猪瘟病毒抗体ELISA检测国家级能力验证结果与分析

猪瘟疫苗免疫是我国猪瘟防控的核心，猪瘟病毒抗体ELISA检测是进行免疫效果评价的最常用手段。中国兽医药品监察所国家/OIE猪瘟参考实验室（以下简称：参考实验室）承担了国家认证认可监督管理委员会（以下简称“认监委”）组织的A类能力验证项目“猪瘟诊断检测技术”（CNCA-19-A01），全面考察和评价我国动物疫病检测机构对猪瘟病毒抗体的检测能力。参考实验室负责制备检测样品，并进行随机编号。向每个参试实验室发放4份待检盲样，由其采用ELISA方法对各盲样进行定性判断，并向参考实验室提供检验结果及原始检验报告。出现“不满意”结果的单位可参加补测1次，若补测结果仍为“不满意”，则表明该实验室暂不具备该参数的检测能力。参加本次能力验证猪瘟病毒抗体检测的实验室共有103家，初测满意率为92.23%，初测和补测的总体满意率为100%。此次能力验证结果表明，参加此次能力比对试验的猪瘟检测机构均能够提供正确的检测结果，可以满足猪瘟病毒抗体监测的需求。通过本次能力验证项目查找出了存在的问题，参试单位可以及时纠正错误，进一步提升猪瘟抗体的检测能力。

Analysis of National Proficiency Testing Program for Classical Swine Fever Virus Antibody Detection by ELISA

Vaccination is the key strategy to prevent and control classical swine fever in China. Detection of vaccine-induced antibody by ELISA is the main method to assess the efficacy of vaccination. In order to evaluate the ability of individual laboratories for antibody detection against classical swine fever virus, Certification and Accreditation of the People's Republic of China organized the national proficiency testing program “Diagnostic Techniques for Classical Swine Fever” (CNCA-19-A01). The National/OIE Reference Laboratory for Classical Swine Fever (NRLCSF) that affiliated to China Institute of Veterinary Drug Control is responsible for the implementation of the program. Positive and negative samples were prepared and numbered randomly. Each participant received 4 different samples, and then the samples were tested according to their selected ELISA methods. All participants should submit their test results and the original reports to NRLCSF. If the results is unsatisfied, the participant will have another chance to retest. If the result is still unsatisfied, the participant will be considered unqualified for CSFV antibody detection. One hundred and three institutions participated this program. The accurate rate is 92.23% (95/103) for the first round of test, and 100% for the first and second tests. This result demonstrated that all participate laboratories provide competence for the detection of CSFV antibody and they could meet the requirement for CSFV diagnosis and surveillance. This proficiency testing program could help participants to investigate the reason for disagreement and implement their deficiencies.