Biosen-c-clin葡萄糖分析仪的临床应用评价

Clinical evaluation of Biosen-c-clin glucose analyzer application

目的对Biosen-c-clin葡萄糖分析仪进行临床应用评估,以确定其性能符合临床实验室多中心系统验证。方法随机收集内分泌科患者血液标本,立即使用Biosen-c-clin对血糖进行检测分析:评价仪器的准确性、重复性、线性范围和试剂对血糖的稳定保存时间;评价Biosen-c-clin对血清标本血糖检测与生化仪检测结果的一致性;评价Biosen-c-clin对全血标本血糖检测与罗氏血糖仪检测结果的一致性;评价该仪器多种模式检测血糖间的结果相关性;评价红细胞在全血中所占体积与血糖结果相关性。结果 Biosen-c-clin葡萄糖分析仪准确度偏差小于1%,重复性全血模式高、中、低值的均值和标准差为(13.69±0.039)、(7.08±0.014)、(3.21±0.009);而血清模式为(12.89±0.051)、(6.61±0.031)、(5.87±0.025),本室检测的线性范围相关回归系数为0.995 7,稀释液对血糖稳定保存时间为8h;对血清标本血糖的检测与生化仪所测结果差异有统计学意义(P<0.05),对全血标本血糖的检测与罗氏所测结果比较差异有统计学意义(P<0.05),但均无临床意义;全血葡萄糖随红细胞所占比例的增加而呈减低趋势,同一标本血清葡萄糖为全血葡萄糖的1.13倍。结论 Biosen-c-clin葡萄糖分析仪性能满足临床应用要求。

Objective Clinical assessment of Biosen-c-clin glucose analyzer,to determine its performance meets the clinical laboratory center system verification.Methods To collected randomly blood samples of Department of Endocrinology patients,immediately detected blood glucose by Biosen-c-clin：accuracy,repeatability,linear range of instruments and stable storage time of blood sugar in reagents were evaluated;The consistency between serum glucose detection by Biosen-c-clin and biochemical analyzer was evaluated.The consistency between blood glucose detection by Biosen-c-clin and Roche glucose meter was evaluated.The correlation of glucose detection result by different model was evaluated.The correlation between volume of red cells in the blood and glucose amount was evaluated.Results Accuracy deviation of Biosen-c-clin glucose analyzer less than 1%,Repeated of blood mode：the standard of high,mean and low value difference was（13.69±0.039）,（7.08±0.014）,（3.21±0.009）;and serum mode for（12.89±0.051）,（6.61±0.031）,（5.87±0.025）.The regression coefficient of the linear range was 0.995 7.Stable storage time of blood sugar in reagents was 8hours.Comparison of glucose detected in different instruments have Statistical significance（P〈0.05）,but had no clinical significance.Blood glucose will decrease with red cell proportion increasing,the same specimens of serum glucose was 1.13times of blood glucose.Conclusion The performance of Biosen-c-clin glucose analyzer meet the requirement of clinical application.