Article(id=1308455734157538028, tenantId=1146029695717560320, journalId=1189982191388893191, issueId=1308455539181114200, articleNumber=null, orderNo=null, doi=10.16438/j.0513-4870.2025-0339, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1743091200000, receivedDateStr=2025-03-28, revisedDate=1749657600000, revisedDateStr=2025-06-12, acceptedDate=null, acceptedDateStr=null, onlineDate=1789889756955, onlineDateStr=2026-09-20, pubDate=1752249600000, pubDateStr=2025-07-12, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1789889756955, onlineIssueDateStr=2026-09-20, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1789889756955, creator=13701087609, updateTime=1789889756955, updator=13701087609, issue=Issue{id=1308455539181114200, tenantId=1146029695717560320, journalId=1189982191388893191, year='2025', volume='60', issue='7', pageStart='1965', pageEnd='2374', issueExtLink='null', onlineDate='null', pubDate='1752249600000', pubDateStr='2025-07-12', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1789889710469, creator='13701087609', updateTime=1789895523604, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1308479921307807825, tenantId=1146029695717560320, journalId=1189982191388893191, issueId=1308455539181114200, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1308479921307807826, tenantId=1146029695717560320, journalId=1189982191388893191, issueId=1308455539181114200, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=2035, endPage=2039, ext={EN=ArticleExt(id=1308455734363058925, articleId=1308455734157538028, tenantId=1146029695717560320, journalId=1189982191388893191, language=EN, title=Establishment and application of the method for the detection of bactericidal antibodies against Neisseria meningitidis in Group X, columnId=1308455542700135265, journalTitle=Acta Pharmaceutica Sinica, columnName=Special Reports: Research progress and development trend of carbohydrate-based vaccines, runingTitle=null, highlight=null, articleAbstract=

The serum bactericidal assay (SBA), a gold standard recommended by the World Health Organization for detecting antibody levels against Neisseria meningitidis (Nm), was utilized in this study. Based on the classic Nm bactericidal antibody detection methodology, we optimized experimental parameters including sample volume, complement selection, Nm target bacterial concentration, bactericidal reaction time, and positive reference serum concentration to establish a serogroup X Nm bactericidal antibody detection protocol. The specificity, repeatability, and stability of the positive reference serum were systematically validated. The established method was applied to analyze bactericidal antibody levels in 508 serum samples of healthy individuals under 5 years old from Hennan, Jiangsu, Anhui and Shanxi provinces. Geometric mean titers (GMT) were calculated and statistically analyzed by region and age group. Results demonstrated that 95.7% serum samples exhibited serogroup X Nm bactericidal antibody titers below 8, with an overall GMT of 2.20. No statistically significant regional differences in GMT were observed (H = 6.688, P = 0.083). Age-stratified analysis revealed that 6.37% of infants aged 0-11 months displayed antibody titers greater than or equal to 8. This proportion progressively declined with age, reaching 0.49% in the 2-5 years group. However, no significant inter-group differences in GMT were detected among age cohorts (H = 4.756, P = 0.093). The findings indicate that the serum bactericidal antibody titers against Neisseria meningitidis serogroup X (Nm X) are relatively low among healthy children under 5 years of age in China. This study has developed a reliable detection method for Nm X SBA with good specificity, stability, and reproducibility. Furthermore, it has provided the data on Nm X SBA levels among children under 5 years old from various regions, offering scientific guidance for the future prevention and control of serogroup X meningococcal disease in China. All the serum used in this experiment were approved by Henan Provincial Center for Disease Control and Prevention Ethics Review Committee (approval number: 2019YM-005-02), Jiangsu Provincial Center for Disease Control and Prevention Ethics Review Committee (approval number: JSJK202-A054-02), and Shanxi Provincial Center for Disease Control and Prevention Ethics Review Committee (approval number: SXCDCIRBP2020050001).

