Journal of biological standardization最新文献_第3页

Measurements of lipopolysaccharide (endotoxin) in meningococcal protein and polysaccharide preparations for vaccine usage 疫苗用脑膜炎球菌蛋白和多糖制剂中脂多糖(内毒素)的测定

Journal of biological standardization Pub Date : 1989-01-01 DOI: 10.1016/0092-1157(89)90017-6

C.-M. Tsai , C.E. Frasch , E. Rivera , H.D. Hochstein

{"title":"Measurements of lipopolysaccharide (endotoxin) in meningococcal protein and polysaccharide preparations for vaccine usage","authors":"C.-M. Tsai , C.E. Frasch , E. Rivera , H.D. Hochstein","doi":"10.1016/0092-1157(89)90017-6","DOIUrl":"10.1016/0092-1157(89)90017-6","url":null,"abstract":"<div><p>Lipopolysaccharide (LPS, i.e. endotoxin) present in meningococcal outer-membrane protein and polysaccharide preparations made for vaccine use was quantitated by a silver-stain method following SDS-PAGE. The reactivities of LPS in the preparations were also measured by rabbit pyrogenicity and <em>Limulus</em> amoebocyte lysate (LAL) assay. Although rabbit pyrogenicity and LAL assay are more sensitive than the silver stain method, the latter provided an actual amount of LPS present in the protein or in the polysaccharide. For a meningococcal protein preparation, rabbit pyrogenicity showed about one-tenth, and even less by LAL assay, of the actual amount of LPS. This is because protein-bound LPS in meningococcal protein preparations is about 10-fold less active in causing fever in rabbits, and 20- to 40-fold less active in the gelation of LAL than the same amount of a purified free LPS which is generally used as a reference in quantitating LPS in these two assays. As for the small amount of LPS present in a meningococcal polysaccharide preparation, similar LPS content was obtained when measured by the three methods suggesting that the LPS is not bound to the polysaccharide in contrast to that in the proteins mentioned above. The purified meningococcal LPS was pyrogenic in rabbits at 1 ng/kg.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"17 3","pages":"Pages 249-252, IN1, 253-258"},"PeriodicalIF":0.0,"publicationDate":"1989-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/0092-1157(89)90017-6","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"13624239","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 53

A modification of the single radial immunodiffusion potency test (SRD) for rabies vaccines 狂犬病疫苗单一径向免疫扩散效价试验(SRD)的改进

Journal of biological standardization Pub Date : 1989-01-01 DOI: 10.1016/0092-1157(89)90030-9

Inge Vogel , Michael Kundi , Franz Gerstl

{"title":"A modification of the single radial immunodiffusion potency test (SRD) for rabies vaccines","authors":"Inge Vogel , Michael Kundi , Franz Gerstl","doi":"10.1016/0092-1157(89)90030-9","DOIUrl":"10.1016/0092-1157(89)90030-9","url":null,"abstract":"<div><p>In 1983 a WHO collaborative study showed that the single radial immunodiffusion test provided a reliable system for the assay of the glycoprotein content of inactivated rabies vaccines. We have modified the method used in the collaborative study by using round plastic plates with wells arranged in a circle. Potency estimates were made by the multiple slope ratio method and not by single slope estimation procedures adjusted for a common intercept.</p><p>We carried out a statistical evaluation of the accuracy and reliability of the precipitation area calculation. We confirmed that for the purpose of the potency estimation the area calculations were sufficiently precise in most instances.</p><p>By analysing the sources of variation for round and for glass plates and by testing the variability of these methods we found that the round plates were as good as the glass plates. The advantage of the round plates was mainly in the ease of their handling: the agarose solution was poured in the plates without the need for a separate mould; an integral moist chamber with these plates was readily available; the precipitation zones were measured easily using a viewer which gave fourfold enlargements and the method required less antiglycoprotein.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"17 1","pages":"Pages 75-76, IN5-IN6, 77-83"},"PeriodicalIF":0.0,"publicationDate":"1989-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/0092-1157(89)90030-9","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"13637918","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 5

The effects of purified pertussis components and lipopolysaccharide on the results of the mouse weight gain test 纯化百日咳成分及脂多糖对小鼠增重试验结果的影响

Journal of biological standardization Pub Date : 1989-01-01 DOI: 10.1016/0092-1157(89)90010-3

引用次数: 0

The production and assessment of a plastic rod for the Chinese Reference Preparation for Opacity 一种塑料棒的制作与评价，为中国不透明度的参考准备

Journal of biological standardization Pub Date : 1989-01-01 DOI: 10.1016/0092-1157(89)90001-2

