only on tests of the new lot of material.
G01N 37/00 - INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES - Details not covered by any other group of this subclass
22.
SYSTEM AND METHOD FOR PRODUCING STATISTICALLY VALID ASSAY MEANS AND RANGES FOR QUALITY CONTROL MATERIALS
A method of establishing statistically valid assay means and ranges for quality control materials, used to qualify medical testing machines, utilizes tests on a new lot of quality control material to establish an assay mean, and uses data from a database of historical test results to establish an assay range. The system may estimate the variability of test results from prior lot data, and then compute the limits of the assay range such that a new test on a new lot of the quality control material will be expected to fall within the range with a specified probability. Because historical data is used to estimate the test variability, the number of new tests required to specify a statistically valid mean and range may be dramatically reduced, as compared with establishing the mean and range based only on tests of the new lot of material.
The present invention generally pertains to a system, method and kit for the detection and measurement of spectroscopic properties of light from a sample, or the scalable detection and measurement of spectroscopic properties of light from each sample present among multiple samples, simultaneously, wherein the system comprises: an optical train comprising a dispersing element; and an image sensor. The light detected and measured may comprise light scattered from a sample, emitted as chemiluminescence by a chemical process within a sample, selectively absorbed by a sample, or emitted as fluorescence from a sample following excitation.
The present invention generally pertains to a system for performing injection of multiple substantially controlled volumes into or out of a droplet, and methods and kits comprising the same. The system of the present invention comprises at least one microfluidic channel, one or more injection channels, an injection inlet associated with each of the one or more injection channels, and a mechanism for disrupting an interface between a droplet and a fluid and/or emulsion, wherein the at least one microfluidic channel comprises one or more droplets are flowing therein, and wherein each of the one or more injection channels comprises at least one fluid and/or emulsion therein.
System, including methods, apparatus, and compositions, for performing a multiplexed digital assay on a greater number of targets through combinatorial use of signals.
C12P 19/34 - Polynucleotides, e.g. nucleic acids, oligoribonucleotides
C40B 30/04 - Methods of screening libraries by measuring the ability to specifically bind a target molecule, e.g. antibody-antigen binding, receptor-ligand binding
Systems and methods for performing cytometry using a linear light sensor. An illumination field, a line scanned by the linear light sensor, or both are swept across a cell to be imaged. Relative motion between the cell and the swept illumination may be created using a movable optical component or components, by adhering cells to a plate and transporting the plate or by other techniques.
Provided herein are improved methods, compositions, and kits for analysis of nucleic acids. The improved methods, compositions, and kits can enable copy number estimation of a nucleic acid in a sample. Also provided herein are methods, compositions, and kits for determining the linkage of two or more copies of a target nucleic acid in a sample (e.g., whether the two or more copies are on the same chromosome or different chromosomes) or for phasing alleles.
C12Q 1/68 - Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
C12Q 1/6809 - Methods for determination or identification of nucleic acids involving differential detection
C12Q 1/683 - Hybridisation assays for detection of mutation or polymorphism involving restriction enzymes, e.g. restriction fragment length polymorphism [RFLP]
The present invention discloses methods of neutralizing apatite surfaces, for example after a flow-through collection of a target and prior to cleaning the chromatography solid support. In some embodiments, the method comprises, (a) contacting a sample comprising the target molecule to an apatite solid surface thereby flowing the target molecule past the apatite solid surface; (b) neutralizing the apatite solid surface by contacting the apatite solid surface with a sufficient concentration and volume of an alkaline hydroxide; and (c) cleaning the apatite solid surface.
The present invention provides for a reaction mixture for signal normalization in a real-time polymerase chain reaction (PCR) amplification of a target nucleic acid wherein the mixture is compatible for use in both (a) a real-time PCR amplification system employing high passive reference dye concentration for the normalization and (b) a real-time peR30 amplification system employing low passive reference dye concentration for the normalization, wherein the mixture comprises a plurality of passive reference dyes that produces fluorescent signals independent of the amplification reactions.
