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13 results about "Assay sensitivity" patented technology

Assay sensitivity is a property of a clinical trial defined as the ability of a trial to distinguish an effective treatment from a less effective or ineffective intervention. Without assay sensitivity, a trial is not internally valid and is not capable of comparing the efficacy of two interventions.

Methods and systems for rapid detection of microorganisms using recombinant bacteriophages

Disclosed herein are methods and systems for rapid detection of microorganisms in a sample without enrichment culture of the microorganisms. Also disclosed is a modified bacteriophage comprising a non-natural indicator gene in the late gene region. The indicator product is not a fusion protein. The specificity of infectious agents allows targeting of specific microorganisms, and the indicator signal can be enlarged to optimize assay sensitivity.
Owner:LABORATORY CORPORATION OF AMERICA HOLDINGS INC

D-dimer detection kit and detection method thereof

The present application relates to the technical field of medical detection, in particular to a D-dimer detection kit and a detection method thereof.The present application provides a D-dimer detection kit, which is composed of reagent R1 and reagent R2.The reagent R1 is mainly composed of a buffer, a preservative, an inorganic salt, a surfactant and a protein stabilizer;the reagent R2 is mainly composed of a buffer, a protein protective agent, sucrose and a preservative.The experiment shows that the kit is easy to operate and has a short analysis time, and the kit also has high analysis sensitivity, optimal precision, good test accuracy and a wide linear range, and can be combined with an automatic analyzer, which is conducive to its wide use in clinical practice.
Owner:AUTOBIO BIOCHEMISTRY CO LTD

Method of sequence independent quantification of proteolytically labile plasma lambda free light chain proteins for AL amyloidosis diagnosis

A method for combining restrictive proteolysis and immunoassays to specifically detect and quantify amyloid-genic XFLC in a biological fluid. This method is accomplished by the use of mAbs that enable the detection and quantification of neoepitopes on dLCCD biomarkers produced after restricted proteolysis of ZFLC, which is very advantageous for kinetically unstable or amyloid-genic LFLC. The methods do not depend on FLC primary sequences in variable and constant domains, and can be used to detect and quantify up to 99% of human XFLC. The clinical utility of the assay includes early detection in individuals suspected of having plasma cell disorders (MGUS, SMM, MM, IgM-AL and AL), differentiation from other amyloidosis such as ATTR, use in companion diagnosis, proving of target conjugation, assessment of treatment response, detection of MRD, detection of recurrence. Assays, such as MSD, lateral flow, mass spectrometry, are also implemented that quantify the resulting dLCCD biomarkers and / or can further increase assay sensitivity.
Owner:PROTEGO BIOPHARMA INC

Selecting low technical noise biomarkers for sensitive molecular diagnostics

Described herein are methods for the detection of molecular residual disease (MRD) and cancer by analysis of cell‑free nucleic acids. The invention provides a capture panel comprising target‑specific probes that are directed to one or more genomic regions encompassing a spectrum of variant types, namely structural variants (SV), large insertions / deletions, phased single‑nucleotide variants, small insertions / deletions, multi‑nucleotide variants and single‑nucleotide variants. By contacting a nucleic‑acid sample derived from a subject with the probe panel, the method enriches variant‑bearing molecules and subjects the captured set to sequencing. Disease presence or the likelihood thereof is determined on the basis of each target region, optionally integrating epigenetic information (e.g., differential methylation) obtained from a tumour biopsy. The probe design is adapted to technical noise, allocating higher probe concentrations to low‑noise, high‑complexity variants, thereby reducing reliance on molecular barcodes, lowering required read depth and improving analytical sensitivity for both fixed‑panel and patient‑specific MRD assays.
Owner:GUARDANT HEALTH INC

Methods and Systems for the Rapid Detection of Microorganisms Using Recombinant Infectious Agents to Express an Indicator Subunit

Disclosed herein are methods and systems for rapid detection of microorganisms such as bacteria in a sample. A genetically modified bacteriophage is also disclosed which comprises an indicator gene encoding one subunit of an indicator protein. The specificity of the bacteriophage allows detection of a particular bacteria of interest and an indicator signal may be amplified to optimize assay sensitivity.
Owner:LABORATORY CORPORATION OF AMERICA HOLDINGS INC

Electrochemiluminescence immunosensor for detecting tumor marker and application thereof

ActiveCN114113046BAntigenGraphite carbon
The application belongs to the technical field of electrochemiluminescence immunosensor, discloses a kind of electrochemiluminescence immunosensor for detecting tumor marker and application thereof, and the preparation system of electrochemiluminescence immunosensor for detecting tumor marker includes: graphite carbon nitride preparation module, working electrode pretreatment module, central control module, antigen standard solution preparation module, modified electrode preparation module, immunosensor preparation module, tumor marker detection module, sensor detection curve drawing module, data storage module, update display module.The electrochemiluminescence immunosensor for detecting tumor marker provided by the application has high analysis sensitivity, strong specificity, is simple to use and low in cost.The application improves the sensitivity of electrochemiluminescence immunosensor by dropping coating bovine serum albumin solution and tumor marker antigen standard solution on the surface of graphite carbon nitride working electrode, and greatly simplifies the electrode preparation process without enzyme and label.
Owner:GUANGDONG MEDICAL UNIV

Assays for lysosomal storage diseases

The disclosure provides the methods of detecting an anti-lysosomal enzyme antibody in a human subject (e.g., in the presence of a circulating lysosomal enzyme) and the methods of improving an efficacy of an anti-lysosomal enzyme antibody assay (e.g., improving the assay sensitivity and the circulating lysosomal enzyme tolerance), comprising pre-treating the biological sample of the subject with a base at pH of about 11 or greater and measuring the presence of the anti-lysosomal enzyme antibody in the biological sample of the subject.
Owner:SANGAMO THERAPEUTICS INC

