英国国家生物制品检定所(NIBSC)

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英国国家生物制品检定所(NIBSC)

英国国家生物制品检定所(NIBSC)  www.nibsc.ac.uk

国家生物标准委员会 (NBSB) 是隶属于英国政府的一家非部门公共机构 (NDPB)，它成立于 1975 年，是《议会法案》的法定团体。 委员会通过对国家生物学标准与控制研究院 (NIBSC) 的管理，确保生物产品的质量与安全，从而保障并促进公众的健康。

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)。 如果出现不能满足药品存放要求或患者出现不良反应等问题，NIBSC 也可对已投入欧盟市场的产品进行检验。

NBSB 认为对 NIBSC工作的核心职能制定并维护一项既均衡而又主次分明的计划至关重要。

控制和评估生物药品。
开发和提供关键的生物学标准和其它参考资料。
开展针对任务的研究和开发工作。

NIBSC 战略目标：
对有关生物产品的问题给出回复和建议；
提供生物药品方面的国家科技力量，维持满足科学和药物学领域新发展需求的灵活性、专业知识和设施；
作为化验方法（如量化生物学活性以及确定生物产品特征和进行安全评估）方面的国际领先权威机构运营并得到认同；
在欧洲生物产品的控制和标准化方面，继续发挥科学基础开发的中心作用；
在生物药品法规的科学方面帮助国际社会达成共识，并籍于此，与世界卫生组织紧密合作；
在控制和标准化的关键领域实现和维护质量鉴定。

生物药品控制
药品中使用的生物物质包括病毒和细菌疫苗、从人类血液提取的产物、荷尔蒙以及其它储如细胞分裂素和生长素等治疗药物。

这些生物物质对药物学和公众健康做出了巨大贡献并发挥着越来越大的作用，它们大大改善了全世界的疾病预防、诊断和治疗。

生物药品是非常复杂的产品，正因为如此，大多数生物药品在投入使用前都会经过独立测试。 在英国和欧盟，生物产品在投入使用前会先提交到欧盟的其中一个 OMCL 进行测试。 确保疫苗的安全性尤其重要，因为它们将在全国范围内的免疫活动中用于大量健康的个人。

通过研究院的测试和评估工作，NIBSC的科学家们帮助确保了生物产品的安全和有效性，同时也帮助缩短了将新产品投入临床使用的时间。 新产品，如最新一代复合疫苗，需要采取新颖的方法加以控制。 作为基因革命带来的影响之一，生物产品在数量和复杂程度上的潜在大幅增长也需要有更为彻底的控制战略方案。

提供标准
用于确保生物产品潜能的复杂化验要求使用生物学活性标准（有一批物质被指定了活性单位并用作“基准”）。 世界卫生组织 (WHO) 国际标准系统提供了一组常用标准，它使得世界各地的质量测试结果具有可比性，也因此而重要非凡。 国际标准是“金标准”，各国以及各生产商都可据此制定出自己的生物学测试标准。

NIBSC 是目前世界上 WHO 国际标准和参考材料的主要制作人和分发人（提供 95% 以上的标准）。 对疫苗、治疗中的大多数生物技术产品以及其它许多生物产品的有效使用都取决于 NIBSC 所提供的国际生物学标准的可用性。

The National Biological Standards Board (NBSB) is a non-departmental public body (NDPB) of the UK **, established, in 1975, as a Statutory Body by Act of Parliament. The Board is responsible for safeguarding and advancing public health by assuring the quality and safety of biologicals, through its management of the National Institute for Biological Standards and Control (NIBSC).

NIBSC provides independent testing of biological medicines for the UK market, in particular with vaccines for the UK children's vaccination programme, and operates as an Official Medicines Control Laboratory (OMCL) of the European Union for release of medicines onto the EU market. NIBSC testing of products already released onto the EU market may also be carried out when particular problems arise such as failure of storage conditions or following adverse reactions in patients.

NBSB considers it essential to maintain a well balanced and clearly prioritised programme of work on the core functions of NIBSC's work.

Control and evaluation of biological medicines.
Development and provision of key biological standards and other reference materials.
Mission-orientated research and development.
NIBSC STRATEGIC AIMS:

To respond to and advise on public health problems involving biologicals;
To provide a national scientific capacity in the field of biological medicine, and to maintain the flexibility, expertise and facilities needed to address new developments in science and medicine;
To operate, and be recognised, as a leading international authority on methods of assay such as those to quantify biological activity and to characterise and assess the safety of biologicals;
To maintain a central role in the development of the scientific basis for control and standardisation of biologicals within Europe;
To assist in the development of international consensus on scientific aspects of the regulation of biological medicines and, in this respect, work closely with the World Health Organisation;
To achieve and maintain Quality Accreditation in key areas of control and standardisation.
To read more about Biological standardization:

A HISTORY OF BIOLOGICAL STANDARDIZATION

The characterization and measurement of complex molecules important in clinical and research medicine. Contributions from the UK 1900-1995. What, why, how, where and by whom: A personal account by D.R. Bangham

This document is provided here with the permission of the Society of Endocrinology