The present invention generally pertains to methods for detecting the presence or absence of a particular nucleic acid sequence. The invention relates to incorporating a detector into a target nucleic acid, adding an oligonucleotide probe, polymerase enzyme and inhibitor to the reaction, and detecting interference of the oligonucleotide probe with the inhibitor as an indication of the presence of a particular target nucleic acid sequence. A detector oligonucleotide conjugated to a fluorophore or quencher is incorporated at the 3' end of a target nucleic acid, and is annealed to an inhibitor oligonucleotide conjugated to the corresponding quencher/fluorophore such that fluorescence of the fluorophore is quenched. An oligonucleotide probe anneals to the target nucleic acid, and serves as a primer for extension by a DNA polymerase to generate a strand complementary to the target nucleic acid, which displaces the inhibitor oligonucleotide to generate fluorescence indicating the detection of the target nucleic acid.
C12Q 1/68 - Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
C12Q 1/6816 - Hybridisation assays characterised by the detection means
C12Q 1/6853 - Nucleic acid amplification reactions using modified primers or templates
C07H 21/00 - Compounds containing two or more mononucleotide units having separate phosphate or polyphosphate groups linked by saccharide radicals of nucleoside groups, e.g. nucleic acids
31.
SORTING OF ADHERENT CELLS BY SELECTIVE TRANSFORMATION OF LABELS
Adherent cells bearing characteristics that are detectable only in the adherent state can be sorted on the basis of these characteristics independently of their adherent state, by applying a transformable label to the entire population of cells, both those bearing the characteristics of interest and those not, in their adherent state and identifying the locations of the cells of interest on the adherent surface. The cells of interest, or all cells other than those of interest, are then selectively treated to transform the labels and achieve differentiation between the cells of interest and the remaining cells. All cells are then released from the adherent state and sorted in the same manner as non-adherent cells but on the basis of whether the labels are transformed or not transformed.
C12Q 1/04 - Determining presence or kind of microorganism; Use of selective media for testing antibiotics or bacteriocides; Compositions containing a chemical indicator therefor
System, including methods, apparatus, and kits, for forming emulsions. The system may include an instrument and a microfluidic chip received by the instrument. The instrument may apply pressure to prospective emulsion phases held by the chip, to drive formation and collection of emulsions in the chip. In some embodiments, the instrument may stop applying pressure to the chip when a change in pressure meeting a predefined condition is detected by the instrument. The change may indicate that an endpoint of droplet generation has been reached.
System, including methods, apparatus, and kits, for forming emulsions. The system may include an instrument and a microfluidic chip received by the instrument. The instrument may apply pressure to prospective emulsion phases held by the chip, to drive formation and collection of emulsions in the chip. In some embodiments, the instrument may stop applying pressure to the chip when a change in pressure meeting a predefined condition is detected by the instrument. The change may indicate that an endpoint of droplet generation has been reached.
System, including methods, apparatus, and kits, for forming emulsions. The system may include an instrument and a microfluidic chip received by the instrument. The instrument may apply pressure to prospective emulsion phases held by the chip, to drive formation and collection of emulsions in the chip. In some embodiments, the instrument may stop applying pressure to the chip when a change in pressure meeting a predefined condition is detected by the instrument. The change may indicate that an endpoint of droplet generation has been reached.
System, including methods, apparatus, and kits, for forming emulsions. The system may include an instrument and a microfluidic chip received by the instrument. The instrument may apply pressure to prospective emulsion phases held by the chip, to drive formation and collection of emulsions in the chip. In some embodiments, the instrument may stop applying pressure to the chip when a change in pressure meeting a predefined condition is detected by the instrument. The change may indicate that an endpoint of droplet generation has been reached.
The invention provides methods and materials for using apatite chromatography supports to dissociate and remove contaminants that are complexed to biological products. The invention further provides materials and methods for dissociating aggregations of target biological molecules or improperly folded target molecules to improve purification of the target molecule.
Proteins, including monoclonal antibodies, that have been retained on hydroxyapatite resins for purposes of protein separation, purification, or both, are eluted from the resins by a elution buffer that contains controlled amounts of calcium and phosphate ions. The buffer allows elution to be performed in repeated runs at an acidic pH without deterioration of the resin.
Systems, apparatuses, and methods can provide parameters of operating results for control products used in biological reactions. For example, automatically updated inserts containing such parameters for clinical quality controls can be provided. A customer can log into a website, provide lot number of quality control products, information about instruments, and tests being performed and then receive updated parameters for the products. The product inserts can be customized for or by a particular customer.
G16H 10/40 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
G16H 40/20 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
39.
