ABSTRACT
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.
Subject(s)
Antibodies, Helminth/immunology , Freeze Drying , Immunoglobulin G/immunology , Reagent Kits, Diagnostic , Schistosomiasis japonica/diagnosis , Animals , China , Humans , Quality Control , Reference Standards , Schistosoma japonicumABSTRACT
Objective To prepare freeze-drying control materials of IgG antibody against Schistosoma japonicum for detec-tion 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 con-trol 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.
