鼠疫耶尔森菌F1抗体检测试剂国家参考品的研制

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摘要: 为研制鼠疫耶尔森菌F1抗体检测试剂国家参考品，制备了6份F1抗体阳性参考品，8份F1抗体阴性参考品，最低检出限参考品及重复性参考品，组成了鼠疫耶尔森菌F1抗体检测试剂国家参考品。对参考品进行均匀性检查及稳定性评估，组织4家实验室进行协作标定。结果显示，参考品均匀性及稳定性良好。协作标定结果显示，6份阳性参考品阳性率均为100%；8份阴性参考品阴性率均为100%；最低检出限参考品的检出水平在原倍到100倍稀释度之间；重复性参考品检测结果一致（其中酶联免疫法及上转发光法试剂的CV值均不高于15%）。研究结果表明，建立的鼠疫耶尔森菌F1抗体检测试剂国家参考品已基本符合体外诊断试剂参考品的要求，可用于相关试剂的质量评价。

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	张园园张平平魏东

Abstract：To prepare a national reference for detection reagents of 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 reference. The collaborative calibrated results of 4 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 between the original solution to 100 times diluted solution, repetitive reference test results were consistent（For Enzyme-linked immunosorbent assay and up-trans-luminescence detection reagent, the CV of test results of reference for precision was no more than 15%. National reference for detection reagents of Yersinia pestis F1 antibody was prepared which was suitable for the quality evaluation and control of related reagents.

ZTFEL:

R516.8

通讯作者: 魏东

引用本文:

张园园张平平魏东. 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.

链接本文:

http://jmi.fudan.edu.cn/CN/ 或 http://jmi.fudan.edu.cn/CN/Y2023/V18/I3/137

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