WO2007066731A1 - 抗リン脂質抗体測定試薬及び抗トレポネーマ・パリダム抗体測定試薬 - Google Patents
抗リン脂質抗体測定試薬及び抗トレポネーマ・パリダム抗体測定試薬 Download PDFInfo
- Publication number
- WO2007066731A1 WO2007066731A1 PCT/JP2006/324473 JP2006324473W WO2007066731A1 WO 2007066731 A1 WO2007066731 A1 WO 2007066731A1 JP 2006324473 W JP2006324473 W JP 2006324473W WO 2007066731 A1 WO2007066731 A1 WO 2007066731A1
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- WIPO (PCT)
- Prior art keywords
- reagent
- antibody
- antiphospholipid
- antigen
- pallidum
- Prior art date
Links
- 239000003153 chemical reaction reagent Substances 0.000 title claims abstract description 143
- 239000000178 monomer Substances 0.000 claims abstract description 39
- 239000000427 antigen Substances 0.000 claims abstract description 34
- 102000036639 antigens Human genes 0.000 claims abstract description 34
- 108091007433 antigens Proteins 0.000 claims abstract description 34
- 229920001577 copolymer Polymers 0.000 claims abstract description 32
- 208000006379 syphilis Diseases 0.000 claims abstract description 23
- 208000015181 infectious disease Diseases 0.000 claims abstract description 18
- 238000005259 measurement Methods 0.000 claims description 69
- 230000001014 anti-treponemal effect Effects 0.000 claims description 62
- HVYWMOMLDIMFJA-DPAQBDIFSA-N cholesterol Chemical compound C1C=C2C[C@@H](O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H]([C@H](C)CCCC(C)C)[C@@]1(C)CC2 HVYWMOMLDIMFJA-DPAQBDIFSA-N 0.000 claims description 12
- 239000002245 particle Substances 0.000 claims description 9
- 125000000129 anionic group Chemical group 0.000 claims description 8
- ZGSPNIOCEDOHGS-UHFFFAOYSA-L disodium [3-[2,3-di(octadeca-9,12-dienoyloxy)propoxy-oxidophosphoryl]oxy-2-hydroxypropyl] 2,3-di(octadeca-9,12-dienoyloxy)propyl phosphate Chemical compound [Na+].[Na+].CCCCCC=CCC=CCCCCCCCC(=O)OCC(OC(=O)CCCCCCCC=CCC=CCCCCC)COP([O-])(=O)OCC(O)COP([O-])(=O)OCC(OC(=O)CCCCCCCC=CCC=CCCCCC)COC(=O)CCCCCCCC=CCC=CCCCCC ZGSPNIOCEDOHGS-UHFFFAOYSA-L 0.000 claims description 7
- WTJKGGKOPKCXLL-RRHRGVEJSA-N phosphatidylcholine Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCCCCCCC=CCCCCCCCC WTJKGGKOPKCXLL-RRHRGVEJSA-N 0.000 claims description 7
- 235000012000 cholesterol Nutrition 0.000 claims description 6
- 229920000642 polymer Polymers 0.000 claims description 6
- 241000589884 Treponema pallidum Species 0.000 claims description 5
- 150000001450 anions Chemical class 0.000 claims description 5
- 125000001997 phenyl group Chemical group [H]C1=C([H])C([H])=C(*)C([H])=C1[H] 0.000 claims description 5
- 239000000725 suspension Substances 0.000 claims description 5
- 150000002632 lipids Chemical class 0.000 claims description 4
- 150000003904 phospholipids Chemical class 0.000 claims description 4
- 238000003745 diagnosis Methods 0.000 claims description 3
- 230000002421 anti-septic effect Effects 0.000 claims 1
- 210000002966 serum Anatomy 0.000 abstract description 29
- 230000007774 longterm Effects 0.000 abstract description 6
- ZSZRUEAFVQITHH-UHFFFAOYSA-N 2-(2-methylprop-2-enoyloxy)ethyl 2-(trimethylazaniumyl)ethyl phosphate Chemical compound CC(=C)C(=O)OCCOP([O-])(=O)OCC[N+](C)(C)C ZSZRUEAFVQITHH-UHFFFAOYSA-N 0.000 abstract 1
- 230000000052 comparative effect Effects 0.000 description 45
- 239000000243 solution Substances 0.000 description 36
- 238000000034 method Methods 0.000 description 29
- 238000002360 preparation method Methods 0.000 description 27
- 239000012898 sample dilution Substances 0.000 description 23
- 239000008363 phosphate buffer Substances 0.000 description 21
- 238000002835 absorbance Methods 0.000 description 20
- 238000006243 chemical reaction Methods 0.000 description 19
- 108091003079 Bovine Serum Albumin Proteins 0.000 description 18
- 229940098773 bovine serum albumin Drugs 0.000 description 18
- 239000012086 standard solution Substances 0.000 description 18
- CERQOIWHTDAKMF-UHFFFAOYSA-N Methacrylic acid Chemical compound CC(=C)C(O)=O CERQOIWHTDAKMF-UHFFFAOYSA-N 0.000 description 16
