化学发光免疫法检测PCT的分析测量范围和临床可报告范围研究

目的研究化学发光免疫法检测降钙素原（PCT）的分析测量范围（AMR）和临床可报告范围（CRR）。方法随机收集临床病人高、低值两份PCT新鲜标本，参照美国临床实验室标准化研究院（CLSI）发布的EP6-A文件要求制备不同实验样品，每个样品在罗氏CobasE601化学发光免疫分析系统上重复测定2次，利用多项式回归法确定PCT的分析测量范围；高值标本通过稀释回收实验确定最大稀释度，结合功能灵敏度和分析测量范围上限确定临床可报告范围。结果Co—basE601化学发光免疫分析系统的分析测量范围为0．02～108．375ng／ml，临床可报告范围为0．06-216．75ng／ml。结论厂商声明的CobasE601化学发光免疫系统检测PCT的分析测量范围得到验证确认，但对于超过分析测量范围的高值标本建议用低值血清1：2稀释。

Research on the Analytical Measuring Range and Clinical Reportable Range of Chemiluminscence Immunoassay in Detection of PCT

Objective To study the analysis of measuring range and clinical reportable range of chemiluminscence immunoas- say in detection of procalcitonin （PCT）. Methods Randomly collected two fresh PCT specimens of high and low value from clinical patients. Referring to NCCLS EP6-A evaluation protocols and pertinent literature, each sample was tested twice on Cobas E601 chemiluminescence immunoassay system. The analysis of the polynomial regression method was used to deter- mine the measurement range. Maximum dilution could be confirmed by recycling experiment on high value samples. It would be established the clinical reportable range combining functional sensitivity. Results The analytical measurement rang of PCT was 0.02 ~ 108. 375 ng/ml and the clinical reportable range was 0. 06 -216.75 ng/ml. Conclusion The analytical measurement range of PCT was the same with the declaration of manufacturer,and the recommended dilution is 1 ： 2 with low serum for high value samples.