SYSTEM AND METHOD FOR PROVIDING AUTOMATICALLY UPDATED PRODUCT INSERTS
Systems, apparatuses, and methods can provide parameters of operating results for control products used in biological reactions. For example, automatically updated inserts containing such parameters for clinical quality controls can be provided. A customer can log into a website, provide lot number of quality control products, information about instruments, and tests being performed and then receive updated parameters for the products. The product inserts can be customized for or by a particular customer.
Disclosed is an optical combiner for combining multiple laser beams in a flow cytometer. A dichroic beam combiner is used to combine a second laser beam with a first laser beam so that the two beams are collinear. A beam size adjuster is utilized to adjust the size and convergence/divergence of the second laser beam so that both laser beams focus in a vertical direction at the same location on a stream in the flow cytometer. A cylindrical lens with a vertically oriented axis in the focusable beam shaping optics can also be adjusted to adjust the location of the focus point of the two beams in the horizontal direction. Alignment is maintained with the opto-mechanical adjustments made on one laser beam relative to the other laser beam path. Additional beams can also be added to the optical path.
41.
SYSTEM AND METHOD FOR PROVIDING AUTOMATICALLY UPDATED PRODUCT INSERTS
There is provided a method of customizing parameters of operating results for control products used in biological reactions. The method comprises receiving a customization request from a user. The request identifies selections of customization information corresponding to the customization information to be provided to the user. The selected customization information is sent to a database comprising first information about the biological reactions to generate analyte results and second information of the control products in the biological reactions to generate control results to confirm a quality of the analyte results. A request to generate an insert, providing information about a product, is sent to a rendering engine. The request includes an entry ID linking the selected customization information with the request. The rendering engine uses the entry ID to access the database to request the selected customization information and parameters corresponding thercto. The rendering engine renders the insert by using the selected customization information and the parameters. The insert is sent to the user.
G16H 10/40 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
G01N 33/48 - Biological material, e.g. blood, urine; Haemocytometers
A system, including method and apparatus, for generating droplets suitable for droplet-based assays. The disclosed systems may include either one-piece or multi-piece droplet generation components configured to form sample-containing droplets by merging aqueous, sample-containing fluid with a background emulsion fluid such as oil, to form an emulsion of sample- containing droplets suspended in the background fluid. In some cases, the disclosed systems may include channels or other suitable mechanisms configured to transport the sample-containing droplets to an outlet region, so that subsequent assay steps may be performed.
A composition for generating a stabilized emulsion which includes a continuous phase formed with an oil composition including a fluorinated oil and at least one fluorinated surfactant. The composition also includes a plurality of aqueous droplets disposed in the continuous phase and including an effective concentration of one or more skin-forming proteins. Heating the continuous phase and the aqueous droplets above a threshold temperature creates an interfacial skin between each droplet and the continuous phase, to transform the droplets into capsules.
A stabilized emulsion which involves a continuous phase formed with an oil composition including a fluorinated oil and at least one fluorinated surfactant. The emulsion also involves a plurality of capsules disposed in the continuous phase. Each capsule includes a proteinaceous, interfacial skin encapsulating an aqueous phase.
System, including methods, apparatus, compositions, and kits, for making and using stabilized emulsions and for assays with an emulsion including capsules. In an exemplary method, an aqueous phase may be provided. The aqueous phase may include a sample and an effective concentration of one or more skin-forming proteins. An emulsion may be formed. The emulsion may include droplets of the aqueous phase disposed in a nonaqueous continuous phase. The emulsion may be heated to create an interfacial skin between each droplet and the continuous phase, to transform the droplets into capsules. Assay data related to the sample may be collected from the capsules.
The invention generally relates to droplet based digital PCR and methods for analyzing a target nucleic acid using the same. In certain embodiments, methods of the invention involve forming sample droplets containing, on average, a single target nucleic acid, amplifying the target in the droplets, excluding droplets containing amplicon from the target and amplicon from a variant of the target, and analyzing target amplicons.
C12N 15/10 - Processes for the isolation, preparation or purification of DNA or RNA
C12P 19/34 - Polynucleotides, e.g. nucleic acids, oligoribonucleotides
C40B 30/04 - Methods of screening libraries by measuring the ability to specifically bind a target molecule, e.g. antibody-antigen binding, receptor-ligand binding
47.
