| HBsAg ELISA诊断试剂临床应用评估方案的建立 |
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| 引用本文： | 冯春颜,胡纪文,罗裕旋,郭华. HBsAg ELISA诊断试剂临床应用评估方案的建立[J]. 实用全科医学, 2008, 6(7): 744-744 |
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| 作者姓名： | 冯春颜 胡纪文 罗裕旋 郭华 |
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| 作者单位： | 广东省深圳市宝安区龙华医院检验科,518109 |
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| 摘 要： | 目的选择本实验室适用的HBsAg ELISA试剂。方法用国内五家主流HBsAg ELISA试剂检测卫生部临床检验中心室内质控参考血清、临床考核血清盘、临床标本，以美国ABBOTT试剂作为参比试剂，对比分析灵敏度、特异性、精密度、临床适用性等指标。结果五家试剂的灵敏度存在一定差异，而特异性、精密度等其它指标相差不大。结论应建立HBsAg ELISA诊断试剂临床应用评估方案，以提高试剂质量。
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| 关 键 词： | 乙肝表面抗原 诊断试剂 评估 |
Establishment of Evaluation Scheme for Clinical Application of HBsAg ELISA Kits |
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| Affiliation: | FENG Chun-yan, HU Ji-wen, LUO Yu-xuan , et al. (Department of Clinical Laboratory ,Longhua Hospital of Baoan District, Guangdong 518109, China) |
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| Abstract: | Objective To select a appropriate HBsAg ELISA kit which was suitable to our laboratory. Methods Samples including NSSL quality control material, panel, and serum samples of patients were used to analyze the sensitivity, specificity, precision of five mainly HBsAg detecting kits in domestic market. Results Difference had been existed in sensitivity among the five brand kits. Conclusions Establishment of Evaluation Scheme for Clinical Application of HBsAg ELISA Kits can improve the quality of diagnostic kit. |
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| Keywords: | Hepatitis B surface antigen Diagnostic kit Evaluation |
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