58 results about "Immunodiagnostics" patented technology

The invention relates to the technical fields of gene engineering, antibody engineering and immunodiagnosis. The invention provides a recombinant humanized anti-Cpn IgM monoclonal antibody. The monoclonal antibody comprises a light chain variable region and a heavy chain variable region, the light chain variable region comprises three complementary determining regions CDR1, CDR2 and CDR3, and the amino acid sequences of the three complementary determining regions are respectively shown as SEQ ID NO.3, SEQ ID NO.4 and SEQ ID NO.5; the heavy chain variable region comprises three complementary determining regions CDR1, CDR2 and CDR3, and the amino acid sequences of the three complementary determining regions are shown as SEQ ID NO.6, SEQ ID NO.7 and SEQ ID NO.8 respectively. The invention also provides a method for preparing the monoclonal antibody. The recombinant humanized anti-Cpn IgM monoclonal antibody provided by the invention is expressed in mammalian cells by utilizing a gene recombination technology, has the characteristics of high purity, small batch difference and the like, and can be applied to a Cpn IgM antibody detection kit as a quality control product; as a quality control product, the recombinant humanized anti-Cpn IgM monoclonal antibody has the advantages of high sensitivity, high safety, inter-batch stability and the like.

The invention belongs to the technical field of antibodies, and particularly relates to an antibody and an antibody pair for resisting human IL-12 / IL-23p40 protein, and application of the antibody and the antibody pair. The antibody is a first antibody or a second antibody, amino acid sequences of light chains CDR1-3 of the first antibody are respectively shown as SEQ ID NO.3-5, and amino acid sequences of heavy chains CDR1-3 of the first antibody are respectively shown as SEQ ID NO.8-10; the amino acid sequences of light chains CDR1-3 of the second antibody are respectively as shown in SEQ ID NO.13-15, and the amino acid sequences of heavy chains CDR1-3 of the second antibody are respectively as shown in SEQ ID NO.18-20. The two antibodies disclosed by the invention have specific recognition and high-affinity binding capacities on recombinant and natural human IL-12 / IL-23p40 protein, and have important practical values in the fields of immunodiagnosis and immunotherapy taking p40 as a target spot.

The invention discloses a recombinant protein for detecting an anti-myelin sheath related glycoprotein MAG antibody and a detection reagent of the recombinant protein, and belongs to the technical field of neural immunodiagnostics, five amino acid sites in MAG protein are subjected to specific amino acid point mutation replacement to obtain an MAG protein mutation sequence, the MAG protein mutation sequence is fused with GlcATP enzyme and HNK-1ST enzyme full-length sequences to construct a lentiviral expression vector, and the recombinant protein and the detection reagent are used for detecting the anti-myelin sheath related glycoprotein MAG antibody. According to the present invention, three genes are constructed, and are stably transfected in a host cell so as to stably express the three genes in one cell at the same time, such that the constructed recombinant protein and the wild type MAG protein have similar anti-MAG IgM antibody binding domain, and on the premise of not using GlcATP enzyme and HNK-1ST enzyme small molecule agonists, the sensitivity and the specificity of the detection of the MAG autoimmune antibody by using the CBA method are improved; the method is suitable for preparing related detection reagents for in-vitro detection of the IgM type anti-MAG antibody.

The invention belongs to the technical field of in-vitro immunodiagnosis, and particularly relates to a test strip for combined detection of AMH and FSH and a preparation method thereof.The test strip comprises a pretreated combination pad, a pretreated sample pad and a nitrocellulose membrane, and the nitrocellulose membrane is coated with an antibody; the preparation method of the test strip comprises the following steps: pretreating the conjugate pad with a conjugate pad pretreatment solution, drying, and spraying a fluorescent microsphere labeled antibody mixed solution; pretreating a sample pad with a sample pad pretreatment solution, and drying for later use; diluting the antibody by adopting a coating antibody diluent, marking on a nitrocellulose membrane, and drying for later use after marking is finished; the sample pad, the combination pad, the nitrocellulose membrane and the water absorption pad are sequentially pasted to a PVC bottom plate, and the test strip is cut. The test strip can jointly detect AMH and FSH indexes, is easy to operate, small in harm to the human body, economical and applicable, comprehensively detects multiple ovarian reserve function biological indexes, can more comprehensively and accurately evaluate the female fertility, and has good application prospects. The actual clinical requirements are met.

