714 results about "In vitro diagnostic" patented technology

The invention belongs to the technical field of immunology and in vitro diagnosis, and particularly relates to a rabbit-derived recombinant monoclonal antibody for specific recognition of type II grass carp reovirus VP4 protein, an eukaryotic expression method and application. According to the invention, a target gene S6 is transfected to an HEK293 cell for expression and purification, a New Zealand white rabbit is immunized in cooperation with a Freund's adjuvant, and the rabbit-derived recombinant monoclonal antibody capable of specifically recognizing the GCRV-II VP4 protein is obtained by using ELISA, single B cell screening and eukaryotic expression technologies. The antibody has strong specificity, provides support for further establishment of a specific II-type grass carp reovirus diagnosis technology, and has great application value in development of GCRV-II related scientific research.

The invention belongs to the technical field of immunology and in vitro diagnosis, and relates to a monoclonal antibody aiming at bovine nodular skin disease virus (LSDV) L1R protein. According to the invention, the LSDV recombinant L1R protein with deletion of a transmembrane region (182-204aa) is obtained through expression; after a mouse is immunized by the protein, a monoclonal antibody 8D5 which is good in reactivity and specificity and aims at the LSDV L1R protein is screened out; heavy chain and light chain variable region sequences for coding the monoclonal antibody 8D5 are obtained; the monoclonal antibody 8D5 can be subjected to specific reaction with LSDV L1R protein, the recombinant protein L1R can be specifically recognized by bovine LSDV positive serum, meanwhile, the monoclonal antibody 8D5 can be used for establishing an LSDV ELISA antibody detection method, and a foundation is laid for LSDV diagnostic technology and vaccine research and development.

The invention provides a multi-channel one-core multi-detection integrated detection method, which is applied to the technical field of in-vitro diagnosis and comprises the following steps: acquiring time sequence original signals of blood routine, liver function and kidney function channels; obtaining a baseline stable primary signal through cross-channel baseline trend coupling and adaptive correction; adopting a machine learning model to identify interference components and performing component offset to obtain a decoupling signal; mapping the decoupling signal into a physiological parameter value and carrying out rationality test; when the low credible parameter exists, a rechecking mechanism is triggered; performing weighted fusion on the basis of the rationality test result and the recheck signal to obtain a comprehensive parameter set; and finally generating a comprehensive detection report containing the credibility score. Cooperative processing and fusion analysis of multi-channel detection signals are realized, and the accuracy and reliability of a detection result are remarkably improved through interference identification and a dynamic recheck mechanism.

The invention relates to the technical field of in-vitro diagnosis automation equipment, and discloses a reaction container feeding device and diagnosis equipment, and the reaction container feeding device comprises a hopper, a partition plate, a driving assembly, a material pushing part and a feeding assembly; a feeding hole is formed in the top of the hopper, and an opening is formed in the bottom; the partition plate is fixedly arranged in the hopper and divides the opening into a first sub-opening and a second sub-opening; the driving assembly is arranged at the lower end of the hopper; the material pushing part and the feeding assembly are connected with the driving assembly, the driving assembly drives the material pushing part to move up and down and penetrate through the first sub-opening so as to jack up the reaction container, and the driving assembly drives the feeding assembly to move up and down and penetrate through the second sub-opening so as to receive the reaction container jacked up by the material pushing part. The driving assembly is adopted to drive the material pushing piece to jack up the reaction container to the feeding assembly, meanwhile, the feeding assembly is driven to move upwards to receive the reaction container, the feeding structure of the reaction container is simplified, the occupied space is small, and the reliability is high.

The invention belongs to the technical field of in-vitro diagnosis, and discloses a microbiological detection kit and a detection method. The kit comprises an elisa plate coated with a captured antibody and an HRP labeled antibody working solution, the capture antibody is a monoclonal antibody LG3A-1 specifically combined with a human giardia antigen, the heavy chain amino acid sequence of the capture antibody is as shown in SEQ ID NO.1, and the light chain amino acid sequence of the capture antibody is as shown in SEQ ID NO.2; the HRP labeled antibody is a monoclonal antibody FLSP4 specifically combined with human giardia antigen, the heavy chain amino acid sequence of the monoclonal antibody FLSP4 is as shown in SEQ ID NO.3, and the light chain amino acid sequence of the monoclonal antibody FLSP4 is as shown in SEQ ID NO.4. The microbiological detection kit provided by the invention can be used for detecting the content of giardia in human excrement, is high in specificity, high in sensitivity, good in stability and simple to operate, and has a very good application prospect.

