| 行业分析 |
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| 体外诊断试剂分析性能评估要点 |
包雯( ) |
| 国家药品监督管理局医疗器械技术审评中心 北京 100081 |
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CLSI. User protocol for evaluation of qualitative test performance. 3rd ed. CLSI guideline EP12-A2. Wayne, PA: Clinical and Laboratory Standards Institute, 2008.
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CLSI. Evaluation of precision performance of quantitative measurement methods. 2nd ed. CLSI guideline EP5-A2. Wayne, PA: Clinical and Laboratory Standards Institute, 2004.
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CLSI. Protocols for determination of limits of detection and limits of quantitation. CLSI guideline EP17-A. Wayne, PA: Clinical and Laboratory Standards Institute, 2004.
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CLSI. Evaluation of the linearity of quantitative measurement procedures: a statistical approach. CLSI guideline EP6-A. Wayne, PA: Clinical and Laboratory Standards Institute, 2003.
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