NIBSC 标准品 英国国家生物标准与检定所(National Institute for Biological Standards and Control, NIBSC)，同时它又是世界卫生组织WHO的一个国际标准品供应中心，它的核心工作是制备、保存和分发WHO用于检测全球生物制品质量的标准品。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。 Type of standard Product Number Acarus Siro Extract 77/662 Acellular Pertussis Vaccine - 1st IS JNIH-3 Activin A, Human, Recombinant 91/626 Alpha-1-Antitrypsin, plasma derived 05/162 Alpha-Foetoprotein AFP Ancrod 74/581 Angiotensin I 71/328 Angiotensin I Human Type Synthetic 86/536 Angiotensin II 70/302 Angiotensin II 86/538 Anti Dengue, WHO Reference Panel 05/248 Anti Filamentous Haemagglutinin Monoclonal Antibody (12G10) 99/574 Anti Filamentous Haemagglutinin Monoclonal Antibody (1C6) 99/570 Anti Hepatitis C Virus 06/188-004 Anti Meningococcal Serosubtype P1.9 Monoclonal Antibody 05/190 Anti Meningococcal Serotype P2.2b Monoclonal Antibody 05/192 Anti nuclear ribonucleoprotein(nRNP) autoantibody W1063 Anti Poliovirus serum types 1,2 and 3 82/585 Anti smooth muscle(anti actin) autoantibody. W1062 Anti-A and Anti-b in IVIG: Positive and Negative control panel. (2 ampoules of 07/306 and 2 ampoules of 07/308) 08/270 Anti-A minimum potency reference preparation 03/188 Anti-Aspergillus fumigatus Serum, Human 78/545 Anti-B minimum potency reference preparation 03/164 Anti-Birch Pollen Serum, Human 76/525 Anti-Bordetella pertussis serum (Human) 89/530 Anti-B-pertussis Fimbriae 2 Monoclonal Antibody 04/154 Anti-B-pertussis Fimbriae 3 Monoclonal Antibody 04/156 Anti-Brucella Ovis Serum, Ovine BOVISDS Anti-C complete blood typing serum,human W1004 Anti-c Incomplete blood typing serum, human W1007 anti-c Serum, Human 84/628 Anti-Canine Distemper Serum CDS Anti-Canine Hepatitis Serum CHS Anti-Cat Fur Serum, Human 79/530 Anti-Cocksfoot Serum, Human 77/503 Anti-D (Rho) Antibodies, Human 73/515 Anti-D for assuring operator and test performance 07/304 Anti-D for use with papain preparation 92/658 91/562 Anti-D Immunoglobulin 01/572 Anti-D Immunoglobulin Control 99/728 Anti-D Minimum Potency Standard for blood grouping reagents 99/836 Anti-D Pteronyssinus Serum, Human 77/584 Anti-Dengue Virus Types 1+2+3+4, Human 02/186 Anti-Dysentery (shiga) serum, Equine DY Anti-E complete blood typing serum, human W1005 Anti-Echinococcus Serum, Human ECHS Anti-Ferritin Monoclonal Antibody (1) 87/654 Anti-Ferritin Monoclonal Antibody (2) 87/662 Anti-Filamentous haemagglutinin Monoclonal Antibody (2E9) 99/572 Anti-Granulocyte Macrophage Colony Stimulating Factor Serum 97/538 Anti-HBc (Anti-hepatitis B core antigen) 95/522 Anti-HBs immunoglobulin 07/164 Anti-HCV (1 in 8 dilution) 06/190-004 Anti-Hepatitis A Immunoglobulin, Human (W1041) 97/646 Anti-hepatitis E Serum, Human 95/584 Anti-Hib Human Reference Serum 96/536 Anti-HPA-1a minimum potency reagent 05/106 Anti-HPA-1a standard 03/152 Anti-HPA-3a(minimum potency) 03/190 Anti-HPA-5b (Minimum Potency) 99/666 Anti-Human Globulin 96/666 Anti-human papillomavirus type 16 serum 05/134 Anti-Japanese Encephalitis (Anti-JE) Virus Control Plasma, Human 02/184 Anti-Japanese Encephalitis Virus Plasma, Human 02/182 Anti-Measles serum 97/648 Anti-Meningiococcal Serosubtype P1.6 mAb 03/210 Anti-Meningococcal human reference serum CDC1992 99/706 Anti-Meningococcal immunotype L3,7,9 mAb 01/412 Anti-Meningococcal Serogroup A mAb 95/674 Anti-Meningococcal Serogroup B mAb 95/750 Anti-Meningococcal Serogroup C mAb 95/678 Anti-Meningococcal Serogroup W-135 mAb 04/246 Anti-Meningococcal Serosubtype P1.10 mAb 03/224 Anti-Meningococcal Serosubtype P1.12 mAb 04/122 Anti-Meningococcal Serosubtype P1.13 mAb 03/236 Anti-Meningococcal Serosubtype P1.14 mAb 03/142 Anti-Meningococcal Serosubtype P1.15 mAb 02/144 Anti-Meningococcal Serosubtype P1.16 mAb 01/538 Anti-Meningococcal Serosubtype P1.19 mAb 04/248 Anti-Meningococcal Serosubtype P1.2 mAb 02/178 Anti-Meningococcal Serosubtype P1.3 mAb 02/320 Anti-Meningococcal Serosubtype P1.4 mAb 02/148 Anti-Meningococcal Serosubtype P1.5 mAb 03/226 Anti-Meningococcal Serosubtype P1.7 mAb 01/514 Anti-Meningococcal Serosutype P1.1 mAb 03/114 Anti-Meningococcal Serotype P2.2a mAb 02/180 Anti-Meningococcal Serotype P3.1 mAb 04/198 Anti-Meningococcal Serotype P3.15 mAb 02/310 Anti-Meningococcal Serotype P3.21 mAb 03/182 Anti-Meningococcal Serotype P3.4 mAb 02/308 Anti-Mycoplasma gallisepticum Serum MGDS Anti-Newcastle Disease Serum NDS Anti-Nuclear Factor Serum (Homogenous) Human 66/233 Anti-Nuclear factor serum,homogenous(66/233) W1064 Anti-Nucleolar Factor Plasma, Human 68/340 Anti-Parvovirus B19, plasma, human 01/602 Anti-PT S1 subunit Monoclonal Antibody (10D6) 99/512 Anti-PT S1 subunit Monoclonal Antibody (11D9) 