The invention relates to a method and kit for the diagnosis of Inflammatory Bowel Disease (IBD) in a subject. The diagnostic method is based on the detection of fecal Calprotectin and at least one further fecal biomarker selected from PGRP-S and MMP-8 in a stool sample from the subject. In a preferred embodiment, the fecal biomarkers concentration data obtained are analyzed and classified as affected by IBD or not affected by IBD by a supervised machine learning diagnosis model.
G01N 33/68 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving proteins, peptides or amino acids
G16H 50/20 - ICT specially adapted for medical diagnosis, medical simulation or medical data miningICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
The present invention relates to a method for detecting Zika vims (ZIKV) infection in a biological sample from a subject. The method comprises testing the sample for IgM- and IgG-ZIKV NSI antibodies and determining the ZIKV IgM and ZIKV IgG signal intensities; and scoring the sample as positive or negative for ZIKV infection based on the combined results of such determinations. The biological sample is preferably blood, serum, plasma, cerebrospinal fluid, saliva or urine.
The present invention is directed to methods for assaying for the presence of SARS-CoV-2 in a sample, including a clinical sample, and to oligonucleotides, reagents, and kits useful in such assays. In particular, the present invention is directed to such assays that are rapid, accurate and specific for the detection of SARS-CoV-2.
C12Q 1/68 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving nucleic acids
C12Q 1/70 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving virus or bacteriophage
The present invention is directed to methods for assaying for the presence of SARS-CoV-2 in a sample, including a clinical sample, and to oligonucleotides, reagents and kits useful in such assays. In particular, the present invention is directed to such assays that are rapid, accurate and specific for the detection of SARS-CoV-2 using labeled oligonucleotides hybridizing to the ORFlab and/or S gene.
C12Q 1/6876 - Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes
C12Q 1/6888 - Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for detection or identification of organisms
C12Q 1/70 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving virus or bacteriophage
5.
Use of 1,25-Dihydroxyvitamin D Values in Ratio with PTH as a Prognostic Biomarker
The present invention relates to the use of 1,25-dihydroxyvitamin D values in ratio with PTH as a prognostic biomarker. More particularly, the present invention relates to a method for predicting or stratifying the risk of worsening renal function (WRF) in a patient at risk of renal injury or affected by renal injury. Levels of 1,25-dihydroxyvitamin D (1,25(OH)2D) are measured in a biological sample and taken together with parathyroid hormone (PTH) levels to provide a ratio indicative of the risk of worsening renal function.
The present invention is directed to methods for assaying for the presence of SARS-CoV-2 in a sample, including a clinical sample, and to oligonucleotides, reagents and kits useful in such assays. In particular, the present invention is directed to such assays that are rapid, accurate and specific for the detection of SARS-CoV-2.
C12Q 1/68 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving nucleic acids
C12Q 1/70 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving virus or bacteriophage
C12Q 1/48 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving transferase
C12N 15/11 - DNA or RNA fragmentsModified forms thereof
7.
Methods for detecting 1,25-dihydroxyvitamin D and related antibodies
There is disclosed an assay method for selectively detecting 1,25-dihydroxy-vitamin D in a biological fluid sample. According to the method, the pH of the test sample is adjusted to 6-9 and a receptor protein comprising the Ligand Binding Domain of Vitamin D Receptor (VDR-LBD) is added to the test sample, thereby obtaining the formation of a VDR-LBD/1,25-dihydroxyvitamin D complex in which the VDR-LBD portion is conformationally changed with respect to unbound VDR-LBD. The VDR-LBD/1,25-dihydroxyvitamin D complex is then detected by means of a capture moiety which is capable of specifically binding to VDR-LBD bound to 1,25-dihydroxyvitamin D. Also disclosed are an assay kit and an antibody for carrying out the method. The assay is preferably a sandwich immunoassay.
