CN104049085A - CRP latex-reinforced immunonephelometry reagent, its kit and use of kit - Google Patents
CRP latex-reinforced immunonephelometry reagent, its kit and use of kit Download PDFInfo
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- CN104049085A CN104049085A CN201310079651.XA CN201310079651A CN104049085A CN 104049085 A CN104049085 A CN 104049085A CN 201310079651 A CN201310079651 A CN 201310079651A CN 104049085 A CN104049085 A CN 104049085A
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- crp
- enhancing immune
- reagent
- turbidimetric assay
- latex
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- 239000003153 chemical reaction reagent Substances 0.000 title claims abstract description 94
- 239000004816 latex Substances 0.000 claims abstract description 71
- 229920000126 latex Polymers 0.000 claims abstract description 71
- 239000002245 particle Substances 0.000 claims abstract description 35
- 239000004094 surface-active agent Substances 0.000 claims abstract description 9
- 230000002421 anti-septic effect Effects 0.000 claims abstract description 8
- 239000000546 pharmaceutical excipient Substances 0.000 claims abstract description 8
- 239000003381 stabilizer Substances 0.000 claims abstract description 6
- 239000000872 buffer Substances 0.000 claims abstract description 4
- 230000002708 enhancing effect Effects 0.000 claims description 36
- PXIPVTKHYLBLMZ-UHFFFAOYSA-N Sodium azide Chemical compound [Na+].[N-]=[N+]=[N-] PXIPVTKHYLBLMZ-UHFFFAOYSA-N 0.000 claims description 30
- 238000007817 turbidimetric assay Methods 0.000 claims description 27
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 24
- 238000013016 damping Methods 0.000 claims description 24
- 239000012530 fluid Substances 0.000 claims description 24
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 20
- 235000002639 sodium chloride Nutrition 0.000 claims description 14
- HEMHJVSKTPXQMS-UHFFFAOYSA-M sodium hydroxide Inorganic materials [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 14
- HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 claims description 10
- HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 claims description 10
- HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 claims description 10
- 235000011187 glycerol Nutrition 0.000 claims description 10
- 239000011780 sodium chloride Substances 0.000 claims description 9
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 claims description 8
- 239000007853 buffer solution Substances 0.000 claims description 8
- GPRLSGONYQIRFK-MNYXATJNSA-N triton Chemical compound [3H+] GPRLSGONYQIRFK-MNYXATJNSA-N 0.000 claims description 8
- 239000000375 suspending agent Substances 0.000 claims description 7
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 claims description 6
- RAXXELZNTBOGNW-UHFFFAOYSA-N imidazole Natural products C1=CNC=N1 RAXXELZNTBOGNW-UHFFFAOYSA-N 0.000 claims description 6
- 150000003839 salts Chemical class 0.000 claims description 5
- NLXLAEXVIDQMFP-UHFFFAOYSA-N Ammonia chloride Chemical compound [NH4+].[Cl-] NLXLAEXVIDQMFP-UHFFFAOYSA-N 0.000 claims description 4
- 108010010803 Gelatin Proteins 0.000 claims description 4
- PMZURENOXWZQFD-UHFFFAOYSA-L Sodium Sulfate Chemical compound [Na+].[Na+].[O-]S([O-])(=O)=O PMZURENOXWZQFD-UHFFFAOYSA-L 0.000 claims description 4
- 229920000159 gelatin Polymers 0.000 claims description 4
- 239000008273 gelatin Substances 0.000 claims description 4
- 235000019322 gelatine Nutrition 0.000 claims description 4
- 235000011852 gelatine desserts Nutrition 0.000 claims description 4
- 239000001103 potassium chloride Substances 0.000 claims description 4
- 235000011164 potassium chloride Nutrition 0.000 claims description 4
- 239000005018 casein Substances 0.000 claims description 3
- BECPQYXYKAMYBN-UHFFFAOYSA-N casein, tech. Chemical compound NCCCCC(C(O)=O)N=C(O)C(CC(O)=O)N=C(O)C(CCC(O)=N)N=C(O)C(CC(C)C)N=C(O)C(CCC(O)=O)N=C(O)C(CC(O)=O)N=C(O)C(CCC(O)=O)N=C(O)C(C(C)O)N=C(O)C(CCC(O)=N)N=C(O)C(CCC(O)=N)N=C(O)C(CCC(O)=N)N=C(O)C(CCC(O)=O)N=C(O)C(CCC(O)=O)N=C(O)C(COP(O)(O)=O)N=C(O)C(CCC(O)=N)N=C(O)C(N)CC1=CC=CC=C1 BECPQYXYKAMYBN-UHFFFAOYSA-N 0.000 claims description 3
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- ZNJHFNUEQDVFCJ-UHFFFAOYSA-M sodium;2-[4-(2-hydroxyethyl)piperazin-1-yl]ethanesulfonic acid;hydroxide Chemical compound [OH-].[Na+].OCCN1CCN(CCS(O)(=O)=O)CC1 ZNJHFNUEQDVFCJ-UHFFFAOYSA-M 0.000 claims description 3
- ZEDAGFBWUVYFQU-UHFFFAOYSA-M sodium;3-morpholin-4-ylpropane-1-sulfonate;hydrate Chemical compound [OH-].[Na+].OS(=O)(=O)CCCN1CCOCC1 ZEDAGFBWUVYFQU-UHFFFAOYSA-M 0.000 claims description 3
- OWEGMIWEEQEYGQ-UHFFFAOYSA-N 100676-05-9 Natural products OC1C(O)C(O)C(CO)OC1OCC1C(O)C(O)C(O)C(OC2C(OC(O)C(O)C2O)CO)O1 OWEGMIWEEQEYGQ-UHFFFAOYSA-N 0.000 claims description 2
- IHPYMWDTONKSCO-UHFFFAOYSA-N 2,2'-piperazine-1,4-diylbisethanesulfonic acid Chemical compound OS(=O)(=O)CCN1CCN(CCS(O)(=O)=O)CC1 IHPYMWDTONKSCO-UHFFFAOYSA-N 0.000 claims description 2
- HVUMOYIDDBPOLL-UHFFFAOYSA-N 2-(3,4-Dihydroxyoxolan-2-yl)-2-hydroxyethyl octadecanoate Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(O)C1OCC(O)C1O HVUMOYIDDBPOLL-UHFFFAOYSA-N 0.000 claims description 2
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims description 2
- 108091003079 Bovine Serum Albumin Proteins 0.000 claims description 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 claims description 2
- 235000008733 Citrus aurantifolia Nutrition 0.000 claims description 2
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims description 2
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 2
- GUBGYTABKSRVRQ-PICCSMPSSA-N Maltose Natural products O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@@H](CO)OC(O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-PICCSMPSSA-N 0.000 claims description 2
