CAJ | 학술논문

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.
목적 평개라씨Modular PPI전자동생화분석의측정Glu적기본공작성능.방법 대동일비호정상수평、병리수평질공혈청재동일천내수표본평행측정20차,계산비내불정밀도;매천각측정1차,측정20천,계산비간불정밀도.근거위생부2010년실간질평적수거급비내、비간불정밀도,계산출확전불준학도.통과대고농도양품안일정비례희석,측정양품중Glu적함량,험증엄가적선성범위.결과 정상수평、병리수평질공혈청비내불정밀도분별위0.49%、0.24%;비간불정밀도분별위0.58%、0.27%;불준학도분별위±3.1%、±2.2%.선성범위위0～32 mmol/L.결론 통과대불정밀도、불준학도화선성범위실험관찰,인위라씨Modular PPI 전자동생화분석의Glu측정적성능가이만족림상화학실험실적요구.
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.