, authors=Dan ZHAO, Bin LI, Yue YANG, Mao-guang LI, Shan-shan WANG, Ying-hua XU^*, Bin WANG^*, authorsList=Dan ZHAO, Bin LI, Yue YANG, Mao-guang LI, Shan-shan WANG, Ying-hua XU, Bin WANG, authorCompany=null, correspAuthors=Ying-hua XU, Bin WANG, authorNote=null, correspAuthorsNote=null, copyrightStatement=Copyright ©2025 Acta Pharmaceutica Sinica. All rights reserved., copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1308455734933484272, articleId=1308455734157538028, tenantId=1146029695717560320, journalId=1189982191388893191, language=CN, title=X群脑膜炎奈瑟氏菌杀菌抗体检测方法的建立及应用, columnId=1308455542851130211, journalTitle=药学学报, columnName=专题报道: 糖疫苗的研究进展与发展趋势, runingTitle=null, highlight=null, articleAbstract=

脑膜炎奈瑟氏菌(Neisseria meningitidis, Nm) 特异性杀菌抗体检测方法血清体外杀菌试验(serum bactericidal assay, SBA) 是世界卫生组织推荐的Nm抗体水平检测的金标准, 本文基于经典的Nm杀菌抗体检测方法, 优化加样体积、筛选补体、Nm靶菌液浓度和杀菌时间以及阳性参考血清浓度等试验因素, 建立了X群Nm杀菌抗体检测方法, 并对方法的特异性、重复性以及阳性参考血清稳定性进行验证。应用建立的方法对来自河南、江苏、安徽和山西省的508份5岁以下健康人群血清进行了杀菌抗体水平检测, 计算杀菌抗体几何平均滴度(geometric mean titer, GMT), 并按照地区和年龄组别进行统计分析。结果显示, 95.7%的血清样本X群Nm杀菌抗体滴度低于8, GMT为2.20, 不同地区X群抗体滴度GMT差异无统计学意义(H = 6.688, P = 0.083)。不同年龄组分析结果显示, 0~11月龄中X群Nm杀菌抗体滴度≥ 8比率为6.37%, 随着年龄的增长, 人群中杀菌抗体滴度≥8比率呈现下降趋势, 在2~5岁组人群中仅为0.49%, 不同年龄组X群杀菌抗体GMT差异无统计学意义(H = 4.756, P = 0.093)。表明我国5岁以下健康人群血清X群Nm杀菌抗体滴度较低。本研究构建了特异性、稳定性、重复性良好的X群Nm杀菌抗体检测方法, 并以此方法获得不同地区5岁以下健康人群X群Nm杀菌抗体水平的背景资料, 为后续我国X群Nm的预防和控制提供科学指导。本试验所有血清均经河南省疾病预防控制中心伦理审查委员会(批准号: 2019-YM-005-02)、江苏省疾病预防控制中心伦理审查委员会(批准号: JSJK2020-A054-02) 及山西省疾病预防控制中心伦理审查委员会(批准号: SXCDCIRBPJ2020050001) 批准。

