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英国NIBSC标准品

NIBSC成立于2004 年,主要负责开发 和生产超过90%的国际标准药品,该 机构在WHO中具有领先地位。NIBSC制备的流感毒株和检测抗原、抗血清标准品,保障了各厂家顺利的研究和生产。NIBSC提供对投入英国市场的生物药品的独立测试,尤其是用于英国儿童免疫计划的疫苗;它同时也是欧盟控制药品进入欧盟市场的官方药品控制实验室(OMCL)。 
                                    英国NIBSC标准品(图1)


Product Number Description
00/410 MAPREC assay of poliovirus type 1 (Sabin).100% 480-A, 525-C DNA(1st International Reference Preparation)
International Reference Preparation
00/416 Low Mutant Virus Reference for MAPREC assay of poliovirus type 1 (Sabin)(1st International Reference Preparation)
International Reference Preparation
00/418 MAPREC assay of poliovirus type 1 (Sabin) (1st International Standard)
International Standard
00/422 High Mutant Virus Reference for MAPREC assay of poliovirus type 1 (Sabin)(1st International Reference Preparation)
International Reference Preparation
00/440 Influenza Antiserum A/Singapore/1/57 (H2)
Influenza
00/442 Influenza anti B/Yamanashi/166/98 Serum
Influenza
00/464 Streptokinase (3rd International Standard 2001)
International Standard
00/498 Diphtheria Antitoxin Human IgG
Working standard single unit sales
00/500 Botulinum Type A-E Antitoxin, Human Serum
Non WHO Reference Material
00/530 Influenza Virus infectious B/Sichuan/379/99
Influenza
00/542 Influenza anti- A/Chick/Scotland/59 (H5N1) Serum
Influenza
00/544 Influenza Virus infectious B/Victoria/504/00
Influenza
00/546 Influenza Antigen B/Johannesburg/5/99
Influenza
00/552 Influenza Antigen A/Duck/Singapore-Q/F119-3/97 (H5N3)
Influenza
00/556 Influenza anti-B/Johannesburg/5/99/ Serum
Influenza
00/572 Interferon Beta (Human, rDNA, Glycosylated) (3rd International standard)
International Standard
00/574 Interferon Beta SER17 Mutein (Human, rDNA derived)
Non WHO Reference Material
00/576 Interferon Beta (Human, Fibroblast-derived, Glycosylated)
Non WHO Reference Material
007SP Human Anti-Pneumococcal capsule Reference Serum (1st International Standard)
International Standard
01/412 Anti-Meningococcal Immunotype L3,7,9 Monoclonal Antibody
Non WHO Reference Material
01/420 Interleukin-17 (Human rDNA derived)(International Reference Reagent)
International Reference Reagent
01/424 Vascular Endothelial Growth Factor, Human rDNA derived
Non WHO Reference Material
01/426 Meningococcal group Y polysaccharide
Non WHO Reference Material
01/428 Meningococcal serogroup W polysaccharide
Non WHO Reference Material
01/450 Influenza anti B/Guangdong/120/2000 Serum
Influenza
01/452 Influenza anti A/Panama/2007/99 (H3N2) HA serum
Influenza
01/506 Botulinum type F antitoxin, equine
Non WHO Reference Material
01/508 Botulinum type C antitoxin, equine
Non WHO Reference Material
01/510 Botulinum Antitoxin Equine Type D
Non WHO Reference Material
01/512 Botulinum type G antitoxin, equine
Non WHO Reference Material
01/514 Anti-Meningococcal Serosubtype P1.7 Monoclonal Antibody
Non WHO Reference Material
01/528 Oral Poliovaccine Sabin Type 1 reference strain [LS-c, 2ab strain] (Panel of 5 ampoules)
International Reference Preparation
01/532 Oral PolioVaccine Sabin Type 3 Reference Strain
International Reference Preparation
01/538 Anti-Meningococcal Serosubtype P1.16 mAb
Non WHO Reference Material
01/546 Influenza Antigen B/Guangdong/120/2000
Influenza
01/580 Thrombin, human(2nd International Standard)
International Standard
01/600 Anti-Toxoplasma IgG, Human(International Standard)
International Standard
01/602 Anti-Parvovirus B19, plasma, human(2nd International Standard)
International Standard
01/612 Influenza Virus infectious B/Hawaii/10/01
Influenza
01/614 Influenza Antigen A/New Caledonia/20/99
Influenza
02/102 Influenza anti A/Panama/2007/99 Serum
Influenza
