Development of national reference for detection reagents for Yersinia pestis F1 antibody
ZHANG Yuanyuan1，*, SUN Zhulin2,*, ZHAO Aihua1, ZHOU Yazhou2, YANG Ruifu2, ZHANG Pingping2, WEI Dong1
1. NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, National Institute for Food and Drug Control, Beijing 102629, China; 2. State Key Laboratory of Pathogens and Biosecurity, Institute of Microbiology and Epidemiology, Academy of Military Medical Sciences, Academy of Military Sciences, Beijing 100071, China
Abstract：The present paper aims to prepare a national reference for detection reagents for Yersinia pestis F1 antibody, which was consisted of six positive references, eight negative references, one minimum detection limit reference and one repetitive reference. The uniformity and stability of this reference met the requirements for national references. The collaborative calibration results of four laboratories showed that six positive references were 100% positive, eight negative references were 100% negative, the detection level of the minimum detection limit reference was 1-100 times dilution, and the testing results of repetitive reference were consistent (for the detection reagents based on enzyme-linked immunosorbent assay and up-converting phosphor technology, the coefficient of variation of testing results was less than 15%). So a national reference for detection reagents for Yersinia pestis F1 antibody was prepared which was suitable for the quality evaluation and control of related reagents.
张园园1，*，孙竹林2，*，赵爱华1，周亚洲2，杨瑞馥2，张平平2，魏东1. 鼠疫耶尔森菌F1抗体检测试剂国家参考品的研制[J]. 微生物与感染, 2023, 18(3): 137-142.
ZHANG Yuanyuan1，*, SUN Zhulin2, *, ZHAO Aihua1, ZHOU Yazhou2, YANG Ruifu2, ZHANG Pingping2, WEI Dong1. Development of national reference for detection reagents for Yersinia pestis F1 antibody. JOURNAL OF MICROBES AND INFECTIONS, 2023, 18(3): 137-142.
2023, Vol. 18 
