CN104155458A - Quantitative detection kit for human chorionic gonadotropin and application of quantitative detection kit - Google Patents
Quantitative detection kit for human chorionic gonadotropin and application of quantitative detection kit Download PDFInfo
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- CN104155458A CN104155458A CN201310616309.9A CN201310616309A CN104155458A CN 104155458 A CN104155458 A CN 104155458A CN 201310616309 A CN201310616309 A CN 201310616309A CN 104155458 A CN104155458 A CN 104155458A
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- human chorionic
- chorionic gonadotrophin
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- latex particle
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/74—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving hormones or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors
- G01N33/76—Human chorionic gonadotropin including luteinising hormone, follicle stimulating hormone, thyroid stimulating hormone or their receptors
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
- G01N33/54313—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals the carrier being characterised by its particulate form
- G01N33/54346—Nanoparticles
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Abstract
The invention discloses a quantitative detection kit for human chorionic gonadotropin. The quantitative detection kit comprises a reagent R1, a reagent R2 and a calibration material, wherein the reagent R1 comprises a Tris buffer solution, a beta-human chorionic gonadotropin monoclonal antibody and coarse nano latex particles; the reagent R2 comprises a Tris buffer solution, a beta-human chorionic gonadotropin monoclonal antibody, and thin nano latex particles; the calibration material is a beta-human chorionic gonadotropin calibration solution. According to the quantitative detection kit, the concentration of the human chorionic gonadotropin in serum is quantitatively determined by adopting a latex enhanced immune nephelometry; measurement results are accurate; the detection process is convenient and quick; determination results are stable; by adopting a dual-nano-latex technology, the determination linear range is wide and can reach 100,000IU/L, while the determination linear range of existing other methods does not exceed 20,000IU/L; moreover, the quantitative detection kit is suitable for existing various fully automatic biochemical analyzers, low in detection cost, and suitable for developing project determination in batches clinically.
Description
Technical field
The present invention relates to field of medical examination, particularly human chorionic gonadotrophin immue quantitative detection reagent box and uses thereof.
Background technology
Human chorionic gonadotrophin is that it is made up of α and the dimeric glycoprotein of β by a kind of glycoprotein of trophocyte's secretion of placenta.Wherein, α-subunit and tethelin are common, and beta subunit is that human chorionic gonadotrophin is special, is usually used in clinically the diagnosis of early pregnancy.Whether normally used early pregnancy Test paper is by human chorionic gonadotrophin in qualitative detection urine, detect pregnant.But, in judgement, the diagnosis of trophoblastic tumor and the auxiliary diagnosis of state of illness monitoring and some other tumour and the state of illness monitoring of abnormal pregnancy and placental function, just need the quantitative concentration value that detects human chorionic gonadotrophin in serum.β human chorionic gonadotrophin (β-HCG) is measured kit and is mainly adopted enzyme linked immunosorbent assay (ELISA) and chemiluminescence immunoassay method in the market.The former can only be qualitative or semiquantitative determination human serum in the concentration of β-HCG, and mensuration process is loaded down with trivial details, speed is slow, human factor impact is large; The latter needs special Full-automatic chemiluminescence apparatus, expensive; And both measurement ranges are all narrower.
Summary of the invention
In order to address the above problem, the invention provides a kind of human chorionic gonadotrophin immue quantitative detection reagent box, adopt latex enhancing immune turbidimetry, by β-HCG labeling of monoclonal antibody on polystyrene nanoparticles surface, carry out specific antigen-antibody reaction with the β-HCG in sample, occur turbidity, and nano particle amplifies this turbidity signal.Under 570-700nm wavelength, detect the variation of its absorbance, its intensity of variation is directly proportional to the β-HCG content in sample.By contrasting with typical curve, can calculate the β-HCG concentration in sample.The technical problem to be solved in the present invention is: the concentration determination process of the β-HCG in existing serum is loaded down with trivial details, and speed is slow, and human factor impact is large; Expensive; Measurement range is all narrower.
Technical scheme in the present invention is: human chorionic gonadotrophin immue quantitative detection reagent box, it is characterized in that, comprise reagent R1, reagent R2, calibration object, described reagent R1 comprises Tris damping fluid, β human chorionic gonadotrophin monoclonal antibody, thick nano rubber latex particle; Described reagent R2 comprises Tris damping fluid, β human chorionic gonadotrophin monoclonal antibody, thin nano rubber latex particle; Described calibration object is β human chorionic gonadotrophin calibration solution.
In such scheme, in described reagent R1, thick nanometer latex particle is 180-300 nano rubber latex particle; In described reagent R2, thin nanometer latex particle is 50-180 nano rubber latex particle.
In such scheme, in described reagent R1: the volumetric molar concentration of Tris damping fluid is 100mM, the weight accounting of β human chorionic gonadotrophin monoclonal antibody is that the weight accounting of 1%, 180-300 nano rubber latex particle is 1.5 ‰; In described reagent R2: the volumetric molar concentration of Tris damping fluid is 80mM, the weight accounting of β human chorionic gonadotrophin monoclonal antibody is that the weight accounting of 0.5%, 50-180 nano rubber latex particle is 2 ‰.
