58 results about "HCV Antibody" patented technology

This invention discloses a kind of immunity chromatography test paper and its preparation method which can diagnose the type-C hepatitis virus fast, the said test paper includes the sampling tray, the gold size tray has labeled HCV mix antigen which links one end of the sampling tray closely, the pyroxylin film which links the other end of the gold size tray closely, and the suction sampling tray which links the other end of the pyroxylin film closely, the film encrusts the test (T) line and the quality control (C) line which are separate with each other, the sampling tray, the gold size tray, the film and the suction sampling tray are affixed in the plastic shoe plate to form the test paper, the said T line is the HCV mix antigen which is entrusted in the NC film, the said gold size tray has HCV recombination mix antigen, the said C line is the antibody of the HCV mix antigen entrusted in the film, it is used to test or clinical diagnosis of the HVC antigen, has the merits that the sensitive is high, the specificity is good, the operation is simple, the reaction is fast, it is fit to test in local and it is economical and useful.

The invention discloses a method for jointly detecting hepatitis C virus (HCV) antigen-antibody. A monoclonal antibody of an anti-HCV core antigen and a chimeric antigen are coated with enzyme-linked plate to be detected simultaneously, so that the method can shorten the 'window period' of HCV virus detection. Moreover, HCV antibodies in serum and the compatibility with the coated monoclonal antibody can be detected as possible so as to avoid the combination of the chimeric antigen and the monoclonal antibody by modifying HCV overall length core antigen, telescoping non-structural areas and realizing the expression of the chimeric antigen, and the positive detection rate is close to the PCR positive detection rate. The HCV detection method also has the advantages of simple operation, low price, so the method is suitable for promotion and application.

The present disclosure relates to polypeptides, including fusions thereof, nucleic acids, vectors, host cells, immunodiagnostic reagents, kits, and immunoassays for use detecting the presence of HCV antibodies. More specifically, the present invention describes specific NS3 antigens that can be used for the detection of anti-HCV antibodies.

The invention belongs to the technical field of immunodiagnosis, in particular relates to a hepatitis C virus (HCV) antibody diagnostic kit adopting a micro particle chemiluminescence method, and a preparation method thereof. The kit consists of anti-HCV detecting magnetic micro particles, an anti-HCV detecting tracer conjugate, anti-HCV sample diluted solution and a quality control material. Theinvention also discloses the preparation method of the diagnostic kit, which adopts micro particle chemiluminescence immunoassay technology, has higher sensitivity and specificity than enzyme-linked immuno sorbent assay (ELISA), is suitable for clinical HCV auxiliary diagnosis and blood donor screening, and makes up the blank of the domestic production of the diagnostic kits for detecting the anti-HCV by the micro particle chemiluminescence method.

The invention discloses a hepatitis C virus (HCV) antigen-antibody combined detection kit. The kit comprises a microwell plate coated with an HCV chimeric antigen and an HCV monoclonal antibody, a sample diluent, an HCV antigen-antibody combined detection enzyme working fluid, an HCV abzyme working fluid, an HCV antigen enzyme working fluid, a substance A fluid, a substance B fluid, a 20-times concentrated washing fluid and a stopping fluid. The invention also discloses preparation and usage of the key components of the kit, such as the microwell plate of the HCV chimeric antigen and the HCV monoclonal antibody, the sample diluent, and the diluent of enzyme working fluid. The kit and detection method, disclosed by the invention, are able to be used for detecting the HCV antigen and antibody at the same time, or individually detecting the situation of the HCV antigen during the early hepatitis c or the acute infection period, or before the antibody is produced, or when an antigen-antibody compound is produced, or individually detecting the situation of the HCV antibody after the antibody is produced; the kit and detection method can be applied to early HCV detection and therapy evaluation, so as to provide important detection evaluation index for clinical guideline.