99/522 Anti-PT S1 subunit Monoclonal Antibody (1B7) 99/506 Anti-PT S1 subunit Monoclonal Antibody (1D7) 99/508 Anti-PT S1 subunit Monoclonal Antibody (3F11) 99/510 Anti-PT S1 subunit Monoclonal Antibody (4D10) 99/524 Anti-PT S1 subunit Monoclonal Antibody (8G4) 99/514 Anti-PT S1 subunit Monoclonal Antibody (E1E) 99/516 Anti-PT S1 subunit Monoclonal Antibody (E2E) 99/518 Anti-PT S1subunit Monoclonal Antibody (3F10) 99/520 Anti-PT S2 subunit Monoclonal Antibody (2H3) 99/538 Anti-PT S2 subunit Monoclonal Antibody (3A12) 99/536 Anti-PT S2 subunit Monoclonal Antibody (9G8) 99/540 Anti-PT S23 subunit Monoclonal Antibody (10B5) 99/530 Anti-PT S23 subunit Monoclonal Antibody (10C9) 99/528 Anti-PT S23 subunit Monoclonal Antibody (11E6) 99/526 Anti-PT S23 subunit Monoclonal Antibody (3F6) 99/534 Anti-PT S23 subunit Monoclonal Antibody (G9A) 99/532 Anti-PT S3 subunit Monoclonal Antibody (2E12) 99/548 Anti-PT S3 subunit Monoclonal Antibody (4G5) 99/546 Anti-PT S3 subunit Monoclonal Antibody (6F8) 99/550 Anti-PT S3 subunit Monoclonal Antibody (7E10) 99/542 Anti-PT S3 subunit Monoclonal Antibody (7G11) 99/544 Anti-PT S4 subunit Monoclonal Antibody (1H2) 99/562 Anti-PT S4 subunit Monoclonal Antibody (6B3) 99/556 Anti-PT S4 subunit Monoclonal Antibody (6D6) 99/566 Anti-PT S4 subunit Monoclonal Antibody (6G8) 99/558 Anti-PT S4 subunit Monoclonal Antibody (7F2) 99/554 Anti-PT S4 subunit Monoclonal Antibody (9C6) 99/564 Anti-PT S4 subunit Monoclonal Antibody (9F3) 99/560 Anti-PT S5 subunit Monoclonal Antibody (7E3) 99/568 Anti-Q Fever Serum, Bovine QF Anti-rabies Immunoglobulin, Human RAI Anti-rubella Immunoglobulin, Human RUBI-1-94 Anti-Rubella Serum, Human 67/182 Anti-Rye Grass Serum, Human 85/551 Anti-Salmonella Pullorum Serum (Std. Form S) SPDS-S2 Anti-Salmonella Pullorum Serum (Variant Form V) SPDS-V Anti-Staphylococcal P-V Leucocidin antiserum, Equine 64/012 Anti-Staphylococcal P-V Leucocidin serum, Equine SPLS AntiStreptolysin O 97/662 Anti-Swine Fever Serum SFS Anti-syphilitic plasma IgG (human) 05/122 Anti-syphilitic plasma IgG and IgM (human) 05/132 Antithrombin Concentrate, Human 06/166 Antithrombin, Plasma, Human 93/768 Anti-Thyroglobulin Serum, Human 65/093 Anti-thyroid Microsome Serum, Human 66/387 Anti-tick borne encephalitis serum TILI Anti-tick borne encephalitis serum TISA Anti-Toxoplasma IgG, Human 01/600 Anti-Varicella zoster immunoglobulin W1044 Anti-Varicella-Zoster Antibody 90/690 Anti-Yellow Fever Serum, monkey YF Arginine Vasopressin 77/501 Aspergillus Fumigatus Extract 78/575 Atrial Natriuretic Factor, Human 85/669 Autoimmune Antibody to Human Spermatazoa 69/065 B19 DNA NAT assays.2nd I.S. 99/802 Basic Fibroblast Growth Factor (Human, rDNA derived) 90/712 Batroxobin 93/526 Bee Venom 78/628 Beta Thromboglobulin, Purified Human 83/501 Beta-2 Microglobulin B2M Biotinylated Brad-5 (Bio-Brad-5) 99/698 Birch Pollen Extract 84/522 Blood Coagulation Factor IX Concentrate, Human, 4th International Standard” 07/182 Blood Coagulation Factor V, Plasma(1st I.S.) 03/116 Blood Coagulation Factor VII Concentrate(1st I.S.) 97/592 Blood Coagulation Factor VIIa, Concentrate, Human, 2nd International Standard” 07/228 Blood Coagulation Factor VIII and Von Willebrand Factor in Plasma (5th I.S.) 02/150 Blood Coagulation Factor VIII Concentrate, Human 02/122 Blood Coagulation Factor VIII:C Concentrate, Human;7th I.S. 99/678 Blood Coagulation Factor Xa, Bovine 75/595 Blood Coagulation Factor XI Plasma, Human(1st I.S.) 04/102 Blood Coagulation Factor XIII, Plasma, Human. 02/206 Blood Coagulation Factors II and X Concentrate(3rd I.S.) 98/590 Blood Coagulation Factors II, IX,and X Concentrate, 6th British Working Standard. 07/326 Blood Coagulation Factors II, VII, IX, X Plasma(3rd I.S.) 99/826 Blood Coagulation Factors IXa Concentrate, Human, recombinant(1st I.S.) 97/562 Bone morphogenetic Protein-2 (Human, rDNA derived) 93/574 Bordetella pertussis (W28) LPS 2ug 89/594 Bordetella pertussis (W28) LPS25ug 89/670 Bordetella pertussis (Whole cell vaccine) 3BRP 88/522 Bordetella pertussis 69kD 90/654 Bordetella pertussis anti 69kD serum (sheep) 97/558 Bordetella pertussis anti FHA serum (mouse) JNIH-11 Bordetella pertussis anti FHA serum (sheep) 97/564 Bordetella pertussis anti Fim3 serum (sheep) 97/574 Bordetella pertussis anti serum (mouse) 1RR 97/642 Bordetella pertussis anti-agglutinogen 1(rabbit) 89/596 Bordetella pertussis anti-agglutinogen 2 (rabbit) 89/598 Bordetella pertussis anti-agglutinogen 3 (rabbit) 89/600 Bordetella pertussis filamentous haemagglutinin (FHA) JNIH-4 Bordetella pertussis PT anti serum (sheep) 97/572 Bordetella pertussis PT( LPF) anti