Objective: To prepare freeze-drying control materials of IgG antibody against Schistosoma japonicum for detection kits.
Methods: The serum samples of schistosomiasis patients from endemic areas and normal people without history of schistosome infection or contact with infested water in Hubei Province were collected. All the sera were detected by the method approved by China Food and Drug Administration and selected for preparation of quality control samples.
Results: Totally twelve positive quality control materials, ten negative quality control materials, and one sensitive and one precision quality control materials were screened. According to the positive serum level, the positive degrees of quality control materials were divided into strong, medium and weak levels. The stability could be valid for one year.
Conclusions: The freeze-drying quality control materials of IgG antibody against S. japonicum for detection kits are prepared. They are easy to use and have good stability, and therefore, they may meet the requirement of quality control for the detection of schistosomiasis diagnostics kits.
[摘要] 目的 制备日本血吸虫病免疫检测试剂IgG抗体质量控制品。方法 收集湖北省血吸虫病流行区粪检筛查血 吸虫感染病人血清和无疫水接触史、无血吸虫感染史且粪检阴性人群血清, 用取得中华人民共和国医疗器械注册证的检 测试剂进行检测, 制成冻干质量控制品。结果 共筛选出12份阳性质控品、1份灵敏度质控品、1份精密度质控品和10 份阴性质控品; 阳性质控品根据ELISA法检测血清效价不同, 分为强、中、弱阳性质控品。经12个月实际储存条件及破 坏稳定性实验, 该质控品稳定性可达1年。结论 所制备的冻干质控品使用方便, 结果稳定, 可以满足日本血吸虫病诊 断试剂实验室质量控制需求。.
Keywords: Freeze-drying quality control material; Immunodiagnosis; Quality control; Schistosomiasis.