- WGZRYTNXGKTLGE-UHFFFAOYSA-N O.[Na].N1(CCOCC1)CCCS(=O)(=O)O Chemical compound O.[Na].N1(CCOCC1)CCCS(=O)(=O)O WGZRYTNXGKTLGE-UHFFFAOYSA-N 0.000 claims description 2
- WNOAAGWOLZDBHY-UHFFFAOYSA-N O.[Na].OCCN(CCO)CC(CS(=O)(=O)O)O Chemical compound O.[Na].OCCN(CCO)CC(CS(=O)(=O)O)O WNOAAGWOLZDBHY-UHFFFAOYSA-N 0.000 claims description 2
- 229920001219 Polysorbate 40 Polymers 0.000 claims description 2
- IYFATESGLOUGBX-YVNJGZBMSA-N Sorbitan monopalmitate Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@@H](O)[C@H]1OC[C@H](O)[C@H]1O IYFATESGLOUGBX-YVNJGZBMSA-N 0.000 claims description 2
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims description 2
- 229930006000 Sucrose Natural products 0.000 claims description 2
- 235000011941 Tilia x europaea Nutrition 0.000 claims description 2
- DVHXJLRODLTJOD-UHFFFAOYSA-N aminoazanium;bromide Chemical compound Br.NN DVHXJLRODLTJOD-UHFFFAOYSA-N 0.000 claims description 2
- 235000019270 ammonium chloride Nutrition 0.000 claims description 2
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims description 2
- GUBGYTABKSRVRQ-QUYVBRFLSA-N beta-maltose Chemical compound OC[C@H]1O[C@H](O[C@H]2[C@H](O)[C@@H](O)[C@H](O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@@H]1O GUBGYTABKSRVRQ-QUYVBRFLSA-N 0.000 claims description 2
- 229940098773 bovine serum albumin Drugs 0.000 claims description 2
- 125000003178 carboxy group Chemical group [H]OC(*)=O 0.000 claims description 2
- 235000009508 confectionery Nutrition 0.000 claims description 2
- 239000008103 glucose Substances 0.000 claims description 2
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- 239000004571 lime Substances 0.000 claims description 2
- 125000000896 monocarboxylic acid group Chemical group 0.000 claims description 2
- 125000000913 palmityl group Chemical group [H]C([*])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])[H] 0.000 claims description 2
- 239000008363 phosphate buffer Substances 0.000 claims description 2
- 238000004375 physisorption Methods 0.000 claims description 2
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims description 2
- 235000010483 polyoxyethylene sorbitan monopalmitate Nutrition 0.000 claims description 2
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- 229940101027 polysorbate 40 Drugs 0.000 claims description 2
- 229920000053 polysorbate 80 Polymers 0.000 claims description 2
- OTYBMLCTZGSZBG-UHFFFAOYSA-L potassium sulfate Chemical compound [K+].[K+].[O-]S([O-])(=O)=O OTYBMLCTZGSZBG-UHFFFAOYSA-L 0.000 claims description 2
- 229910052939 potassium sulfate Inorganic materials 0.000 claims description 2
- 235000011151 potassium sulphates Nutrition 0.000 claims description 2
- JFUQUKRNULFTJS-UHFFFAOYSA-N propane-1-sulfonic acid;sodium;hydrate Chemical compound O.[Na].CCCS(O)(=O)=O JFUQUKRNULFTJS-UHFFFAOYSA-N 0.000 claims description 2
- 239000001397 quillaja saponaria molina bark Substances 0.000 claims description 2
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- RTKIYNMVFMVABJ-UHFFFAOYSA-L thimerosal Chemical compound [Na+].CC[Hg]SC1=CC=CC=C1C([O-])=O RTKIYNMVFMVABJ-UHFFFAOYSA-L 0.000 claims description 2
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Classifications
-
- 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
- G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
- G01N33/6803—General methods of protein analysis not limited to specific proteins or families of proteins
-
- 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
- G01N33/536—Immunoassay; Biospecific binding assay; Materials therefor with immune complex formed in liquid phase
- G01N33/537—Immunoassay; Biospecific binding assay; Materials therefor with immune complex formed in liquid phase with separation of immune complex from unbound antigen or antibody
- G01N33/539—Immunoassay; Biospecific binding assay; Materials therefor with immune complex formed in liquid phase with separation of immune complex from unbound antigen or antibody involving precipitating reagent, e.g. ammonium sulfate
-
- 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
- G01N33/544—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals the carrier being organic
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Immunology (AREA)
- Engineering & Computer Science (AREA)
- Molecular Biology (AREA)
- Urology & Nephrology (AREA)
- Biomedical Technology (AREA)
- Hematology (AREA)
- Chemical & Material Sciences (AREA)
- Physics & Mathematics (AREA)
- Food Science & Technology (AREA)
- General Health & Medical Sciences (AREA)
- Cell Biology (AREA)
- Medicinal Chemistry (AREA)
- Biotechnology (AREA)
- Analytical Chemistry (AREA)
- Biochemistry (AREA)
- Microbiology (AREA)
- General Physics & Mathematics (AREA)
- Pathology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Bioinformatics & Computational Biology (AREA)
- Biophysics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Investigating Or Analysing Biological Materials (AREA)
Abstract
The invention provides a CRP latex-reinforced immunonephelometry reagent. The CRP latex-reinforced immunonephelometry reagent comprises CRP antibody-labeled latex particles, a buffer, a surfactant, an inorganic salt, a stabilizing agent, a suspending assistant, an excipient and an antiseptic. The invention also provides a kit for single-reagent CRP latex-reinforced immunonephelometry and a use thereof. The CRP latex-reinforced immunonephelometry reagent has simple composition, can be used simply and conveniently, has a fast reaction rate, high sensitivity and good repeatability, can be operated by a simple apparatus, has a wide apparatus adaptation range, has a low cost, can be widely used in large, middle and small hospitals and is suitable for clinical fast infection diagnosis and infection prognosis evaluation.