The invention relates to the technical field of in-vitro diagnosis automation equipment, in particular to a pipe cap limiting block, a cap opening device and a using method of the cap opening device. And the number of the tube cover limiting blocks is multiple, and each tube cover limiting block comprises a limiting block bottom face connected with the tube cover bottom face in an abutting mode. And the plurality of test tubes are limited and fixed through the plurality of tube cover limiting blocks. Furthermore, the tube cover can be moved to the tube cover limiting block through one clamping jaw, and then the next tube cover is transferred through the clamping jaw, so that the opening and closing actions of the tube covers of a plurality of test tubes are realized. According to the structure, cover opening and closing actions are executed on a plurality of specific test tubes through one set of equipment, and the test tube cover opening and closing efficiency is high.

The invention provides a chemically modified tetanus toxin C fragment as well as preparation and application thereof. The method for chemically modifying the tetanus toxin C fragment comprises the following steps: 1) reacting the tetanus toxin C fragment with a reducing agent to reduce a disulfide bond in the tetanus toxin C fragment; and 2) carrying out a reaction on the reduced tetanus toxin C fragment and an alkylation reagent, and carrying out modification. The recombinant tetanus toxin C fragment prepared by the method disclosed by the invention not only meets the quality standard required by pharmacopeia, but also has the advantages of stable conformation, high yield, easiness in amplification and low cost, and has a wide application prospect in the preparation of human vaccines, veterinary vaccines and antibody drugs and the development process of in-vitro diagnostic reagents.

The invention relates to the technical field of in-vitro diagnostic kits, and provides an apolipoprotein E4 detection kit and application thereof. The immunochromatography test paper comprises detection immunochromatography test paper, the detection immunochromatography test paper comprises a bottom plate, a sample pad, a combination pad, an NC membrane and a water absorption pad, the combination pad and the sample pad are sequentially arranged on one side of the NC membrane, and the water absorption pad is arranged on the other side of the NC membrane; the combination pad is marked with gold manganese oxide nanometer developing particles and an apolipoprotein APOE4 monoclonal antibody. According to the technical scheme, the problems of complicated operation, high cost, low detection sensitivity and weak specificity of apolipoprotein E4 detection in related technologies are solved.

The invention relates to the technical field of in-vitro diagnostic kits, in particular to carboxyl polystyrene microspheres, a preparation method and application of the carboxyl polystyrene microspheres in a kit for quantitatively detecting MxA. The preparation method of the carboxyl polystyrene microspheres comprises the steps that firstly, polystyrene microspheres with the surface rich in aldehyde groups are prepared through a soap-free emulsion polymerization method; then carrying out a Schiff alkali reaction with 2-aminoethyl methacrylate hydrochloride to carry out double bond modification on the surface of the microsphere, and meanwhile, improving the hydrophilicity of the microsphere by an ester group and an imino group; and finally, carrying out sulfydryl-double bond addition reaction on the polystyrene microspheres and mercaptosuccinic acid to generate the polystyrene microspheres rich in carboxyl on the surfaces. The carboxyl polystyrene microspheres prepared by the invention can improve the binding efficiency of latex and an MxA antibody, so that the detection sensitivity is improved, the purpose of high-sensitivity quantitative detection of MxA protein can be achieved, and the detection time is greatly shortened.

The invention belongs to the technical field of in-vitro diagnosis, and particularly relates to a detection kit and a detection method for a pretumor marker. The kit comprises an elisa plate coated with a captured antibody, an HRP labeled antibody, an antigen standard substance, a washing solution, a developing solution and a stop solution, the capture antibody and the HRP labeled antibody are both prepared from a monoclonal antibody of the anti-SLC31A1 protein. According to the detection method of the kit for detecting the pretumor marker, the SLC31A1 protein content in human serum is detected through the kit, the specificity is high, a large batch of samples can be rapidly detected in a high-throughput mode, the cancer risk of a to-be-detected crowd can be effectively judged, and therefore relevant patients can find and treat the pretumor marker in advance, treatment prognosis is improved, and the death rate is reduced.