serum, (mouse) JNIH-12 Bordetella Pertussis toxin (PT) 90/518 Bordetella pertussis toxin (PT) 1st IS JNIH-5 Bordetella pertussis, filamentous haemagglutinin (FHA) 90/520 Botulinum Antitoxin Equine Type A 59/021 Botulinum Antitoxin Equine Type B 60/001 Botulinum Antitoxin Equine Type B BUSB Botulinum Antitoxin Equine Type C 01/508 Botulinum Antitoxin Equine Type D 01/510 Botulinum Antitoxin Equine Type D 61/001 Botulinum Antitoxin Equine Type E 02/318 Botulinum Antitoxin Equine Type F 01/506 Botulinum Antitoxin Equine Type G 01/512 Botulinum Antitoxin Human 00/500 Brain-derived Neurotrophic Factor (Human, rDNA derived) 96/534 C- Peptide of Human Insulin 84/510 Calcitonin, ASU 1-7 Eel Calcitonin Analogue (Elcatonin) 84/614 Calcitonin, Eel 88/556 Calcitonin, Human 89/620 Calcitonin, Salmon 98/586 Carcinoembryonic Antigen (CEA), Human 73/601 Cholera Antitoxin, Goat CHAN Cholera Vaccine (Inaba) 73/554 Chorionic Gonadatrophin, beta core fragment, Human 99/708 Chorionic Gonadatrophin, intact, Human 99/688 Chorionic Gonadotrophin alpha subunit, Human 75/569 Chorionic Gonadotrophin alpha Subunit, Human, for Radioiodination 76/508 Chorionic Gonadotrophin beta Subunit, Human 75/551 Chorionic Gonadotrophin beta, Human, for Radioiodination 75/535 Chorionic Gonadotrophin, alpha subunit, Human (purified) 99/720 Chorionic Gonadotrophin, beta subunit, human 99/650 Chorionic Gonadotrophin, Human 75/589 Chorionic Gonadotrophin, Human, for Radioiodination 75/533 Chorionic Gonadotrophin, nicked beta subunit, Human 99/692 Chorionic Gonadotrophin, nicked, human 99/642 Ciliary Neurotrophic Factor (Human, rDNA derived) 94/684 Clostridium novyi (alpha) Toxoid COT Clostridium Perfringens Beta Antitoxin 2CPBETAAT Clostridium Perfringens Beta Toxoid CWBETATD Clostridium Perfringens Epsilon Antitoxin 2CPEPSILONAT Clostridium Perfringens Epsilon Toxoid CWEPSILONTD Clostridium Sordellii anti-serum (1st International standard) 09/154 Cocksfoot Pollen Extract 75/506 Control Guinea Pig Serum 98/686 Corticotrophin (ACTH), Human 74/555 Corticotrophin (ACTH), Porcine 59/016 Corticotrophin (ACTH), Porcine 74/586 C-Reactive Protein, Human 85/506 Dermatophagoides Pteronyssinus Extract 82/518 Diphtheria (Schick) Test Toxin STT Diphtheria and Tetanus Antitoxin, Guinea Pig Serum 98/572 Diphtheria Antitoxin Human Serum 00/496 Diphtheria Antitoxin, Equine 07/200 Diphtheria Antitoxin, Equine 66/153 Diphtheria Antitoxin, Equine, for Flocculation Test 63/007 Diphtheria Toxoid for use in Flocculation Test. 02/176 Diphtheria Toxoid, Plain 69/017 Dog (Canis Familiaris) Hair Dander Extract 84/685 Endotoxin 94/580 Epidermal Growth Factor (1-52) (Human, rDNA derived) 91/550 Epidermal Growth Factor (Human, rDNA derived) 91/530 Erythropoietin, Human recombinant 88/574 Erythropoietin, Human, Urinary 67/343 Factor V Leiden, Human gDNA, 1st International Genetic Reference Panel 2004 04/224 FEIBA Concentrate 1st NIBSC Working Reference Standard 06/172 Ferritin, Human, recombinant 94/572 Fibrinogen Concentrate, Human, 1st International Standard 98/614 Fibrinogen, Plasma, Human 98/612 FMS-like tyrosine kinase 3 ligand (Human, rDNA derived) 96/532 Folate, Whole Blood 95/528 Follicle Stimulating Hormone and Luteinizing Hormone, Human Urinary 98/704 Follicle Stimulating Hormone, Human, recombinant 92/510 Follicle Stimulating Hormone, Human, recombinant 92/642 Follicle Stimulating Hormone, Pituitary 83/575 Follicle Stimulating Hormone, urofollitropin Human Urinary 92/512 Follicle Stimulating Hormone/Luteinizing Hormone, Human Pituitary 94/632 Fragile X Syndrome gDNA Genetic Reference Panel 08/158 Gas Gangrene (Cl. Perfringens(Cl. Welchii) Type A), Equine 59/015 Gas Gangrene Antitoxin (Cl. Histolyticum), Equine 63/005 Gas Gangrene Antitoxin (Cl. Noyvi), Equine OE Gas Gangrene Antitoxin (Cl. Oedematiens), Equine 64/024 Gas Gangrene Antitoxin (Cl. Perfringens alpha antitoxin) Equine PE Gas Gangrene Antitoxin (Cl. Septicum), Equine 64/014 Gas Gangrene Antitoxin (Cl. Septicum), Equine VI Gastrin II, Porcine 66/138 Glucagon, Porcine 69/194 Glycyphagus destructor Extract 77/664 Granulocyte Colony Stimulating Factor (Human, rDNA derived) 88/502 Granulocyte Macrophage Colony Stimulating Factor (Human, rDNA derived) 88/646 Granulocyte Macrophage Colony Stimulating Factor (Mouse rDNA derived) 91/658 Growth Hormone, Human, Pituitary 80/505 Haemiglobincyanide 98/708 Haemoglobin A2 Lysate, Raised 89/666 Haemoglobin F Lysate, Raised 85/616 Haemophilia A, Intron-22 inversion, gDNA, Genetic Reference Panel 08/160 Haemophilus influenzae b PRP 02/208 HBV DNA Working reagent for Nucleic Acid Amplification Techniques 05/148 HCV RNA Genotype