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
G01N 33/82 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving vitamins
C07K 16/26 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against hormones
A biological sample, for example blood, serum, or plasma, is evaluated for the presence of anti-Zika virus (ZIKV) IgM- and IgG antibodies specific for ZIKV nonstructural protein 1 (NS1) by measuring the signal intensities of such antibodies in an immunoassay of the sample. Subjects are scored as being positive or negative for ZIKV infection based on the combined results of such determinations.
The invention concerns a method for detecting isothermal loop-mediated (LAMP) amplification of a target nucleic acid sequence which is based on the fluorescence resonance energy transfer (FRET) mechanism. The invention also concerns a set of oligonucleotides and a kit adapted for carrying out the LAMP-FRET method of the invention.
A method includes performing a nucleic acid amplification of a nucleic acid sample using a detection probe, wherein the nucleic acid amplification occurs over one or more interrogation periods, and, from the nucleic acid amplification, acquiring amplification data that indicates an amount of nucleic acid present for each of the one or more interrogation periods. The method also includes, based on the amplification data, determining a crosstalk correction value associated with a spectral neighbor to the probe to reduce spectral crosstalk from the spectral neighbor; and applying the crosstalk correction value to amplification data collected from multiplex nucleic acid amplifications of nucleic acid samples.
2D) are measured in a biological sample and taken together with parathyroid hormone (PTH) levels to provide a ratio indicative of the risk of worsening renal function.
There is disclosed an assay method for selectively detecting 1,25-dihydroxy-vitamin D in a biological fluid sample. According to the method, the pH of the test sample is adjusted to 6-9 and a receptor protein comprising the Ligand Binding Domain of Vitamin D Receptor (VDR-LBD) is added to the test sample, thereby obtaining the formation of a VDR-LBD/1,25-dihydroxyvitamin D complex in which the VDR-LBD portion is conformationally changed with respect to unbound VDR-LBD. The VDR-LBD/1,25-dihydroxyvitamin D complex is then detected by means of a capture moiety which is capable of specifically binding to VDR-LBD bound to 1,25-dihydroxyvitamin D. Also disclosed are an assay kit and an antibody for carrying out the method. The assay is preferably a sandwich immunoassay.
G01N 33/82 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving vitamins
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
C07K 16/26 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against hormones
13.
Systems and methods for detecting the presence of a selected volume of material in a sample processing device
Systems and methods for processing sample processing devices. The system can include a sample processing device comprising a detection chamber, a motor configured to rotate the sample processing device about an axis of rotation, and an optical module operatively positioned relative to the sample processing device and configured to determine whether a selected volume of material is present in the detection chamber of the sample processing device. The method can include rotating the sample processing device about an axis of rotation, and determining whether a selected volume of material is present in the detection chamber, while rotating the sample processing device. In some embodiments, determining whether a selected volume of material is present can be performed by optically interrogating the detection chamber for an optical property of the material.
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
There is disclosed an assay method for selectively detecting 1,25-dihydroxy-vitamin D in a biological fluid sample. According to the method of the invention, the pH of the test sample is adjusted to 6-9 and a receptor protein comprising the Ligand Binding Domain of Vitamin D Receptor (VDR-LBD) is added to the test sample, thereby obtaining the formation of a VDR-LBD/1,25-dihydroxyvitamin D complex in which the VDR-LBD portion is conformationally changed with respect to unbound VDR-LBD. The VDR-LBD/1,25-dihydroxyvitamin D complex is then detected by means of a capture moiety which is capable of specifically binding to VDR-LBD bound to 1,25-dihydroxyvitamin D. Also disclosed are an assay kit and an antibody for carrying out the method of the invention. The assay of the invention is preferably a sandwich immunoassay.
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
G01N 33/82 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving vitamins
C07K 16/26 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against hormones
A system and method for valving on a sample processing device. The system can include a valve chamber, a process chamber, and a valve septum located between the valve chamber and the process chamber. The system can further include a fluid pathway in fluid communication with an inlet of the valve chamber, wherein the fluid pathway is configured to inhibit a liquid from entering the valve chamber and collecting adjacent the valve septum when the valve septum is in a closed configuration. The method can include rotating the sample processing device to exert a first force on the liquid that is insufficient to move the liquid into the valve chamber; forming an opening in the valve septum; and rotating the sample processing device to exert a second force on the liquid to move the liquid into the valve chamber.
