36 results about "Treponema pallidum antibody" patented technology

The invention discloses a kit of chemiluminescent immunological analysis measurement of a Treponema pallidum antibody, and preparation method thereof, which belongs to the technical field of immunological analysis medical diagnosis. The kit comprises (1) a carrier coated with a treponema pallidum specific recombination protein antigen; (2) treponema pallidum antibody negative and positive reference substances; (3) an enzyme labeled treponema pallidum specific recombination protein antigen; and (4) an enzyme acted chemiluminescent primer. Furthermore, the preparation method of the kit based on the invention comprises the following steps of (1) preparing TP antibody negative and positive reference substances; (2) labeling the TP specific recombination protein antigen with an enzyme; (3) coating with the carrier; (4) sub-packaging; and (5) assembling. The kit of the detection of the Treponema pallidum antibody has the advantages of easy and simple operation, easy popularization, high sensitivity, strong specificity, good repeatability, safety, non toxicity, and no pollution.

The invention aims to provide a reagent for assaying an antiphospholipid antibody which is excellent in long-term storage stability and capable of diagnosing syphilis infection or the like and a reagent for assaying an anti-Treponema pallidum antibody which is capable of diagnosing syphilis infection with high accuracy by preventing the occurrence of serum interference. The invention is directed to the reagent for assaying an antiphospholipid antibody to be used for diagnosing syphilis infection comprising an insoluble carrier carrying an antiphospholipid antigen and a copolymer with a segment derived from 2-methacryloyloxyethyl phosphorylcholine and a segment derived from a hydrophilic monomer.

The invention belongs to the technical field of immunologic diagnosis, in particular to a treponema pallidum antibody diagnostic kit by a chemiluminescence method and a preparation method thereof. The kit comprises an anti-TP test reaction plate, an anti-TP test enzyme complex, chemiluminescence substrate liquid, concentrated washing liquor, a negative contrast and a positive contrast. The invention also discloses a preparation method of the diagnostic kit, which adopts a chemiluminescence immunoassay technology; compared with ELISA (enzyme-linked immuno sorbent assay), the method has higher sensitivity and specificity, is suitable for the auxiliary diagnosis of clinical syphilis and screening of blood donors and fills a blank of the production of a treponema pallidum antibody diagnostic reagent detected by the domestic chemiluminescence method.

The invention belongs to the technical field of immunoassay and diagnosis and relates to a method for magnetic antibody immunoassay chemiluminescence detection of treponema pallidum antibodies. The method comprises the following steps of: using GoldMag particles as carriers, coating one or more antigens of specific recombinant proteins of treponema pallidum antibodies, TP15, TP17, TP47 and TP44.5, then adding a sample to be detected and enzyme labeled antigens, and finally adding luminescence substrates for luminescence detection. The GoldMag particle surface has a larger coupling capacity to the antigen and has characteristics of high specificity and no pollution of the enzyme linked immunoassay as well as high sensitivity of chemiluminescence, and therefore, the method has the advantages of high detection sensitivity, good specificity, wide linear range, no radioactive pollution and the like.

The invention relates to a treponema pallidum (TP) antibody test kit based on the flow microspheric carrier technology and a preparation method and detection method thereof, belonging to the technical field of immunoassay medical diagnosis. The preparation method comprises the following steps: using TP recombinant antigen to coat heavy polymer microsphere, using bovine serum albumin to seal empty binding site, preparing specific TP probe-heavy polymer microsphere; performing coculture with a sample to be tested to capture TP antibody, washing and centrifuging to remove the unbound TP antibody, then adding fluorescently-labeled anti-human IgG or IgM antibody; and using a flow cytometry to detect the fluorescence intensity of the microsphere, and performing qualitative or quantitative analysis to the tested antibody. The method has the advantages of high sensitivity and specificity and good stability and can be used to perform microanalysis or multivalent analysis to the sample.

The invention discloses a kit for detecting a treponema pallidum antibody as well as a detection method and an application thereof, and belongs to the technical field of in vitro diagnosis and detection. The kit consists of the following components: (1) a marker system: including a treponema pallidum recombinant antigen 1 in direct or indirect connection to a marking tracer, or staphylococcus aureus A protein in direct or indirect connection to the marking tracker; (2) a bridged compound system: including a treponema pallidum recombinant antigen 2 in direct or indirect connection to a first bridged compound; and (3) a magnetic microsphere system: comprising a magnetic microsphere in direct or indirect connection to a second bridged compound, wherein the first bridged compound is combined with the second bridged compound. The kit and the detection method disclosed by the invention can promote the full implementation of conjugation reaction between antigen and antibody; and detection sensitivity can be improved.

