Establishment and operation of schistosomiasis diagnostic reference laboratory in Jiangsu Province

: ［摘要］目的 建立江苏省血吸虫病诊断参比实验室, 评价参比实验室的作用与检测能力。方法 按照国家血吸虫病诊断参比实验室建设要求, 开展江苏省血吸虫病诊断参比实验室建设, 并参加国家血吸虫病诊断参比中心的实验室室间比对, 对江苏省基层实验室血吸虫病检测能力进行评估。结果 江苏省血吸虫病诊断参比实验室组织结构、环境条件、管理和质量体系等符合国家血吸虫病诊断参比实验室建设要求, 获得了省级血吸虫病诊断参比实验室准入资质。在由国家血吸虫病诊断参比中心组织的6次实验室室间比对活动中, 各检测项目的定性和定量检测结果与参考品均完全一致 (Kappa 值= 1), 检测能力评定等级均为优秀。对4个基层实验室的426份血清样本进行了间接血凝试验 (IHA) 检测复核, 各实验室检测结果的平均符合率为94.13% (92.08%～96.25%), 平均Kappa 值为0.85 (0.83～0.86), 平均漏检率为 10.19% (0～17.65%)。结论 江苏省血吸虫病诊断参比实验室已成功建立并有效运行, 对提高全省血吸虫病检测质量和能力提升发挥了积极作用。. METHODS: A schistosomiasis diagnostic reference laboratory was built in Jiangsu Province according to the requirements of the construction of the national schistosomiasis diagnostic reference laboratory in China. Inter-laboratory comparisons were conducted and the diagnostic capability of grassroots laboratories was evaluated in Jiangsu Province. RESULTS: The organization structure, environmental conditions, administration and quality systems of the schistosomiasis diagnostic reference laboratory in Jiangsu Province all met the requirements for construction of the national schistosomiasis diagnostic reference laboratory in China, and the schistosomiasis diagnostic reference laboratory in Jiangsu Province was issued a certificate of a province-level schistosomiasis diagnostic reference laboratory. During the 6 inter-laboratory comparisons performed by national schistosomiasis diagnostic reference centers of China, the qualitative and quantitative results of each detection item were all in agreement with the reference samples (Kappa = 1), and the diagnostic capability was identified excellent. The results of indirect hemagglutination assay of 426 serum samples from 4 grassroots laboratories were re-examined, and the mean coincidence rate was 94.13% (range, 92.08% to 96.25%) with the grassroots laboratories, with a mean Kappa value of 0.85 (range, 0.83 to 0.86) and a mean missing rate of 10.19% (range, 0 to 17.65%). CONCLUSIONS: The schistosomiasis diagnostic reference laboratory has been successfully established and effectively operated in Jiangsu Province, which plays an active role in improving the capability of schistosomiasis diagnostic equality in the province.