免疫定量分析仪md-qmt001检测降钙素原的方法-第三军医大学学报.docVIP

免疫定量分析仪MD-QMT001检测降钙素原的方法学性能评价 李文静1 徐卫东1 赵建华2吴元健1 （1.南京医科大学附属苏州市立医院本部 检验科 苏州 215002，2.江苏省临床检验中心 南京210009） [摘要] 目的 对免疫定量分析仪MD-QMT001检测降钙素原(PCT) 的标准操作程序及主要性能进行说明与评价。方法 按照说明书进行降钙素原免疫定量分析仪的组装与操作。参考美国临床和实验室标准化协会(Association of clinical and laboratory standards，CLSI)系列文件，结合实际工作设计验证方案，对免疫定量分析仪MD-QMT001检测全血 PCT 的精密度、线性、可比性、抗干扰能力等4 项分析性能进行验证和评价，并将实验结果与厂商（武汉明德生物）提供的分析性能进行比较。结果 该定量方法操作简便、快速，整个检测过程约17分钟；PCT定量时批内、批间变异系数均符合相关要求；线性实验表明免疫定量分析仪MD-QMT001检测线性与厂商承诺范围接近，回归方程检验有意义；该定量法与胶体金半定量法具有一定的可比性；甘油三酯、胆红素对检测结果无明显影响，溶血可使检测结果显著偏高。结论 本科室引进的降钙素原免疫定量分析仪操作简便、主要性能评价良好，可满足临床指导抗生素的应用等需要。 [关键词] 降钙素原(PCT)；定量；全血；脓毒症；抗生素 [中图分类号] R446.6 Methodological evaluation of performance of immune quantitative analyzer MD-QMT001 for detecting Procalcitonin Li Wenjing1, Xu Weidong1, Zhao Jianhua2 , Wu Yuanjian1 (1. Clinical Laboratory of Suzhou Municipal Hospital Affiliated to Nanjing Medical University, Suzhou 215002, China; 2. Jiangsu Center of Clinical Laboratory, Nanjing 210009, China.) [Abstract] Objective To describe the standard operating procedure and evaluate the main performance of immune quantitative analyzer MD-QMT001 for detecting procalcitonin (PCT). Methods Install and operate the immune quantitative analyzer according to the description. Referencing to the series of documents by U.S.A Association of clinical and laboratory standards (CLSI) combined with actual practice, an validation program was designed to verify and evaluate the precision, linearity, comparability and antiinterference ability of immune quantitative analyzer MD-QMT001 for detecting PCT. The experimental results were compared with the performance indicators provided by the manufacturer (Wuhan EasyDiagnosis Biomedicine Co., Ltd.). Results This quantitative method was simple, rapid, and the whole detection process is about 17 minutes; On quantifying PCT，the variation coefficient inside batch and between batches conformed to the relevant requirements; Linear experiments showed that the linearity was in close range with that prov