02/144 Anti-Meningococcal Serosubtype P1.15 mAb
Non WHO Reference Material
02/148 Anti-Meningococcal Serosubtype P1.4 mAb
Non WHO Reference Material
02/168 Prekallikrein Activator (PKA), Human(2nd International Standard)
International Standard
02/178 Anti-Meningococcal Serosubtype P1.2 mAb
Non WHO Reference Material
02/180 Anti-Meningococcal Serotype P2.2a mAb
Non WHO Reference Material
02/182 Anti-Japanese Encephalitis Virus Plasma, Human
Non WHO Reference Material
02/184 Anti-Japanese Encephalitis (Anti-JE) Virus Negative Control Plasma, Human
Non WHO Reference Material
02/206 Factor XIII Plasma, Human (1st International Standard)
International Standard
02/210 HIV (antibody), 1st International Reference Panel
International Reference Preparation
02/226 IVIG negative control for use with IVIG + anti-D(International Reference Reagent)
International Reference Reagent
02/228 IVIG + anti-D for use with negative control IVIG(International Reference Reagent)
International Reference Reagent
02/230 Biotinylated Brad-5 (Bio-Brad-5)
Working Standard
02/232 Tetanus Toxoid (Non-Adsorbed)
Non WHO Reference Material
02/254 Insulin-like Growth Factor-1, recombinant, human, for immunoassay(1st International Standard)
International Standard
02/262 Influenza Virus infectious B/Brisbane/32/2002
Influenza
02/286 Vascular Endothelial Growth Factor 165 (VEGF165)(recDNA, human sequence)(International Reference Reagent)
International Reference Reagent
02/294 Influenza Antiserum A/chick/Italy/1347/99 (H7N1)
Influenza
02/308 Anti-Meningococcal Serotype P3.4 mAb
Non WHO Reference Material
02/310 Anti-Meningococcal Serotype P3.15 mAb
Non WHO Reference Material
02/318 Botulinum Antitoxin Equine Type E
Non WHO Reference Material
02/320 Anti-Meningococcal Serosubtype P1.3 mAb
Non WHO Reference Material
02/336 Influenza Antigen A/New Caledonia/20/99
Influenza
02/338 Influenza anti A/Panama/2007/99 Serum
Influenza
02/342 Protein C Plasma, Human(2nd International Standard)
International Standard
03/104 HTLV-1 (antibody) Monitor Sample
European Certification
03/110 Influenza anti B/Shangdong/9/97 Serum
Influenza
03/114 Anti-Meningococcal Serosubtype P1.1 mAb
Non WHO Reference Material
03/116 Blood Coagulation Factor V, Plasma Human (1st International Standard)
International Standard
03/124 Thrombopoietin ( Human rDNA derived)
Non WHO Reference Material
03/142 Anti-Meningococcal Serosubtype P1.14 mAb
Non WHO Reference Material
03/148 Keratinocyte growth factor (KGF, FGF-7)(24-163)(1st International Reference Reagent)
International Reference Reagent
03/150 Keratinocyte Growth Factor (KGF,FGF-7)(1st International Reference Reagent)
International Reference Reagent
03/152 Anti-HPA-1a (International Standard)
International Standard
03/164 Anti-B minimum potency reference preparation(International Standard)
International Standard
03/178 Vitamin B12, Serum Folate and holoTC (International standard)
International Standard
03/182 Anti-Meningococcal Serotype P3.21 mAb
Non WHO Reference Material
03/188 Anti-A minimum potency reference preparation(International Standard)
International Standard
03/190 Anti-HPA-3a(minimum potency)(International Reference Reagent)
International Reference Reagent
03/192 Thyroid-Stimulating Hormone, Recombinant, Human, for Bioassay (1st International standard)
International Standard
03/198 Influenza Virus infectious A/Kumamoto/102/02
Influenza
03/200 Interleukin - 18 (Human rDNA derived)(International Reference Reagent)
International Reference Reagent
03/210 Anti-Meningiococcal Serosubtype P1.6 mAb
Non WHO Reference Material
03/212 Influenza anti A/Wyoming/03/03 Serum
Influenza
03/220 Influenza Antigen A/Wyoming/03/03
Influenza