- 238000004220 aggregation Methods 0.000 description 16
- 229920000126 latex Polymers 0.000 description 16
- 239000004816 latex Substances 0.000 description 16
- 230000002776 aggregation Effects 0.000 description 15
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 12
- 239000000306 component Substances 0.000 description 11
- 239000007788 liquid Substances 0.000 description 9
- 238000012360 testing method Methods 0.000 description 9
- 230000007423 decrease Effects 0.000 description 8
- 230000000405 serological effect Effects 0.000 description 8
- 238000011156 evaluation Methods 0.000 description 7
- 230000003287 optical effect Effects 0.000 description 7
- 230000035945 sensitivity Effects 0.000 description 7
- 239000000126 substance Substances 0.000 description 7
- -1 2-methacryloyloxycetylphosphorylcholine Chemical compound 0.000 description 6
- 241000755093 Gaidropsarus vulgaris Species 0.000 description 6
- 229920001218 Pullulan Polymers 0.000 description 6
- 239000004373 Pullulan Substances 0.000 description 6
- 210000004369 blood Anatomy 0.000 description 6
- 239000008280 blood Substances 0.000 description 6
- 235000019423 pullulan Nutrition 0.000 description 6
- 238000011084 recovery Methods 0.000 description 6
- HRPVXLWXLXDGHG-UHFFFAOYSA-N Acrylamide Chemical compound NC(=O)C=C HRPVXLWXLXDGHG-UHFFFAOYSA-N 0.000 description 4
- KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical compound OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 description 4
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 description 4
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 4
- 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 description 4
- 229930006000 Sucrose Natural products 0.000 description 4
- 230000004520 agglutination Effects 0.000 description 4
- 239000000872 buffer Substances 0.000 description 4
- 239000003995 emulsifying agent Substances 0.000 description 4
- 244000052769 pathogen Species 0.000 description 4
- 230000001717 pathogenic effect Effects 0.000 description 4
- 239000002504 physiological saline solution Substances 0.000 description 4
- 239000003505 polymerization initiator Substances 0.000 description 4
- 230000001737 promoting effect Effects 0.000 description 4
- 239000000523 sample Substances 0.000 description 4
- 239000005720 sucrose Substances 0.000 description 4
- 239000004094 surface-active agent Substances 0.000 description 4
- 229920002307 Dextran Polymers 0.000 description 3
- 239000004793 Polystyrene Substances 0.000 description 3
- 230000003247 decreasing effect Effects 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 229920002223 polystyrene Polymers 0.000 description 3
- 239000002244 precipitate Substances 0.000 description 3
- 102000004169 proteins and genes Human genes 0.000 description 3
- 108090000623 proteins and genes Proteins 0.000 description 3
- 159000000000 sodium salts Chemical class 0.000 description 3
- SMZOUWXMTYCWNB-UHFFFAOYSA-N 2-(2-methoxy-5-methylphenyl)ethanamine Chemical compound COC1=CC=C(C)C=C1CCN SMZOUWXMTYCWNB-UHFFFAOYSA-N 0.000 description 2
- NIXOWILDQLNWCW-UHFFFAOYSA-N 2-Propenoic acid Natural products OC(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 description 2
- AGBXYHCHUYARJY-UHFFFAOYSA-N 2-phenylethenesulfonic acid Chemical compound OS(=O)(=O)C=CC1=CC=CC=C1 AGBXYHCHUYARJY-UHFFFAOYSA-N 0.000 description 2
- NIXOWILDQLNWCW-UHFFFAOYSA-M Acrylate Chemical compound [O-]C(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-M 0.000 description 2
- 239000004471 Glycine Substances 0.000 description 2
- WOBHKFSMXKNTIM-UHFFFAOYSA-N Hydroxyethyl methacrylate Chemical compound CC(=C)C(=O)OCCO WOBHKFSMXKNTIM-UHFFFAOYSA-N 0.000 description 2
- 239000002202 Polyethylene glycol Substances 0.000 description 2
- PPBRXRYQALVLMV-UHFFFAOYSA-N Styrene Chemical compound C=CC1=CC=CC=C1 PPBRXRYQALVLMV-UHFFFAOYSA-N 0.000 description 2