The present disclosure relates to a diagnostic cartridge for immunodiagnosis, and a reader and a diagnostic system using the same. A diagnostic cartridge, including the diagnostic pad and the color reaction pad, is provided to detect a color reaction and a fluorescence reaction through the single diagnostic cartridge.

The invention discloses an antibody pair, a reagent and a method for detecting helicobacter pylori, and relates to the field of immunodiagnosis. The antibody pair for detecting the helicobacter pylori comprises the first antibody and the second antibody, and the reagent and the detection method based on the antibody pair can accurately detect the existence of the helicobacter pylori.

The invention discloses an antibody for detecting RhD blood group antigen and application thereof, and relates to the technical field of immunodiagnosis. The anti-RhD blood group antigen antibody disclosed by the invention comprises a heavy chain complementarity determining region and a light chain complementarity determining region, provides an important raw material source for detection of the RhD blood group antigen, and has improved low-temperature stability.

This invention relates to a high-titer prealbumin antibody purification method and its application, belonging to the field of biotechnology. The method utilizes Protein A affinity chromatography to capture total IgG from antiserum, followed by purification using an affinity chromatography column prepared by targeted conjugation of a specific sequence peptide. The antibody purified by this method achieves a titer of 1:256,000 in ELISA detection, with a half-maximal effective concentration (EC50). 50 The antibody concentration was 3.2 ng / mL, exhibiting extremely high affinity and reactivity. When used in a double-antibody sandwich chemiluminescent immunoassay, it achieved a detection limit of 0.08 µg / mL, a wide dynamic range (0.08–400 µg / mL), and a titer retention rate as high as 88% after accelerated storage at 37°C for 14 days, demonstrating significantly better stability than antibodies prepared by traditional methods. This invention provides a highly active and stable core antibody raw material for the preparation of high-performance immunodiagnostic reagents.

The invention discloses an antibody pair, a reagent and a method for detecting CA15-3, and relates to the field of immunodiagnosis. The antibody pair for detecting the CA15-3 disclosed by the invention comprises the first antibody and the second antibody, and the reagent and the detection method based on the antibody combination can accurately detect the existence of the CA15-3.

The present invention discloses a recombinant protein for detecting anti-myelin associated glycoprotein (MAG) antibody and a detection reagent thereof, belonging to the technical field of neuro-immunodiagnosis. By performing specific amino acid point mutation substitutions at five amino acid positions in the MAG protein, a MAG protein mutant sequence is obtained, and then it is fused with the full-length sequences of GlcATPase and HNK-1ST enzyme to construct a lentiviral expression vector, which is stably transfected into host cells, enabling the simultaneous stable expression of the three genes in one cell. The constructed recombinant protein has a similar anti-MAG IgM antibody binding domain to the wild-type MAG protein, and without using small molecule agonists of GlcATPase and HNK-1ST enzyme, it improves the sensitivity and specificity of detecting MAG autoantibodies by the CBA method, and is suitable for preparing related detection reagents for in vitro detection of IgM-type anti-MAG antibodies.

The invention discloses a small molecule hapten detection reagent and a detection method, and relates to the technical field of immunodiagnosis. The detection reagent disclosed by the invention comprises a small-molecule hapten, an anti-small-molecule hapten antibody, a compound antibody and a signal marker, the detection method includes detecting at least a first signal and a second signal. According to the small-molecule hapten detection scheme, a more accurate detection reagent is provided for small-molecule hapten detection, and meanwhile, a novel more accurate detection method is provided for small-molecule hapten detection.

The invention belongs to the technical field of medical immunodiagnostic reagents, and discloses a freeze-dried VB12 rapid detection kit and a VB12 detection method. According to the kit provided by the invention, in the preparation process of a freeze-dried microsphere detection reagent, trehalose, glucose, gelatin, triton, polyethylene glycol, Proclin 950, 5-bromo-5-nitro-1, 3-dioxane, mannitol and glycine in a specific mass ratio are adopted as a freeze-drying solution system; stress damage to VB12 binding protein and a VB12 compound antibody in the freeze-drying process is reduced, the stability of the reagent in the preparation and storage process is improved, meanwhile, quick redissolution of the freeze-drying reagent can be achieved, and a detection system formed by compounding a reagent storage solution, a freeze-drying microsphere redissolution solution and a sample dissociation solution has the excellent anti-interference capacity and can be used for detecting the VB12 binding protein and the VB12 compound antibody in the freeze-drying process. The obtained detection kit has the advantages of excellent detection sensitivity, reliability, stability and the like, and has a very excellent practical application prospect.

