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Influence of Simulated Pre-Hospital Transport, Time to Analysis, and Storage Temperature on S100 Calcium-Binding Protein B Values.
Journal of Neurotrauma ( IF 4.2 ) Pub Date : 2020-08-14 , DOI: 10.1089/neu.2019.6907
Julie Linding Kjerulff 1 , Sophie-Charlott Seidenfaden 1 , Niels Juul 2 , Mette Fogh Møller 3 , Anna-Marie Bloch Munster 4 , Morten Thingemann Bøtker 1
Affiliation  

According to in-hospital guidelines, the biomarker, S100 calcium-binding protein B (S100B), is used to rule out intracranial lesions in mild-moderate traumatic brain injury (TBI). It is currently investigated whether S100B is applicable in a pre-hospital setting. The aim was to compare S100B values and hemolysis index in blood samples drawn and stored under simulated pre-hospital conditions to standardized blood samples. Thirty patients undergoing craniotomy at Department of Neurosurgery, Aarhus University Hospital (Aarhus, Denmark) each had six blood samples drawn. Two samples, drawn in in-hospital standardized Beckton Dickinson tubes and pre-hospital Monovette tubes, respectively, were stored as references at 21°C for 30 min. Two samples were stored at 15°C and 29°C, respectively, one sample was stored at prolonged time (60 min), and one sample was transported for 30 min before centrifugation. S100B values were compared by equivalence test with a pre-defined equivalence margin of ±8.5%. There was no clinically relevant difference between samples stored in different tubes, at various temperatures, or time to analysis compared to reference samples. Transported samples had an 11.5% (90% confidence interval [CI], 6.55; 16.61) higher median S100B value and a 430% (95% CI, 279.6; 661.4) higher median hemolysis index compared to reference samples. Three of 30 (10%) patients had an S100B value above guideline cutoff in the transported sample, which was not found in reference samples (false positive). There were no false negatives. In conclusion, S100B values were not influenced by different tubes, temperatures, and time to analysis. Transported samples had higher median S100B values and hemolysis, icterus, and lipemia index compared to reference samples.

中文翻译:

模拟的院前转运、分析时间和储存温度对 S100 钙结合蛋白 B 值的影响。

根据住院指南,生物标志物 S100 钙结合蛋白 B (S100B) 用于排除轻中度创伤性脑损伤 (TBI) 的颅内病变。目前正在调查 S100B 是否适用于院前环境。目的是将在模拟院前条件下抽取和储存的血样中的 S100B 值和溶血指数与标准化血样进行比较。在奥胡斯大学医院(丹麦奥胡斯)神经外科接受开颅手术的 30 名患者每人抽取了 6 份血样。两个样本分别在院内标准化 Beckton Dickinson 管和院前 Monovette 管中抽取,作为参考在 21°C 下储存 30 分钟。两个样品分别保存在 15°C 和 29°C,一个样品长时间保存(60 分钟),一份样品在离心前运输 30 分钟。S100B 值通过等效性测试与 ±8.5% 的预定义等效性裕度进行比较。与参考样品相比,储存在不同试管、不同温度或分析时间的样品之间没有临床相关差异。与参考样品相比,运输样品的 S100B 值中位数高 11.5%(90% 置信区间 [CI],6.55;16.61),溶血指数中位数高 430%(95% CI,279.6;661.4)。30 名 (10%) 患者中的 3 名 (10%) 患者在运输样本中的 S100B 值高于指南截止值,而这在参考样本中未发现(假阳性)。没有假阴性。总之,S100B 值不受不同管、温度和分析时间的影响。
更新日期:2020-09-08
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