Electrospray ion source device and mass spectrometer

ActiveCN116344321BIon sources/gunsChemical physicsElectro spray
The application relates to an electrospray ion source device and a mass spectrometer, the electrospray ion source device comprising: a hollow spray needle assembly, an air amplification mechanism, a headspace mechanism, the headspace mechanism being in communication with the amplification cavity, and the headspace mechanism being used for introducing compressed gas into the amplification cavity to increase the gas flow rate in the amplification cavity. In the working process of the above-mentioned electrospray ion source device, the sample forms charged droplets under the action of the hollow spray needle assembly and is sprayed into the amplification cavity through the inlet; at the same time, the headspace mechanism introduces compressed gas into the amplification cavity to increase the gas flow rate in the amplification cavity, the fast-flowing gas contacts the charged droplets, the volatilization of the solvent in the charged droplets is accelerated, the reaction molecules contact and react with the charged droplets or the gaseous sample to generate ions, and the ions or the charged droplets are driven to move towards the mass spectrometer sampling port structure, thereby improving the droplet desolvation effect and the ionization efficiency of the ion source, so as to be beneficial to improving the analysis sensitivity of the mass spectrometer.
Owner:KUSN HEXIN MASS PECTRUM TECH +1

Method for generating mutant bacteriophage for detecting listeria genus

Disclosed herein are methods for producing a mutant bacteriophage having an altered range of hosts. In addition, the present application discloses methods and systems for the rapid detection of microorganisms in a sample, such as a plurality of species of the genus Listeria. Also disclosed is a genetically modified bacteriophage comprising an indicator gene in an advanced gene region. The specificity of a bacteriophage, such as a Listeria specific bacteriophage, allows the detection of a particular microorganism, such as a variety of species of Listeria, and the indicator signal can be amplified to optimize assay sensitivity.
Owner:LABORATORY CORPORATION OF AMERICA HOLDINGS INC

Serum amyloid protein A determination kit

The utility model relates to a serum amyloid protein A determination kit. The kit comprises a shell and a test strip, the test strip comprises a support plate, a sample pad, a combination pad, a reaction film and absorbent paper, the shell comprises an upper cover and a lower cover, and the upper cover is provided with a sample adding hole and an observation window; colloidal carbon marked by a first serum amyloid protein A monoclonal antibody is sprayed on the combination pad; the reaction film is provided with a detection line and a quality control line, the detection line is sprayed with a second serum amyloid protein A monoclonal antibody, and the quality control line is sprayed with a goat-anti-mouse second antibody; the sample pad, the combination pad, the reaction film and the absorbent paper are fixed on the surface of the support plate; the conjugate pad is overlapped with one end, close to the detection line, of the reaction film, the sample pad is overlapped with the other end of the conjugate pad, the absorbent paper is overlapped with one end, close to the quality control line, of the reaction film, and all overlapping distances are within a preset distance range; the test strip is fixed in the shell; the sample adding hole is formed above the sample pad; the observation window is arranged above the reaction film and is large enough to expose the detection line and the quality control line on the reaction film, so that the measurement sensitivity is improved.
Owner:HANGZHOU ZHIWEI AIDI BIOTECHNOLOGY CO LTD

Finger-actuated systems and methods for electrochemical measurements of protein biomarkers for point-of-care testing

PendingUS20260021484A1Laboratory glasswaresFluid controllersAntibody antigen reactionsImmune complex
Embodiments of the present disclosure include apparatus, systems and methods related to sample analysis. Particular embodiments include a microfluidic electrochemical immunosensor that employ a unique finger-actuated mixer for rapid, ultrasensitive measurements of protein biomarkers. This mixer generates swirling microflows in the liquid sample, which accelerates biomolecular transport, enhances antibody-antigen reactions and promotes immunocomplex formation. In specific embodiments, mixing can be implemented during the incubation steps, which accelerates biomolecular transport and promotes immunocomplex formation, leading to enhanced analytical sensitivity and a shortened detection time.
Owner:WILLIAM MARCH RICE UNIVERSITY

A blood detection equipment performance evaluation method and system based on big data

ActiveCN121117644BManufacturing computing systemsAssay sensitivityTrend analysis
The present application relates to the technical field of device performance evaluation, in particular to a blood detection device performance evaluation method and system based on big data, comprising collecting real sample detection data of the detection device within a preset time period; determining an upper critical region and a lower critical region, and establishing a critical sample database; calculating a critical resolution index based on the critical sample database, wherein the critical resolution index is obtained by weighted calculation of a critical precision index, a boundary separation index and a distribution continuity index; grouping the critical sample database according to matrix types, calculating the critical resolution index, and comparing and analyzing the sensitivity difference; setting a sliding time window, obtaining the critical resolution index of different time periods, obtaining the time series of the analysis sensitivity, and performing trend analysis to output a performance degradation curve and trigger a performance degradation warning; and fusing the critical resolution index, the analysis sensitivity difference and the performance degradation curve to output a device performance evaluation report.
Owner:NANJING HUAYIN MEDICAL LAB CO LTD

Improving Signal to Noise in Immunoassays

PendingUS20260049982A1Chemiluminescene/bioluminescenceAssay sensitivityChemiluminescence
The present disclosure includes certain steps in immunoassays, such as immunoassays based on chemiluminescence, which increase assay sensitivity as based on a variety of metrics including increasing signal to noise and decreasing limits of detection. One strategy for these enhancements involves movement, and potential sequestration, of solid phases in one triggering reagent prior to addition of a second triggering reagent for chemiluminescence.
Owner:SIEMENS HEALTHCARE DIAGNOSTICS INC