- 238000011481 absorbance measurement Methods 0.000 description 2
- 239000012503 blood component Substances 0.000 description 2
- 239000007853 buffer solution Substances 0.000 description 2
- 125000002091 cationic group Chemical group 0.000 description 2
- 210000004027 cell Anatomy 0.000 description 2
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- 230000001804 emulsifying effect Effects 0.000 description 2
- 230000001771 impaired effect Effects 0.000 description 2
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- 238000002156 mixing Methods 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- 238000006386 neutralization reaction Methods 0.000 description 2
- JRKICGRDRMAZLK-UHFFFAOYSA-L persulfate group Chemical class S(=O)(=O)([O-])OOS(=O)(=O)[O-] JRKICGRDRMAZLK-UHFFFAOYSA-L 0.000 description 2
- 229920001223 polyethylene glycol Polymers 0.000 description 2
- 238000006116 polymerization reaction Methods 0.000 description 2
- USHAGKDGDHPEEY-UHFFFAOYSA-L potassium persulfate Chemical compound [K+].[K+].[O-]S(=O)(=O)OOS([O-])(=O)=O USHAGKDGDHPEEY-UHFFFAOYSA-L 0.000 description 2
- 239000011780 sodium chloride Substances 0.000 description 2
- 238000013112 stability test Methods 0.000 description 2
- QAOWNCQODCNURD-UHFFFAOYSA-L sulfate group Chemical group S(=O)(=O)([O-])[O-] QAOWNCQODCNURD-UHFFFAOYSA-L 0.000 description 2
- LENZDBCJOHFCAS-UHFFFAOYSA-N tris Chemical class OCC(N)(CO)CO LENZDBCJOHFCAS-UHFFFAOYSA-N 0.000 description 2
- KTZVZZJJVJQZHV-UHFFFAOYSA-N 1-chloro-4-ethenylbenzene Chemical compound ClC1=CC=C(C=C)C=C1 KTZVZZJJVJQZHV-UHFFFAOYSA-N 0.000 description 1
- IXPNQXFRVYWDDI-UHFFFAOYSA-N 1-methyl-2,4-dioxo-1,3-diazinane-5-carboximidamide Chemical compound CN1CC(C(N)=N)C(=O)NC1=O IXPNQXFRVYWDDI-UHFFFAOYSA-N 0.000 description 1
- IIZPXYDJLKNOIY-JXPKJXOSSA-N 1-palmitoyl-2-arachidonoyl-sn-glycero-3-phosphocholine Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCC\C=C/C\C=C/C\C=C/C\C=C/CCCCC IIZPXYDJLKNOIY-JXPKJXOSSA-N 0.000 description 1
- YYKSKBIRAIJXJT-UHFFFAOYSA-N 2-phenylethenesulfonic acid;styrene Chemical compound C=CC1=CC=CC=C1.OS(=O)(=O)C=CC1=CC=CC=C1 YYKSKBIRAIJXJT-UHFFFAOYSA-N 0.000 description 1
- IWTYTFSSTWXZFU-UHFFFAOYSA-N 3-chloroprop-1-enylbenzene Chemical compound ClCC=CC1=CC=CC=C1 IWTYTFSSTWXZFU-UHFFFAOYSA-N 0.000 description 1
- 102000002322 Egg Proteins Human genes 0.000 description 1
- 108010000912 Egg Proteins Proteins 0.000 description 1
- 239000006173 Good's buffer Substances 0.000 description 1
- 241001465754 Metazoa Species 0.000 description 1
- 206010029719 Nonspecific reaction Diseases 0.000 description 1
- 229920001007 Nylon 4 Polymers 0.000 description 1
- 108010071390 Serum Albumin Proteins 0.000 description 1
- 102000007562 Serum Albumin Human genes 0.000 description 1
- 208000030452 Transient pseudohypoaldosteronism Diseases 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- XECAHXYUAAWDEL-UHFFFAOYSA-N acrylonitrile butadiene styrene Chemical compound C=CC=C.C=CC#N.C=CC1=CC=CC=C1 XECAHXYUAAWDEL-UHFFFAOYSA-N 0.000 description 1
- 229920000122 acrylonitrile butadiene styrene Polymers 0.000 description 1
- 239000004676 acrylonitrile butadiene styrene Substances 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- 230000000996 additive effect Effects 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- 150000003863 ammonium salts Chemical class 0.000 description 1
- 239000003963 antioxidant agent Substances 0.000 description 1
- 230000001580 bacterial effect Effects 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- MPMBRWOOISTHJV-UHFFFAOYSA-N but-1-enylbenzene Chemical compound CCC=CC1=CC=CC=C1 MPMBRWOOISTHJV-UHFFFAOYSA-N 0.000 description 1
- 239000000969 carrier Substances 0.000 description 1
- 238000007334 copolymerization reaction Methods 0.000 description 1
- 239000012470 diluted sample Substances 0.000 description 1
- 238000012674 dispersion polymerization Methods 0.000 description 1