The invention discloses a recombinant peanut allergen fusion protein and application thereof, the amino acid sequence of the recombinant peanut allergen fusion protein is as shown in SEQ ID NO.1, and the corresponding coding nucleotide sequence of the recombinant peanut allergen fusion protein is as shown in SEQ ID NO.2. The recombinant peanut allergen fusion protein comprises an Ara h 8 protein 1-157aa sequence fragment, an Ara h 9 protein 1-116aa sequence fragment and an Ara h 2 protein 22-172aa sequence fragment, the three proteins are sequentially connected through a Linker sequence to obtain the peanut allergen fusion protein, and a recombinant fusion expression method of the fusion protein and a detection kit based on the protein are provided. The fusion protein and the kit thereof can be applied to peanut desensitization treatment, can also improve the positive detection rate in immunodiagnosis application and eliminate cross interference caused by homologous sequences of other allergens, and can improve the performance of a peanut allergy diagnostic reagent as a raw material.

The invention discloses a vitamin B12 detection kit and a preparation method thereof, and relates to the technical field of immunodiagnosis, the vitamin B12 detection kit comprises a releasing agent solution, a neutralizer solution, a solid phase coating reagent solution, a liquid phase labeling reagent solution and a transcobalamin antibody solution. The releasing agent solution comprises a releasing agent, and the releasing agent comprises at least one of sodium hydroxide and potassium hydroxide; the solid-phase coating reagent solution comprises a goat anti-mouse IgG coated with carboxyl magnetic beads and a mouse vitamin B12 monoclonal antibody compound; the liquid phase labeling reagent solution comprises vitamin B12-BSA labeled by acridinium ester. According to the invention, the transcobalamin site obtained after the vitamin B12-transcobalamin compound is released is closed by using the transcobalamin antibody, so that the vitamin B12 and the transcobalamin are prevented from forming a compound again, and the value measurement accuracy of the vitamin B12 detection kit is improved.

The invention discloses a mycobacterium tuberculosis deletion region protein Rv1577c and a fusion antigen LB28 containing a mycobacterium tuberculosis RD region and a latent infection related antigen, wherein the fusion antigen comprises Rv1577c and Rv1738. The invention provides a candidate antigen Rv1577c of a tuberculosis subunit vaccine through antigen screening and experimental verification. The Rv1577c is deleted in BCG, so that the immunogenicity is better, and the Rv1577c has certain consistency with ESAT6 and CFP10 in bovine tuberculosis immunodiagnosis. And the Rv1577 is combined with a latent infection associated antigen Rv1738 to construct the tuberculosis fusion protein LB28. Under the assistance of an adjuvant DDA + PolyI: C (DP), the fusion protein LB28 shows good immunogenicity in a mouse model, and has an immune protection effect of resisting mycobacterium bovis infection. The Rv1577 and the fusion protein LB28 constructed based on the Rv1577 can be applied to animal and human tuberculosis prevention and treatment.

The invention discloses differential temperature comparison single molecule detection based on a reversible thermal change renaturation query probe, and relates to the field of single molecule immunodiagnosis. According to the invention, the property of repeated thermal denaturation / renaturation of the query probe is utilized, and the specific binding activity of the query probe is controlled, so that a specific binding molecular signal and a non-specific binding molecular signal of the query probe are distinguished, and a novel high-specificity single-molecule immunodiagnosis method is provided.

