Butler Madison, Maywar Anna, Ruppert Kristine, Fuhrman Dana, Kim-Campbell Nahmah
Department of Bioengineering, University of Pittsburgh, Pittsburgh, PA, USA.
Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA, USA.
Perfusion. 2024 Oct 15:2676591241292674. doi: 10.1177/02676591241292674.
Monitoring cell-free plasma hemoglobin (PHb) during extracorporeal therapies allows early intervention of significant hemolysis, but timely measurements are often challenging. We thus present an analysis of a rapid benchtop device's ability to detect clinically significant hemolysis (PHb ≥50 mg/dL).
PHb was measured in 419 plasma samples from 88 pediatric patients undergoing cardiopulmonary bypass via both the benchtop device (HemoCue® Plasma/Low Hb system) and the clinical laboratory at the Children's Hospital of Pittsburgh (reference standards). Values of PHb ≥50 mg/dL as measured by the reference standard was defined as the binary outcome of clinically significant hemolysis. Analyses included Pearson correlations, logistic regression, receiver operating characteristic curves, and Bland-Altman. Because the manufacturer specifications identify the measurement range of the HemoCue® system as 30-3000 mg/dL, a secondary analysis was completed using PHb ≥30 mg/dL.
Using reference measurements, 66/88 subjects had at least one PHb level that fell within the range of detection (≥30 mg/dL) of the benchtop device and 46/88 had significant hemolysis as defined by PHb ≥50 mg/dL. PHb levels ≥30 mg/dL largely correlated with measurements made with the benchtop device (r = 0.82, < .001). The device was able to predict PHb values ≥30 mg/dL (AUROC 0.9582) and ≥50 mg/dL (AUROC 0.9637). The Bland-Altman demonstrated a mean difference of 7.0 mg/dL with <5% outside the 95% limits of agreement.
The HemoCue® system is an effective surrogate for more robust laboratory testing to identify clinically significant hemolysis during cardiopulmonary bypass.
在体外治疗过程中监测游离血浆血红蛋白（PHb）有助于对严重溶血进行早期干预，但及时测量往往具有挑战性。因此，我们对一种快速台式设备检测具有临床意义的溶血（PHb≥50mg/dL）的能力进行了分析。
通过台式设备（HemoCue®血浆/低血红蛋白系统）和匹兹堡儿童医院临床实验室（参考标准），对88例接受体外循环的儿科患者的419份血浆样本进行了PHb测量。参考标准测量的PHb≥50mg/dL值被定义为具有临床意义的溶血的二元结果。分析包括Pearson相关性分析、逻辑回归分析、受试者工作特征曲线分析和Bland-Altman分析。由于制造商规格将HemoCue®系统的测量范围确定为30 - 3000mg/dL，因此使用PHb≥30mg/dL进行了二次分析。
根据参考测量，66/88名受试者至少有一个PHb水平落在台式设备的检测范围内（≥30mg/dL），46/88名受试者根据PHb≥50mg/dL被定义为有严重溶血。PHb水平≥30mg/dL与台式设备测量结果高度相关（r = 0.82，P <.001）。该设备能够预测PHb值≥30mg/dL（曲线下面积0.9582）和≥50mg/dL（曲线下面积0.9637）。Bland-Altman分析显示平均差异为7.0mg/dL，95%一致性界限外的比例<5%。
HemoCue®系统是一种有效的替代方法，可用于更可靠的实验室检测，以识别体外循环期间具有临床意义的溶血。