- 238000010494 dissociation reaction Methods 0.000 description 1
- 230000005593 dissociations Effects 0.000 description 1
- 235000013345 egg yolk Nutrition 0.000 description 1
- 210000002969 egg yolk Anatomy 0.000 description 1
- 238000007720 emulsion polymerization reaction Methods 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- LEDCJBCTEYLBJO-UHFFFAOYSA-N ethyl 2-phenylethenesulfonate Chemical compound CCOS(=O)(=O)C=CC1=CC=CC=C1 LEDCJBCTEYLBJO-UHFFFAOYSA-N 0.000 description 1
- 239000012634 fragment Substances 0.000 description 1
- 230000035931 haemagglutination Effects 0.000 description 1
- 229920001519 homopolymer Polymers 0.000 description 1
- 230000007062 hydrolysis Effects 0.000 description 1
- 238000006460 hydrolysis reaction Methods 0.000 description 1
- 230000001900 immune effect Effects 0.000 description 1
- 235000010445 lecithin Nutrition 0.000 description 1
- 239000000787 lecithin Substances 0.000 description 1
- 229940067606 lecithin Drugs 0.000 description 1
- 229920003008 liquid latex Polymers 0.000 description 1
- 229910003002 lithium salt Inorganic materials 0.000 description 1
- 159000000002 lithium salts Chemical class 0.000 description 1
- 239000011259 mixed solution Substances 0.000 description 1
- 239000008055 phosphate buffer solution Substances 0.000 description 1
- 230000000379 polymerizing effect Effects 0.000 description 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 1
- 239000001267 polyvinylpyrrolidone Substances 0.000 description 1
- XAEFZNCEHLXOMS-UHFFFAOYSA-M potassium benzoate Chemical compound [K+].[O-]C(=O)C1=CC=CC=C1 XAEFZNCEHLXOMS-UHFFFAOYSA-M 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 239000000047 product Substances 0.000 description 1
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- 230000035484 reaction time Effects 0.000 description 1
- 230000006798 recombination Effects 0.000 description 1
- 238000005215 recombination Methods 0.000 description 1
- 150000003839 salts Chemical class 0.000 description 1
- 235000010413 sodium alginate Nutrition 0.000 description 1
- 239000000661 sodium alginate Substances 0.000 description 1
- 229940005550 sodium alginate Drugs 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 239000010421 standard material Substances 0.000 description 1
- 125000001174 sulfone group Chemical group 0.000 description 1
- 238000010557 suspension polymerization reaction Methods 0.000 description 1
- 230000000007 visual effect Effects 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
- 229920003169 water-soluble polymer Polymers 0.000 description 1
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
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/531—Production of immunochemical test materials
-
- 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
- G01N33/569—Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
- G01N33/571—Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses for venereal disease, e.g. syphilis, gonorrhoea
-
- 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
- G01N33/545—Synthetic resin
-
- 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
- G01N33/92—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving lipids, e.g. cholesterol, lipoproteins, or their receptors
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
- G01N2333/195—Assays involving biological materials from specific organisms or of a specific nature from bacteria
- G01N2333/20—Assays involving biological materials from specific organisms or of a specific nature from bacteria from Spirochaetales (O), e.g. Treponema, Leptospira
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2469/00—Immunoassays for the detection of microorganisms
- G01N2469/20—Detection of antibodies in sample from host which are directed against antigens from microorganisms
Definitions
- neoe dam (e o e a a d) infects a living body, not only the body for the body, but also a body having reactivity with the substance is produced.