Description
technical field
The present invention relates to medical science detection field, be specifically related to a kind of CRP latex enhancing immune than turbid quantitative measurement reagent and kit and application thereof.
Background technology
CRP is one of albumen important in acute phase reactive protein, is a kind of marker of inflammation of sensitivity, and in the time of acute injury and infection, its blood concentration sharply raises.In normal human serum, CRP content is very micro-, but in the situations such as infection, inflammatory disease, tissue damage, operation wound and necrosis, raises rapidly, and continue sharply to rise in several hours, can reach peak at 24～72h.After pathology disappears, CRP can be dropped rapidly to normally.The order of severity of CRP ascending velocity, amplitude and duration and the state of an illness and tissue damage is closely related, and is not subject to the impact of the treatment meanss such as radiotherapy, chemotherapy, cortin.Therefore, compare with other acute phase proteins with traditional inspection item, CRP is more sensitive reliable.
Latex enhancing immune turbidimetry (particle-enhanced turbidimetric immune-assay, PETIA) be that the one that occurs is in recent years comparatively stable, body fluid albumen homogeneous phase immunoturbidimetry assay method accurately, be widely used at present clinical diagnosis field.PETIA method is the surface-crosslinked antibody at polymer latex microballoon, after the crosslinked microballoon that has antibody is combined with antigen, can flock together rapidly at short notice, has changed astigmatic performance or the light transmission of reactant liquor.Reactant liquor astigmatism performance or the change of light transmission (inhaling brightness) and the concentration of tested antigen have inherent correlativity, can reflect within the specific limits the concentration of tested antigen.CRP latex enhancing immune than turbid be exactly the prominent example of this class assay method, it is the mensuration of carrying out antigen, antibody response and result in homogeneous reaction system.
Commercially available CRP latex enhancing immune turbidimetric assay reactant liquor and kit is double reagent at present, by reaction buffer 1(R1), the latex intensified particle reagents 2(R2 of CRP antibody labeling) composition.R1, R2 mixes in advance and easily causes antibody inactivation, latex particle in R2 easily to assemble, and kit can not be preserved for a long time.For the mensuration of whole blood sample, commercial reagent box needs first haemolysis, the two step operations of rear mensuration at present, both expends time in especially, and repeatability is also bad.
Summary of the invention
The object of this invention is to provide a kind of simple and quick, easy preservation, reproducible single reagent CRP latex enhancing immune that can quantitative measurement CRP than turbid quantitative measurement reagent and kit thereof.
For achieving the above object, technical scheme of the present invention is: a kind of CRP latex enhancing immune turbidimetric assay reagent, described CRP latex enhancing immune turbidimetric assay reagent comprises latex particle, damping fluid, surfactant, inorganic salts, stabilizing agent, suspending agent, excipient and the antiseptic of CRP antibody labeling.
Preferably, the diameter of described latex particle is 50nm-4000nm; Its finishing group is-one or physisorption type latex particle in COOH ,-NH2 ,-SH ,-OH ,-CHO.
Preferably, the diameter of described latex particle be 100-250nm and finishing group be-COOH or-one in NH2.
Preferably, described stabilizing agent is the one in bovine serum albumin(BSA), gelatin or casein; Described inorganic salts are a kind of, two or more the combination in sodium chloride, potassium chloride, lime chloride, ammonium chloride, sodium sulphate, potassium sulfate; Described surfactant is a kind of, two or more the combination in polysorbas20, polysorbate40, Tween 80, triton x-100, span 40, sorbester p18, saponin, cetyl-3-ammonio methacrylate, the amino ammonium bromide of cetyl, lysophosphatide; Described excipient is a kind of, two or more the combination in sucrose, glucose, maltose, trehalose, sweet mellow wine; Described suspending agent is a kind of, two or more the combination in ethylene glycol, glycerine, lactose; Described antiseptic is the one in Sodium azide, thimerosal, Proclin-300.
Preferably, described surfactant is that existing dissolving haemocyte function has again the one in reagent triton x-100, the Tween-20 of surfactant function.
Preferably, described excipient is the trehalose of concentration 1%-5%.
Preferably, described suspending agent is the glycerine of concentration 1%-20%.
Preferably, the regulating power of described damping fluid requires pH scope between 7.0-9.0, and concentration range is 10-100mmol/L.