03/224 Anti-Meningococcal Serosubtype P1.10 mAb
Non WHO Reference Material
03/226 Anti-Meningococcal Serosubtype P1.5 mAb
Non WHO Reference Material
03/228 Protein S, Plasma, Human(2nd International Standard)
International Standard
03/236 Anti-Meningococcal Serosubtype P1.13 mAb
Non WHO Reference Material
03/242 Influenza anti A/Puerto Rico/8/34 (H1N1) HA Serum
Influenza
03/244 Influenza Antiserum A/chick/Germany/N/49
Influenza
03/258 Influenza Antigen A/New Caledonia/20/99 (IVR-116)
Influenza
03/262 Hepatitis B Surface Antigen subtype adw2, genotype A (International Reference Panel)
International Reference Preparation
04/122 Anti-Meningococcal Serosubtype P1.12 mAb
Non WHO Reference Material
04/140 IVIG Negative Control for use with IVIG & Anti-D
Non WHO Reference Material
04/150 Tetanus Toxoid For Flocculation Test(2nd International Standard)
International Standard
04/160 Influenza Virus infectious NYMC X-147
Influenza
04/166 TNF-related Apoptosis-Inducing Ligand (trail), Human, rDNA-derived(1st International Reference Reagent)
International Standard
04/170 Influenza Virus infectious A/Wellington/1/2004
Influenza
04/172 Influenza Virus infectious IVR-139
Influenza
04/176 Plasmodium falciparum DNA for NAT Assays(1st International Standard)
International Standard
04/198 Anti-Meningococcal Serotype P3.1 mAb
Non WHO Reference Material
04/202 Influenza Antigen B/ Jiangsu/10/2003
Influenza
04/224 Factor V Leiden, Human gDNA, 1st International Genetic Reference Panel 2004
International Standard
04/228 Influenza anti B/ Neuraminidase Serum
Influenza
04/242 Influenza anti B/Jiangsu/10/2003 HA Serum
Influenza
04/246 Anti-Meningococcal Serogroup W-135 mAb
Non WHO Reference Material
04/248 Anti-Meningococcal Serosubtype P1.19 mAb
Non WHO Reference Material
04/252 Protein C Concentrate, Human(1st International Standard)
International Standard
04/260 Influenza anti A/New Caledonia/20/99 HA Serum
Influenza
04/262 Influenza anti A/New York/55/2004 HA Serum
Influenza
04/264 Influenza Antigen A/New York/55/2004 (H3N2) (NYMC X-157)
Influenza
05/102 Influenza Virus infectious NYMC BX-7
Influenza
05/106 Anti-HPA-1a minimum potency reagent(2nd International Reference reagent)
International Reference Reagent
05/110 Influenza Virus infectious A/California/7/2004
Influenza
05/112 Low Molecular Weight Heparin for Molecular Weight Calibration (2nd International Standard).
International Standard
05/122 Syphilitic plasma IgG (human)(1st International Standard)
International Standard
05/130 Prothrombin Mutation G20210A, Human gDNA(1st International Genetic Reference Panel 2005)
International Standard
05/134 Anti-human papillomavirus type 16 serum (1st International Standard)
International Standard
05/138 Influenza Virus infectious B/Shanghai/361/2002
Influenza
05/162 Alpha-1-Antitrypsin, plasma derived(1st International standard)
International Standard
05/190 Anti Meningococcal Serosubtype P1.9 Monoclonal Antibody
Non WHO Reference Material
05/192 Anti Meningococcal Serotype P2.2b Monoclonal Antibody
Non WHO Reference Material
05/234 Influenza Antigen A/Hiroshima/52/2005 (H3N2) (IVR-142)
Influenza
05/236 Influenza anti A/Wisconsin/67/2005 Serum
Influenza
05/242 IVIG, Anti-D and Negative Control Panel
Non WHO Reference Material
05/252 Influenza anti B Neuraminidase Serum
Influenza
06/108 Influenza Virus infectious IVR-116
Influenza
06/124 Monoclonal Antibody for Serotyping Bordetella pertussis Fimbrial Antigen 2 (1st International Standard)
International Standard
06/128 Monoclonal Antibody for Serotyping Bordetella pertussis Fimbrial Antigen 3 (1st International Standard)
International Standard
06/140 Pertussis Antiserum(human)1st IS-WHO international Standard.