Panel for Nucleic acid amplification techniques 08/264 HCV RNA Working Reagent for Nucleic Acid Amplification Techniques 02/264-001 Heparin, Porcine, Mucosal 97/578 Hepatitis A Vaccine, inactivated 95/500 Hepatitis A Virus RNA NAT Assays 00/560 Hepatitis A Virus RNA Working Reagent for NAT assays 01/488 Hepatitis B Surface Antigen (HBsAg) subtype adw2, genotype A 00/588 Hepatitis B Surface Antigen 0.2IU/ml 07/288-001 Hepatitis B Surface Antigen Monitor Sample 07/286-002 Hepatitis B Surface Antigen subtype adw2, genotype A Reference Panel 03/262 Hepatitis B Virus DNA for nucleic acid amplification techniques 97/750 Hepatitis C Virus (HCV) RNA 06/100 Hepatocyte Growth Factor/Scatter Factor (Human, rDNA derived) 96/564 Hepatocyte Growth Factor/Scatter Factor (precursor), (Human rDNA derived) 96/556 HIV (antibody), 1st International Reference Panel 02/210 HIV-1 (antibody) (1 in 5 dilution) British Working Standard 99/710-011 HIV-1 (antibody), British Working Standard 99/750-011 HIV-1 P24 Antigen 90/636 HIV-1 RNA Genotype panel for NAT Assays 01/466 HIV-1 RNA working reagent (high copy number) for NAT assays (PWS-2) 99/636-004 HIV-1 RNA Working Reagent 1 (PWS-1) for NAT Assays 99/634-005 HIV-1 RNA Working Reagent 3 for NAT Assays 05/158-002 HIV-1 RNA, 2nd International Standard 97/650 HIV-2 (antibody) Monitor sample 99/674-009 HLA-A Genotyping Reference Panel. 05/208-001 HPV 16 DNA 06/202 HPV 18 DNA 06/206 HTLV-1 (antibody) Monitor Sample 03/104-007 Human Plasma Anti-Influenza H5 07/150 Human Serum Vitamin B12, Pernicous anaemia 82/652 Immunoglobulin D (IgD) Serum, Human 67/037 Immunoglobulins G, A & M Serum Human 67/099 Immunoglobulins G, A, M Serum Human 67/086 Influenza anti A/Anhui/1/05 (H5) HA serum (IBCDC-RG6) (Sheep SH477) 07/338 Influenza anti A/Anhui/1/05 (H5) HA serum (IBCDC-RG6) (sheep SH477) 08/142 Influenza anti A/Bangkok/1/79 Serum (sheep) 80/525 Influenza anti A/Beijing/262/95 Serum (sheep) 98/772 Influenza anti A/Beijing/32/92 (H3N2) Serum (sheep) 93/518 Influenza anti A/Beijing/352/89 (H3N2) Serum (sheep) 92/632 Influenza anti A/Brazil/11/78 Serum (goat) 79/516 Influenza anti A/Brisbane/10/2007- like HA serum 08/246 Influenza Anti A/California/7/2009 (H1N1)v HA serum (sheep 506 and 507) 09/152 Influenza anti A/California/7/2009 (H1N1)v HA serum (Sheep 506) 09/142 Influenza anti A/Chile/1/8 Serum(sheep) 84/640 Influenza anti A/England/427/88 Serum(sheep) 88/846 Influenza anti A/Equine/Kentucky/1/81 HA Serum (sheep) 85/516 Influenza anti A/equine/Miami/63 (H3N8) Serum(goat) 84/677 Influenza anti A/equine/Newmarket/1/93 Serum(sheep) 97/610 Influenza anti A/Equine/Newmarket/2/93 (H3N8) HA Serum (SH-376) 97/614 Influenza anti A/equine/Prague/56 (H7N7) Serum(goat) 84/673 Influenza anti A/Guangdong/39/89 Serum(sheep) 90/504 Influenza anti A/Johannesburg/33/94 Serum(sheep) 95/524 Influenza anti A/Leningrad/360/86 Serum (sheep) 87/578 Influenza anti A/Mississippi/1/85 Serum(sheep) 86/590 Influenza anti A/Nanchang/933/95 (H3N2) 97/612 Influenza anti A/New Caledonia/20/99 HA Serum (sheep) 04/260 Influenza anti A/New Jersey/8/76 (H1N1) Serum(sheep) 77/531 Influenza anti A/New York/55/2004 HA Serum (sheep) 04/262 Influenza anti A/Panama/2007/99 Serum (sheep) 01/452 Influenza anti A/Panama/2007/99 Serum (sheep) 02/102 Influenza anti A/Panama/2007/99 Serum (sheep) 02/338 Influenza anti A/Philippine/2/82 Serum (sheep) 83/545 Influenza anti A/Shanghai/24/90 (H3N2) Serum (sheep) 93/522 Influenza anti A/Shanghai/9/93 Serum(sheep) 94/504 Influenza anti A/Sichuan/2/87 Serum(sheep) 88/672 Influenza anti A/Solomon Islands/3/2006 (H1N1) (IVR-145) HA Serum (sheep 467,468,469,470) 07/104 Influenza anti A/Taiwan/1/86 Serum (H1N1) 95/536 Influenza anti A/Taiwan/1/86 Serum (sheep) 91/612 Influenza anti A/Texas/1/77 Serum (sheep) 78/569 Influenza anti A/turkey/Turkey/1/05 (NIBRG-23) HA serum(sheepSH465 & SH466) 06/192 Influenza anti A/turkey/Turkey/1/05(N1) NA Serum (NIBRG-74) (Sheep SH485) 08/126 Influenza anti A/Victoria/3/75 Serum(goat) 76/547 Influenza anti A/Wisconsin/67/2005 Serum (sheep) 05/236 Influenza anti A/Wyoming/03/03 Serum 03/212 Influenza anti B Neuraminidase Serum (Sheep SH463) 05/252 Influenza anti B/ Neuraminidase Serum 04/228 Influenza anti B/Ann Arbor/1/86/HA Serum (sheep) 86/592 Influenza anti B/Beijing/1/87 Serum(sheep) 88/678 Influenza anti B/Guangdong/120/2000 Serum (sheep) 01/450 Influenza anti B/Harbin/7/94/HA Serum (sheep) 98/604 Influenza anti B/Hong Kong/8/73 Serum(sheep) 77/568 Influenza anti B/Jiangsu/10/2003 HA Serum (sheep) 04/242 Influenza anti B/Johannesburg/5/99/ Serum (sheep) 00/556 Influenza anti B/Malaysia/2506/2004-HA