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

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 (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.