The invention relates to a biotechnology, and particularly discloses a soluble fibrous protein (SF) antibody and an application of the soluble fibrous protein antibody. According to the present invention, the single B cell antibody preparation technology and the flow cytometry sorting method are firstly applied to the blood coagulation in vitro diagnosis fibrinolysis system detection antibody development, and the mammalian cell expression system (293F) is adopted to successfully express and obtain the three strains of the SF monoclonal antibodies (the antibody numbers are SF-1, SF-2 and SF-3) with the biological activity; the three antibodies have specific reactions with SF, have no cross reactions with primary fibrinolytic substances (X, Y and D), can be applied to the fields of SF indirect ELISA and Western blotting detection and screening, make up the vacancy of domestic SF antibodies in the market, and realize fibrinolytic system detection integrity.

The invention belongs to the field of in-vitro diagnosis and detection, and particularly relates to a primer pair, a probe, a kit and a detection method for norovirus detection. The norovirus detection primer pair provided by the invention comprises a primer pair for detecting a norovirus GI type, a primer pair for detecting a norovirus GII type and a primer pair for detecting a norovirus GIV type, and specific primers and probes are designed on the basis of a norovirus GI / GII / GIV type gene conserved region; and a plurality of pairs of primers or probes are introduced, and degenerate primers and degenerate probes are introduced, so that the existing norovirus subtypes are better matched, the detection coverage rate is increased, and the omission ratio is reduced.

The application belongs to the technical field of immunology and in vitro diagnosis, and particularly relates to a rabbit-derived recombinant monoclonal antibody specifically recognizing type II grass carp reovirus VP4 protein, a eukaryotic expression method and application. The S6 gene in GCRV-II encodes VP4 protein, the application transfects the target gene S6 into HEK293 cells for expression and purification, cooperates with Freund's adjuvant to immunize New Zealand white rabbits, and uses ELISA, single B cell screening and eukaryotic expression technology to obtain a rabbit-derived recombinant monoclonal antibody specifically recognizing GCRV-II VP4 protein. The antibody has strong specificity, provides support for further establishment of specific type II grass carp reovirus diagnosis technology, and has great application value for development of GCRV-II related scientific research.

The invention relates to the technical field of reagent cold-chain transportation monitoring, and particularly discloses a dynamic monitoring and adjusting system for cold-chain transportation of in-vitro diagnostic reagents, which is used for solving the problem that the temperatures of some regions cannot reach or keep a set value in time because local hot spots or cold regions are formed due to non-uniform stacking of the existing in-vitro diagnostic reagents. According to the method, the global temperature data and the reference three-dimensional temperature data in the warehouse are acquired, the first temperature abnormal fluctuation value is calculated, the abnormal deviation between the local temperature data and the global data is automatically identified, the consistency of the temperature data is ensured, the temperature gradient is quantitatively calculated from the global and local angles, and the accuracy of the temperature gradient is improved. Temperature distribution characteristics in the warehouse can be captured in detail, temperature gradient difference values are calculated by comparing different data sources, a reasonable threshold value is set, and automatic early warning is achieved, so that the stability of a temperature control environment is guaranteed, and the quality of an in-vitro diagnostic reagent is protected.

The invention discloses a magnetic porous microsphere for in-vitro diagnosis and a preparation method of the magnetic porous microsphere, and belongs to the technical field of preparation of micro-nano materials. According to the invention, styrene is used as a polymerization monomer, and a dispersion polymerization method is adopted to prepare monodisperse polystyrene microspheres; ferric chloride and ferrous sulfate are selected as precursors, magnetic nanoparticles are synthesized through a coprecipitation method under the alkaline condition, the initial loading capacity is changed, the magnetic nanoparticles are loaded on the surfaces and in pore channels of polymer porous microspheres through a multi-step seed growth method, and the magnetic nanoparticles are prepared. The composite magnetic polystyrene microspheres with high magnetic content, good magnetic responsiveness and superparamagnetism are synthesized; finally, functional groups are introduced to the surfaces of the magnetic spheres by monomers containing the functional groups through a monomer swelling polymerization method, and the prepared magnetic porous microspheres have the advantages of uniform particle size, small coefficient of variation and large specific surface area, and can be better combined with antigens and antibodies, so that in-vitro diagnostic function detection such as nucleic acid extraction and chemiluminescence is carried out.