The utility model relates to the technical field of immunoassay instruments, in particular to a detection and analysis device with an anti-pollution function for immunodiagnosis, which comprises a fluorescence immunoassay instrument, a kit, a sealing assembly and a cleaning plate, the fluorescence immunoassay analyzer is provided with a detection area, the detection area is rotatably provided with a cover plate, the bottom of the detection area is provided with a placing groove, the placing groove is used for placing a kit, and the detection area is provided with a sliding cavity; a detection sample is linearly placed in the kit; a sealing assembly is arranged above the detection area, the sealing assembly is located above the kit, and when the cover plate closes the detection area, the sealing assembly seals the kit, the kit is sealed through the cover plate and the sealing assembly, so that the airtightness of the kit is guaranteed in the detection process of the fluorescence immunoassay analyzer, and the detection accuracy is improved. The reagent is prevented from volatilizing into the detection area and depositing in the detection area, so that the influence on subsequent light detection analysis of the reagent is avoided.

This invention relates to the field of immunodiagnostics and provides recombinant HIV antigens for HIV antibody detection. Specifically, it concerns recombinant HIV antigens, nucleic acid molecules, expression vectors, host cells, reagents, kits, and their use. When recombinant HIV antigen proteins are used as the labeling end, the marker activity of the recombinant HIV antigen can be significantly improved, and nonspecific immunobinding activity can be reduced, thereby increasing sensitivity.

The application discloses an antibody for detecting RhD blood group antigen and application thereof, and relates to the technical field of immunodiagnosis. The antibody for detecting RhD blood group antigen provided by the application comprises a heavy chain complementarity determining region and a light chain complementarity determining region, and the antibody provides an important raw material source for the detection of RhD blood group antigen and has improved low-temperature stability.

The invention discloses an antibody pair, a reagent and a method for detecting BNP (Brain Natriuretic Peptide), and relates to the field of immunodiagnosis. The antibody pair for detecting the BNP disclosed by the invention comprises the first antibody and the second antibody, and the reagent and the detection method based on the antibody combination can accurately detect the existence of the BNP.

The invention provides a recombinant antigen, a kit containing the same and application, and belongs to the technical field of immunodiagnosis. The invention particularly relates to a recombinant antigen containing rraB or MysB as a fusion partner, a recombinant nucleic acid molecule, a recombinant expression vector, a recombinant host cell, a marker conjugate, a kit and application. When the recombinant antigen is used for immunodiagnosis, the activity and specificity of immunodiagnosis can be remarkably improved.

The invention relates to the field of in-vitro immunodiagnosis detection, in particular to an IgG antibody of HSV-II, a recombinant IgM antibody and application. Wherein the IgG antibody comprises a heavy chain constant region, a light chain constant region, and a heavy chain variable region and a light chain variable region of the IgG monoclonal antibody specifically combined with the herpes simplex virus HSV-II, and the IgG monoclonal antibody is of a mouse source or a rabbit source. According to the present invention, the IgG antibody is modified to obtain the recombinant IgM antibody, and the IgG antibody and the recombinant IgM antibody not only are suitable for the chemiluminescence method, but also show the expected sensitivity amplification factor in other immunological detection methods, such that the low-abundance detection of the specific binding herpes simplex virus HSV-II can be easily achieved.

The invention belongs to the technical field of gene engineering, antibody engineering and immunodiagnosis, and discloses a recombinant humanized monoclonal antibody for resisting treponema pallidum membrane protein TP17 and application of the recombinant humanized monoclonal antibody for resisting the treponema pallidum membrane protein TP17. The sequence of a light chain amino acid fragment of the monoclonal antibody is shown as SEQ ID NO.11, and the sequence of a light chain amino acid fragment of the monoclonal antibody is shown as SEQ ID NO.12. The sequence of a light chain amino acid fragment of the monoclonal antibody is shown as SEQ ID NO.13. The sequence of a heavy chain amino acid fragment of the monoclonal antibody is as shown in SEQ ID NO. 12. The invention further discloses the monoclonal antibody, nucleic acid encoded by the monoclonal antibody, a recombinant expression vector carrying the nucleic acid and a host cell of the recombinant expression vector. The monoclonal antibody has high specificity and high detection sensitivity, and can be applied to preparation of a treponema pallidum detection kit and detection of treponema pallidum.

This invention discloses an antibody that binds to a T4-T4 antibody complex and its applications, relating to the field of immunodiagnostics. The antibody that binds to the T4-T4 antibody complex disclosed in this invention includes a heavy chain variable region and a light chain variable region. This antibody exhibits good activity, detection sensitivity, and clinical relevance, providing an important source of raw materials for the detection of T4.