The invention relates to a diagnostic reagent kit for testing the hepatitis c virus (HCV) and the preparation and test method, which is to add the HCV recombinant antigen used for peridium into the buffer solution, blend it, move into the luminous microplate, make incubation for 18 hours under 4DEG.C, wash the luminous microplate, add into the confining liquid, leave the liquid after incubation and fully dry the luminous microplate to complete the preparation of the pre-peridium luminous microplate; combine the anti-human IgG used for marking and the horse radish peroxidase by improving the sodium periodate to complete the preparation of the enzyme marker; prepare the chemical luminous substrate solution A with luminal, Tween20 and luminous intensifier and prepare the chemical luminous substrate solution B with the hydrogen peroxide. The reagent kit also comprises the sample diluent and concentrated scrub solution. The negative corresponds to the normal human serum while the positive corresponds to the people with serum of pooled serum with HCV antibody. The reagent kit provided in the invention has much higher detection sensitivity than the ELISA, which is safe and reliable, easy to operate with low cost, and without any expensive full-automatic chemical luminous measuring apparatus required.

This invention relates to hepatitis C virus diagnose agent box and its process method, which comprises the following steps: joining HCV regroup antigen to the buffer liquid into the enzyme yoke plate; hatching overnight for buffer liquid washing enzyme yoke plate; then joining buffer liquid and after hatching to abandon hole liquid for total enzyme yoke plate to complete the process of yoke plate; combining the marked HCV regroup antigen and horse radish peroxides enzyme through improved iodic acid method to complete the enzyme marked HCV antigen. The agent box has color liquid A and B, terminal liquid, sample diluent, negative comparing normal serum, positive comparing human serum with HCV antibody.

The invention relates to a HCV (Hepatitis C Virus) antibody detection kit based on a flowing microsphere carrier technology as well as a preparation method and a detection method thereof. The preparation method and the detection method comprise the following steps of: coating activated high molecular polymer microspheres on HCV recombinant antigen, enclosing blank combination points by using bovine serum albumin, and preparing specific HCV probe-high molecular polymer microspheres; co-culturing with a specimen to be tested and capturing HCV antibodies to the tested; washing and centrifugally removing combined HCV antibodies, and then adding fluorescently-labeled anti-human IgG or IgM antibodies; detecting the fluorescence intensity of the microspheres by using a flow cytometry and indirectly carrying out qualitative and quantitative analysis on the tested antibodies. The kit has high sensitivity, good specificity and good stability and can carry out multivalence detections including HCV antibodies simultaneously.

The present invention provides a kit for the detection of anti-hepatitis C virus (HCV) antibodies using a double-antigen sandwich technique, said kit carries out the detection by the process ‘solid support-first antigen-HCV antibody to be detected-second antigen-enzyme linked substance-recognizable signal’, wherein one or more coupling reactions between the second antigen and the enzyme linked substance occur, and the diluent for the second antigen and that for the enzyme linked substance are respectively placed into two container, they are added in order in two steps to reaction system and incubated respectively. The present invention can solve the following problems encountered by prior art: 1) the influence of the enzyme linked substance on the activity of the second antigen; 2) the mismatch of disulfide bonds in second antigen, thereby enhance the activity of the second antigen and obviate loss of enzyme activity, therefore, the present kit highly improves the sensitivity and specificity of the detection.

The invention belongs to the field of biotechnology and in particular relates to a method for detecting hepatitis C virus (HCV) antibody in serum, which comprises the following steps of: constructing an HCV gene and reporter gene recombinant plasmid provided with tagged protein gene, introducing the recombinant plasmid into a mammal cell line for expression, purifying fusion protein by using the tagged protein antibody, incubating the fusion protein and the serum, capturing an antigen-antibody complex by using immunomagnetic beads, and adding a reporter gene substrate to detect reporter gene activation level so as to reflect the content of the HCV antibody.

