迈瑞BS-800M与OLYMPUS AU2700全自动生化分析仪性能比较

目的通过对迈瑞BS-800M(后简称BS-800M)和OLYMPUS AU2700(后简称AU2700)全自动生化分析仪进行性能比较,探讨国产全自动生化分析仪在临床应用的可行性。方法按照行业标准推荐方法检测BS-800M和AU2700全自动生化分析仪的反应盘温度准确度与波动度、杂散光、吸光度线性、吸光度准确度、吸光度重复性、样品携带污染率、加试剂准确度和精密度、加样准确度和精密度等,并与YY/T0654-2008自动生化分析仪行业标准的性能要求进行比较。结果 BS-800M的孵育温度为(36.96±0.05)℃,略优于AU2700的(37.10±0.11)℃。BS-800M的吸光度重复性可低至0.30%,与AU2700的0.27%非常接近,均小于行业标准的1.50%。BS-800M试剂加样准确度相对偏差为0.71%~1.06%,精密度为0.86%~0.97%;AU2700分别为0.86%~1.58%与0.75%~0.91%;两者均显著优于行业标准。BS-800M的样品携带污染率仅为0.38%,与AU2700大致相当。两者的吸光度线性偏倚虽符合行业标准,但BS-800M最大为3.48%,显著高于AU2700(-1.33%)。其他试验结果均显示,BS800-M在杂散光影响、吸光度准确度、样品加注准确度与精密度等方面已达到甚至优于行业标准,与进口产品并无显著差别。结论 BS-800M与AU2700生化分析仪多方面的硬件性能均符合我国YY/T0654-2008行业标准,BS-800M生化分析仪满足临床生化检测的使用要求。

Comparison of performance of MINDRAY BS-800M and OLYMPUS AU2700 automatic biochemical analyzer

Objective To explore the feasibility of domestic automatic biochemical analyzer in clinical application through the comparison of the performance of Mindray BS‐800M and Olympus AU2700 automatic biochemical analyzer .Methods Multiple bio‐chemical quality control indexes ,including reaction temperature of the disc accuracy and volatility ,stray light ,the linear range ,accu‐racy ,and repeatability of absorbance ,carryover rate of sample as well as the accuracy and precision of adding reagent or sample , were analyzed between the Mindray BS‐800M and Olympus AU2700 automatic biochemical analyzer based on the recommendation method of industrial standards .Meanwhile ,the performance of Mindray BS‐800M and Olympus AU2700 automatic biochemical ana‐lyzer were compared with the YY/T0654 - 2008 requirements of the industry standard .Results Incubation temperature of Mindray BS‐800M was(36 .96 ± 0 .05) ℃ ,slightly better than the AU2700[(37 .10 ± 0 .11) ℃ ] .Absorbance CV of BS‐800M was as low as 0 . 30% ,which was very closed to AU2700(0 .27% ) ,and both the values were far less than the industry standard 1 .50% .Relative de‐viation of BS‐800M reagent filling system was 0 .71% - 1 .06% ,precision was 0 .86% - 0 .97% ,which of the AU2700 was 0 .86% - 1 .58% and 0 .75% - 0 .91% ,and both the values were much better than the industry standard .The carryover rate of sam‐ple in BS‐800M was only 0 .38% ,which was roughly equivalent to that of AU2700 .The linear bias of absorbance of the two analyz‐ers were in line with industry standards ,but the maximum value of BS‐800M was 3 .48% ,which was much higher than that of AU2700( - 1 .33% ) .The rest of the experiment results showed that ,stray light affected ,absorbance accurate degree ,sample filling accuracy and precision performance of BS‐800M had reached or even better than the industry standard ,and which had no difference with imported products .Conclusion The hardware performance of Mindray BS‐800M and Olympus AU2700 biochemical analyzer in many aspects meet with YY/T0654 - 2008 industry standard in our country .And the domestic Mindray BS‐800M meet the needs of clinical biochemical detection .