中华微生物学和免疫学杂志
中華微生物學和免疫學雜誌
중화미생물학화면역학잡지
CHINESE JOURNAL OF MICROBIOLOGY AND IMMUNOLOGY
2014年
6期
459-464
,共6页
赵志强%王欣茹%李亚南%王浩%刘方蕾%袁菲%乔瑞洁%蒋井明%何彦林%林纪胜%叶强%谢贵林
趙誌彊%王訢茹%李亞南%王浩%劉方蕾%袁菲%喬瑞潔%蔣井明%何彥林%林紀勝%葉彊%謝貴林
조지강%왕흔여%리아남%왕호%류방뢰%원비%교서길%장정명%하언림%림기성%협강%사귀림
人脑膜炎球菌参考血清%抗体含量%酶联免疫吸附试验%血清杀菌试验
人腦膜炎毬菌參攷血清%抗體含量%酶聯免疫吸附試驗%血清殺菌試驗
인뇌막염구균삼고혈청%항체함량%매련면역흡부시험%혈청살균시험
Human meningococcal reference serum%Antibody concentration%Enzyme-linked im-munosorbent assay (ELISA)%Serum bactericidal assay (SBA)
目的：制备人脑膜炎球菌参考血清，对其中A、C、Y、W135血清群的抗荚膜多糖抗体IgG含量和体外杀菌试验（ serum bactericidal assay ， SBA）滴度进行定值。方法用4价A、C、Y、W135群脑膜炎荚膜多糖疫苗免疫20名健康成人，采集免疫后的血浆进行混合、去纤维蛋白原、过滤、分装、冻干，得到人脑膜炎球菌参考血清Men10。在兰州生物制品研究所有限责任公司（ LIBP ）实验室，用标准检测人血清中抗脑膜炎球菌荚膜多糖抗体IgG定量ELISA方法，以国际标准血清CDC1992为标准，对其中4个血清群抗荚膜多糖抗体IgG含量定值；以临时定值的Men10和CDC1992分别为标准检测12份美国疾病预防控制中心（ CDC）的校正血清、56份4价多糖疫苗免疫后的血清，通过比较对定值的准确性进一步验证。同时以体外杀菌试验测定针对4个血清群的SBA滴度。结果制备了4000支（0．5 ml/支）冻干人脑膜炎球菌参考血清Men10。该血清HBV、HCV、HIV、梅毒螺旋体检测均阴性，残留水分含量2．3％。以Men10为标准检测的12份CDC校正血清和56份4价多糖疫苗免疫后的血清群抗荚膜多糖抗体结果，与以CDC1992为标准检测的结果均具有良好的直线相关关系（ r＝0．99，P＜0．05）；以Men10为标准检测的CDC1992的4个血清群抗荚膜多糖抗体的新值与其原定值比较，各血清型的误差均＜10％。同时确立了Men10中各血清群的体外杀菌试验滴度。结论 LIBP成功制备了人脑膜炎球菌参考血清Men10并完成了对其中的4个血清群抗荚膜多糖抗体IgG含量的准确定值，并确定了其中各群别抗体的体外杀菌试验滴度。
目的：製備人腦膜炎毬菌參攷血清，對其中A、C、Y、W135血清群的抗莢膜多糖抗體IgG含量和體外殺菌試驗（ serum bactericidal assay ， SBA）滴度進行定值。方法用4價A、C、Y、W135群腦膜炎莢膜多糖疫苗免疫20名健康成人，採集免疫後的血漿進行混閤、去纖維蛋白原、過濾、分裝、凍榦，得到人腦膜炎毬菌參攷血清Men10。在蘭州生物製品研究所有限責任公司（ LIBP ）實驗室，用標準檢測人血清中抗腦膜炎毬菌莢膜多糖抗體IgG定量ELISA方法，以國際標準血清CDC1992為標準，對其中4箇血清群抗莢膜多糖抗體IgG含量定值；以臨時定值的Men10和CDC1992分彆為標準檢測12份美國疾病預防控製中心（ CDC）的校正血清、56份4價多糖疫苗免疫後的血清，通過比較對定值的準確性進一步驗證。同時以體外殺菌試驗測定針對4箇血清群的SBA滴度。結果製備瞭4000支（0．5 ml/支）凍榦人腦膜炎毬菌參攷血清Men10。該血清HBV、HCV、HIV、梅毒螺鏇體檢測均陰性，殘留水分含量2．3％。以Men10為標準檢測的12份CDC校正血清和56份4價多糖疫苗免疫後的血清群抗莢膜多糖抗體結果，與以CDC1992為標準檢測的結果均具有良好的直線相關關繫（ r＝0．99，P＜0．05）；以Men10為標準檢測的CDC1992的4箇血清群抗莢膜多糖抗體的新值與其原定值比較，各血清型的誤差均＜10％。同時確立瞭Men10中各血清群的體外殺菌試驗滴度。結論 LIBP成功製備瞭人腦膜炎毬菌參攷血清Men10併完成瞭對其中的4箇血清群抗莢膜多糖抗體IgG含量的準確定值，併確定瞭其中各群彆抗體的體外殺菌試驗滴度。
목적：제비인뇌막염구균삼고혈청，대기중A、C、Y、W135혈청군적항협막다당항체IgG함량화체외살균시험（ serum bactericidal assay ， SBA）적도진행정치。방법용4개A、C、Y、W135군뇌막염협막다당역묘면역20명건강성인，채집면역후적혈장진행혼합、거섬유단백원、과려、분장、동간，득도인뇌막염구균삼고혈청Men10。재란주생물제품연구소유한책임공사（ LIBP ）실험실，용표준검측인혈청중항뇌막염구균협막다당항체IgG정량ELISA방법，이국제표준혈청CDC1992위표준，대기중4개혈청군항협막다당항체IgG함량정치；이림시정치적Men10화CDC1992분별위표준검측12빈미국질병예방공제중심（ CDC）적교정혈청、56빈4개다당역묘면역후적혈청，통과비교대정치적준학성진일보험증。동시이체외살균시험측정침대4개혈청군적SBA적도。결과제비료4000지（0．5 ml/지）동간인뇌막염구균삼고혈청Men10。해혈청HBV、HCV、HIV、매독라선체검측균음성，잔류수분함량2．3％。이Men10위표준검측적12빈CDC교정혈청화56빈4개다당역묘면역후적혈청군항협막다당항체결과，여이CDC1992위표준검측적결과균구유량호적직선상관관계（ r＝0．99，P＜0．05）；이Men10위표준검측적CDC1992적4개혈청군항협막다당항체적신치여기원정치비교，각혈청형적오차균＜10％。동시학립료Men10중각혈청군적체외살균시험적도。결론 LIBP성공제비료인뇌막염구균삼고혈청Men10병완성료대기중적4개혈청군항협막다당항체IgG함량적준학정치，병학정료기중각군별항체적체외살균시험적도。