International Standard
06/142 Pertussis Antiserum (Human) 1st WHO Reference Reagent
International Reference Reagent
06/164 Influenza Virus infectious 1 VR-142
Influenza
06/166 Antithrombin Concentrate, Human (3rd International Standard)
International Standard
06/170 Influenza Antigen A/New Caledonia/20/99
Influenza
06/192 Influenza anti A/turkey/Turkey/1/05 (NIBRG-23) HA serum(sheepSH465 & SH466)
Influenza
06/202 Human Papillomavirus (HPV) Type 16 DNA (1st International Standard)
International Standard
06/206 Human Papillomavirus (HPV) Type 18 DNA (1st International Standard)
International Standard
06/242 Influenza Virus Infectious NYMC X-161B (A/Wisconsin/67/2005 HGR)
Influenza
07/102 Influenza Antigen A/Solomon Islands/3/2006 (H1N1)(IVR-145)
Influenza
07/104 Influenza anti A/Solomon Islands/3/2006 (H1N1) (IVR-145) HA Serum
Influenza
07/112 Influenza Antigen A/turkey/Turkey/1/2005 (H5N1) NIBRG-23
Influenza
07/132 Influenza Virus infectious B/Malaysia/2506/2004
Influenza
07/144 Influenza Virus infectious IVR-145,
Influenza
07/146 Influenza anti A/HongKong/1073/99 like (H9) HA Serum (sheep)
Influenza
07/148 Influenza anti A/Vietnam/1194/04 (H5N1) HA Serum
Influenza
07/150 Human Plasma Anti-Influenza H5N1 (1st International Standard)
International Standard
07/164 Anti-hepatitis B surface antigen(Anti-HBs) immunoglobulin (2nd International Standard)
International Standard
07/184 Influenza anti B/Malaysia/2506/2004-HA Serum
Influenza
07/202 Recombinant soluble transferrin receptor (rsTfR)(1st WHO Reference Reagent)
International Reference Reagent
07/204 Influenza Virus Infectious NIBRG-60 VE2 25820
Influenza
07/214 Positive Control for use in flow cytometry cross matching (FCXM)
European Certification
07/216 Diphtheria Toxoid (Adsorbed) (4th International Standard)
International Standard
07/222 RhD/SRY Plasma DNA sensitivity standard (1st International Reference Reagent)
International Reference Reagent
07/226 Influenza Virus Infectious A/New Caledonia/20/99
Influenza
07/228 Blood Coagulation Factor VIIa, Concentrate, Human, 2nd International Standard”
International Standard
07/268 Influenza Virus Infectious B/Brisbane/3/2007
Influenza
07/270 BCG Vaccine of Danish 1331 sub-strain (1st WHO Reference Reagent)
International Reference Reagent
07/272 BCG Vaccine of Tokyo 172 sub-strain(1st WHO Reference Reagent)
International Reference Reagent
07/274 BCG Vaccine of Russian BCG-I sub-strain(1st WHO Reference Reagent)
International Reference Reagent
07/278 Influenza anti A/mallard/Netherlands/12/2000 (H7) HA serum (NIBRG-60) (sheep SH474 AND SH475)
Influenza
07/286 Monitor sample for HBsAg 0.05IU/ml
European Certification
07/288 Hepatitis B Surface Antigen (HBsAg) British Working Standard 0.2 IU/ml
European Certification
07/290 Influenza Antigen A/Anhui/1/05 (H5N1) IBCDC-RG-6
Influenza
07/296 Influenza Virus (A/Christchurch/1/2003, H1N1) for Nucleic Acid Amplification Techniques
Clinical Virology Network
07/298 Influenza Virus (A/Wyoming/3/2003, H3N2) for Nucleic Acid Amplification Techniques
Clinical Virology Network
07/300 Influenza Virus (B/Jiangsu/10/2003) for Nucleic Acid Amplification Techniques
Clinical Virology Network
07/304 Anti-D for assuring operator and test performance
Working Standard
07/306 Anti-A and anti-B in IVIG: Positive control for haemagglutination tests (International Reference Reagent)
International Reference Reagent
07/316 Blood Coagulation Factor VIII and Von Willebrand Factor in Plasma (6th I.S.)