Preferably, described damping fluid is 3-[N, N-bis-(hydroxyethyl) amino]-2-hydroxy-propanesulfonic acid-sodium hydrate buffer solution (DIPSO-NaOH), 4-(2-hydroxyethyl)-1-piperazine propane sulfonic acid-sodium hydrate buffer solution (HEPPS-NaOH), 3-(N-morpholinyl) propane sulfonic acid-sodium hydrate buffer solution (MOPS-NaOH), N-(2-hydroxyethyl) piperazine-N'-2-ethane sulfonic acid-NaOH damping fluid (HEPES-NaOH), trishydroxymethylaminomethane-HCL damping fluid (Tris-HCL), phosphate buffer, imidazole buffer, glycocoll-NaOH damping fluid, one in barbitol buffer solution.
Preferably, described antiseptic is Sodium azide, and concentration is 0.1%.
Quick haemolysis function when the stability that in single reagent CRP latex enhancing immune turbidimetric assay reagent, reagent stores and mensuration whole blood sample is extremely important.We according to stabilized latex particle, dissolve fast haemocyte principle select plurality of reagents combine, wherein following reagent is best of breed:
In described kit, the regulating power of damping fluid requires pH scope between 7.0-9.0, preferably DIPSO-NaOH damping fluid.
Described DIPSO-NaOH pH of buffer is between 6.8-8.2, and concentration range is 10-100mmol/L, is preferably 30-60mmol/L.
Surfactant has multiple choices, and preferred existing dissolving haemocyte function has again reagent triton x-100 or the Tween-20 of surfactant function.They have quick lysed erythrocyte and leukocytic function, can be adsorbed onto again the function on latex particle surface, make the unsuitable aggregate and precipitate of latex particle, thereby have ensured the long-term preservation that latex particle can be under liquid condition.Preferably triton x-100, concentration is 0.1%-0.5%.
Inorganic salts can maintain the osmotic pressure of solution, and the long-term stability that is conducive to antibody activity is preserved, preferably NaCL, and concentration is 0.6%-1%.
Stabilizing agent, can play good colloid to the antibody of latex particle surface indicia and disperse and bioactive protective effect.Preferably BSA, concentration is 0.5%-2%.
Suspending agent, can well make latex particle disperse, be suspended in solution, is conducive to the colloidization of latex particle, and long-term preservation does not precipitate.Preferably glycerine, concentration is 1%-10%.
Excipient, the long-term stability that is conducive to antibody is preserved, preferably trehalose, concentration is 1%-5%.
Antiseptic, preferably Sodium azide, concentration is 0.1%.
When mensuration, the antigen-antibody reaction that in sample, CRP and CRP antibody latex particle occur is risen the turbidity of reaction system, can cause the transmittance in reaction system to reduce, and the CRP content in its rate of change and sample is inversely proportional to.Scattered light strengthens, the CRP content direct ratio in its rate of change and sample.Adopt transilluminator or scattering turbidimetry instrument to measure the rate of change of transmitted light or scattered light, with reference to the calibration curve of setting up by CRP calibration object concentration, thereby can calculate the content of CRP.
The present invention also provides a kind of single reagent CRP latex enhancing immune turbidimetric assay kit, described single reagent CRP latex enhancing immune turbidimetric assay kit comprises at least one detector tube, is loaded with CRP latex enhancing immune turbidimetric assay reagent of the present invention in detector tube.
The present invention also provides a kind of application of single reagent CRP latex enhancing immune turbidimetric assay kit, and described single reagent CRP latex enhancing immune turbidimetric assay kit is applicable to various transilluminators or scatterometer.
Concentration described in the present invention, as do not carried out specified otherwise, is the grams of contained solute in quality concentration of volume percent or 100ml solution.
The present invention compared with prior art, has following features:
1. reagent composition is simple, only has single agents.
2. simple to operate, only sample directly need be added in single reagent CRP reactant liquor, without
First reagent adding 1 as commercially available prod, then add sample, then reagent adding 2, complex operation, time-consuming taking a lot of work.
3. for whole blood sample, single reagent CRP reactant liquor can haemolysis, can detect again in sample
CRP content.
4. fast, whole reaction only needs 60-90 second in reaction.
5. reagent stability is good, can preserve 18 months for 4 degrees Celsius, can preserve 15 days after uncork
There is not obvious variation in quality.
6. adapt to instrument extensive, transilluminator, scatterometer all can mate.Be made into
POCT reagent more meets the demand of outpatient service, emergency treatment.
Brief description of the drawings
Fig. 1 is the calibration curve of the embodiment of the present invention 1 in biochemical instruments.
Fig. 2 is the range of linearity correlativity of the embodiment of the present invention 1 in biochemical instruments.
Fig. 3 is the calibration curve of the embodiment of the present invention 2 on scattering turbidimetry instrument
Fig. 4 is the range of linearity correlativity of the embodiment of the present invention 2 on scattering turbidimetry instrument.
Embodiment
Below in conjunction with specific embodiment, further set forth the present invention.Should be understood that these embodiment are only not used in and limit the scope of the invention for the present invention is described.In addition should be understood that, after having read content of the present invention, those skilled in the art can make various changes or modifications the present invention, these equivalent form of values fall within equally the application the scope that limits of attached claims.
Embodiment 1
One, measure the preparation of reagent and kit:
1. polystyrene latex particle (103nm) carboxylated surface is diluted to 10ml with the MES damping fluid of the pH6.0 of 50mM, final concentration is 1%;
2. add 200 milligrams of EDC in above-mentioned solution, add the CRP antibody of 10 milligrams of affinity chromatographys, mixed at room temperature 2 hours;
3. the glycocoll that adds 10ml 100mM reacts 2 hours in above-mentioned solution, the unnecessary active group in sealing latex particle surface;
4. centrifugal 20 minutes of 12000rpm, removes supernatant;
5. with following damping fluid, the CRP antibody latex particle of above-mentioned mark is diluted to working concentration, is equipped with calibration object and is single reagent CRP latex enhancing immune than turbid kit.Single reagent formula: 35mM DIPSO-NaOH, pH 7.0; 0.2% triton x-100; 0.7%NaCl; 0.5% BSA; 2% glycerine; 1% trehalose; 0.1% Sodium azide.