- the syphilis staining can be determined by measuring the presence or absence of a substance that reacts with the amount of substances in the blood.
- sensitization that promotes antigen response may be added.
- sensitizations include potting and kisstran.
- the patent shows that Dong Lang is effective.
- an anti-tone drug capable of inhibiting syphilis staining, preventing the occurrence of sera, and having excellent long-term storage stability.
- copolymer having a segment derived from an aqueous solution (hereinafter, also simply referred to as a copolymer).
- TACHIOKIN Since TACHIOKIN has a metaquine group, it can be copolymerized with other polymerizable groups.
- Polymerizable hydrophilic Examples of the (meta) activator include 2-metameth, (meth) act, and (aqua).
- the aqueous solution is not particularly limited, and examples thereof include (meth) ac and (aqua). Among them, the cationic group (meth) is preferable because it is expected to electrostatically generate blood tank. ) Acrylic acid is preferred.
- (meth) ac means acetic acid.
- the polymer is not particularly limited as to the segment derived from the above-mentioned 2 quinokine and the segment derived from the hydrophilicity, and may be selected as necessary, but the ratio is 5 to 3 7 is preferred.
- the average molecular weight of the polymer is not particularly limited, but the lower limit is preferably 5 and the upper limit is preferably 50,000. If it is 5, the result may be poor, and if it exceeds 50,000, the viscosity may increase excessively when added to the reagent, resulting in poor reproducibility.
- the lower limit of the abundance of the above-mentioned polymer in the case of 001 Ming is. (), And the upper limit is preferably .2 (). ⁇ If it is (), it may not be possible to effectively prevent the occurrence of serum interference. ⁇ If it exceeds 2 (), the reagent may become too active and reproducibility may be deteriorated.
- the more preferable lower limit is ⁇ 2 (), and the more preferable upper limit is ⁇ 8 ().
- the preferred source is, for example, a source consisting of ,,,,,,.
- a product produced from spleen of OO19 but it may also be a synthetic product.
- the 002 starch may be animal-derived or chemically-synthesized.
- phosphatidin, and staphylin are not particularly limited as long as they have the ability to judge the syphilis stain, but phosphatidin 8 to 2 and stapl 5 are I like it.
- the solubility is not particularly limited, but it is preferable to use a mixture of a polymerizable monomer having a group and / or an anionic polymerizable monomer.
- the polymerizable monomer having a 024 group is not particularly limited, and examples thereof include tin, benzene, histine, methine, custine, and coumethine. These may be used alone or in combination.
- the ionic polymerizable monomer is not particularly limited and includes, for example, styrene salts, (meth) acnes, nsene salts, and thion salts. Examples include salt and salt. In this case, there is no particular limitation, and examples thereof include sodium, potassium, titanium, and ammonium.
- the obtained insoluble body has a good content.
- the agent Since it is an insoluble and surface-loading substance obtained by using an ionic polymerizable monomer, it can be well dispersed in the liquid even without the agent.
- an agent When an agent is present in the insoluble state, when it is used as a drug, the agent inhibits the assembly of macromolecules due to a specific antigen reaction, or in some cases, participates in a reaction. In some cases, it is preferable that no agent be included.
- the content of the polymer component of each compatible monomer is not particularly limited, but the amount of the ionic component of the polymer component of the polymerizable monomer having the above group is not limited. It is preferable that the polymer component of the polymerizable monomer is 5 or less. When the polymerized amount of the ionic polymerizable monomer exceeds 5, the obtained insoluble matter may become dispersed. More preferred is below 3.
- 002 is soluble and has a surface load. This is based on the ionic polymerizable monomer which is the above-mentioned copolymerization component, and on the basis of the ion of the fragmentation initiator used at the time of polymerization. It is due to. For example, when a persulfate such as ammonium persulfate is used, sulfuric acid (S), which is a segment, exists on the copolymerization surface, and this is gradually hydrolyzed. In response to this, the following was done.
- S sulfuric acid
- the above-mentioned substances are used for immunological tests, and examples thereof include water, physiological saline, and serum.
- the optical variable due to the cluster may be small and the high sensitivity required for measurement may not be obtained. If it exceeds 7, the optical variable due to the cluster of particles may exceed, and the measurement range may be exceeded. Can be small.
- the more preferable lower limit is ⁇ 2, and the more preferable upper limit is ⁇ 5.
- the method of polymerizing the 003 compatible monomer is not particularly limited, and examples thereof include a polymerization method, a suspension method, a suspension method, and a dispersion method.