Serum (sheep) 07/184 Influenza anti B/Panama/45/90 Serum(sheep) 94/520 Influenza anti B/Shangdong/9/97 Serum (sheep) 03/110 Influenza anti B/Singapore/222/79 Serum 80/523 Influenza anti B/USSR/100/83 Serum(sheep) 84/636 Influenza anti B/Yamagata/16/88 Serum(sheep) 92/582 Influenza anti B/Yamanashi/166/98 Serum (sheep) 00/442 Influenza anti N1 Neuraminidase Serum 04/230 Influenza anti N2 Neuraminidase Serum(prepared from A/Wyoming/3/2003) 04/258 Influenza Anti-A/Brisbane/59/2007 (IVR-148) HA Serum (Sheep 482, 483, 484) 08/112 Influenza Anti-B/Florida/4/2006 HA serum (sheep 478, 479) 07/356 Influenza Antigen A/Anhui/1/05 (H5N1) IBCDC-RG-6 07/290 Influenza Antigen A/Bangkok/1/79 80/517 Influenza Antigen A/Beijing/262/95 97/760 Influenza Antigen A/Beijing/32/92 93/500 Influenza Antigen A/Brazil/11/78 79/560 Influenza Antigen A/Brazil/11/78 83/550 Influenza Antigen A/Brisbane/10/2007-like (Prepared from A/Uruguay/716/2007 (NYMC X-175C)) 08/278 Influenza Antigen A/Brisbane/59/2007 (IVR-148) (H1N1) 08/100 Influenza Antigen A/California/7/2009 (H1N1)v (NYMC-179A) (Egg derived) 09/146 Influenza Antigen A/Chile/1/83 84/538 Influenza Antigen A/England/427/88 88/654 Influenza Antigen A/Equine/Kentucky/1/81 85/520 Influenza Antigen A/Equine/Miami/63 87/510 Influenza Antigen A/Equine/Newmarket/1/93 97/596 Influenza Antigen A/Equine/Newmarket/2/93 97/584 Influenza Antigen A/Equine/Prague/56 (H7N7) 85/553 Influenza Antigen A/Guizhou/54/89 90/502 Influenza Antigen A/Johannesburg/33/94 95/516 Influenza Antigen A/Johannesburg/82/96 97/518 Influenza Antigen A/Leningrad/360/86 87/584 Influenza Antigen A/Mississippi/1/85 86/576 Influenza Antigen A/New Caledonia/20/99 01/614 Influenza Antigen A/New Caledonia/20/99 02/336 Influenza Antigen A/New Caledonia/20/99 06/170 Influenza Antigen A/New Caledonia/20/99 (IVR-116) 03/258 Influenza Antigen A/New Jersey/8/76 77/530 Influenza Antigen A/New York/55/2004 (H3N2) (NYMC X-157) 04/264 Influenza Antigen A/OMS/5389/88 89/568 Influenza Antigen A/Philippines/2/82 83/537 Influenza Antigen A/Shangdong/9/93 94/516 Influenza Antigen A/Shanghai/16/89 90/500 Influenza Antigen A/Shanghai/24/90 93/516 Influenza Antigen A/Sichuan/2/87 87/714 Influenza Antigen A/Solomon Islands/3/2006 (IVR-145)(H1N1) 07/102 Influenza Antigen A/Sydney/5/97 99/614 Influenza Antigen A/Sydney/5/97 99/624 Influenza Antigen A/Taiwan/1/86 94/510 Influenza Antigen A/Texas/1/77 78/560 Influenza Antigen A/Texas/36/91 92/530 Influenza Antigen A/Texas/36/91 95/510 Influenza Antigen A/turkey/Turkey/1/2005 (H5N1) NIBRG-23 07/112 Influenza Antigen A/USSR/92/77 79/552 Influenza Antigen A/USSR/92/77 79/558 Influenza Antigen A/Wisconsin/67/2005 - Like 05/234 Influenza Antigen A/Wisconsin/67/2005 (H3N2) (NYMCX-161) 06/106 Influenza Antigen A/Wisconsin/67/2005 (H3N2) (NYMCX-161-B) 06/120 Influenza Antigen A/Wyoming/03/03 03/220 Influenza Antigen B/ Jiangsu/10/2003 04/202 Influenza Antigen B/Ann Arbor/1/86 86/630 Influenza Antigen B/Beijing/7/87 88/554 Influenza Antigen B/Brisbane/60/2008-like 08/352 Influenza Antigen B/Florida/4/2006 08/140 Influenza Antigen B/Guangdong/120/2000 01/546 Influenza Antigen B/Harbin/7/94 97/748 Influenza Antigen B/Hong Kong/8/73 79/568 Influenza Antigen B/Johannesburg/5/99 00/546 Influenza Antigen B/Malaysia/2506/2004 08/184 Influenza Antigen B/Norway/1/84 84/542 Influenza Antigen B/Panama/45/90 94/500 Influenza Antigen B/Shangdong/7/97 98/774 Influenza Antigen B/Singapore/222/79 80/519 Influenza Antigen B/Victoria/2/87 87/774 Influenza Antigen B/Yamagata/16/88 92/628 Influenza Antigen B/Yamanashi/166/98 99/586 Influenza Antigen B/Yamanashi/166/98 99/828 Influenza Antiserum B/Brisbane/60/2008-like (Sheep SH501 SH502) 08/354 Inhibin A, Human, recombinant 91/624 Inhibin B, Human 96/784 Inhibin, Porcine 86/690 Insulin Like Growth Factor I 02/254 Insulin, Bovine 83/511 Insulin, Human 66/304 Insulin, Human 83/500 Insulin, Porcine 83/515 Insulin-Like Growth Factor Binding Protein-3 93/560 Insulin-like growth factor-1 91/554 Insulin-like growth factor-II (Human rDNA derived) 96/538 Interferon alpha (Human, leukocyte derived) 94/784 Interferon alpha Concensus Sequence (Human rDNA derived) 94/786 Interferon Alpha n1 (Human lymphoblastoid cell derived) 95/568 Interferon Alpha n3 (Human, leukocyte derived) 95/574 Interferon alpha-1/8 (Human, rDNA derived) 95/572 Interferon alpha-1D, (Human rDNA derived) 83/514 Interferon alpha-2a (Human, rDNA derived) 95/650 Interferon alpha-2b (Human, rDNA derived) 95/566 Interferon alpha-2c (Human, rDNA derived) 95/580 Interferon Beta (Human, rDNA; CHO cell-derived; Glycosylated) 00/572 Interferon Beta Ser 17 