Systems and methods for processing sample processing devices. The system can include a sample processing device comprising a detection chamber, a motor configured to rotate the sample processing device about an axis of rotation, and an optical module operatively positioned relative to the sample processing device and configured to determine whether a selected volume of material is present in the detection chamber of the sample processing device. The method can include rotating the sample processing device about an axis of rotation, and determining whether a selected volume of material is present in the detection chamber, while rotating the sample processing device. In some embodiments, determining whether a selected volume of material is present can be performed by optically interrogating the detection chamber for an optical property of the material.
A system and method for volumetric metering on a sample processing device. The system can include a metering reservoir, and a waste reservoir positioned in fluid communication with a first end of the metering reservoir to catch excess liquid from the metering reservoir that exceeds a selected volume. The system can further include a capillary valve in fluid communication with the second end of the metering reservoir to inhibit liquid from exiting the metering reservoir until desired. The method can include metering the liquid by rotating the sample processing device to exert a first force on the liquid that is insufficient to move the liquid into the capillary valve, and rotating the sample processing device to exert a second force on the liquid that is greater than the first force to move the metered volume of the liquid to the process chamber via the capillary valve.
G01F 11/22 - Apparatus requiring external operation adapted at each repeated and identical operation to measure and separate a predetermined volume of fluid or fluent solid material from a supply or container, without regard to weight, and to deliver it with measuring chambers moved during operation of the valve type, i.e. the separating being effected by fluid-tight or powder-tight movements wherein the measuring chamber rotates or oscillates for liquid or semiliquid
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glasswareDroppers
A method includes performing a nucleic acid amplification of a nucleic acid sample using a detection probe, wherein the nucleic acid amplification occurs over one or more interrogation periods, and, from the nucleic acid amplification, acquiring amplification data that indicates an amount of nucleic acid present for each of the one or more interrogation periods. The method also includes, based on the amplification data, determining a crosstalk correction value associated with a spectral neighbor to the probe to reduce spectral crosstalk from the spectral neighbor; and applying the crosstalk correction value to amplification data collected from multiplex nucleic acid amplifications of nucleic acid samples.
G01N 33/48 - Biological material, e.g. blood, urineHaemocytometers
G01N 33/50 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing
C12Q 1/68 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving nucleic acids
G06F 19/20 - for hybridisation or gene expression, e.g. microarrays, sequencing by hybridisation, normalisation, profiling, noise correction models, expression ratio estimation, probe design or probe optimisation
G06F 19/18 - for functional genomics or proteomics, e.g. genotype-phenotype associations, linkage disequilibrium, population genetics, binding site identification, mutagenesis, genotyping or genome annotation, protein-protein interactions or protein-nucleic acid interactions
A system and method for processing sample processing devices. The system can include a base plate adapted to rotate about a rotation axis. The system can further include a cover including a first projection, and a housing. A portion of the housing can be movable with respect to the base plate between an open position and a closed position, and can include a second projection. The first projection and the second projection can be adapted to be coupled together when the portion is in the open position and decoupled when the portion is in the closed position. The method can include coupling the cover to the portion of the housing, moving the portion of the housing from the open position to the closed position, and rotating the base plate about the rotation axis.
G01N 9/30 - Investigating density or specific gravity of materialsAnalysing materials by determining density or specific gravity by using centrifugal effects
G01N 21/00 - Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glasswareDroppers
B01L 7/00 - Heating or cooling apparatusHeat insulating devices
23.