The related fast detection agent for syphilis spirochete antibody comprises a fast detection paper prepared by cellulose nitrate covered by pure syphilis spirochete monoclonal antibody and dried gold-mark monoclonal antibody. Wherein, with colloid gold immune chromatography technology and double antigen sandwich way, detecting syphilis spirochete and its fragment in humor, secretion and culture. This invention has more clinic meaning, high specificity, well sensitivity, and fit to wide spread.

This invention discloses a diagnostic reagent of syphilis spirochete antibody enzyme labeling for diagnosing syphilis spirochete infection, containing synthetic peptide antigen or genetic engineering expressed antigen: antigen P15, P17, P47, 0.1-10 mg / ml coated on the enzyme labeling, the enzyme labeling two antigens (IgG, IgM): containing 1:20-1:100K their diluents solution and color-developing agent combination and solubilizer in which the said color-developing agent in the combination is TMB. The said combination can include combination of TMB with hydrogen peroxide cumon ir its derivatives or TMB with hydroxyurea. On the bases of applied synthetic peptide antigen and genetic engineering expressing antigen, a TMB saline is used in the diagnostic reagent with excellent water solubility and stable performance, matched with proper solubilizers, stabilizers to get much better stable performance.

The invention discloses a spittle rapid detection strip for a treponema pallidum antibody, comprising a baseboard, to which a sample pad, a colloidal gold pad, a nitrocellulose membrane and a sample-drawing pad are sequentially adhered. The invention is characterized in that a mouse-anti-human IgG antibody which is marked by the colloidal gold and can be integrated with the specificity of the treponema pallidum antibody is attached to the colloidal gold pad; and the nitrocellulose membrane is coated with a detection line formed by the treponema pallidum antibody and a quality control line formed by a goat-anti-mouse antiantibody which can be integrated with the specificity of the mouse-anti-human IgG antibody. The spittle rapid detection strip provided by the invention adopts the colloidalgold marking technology to detect the treponema pallidum antibody in spittle so as to determine whether the person is infected with syphilis, and has the advantages that operation is simple; reactionis quick; sensitivity is high; specificity is strong; and the spittle rapid detection strip can be applied to both on-site detection and self-detection, and is economical and practical and the like.

An antigen composition and method for the detection of antibodies to Treponema pallidum and the diagnosis of syphilis are described. The antigen composition contains synthetic cardiolipin and synthetic lecithin. The antigen composition may additionally contain cholesterol and an alcohol. The antigen composition is useful as an immunoreagent in immunoassays for the detection of antibodies associated with T. pallidum infection. The methods are sensitive and specific for T. pallidum infection.

The invention relates to a treponema pallidum IgG antibody biotin avidin enzyme-linked immune detection kit and a preparation method thereof, which relates to the syphilis detection. The kit comprises a concentrated washing liquid bottle, a negative and positive control bottle, a biotin mark antihuman IgG specific fragment gamma chain monoclonal antibody bottle, a horseradish peroxidase mark avidin bottle, a TMB coloured solution bottle A, a coloured solution bottle B, a reaction stopping solution bottle, a micropore plate coated with recombinant antigen. The treponema pallidum has infectious standard strain Nichol strain and treponema pallidum non-infectious standard strain Reiter strain, by using a proteomics method, the treponema pallidum proteomics can be separated through dimensional electrophoresis, protein with strong immunogenicity can be identified by different patient or infectious animal serum, and then an antigen marker can be searched. The antigen marker is used for syphilis confirmation test, so that diagnosis sensitivity and specificity can be increased, a window stage is shortened. The treponema pallidum antibody can be sensitively detected and enables quantitative measurement, and has the advantages of cheap price, simple operation and accurate result.

It is an object of the present invention to provide a reagent for assaying anti-phospholipid antibodies, which is excellent in long-term storage stability and enables an accurate diagnosis of syphilitic infection, and a reagent for assaying anti-Treponema pallidum antibodies, which enables an accurate diagnosis of syphilitic infection by preventing an occurrence of serum interference.The present invention is a reagent for assaying anti-phospholipid antibodies used for diagnosing syphilitic infection, which contains an insoluble carrier supporting an anti-phospholipid antigen thereon and a copolymer having a segment derived from 2-methacryloyloxyethyl phosphorylcholine and having a segment derived from a hydrophilic monomer.