- the start of the combination is not particularly limited, and examples thereof include persulfates such as ammonium persulfate Is mentioned.
- the solubility is not particularly limited as the above-mentioned method, and the conventional method may be a physical and / or a combined method.
- Tex drug by dispersing and dissolving the above polymer in the same body, or two drugs consisting of the above insoluble drug and the liquid containing the above polymer added to the body. May be used as a second drug consisting of and.
- the 003 form is not particularly limited, and examples thereof include N, G, and T.
- the above-mentioned body is not particularly limited, but the preferred lower limit is 5.5, the preferred upper limit is 8.5, and the more preferred lower limit is 6.5.
- 003 Tex drug also contains an, yo, sodium, 2a, unsolved.
- the latex drug and the liquid drug described above can be used as an an, yo, sodium, 2a,
- the preferred lower limit is ⁇
- the preferred upper limit is, and the more preferred lower limit is ⁇ , and the more preferred upper limit is.
- the concentration of 003 As a method for optically determining the concentration of 003, the following method is used. For example, the decrease of scattering, absorption, and transmission can be measured by the size of insoluble particles, the selection of concentration, and the determination of reaction time. To do. It is also possible to use these methods together. In addition, 3 to 9 is preferable as the wavelength of light in the above conditions. .
- a method of observing the collection of 003 usually, a method of mixing the test with the drug of the present invention on the judgment plate, shaking the mixture, and then judging the absence of the collection can be used. . It is also possible to use a method of photographing the condition with a video camera and applying image processing, in addition to the method described above, in the case of the collection.
- the anti-tone / dumb drug contained a copolymer having a segment derived from 2 tequinokines as a sensitization and a segment derived from aqueous phenotype.
- a copolymer having a segment derived from 2 tequinokines as a sensitization and a segment derived from aqueous phenotype was found that it is possible to prevent the occurrence of serum interference and determine the tone-dam body when measuring the pure-tone dam body.
- Came to the end. 004 Akira Tone Dam, Insoluble in syphilis, 2 Tactioline-derived segment Copolymer having a segment derived from aqueous solution (below, simply containing copolymer and original.
- an addition recovery method can be used. Addition and recovery, after adding a standard of high-concentration antibody to physiological saline (depletion of minute blood plasma) to ⁇ 5 ° C, determine the difference between the constant values before and after. Similarly, the difference between the constant values before and after the addition of the quality antibody containing the quality antibody is calculated, and the difference between the constant values when the standard quality is added to physiological saline is taken as the recovery rate. By doing so, it is a test to confirm the liveness of serum. Since TACQUIOKIIN has a metaquino group, it can be copolymerized with other polymerizable groups. Examples of the polymerizable hydrophilic group include (meth) actic acid such as 2-methacryl, (meth) act, and (aqua).
- the water-based solvent is not particularly limited, and examples thereof include (meth) ac and (aqua). Among them, those having a cationic property (meta) are expected because they are expected to electrostatically generate blood tanks. ) Acrylic acid is preferred.
- (meth) ac means acetic acid.
- segment derived from the above-mentioned 2 thioquine and the segment derived from the hydrophilic group in the polymer It may be selected as needed, but the ratio is preferably 5 5 to 3 7. 2 If the ratio of the segments derived from Takuiokiin is this, it may not be possible to effectively prevent the occurrence of serum interference in the determination of TONE / DAM.
- the average molecular weight of the polymer is not particularly limited, but the lower limit is preferably 5 and the upper limit is preferably 50,000. If it is 5, the result may be poor, and if it exceeds 50,000, the viscosity may increase excessively when added to the reagent, resulting in poor reproducibility.
- the lower limit of the abundance of the above-mentioned polymer in Mitsune Tone Dam is ⁇ (), and the preferable upper limit is ⁇ 2 (). ⁇ If it is (), it may not be possible to effectively prevent the occurrence of serum interference. ⁇ If it exceeds 2 (), the reagent may become too active and the reproducibility may decrease.
- the more preferable lower limit is ⁇ 2 (), and the more preferable upper limit is ⁇ 8 ().
- Tone Dam The source is, for example, Tone Dam
- the solubility is not particularly limited, and examples thereof include those made of postins, stint stint polymers, actin stin polymers, salt actin polymers, poviacts, and the like. .