CELL COUNTING SLIDE WITH LATERAL RESERVOIR FOR PROMOTING UNIFORM CELL DISTRIBUTION
Cells in a suspension are counted in a hemocytometer slice with a chamber of controlled depth and one or more reservoirs along one or more side edges of the chamber. The suspension is fed to a reservoir to first fill the reservoir, and then to overflow into the chamber. The result is an even distribution of the cells in the chamber.
The present invention discloses methods of neutralizing apatite surfaces, for example during chromatography and before protein elution. Specifically, provided are methods for purifying a target molecule in a sample, comprising contacting a sample comprising the target molecule to an apatite solid surface, contacting the solid surface comprising the adsorbed target molecule with a solution comprising a basic amino compound and alkali metal ion or alkali earth ion; or a sulphonated amine compound and alkali metal ion or alkali earth ion, and eluting the target molecule from the solid support by contacting the solid support with a different solution.
Hemoglobin, its variants, and glycated forms of each are determined individually in a multiplex assay that permits correction of the measured level of IIbAI c to account for glycated variants and other factors related to the inclusion of the variants in the sample. New antibodies that are particularly well adapted to the multiplex assay are also provided.
C07K 16/18 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans
C40B 30/04 - Methods of screening libraries by measuring the ability to specifically bind a target molecule, e.g. antibody-antigen binding, receptor-ligand binding
G01N 33/72 - Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood pigments, e.g. hemoglobin, bilirubin
A method for lysing cells is disclosed. The method includes stirring cells with a magnetic stir element in the presence of a plurality of cell lysis beads at a speed sufficient to lyse the cells. Also disclosed is a device for lysing cells. The device includes a container having a magnetic stir element and a plurality of cell lysis beads disposed therein. The container is dimensioned to allow rotation of the magnetic stir element inside the container.
A method for lysing cells is disclosed. The method includes stirring cells with a magnetic stir element in the presence of a plurality of cell lysis beads at a speed sufficient to lyse the cells. Also disclosed is a device for lysing cells. The device includes a container having a magnetic stir element and a plurality of cell lysis beads disposed therein, The container is dimensioned to allow rotation of the magnetic stir element inside the container.
C12Q 1/00 - Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
G01N 1/44 - Sample treatment involving radiation, e.g. heat
G01N 31/20 - Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroups; Apparatus specially adapted for such methods using microanalysis, e.g. drop reaction
53.
SYSTEM FOR MIXING FLUIDS BY COALESCENCE OF MULTIPLE EMULSIONS
A method of sample analysis which involves forming two or more types of reagent droplets, with each type having a code to identify the type. The method also involves encapsulating the two or more types of reagent droplets in sample droplets and inducing fusion of the sample droplets with the encapsulated two or more types of reagent droplets to produce fused droplets each having the code of one of the two or more types of reagent droplets.
C12Q 1/00 - Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
G01N 1/38 - Diluting, dispersing or mixing samples
G01N 33/48 - Biological material, e.g. blood, urine; Haemocytometers
54.
SYSTEM FOR MIXING FLUIDS BY COALESCENCE OF MULTIPLE EMULSIONS
A method of sample analysis which involves obtaining an emulsion including a plurality of outer droplets disposed in a liquid carrier phase and each encapsulating at least one inner droplet. The outer droplets are sample-containing droplets and the at least one inner droplet is at least one reagent-containing droplet or the outer droplets are reagent-containing droplets and the at least one inner droplet is at least one sample-containing droplet. The method also involves heating the emulsion to induce fusion of the outer droplets with the at least one inner droplet to form fused droplets that combine sample and reagent to create assay mixtures for performing an assay.
C12Q 1/00 - Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
G01N 1/38 - Diluting, dispersing or mixing samples
55.
SYSTEM AND METHOD FOR DETERMINING SIGMA OF A CLINICAL DIAGNOSTIC PROCESS
A system and method for determining a sigma of a clinical diagnostic process are disclosed. Specimen data are collected from a plurality of laboratory instruments. The specimen data are evaluated to determine a concentration and an analytical standard deviation for each data point. A clinical diagnostic process is run and patient analyte values are acquired, and a standard deviation is assigned to each patient analyte value based on the standard deviation of specimen data having a corresponding concentration. A single sigma-metric is computed based on the patient analyte assigned standard deviations, the sigma- metric representing the sigma of the clinical diagnostic process. The computed sigma-metric is reported to a user or laboratory manager.
