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Establishment and application of the method for the detection of bactericidal antibodies against Neisseria meningitidis in Group X
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Dan ZHAO, Bin LI, Yue YANG, Mao-guang LI, Shan-shan WANG, Ying-hua XU*, Bin WANG*
Acta Pharmaceutica Sinica | 2025, 60(7) : 2035 - 2039
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Acta Pharmaceutica Sinica | 2025, 60(7): 2035-2039
• Special Reports: Research progress and development trend of carbohydrate-based vaccines •
Establishment and application of the method for the detection of bactericidal antibodies against Neisseria meningitidis in Group X
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Dan ZHAO, Bin LI, Yue YANG, Mao-guang LI, Shan-shan WANG, Ying-hua XU*, Bin WANG*
Affiliations
  • State Key Laboratory of Drug Regulatory Science, NMPA Key Laboratory for Research on Quality and Standardization of Biotech Products, National Institute for Food and Drug Control, Beijing 102629, China
Published: 2025-07-12 doi: 10.16438/j.0513-4870.2025-0339
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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).

meningococcus  /  group X  /  bactericidal antibody  /  reference serum  /  rabbit complement
赵丹, 李彬, 杨越, 李茂光, 王珊珊, 徐颖华, 王斌. X群脑膜炎奈瑟氏菌杀菌抗体检测方法的建立及应用. 药学学报, 2025 , 60 (7) : 2035 -2039 . DOI: 10.16438/j.0513-4870.2025-0339
Dan ZHAO, Bin LI, Yue YANG, Mao-guang LI, Shan-shan WANG, Ying-hua XU, Bin WANG. Establishment and application of the method for the detection of bactericidal antibodies against Neisseria meningitidis in Group X[J]. Acta Pharmaceutica Sinica, 2025 , 60 (7) : 2035 -2039 . DOI: 10.16438/j.0513-4870.2025-0339
Year 2025 volume 60 Issue 7
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doi: 10.16438/j.0513-4870.2025-0339
  • Receive Date:2025-03-28
  • Online Date:2026-09-20
  • Published:2025-07-12
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  • Received:2025-03-28
  • Revised:2025-06-12
Affiliations
    State Key Laboratory of Drug Regulatory Science, NMPA Key Laboratory for Research on Quality and Standardization of Biotech Products, National Institute for Food and Drug Control, Beijing 102629, China
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表12种不同金属材料的力学参数
科
Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)
属
Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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