6.CRP calibration object: commercially available CRP sterling is dissolved in to 50mM Tris-HCL, pH7.5,0.85% NaCl, 0.5% BSA, 0.1% Sodium azide, CRP concentration is respectively 0mg/L, 5mg/L, 15mg/L, 50mg/L, 100mg/L, 150mg/L.
Two, the application of kit in biochemical instruments:
1. with 6 variable concentrations CRP calibration object 150mg/L, 100mg/L, 50mg/L, 15mg/L, 5mg/L, 0mg/L coordinates single reagent to calibrate.Taking wavelength 575nm as measuring wavelength, in detector tube, add reagent R, 300ul, 37 degree reactions 90 seconds. the calibration object 4ul that gets respectively variable concentrations adds in above-mentioned detector tube and mixes, the assaying reaction suction brightness value (A1, A2) of the 10th second, the 90th second, calculates the difference DELTA A=A2-A1 that inhales brightness.Using the suction luminance difference Δ A of each calibration tube as ordinate, corresponding concentration, as horizontal ordinate, is made " concentration-absorbance difference " calibration curve.Fig. 1 is the calibration curve of embodiment 1 in biochemical instruments.
2. be measured in the same method the suction luminance difference of blood serum sample (if measure the sample size that whole blood sample need add 10ul, plasma sample amount is 6ul), substitution calibration curve calculates sample CRP concentration.
3. range of linearity correlativity
By CRP enriched sample (200mg/L), become 150.00 mg/L with normal saline dilution, 50 .00mg/L, 25.0 mg/L, 10.0 mg/L, 5.0 mg/L, wavelength with 575nm in biochemical instruments is measured, each concentration replication 3 times, carries out linear regression analysis by mean value and the theoretical concentration of measuring concentration, and related coefficient is R
2=0.9979, result: within the scope of 5.0-150mg/L linear determination, range of linearity good relationship (see figure 2).
4. sensitivity (lowest detectable limit) is taking 5% human serum albumins as dummy, replication 20 times, and result of calculation average X is 0.05mg/L, standard deviation SD is 0.15.Calculating X+2SD is 0.35mg/L, and therefore this kit is measured CRP sensitivity and can be reached 0.35 mg/L in biochemical instruments.
5. repeatability assessment:
Adopt same batch of reagent to carry out replication 10 times to Randox Specific Protein Control1 (target value is 24.0mg/L), calculate coefficient of variation CV(< 6%), measurement result is in table 1.
SD=
CV=SD/
×100%
The repeated assess and determine result of table 1 table
6. difference between batch assessment: three batches of reagent are carried out to Randox Specific Protein Control 1 (target value is 24.0mg/L) and measure, every batch of reagent is measured 3 times, and measurement result gathers in table 2.
Table 2 difference between batch assess and determine result table
embodiment 2
One, measure the preparation of reagent and kit:
1. polystyrene latex particle (150nm) carboxylated surface is diluted to 10ml with the MES damping fluid of the pH6.0 of 50mM, final concentration is 1%;
2. add 200 milligrams of EDC in above-mentioned solution, add the CRP antibody of 10 milligrams of affinity chromatographys, mixed at room temperature 2 hours;
3. the glycocoll that adds 10ml 100mM reacts 2 hours in above-mentioned solution, the unnecessary active group in sealing latex particle surface;
4. centrifugal 20 minutes of 12000rpm, removes supernatant;
5. with following damping fluid, the CRP antibody latex particle of above-mentioned mark is diluted to work dense
Degree, is equipped with calibration object and is single reagent CRP latex enhancing immune than turbid kit.Single reagent formula: 45mM MOPS-NaOH, pH 7.5; 0.3% polysorbas20; 0.8%NaCl; 1% gelatin; 5% glycerine; 3% trehalose; 0.1% Sodium azide.
6. CRP calibration object: commercially available CRP sterling is dissolved in to 50mM Tris-HCL, pH7.5,
0.85% NaCl, 0.5% BSA, 0.1% Sodium azide, CRP concentration is respectively 0mg/L, 5mg/L, 15mg/L, 50mg/L, 100mg/L, 150mg/L.
Two, the application of kit on scattering turbidimetry instrument
1. with 6 variable concentrations CRP calibration object 150mg/L, 100mg/L, 50mg/L, 15mg/L, 5mg/L, 0mg/L coordinates single reagent to calibrate.Taking wavelength 630nm as measuring wavelength, in detector tube, add reagent R, 300ul, 37 degree reactions 90 seconds. the calibration object 4ul that gets respectively variable concentrations adds in above-mentioned detector tube and mixes, the assaying reaction scattered light signal value (A1 of the 10th second, the 90th second, A2), calculate the difference DELTA A=A2-A1 of scattered light signal.Using the scattered light signal difference DELTA A of each calibration tube as ordinate, corresponding concentration, as horizontal ordinate, is made " concentration-scattered light difference " calibration curve.(see figure 3)
2. measure blood serum sample and need add the sample size of 4ul if be measured in the same method whole blood sample 10ul(, plasma sample amount is 6ul) scattered light signal difference, substitution calibration curve calculates sample CRP concentration.
