[江苏省血吸虫病诊断参考实验室的建立与运行]

[Establishment and operation of schistosomiasis diagnostic reference laboratory in Jiangsu Province].

作者信息

Hang D R, Zhang J F, Li W, Huang Y X, Zhao S, Gao Q, Tang F, Xiong C R, Yao Y Y, Yang K

机构信息

National Health Commission Key Laboratory of Parasitic Disease Control and Prevention, Jiangsu Provincial Key Laboratory on Parasite and Vector Control Technology, Jiangsu Institute of Parasitic Diseases, Wuxi 214064, China.

出版信息

Zhongguo Xue Xi Chong Bing Fang Zhi Za Zhi. 2019 Nov 8;31(6):669-672. doi: 10.16250/j.32.1374.2019157.

DOI:10.16250/j.32.1374.2019157

PMID:32064818

Abstract

OBJECTIVE

To construct the schistosomiasis diagnostic reference laboratory in Jiangsu Province, and to examine the role and diagnostic efficiency of the reference laboratory.

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 ( = 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 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.

摘要

目的

构建江苏省血吸虫病诊断参考实验室，并考察该参考实验室的作用及诊断效能。

方法

按照国家血吸虫病诊断参考实验室建设要求，在江苏省建立血吸虫病诊断参考实验室。开展实验室间比对，并对江苏省基层实验室的诊断能力进行评估。

结果

江苏省血吸虫病诊断参考实验室的组织结构、环境条件、管理及质量体系均符合国家血吸虫病诊断参考实验室建设要求，江苏省血吸虫病诊断参考实验室获得省级血吸虫病诊断参考实验室证书。在国家血吸虫病诊断参考中心进行的6次实验室间比对中，各检测项目的定性和定量结果均与参考样本一致（κ = 1），诊断能力评定为优秀。对4个基层实验室的426份血清样本间接血凝试验结果进行复检，与基层实验室结果的平均符合率为94.13%（范围92.08%～96.25%），平均κ值为0.85（范围0.83～0.86），平均漏检率为10.19%（范围0～17.65%）。