Yi Xiao-bian , Xu Hong-li , Qin Jin-cai , Qiao Lai-yan

{"title":"The production and assessment of a plastic rod for the Chinese Reference Preparation for Opacity","authors":"Yi Xiao-bian , Xu Hong-li , Qin Jin-cai , Qiao Lai-yan","doi":"10.1016/0092-1157(89)90001-2","DOIUrl":"10.1016/0092-1157(89)90001-2","url":null,"abstract":"<div><p>A reference preparation for opacity consisting of a plastic rod was introduced by Perkins <em>et al.</em> in 1973. It was adopted as the International Reference Preparation for Opacity in 1975. This plastic rod opacity reference preparation has been used to standardize the Chinese National Bacterial Opacity Standard. The material was prepared from plastic sheet by a water-bath method and by a dry-heat method; the sheet was then machined into the plastic rods. We have studied the technical processes and set up methods for the examination of the sheets and rods. The water-bath method was found to be better than the dry-heat method in our tests. Collaborative assays in research institutes of biological products have shown that the plastic rod can replace the glass-powder suspension. The duration of validity of the plastic rod opacity reference preparation and that of the glass-powder suspension used for the Chinese National Bacterial Opacity Standard were studied and found to be similar. For this reason the plastic rod opacity reference preparation has not been widely used in China.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"17 2","pages":"Pages 105-115"},"PeriodicalIF":0.0,"publicationDate":"1989-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/0092-1157(89)90001-2","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"13855207","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

EEC guidelines on medicinal products derived from modern biotechnological processes 欧洲经济共同体关于从现代生物技术过程中获得的医药产品的指南

Journal of biological standardization Pub Date : 1989-01-01 DOI: 10.1016/0092-1157(89)90011-5

Fernand Sauer

引用次数: 0

The potency testing of pseudorabies vaccines in pigs. A proposal for a quantitative criterion and a minimum requirement 猪伪狂犬疫苗的效价检测。关于数量标准和最低要求的建议

Journal of biological standardization Pub Date : 1989-01-01 DOI: 10.1016/0092-1157(89)90024-3

C. Stellmann , P. Vannier , G. Chappuis , A. Brun , M. Dauvergne , D. Fargeaud , M. Bugand , X. Colson

引用次数: 45

The suitability of different microtitre plates for detection of antibody to virus antigens by indirect ELISA 不同微滴板间接ELISA检测病毒抗原抗体的适用性

Journal of biological standardization Pub Date : 1989-01-01 DOI: 10.1016/0092-1157(89)90003-6

J.C. Craig , D. Parkinson , N. Knowles

{"title":"The suitability of different microtitre plates for detection of antibody to virus antigens by indirect ELISA","authors":"J.C. Craig , D. Parkinson , N. Knowles","doi":"10.1016/0092-1157(89)90003-6","DOIUrl":"10.1016/0092-1157(89)90003-6","url":null,"abstract":"<div><p>To optimize enzyme linked immunosorbent assays (ELlSAs) for the detection of virus-specific antibodies, a range of commercially available microtitre plates was evaluated for their ability to bind virus antigen. Rinderpest virus and foot-and-mouth disease virus were investigated as target antigens. Binding capacity for antigen, binding ratios (attachment of specific antibody versus that of non-immune antibody) and the variation in the results of the tests within and between plates were measured. Binding capacity was found to be greater with rinderpest virus (RPV) antigen than with foot-and-mouth disease virus (FMDV) antigen, although higher binding ratios were obtained with FMDV antigen. Variation within and between plates was generally less with RPV antigen than with FMDV antigen. One plate could not be said to out-perform the other plates in all tests. For our purpose, that is the detection of monoclonal antibody production against a variety of virus antigens, a number of plates were found to be suitable (e.g. Dynatech M129B, Flow 77-172-05 and Nunc 4-39454). The differences in the performances of the microtitre plates with these two virus antigens highlights the need for consideration of the solid phase as part of the standardization procedures for ELISAs.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"17 2","pages":"Pages 125-135"},"PeriodicalIF":0.0,"publicationDate":"1989-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/0092-1157(89)90003-6","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"13684988","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 4

Intravenous human rabies immunoglobulin for post-exposure prophylaxis: serum rabies neutralizing antibody concentrations and side-effects 暴露后预防用静脉注射人狂犬病免疫球蛋白:血清狂犬病中和抗体浓度和副作用

Journal of biological standardization Pub Date : 1989-01-01 DOI: 10.1016/0092-1157(89)90032-2

Fred Y. Aoki , Margaret E. Rubin , Albert D. Friesen , John M. Bowman , J.Robert Saunders