- the preferred lower limit is ⁇ 5 and the preferred upper limit is ⁇ , depending on the fixed method and fixed equipment used. ⁇ If it is 5 x, the optical variable due to the collection may be small and the high sensitivity required for the measurement may not be obtained, and if it exceeds, the optical variable due to the collection of the latex particles may exceed. The measurement range may become smaller.
- 005 Mine Tone Dam Insoluble in the above Tone Dam, may be used as a Tex drug by dispersing and dissolving the above polymer in the same body, and insoluble in the above Tone Dam It may also be used as a second drug composed of a drug containing the drug and a drug containing the above polymer added to the body.
- the 005 form is not particularly limited, and examples thereof include dan, gan, and toss.
- the preferred lower limit is ⁇
- the preferred upper limit is, and the more preferred lower limit is ⁇ , and the more preferred upper limit is.
- the upper limit of the antigenic response of the Akira Tone-dam drug is 4.5, the preferred lower limit is, the more preferred lower limit is 6, and the more preferred upper limit is 8.
- the lower limit of reactivity is C and the upper limit of reactivity is 5 C.
- the method of As a method for optically determining the concentration of the aggregates, the method of is used. For example, depending on the size of the insoluble particles to be used, the concentration selection, and the reaction duration, the scattering is determined. Measure the decrease in absorption, absorption and transmission. It is also possible to use these methods together. In addition, 3 to 9 is preferable as the wavelength of light in the above conditions.
- the equipment used for the method described in 006 is scattering, transmission, absorption.
- the liquid containing the test and the drug of the present invention is mixed on the judgment plate, and after shaking the mixture, the absence of the collection is judged. You can use the method.
- the drug was prepared by neutralizing d e 2 (, molecule 55) having an (o dica) with aO, and then adding 2.
- Medice P manufactured by Kogyo Co., Ltd.
- Tex solution was used as it was to make 2 drugs.
- This Tex solution has a post tech of an average of 4 and a phone of 38 x o 2 and a phosphine stain. It is a sensitized thing.
- the automatic type 7 7 was used for the degree measurement. This is the unit that represents the future body price of the body when measured using P (manufactured by Kogyo Co., Ltd.).
- the qualitative value was evaluated by determining the value of () and determining the bs of the drug after preparation.
- Antibodies usually exist at 2 to 0 C, but qualitatively can be evaluated as an accelerated test by storing at 3 C.
- the qualitative value was evaluated by determining the value of () and determining the bs of the drug after preparation.
- Antibodies usually exist at 2 to 0 C, but qualitatively can be evaluated as an accelerated test by storing at 3 C.
- Tone-Dam latex solution was prepared.
- the drug was prepared.
- Tone dam collect syphilis (manufactured by Kogyo Co., Ltd., 5) 6, hold it at 75 in C, add anti-tone redam latex 25, and after about 8 seconds to 3 seconds The amount of power at wave 7 between was measured and defined as the degree of variation (abs). An automatic 7-type 7 was used. The results are shown in Table 3.
- ⁇ ⁇ is the unit price of the Tone ⁇ dam body when measured with the Tone ⁇ Dam Is P (manufactured by Kogyo Co., Ltd.).
- the difference between the constant price before and after was calculated by adding 2 ⁇ n dam 5 to physiological saline 245 and measuring the variable before and after by the same method as the evaluation (). In the same manner, when adding 2 OO .. .. Tone dam 5 to each of 245 of 5 types, obtaining the difference between the constant body price before and after, and adding anti-tone dam to physiological saline. The recovery rate was calculated using the difference in the fixed price before and after in. The results are shown in Table 4.
- Example 7 was prepared in the same manner as in Example 7 except that S (o 4) was used in (2) of 7.
- 0112 Ming a drug with excellent long-term storage qualities that can stain syphilis, prevent the occurrence of serum interference, and stop syphilis staining.