International Standard
07/318 Meningococcal Group C Polysaccharide
Non WHO Reference Material
07/328 Unfractionated Heparin (6th I.S.)
International Standard
07/336 Influenza Antigen A/mallard/Netherlands/12/00(H7N3) NIBRG-60
Influenza
07/338 Influenza antiserum A/Anhui/1/05 (H5)
Influenza
07/348 Influenza Virus infectious NYMC X-171B
Influenza
07/350 Blood Coagulation Factor VIII Concentrate (8th I.S.)
International Standard
07/358 Influenza Virus infectious NIB-50
Influenza
07/362 Influenza Virus infectious IVR-149
Influenza
07/364 Chorionic Gonadotrophin, (5th IS)
International Standard
07/B498 QCRHBclgMQC1-IgM Anti-HBc Quality Control Serum: Sample1
Quality Control Reagent
08/100 Influenza Antigen A/Brisbane/59/2007 (IVR-148) (H1N1)
Influenza
08/108 Influenza Virus Infectious NIBRG-91
Influenza
08/118 Parainfluenza Virus serotype 3 for Nucleic Acid Amplification Techniques
Clinical Virology Network
08/120 Human Respiratory syncytial virus A2 for Nucleic Acid Amplification Techniques
Clinical Virology Network
08/126 Influenza Anti N1 Neuraminidase Serum SH485
Influenza
08/138 Influenza Virus Infectious B/Florida/4/2006
Influenza
08/140 Influenza Antigen B/Florida/4/2006
Influenza
08/142 Influenza antiserum A/Anhui/1/05 (H5)
Influenza
08/148 Positive control for Luminex based anti-HLA Class II serology
European Certification
08/156 Influenza Virus Infectious NIBRG-23 30060 VE3
Influenza
08/158 Fragile X Syndrome gDNA (1st International Genetic Reference Panel)
International Standard
08/160 Haemophilia A, Intron-22 inversion, gDNA, (1st International Genetic Reference Panel)
International Standard
08/174 Human Coxsackie B4 for Nucleic Acid Amplification Techniques
Clinical Virology Network
08/176 Parainfluenza Virus serotype 1 for Nucleic Acid Amplification Techniques
Clinical Virology Network
08/178 Parainfluenza Virus serotype 2 for Nucleic Acid Amplification Techniques
Clinical Virology Network
08/180 Parainfluenza virus serotype 4 for Nucleic Acid Amplification Techniques
Clinical Virology Network
08/184 Influenza Antigen B/Malaysia/2506/2004
Influenza
08/202 Influenza anti A/chick/Hong Kong/G9/1997/(H9) HA serum (NIBRG-94)(H9N1)
Influenza
08/204 Thyroid Stimulating Antibody (2nd I.S.)
International Standard
08/208 Influenza Antigen Hong Kong/1073/99 (H9N2)
Influenza
08/210 Influenza anti A/Cambodia/R0405050/2007 (H5) HA serum (NIBRG-86)
Influenza
08/214 Meningococcal Serogroup C polysaccharide (1st International Standard)
International Standard
08/216 Influenza Antigen A/Cambodia/RO405050/2007 (H5N1)
Influenza
08/218 Tetanus Toxoid Adsorbed (4th International Standard)
International Standard
08/228 Influenza Antigen A/chick/Hong Kong/G9/1997 (H9N2) NIBRG-91
Influenza

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