The invention relates to a four-in-one combined detection test paper box. A coating film of a test paper strip is provided with a quality control region and a detection region in sequence from top to bottom; the quality control region and the detection region are provided with a quality control line and a detection line respectively; and the detection line is composed of an AIDS (Acquired Immune Deficiency Syndrome) virus 1 / 2 type antibody detection line, a hepatitis B surface antigen detection line, a hepatitis C antibody detection line and a treponema pallidum antibody detection line, which are arrayed in sequence from top to bottom. The invention further relates to a preparation process of the test paper box. The preparation process comprises the steps of preparing a label pad, preparing the detection line, preparing the quality control line, preparing a sample pad and preparing a sample diluted solution. According to the product provided by the invention, four infectious diseases can be simultaneously detected on one test paper strip in one step; and the required amount on samples is less and the detection is rapid and accurate.

The invention discloses a treponema pallidum antibody detection kit. The kit comprises a magnetic separation reagent, a biotin antigen, an enzyme-labeled reagent comprising a detection antigen and a detection antibody coupled alkaline phosphatase, a negative control, a positive control and a calibration solution. The biotin antigen and detection antigen are recombinant antigens. The detection antibodies comprise a mouse monoclonal antibody and a mouse second antibody. The calibration solution contains an antibody to be detected. The invention discloses a detection method of the kit. Through combination of an indirect method and a double antigen sandwiching method, double antigen sandwiching method specificity is guaranteed and the problem that according to the double antigen sandwiching method, two solid phase antigens or two tracer-labeled antigens are bonded to the same antibody so that detection is unsuccessful and false positive or false negative detection result is avoided. The combined indirect method and double antigen sandwiching method produce effects better than those of the single indirect method or double antigen sandwiching method.

It is an object of the present invention to provide a method for preventing serum interference for assaying anti-Treponema pallidum antibodies and for improving storage stability of reagent of anti-phospholipid antibodies, which is excellent in long-term storage stability and enables an accurate diagnosis of syphilitic infection by preventing an occurrence of serum interference. The step of assaying anti-Treponema pallidum antibodies comprises a process that a sample is contacted with the anti-Treponema pallidum antibody reagent having an insoluble carrier supporting an anti-Treponema pallidum antigen thereon, a process that the insoluble carrier supporting an anti-Treponema pallidum antigen thereon is reacted with the anti-Treponema pallidum antibody in the sample, and a process that agglutination level of the antigen-antibody reaction is determined by optical measurement or visual observation, wherein the anti-Treponema pallidum antibody assaying reagent is added with a copolymer having a segment derived from 2-methacryloyloxyethyl phosphorylcholine and a segment derived from a hydrophilic monomer.

A reagent using magnetic agglutination method to detect antibody of syphilis spire is prepared as enveloping recombined syphilis antigen on surface of magnetic particle then using magnetic agglutination method to carry out detection on antibody of syphilis spire and forming said magnetic particle by NaOH, HCI, FeCI2.4H2O and FeCI3 .6H2O.

The invention discloses a rapid detection method of the treponema pallidum antibody in serum and an application thereof. According to the rapid detection method of the treponema pallidum antibody in serum, resin particles modified with protein A and protein G are used for capturing the antibody in serum; the luciferase-fused syphilis lipoproteins TP15, TP17 and TP47 are used for combination with the antibody captured on the resin; and then sensitive and rapid detection of the treponema pallidum antibody in serum is realized by detecting the luminescent activity of the fused thermostable luciferase. The luciferase and syphilis lipoprotein fusion protein used by the rapid detection method of the treponema pallidum antibody in serum can specifically bind to the antibody of treponema pallidum,and the luciferase therein is a luciferase with good thermal stability. The fusion protein is applied to the rapid detection method disclosed by the invention, the rapid detection method uses a smallamount of serum sample, and only 1 [Mu]L of serum can be used to detect the treponema pallidum antibody in serum within 20 minutes, which can accurately distinguish negative or positive of the antibody and has similar sensitivity to the traditional ELISA.