In such scheme, in described reagent R1, also contain 1 ‰ antiseptic, in described reagent R2, also contain 1 ‰ antiseptic.
In such scheme, described kit also comprises quality-control product, and described quality-control product is β human chorionic gonadotrophin control liquid 1, β human chorionic gonadotrophin control liquid 2, β human chorionic gonadotrophin control liquid 3.
Purposes of the present invention: for the monitoring of the controlled excess stimulation protocol of auxiliary diagnosis, Assisted Reproductive Technology ART of female sterility and male sexual dysfunction, sterile, delayed puberty, the auxiliary diagnosis of cryptorchidism.
Advantage of the present invention and beneficial effect are: the invention provides a kind of human chorionic gonadotrophin immue quantitative detection reagent box, adopt the concentration of human chorionic gonadotrophin in latex enhancing immune turbidimetry quantitative measurement serum, measurement result is accurate, testing process is convenient and swift, measurement result is stable, adopts double nano emulsion technique, measures the range of linearity wide, can reach 100000IU/L, and the mensuration range of linearity of existing other method is no more than 20000IU/L; And be applicable to existing various automatic clinical chemistry analyzers, inspection cost is low, is applicable to clinical batch and carries out this project mensuration.
Brief description of the drawings
Fig. 1 is the setting parameter table of the present invention on Olympus AU400/640/2700/5400 automatic clinical chemistry analyzer
Fig. 2 is the test process figure of the embodiment of the present invention
Embodiment
Below in conjunction with embodiment, the specific embodiment of the present invention is further described.Following examples are only for technical scheme of the present invention is more clearly described, and can not limit the scope of the invention with this.
The present invention is a kind of kit that adopts the concentration of human chorionic gonadotrophin in latex enhancing immune turbidimetry quantitative measurement serum, comprise reagent R1, reagent R2, calibration object, quality-control product, in reagent R1, comprise that volumetric molar concentration is the Tris damping fluid of 100mM, the β human chorionic gonadotrophin monoclonal antibody that weight accounting is 1%, the 180-300 nano rubber latex particle that weight accounting is 1.5 ‰, 1 ‰ antiseptic; In reagent R2, comprise that volumetric molar concentration is the Tris damping fluid of 80mM, β human chorionic gonadotrophin monoclonal antibody, weight accounting that weight accounting the is 0.5% thin nano rubber latex particle that is 2 ‰, 1 ‰ antiseptic; Calibration object is β human chorionic gonadotrophin calibration solution; Quality-control product is β human chorionic gonadotrophin control liquid 1, β human chorionic gonadotrophin control liquid 2, β human chorionic gonadotrophin control liquid 3.
In kit, the packing specification of reagent is reagent R130ml × 1; Reagent R210ml × 1.Kit is placed in 2-8 DEG C of lucifuge sealing and preserves, and from certainly producing, can stablize 12 months.
Set Olympus 2700 automatic clinical chemistry analyzers according to parameter list shown in Fig. 1: HCG parameter list (OLYMPUS AU400/640/2700/5400 is suitable for), ※ standard items concentration and position are please inputted according to actual conditions.
After blood sample collection to be measured, carry out centrifugal treating, get serum stand-by; Use Olympus 2700 automatic clinical chemistry analyzers, first reagent R1 is joined in cuvette, record absorbance A 1; In ten seconds, add working sample serum, hatch 1 minute in 37 DEG C; Then, add reagent R2, fully stir; React after 5 minutes to reaction end, record absorbance A 2.Adopt Two point end assay, by contrasting with typical curve, can calculate the HCG concentration in sample serum.Test process figure is shown in Fig. 2, its single wavelength: 600nm; Reaction method: end-point method; The Direction of Reaction: just; Calibration mode: non-linear Logit-log (5p) or spline.
Use the concentration of human chorionic gonadotrophin in quantitative measurement serum of the present invention can also be used in Hitachi 7060,7180; Roche COBAS; Olympus 2700; Beckman CX9, DXC800; Toshiba 40; The RXL of Du Pont; The C8000 of Abbott Laboratories; Step the automatic clinical chemistry analyzer of the models such as auspicious BS300.
The foregoing is only preferred embodiment of the present invention, in order to limit the present invention, within the spirit and principles in the present invention not all, any amendment of doing, be equal to replacement, improvement etc., within all should being included in protection scope of the present invention.
Claims (6)
1. human chorionic gonadotrophin immue quantitative detection reagent box, is characterized in that, comprises reagent R1, reagent R2, calibration object, and described reagent R1 comprises Tris damping fluid, β human chorionic gonadotrophin monoclonal antibody, thick nano rubber latex particle; Described reagent R2 comprises Tris damping fluid, β human chorionic gonadotrophin monoclonal antibody, thin nano rubber latex particle; Described calibration object is β human chorionic gonadotrophin calibration solution.
2. human chorionic gonadotrophin immue quantitative detection reagent box according to claim 1, is characterized in that, in described reagent R1, thick nanometer latex particle is 180-300 nano rubber latex particle; In described reagent R2, thin nanometer latex particle is 50-180 nano rubber latex particle.
