Duke Rina P, Bai Shasha, Bornhorst Joshua A, ElHassan Nahed O, Kaiser Jeffrey R
Department of Pediatrics (Neonatology), Lehigh Valley Reilly Children's Hospital, Allentown, PA, United States.
Pediatrics Biostatistics Core, Department of Pediatrics, Emory University School of Medicine, Atlanta, GA, United States.
Front Pediatr. 2022 Sep 21;10:933508. doi: 10.3389/fped.2022.933508. eCollection 2022.
The American Academy of Pediatrics and Pediatric Endocrine Society neonatal hypoglycemia guidelines based their glucose concentration treatment thresholds on studies that predominantly used Beckman and Yellow Springs Glucose Oxidase Analyzers. Currently, a majority (76%) of U.S. hospital laboratories utilizing glucose oxidase methodology use Vitros Glucose Analyzers. However, a bias of ~+5% between glucose concentrations from Beckman vs. Vitros Glucose Analyzers has been reported; this could have a clinically significant effect when using published guideline treatment thresholds.
To determine if there is similar instrument bias between Beckman and Vitros Analyzers in reported glucose concentrations from term newborns, we compared plasma glucose concentrations measured within the first 3 h after birth by Beckman vs. Vitros Analyzers in a total of 1,987 newborns (Beckman = 904, Vitros = 1,083). Data were fit using nonlinear cubic spline models between collection time and glucose concentration.
The non-linear patterns of initial glucose concentrations (during the first 3 h after birth) as measured by Beckman and Vitros Analyzers paralleled each other with no overlap of the fit spline curve 95% confidence intervals, with an approximate +5 mg/dL constant bias. Additionally, in method comparison studies performed in the Chemistry Laboratory on adult samples, there was a +4.2-7.4 mg/dL measured glucose bias for the Beckman vs. Vitros Analyzer.
Glucose concentrations from term, appropriate size for gestational age newborns were about 5 mg/dL higher when measured by Beckman vs. Vitros Analyzers. Perhaps, concentrations of 45 mg/dL reported from Beckman Analyzers may be equivalent to 40 mg/dL from Vitros Analyzers. When managing neonatal hypoglycemia, it is important to know which analyzer was used and whether adjusting for potential instrument bias is necessary when following published guidelines.
美国儿科学会和儿科内分泌学会的新生儿低血糖指南,其葡萄糖浓度治疗阈值是基于主要使用贝克曼和黄泉葡萄糖氧化酶分析仪的研究得出的。目前,美国大多数(76%)采用葡萄糖氧化酶方法的医院实验室使用的是维特罗斯葡萄糖分析仪。然而,据报道,贝克曼葡萄糖分析仪和维特罗斯葡萄糖分析仪所测葡萄糖浓度之间存在约+5%的偏差;在使用已发布的指南治疗阈值时,这可能会产生具有临床意义的影响。
为了确定贝克曼分析仪和维特罗斯分析仪在足月新生儿报告的葡萄糖浓度中是否存在类似的仪器偏差,我们比较了总共1987名新生儿(贝克曼分析仪检测904例,维特罗斯分析仪检测1083例)出生后3小时内由贝克曼分析仪和维特罗斯分析仪所测的血浆葡萄糖浓度。使用收集时间和葡萄糖浓度之间的非线性三次样条模型对数据进行拟合。
贝克曼分析仪和维特罗斯分析仪所测初始葡萄糖浓度(出生后3小时内)的非线性模式相互平行,拟合样条曲线95%置信区间没有重叠,存在约+5mg/dL的恒定偏差。此外,在化学实验室对成人样本进行的方法比较研究中,贝克曼分析仪与维特罗斯分析仪所测葡萄糖偏差为+4.2 - 7.4mg/dL。
对于足月、适于胎龄的新生儿,贝克曼分析仪所测葡萄糖浓度比维特罗斯分析仪所测约高5mg/dL。或许,贝克曼分析仪报告的45mg/dL浓度可能相当于维特罗斯分析仪的40mg/dL。在处理新生儿低血糖时,了解使用的是哪种分析仪以及在遵循已发布指南时是否需要调整潜在的仪器偏差非常重要。