Department of Cardiovascular Perfusion, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio; Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio; Heart Institute Research Core, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio; and Division of Cardiothoracic Surgery, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
J Extra Corpor Technol. 2021 Sep;53(3):181-185. doi: 10.1182/ject-2100003.
To examine the accuracy between analyzers, the Terumo CDI 500 and the Spectrum Medical Quantum were compared to each other and to the ABL90 FLEX benchtop blood analyzer. Patients were retrospectively identified who underwent cardiac surgery requiring cardiopulmonary bypass between August 1, 2018 and November 1, 2019. Hemoglobin and venous saturation (SvO) values from all three analyzers were collected. Measurements from the Quantum and the CDI 500 were averaged over 1 minute to provide a single value for the minute for the given device. Blood analysis on the ABL90 benchtop device was performed at a minimum of every hour during congenital cardiopulmonary bypass (CPB). There were 519 patients included in the analysis. Data points numbering 69,404 and 70,598 were analyzed when comparing the CDI 500 to the Quantum for hemoglobin and SvO, respectively. Comparison of hemoglobin and SvO for the CDI 500 and Quantum versus ABL90 used 2283 and 1414 data points respectively, in each group. The CDI 500 and Quantum reported hemoglobin within 1 g/dL of the ABL90 86.9% and 87.5% of the time, respectively. The CDI 500 and Quantum reported SvO within 3% of the ABL90 61.0% and 57.9% of the time, respectively. The mean difference between the CDI 500 and Quantum hemoglobin and SvO measurements equaled .194 g/dL ( < .001) and .861% ( < .001), respectively and were both significantly different from zero. All device comparisons were statistically significantly different when compared to zero difference, likely due to the large data set as the magnitudes of these differences are all quite small and may not be clinically significant. However, while the reader should judge for themselves based upon their specific practice, in our opinion, the 95% Limit of Agreement was too large for either the CDI 500 or Quantum hemoglobin and SvO values to be substituted for ABL90 values. As recommended by the manufacturers, the CDI 500 and Quantum should only be used as a trending device.
为了检验各分析仪之间的准确性，我们将 Terumo CDI 500 与 Spectrum Medical Quantum 进行了比较，并与 ABL90 FLEX 台式血分析仪进行了比较。我们回顾性地确定了 2018 年 8 月 1 日至 2019 年 11 月 1 日期间接受体外循环心脏手术的患者。收集了来自所有三种分析仪的血红蛋白和静脉血氧饱和度（SvO2）值。为了提供给定设备每分钟的单个值，将 Quantum 和 CDI 500 的测量值平均 1 分钟。ABL90 台式设备上的血液分析在体外循环（CPB）期间至少每小时进行一次。分析中包括 519 名患者。在比较血红蛋白和 SvO2 时，CDI 500 与 Quantum 分别分析了 69404 个和 70598 个数据点。CDI 500 和 Quantum 与 ABL90 的血红蛋白和 SvO2 比较分别使用了 2283 个和 1414 个数据点。CDI 500 和 Quantum 分别报告了 ABL90 血红蛋白的 86.9%和 87.5%在 1g/dL 以内，分别报告了 SvO2 的 61.0%和 57.9%在 3%以内。CDI 500 和 Quantum 血红蛋白和 SvO2 测量值之间的平均差异分别为.194g/dL（<.001）和.861%（<.001），均显著不等于零。与零差值相比，所有设备比较均具有统计学意义，这可能是由于数据集较大，这些差异的幅度都相当小，可能没有临床意义。然而，尽管读者应该根据自己的具体实践进行判断，但在我们看来，CDI 500 或 Quantum 血红蛋白和 SvO2 值的 95%一致性界限太大，无法替代 ABL90 值。按照制造商的建议，CDI 500 和 Quantum 只能作为趋势设备使用。