3. range of linearity correlativity
By CRP enriched sample (180mg/L), become 150.00 mg/L with normal saline dilution, 75 .00mg/L, 25.0 mg/L, 10.0 mg/L, 5.0 mg/L, wavelength with 630nm on scatterometer is measured, each concentration replication 3 times, carries out linear regression analysis by mean value and the theoretical concentration of measuring concentration, and related coefficient is R
2=0.9969, result: within the scope of 5.0-150mg/L linear determination, range of linearity good relationship (see figure 4).
4. sensitivity (lowest detectable limit)
Taking 5% human serum albumins as dummy, replication 20 times, result of calculation average X is 0.1mg/L, standard deviation SD is 0.20.Calculating X+2SD is 0.5mg/L, and therefore this kit is measured CRP sensitivity and can be reached 0.5 mg/L on scatterometer.
5. repeatability assessment:
Adopt same batch of reagent to carry out replication 10 times to Randox Specific Protein Control1 (target value is 24.0mg/L), calculate coefficient of variation CV(< 6%), the results are shown in Table 3.
The repeated assessment result table of table 3
6. difference between batch assessment: three batches of reagent are carried out to Randox Specific Protein Control 1 (target value is 24.0mg/L) and measure, every batch of reagent is measured 3 times, and measurement result is in table 4.
Table 4 difference between batch assessment result table
Embodiment 3
One, measure the preparation of reagent and kit:
1. the polystyrene latex particle (200nm) of surface amination is diluted to 10ml with the MES damping fluid of the pH6.0 of 50mM, final concentration is 1%;
2. add 200 milligrams of EDC in above-mentioned solution, add the CRP antibody of 10 milligrams of affinity chromatographys, mixed at room temperature 2 hours;
3. the glycocoll that adds 10ml 100mM reacts 2 hours in above-mentioned solution, sealing latex
The active group that particle surface is unnecessary;
4. centrifugal 20 minutes of 12000rpm, removes supernatant;
5. with following damping fluid, the CRP antibody latex particle of above-mentioned mark is diluted to work dense
Degree, is equipped with calibration object and is single reagent CRP latex enhancing immune than turbid kit.Single reagent formula: 55mM Tris-HCL, pH 8.0; 0.4% triton x-100; 0.9%KCl; 1.5% BSA; 8% glycerine; 5% trehalose; 0.1% Sodium azide.
6. CRP calibration object: commercially available CRP sterling is dissolved in to 50mM Tris-HCL, pH7.5,
0.85% NaCl, 0.5% BSA, 0.1% Sodium azide, CRP concentration is respectively 0mg/L, 5mg/L, 15mg/L, 50mg/L, 100mg/L, 150mg/L.
Two, the application of kit on scattering turbidimetry instrument
1. with 6 variable concentrations CRP calibration object 150mg/L, 100mg/L, 50mg/L, 15mg/L, 5mg/L, 0mg/L coordinates single reagent to calibrate.Taking wavelength 630nm as measuring wavelength, in detector tube, add reagent R, 300ul, 37 degree reactions 90 seconds. the calibration object 4ul that gets respectively variable concentrations adds in above-mentioned detector tube and mixes, the assaying reaction scattered light signal value (A1 of the 10th second, the 90th second, A2), calculate the difference DELTA A=A2-A1 of scattered light signal.Using the scattered light signal difference DELTA A of each calibration tube as ordinate, corresponding concentration, as horizontal ordinate, is made " concentration-scattered light difference " calibration curve.
2. measure blood serum sample and need add the sample size of 4ul if be measured in the same method whole blood sample 10ul(, plasma sample amount is 6ul) scattered light signal difference, substitution calibration curve calculates sample CRP concentration.
3. range of linearity correlativity
By CRP enriched sample (180mg/L), become 150.00 mg/L with normal saline dilution, 75 .00mg/L, 25.0 mg/L, 10.0 mg/L, 5.0 mg/L, wavelength with 630nm on scatterometer is measured, each concentration replication 3 times, carries out linear regression analysis by mean value and the theoretical concentration of measuring concentration, and related coefficient is R
2=0.9945, result: within the scope of 5.0-150mg/L linear determination, range of linearity good relationship.
4. sensitivity (lowest detectable limit)
Taking 5% human serum albumins as dummy, replication 20 times, result of calculation average X is 0.16mg/L, standard deviation SD is 0.15.Calculating X+2SD is 0.46mg/L, and therefore this kit is measured CRP sensitivity and can be reached 0.46 mg/L on scatterometer.
5. repeatability assessment:
Adopt same batch of reagent to carry out replication 10 times to Randox Specific Protein Control1 (target value is 24.0mg/L), calculate coefficient of variation CV(< 6%), measurement result is in table 5.
The repeated assessment result table of table 5
6. difference between batch assessment: three batches of reagent are carried out to Randox Specific Protein Control 1 (target value is 24.0mg/L) and measure, every batch of reagent is measured 3 times, and measurement result is in table 6.
Table 6 difference between batch assessment result table
Embodiment 4
One, measure the preparation of reagent and kit:
1. the polystyrene latex particle (135nm) of surface amination is diluted to 10ml with the MES damping fluid of the pH6.0 of 50mM, final concentration is 1%;
2. add 200 milligrams of EDC in above-mentioned solution, add the CRP antibody of 10 milligrams of affinity chromatographys, mixed at room temperature 2 hours;
3. the glycocoll that adds 10ml 100mM reacts 2 hours in above-mentioned solution, sealing latex
The active group that particle surface is unnecessary;
4. centrifugal 20 minutes of 12000rpm, removes supernatant;
5. with following damping fluid, the CRP antibody latex particle of above-mentioned mark is diluted to work dense
Degree, is equipped with calibration object and is single reagent CRP latex enhancing immune than turbid kit.Single reagent formula: 40mM HEPES-NaOH, pH 8.0; 0.35% polysorbas20; 0.85%CaCl2; 2% gelatin; 8% glycerine; 5% trehalose; 0.1% Sodium azide.