The invention belongs to the field of biological detection technologies and relates to a treponema pallidum antibody detection card, a kit and a detection method. The treponema pallidum antibody detection card comprises test paper and a plastic shell; the test paper comprises a bottom plate; a sample pad, a bonding pad, nitrocellulose membrane and absorbent paper are sequentially arranged on the bottom plate from the left to right of the bottom plate; the nitrocellulose membrane is provided with a detection zone and a control zone from the left to right of the nitrocellulose membrane; a glassfibre membrane is soaked by a sample pad treatment liquid and dried, so that the sample pad can be obtained; a mixed immunogold solution is sprayed onto the glass fibre membrane, so that the bonding pad can be obtained; a treponema pallidum recombinant antigen diluted by a coating solution is sprayed onto the nitrocellulose membrane, so that the detection zone can be formed; and an anti-chicken IgY antibody diluted by the coating solution is sprayed onto the nitrocellulose membrane, so that the control zone can be formed. The detection card of the invention has the advantages of convenience inapplication and accurate results, and provides a basis for the accurate treatment of syphilis in the next step, and is suitable for being popularized and applied on a large scale.

The invention discloses a Treponema pallidum antibody detection kit and a preparation method thereof. The Treponema pallidum antibody detection kit is composed of the following components: TP antigen-coating magnetic microspheres, a negative reference substance, a positive reference substance, a TP antigen marker bound to lanthanides, an analytical buffer, a cleaning solution, an enhancement solution and an RFID card. Based on combination of the magnetic microspheres and a time-resolved immunoassay method, the drawbacks of long physical adsorption reaction time and slow detection result of anenzyme label plate are overcome, and the reaction time is greatly shortened; and besides, the advantages of high accuracy, high sensitivity, strong specificity, wide linear range, and stable and convenient detection of a time-resolved detection technology can also be realized. The magnetic microspheres are coated with corresponding antigens or antibodies, due to the stereoscopic characteristic ofthe magnetic microspheres, the contact surface area of an immune response is greatly increased, the detection time is greatly shortened, and a result can be obtained through detection in 30 minutes.

The invention relates to the technical field of in vitro diagnosis, in particular to a treponema pallidum antibody detection kit. The kit comprises treponema pallidum antigen coupling magnetic particles, a treponema pallidum antigen enzyme conjugate and a chemiluminiscence substrate, the treponema pallidum antigen enzyme conjugate is a buffer solution containing a treponema pallidum antigen markedby a biological enzyme, urokinase and calf serum. According to the invention, magnetic particles are used as a solid-phase carrier of the antibody, and a chemiluminescence immunoassay technology is utilized, so that single-person, random, rapid and automatic detection can be realized on a full-automatic chemiluminescence analyzer. Tests prove that adding 0.1-30U / mL of urokinase into the enzyme conjugate has no influence on indexes such as sensitivity, specificity, stability, precision and the like, but the clinical retest rate is greatly improved.

The invention discloses a method and a device for judging the detection result of a treponema pallidum antibody. The method comprises the following steps: performing agglutination reaction on serum or plasma of a to-be-detected patient by the treponema pallidum antibody and performing reaction on the serum or plasma of the to-be-detected patient without the treponema pallidum antibody separately by a treponema pallidum gelatin agglutination test method to acquire respective sample reaction plates; obtaining pictures of a to-be-detected sample and the control sample reaction plates; performing imaging processing on the pictures to acquire a plurality of pixel points and corresponding agglutination color pixel values from the pictures, and converting the pictures into two-dimensional data for storage; comparing parameters, such as shape, peak value, ratio of peak height to peak width, peak valley, difference value between peak height and peak valley and agglutination ring size, of agglutination color gray value curves of a to-be-detected group and a control group with a standard threshold value to judge the detection result. According to the method and the device for judging the detection result of the treponema pallidum antibody, the detection result of the treponema pallidum antibody can be judged more accurately and the detection efficiency is improved.

To provide a reagent for assaying anti-Treponema pallidum antibody which reagent contains a polypeptide antigen and which reagent provides high assay sensitivity and high specificity, and to provide an assay method employing the assay reagent.The reagent for assaying anti-Treponema pallidum antibody, for use in an assay of anti-Treponema pallidum antibody on the basis of antigen-antibody reaction is characterized in that the reagent contains, as an antigen, a recombinant polypeptide containing at least domain C and domain D of Treponema pallidum 47 kDa antigen but containing no domain A1 of the 47 kDa antigen.

