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[Development and assessment of Schistosoma japonicum antibody test kit (IHA)]
Wei-Sheng Jiang1, Nian-Gao Chen1, Mei-Jiao Huang1
1Jiangxi Provincial Institute of Parasitic Diseases, Nanchang 330046, China.
Objective:
To develop a Schistosoma japonicum antibody test kit (IHA).
Methods:
According to the requirement of Good Manufacturing Practice (GMP) and Quality Control (QC) of drugs, the components of kit as well as its preparation method and procedure were studied, and the test kit was assembled and its diagnostic effect was assessed.
Results:
The sensitivity and specificity were up to 94.49% and 97.14% when testing the serum samples of chronic schistosomiasis patients and normal serum samples by the kit, respectively. The Youden Index of the Kit was 0.92. The cross reaction rates with paragonimus and trichina were 15.00% and 10.00%, respectively. Compared with ELISA and another IHA kit produced by An'Ji company which were used to test schistosome antibody in residents of endemic areas at the same time, the coincident rates of the developed kit were 93.06% and 92.25%, respectively.
Conclusion:
The IHA kit for Schistosomajaponicum antibody has a high sensitivity and specificity, and has the value of application and popularization in the field.