Abstract
Description
Claims
Priority Applications (8)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN2006800455547A CN101341408B (zh) | 2005-12-07 | 2006-12-07 | 抗磷脂抗体测定试剂以及抗梅毒螺旋体抗体测定试剂 |
EP06834228.6A EP1956373B1 (en) | 2005-12-07 | 2006-12-07 | Method for assaying anti-treponema pallidum antibody |
AU2006323739A AU2006323739B2 (en) | 2005-12-07 | 2006-12-07 | Reagent for assaying antiphospholipid antibody and reagent for assaying anti-treponema pallidum antibody |
ES06834228.6T ES2615524T3 (es) | 2005-12-07 | 2006-12-07 | Método para analizar anticuerpos anti- Treponema pallidum |
DK06834228.6T DK1956373T3 (en) | 2005-12-07 | 2006-12-07 | PROCEDURE FOR ANALYTICAL ANTI-TREPONEMA PALLIDUM ANTIBODY ANALYSIS |
KR1020087012187A KR101440938B1 (ko) | 2005-12-07 | 2006-12-07 | 항인지질 항체 측정 시약 및 항트레포네마팔리덤 항체 측정시약 |
CA2631636A CA2631636C (en) | 2005-12-07 | 2006-12-07 | Reagent for assaying antiphospholipid antibody and reagent for assaying anti-treponema pallidum antibody |
US12/086,082 US20090246884A1 (en) | 2005-12-07 | 2006-12-07 | Reagent for Assaying Antiphospholipid Antibody and Reagent for Assaying Anti-Treponema Pallidum Antibody |
Applications Claiming Priority (4)
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JP2005354080A JP4629563B2 (ja) | 2005-12-07 | 2005-12-07 | 抗リン脂質抗体測定試薬 |
JP2005-354080 | 2005-12-07 | ||
JP2005354081A JP4629564B2 (ja) | 2005-12-07 | 2005-12-07 | 抗トレポネーマ・パリダム抗体測定試薬 |
JP2005-354081 | 2005-12-07 |
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WO2007066731A1 true WO2007066731A1 (ja) | 2007-06-14 |
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PCT/JP2006/324473 WO2007066731A1 (ja) | 2005-12-07 | 2006-12-07 | 抗リン脂質抗体測定試薬及び抗トレポネーマ・パリダム抗体測定試薬 |
Country Status (9)
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US (1) | US20090246884A1 (ja) |
EP (1) | EP1956373B1 (ja) |
KR (1) | KR101440938B1 (ja) |
CN (1) | CN102565397B (ja) |
AU (1) | AU2006323739B2 (ja) |
CA (1) | CA2631636C (ja) |
DK (1) | DK1956373T3 (ja) |
ES (1) | ES2615524T3 (ja) |
WO (1) | WO2007066731A1 (ja) |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
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JP2009222692A (ja) * | 2008-03-19 | 2009-10-01 | Jsr Corp | 免疫化学反応のシグナル増強剤および免疫学的測定方法 |
CN103443628A (zh) * | 2011-03-28 | 2013-12-11 | 积水医疗株式会社 | Psa测定方法及其试剂 |
WO2016068225A1 (ja) * | 2014-10-31 | 2016-05-06 | 日油株式会社 | デング熱ウイルスを測定対象物質とするイムノクロマト測定法用増感剤及び該増感剤を使用した測定法 |
Families Citing this family (3)
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JP5328665B2 (ja) * | 2007-10-22 | 2013-10-30 | アルフレッサファーマ株式会社 | 免疫学的微小粒子の凝集反応を用いる検体のアクロレイン付加体の測定方法および測定用キット |
CN106198957B (zh) * | 2016-06-30 | 2018-10-02 | 深圳市亚辉龙生物科技股份有限公司 | 改性心磷脂包被的纳米磁珠及其制备方法 |
CN110392831B (zh) * | 2017-01-27 | 2023-09-05 | 豪夫迈·罗氏有限公司 | 用于在相互作用测定中调节信号强度的方法 |
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CN103443628A (zh) * | 2011-03-28 | 2013-12-11 | 积水医疗株式会社 | Psa测定方法及其试剂 |
WO2016068225A1 (ja) * | 2014-10-31 | 2016-05-06 | 日油株式会社 | デング熱ウイルスを測定対象物質とするイムノクロマト測定法用増感剤及び該増感剤を使用した測定法 |
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Also Published As
Publication number | Publication date |
---|---|
AU2006323739B2 (en) | 2012-05-03 |
EP1956373A4 (en) | 2009-02-04 |
CN102565397A (zh) | 2012-07-11 |
EP1956373A1 (en) | 2008-08-13 |
ES2615524T3 (es) | 2017-06-07 |
KR20080077357A (ko) | 2008-08-22 |
EP1956373B1 (en) | 2017-01-25 |
CN102565397B (zh) | 2015-07-08 |
US20090246884A1 (en) | 2009-10-01 |
CA2631636A1 (en) | 2007-06-14 |
KR101440938B1 (ko) | 2014-09-17 |
CA2631636C (en) | 2014-06-03 |
AU2006323739A1 (en) | 2007-06-14 |
DK1956373T3 (en) | 2017-05-01 |
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