This application relates to the field of tumor immunodiagnostic technology, and particularly to a monoclonal antibody, polynucleotide, preparation method, and application of antiphosphatidylinositol proteoglycan-3; the monoclonal antibody includes a heavy chain variable region and a light chain variable region, wherein the heavy chain variable region includes heavy chain region CDR1 with amino acid sequence as shown in SEQ ID NO:1, heavy chain region CDR2 with amino acid sequence as shown in SEQ ID NO:2, and heavy chain region CDR3 with amino acid sequence as shown in SEQ ID NO:3; the light chain variable region includes light chain region CDR1 with amino acid sequence as shown in SEQ ID NO:4, light chain region CDR2 with amino acid sequence as shown in SEQ ID NO:5, and light chain region CDR3 with amino acid sequence as shown in SEQ ID NO:6; the dissociation constant KD(M) of the monoclonal antibody against GPC3 antigen is 1.21E-11, which is a high-affinity N-terminal antibody, suitable for the detection of GPC3 in clinical serum samples.

The invention relates to novel HIV gp41 antigen compositions that are suitable for detecting antibodies against HIV in an isolated biological sample providing high specificity immunoassay results. It further relates to methods detecting HIV antibodies, use of novel HIV gp41 antigen compositions in immunoassays as well as to reagent kits comprising novel HIV gp41 antigen compositions.

The application relates to the technical field of immunodetection and immunodiagnosis, in particular to a chemiluminescence substrate solution, a chemiluminescence detection kit and a detection method. The chemiluminescence substrate solution comprises a substrate solution 1 or comprises the substrate solution 1 and a substrate solution 2; the substrate solution 1 comprises sodium hydroxide, a surfactant and a blue light absorber capable of absorbing blue light with a wavelength of 400-500 nm; and the substrate solution 2 comprises an inorganic acid and hydrogen peroxide. The blue light absorber is added in the chemiluminescence substrate solution, can absorb the blue light emitted by acridinium ester, reduce the light emission signal, in particular reduce the light emission value of the background caused by non-specific adsorption, and thus improve the signal-to-noise ratio.

The invention discloses a component liquid capable of improving the combination efficiency of Biotin and SA magnetic beads and a preparation method of the component liquid. The component liquid is mainly composed of a catalyst, other compounds, a surfactant, a metal chelating agent and the like. The component liquid provided by the invention can be applied to the field of detection of chemiluminescence immunodiagnostic reagents, in particular to numerous clinical sample detection items such as nail function, inflammation, hypertension, cytokines, bone metabolism, growth hormone and the like. The method not only can effectively shorten the time required by the reaction process, but also can remarkably amplify the sensitivity of the reagent. The shortening of the reaction time is beneficial to quickly obtaining a detection result in a third-level hospital with a huge sample size, and the method shows remarkable application advantages.

The invention belongs to the technical field of gene engineering, antibody engineering and immunodiagnosis, and discloses a preparation method of a monoclonal antibody for resisting treponema pallidum membrane protein TP17, which comprises the following steps: connecting a coding gene of the monoclonal antibody for resisting treponema pallidum membrane protein TP17 to an expression vector to construct a recombinant expression vector; transfecting the recombinant expression vector into a host cell, culturing, and finally collecting and separating a monoclonal antibody in a culture product; wherein the coding gene of the monoclonal antibody comprises a full-length coding gene sequence which is shown as SEQ ID NO.13 and is used for coding a light chain of the monoclonal antibody, and a coding gene which is shown as SEQ ID NO.14 and is used for coding the full length of a heavy chain of the monoclonal antibody. The yield and purity of the anti-treponema pallidum membrane protein TP17 monoclonal antibody prepared by the method are remarkably improved, the sensitivity and specificity of the antibody are high, and the monoclonal antibody can be applied to preparation of a treponema pallidum detection kit and detection of treponema pallidum.

Provided herein are compositions comprising protein encapsulated nanoparticles, and methods of making said compositions. In an aspect, provided herein are compositions comprising cytokine encapsulated nanoparticles, and methods of making said compositions. Further provided herein are methods of monitoring an immunophenotype of a subject and associated immunodiagnostic assays and immunodiagnostic compositions.