{"title":"Intravenous human rabies immunoglobulin for post-exposure prophylaxis: serum rabies neutralizing antibody concentrations and side-effects","authors":"Fred Y. Aoki , Margaret E. Rubin , Albert D. Friesen , John M. Bowman , J.Robert Saunders","doi":"10.1016/0092-1157(89)90032-2","DOIUrl":"10.1016/0092-1157(89)90032-2","url":null,"abstract":"<div><p>The beneficial effect of passive immunization for post-exposure rabies prophylaxis is associated with the appearance of serum neutralizing antibody (SNA) earlier than occurs with vaccine alone. We compared the SNA response and the side-effects in 30 previously unimmunized healthy volunteers given a commercially available human rabies immunoglobulin (HRIG) intramuscularly (i.m.) or an experimental HRIG prepared by DEAE Sephadex column chromatography, intravenously (i.v.) with or without human diploid-cell culture rabies vaccine (HDCS). The subjects were divided into five equal groups: HDCS alone, HDCS + i.m. HRIG 20 IU/kg (currently recommended) i.v. HRIG alone 15 IU/kg, HDCS + i.v. HRIG 15 IU/kg or HDCS + HRIG 5 IU/kg i.v. plus 10 IU/kg i.m. to simulate local bite wound infiltration. HDCS, 1·0 ml, was injected subcutaneously (s.c.) on days 0, 3, 7, 14 and 28. Only local discomfort at injection sites was observed without differences between groups. SNA was demonstrated in all HRIG recipients at day 1, but the concentrations were higher in those receiving it intravenously. No difference in the SNA response to vaccine was observed between the i.v. and i.m. HRIG groups given the same vaccine lot. It would appear that i.v. HRIG 15 IU/kg can be substituted for i.m. HRIG 20 IU/kg for post-exposure prophylaxis. Since the current regimen is almost 100% protective, there is noway of proving that i.v. HRIG 15 IU/kg is more efficacious. The immediate SNA level and economy are the chief advantages of i.v. HRIG 15 IU/kg.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"17 1","pages":"Pages 91-104"},"PeriodicalIF":0.0,"publicationDate":"1989-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/0092-1157(89)90032-2","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"13788558","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 16

A comparison of polyclonal antisera to pregnanediol 3 alpha glucuronide obtained from three different rabbits and their use in ELISA 三种不同家兔孕二醇- 3 α -葡糖苷多克隆抗血清的比较及其在ELISA中的应用

Journal of biological standardization Pub Date : 1989-01-01 DOI: 10.1016/0092-1157(89)90026-7

G.M. Sankolli , Usha M. Joshi

引用次数: 3

In vitro induction of antigen specific antibody synthesis and proliferation of T lymphocytes with acellular pertussis vaccines, pertussis toxin and filamentous haemagglutinin in humans 人无细胞百日咳疫苗、百日咳毒素和丝状血凝素体外诱导抗原特异性抗体合成和T淋巴细胞增殖的研究

Journal of biological standardization Pub Date : 1989-01-01 DOI: 10.1016/0092-1157(89)90008-5

Emmanuel J.H.J. Wiertz , Henk G. Loggen , Hendrik C. Walvoort , Johan G. Kreeftenberg

{"title":"In vitro induction of antigen specific antibody synthesis and proliferation of T lymphocytes with acellular pertussis vaccines, pertussis toxin and filamentous haemagglutinin in humans","authors":"Emmanuel J.H.J. Wiertz , Henk G. Loggen , Hendrik C. Walvoort , Johan G. Kreeftenberg","doi":"10.1016/0092-1157(89)90008-5","DOIUrl":"10.1016/0092-1157(89)90008-5","url":null,"abstract":"<div><p>The <em>in vitro</em> response of human B- and T-lymphocytes to the acellular vaccines JNIH-6 (containing pertussis toxoid and filamentous hemagglutinin), and JNIH-7 (containing pertussis toxoid), and to the purified components JNIH-4 (filamentous hemagglutinin) and JNIH-5 (pertussis toxin) was investigated. Pertussis toxoid and filamentous hemagglutinin induced specific Ig synthesis <em>in vitro</em> in lymphocytes obtained from convalescent pertussis patients as target cells. The antigen-dependent Ig production was demonstrated in lymphocyte culture supernatants by ELISA techniques and by a Chinese hamster ovary cell toxin neutralization assay. Particularly with JNIH-4, -6 and -7, high antibody titers were obtained.</p><p>At optimal antigen concentrations a marked lymphocyte blast transformation was found in lymphocyte cultures from whooping cough patients, but not in cultures of lymphocytes obtained from healthy volunteers. At high concentrations native pertussis toxin as well as the B oligomer (S2–5) of the toxin induced a strong proliferation of patient as well as control lymphocytes, indicating non-specific mitogenic activity. At lower concentrations lymphocyte blast transformation was seen in patient cultures only, which indicates an antigen-specific T-cell response. The A protomer (S1), dimer 1(S2 + 4) and dimer 2(S3 + 4) induced proliferation of patient lymphocytes, which demonstrates the presence of T-cell epitopes on these peptides.</p><p>The <em>in vitro</em> B-cell response and the lymphocyte blast transformation assay are both useful tools for estimating the potency of acellular pertussis vaccines in man. Spontaneously acquired and vaccine induced immunity to <em>Bordetella pertussis</em> can be investigated at the level of B- and T-lymphocytes.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"17 2","pages":"Pages 181-190"},"PeriodicalIF":0.0,"publicationDate":"1989-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/0092-1157(89)90008-5","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"13924674","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 12