6. CRP calibration object: commercially available CRP sterling is dissolved in to 50mM Tris-HCL, pH7.5,
0.85% NaCl, 0.5% BSA, 0.1% Sodium azide, CRP concentration is respectively 0mg/L, 5mg/L, 15mg/L, 50mg/L, 100mg/L, 150mg/L.
Two, the application of kit on scattering turbidimetry instrument
1. with 6 variable concentrations CRP calibration object 150mg/L, 100mg/L, 50mg/L, 15mg/L, 5mg/L, 0mg/L coordinates single reagent to calibrate.Taking wavelength 630nm as measuring wavelength, in detector tube, add reagent R, 300ul, 37 degree reactions 90 seconds. the calibration object 4ul that gets respectively variable concentrations adds in above-mentioned detector tube and mixes, the assaying reaction scattered light signal value (A1 of the 10th second, the 90th second, A2), calculate the difference DELTA A=A2-A1 of scattered light signal.Using the scattered light signal difference DELTA A of each calibration tube as ordinate, corresponding concentration, as horizontal ordinate, is made " concentration-scattered light difference " calibration curve.
2. measure blood serum sample and need add the sample size of 4ul if be measured in the same method whole blood sample 10ul(, plasma sample amount is 6ul) scattered light signal difference, substitution calibration curve calculates sample CRP concentration.
3. range of linearity correlativity
By CRP enriched sample (180mg/L), become 150.00 mg/L with normal saline dilution, 75 .00mg/L, 25.0 mg/L, 10.0 mg/L, 5.0 mg/L, wavelength with 630nm on scatterometer is measured, each concentration replication 3 times, carries out linear regression analysis by mean value and the theoretical concentration of measuring concentration, and related coefficient is R
2=0.9959, result: within the scope of 5.0-150mg/L linear determination, range of linearity good relationship.
4. sensitivity (lowest detectable limit)
Taking 5% human serum albumins as dummy, replication 20 times, result of calculation average X is 0.10mg/L, standard deviation SD is 0.13.Calculating X+2SD is 0.36mg/L, and therefore this kit is measured CRP sensitivity and can be reached 0.36 mg/L on scatterometer.
5. repeatability assessment:
Adopt same batch of reagent to carry out replication 10 times to Randox Specific Protein Control1 (target value is 24.0mg/L), calculate coefficient of variation CV(< 6%), measurement result is in table 7.
The repeated assessment result table of table 7
6. difference between batch assessment: three batches of reagent are carried out to Randox Specific Protein Control 1 (target value is 24.0mg/L) and measure, every batch of reagent is measured 3 times, and measurement result is in table 8.
Table 8 difference between batch assessment result table
Embodiment 5
One, measure the preparation of reagent and kit:
1. the polystyrene latex particle (245nm) of surface amination is diluted to 10ml with the MES damping fluid of the pH6.0 of 50mM, final concentration is 1%;
2. add 200 milligrams of EDC in above-mentioned solution, add the CRP antibody of 10 milligrams of affinity chromatographys, mixed at room temperature 2 hours;
3. the glycocoll that adds 10ml 100mM reacts 2 hours in above-mentioned solution, sealing latex
The active group that particle surface is unnecessary;
4. centrifugal 20 minutes of 12000rpm, removes supernatant;
5. with following damping fluid, the CRP antibody latex particle of above-mentioned mark is diluted to work dense
Degree, is equipped with calibration object and is single reagent CRP latex enhancing immune than turbid kit.Single reagent formula: 50mM glycocoll-NaOH, pH 7.5; 0.35% triton x-100; 1%KCl; 1% casein; 7% glycerine; 4% trehalose; 0.1% Sodium azide.
6. CRP calibration object: commercially available CRP sterling is dissolved in to 50mM Tris-HCL, pH7.5,
0.85% NaCl, 0.5% BSA, 0.1% Sodium azide, CRP concentration is respectively 0mg/L, 5mg/L, 15mg/L, 50mg/L, 100mg/L, 150mg/L.
Two, the application of kit on scattering turbidimetry instrument
1. with 6 variable concentrations CRP calibration object 150mg/L, 100mg/L, 50mg/L, 15mg/L, 5mg/L, 0mg/L coordinates single reagent to calibrate.Taking wavelength 630nm as measuring wavelength, in detector tube, add reagent R, 300ul, 37 degree reactions 90 seconds. the calibration object 4ul that gets respectively variable concentrations adds in above-mentioned detector tube and mixes, the assaying reaction scattered light signal value (A1 of the 10th second, the 90th second, A2), calculate the difference DELTA A=A2-A1 of scattered light signal.Using the scattered light signal difference DELTA A of each calibration tube as ordinate, corresponding concentration, as horizontal ordinate, is made " concentration-scattered light difference " calibration curve.
2. measure blood serum sample and need add the sample size of 4ul if be measured in the same method whole blood sample 10ul(, plasma sample amount is 6ul) scattered light signal difference, substitution calibration curve calculates sample CRP concentration.
3. range of linearity correlativity
By CRP enriched sample (180mg/L), become 150.00 mg/L with normal saline dilution, 75 .00mg/L, 25.0 mg/L, 10.0 mg/L, 5.0 mg/L, wavelength with 630nm on scatterometer is measured, each concentration replication 3 times, carries out linear regression analysis by mean value and the theoretical concentration of measuring concentration, and related coefficient is R
2=0.9973, result: within the scope of 5.0-150mg/L linear determination, range of linearity good relationship.