G16H 10/40 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
G01N 33/48 - Biological material, e.g. blood, urine; Haemocytometers
G06F 17/18 - Complex mathematical operations for evaluating statistical data
56.
SYSTEM AND METHOD FOR AUTOMATIC QUALITY CONTROL OF CLINICAL DIAGNOSTIC PROCESSES
A system and method to automatically implement quality control of a clinical diagnostic process are disclosed. Upon generation of an internal error Hag, a confirmation rule automatically checks a questionable patient statistic alert by testing a quality control specimen, applying event-related quality control rules to the results of that test, and provides an alert to the operator only upon a confirmed patient signal T he automatic quality control process thus eliminates the uncertainty of operator reaction to an alert signal and implements the quality control run automatically, without operator intervention.
G16H 40/20 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
G16H 10/40 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
G16H 40/40 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
G01N 35/00 - Automatic analysis not limited to methods or materials provided for in any single one of groups ; Handling materials therefor
The present invention provides for novel analogs of fresh human platelets for use in hematological instrument. Methods for preparing such analogs are also described.
The invention relates to methods of amplifying target nucleic acids with improved efficiency using an exonuclease deficient hybrid polymerase comprising a B family polymerase domain and a heterologous DNA binding domain.
A method of analysis which involves selecting a device having a port connected to a chamber and placing a sample-containing fluid into the port. The method also involves creating a pressure differential that drives the sample-containing fluid from the port to the chamber and separates the sample-containing fluid into droplets, forming a two-dimensional monolayer of the droplets in the chamber, and imaging at least a portion of the monolayer.
Systems, including apparatus and methods, for performing assays. These systems may involve separating sample components by partitioning them into droplets or other partitions, amplifying or otherwise reacting the components within the droplets, detecting the amplified components, or characteristics thereof, and/or analyzing the resulting data, among others.
G01N 33/48 - Biological material, e.g. blood, urine; Haemocytometers
G01N 35/08 - Automatic analysis not limited to methods or materials provided for in any single one of groups ; Handling materials therefor using a stream of discrete samples flowing along a tube system, e.g. flow injection analysis
G01N 35/10 - Devices for transferring samples to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
A method of performing a droplet-based assay involving obtaining droplets encapsulated by an immiscible liquid and packed closely together in a monolayer. The method also involves performing a reaction in the droplets while packed closely together in the monolayer, and collecting data related to an analyte from a plurality of the droplets while the droplets remain closely packed together in the monolayer.
G01N 33/48 - Biological material, e.g. blood, urine; Haemocytometers
G01N 31/20 - Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroups; Apparatus specially adapted for such methods using microanalysis, e.g. drop reaction
G01N 33/52 - Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper
G01N 35/02 - Automatic analysis not limited to methods or materials provided for in any single one of groups ; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
A method of analysis which involves selecting a device having a chamber connected separately to a port and a vent, placing an aqueous fluid into the port and applying gas pressure to the device to drive the aqueous fluid from the port to the chamber and form partitions of the aqueous fluid. The partitions are separated from one another by a carrier liquid. The method also involves amplifying a nucleic acid target in only of a subset of the partitions while the partitions are arranged in a two- dimensional monolayer in the chamber, imaging at least a portion of the monolayer to create one or more images, and determining whether individual partitions of the monolayer contain the nucleic acid target using the one or more images.
C12M 1/40 - Apparatus specially designed for the use of free, immobilised, or carrier-bound enzymes, e.g. apparatus containing a fluidised bed of immobilised enzymes
C12Q 1/68 - Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
RNA is extracted from cellular material with a reagent that includes heparin, a reducing agent to reduce disulfide bonds, a chelating agent, a buffer, and an alkali metal halide. The reagent does not require the use of organic solvents, and the reagent allows extraction to be performed in a relatively short period of time in comparison to the prior art.
The present invention provides a method for determining whether a subject is suffering from celiac disease by contacting a sample of bodily fluid from the subject, with an antigen formed from a gliadin fusion protein immobilized on a solid support. The gliadin fusion protein of the antigen includes a recombinant deamidated gliadin linked to a tag such as Glutathione-S transferase (GST) protein. The antigen is prepared by immobilizing on the solid support the gliadin fusion protein via the tag. The antigen can further include tissue Transglutaminase (tTG) cross-linked to the gliadin fusion protein. When tTG is present, the tTG and recombinant deamidated gliadin are mixed together prior to immobilization to the solid phase.
