Frontiers in Pediatrics ( IF 2.1 ) Pub Date : 2022-09-21 , DOI: 10.3389/fped.2022.933508 Rina P Duke 1 , Shasha Bai 2 , Joshua A Bornhorst 3 , Nahed O ElHassan 4 , Jeffrey R Kaiser 5
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
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.
中文翻译:
不同的葡萄糖分析仪报告足月新生儿不同的葡萄糖浓度值
美国儿科学会和儿科内分泌学会新生儿低血糖指南的葡萄糖浓度治疗阈值基于主要使用贝克曼和黄泉葡萄糖氧化酶分析仪的研究。目前,大多数 (76%) 使用葡萄糖氧化酶方法的美国医院实验室使用 Vitros ®葡萄糖分析仪。然而,据报道,Beckman 与 Vitros 葡萄糖分析仪的葡萄糖浓度之间存在约 +5% 的偏差;当使用已发布的指南治疗阈值时,这可能会产生显着的临床效果。
为了确定 Beckman 和 Vitros 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 Beckman 与 Vitros 分析仪在总共 1,987 名新生儿中测量的出生后前 3 小时内的血浆葡萄糖浓度(Beckman
由 Beckman 和 Vitros 分析仪测量的初始葡萄糖浓度(出生后前 3 小时)的非线性模式相互平行,拟合样条曲线没有重叠 95% 置信区间,常数约为 +5 mg/dL偏见。此外,在化学实验室对成人样本进行的方法比较研究中,Beckman 与 Vitros 分析仪的测量葡萄糖偏差为 +4.2-7.4 mg/dL。
当用 Beckman 与 Vitros 分析仪测量时,足月、适合胎龄新生儿的葡萄糖浓度高出约 5 mg/dL。也许,贝克曼分析仪报告的 45 mg/dL 浓度可能相当于 Vitros 分析仪的 40 mg/dL。在管理新生儿低血糖症时,重要的是要知道使用了哪种分析仪,以及在遵循已发布的指南时是否需要针对潜在的仪器偏差进行调整。