Quality evaluation for immunological diagnosis kits of schistosomiasis / 中国血吸虫病防治杂志

ABSTRACT

Objective To evaluate the quality of immunological diagnosis kits of schistosomiasis. Methods The national reference IgG serum of schistosomiasis was applied for evaluating eight immunological diagnosis kits of schistosomiasis. Results All eight diagnosis kits had no National Production Certificate issued by State Food and Drug Administration. Six kits had good quality with high precision. After the physical examination, two kits did not meet the quality standards. Conclusions The good and bad quality of immunological diagnosis kits of schistosomiasis used in market is intermingled. The quality of these kits should be monitored.