3. human chorionic gonadotrophin immue quantitative detection reagent box according to claim 2, it is characterized in that, in described reagent R1: the volumetric molar concentration of Tris damping fluid is 100mM, the weight accounting of β human chorionic gonadotrophin monoclonal antibody is that the weight accounting of 1%, 180-300 nano rubber latex particle is 1.5 ‰; In described reagent R2: the volumetric molar concentration of Tris damping fluid is 80mM, the weight accounting of β human chorionic gonadotrophin monoclonal antibody is that the weight accounting of 0.5%, 50-180 nano rubber latex particle is 2 ‰.
4. human chorionic gonadotrophin immue quantitative detection reagent box according to claim 3, is characterized in that, in described reagent R1, also contains 1 ‰ antiseptic, in described reagent R2, also contains 1 ‰ antiseptic.
5. according to the arbitrary described human chorionic gonadotrophin immue quantitative detection reagent box of claim 1～4, it is characterized in that, described kit also comprises quality-control product, and described quality-control product is β human chorionic gonadotrophin control liquid 1, β human chorionic gonadotrophin control liquid 2, β human chorionic gonadotrophin control liquid 3.
6. the purposes of human chorionic gonadotrophin immue quantitative detection reagent box, for the monitoring of the controlled excess stimulation protocol of auxiliary diagnosis, Assisted Reproductive Technology ART of female sterility and male sexual dysfunction, sterile, delayed puberty, the auxiliary diagnosis of cryptorchidism.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN201310616309.9A CN104155458A (en) | 2013-11-27 | 2013-11-27 | Quantitative detection kit for human chorionic gonadotropin and application of quantitative detection kit |
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| CN201310616309.9A CN104155458A (en) | 2013-11-27 | 2013-11-27 | Quantitative detection kit for human chorionic gonadotropin and application of quantitative detection kit |
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| CN104155458A true CN104155458A (en) | 2014-11-19 |
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| CN201310616309.9A Pending CN104155458A (en) | 2013-11-27 | 2013-11-27 | Quantitative detection kit for human chorionic gonadotropin and application of quantitative detection kit |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107677837A (en) * | 2017-09-30 | 2018-02-09 | 安徽伊普诺康生物技术股份有限公司 | A kind of preparation method of β human chorionic gonadotrophins detection kit |
| CN107748266A (en) * | 2017-09-30 | 2018-03-02 | 安徽伊普诺康生物技术股份有限公司 | A kind of β human chorionic gonadotrophins detection kit and its application |
| CN110133247A (en) * | 2019-05-24 | 2019-08-16 | 深圳上泰生物工程有限公司 | A kind of immune latex turbidimetry method assay kit for testing goal antigen |
| CN110806487A (en) * | 2019-12-02 | 2020-02-18 | 深圳上泰生物工程有限公司 | Kit for detecting human heparin binding protein and preparation method thereof |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4003988A (en) * | 1976-06-01 | 1977-01-18 | Warner-Lambert Company | Direct agglutination test for pregnancy |
| WO2009066731A1 (en) * | 2007-11-21 | 2009-05-28 | Arkray, Inc. | Measurement reagent, immune nephelometry using the same, and analyte analysis tool |
| CN102590524A (en) * | 2011-12-30 | 2012-07-18 | 北京九强生物技术股份有限公司 | Assay kit for neutrophil gelatinase-associated lipocalin |
| CN102590497A (en) * | 2012-01-13 | 2012-07-18 | 宁波美康生物科技股份有限公司 | Cysteine protease inhibitor C test kit |
-
2013
- 2013-11-27 CN CN201310616309.9A patent/CN104155458A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4003988A (en) * | 1976-06-01 | 1977-01-18 | Warner-Lambert Company | Direct agglutination test for pregnancy |
| WO2009066731A1 (en) * | 2007-11-21 | 2009-05-28 | Arkray, Inc. | Measurement reagent, immune nephelometry using the same, and analyte analysis tool |
| CN102590524A (en) * | 2011-12-30 | 2012-07-18 | 北京九强生物技术股份有限公司 | Assay kit for neutrophil gelatinase-associated lipocalin |
| CN102590497A (en) * | 2012-01-13 | 2012-07-18 | 宁波美康生物科技股份有限公司 | Cysteine protease inhibitor C test kit |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107677837A (en) * | 2017-09-30 | 2018-02-09 | 安徽伊普诺康生物技术股份有限公司 | A kind of preparation method of β human chorionic gonadotrophins detection kit |
| CN107748266A (en) * | 2017-09-30 | 2018-03-02 | 安徽伊普诺康生物技术股份有限公司 | A kind of β human chorionic gonadotrophins detection kit and its application |
| CN110133247A (en) * | 2019-05-24 | 2019-08-16 | 深圳上泰生物工程有限公司 | A kind of immune latex turbidimetry method assay kit for testing goal antigen |
| CN110806487A (en) * | 2019-12-02 | 2020-02-18 | 深圳上泰生物工程有限公司 | Kit for detecting human heparin binding protein and preparation method thereof |
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Application publication date: 20141119 |