The invention discloses a kit for detecting a treponema pallidum antibody in urine, a preparation method and a use method. The kit comprises a detection test strip. The detection test strip comprisesa sample pad, a combination pad, a nitrocellulose membrane, absorbent paper and a PVC bottom plate, wherein the sample pad, the combination pad, the nitrocellulose membrane and the absorbent paper aresequentially adhered to the PVC bottom plate; the combination pad is coated with a recombinant protein A (SPA)-colloidal gold marker, and the nitrocellulose membrane is respectively coated with a detection line composed of TP recombinant antigen and a quality control line composed of rabbit anti-SPA. Besides, a urine sample is concentrated through a concentration medium, so that the content of the treponema pallidum antibody in urine is increased, and the sensitivity of the kit for detecting the treponema pallidum antibody in the urine is improved. The detection sensitivity can be improved by2 to 6 times. While the kit is used, the urine is used as a detection sample, and sampling operation can be conducted in asafe, simple, convenient and noninvasive manner. And the kit is high in sensitivity, strong in specificity, convenient to operate and suitable for detection under various conditions.

The invention aims to provide a reagent for assaying an antiphospholipid antibody which is excellent in long-term storage stability and capable of diagnosing syphilis infection or the like and a reagent for assaying an anti-Treponema pallidum antibody which is capable of diagnosing syphilis infection with high accuracy by preventing the occurrence of serum interference. The invention is directed to the reagent for assaying an antiphospholipid antibody to be used for diagnosing syphilis infection comprising an insoluble carrier carrying an antiphospholipid antigen and a copolymer with a segment derived from 2-methacryloyloxyethyl phosphorylcholine and a segment derived from a hydrophilic monomer.

The invention relates to a treponema pallidum IgM antibody biotin avidin enzyme-linked immune detection kit and a preparation method thereof, which relates to the syphilis detection. The kit comprises a concentrated washing liquid bottle, a negative and positive control bottle, a biotin mark antihuman IgM specific fragment mum chain monoclonal antibody bottle, a horseradish peroxidase mark avidin bottle, a TMB coloured solution bottle A, a coloured solution bottle B, a reaction stopping solution bottle, a micropore plate coated with recombinant antigen. The treponema pallidum has infectious standard strain Nichol strain and treponema pallidum non-infectious standard strain Reiter strain, by using a proteomics method, the treponema pallidum proteomics can be separated through dimensional electrophoresis, protein with strong immunogenicity can be identified by different patient or infectious animal serum, and then an antigen marker can be searched. The antigen marker is used for syphilis confirmation test, so that diagnosis sensitivity and specificity can be increased, a window stage is shortened. The treponema pallidum antibody can be sensitively detected and enables quantitative measurement, and has the advantages of cheap price, simple operation and accurate result.

To provide a reagent for assaying anti-Treponema pallidum antibody which reagent contains a polypeptide antigen and which reagent provides high assay sensitivity and high specificity, and to provide an assay method employing the assay reagent.The reagent for assaying anti-Treponema pallidum antibody, for use in an assay of anti-Treponema pallidum antibody on the basis of antigen-antibody reaction is characterized in that the reagent contains, as an antigen, a recombinant polypeptide containing at least domain C and domain D of Treponema pallidum 47 kDa antigen but containing no domain A1 of the 47 kDa antigen.

The invention relates to a treponema pallidum total antibody biotin avidin enzyme-linked immune detection kit and a preparation method thereof, which relates to the syphilis detection. The kit comprises a concentrated washing liquid bottle, a negative and positive control bottle, a biotin mark antihuman recombination antigen bottle, a horseradish peroxidase mark avidin bottle, a TMB coloured solution bottle A, a coloured solution bottle B, a reaction stopping solution bottle, a micropore plate coated with recombinant antigen. The treponema pallidum has infectious standard strain Nichol strain and treponema pallidum non-infectious standard strain Reiter strain, by using a proteomics method, the treponema pallidum proteomics can be separated through dimensional electrophoresis, protein with strong immunogenicity can be identified by different patient or infectious animal serum, and then an antigen marker can be searched. The antigen marker is used for syphilis confirmation test, so that diagnosis sensitivity and specificity can be increased, a window stage is shortened. The treponema pallidum antibody can be sensitively detected and enables quantitative measurement, and has the advantages of cheap price, simple operation and accurate result.

The present invention relates to a recombinant chimeric antigen of Treponema pallidum, which consists of the amino acid sequence shown in SEQ ID NO.12, the first flexible linker, the amino acid sequence shown in SEQ ID NO.9, the second flexible linker It is formed in series with the amino acid sequence shown in SEQ ID NO.13. The recombinant chimeric antigen of the invention can be used for serological detection of treponema pallidum antibody, and has improved dissolution expression ability, activity and thermal stability. The present invention also relates to a method for preparing the recombinant chimeric antigen.