The invention relates to the technical field of automatic equipment for in-vitro diagnosis, in particular to a method for cleaning a reaction cup, a mode selection method and a chemiluminescence immunoassay analyzer. The method for cleaning the reaction cup comprises the following steps that the first gripper is driven to move on the gripper movement axis in the linear direction, the reaction cup in a reaction cup hole in a first target is grabbed, and the cup throwing action is completed; meanwhile, the second gripper is driven to move on the gripper movement axis in the linear direction, the reaction cup in the reaction cup hole in the second target is grabbed, and the cup throwing action is completed. The reaction cups in the reaction cup holes can be cleaned through linear motion of the grippers, and the multiple grippers work separately. The problems that in the prior art, cup grabbing and cup throwing actions can be achieved only by moving cup grabbing hands for a long distance, avoiding control logic is lacked between the cup grabbing hands, position interference is prone to occurring, and the cup cleaning efficiency of an analytical instrument is affected are effectively solved.

The invention relates to the field of monoclonal antibodies, in particular to a von Willebrand factor cleavage protease (ADAMTS13) monoclonal antibody as well as a preparation method and application thereof. The ADAMTS13 monoclonal antibody provided by the invention is high in sensitivity and strong in affinity and can effectively inhibit ADAMTS13 enzyme activity, in addition, the invention also develops an in-vitro diagnosis detection kit applying the antibody, and the kit has the advantages of wide detection range, few interfering substances, short detection time and good stability and repeatability. And a new thought is provided for treatment and research of diseases.

The invention discloses an IV-type collagen detection kit and a preparation method thereof, and relates to the technical field of in vitro diagnos.The kit comprises a reagent R1 and a reagent R2, and the volume ratio of the reagent R1 to the reagent R2 is 3: 1; through an elaborately designed reagent formula, especially the accurate proportion of all components in the reagent R1, such as ammonium chloride, sodium azide and Brij-35, the detection sensitivity and accuracy are improved, the stability and repeatability of the kit are also ensured, and particularly, the natural plant extract astragalus polysaccharide and the protease K inhibitor are introduced into the reagent R1 as key components, so that the detection sensitivity and accuracy are improved, and the detection sensitivity and repeatability are improved. According to the present invention, the unique preparation method and the activity promotion effect on the IV-type collagen hydrolase significantly enhance the biological activity of the kit, such that the detection result is reliable, and the two latex particles coated with the paired mouse monoclonal antibodies adopted in the reagent R2 have high specificity and affinity, such that the kit can be used for the detection of the IV-type collagen hydrolase. And the detection accuracy and sensitivity are further improved.

The utility model provides a quantifiable detection consumable and detection equipment, and relates to the in vitro diagnostic technology, the quantifiable detection consumable comprises a sample tube with a cavity and a reaction tube communicated with the sample tube, the reaction tube is provided with a reaction cavity and a sealing film for sealing the reaction cavity; the piston structure is arranged in the cavity; a first limiting structure used for limiting the piston structure to the first position and a second limiting structure used for limiting the piston structure to the third position are further arranged on the inner wall of the sample tube, the piston structure pierces the sealing film when moving to the third position from the first position, and the treatment liquid quantitatively flows into the reaction cavity; the piston structure is used for puncturing the isolating membrane isolated between the cavity and the reaction cavity, so that the treatment liquid enters the reaction cavity, the step of container replacement is omitted, meanwhile, the piston structure is pushed to move by a preset stroke, it is ensured that the mixed solution quantitatively flows into the reaction cavity, and it is avoided that excessive mixed solution enters the reaction cavity, and the detection result is affected.

The invention provides a metabolic marker combination for ovarian cancer diagnosis and application thereof, and belongs to the technical field of in-vitro diagnosis. The invention provides a metabolic marker combination for ovarian cancer diagnosis. The metabolic marker combination comprises phosphatidylcholine 34: 4, threonic acid, phosphatidylcholine 32: 2, pyroglutamic acid, phosphatidylcholine 36: 6 and ceramide d38: 2. According to the metabolic marker combination, plasma samples of a healthy subject and an ovarian cancer patient are analyzed, a group of biomarkers with significant difference are screened from the plasma samples, and the metabolic marker combination is a non-invasive, non-invasive and high-accuracy metabolic marker combination for distinguishing the healthy subject and the ovarian cancer patient. The method can be used for constructing a diagnostic model for distinguishing healthy subjects from ovarian cancer patients. The metabolic marker combination disclosed by the invention can be used for improving the diagnosis and evaluation capability of ovarian cancer patients, so that early discovery, early diagnosis and early intervention can be realized clinically, and the survival rate of the ovarian cancer patients is improved.