Human, recDNA, E-coli-derived, non-glycosylated 00/574 Interferon Beta, Human, Fibroblast Cell-Derived, Glycosylated 00/576 Interferon Gamma (Human, Leukocyte derived) 82/587 Interferon Gamma (Human, rDNA derived) 87/586 Interferon Omega (Human, rDNA derived) 94/754 Interferon, Chick 67/018 Interleukin - 18 (Human rDNA derived) 03/200 Interleukin-1 alpha (Human rDNA derived) 86/632 Interleukin-1 alpha (Human, rDNA derived) 86/678 Interleukin-1 alpha (Mouse, rDNA derived) 93/672 Interleukin-1 Beta (Human, rDNA derived) 86/552 Interleukin-1 beta (Human, rDNA derived) 86/680 Interleukin-1 beta (Mouse, rDNA derived) 93/668 Interleukin-1 Receptor Antagonist (IL-1ra) (Human, rDNA derived) 92/644 Interleukin-10 (Human rDNA derived) 93/722 Interleukin-11 (Human, rDNA derived) 92/788 Interleukin-12 (Human, rDNA derived) 95/544 Interleukin-13 (Human, rDNA derived) 94/622 Interleukin-15 (Human, rDNA derived) 95/554 Interleukin-17 Human rec DNA 01/420 Interleukin-2 (Human, Jurkat derived) 86/504 Interleukin-2 (Human, rDNA derived) 86/564 Interleukin-2 (Mouse, rDNA derived) 93/566 Interleukin-2 Soluble Receptor (human, rDNA derived) 97/600 Interleukin-3 (Human, rDNA derived) 91/510 Interleukin-3 (Mouse, rDNA derived) 91/662 Interleukin-4 (Human, rDNA derived) 88/656 Interleukin-4 (Mouse, rDNA derived) 91/656 Interleukin-5 (Human, rDNA derived) 90/586 Interleukin-6 (Human, rDNA derived) 89/548 Interleukin-6 (Mouse, rDNA derived) 93/730 Interleukin-7 (Human, rDNA derived) 90/530 Interleukin-7 (Mouse, rDNA derived) 93/740 Interleukin-8 (Human, rDNA derived) 89/520 Interleukin-9 (Human,rDNA derived) 91/678 Islet Cell Antibodies 97/550 IVIG + anti-D for use with negative control IVIG 02/228 IVIG + Anti-D for use with negative control IVIG 04/132 IVIG and Anti-A and Anti-B Limit reference preparation 07/310 IVIG Negative Control for use with IVIG & Anti-D 04/140 IVIG negative control for use with IVIG + anti-D 02/226 IVIG, Anti-D and Negative Control Panel 05/242 Keratinocyte growth factor (KGF, FGF-7)(24-163) 03/148 Keratinocyte Growth Factor (KGF,FGF-7) 03/150 Kininogenase, Porcine 78/543 Leptin, Human, Recombinant 97/594 Leptin, Mouse, Recombinant 97/626 Leukaemia Inhibitory Factor (Human, rDNA derived) 93/562 Long-acting Thyroid Stimulator, Human 65/122 Low Molecular Weight Heparin for Molecular Weight Calibration(2nd International Standard) 05/112 Low Molecular Weight Heparin, 2nd International Standard 01/608 Lupus Anticoagulant Negative Control 96/522 Luteinizing Hormone, Bovine 98/566 Luteinizing Hormone, Human, Pituitary 80/552 Luteinizing Hormone, Human, recombinant 96/602 Luteinizing Hormone, Pituitary, alpha subunit 78/554 Luteinizing Hormone, Pituitary, beta subunit 78/556 Lysine Vasopressin 77/512 Lysine Vasopressin, Porcine 62/014 Macrophage Colony Stimulating Factor (CSF-1) (Human rDNA derived) 89/512 Macrophage Inflammatory Protein-1 alpha (Human, rDNA derived) 92/518 Mannan (C. Albians) Purified 76/515 Mannan (C. Albicans) Purified 77/600 MAPREC analysis of Poliovirus type 2 (Sabin) Synthetic DNA 0.67%481-G 97/758 MAPREC analysis of Poliovirus type 2 (Sabin) Synthetic DNA, 100%481-G 98/524 MAPREC analysis of Poliovirus type 2 (Sabin), high virus reference 1.21% 481-G 98/596 MAPREC analysis of Poliovirus type 2 (Sabin), low virus reference 0.65%481-G 97/756 MAPREC analysis of Poliovirus type 3 (Sabin) High virus reference 1.1%472-C 96/578 MAPREC analysis of Poliovirus type 3 (Sabin) Low virus reference 0.7%472-C 96/572 MAPREC analysis of Poliovirus type 3 (Sabin) Synthetic DNA 0.9% 472-C 95/542 MAPREC analysis of Poliovirus type 3 (Sabin). Synthetic DNA 100% 472-C 94/790 Measles Vaccine (Live) 92/648 Meningoccoccal Group C Polysaccharide 07/318 Meningococcal group A polysaccharide 98/722 Meningococcal group W135 polysaccharide 01/428 Meningococcal group Y polysaccharide 01/426 Methylated Human Serum Albumin (mHSA) 99/592 Monocyte Chemoattractant Protein-1 (Human,rDNA derived) 92/794 Multiplex Working Reagent (HCV, HBV, HAV, HIV, B19) 99/732 Mumps Vaccine (Live) 90/534 Negative Control for FCXM 02/282 Nerve Growth Factor (Human, rDNA derived) 93/556 Neurotrophin 3 98/718 Newcastle Disease Vaccine (Inactivated) NVIA Oncostatin M (Human, rDNA derived) 93/564 Opacity 5IRP 76/522 Oxytocin 76/575 Papain preparation for use with Anti-D preparation 91/562 92/658 Parathyroid hormone 1-34 Recombinant, Human 04/200 Parathyroid Hormone, Bovine 76/572 Parathyroid Hormone, Bovine 82/632 Parathyroid Hormone, Bovine-Type, Synthetic (1-34) fragment 82/512 Parathyroid Hormone, Human 75/549 Parathyroid Hormone, Human 79/500 Parathyroid Hormone, Human 95/646 Parathyroid Hormone, Human-Type, Synthetic (1-34) fragment 82/508 Parvovirus B19 DNA Working reagent 99/736 Pertussis Antiserum (Human) 1st WHO Reference Reagent 06/142 Pertussis Antiserum (human)1st IS - WHO international Standard. 