Analysis of nucleic acid amplification curves using wavelet transformation
A method comprising acquiring amplification data proportional to an amount of nucleic acid present for each of a plurality of PCR cycles includes applying wavelet transformation to the amplification data to determine a PCR cycle corresponding to a point within a growth period of the amplification data, and updating a display A device including a control module, an analysis module and an interface module for initialization of PCR analysis of a nucleic acid sample, receiving amplification data proportional to an amount of nucleic acid present applying wavelet transformation to the amplification data to determine a PCR cycle corresponding to a point within a growth period of the amplification data, and updating a display based on the amplification data is also provided.
C12Q 1/68 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving nucleic acids
G06F 19/00 - Digital computing or data processing equipment or methods, specially adapted for specific applications (specially adapted for specific functions G06F 17/00;data processing systems or methods specially adapted for administrative, commercial, financial, managerial, supervisory or forecasting purposes G06Q;healthcare informatics G16H)
24.
Method for detection of mutant alleles combining real time PCR and REMS-PCR
The invention provides an amplification system for the simultaneous detection of mutant alleles, and identification of the specific mutated sequence. A sample is enriched and simultaneously genotyped by the presence of peptide nucleic acids (PNAs) probes in an homogeneous single tube amplification reaction, by detecting the cleavage of a fluorophore quencher from the 5′-end of PCR products and, concurrently, selecting DNA that includes specific mutations relative to wild type, by employing a thermostable endonuclease that will only cleave an amplicon formed on a mutation bearing template strand. Oligonucleotides and kits for conducting the amplification system are also provided.
Methods of providing at least one reagent for use in a device for processing sample material, delivering at least one reagent to a device for processing sample material, and adding at least one reagent to at least one of the steps in a process for detecting or assaying a nucleic acid; a support film coated with a dry reagent layer; and a device for processing sample material having a support film coated with a dry reagent layer contained within at least one chamber of the device are disclosed.
Processing devices that include one or more process arrays with thermal transfer structures that can be used alone or in conjunction with gravity/rotation to transport fluids within a microfluidic system. The thermal transport function can be accomplished by changing the temperature of one or more chambers to create a vacuum to draw fluids in selected directions within the process array. The methods and apparatus of the present invention may provide the ability to move fluids in a direction that is against the direction of gravity or any centrifugal forces generated by rotating a processing device using the thermal transfer structures. In other words, fluids may be moved against the direction of gravity or towards the axis of rotation using the thermally-activated vacuum.
Modular sample processing apparatus kits that can provide a user with the flexibility to customize a disk-based assay in view of a variety of factors are disclosed. The sample processing apparatus kits of the present invention include one or more process modules that can be retained within openings in a frame. The frame and process modules of the sample processing apparatus kits are preferably adapted for use in sample processing systems that compress the apparatus. The process modules may contain different reagents to perform different tests on the same sample materials or a variety of sample materials. As a result, a single sample processing apparatus can be used to perform a variety of different tests and may include a quality control module capable of providing feedback to the user as to the accuracy of the processes run using the sample processing apparatus. Methods of using the sample processing apparatus that include deforming the process modules and frame are also disclosed.
F27B 9/16 - Furnaces through which the charge is moved mechanically, e.g. of tunnel type Similar furnaces in which the charge moves by gravity characterised by the path of the charge during treatmentFurnaces through which the charge is moved mechanically, e.g. of tunnel type Similar furnaces in which the charge moves by gravity characterised by the means by which the charge is moved during treatment the charge moving in a circular or arcuate path
C12Q 1/34 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving hydrolase
Microfluidic sample processing disks with a plurality of fluid structures formed therein are disclosed. Each of the fluid structures preferably includes an input well and one or more process chambers connected to the input well by one or more delivery channels. The process chambers may be arranged in a compliant annular processing ring that is adapted to conform to the shape of an underlying thermal transfer surface under pressure. That compliance may be delivered in the disks of the present invention by locating the process chambers in an annular processing ring in which a majority of the volume is occupied by the process chambers. Compliance within the annular processing ring may alternatively be provided by a composite structure within the annular processing ring that includes covers attached to a body using pressure sensitive adhesive.