4. sensitivity (lowest detectable limit)
Taking 5% human serum albumins as dummy, replication 20 times, result of calculation average X is 0.16mg/L, standard deviation SD is 0.20.Calculating X+2SD is 0.56mg/L, and therefore this kit is measured CRP sensitivity and can be reached 0.56 mg/L on scatterometer.
5. repeatability assessment:
Adopt same batch of reagent to carry out replication 10 times to Randox Specific Protein Control1 (target value is 24.0mg/L), calculate coefficient of variation CV(< 6%), measurement result is in table 9.
The repeated assessment result table of table 9
6. difference between batch assessment: three batches of reagent are carried out to Randox Specific Protein Control 1 (target value is 24.0mg/L) and measure, every batch of reagent is measured 3 times, and measurement result is in table 10.
Table 10 difference between batch assess and determine result
The invention provides a kind of CRP latex enhancing immune turbidimetric assay reagent, a kind of single reagent CRP latex enhancing immune turbidimetric assay kit and application thereof, reagent composition of the present invention is simple, simple to operation, and reaction fast, reagent stability is good, highly sensitive, reproducible, use instrument simple, adapt to instrument extensive, with low cost, can be widely used for large, middle and small hospital, the clinical quick diagnosis of outpatient service infects and infects the evaluation of prognosis.
Foregoing is exemplifying of specific embodiments of the invention, for the wherein not reagent of detailed description, equipment, method of operating etc., should be understood to take the existing common and conventional reagent in this area, equipment, method of operating etc. to be implemented.
Be more than the description to the embodiment of the present invention, by the above-mentioned explanation to the disclosed embodiments, make professional and technical personnel in the field can realize or use the present invention.To be apparent for those skilled in the art to the multiple amendment of these embodiment, General Principle as defined herein can, in the situation that not departing from the spirit or scope of the present invention, realize in other embodiments.Therefore, the present invention will can not be restricted to these embodiment shown in this article, but will meet the widest scope consistent with principle disclosed herein and features of novelty.
Claims (11)
1. a CRP latex enhancing immune turbidimetric assay reagent, it is characterized in that, described CRP latex enhancing immune turbidimetric assay reagent comprises latex particle, damping fluid, surfactant, inorganic salts, stabilizing agent, suspending agent, excipient and the antiseptic of CRP antibody labeling.
2. CRP latex enhancing immune turbidimetric assay reagent according to claim 1, is characterized in that, the diameter of described latex particle is 50nm-4000nm; Its finishing group is-one or physisorption type latex particle in COOH ,-NH2 ,-SH ,-OH ,-CHO.
3. CRP latex enhancing immune turbidimetric assay reagent according to claim 2, is characterized in that, the diameter of described latex particle be 100-250nm and finishing group be-COOH or-one in NH2.
4. CRP latex enhancing immune turbidimetric assay reagent according to claim 1, is characterized in that, described stabilizing agent is the one in bovine serum albumin(BSA), gelatin or casein; Described inorganic salts are a kind of, two or more the combination in sodium chloride, potassium chloride, lime chloride, ammonium chloride, sodium sulphate, potassium sulfate; Described surfactant is a kind of, two or more the combination in polysorbas20, polysorbate40, Tween 80, triton x-100, span 40, sorbester p18, saponin, cetyl-3-ammonio methacrylate, the amino ammonium bromide of cetyl, lysophosphatide; Described excipient is a kind of, two or more the combination in sucrose, glucose, maltose, trehalose, sweet mellow wine; Described suspending agent is a kind of, two or more the combination in ethylene glycol, glycerine, lactose; Described antiseptic is the one in Sodium azide, thimerosal, Proclin-300.
5. CRP latex enhancing immune turbidimetric assay reagent according to claim 4, is characterized in that, described excipient is the trehalose of concentration 1%-5%.
6. CRP latex enhancing immune turbidimetric assay reagent according to claim 4, is characterized in that, described suspending agent is the glycerine of concentration 1%-20%.
7. CRP latex enhancing immune turbidimetric assay reagent according to claim 1, is characterized in that, the regulating power of described damping fluid requires pH scope between 7.0-9.0, and concentration range is 10-100mmol/L.
8. CRP latex enhancing immune turbidimetric assay reagent according to claim 8, it is characterized in that, described damping fluid is 3-[N, N-bis-(hydroxyethyl) amino]-2-hydroxy-propanesulfonic acid-sodium hydrate buffer solution (DIPSO-NaOH), 4-(2-hydroxyethyl)-1-piperazine propane sulfonic acid-sodium hydrate buffer solution (HEPPS-NaOH), 3-(N-morpholinyl) propane sulfonic acid-sodium hydrate buffer solution (MOPS-NaOH), N-(2-hydroxyethyl) piperazine-N'-2-ethane sulfonic acid-NaOH damping fluid (HEPES-NaOH), trishydroxymethylaminomethane-HCL damping fluid (Tris-HCL), phosphate buffer, imidazole buffer, glycocoll-NaOH damping fluid, one in barbitol buffer solution.
9. CRP latex enhancing immune turbidimetric assay reagent according to claim 1, is characterized in that, described antiseptic is Sodium azide, and concentration is 0.1%.
10. a single reagent CRP latex enhancing immune turbidimetric assay kit, it is characterized in that, described single reagent CRP latex enhancing immune turbidimetric assay kit comprises at least one detector tube, is loaded with the arbitrary described CRP latex enhancing immune turbidimetric assay reagent of claim 1 to 10 in detector tube.
The application of 11. 1 kinds of single reagent CRP latex enhancing immune turbidimetric assay kits, is characterized in that, described single reagent CRP latex enhancing immune turbidimetric assay kit is applicable to various transilluminators or scatterometer.
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