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Roche Modular PPI全自动生化分析仪测定Glu的性能评价

摘要

Objective To evaluate the performance of Roche Modular PPI automatic biochemical analyzer for glucose detection. Methods Normal or pathological level of serum in the same batches was detected 20 times within a day and the within-run %CV was calculated; then the serum was detected once a day for 20 days and the between-run %CV was calculated. According to the date on external quality assessment from the Ministry of Pubic Health in 2010 and the within-run %CV and between-run %CV, the extend inaccuracy was calculated. The glucose level in the samples diluted on a specific ratio was detected, the linear range was verified. Results The within-run %CV was 0.49% for the normal level of quality control serum and 0.24% for the pathological level; the between-run %CV was 0.58% and 0.27% and the inaccuracy was ±3.1% and ± 2.2%, respectively. The linear range was 0 - 32mmol/L. Conclusions The performance of Roche Modular PPI automatic biochemical analyzer for glucose detection can satisfied the demand of clinical chemical labs.%目的 评价罗氏Modular PPI全自动生化分析仪测定Glu的基本工作性能.方法 对同一批号正常水平、病理水平质控血清在同一天内随标本平行测定20次,计算批内不精密度;每天各测定1次,测定20天,计算批间不精密度.根据卫生部2010年室间质评的数据及批内、批间不精密度,计算出扩展不准确度.通过对高浓度样品按一定比例稀释,测定样品中Glu的含量,验证厂家的线性范围.结果 正常水平、病理水平质控血清批内不精密度分别为0.49%、0.24%;批间不精密度分别为0.58%、0.27%;不准确度分别为±3.1%、±2.2%.线性范围为0~32 mmol/L.结论 通过对不精密度、不准确度和线性范围实验观察,认为罗氏Modular PPI 全自动生化分析仪Glu测定的性能可以满足临床化学实验室的要求.

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