VITROS950全自动干化学分析仪生物参考区间适用性验证探讨

Study on the Validation for Biological Reference Interval of the John＆John Vitros 950 Assay System

目的对950型全自动生化分析仪检验项目的现用生物参考区间进行验证，确保其适用于该实验室，为临床提供准确的诊断依据。方法按照美国临床实验室标准化委员会（NCCLS）C28一A2推荐方法，采集符合要求健康参考个体标本20名．按实验室标准化操作程序（SOP）文件要求规范用VITROS950全自动干化学分析仪检测标本．分析实验结果。结果共计测定19项。其中总蛋白（TP）、白蛋白（ALB）和肌酐（CREA）5％以上在现用的生物参考区问以外，TP、ALB超出上限，CREA超出下限；尿素（UREA）、氯（CI）、总胆红素（TBIL）和乳酸脱氢酶（LDH）95％结果在现用的生物参考区间内；其余项目100％在现用的生物参考区间内。结论该次验证的项目除TP、ALB和CREA外，现用的生物参考区间适用于该实验室，可以继续使用；实验的验证具有科学的说服力，容易发现生物参考区间的偏离，建立完善的验证制度、程序，值得推广应用。

Objective To validate the biology referende interval of John＆John vitros 950 assay system biochemistry test items and provide accurate diagnosis basis for the clinic. Methods According to NCCLS C28-A2 recommendation method,20 healthy individuals were chosen.The samples were detected by the VITROS 950 automatic dry biochemical analyzer according to the laboratory operation document（SOP） requiring. Results In 19 test items participating in this investigation,the analysis showed more than 5% results fell outside the biology reference interval for TP, ALB and CREA,whereas 95% results fell in the biology reference interval for UREA,CI,TBIL and LDH.AII other results fell in the biology reference interval. Conclusions This validation indicates that except TP, ALB and CREA,the biology reference intervals which are currently being used are suitable for our laboratory.It is easy to discover the deviation of the biological reference interval and it is necessary to establish a perfect verification system and promote it＇s popularization.