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国产新型冠状病毒(2019-nCoV)抗原检测试剂盒的性能比较

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目的 探讨不同国产新型冠状病毒(2019-nCoV)抗原检测试剂盒的阳性符合率、阴性符合率及最低检测限的差异.方法 为准确衡量产品的性能,选择具有代表性的16个国产新型冠状病毒(2019-nCoV)抗原检测试剂盒,分别检测国家参考品中的阳性参考品、阴性参考品和最低检测限参考品,得出阳性符合率、阴性符合率和最低检测限并分析结果.结果 16个新冠抗原检测试剂盒的阳性符合率和阴性符合率均为100%;16个新冠抗原检测试剂盒的最低检测限结果呈梯度分布.结论 新型冠状病毒(2019-nCoV)抗原检测试剂盒的检测方法学及原材料不同影响试剂盒最低检测限检测结果.
A Comparative Study of the Performance of Domestic Novel Coronavirus(2019 nCoV)Antigen Detection Kits
Objective To evaluate differences in the positive rate,negative rate and limit of detection of different types of China's severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)antigen detection kits.Methods 16 representative China's SARS-CoV-2 antigen detection kits were selected and tested for positive reference,negative reference and limit of detection reference in the reference products,and the positive rate,negative rate and limit of detection were derived and analyzed.Results Among 16 selected kits, all positive rates reached 100%,while all negative rates reached 100%,and limit of detection were distributed in a gradient.Conclusion The detection methodology and raw materials of SARS-CoV-2 antigen detection kits are different which can influence the results of limit of detection.

SARS-CoV-2 antigen detectionPositive rateNegative rateLimit of detectionRaw material

孙莉、孙雪晴、陈微、朱晋升、彭絮、王会如

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北京市医疗器械检验研究院(北京市医用生物防护装备检验研究中心),北京 101111

新型冠状病毒(2019-nCoV)抗原检测 阳性符合率 阴性符合率 最低检测限 原材料

2024

标记免疫分析与临床
中国同辐股份有限公司

标记免疫分析与临床

CSTPCD
影响因子:0.978
ISSN:1006-1703
年,卷(期):2024.31(3)
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