Bush V J, Smola C, Schmitt P
Bassett Medical Center, Cooperstown, NY, USA.
Pract Lab Med. 2019 Nov 20;18:e00148. doi: 10.1016/j.plabm.2019.e00148. eCollection 2020 Jan.
We evaluated and defined the analytical performance of the Beckman Coulter DxC 700 AU analyzer compared to the Siemens Dimension Vista 500 analyzer.
and Methods: Performance characteristics included intra and inter-run precision, linearity/analytical measurement range, method correlation, and reference range verification. A total of 53 assays including 11 critical care, 19 general chemistries, 11 proteins, 10 urines, and 2 CSF analytes were tested. We also evaluated similarities and differences in assay methodologies between the 2 systems.
The DxC 700 AU demonstrated excellent precision, comparable analytical measurement ranges and strong method correlation with the Dimension Vista 500 for most serum/plasma assays. 95% of the intra-run and 95% of the inter-run precision QC levels showed <3.0%CV and <6.0%CV, respectively. None of the deviations were clinically significant. The AMRs for all analytes except 5 met the manufacturer's stated range. ALP, Lactate, U-glucose and CSF-glucose all recovered above the stated upper limit range, while prealbumin showed a smaller range. All analytes, except 14, showed slopes between 0.9 and 1.1 and/or biases <10%. Only ammonia, ferritin and lipase required significant reference range changes. The urine and CSF assays correlated very well with no adjustments in reference ranges required.
The analytical performance of the DxC 700 AU analyzer was acceptable with only a small number of analytes requiring significant reference range changes.
我们评估并定义了贝克曼库尔特DxC 700 AU分析仪相对于西门子Dimension Vista 500分析仪的分析性能。
性能特征包括批内和批间精密度、线性/分析测量范围、方法相关性以及参考范围验证。共测试了53种分析物,包括11种重症监护、19种常规化学、11种蛋白质、10种尿液和2种脑脊液分析物。我们还评估了这两种系统在分析方法上的异同。
对于大多数血清/血浆分析物,DxC 700 AU表现出优异的精密度、相当的分析测量范围以及与Dimension Vista 500很强的方法相关性。批内精密度质量控制水平的95%和批间精密度质量控制水平的95%分别显示变异系数<3.0%和<6.0%。所有偏差均无临床意义。除5种分析物外,所有分析物的分析测量范围均符合制造商规定的范围。碱性磷酸酶、乳酸、尿葡萄糖和脑脊液葡萄糖均超出规定的上限范围,而前白蛋白的范围较小。除14种分析物外,所有分析物的斜率在0.9至1.1之间和/或偏差<10%。只有氨、铁蛋白和脂肪酶需要显著改变参考范围。尿液和脑脊液分析相关性很好,无需调整参考范围。
DxC 700 AU分析仪的分析性能是可接受的,只有少数分析物需要显著改变参考范围。