Objective To prepare a human meningococcal reference serum and standardize IgG concentrations to capsular polysaccharides and in vitro bactericidal activities of the reference serum against serogroup A, C, Y and W135 strains.Methods Twenty healthy adults were recruited and given one dose of immunization with tetravalent (serogroups A, C, Y and W135) meningococcal polysaccharide vaccine . Plasma samples were collected and gone through a series of process treatments including defibrination , filtra-tion, and lyophilization to prepare the meningococcal reference serum Men 10.The IgG concentrations of Men10 to capsular polysaccharides of serogroups A , C, Y and W135 were calibrated by using an internation-al reference serum CDC1992 as the standard in enzyme-linked immunosorbent assay (ELISA).Provisional IgG concentrations of Men10 were intensively validated by testing a panel of 12 calibration serum samples from Centers for Disease Control and Prevention , USA ( US CDC) and a panel of 56 serum samples immu-nized with A, C, Y and W135 meningococcal polysaccharide vaccine from Lanzhou Institute of Biological Products Co., Ltd.(LIBP) with the assays using Men10 and CDC1992 as the standard and/or test sam-ples, respectively.The bactericidal titers against serogroup A , C, Y and W135 strains were measured by se-rum bactericidal assay (SBA).Results Four thousand vials (0.5 ml/vial)of lyophilized human meningo-coccal reference serum Men10 were successfully prepared with 2.5%of residual moisture .Reference serum Men10 was sterile and free from contamination by hepatitis B virus , hepatitis C virus , human immunodefi-ciency virus and syphilis .Provisional IgG concentration of Men 10 to capsular polysaccharide of serogroups A, C, Y and W135 was calibrated by using CDC1992 as the standard.Furthermore, IgG concentrations of both panels of 12 CDC calibration serum samples and 56 LIBP serum samples calibrated by using Men 10 as the standard correlated well with those by using CDC1992 as the standard (r=0.99,P<0.05).The IgG concentrations of CDC1992 as calibrated by using Men10 as the standard showed significant correlation with its previously determined values with variation <10%.SBA titers for serotype A , C, Y and W135 strains were established as well .Conclusion A panel of new human meningococcal reference serum Men 10 with accurately calibrated IgG concentration against capsular polysaccharide of serogroups A , C, Y and W135 as well as SBA titers was successfully established .
