| 人巨细胞病毒IgM抗体国家参考品的研制 |
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| 引用本文： | 范行良,英志芳,李长贵,白东亭,王军志.人巨细胞病毒IgM抗体国家参考品的研制[J].微生物学免疫学进展,2012,40(3):30-33. |
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| 作者姓名： | 范行良 英志芳 李长贵 白东亭 王军志 |
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| 作者单位： | 中国食品药品检定研究院,北京,100050 |
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| 摘 要： | 目的为了对人巨细胞病毒(Human cytomegalovirus,HCMV)IgM抗体检测试剂进行统一评价,研制HCMVIgM抗体国家参考品,用于控制试剂盒的质量。方法收集正常人与感染者的标本,采用多实验室联合标定的方法确认参考品的试验结果,并经一系列的破坏条件进行稳定性和均匀性考核。结果考核的敏感性和准确性符合国家参考品的要求。结论该参考品能用于临床检测试剂的质量控制。
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| 关 键 词： | 巨细胞病毒 国家参考品 质量控制 IgM |
Establishment of national reference panel for detecting HCMV IgM |
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| FAN Xing-liang
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YING Zhi-fang
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LI Chang-gui
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BAI Dong-ting
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WANG Jun-zhi.Establishment of national reference panel for detecting HCMV IgM[J].Progress In Microbiology and Immunology,2012,40(3):30-33. |
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| Authors: | FAN Xing-liang YING Zhi-fang LI Chang-gui BAI Dong-ting WANG Jun-zhi |
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| Institution: | (National Institute for Food and Drug Control, Beijing 100050, China) |
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| Abstract: | Objective To establish the new national reference panel in detection of HCMV IgM antibodies. Methods 5 positive samples and 12 negtive samples of HCMV IgM antibodies were collected, respectively. Identification and verifica- tion were carried out by uing six commercial HCMV detection kits registered in China and/or foreign countries. Results The sensitivity and accuracy of the panel are in line with the requirements of national reference material of P. R. China. Conclusions The panel is suitable to be used as the reference in quality control for HCMV IgM diagnostic reagents. |
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| Keywords: | Human cytomegolovirus（HCMV） National reference panel Quality control IgM |
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