The invention discloses a truncated type hepatitis c virus HCV NS3 antigen which is a nonstructural protein amino acid sequence of the NS3 full-length gene encoded 1252th-1526aath segment in an HCV genome. The amino acid sequence is shown as SEQ ID NO.1, and a corresponding nucleotide sequence is shown as SEQ ID NO.2. A preparation method of HCV NS3 recombinant antigen protein comprises the steps that an optimized escherichia coli codon for expressing the truncated type hepatitis c virus HCV NS3 antigen are established, the nucleotide sequence of the codon is shown as SEQ ID NO.3, the gene segment of the codon undergoes double enzyme digestion and then is connected with an expression vector undergoing the enzyme digestion as well to obtain a recombinant expression plasmid, the antigen can perform expression by adopting a conventional method, and the antigen protein is obtained through purification. The antigen protein has high sensitivity and good specificity and is used for detecting an HCV antibody, and the coincidence rate of a detection result of a patient with positive hepatitis c virus RNA is as high as 97%. It is indicated that the antigen can be applied to polyclonal or monoclonal antibodies and preparation of hepatitis c virus detection kits and has good prospect of clinical application.

The invention relates to an HCV (hepatitis c virus) antibody detection reagent containing recombinant fusion antigens A and B, an application and the recombinant fusion antigens A and B, and belongs to the technical field of bioengineering. According to the HCV antibody detection reagent containing the recombinant fusion antigens A and B, the recombinant fusion antigen A contains an amino acid sequence as shown in SEQ ID NO: 2; the recombinant fusion antigen B contains an amino acid sequence as shown in SEQ ID NO: 4; the detection reagent comprises a reagent R1, a reagent R2, a reagent R3 anda reagent R4. The detection reagent has the following advantages: the two recombinant fusion antigens have the characteristics of high specificity and good stability and can be used for preparing thehepatitis C virus antibody detecting reagent by mixing in a certain ratio, and the clinical detection effect of the reagent is remarkable. Meanwhile, the detection reagent has high anti-interference capacity to chylomicron, bilirubin and hemoglobin, and can greatly meet requirements of clinical diagnosis of HCV.

The invention relates to a nondiagnostic HCV (hepatitis c virus) antibody immunodetection method and a kit. The method comprises steps as follows: an HCV antigen specifically captures an HCV antibody in a detection sample, a biotin-labeled second antibody is added, and an antigen-antibody-biotin-labeled second antibody compound is formed after incubation; in the presence of streptavidin, a biotin primer Biotin-I is added, incubation is performed, so that the compound and the Biotin-I are bound, and then, a hair grip chain H1 and a hairpin chain Biotin-H2 are added for a hybridization reaction; avidin-labeled horseradish peroxidase is added, a substrate solution is catalyzed to develop, and quantitative detection of the HCV antibody is performed by measuring the absorbance. ELISA (enzyme-linked immuno sorbent assay) is introduced into an HCR (hybridization chain reaction), HCR is used for signal amplification, ultra-sensitive detection of the HCV antibody is realized, and the lower limit of detection is lower than 10 pg/mL and is improved by at least two orders of magnitude as compared with conventional ELISA.

The invention discloses a multi sub-gene resistant type HCV (Hepatitis C Virus) antibody gene R3-19, wherein the heavy chain amino acid sequence thereof is shown by SEQ ID NO.38, and the light chain amino acid sequence is shown by SEQ ID NO.39, the antibody gene is obtained by vanning in an independently-constructed anti-HCV scFv antibody library through E2 region aa412-423 linear epitope (an HCV CD81 receptor binding epitope) synthetic peptide which is highly conservative in various subtype HCVs; the antibody library is formed by 39 parts of anti-HCV antibody positive peripheral blood samples of Chinese patients, the HCVs infected by the patients cover the main HCV popular subtypes in China, therefore, the R3-19 is an anti-HCV antibody which is typical in China and has wide binding characteristic, and has excellent application value in the fields of HCV diagnosis, HCV treatment, vaccine research and development and the like in China.

The invention relates to anti-HCV antibodies and more specifically to neutralizing anti-HCV antibodies and their variable and complementarity determining regions (CDR). In particular, the neutralizing anti-HCV antibodies are neutralizing anti-HCV envelope protein 1 (HCV E1) antibodies. Also subject of the invention are compositions comprising these antibodies, CDRs or variable regions, and compounds comprising at least one of the CDRs or variable regions of said antibodies. Further subject of the invention are the application of any of said antibodies, CDRs, variable regions or compounds in HCV prophylaxis, therapy, and diagnosis, as well as methods for producing the antibodies.