06/140 Pertussis Vaccine Whole Cell 94/532 Placental Lactogen, Human 73/545 Plasmin, Human 97/536 Plasminogen Activator Inhibitor-1 (PAI-1), plasma Human 92/654 Plasmodium falciparum DNA for NAT Assays 04/176 Platelet Factor 4 Human, Purified 83/505 Platelet-derived Growth Factor-BB (Human, rDNA derived) 94/728 Polio Virus Sabin Types 1, 2 and 3 02/306 Poliomyelitis Vaccine (Inactivated) 91/574 Positive control for FCXM 07/214 Prekallikrein Activator (PKA), Human 02/168 Prekallikrein Activator (PKA), Human 79/572 Primary Biliary Cirrhosis Serum, Human 67/183 Proinsulin, Bovine 84/514 Proinsulin, Human 84/611 Proinsulin, Porcine 84/528 Prolactin Human, recombinant, glycosylated 98/580 Prolactin, Human 83/573 Prolactin, Human 84/500 Prolactin, Human, recombinant 97/714 Prolactin, Human, recombinant, non-glycosylated 98/582 Prostate Specific Antigen (90:10) 96/670 Prostate Specific Antigen (free) 96/668 Protein C Concentrate, Human 04/252 Protein C Plasma 02/342 Protein S, Plasma, Human 03/228 Prothrombin Mutation G20210A, Human gDNA, 1st International Genetic Reference Panel 2005 05/130 Purified Protein Derivative (PPD) of Bovine Tuberculin PPDBOV Purified Protein Derivative (PPD) of M Avium Tuberculin PPDA Purified Protein Derivative (PPD) of M. Tuberculosis Tuberculin PPDT Rabies vaccine 07/162 Rantes (Human, rDNA derived) 92/520 Renin, Human 68/356 Renin, Human, rec DNA 89/544 Renin, Porcine 65/119 Rheumatoid Arthritis Serum 64/002 Rheumatoid Arthritis serum. W1066 Rubella Vaccine (Live) 91/688 Secretin 77/643 Serum amyloid A protein 92/680 Serum Gonadotrophin, Equine 62/001 Serum Immunoglobulin E (IgE) Human 75/502 Serum Proteins (Other than Immunoglobulins) Human 74/520 Sex Hormone Binding Globulin (SHBG) 95/560 Short Ragweed Pollen Extract 84/581 Single Chain Urinary-Type Plasminogen Activator (SCuPA), (Glyc) 95/668 Single Chain Urinary-Type Plasminogen Activator (SCuPA), (Non-Glyc) 95/564 Smallpox Vaccine SMV Soluble Tumor Necrosis Receptor factor Type II (Human, rDNA derived) 93/524 Soluble Tumour Necrosis Factor Receptor Type 1, (Human, rDNA derived) 96/528 Somatropin 98/574 Staphylococcus alpha antitoxin, Equine 63/020 Staphylococcus Alpha Antitoxin, Equine STA Stem Cell Factor (Human rDNA derived) 91/682 Straphylokinase, rec (STAR) 94/718 Streptokinase 00/464 Streptokinase and Streptodornase 62/007 Swine Erysipelas Serum (anti-N) SES Tetanus Antitoxin, Equine, for Bioassay 60/013 Tetanus Antitoxin, Equine, for Flocculation Test 66/021 Tetanus Antitoxin, Human, Immunoglobulin 76/589 Tetanus Immunoglobulin, Human TE-3 Tetanus Toxoid Adsorbed 98/552 Tetanus Toxoid For Flocculation Test 04/150 Tetanus Toxoid Not Adsorbed 02/232 Tetracosactide 80/590 Thrombin, human, 2nd International Standard 01/580 Thromboplastin, human, recombinant, plain (pack of 5 x W1054. use with reconstitution fluid rTF/95 RF) RTF/95 Thromboplastin,rabbit,plain(pack of 5 ampoules with diluent(04/210) RBT/05 Thrombopoietin, human rDNA derived 03/124 Thyroid Stimulating Hormone beta subunit 85/522 Thyroid Stimulating Hormone, Human 00/504 Thyroid Stimulating Hormone, Human 81/565 Thyroid Stimulating Hormone, Human recombinant 94/674 Thyroid Stimulating Hormone, recombinant 03/192 Thyroxine-binding globulin 88/638 Timothy Pollen Extract 82/520 Tissue Plasminogen Activator (tPA) Antigen in Plasma 94/730 Tissue Plasminogen Activator, Human, Recombinant 98/714 TNF-related Apoptosis-Inducing Ligand (trail), Human, rDNA-derived 04/166 Transforming Growth Factor beta-1 (Bovine) 89/516 Transforming Growth Factor beta-1 (Human, rDNA derived) 89/514 Transforming Growth Factor beta-2 (Bovine) 89/518 Transforming Growth Factor beta-2, Human, rec DNA 90/696 Transforming Growth Factor beta-3 (Human, rDNA derived) 98/608 Tuberculin, Old TU Tumour Necrosis Factor alpha (Human Natural) 88/786 Tumour Necrosis Factor alpha (Mouse, rDNA derived) 88/532 Tumour Necrosis Factor beta (Human, rDNA derived) 87/640 Twelve Grass Pollen Extract 77/616 Typhoid Vaccine (acetone-inactivated) TYVK Typhoid Vaccine (heat-phenol-inactivated) TYVL Tyrophagus Longior Extract 78/582 Tyrophagus Putrescentiae Extract 78/517 Urokinase, High Molecular Weight 87/594 Vascular Endothelial Growth Factor 02/286 Vascular Endothelial Growth Factor, Human rDNA derived 01/424 Vitamin B12, Serum Folate 03/178 Von Willebrand factor, Concentrate 00/514 Yellow Fever Vaccine 99/616

梅阿查

英国国家生物制品检定所，很多标准品这买的还是记不住这个名字