A method for automatically generating a research and development proposal for an in vitro diagnostic kit, performed by a server for automatically generating the research and development proposal, includes: acquiring an initial proposal including intended use information for the kit; providing the acquired initial proposal to a pre-trained language model; acquiring a specification (spec) for the kit from the language model receiving the initial proposal, wherein the acquired specification for the kit includes at least one of a technical specification to be used for the research and development of the kit, a resource specification for the research and development, a design specification for the kit, a regulatory approval specification that is needed to meet for approval, and a performance specification for the kit; and controlling to generate the research and development proposal for the kit including the acquired specification and the intended use information for the kit.

The invention discloses a creatinine detection device, and belongs to the field of in-vitro diagnosis equipment. The creatinine detection device comprises a substrate, a reagent 1 assembly and a reagent 2 assembly, the reagent 1 assembly comprises a flow pad, an enzyme pad and a blood filter membrane, the reagent 2 assembly comprises a start inhibition layer, a separation layer and a color development layer, the reagent 1 assembly and the reagent 2 assembly are stored in a non-contact mode in a normal state, and the reagent 1 assembly and the reagent 2 assembly are in contact to start a reaction during testing; the separation layer contains perfluorooctane sulfonic acid and / or perfluorooctane carboxylic acid. According to the creatinine detection device provided by the invention, interference of endogenous ammonia can be eliminated, the diffusivity of the ammonia is improved, and the detection sensitivity is improved.

The present invention discloses a magnetic separation cleaning device and method, relating to the technical field of in vitro diagnostic medical devices. The device includes a turntable that can rotate counterclockwise around a central axis; 14 reaction cup placement grooves that can rotate together with the turntable are evenly arranged along the circumferential direction on the top surface of the turntable; along the counterclockwise direction, the positions where each reaction cup placement groove is located are sequentially used as the first to fourteenth workstations, and each workstation does not rotate with the turntable; first permanent magnets are respectively arranged at the third, seventh, and eleventh workstations, second permanent magnets are respectively arranged at the fourth, eighth, and twelfth workstations, and third permanent magnets are respectively arranged at the fifth, ninth, and thirteenth workstations; the permanent magnet placement grooves do not change their positions with the rotation of the turntable. The device of the present invention optimizes the working timing. One sample to be cleaned can be placed every T seconds. In the case of three rounds of cleaning, it takes 14*T seconds for the first sample to complete cleaning, and the time for each subsequent sample to complete cleaning is only separated from the previous sample by T seconds, greatly improving the throughput of cleaning samples.

The invention provides a blood marker combination for distinguishing lung non-cancerous diseases and early lung cancer as well as a screening method and application thereof, and belongs to the technical field of in-vitro diagnosis. By analyzing clinical indexes and metabonomics data of blood samples of patients with lung non-cancerous diseases and early-stage lung cancer, 27 specific blood marker combinations related to lung cancer are found, and can be used for developing a non-invasive, non-invasive and high-accuracy diagnostic product for distinguishing lung non-cancerous diseases and early-stage lung cancer. Effective clinical treatment strategies and guidance are provided for early discovery, early diagnosis and early intervention of the lung cancer.

The invention belongs to the technical field of in-vitro diagnosis, and discloses a chemiluminescence-based FGF21 detection kit and a preparation method thereof, and the kit comprises magnetic microspheres of which the surfaces are coupled with FGF21 specific antibodies, the FGF21 specific antibodies containing acridinium ester labels, a sample diluent, a luminescence pre-excitation liquid, an excitation liquid and FGF21 calibrators with different concentrations. According to the FGF21 detection kit disclosed by the invention, a method for preparing magnetic bead microspheres, carrying out surface modification and carrying out surface coupling on an FGF21 specific antibody is deeply explored, and the FGF21 specific antibody containing an acridinium ester label and a luminescence excitation system are matched, so that the prepared FGF21 detection kit can be used for accurately detecting FGF21 protein; and the detection kit has the advantages of high sensitivity, good accuracy, good repeatability and high automation degree of test operation, can treat a large batch of samples, further provides effective detection products and methods for clinical detection, and has strong practicability.

