王丽萍;臧京帅;丁凯;张丽;苏莹;龚振华;张鹤晓;
WANG Li-ping;ZANG Jing-shuai;DING Kai;ZHANG Li;SU Ying;GONG Zhen-hua;ZHANG He-xiao;Beijing Senkang Biotechnology Development Co., Ltd.;China Animal Health and Epidemiology Center;Science and Technology Research Center of China Customs;

• 1:北京森康生物技术开发有限公司
• 2:中国动物卫生与流行病学中心
• 3:中国海关科学技术研究中心

摘要(Abstract)：

为了比较市场上国产及进口非洲猪瘟病毒(ASFV)ELISA抗体检测试剂盒的产品质量和使用效果，本试验对B、C、D三种进口试剂盒和A、E、F三种国产试剂盒进行敏感性、特异性和重复性比较。结果显示，试剂盒B、D、E、F分析敏感性均为1∶512;试剂盒C分析敏感性为1∶256;试剂盒A分析敏感性为1∶128;诊断敏感性比较结果为试剂盒B>试剂盒D、F>试剂盒E>试剂盒C>试剂盒A;6种试剂盒对7份特异性质控血清的检测结果均为阴性，表明6种试剂盒均具有排除潜在交叉反应的病原抗体的能力；诊断特异性比较结果为试剂盒A、C、D>试剂盒F>试剂盒E>试剂盒B;批内重复性结果显示，6种试剂盒的批内变异系数(CV%)均在15%以内。结果表明，非洲猪瘟病毒ELISA抗体检测国产试剂盒与进口试剂盒的敏感性、特异性和批内重复性相差无几，国产试剂盒的兴起解决了以往过度依赖昂贵的进口试剂盒的问题，国产化替代进程在不断加速。
In order to evaluate the quality and efficacy of domestic and imported ELISA antibody detection kits for African swine fever virus(ASFV), this study comparatively examined the sensitivity, specificity and repeatability of imported kits B, C and D and domestic kits A, E and F. The results showed that the analytical sensitivity of kits B, D, E and F was 1∶512; kit C was 1∶256; kit A was 1∶128; the diagnostic sensitivity ranked kit B>kit D, F>kit E>kit C>kit A; the specificity of the 6 kits was high, with negative reaction for 7 specific quality control sera, indicating that all the 6 kits had no cross-reaction with other pathogens; the diagnostic specificity ranked kits A, C, D>kit F>kit E>kit B. Repetitive experiments showed that the coefficient of variation(CV%) of all the 6 kits was less than 15%. Thus, domestic kits for ASFV demonstrate similar sensitivity, specificity and in-batch repeatability to imported kits, and offer credible alternatives to expensive imported kits for detection of ASFV.

关键词(KeyWords)： 非洲猪瘟病毒;抗体检测试剂盒;敏感性;特异性;重复性
African swine fever virus;antibody detection kit;sensitivity;specificity;repeatability

Abstract:

Keywords:

基金项目(Foundation):

作者(Authors): 王丽萍;臧京帅;丁凯;张丽;苏莹;龚振华;张鹤晓;
WANG Li-ping;ZANG Jing-shuai;DING Kai;ZHANG Li;SU Ying;GONG Zhen-hua;ZHANG He-xiao;Beijing Senkang Biotechnology Development Co., Ltd.;China Animal Health and Epidemiology Center;Science and Technology Research Center of China Customs;

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