Methods, kits and apparatuses for chromatography purification of antibodies are provided. In some embodiments, antibodies are purified by mixed mode chromatography that does not comprise hydroxyapatite (HT) or fluorapatite (FT). The mixed mode chromatography step is then followed by a HT/FT chromatography step.
A thermal cycling instrument for PCR and other reactions performed on multiple samples with tem-perature changes between sequential stages in the reaction procedure is supplied with a thermal block to provide rapid changes and close control over the temperature in each sample vessel and a pressure plate incorporated into a motorized lid that detects anomalies in the reaction ves-sels or in their positioning over the thermal block, and au-tomatically adjusts the plate position to achieve an even force distribution over the sample vessels.
The present invention provides a method for amplifying a nucleic acid molecule. The method involves mixing an RNA template with a composition having a reverse transcriptase, a DNA polymerase and a RT inhibition reducer. The RT inhibition reducer can be Sso7d, Sac7d, Sac7e, Sso7e, AluI methylase, suramin, a phosphorothioate oligodeoxycytosine, a phosphorothioate oligodeoxyadenine, a phosphorothioate oligodeoxythymine or poly(rA)(dT). The mixing forms a mixture that is incubated under conditions sufficient to synthesize a DNA molecule complementary to all or a portion of the RNA template, thereby amplifying the nucleic acid molecule.
The present. specification provides a method for amplifying a nucleic acid molecule. The method involves mixing an RNA template with a composition having a reverse transcriptase, a DNA polymerase and a RT inhibition reducer. The RT inhibition reducer can be Sso7d, Sac7d, Sac7e, Sso7e, AluI methylase, suramin, a phosphorothioate oligodeonucleotide or poly(rA)(dT). The mixing forms a mixture that is incubated under conditions sufficient to synthesize a DNA molecule complementary to all or a portion of the mA template, thereby amplifying the nucleic acid molecule.
This invention relates to the use of mixed mode chromatography for purification of at least one intact non-aggregated antibody from a mixture containing intact non-aggregated antibodies and undesirable materials, including fragmented or aggregated antibodies, host cell proteins, DNA, endotoxin, and/or virus. This invention further relates to the integration of such a method into a multi-step procedure with other fractionation methods for purification of antibodies suitable for in vivo applications.
Red blood cells from a vertebrate are treated to make them effective components of a hematology control, allowing the control to be used for detecting all blood cell components, including white blood cells and platelets. The treatment includes the use of a fixative under limited conditions of concentration and exposure time, and the resulting red blood cells are stable but lysable in a hematology instrument and have a reduced tendency to form particulates.
G01N 33/96 - Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood or serum control standard
G01N 33/48 - Biological material, e.g. blood, urine; Haemocytometers
71.
LOW-MASS SAMPLE BLOCK WITH RAPID RESPONSE TO TEMPERATURE CHANGE
A sample block for use in the polymerase chain reaction, DNA sequencing, and other procedures that involve the performance of simultaneous reactions in multiple samples with temperature control by heating or cooling elements contacting the bottom surface of the block is improved by the inclusion of hollows in the block that are positioned to decrease the mass of the block in the immediate vicinity of the wells.
C12M 1/40 - Apparatus specially designed for the use of free, immobilised, or carrier-bound enzymes, e.g. apparatus containing a fluidised bed of immobilised enzymes
Translational motion of a scanning head relative to a planar target, or vice versa, is achieved by a belt and pulley system with a counterweight that is also driven by a belt and pulley system at the same speed but in the opposite direction as the scanning head. The components and belt and pulley system are oriented such that all moving components remain on one side of the target and remain so during their entire range of movement.
The present invention provides novel microfluidic devices and methods that are useful for performing high-throughput screening assays and combinatorial chemistry. Such methods can include labeling a library of compounds by emulsifying aqueous solutions of the compounds and aqueous solutions of unique liquid labels on a microfluidic device, which includes a plurality of electrically addressable, channel bearing fluidic modules integrally arranged on a microfabricated substrate such that a continuous channel is provided for flow of immiscible fluids, whereby each compound is labeled with a unique liquid label, pooling the labeled emulsions, coalescing the labeled emulsions with emulsions containing a specific cell or enzyme, thereby forming a nanoreactor, screening the nanoreactors for a desirable reaction between the contents of the nanoreactor, and decoding the liquid label, thereby identifying a single compound from a library of compounds.