A process for ultrasensitive in vitro detection and / or quantification of a substance of interest in a sample is performed by detecting the luminescence emission by photoluminescent inorganic nanoparticles. The process includes (i) use of photoluminescent particles comprising a photoluminescent inorganic nanoparticle consisting of a crystalline matrix having at least 103 rare-earth ions, and coupled to a targeting agent for the substance to be analyzed, under conditions conducive to their association with the sample substance to be analyzed; (ii) exciting the rare-earth ions of the particles by an illumination device having a power of at least 50 mW and an excitation intensity of at least 1 W / cm2; (iii) detecting the luminescence emission by the particles after single-photon absorption; and (iv) determining the presence and / or concentration of the substance by interpreting said luminescence measurement. This process can be used for in vitro diagnostic purposes and as an in vitro diagnostic kit.

The invention is applicable to the field of in vitro diagnostic equipment, and discloses sample analysis equipment and a control method of the sample analysis equipment, the sample analysis equipment comprises a sample measuring device, a camera device, a display device and a control device, the display device is used for displaying a first interface, and the control device is used for controlling the camera device. The first interface is used for displaying a first target image obtained by shooting the sample container according to the camera device; and displaying a second target image obtained by shooting the sample container according to the camera device, information used for representing a hematocrit detection result of the blood sample, information used for representing a clot detection result of the blood sample, and information used for representing a liquid amount detection result of the blood sample. The information is at least one of information for representing a hemolysis detection result of the blood sample, information for representing a jaundice detection result of the blood sample, and information for representing a lipid detection result of the blood sample. According to the invention, the efficiency and intuition of blood sample quality auditing are improved.

The invention relates to the field of reagent strip packaging quality detection, in particular to an in-vitro diagnostic reagent strip packaging quality control method and system. The method comprises the following steps: acquiring a packaged in-vitro diagnostic reagent monitoring image; performing multi-scale reconstruction on the in-vitro diagnostic reagent monitoring image so as to generate a multi-scale noise reduction reconstructed monitoring image; performing image visual segmentation and image iteration packaging defect detection on the multi-scale noise reduction reconstruction monitoring image one by one so as to obtain a packaging defect part expansion monitoring image; carrying out surface defect texture mining on the packaging defect part expansion monitoring image, and carrying out deep defect factor inference so as to generate packaging defect inference factors; obtaining a reagent strip packaging log; and defect process tracing is performed on the reagent strip packaging log according to the packaging defect inference factors, so that packaging process stages causing defects are marked. The packaging parameters are automatically adjusted through real-time feedback, so that the packaging quality of the in-vitro diagnostic reagent strip is accurately improved.

A biodegradable and mouldable cassette for lateral flow assay device, and a lateral flow assay device comprising said cassette, and a kit comprising such a lateral flow assay device, for in vitro diagnostics of a biological sample comprising a diagnostic test strip inserted into the cassette. The cassette comprises a first cassette part and a second cassette part coupled to each other and defining a test chamber there between containing the diagnostic test strip. The cassette is made of a biodegradable material and at least one of the first cassette part and second cassette part is made of injection mouldable material, in particular gelatin or a gelatin composition.

The invention belongs to the technical field of in-vitro diagnostic reagents, and particularly relates to application of a detection reagent for GDF15 protein in extracellular vesicles in preparation of a prostate cancer diagnosis and / or staging kit. According to the invention, enrichment and proteomics detection are carried out on plasma EVs of patients with prostatic cancer (PCa) and benign prostatic hyperplasia (BPH), and through bioinformatics analysis, a potential EV protein marker GDF15 which can be used for early diagnosis of PCa is screened for the first time. The GDF15 protein is verified in a plurality of groups of new clinical queues by further adopting an immunological technology and a targeted quantitative mass spectrometry technology, and the distinguishing ability of the GDF15 protein to PCa and BPH and the distinguishing ability of the GDF15 protein to different PCa stages are determined. The method is expected to promote noninvasive precise diagnosis of clinical PCa, and has a good application prospect.