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体外诊断试剂阳性判断值或参考区间确定要点 |
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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[1] |
NCCLS. How to define and determine reference intervals in the clinical laboratory. 2nd ed. NCCLS guideline C28-A2. Wayne, PA: National Committee for Clinical Laboratory Standards, 2000.
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[2] |
NCCLS. Assessment of the clinical accuracy of laboratory tests using receiver operating characteristic (ROC) plots. NCCLS guideline GP10-A. Wayne, PA: National Committee for Clinical Laboratory Standards, 1995.
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