The present invention provides methods and reagents for detecting antibodies against phospholipid-cofactor proteins. Phospholipids include cardiolipin. Cofactor proteins include beta-2-glycoprotein-1 (i.e., apolipoprotein H) or a prothrombin protein. Detection is accomplished with flow cytometry (e.g., fluorescence-activated cell sorting, facs).
A priming unit (31) for a microfluidics device (11) containing a pressurization unit (35) and pressure (46) and temperature detectors as part of a feedback loyg (55) that controls the pressure applied by the pressurization unit (35) an the time during which the pressure is applied. This control feature is particularly useful in controlling the exposure time of the microchannels (15) to dyes in the priming liquids since certain dyes tend to adhere to the walls of the channels and produce non-uniform results.
Localized temperature control in a thermal cycler containing a plurality of samples is achieved by an apparatus comprising a multi-receptacle sample block, a thermoelectric module, and a finned heat sink block, all shaped to be capable of arrangement in a stacked configuration in which the sample block is in thermal contact with the thermoelectric module and the thermoelectric module is in thermal contact with the heat sink block. A support frame is sized to receive the sample block, the thermoelectric module, and the finned heat sink block in the stacked configuration. A bar sized to fit between adjacent fins of the finned heat sink block, and a system for affixing the bar to the support frame is used to secure the finned heat sink block against the thermoelectric module when in the stacked configuration.
A molded housing for an electronic instrument comprises a sealed enclosure. The sealed enclosure includes a molded partition separating an interior from atmospheric exposure and a U-shaped electric lead defined by first and second legs joined by an end cross-bar. The end cross-bar is embedded in the partition with the first leg extending to one side of the partition and the second leg extending to another side of the partition.
Localized temperature control in a thermal cycler is achieved by thermoelectric modules that are protected from exposure to atmospheric moisture by a pair of loop-shaped gaskets that seal off an enclosure formed by the sample block, the heat sink, and a support frame to which the components are secured. The heat sink is a block with a plurality of fins and is secured to the thermoelectric modules by one or more clamping bars that fit between the fins and are arranged to eliminate interference with the fin geometry and with the functional surface area of the fins. Electric leads are embedded in a molded retainer element, each lead being in the shape of a "U" with two exposed legs joined by a bar at one end, one of the leads extending into the region sealed from the atmosphere and the other extending outside the region.
The present invention relates to peptides that are derived from HSV-2 glycoprotein G2 and represent HSV-2 type-specific epitopes. The present invention also provides for compositions comprising these peptides for type- specific serological diagnosis of HSV-2 infection. Methods of using these peptides for type-specific detection of HSV-2 antibodies and differentiation of HSV-2 viral infection from HSV-1 and other herpes family viral infections are further provided.
C12Q 1/70 - Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving virus or bacteriophage
80.
QUANTITATIVE AMPLIFICATION WITH A LABELED PROBE AND 3' TO 5' EXONUCLEASE ACTIVITY
This invention provides methods and kits for performing a quantitative amplification reaction. The method employs a polymerase enzyme and an enzyme having a 3' to 5' exonuclease activity that cleaves the 3' oligonucleotide of the probe.
Oligonucleotide structures are provided that are capable of forming more stable bonds to a lipid membrane and thereby generate an improved control of the process whereby oliogonucleotide linkers are introduced to lipid membranes. Methods of forming lipid membrane oligonucleotide attachments are provided including lipid vesicles. The oligonucleotides typically comprise at least two hydrophobic anchoring moieties capable of being attached to a lipid membrane. Said moieties may be attached at the terminalends of an oligonucleotide or, in the case of a first and second strand forming a duplex, at the same terminal end one of the strands other end not being part of the duplex leaving it free to hybridize to additional strands. The lipid vesicles attached with the oligonucleotide can be used in biosensors and may contain membrane proteins.
