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乳胶增强免疫比浊法检测血清降钙素原的空白限、检出限和定量限的建立与评价 被引量:2

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摘要 目的建立并评价乳胶增强免疫比浊法降钙素原(PCT)试剂的空白限(LoB),检出限(LoD)和定量限(LoQ)。方法参照美国临床和实验室标准化协会(CLSI)EP-17A文件,采用乳胶增强免疫比浊法PCT试剂检测空白样本(生理盐水)和一系列1~4倍该项目LoB梯度浓度的血清标本,依据数据的分布规律并采用相应的统计学方法,建立该方法试剂的LoB,LoD和LoQ。结果按EP17-A方案建立的LoB为0.044ng/mL,LoD为0.088 5ng/mL,LoQ为0.1ng/mL。结论确定了乳胶增强免疫比浊法PCT试剂的LoB,LoD和LoQ,且该试剂的LoD符合厂家说明书上面的要求,也为临床诊断和治疗提供了有价值的信息。
作者 陈雪莹
出处 《国际检验医学杂志》 CAS 2015年第20期3054-3056,共3页 International Journal of Laboratory Medicine
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