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rfOrder=0, authorNames=null, journalName=null, refType=null, unstructuredReference=Xu J, Yan DS, Xu L, et al. 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JAMA, 2019, 321: 1014., articleTitle=null, refAbstract=null), Reference(id=1308498153276539318, tenantId=1146029695717560320, journalId=1189982191388893191, articleId=1308455734157538028, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=3, rfOrder=2, authorNames=null, journalName=null, refType=null, unstructuredReference=Global Burden of Disease Collaborative Network. Global burden of disease study 2019 (GBD 2019) results [EB/OL]. Seattle: Institute for Health Metrics and Evaluation, 2019 (2020-01-20) [2021-06-07]. http://ghdx.healthdata.org/gbd-2019., articleTitle=null, refAbstract=null), Reference(id=1308498153557557687, tenantId=1146029695717560320, journalId=1189982191388893191, articleId=1308455734157538028, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=4, rfOrder=3, authorNames=null, journalName=null, refType=null, unstructuredReference=Sadarangani M, Scheifele DW, Halperin SA, et al. Outcomes of invasive meningococcal disease in adults and children in Canada between 2002 and 2011: a prospective cohort study [J]. 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Hum Vaccin Immunother, 2018, 14: 1107-1115., articleTitle=null, refAbstract=null), Reference(id=1308498153939239353, tenantId=1146029695717560320, journalId=1189982191388893191, articleId=1308455734157538028, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=6, rfOrder=5, authorNames=null, journalName=null, refType=null, unstructuredReference=Azure S, Abdul-Karim A, Abubakari BB, et al. Trends in Neisseria meningitides serogroups amongst patients with suspected cerebrospinal meningitis in the meningitis belt of Ghana: a 5-year retrospective study [J]. 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Pathogenic analysis of the first case of X group epidemic Neisseria meningitid is in Wenzhou City [J]. Chin J Health Quarant, 2015, 25: 44-46., articleTitle=null, refAbstract=null), Reference(id=1308498155839259069, tenantId=1146029695717560320, journalId=1189982191388893191, articleId=1308455734157538028, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=10, rfOrder=9, authorNames=null, journalName=null, refType=null, unstructuredReference=Wang S, Zhao D, Li B, et al. Age-specific prevalence of serum bactericidal antibody against meningococcal serogroup Y in China [J]. J Infect, 2024, 89: 106278., articleTitle=null, refAbstract=null), Reference(id=1308498156028002750, tenantId=1146029695717560320, journalId=1189982191388893191, articleId=1308455734157538028, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=11, rfOrder=10, authorNames=null, journalName=null, refType=null, unstructuredReference=Maslanka SE, Gheesling LL, Libutti DE, et al. Standardization and a multilaboratory comparison of Neisseria meningitides serogroup A and C serum bactericidal assays [J]. Clin Diagn Lab Immunol, 1997, 4: 156-167., articleTitle=null, refAbstract=null), Reference(id=1308498156095111615, tenantId=1146029695717560320, journalId=1189982191388893191, articleId=1308455734157538028, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=12, rfOrder=11, authorNames=null, journalName=null, refType=null, unstructuredReference=Findlow H, Tapia MD, Sow SO, et al. Kinetics of maternally-derived serogroup A, C, Y and W-specific meningococcal immunoglobulin G in Malian women and infants [J]. 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Group of regions	Number of people (case)	GMT	Lower limit of 95% CI	Upper limit of 95% CI	≥8 (case)
Henan	204	2.27	2.11	2.43	13
Shanxi	102	2.04	1.96	2.13	1
Jiangsu	101	2.31	2.06	2.60	6
Anhui	101	2.11	1.95	2.29	2
Total	508	2.20	2.11	2.29	22

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Analysis results of serogroup X Nm bactericidal antibodies in different regions in healthy individuals under 5 years old. GMT: Geometric mean titer; CI: Confidence interval

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Group of regions	Number of people (case)	GMT	Lower limit of 95% CI	Upper limit of 95% CI	≥8 (case)
Henan	204	2.27	2.11	2.43	13
Shanxi	102	2.04	1.96	2.13	1
Jiangsu	101	2.31	2.06	2.60	6
Anhui	101	2.11	1.95	2.29	2
Total	508	2.20	2.11	2.29	22

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Group of age	Number of people (case)	GMT	Lower limit of 95% CI	Upper limit of 95% CI	≥8 (case)
0-11 month	204	2.27	2.11	2.43	13
12-23 month	202	2.21	2.06	2.37	8
2-5 year	102	2.04	1.96	2.13	1
Total	508	2.20	2.11	2.29	22

), ArticleFig(id=1308498152890663347, tenantId=1146029695717560320, journalId=1189982191388893191, articleId=1308455734157538028, language=CN, label=Tab.2, caption=

Analysis results of serogroup X Nm bactericidal antibodies in different age groups in healthy individuals under 5 years old

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Group of age	Number of people (case)	GMT	Lower limit of 95% CI	Upper limit of 95% CI	≥8 (case)
0-11 month	204	2.27	2.11	2.43	13
12-23 month	202	2.21	2.06	2.37	8
2-5 year	102	2.04	1.96	2.13	1
Total	508	2.20	2.11	2.29	22

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