C07H 21/00 - Compounds containing two or more mononucleotide units having separate phosphate or polyphosphate groups linked by saccharide radicals of nucleoside groups, e.g. nucleic acids
G01N 33/543 - Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
G01N 33/68 - Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
The present invention provides a system and method for the simultaneous detection of multiple analytes in a sample. The detection system includes a housing that holds a reagent carousel rotatably coupled thereto. Further included in the housing is an incubator carousel rotatably coupled thereto. The housing also includes magnetic material that is associated with the incubation carousel for assisting in separation beads from reagent and wash solution. A robot, associated with the housing is configured to manipulate at least either the reagent carousel or the incubator carousel and transfer materials therebetween. Reaction vessels hold samples and reaction vessels handlers move the reaction vessels. Sample analysis is determined by at least one laser based detector.
G01N 35/02 - Automatic analysis not limited to methods or materials provided for in any single one of groups ; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
G01N 1/38 - Diluting, dispersing or mixing samples
G01N 1/44 - Sample treatment involving radiation, e.g. heat
The present invention provides a system and method for the simultaneous detection of multiple analytes in a sample. The detection system includes a housing that holds a reagent carousel rotatably coupled thereto. Further included in the housing is an incubator carousel rotatably coupled thereto. The housing also includes magnetic material that is associated with the incubation carousel for assisting in separation beads from reagent and wash solution. A robot, associated with the housing is configured to manipulate at least either the reagent carousel or the incubator carousel and transfer materials therebetween. Reaction vessels hold samples and reaction vessels handlers move the reaction vessels. Sample analysis is determined by at least one laser based detector.
G01N 35/02 - Automatic analysis not limited to methods or materials provided for in any single one of groups ; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
84.
SYSTEMS AND METHODS FOR FLUORESCENCE DETECTION WITH A MOVABLE DETECTION MODULE
A fluorescence detection apparatus for analyzing samples located in a plurality of wells in a thermal cycler and methods of use are provided. In one embodiment, the apparatus includes a support structure attachable to the thermal cycler and a detection module movably mountable on the support structure. The detection module includes one or more channels, each having an excitation light generator and an emission light detector both disposed within the detection module. When the support structure is attached to the thermal cycler and the detection module is mounted on the support structure, the detection module is movable so as to be positioned in optical communication with different ones of the plurality of wells. The detection module is removable from the support structure to allow easy replacement.
A system and method that enables a laboratory to integrate its internal and external quality control programs to thereby control the quality of its laboratory testing services. The system comprises a storage device (28) and a processor (26) operable to maintain in the storage device (28) a database (32) identifying a plurality of laboratory tests (34a, 36a, 38a, 40a) and the corresponding internal laboratory statistical data (36b), group statistical summary data (38b) and control rules (40b). The processor (26) is also operable to calculate a control range for a specified laboratory test by applying the group statistical summary data (and, in some cases, the internal laboratory statistical data) to the control rule corresponding to the specified laboratory test. Preferably, the processor (26) is also operable to receive a test result from a laboratory instrument (20), and determine whether the test result falls within the calculated control range for the specified laboratory test. Various exemplary embodiments of the system and associated method are provided.
G01N 37/00 - INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES - Details not covered by any other group of this subclass
G16H 10/40 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
G06F 17/18 - Complex mathematical operations for evaluating statistical data
ABSTRACT OF THE DISCLOSURE A novel ion exchange method is provided for the separation of hemoglobin AlC from other hemoglobin com- ponents in a sample of human blood. According to the dis- closed method, the sample is lysed then used to impregnate a weak cation exchanger. Two buffer solutions are then passed through the column in succession, the first having an alkali metal ion concentration of from about 0.02M to about 0.05M and the second having an alkali metal ion concentra- tion of from about 0.06M to about 0.11M. The second eluate contains substantially all of the hemoglobin AlC and sub- stantially none of the other hemoglobin components in the original sample. Analysis of the second eluate thus pro- vides a reliable indication of the long-term glucose level in the blood of a patient, and hence the patient's ability to regulate the quantity of glucose ingested.
Novel peptides are provided having substantially the same sequence as immunologically significant fragments of AIDS-related viruses. The polypeptides can be used as reagents in the determination of exposure of a human host to the virus. Of particular interest is the use of polypeptides in screening blood products.
A61K 39/21 - Retroviridae, e.g. equine infectious anemia virus
C12Q 1/70 - Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving virus or bacteriophage