Modular sample processing apparatus kits that can provide a user with the flexibility to customize a disk-based assay in view of a variety of factors are disclosed. The sample processing apparatus kits of the present invention include one or more process modules that can be retained within openings in a frame. The frame and process modules of the sample processing apparatus kits are preferably adapted for use in sample processing systems that compress the apparatus. The process modules may contain different reagents to perform different tests on the same sample materials or a variety of sample materials. As a result, a single sample processing apparatus can be used to perform a variety of different tests and may include a quality control module capable of providing feedback to the user as to the accuracy of the processes run using the sample processing apparatus. Methods of using the sample processing apparatus that include deforming the process modules and frame are also disclosed.
F27B 9/16 - Furnaces through which the charge is moved mechanically, e.g. of tunnel type Similar furnaces in which the charge moves by gravity characterised by the path of the charge during treatmentFurnaces through which the charge is moved mechanically, e.g. of tunnel type Similar furnaces in which the charge moves by gravity characterised by the means by which the charge is moved during treatment the charge moving in a circular or arcuate path
C12Q 1/34 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving hydrolase
30.
Valve control system for a rotating multiplex fluorescence detection device
Techniques are described for the detection of multiple target species in real-time PCR (polymerase chain reaction). For example, a system comprises a data acquisition device and a detection device coupled to the data acquisition device. The detection device includes a rotating disk having a plurality of process chambers having a plurality of species that emit fluorescent light at different wavelengths. The device further includes a plurality of removable optical modules that are optically configured to excite the species and capture fluorescent light emitted by the species at different wavelengths. A fiber optic bundle coupled to the plurality of removable optical modules conveys the fluorescent light from the optical modules to a single detector. In addition, the device may control the flow of fluid in the disk by locating and selectively opening valves separating chambers by heating the valves with a laser.
Sample processing systems and methods of using those systems for processing sample materials located in sample processing devices are disclosed. The sample processing systems include a rotating base plate on which the sample processing devices are located during operation of the systems. The systems also include a cover and compression structure designed to force a sample processing device towards the base plate. The preferred result is that the sample processing device is forced into contact with a thermal structure on the base plate. The systems and methods of the present invention may include one or more of the following features to enhance thermal coupling between the thermal structure and the sample processing device: a shaped transfer surface, magnetic compression structure, and floating or resiliently mounted thermal structure. The methods may preferably involve deformation of a portion of a sample processing device to conform to a shaped transfer surface.
Techniques are described for the detection of multiple target species in real-time PCR (polymerase chain reaction). For example, a system comprises a data acquisition device and a detection device coupled to the data acquisition device. The detection device includes a rotating disk having a plurality of process chambers having a plurality of species that emit fluorescent light at different wavelengths. The device further includes a plurality of removable optical modules. Each of the removable optical modules is optically configured to excite the species and capture fluorescent light emitted by the species at different wavelengths. A fiber optic bundle coupled to the plurality of removable optical modules conveys the fluorescent light from the optical modules to a single detector.
Techniques are described for the detection of multiple target species in real-time PCR (polymerase chain reaction). For example, a system is described that includes a data acquisition device and a detection device coupled to the data acquisition device. The detection device includes a rotating disk having a plurality of process chambers having a plurality of species that emit fluorescent light at different wavelengths. The device further includes a plurality of optical modules. Each of the optical modules is optically configured to excite the species and capture fluorescent light emitted by the species at different wavelengths. A fiber optic bundle coupled to the plurality of optical modules conveys the fluorescent light from the multiple optical modules to a single detector.
The present invention provides methods and kits for isolating nucleic acid from a sample, preferably from a biological sample, using a microfluidic device and a concentration step.
Mixing structures for use on sample processing devices are disclosed. The mixing structures include one or more mixing chambers in fluid communication with a process chamber, such that changing the rotational speed of the sample processing device forces sample material into and out of the mixing chamber to achieve mixing of the sample material. The mixing chambers are in fluid communication with the process chambers through mixing ports that are located on the distal sides of the process chambers with respect to the axis about which the sample processing device is rotated.
patents
