Atallah Johnny, Archambault Dakota, Randall Jeffrey D, Shepro Adam, Styskal Lauren E, Glenn David R, Connolly Colin B, Katsis Katelin, Gallagher Kathleen, Ghebremichael Musie, Mansour Michael K
Division of Infectious Diseases, Massachusetts General Hospital, Boston, MA 02114, USA.
Department of Medicine, Harvard Medical School, Boston, MA 02115, USA.
Diagnostics (Basel). 2022 May 7;12(5):1164. doi: 10.3390/diagnostics12051164.
Interleukin-6 (IL-6) has been linked to several life-threatening disease processes. Developing a point-of-care testing platform for the immediate and accurate detection of IL-6 concentrations could present a valuable tool for improving clinical management in patients with IL-6-mediated diseases. Drawing on an available biobank of samples from 35 patients hospitalized with COVID-19, a novel quantum-magnetic sensing platform is used to determine plasma IL-6 concentrations. A strong correlation was observed between IL-6 levels measured by QDTI10x and the Luminex assay (r = 0.70, p-value < 0.001) and between QDTI80x and Luminex (r = 0.82, p-value < 0.001). To validate the non-inferiority of QDTI to Luminex in terms of the accuracy of IL-6 measurement, two clinical parameters—the need for intensive care unit admission and the need for mechanical intubation—were chosen. IL-6 concentrations measured by the two assays were compared with respect to these clinical outcomes. Results demonstrated a comparative predictive performance between the two assays with a significant correlation coefficient. Conclusion: In short, the QDTI assay holds promise for implementation as a potential tool for rapid clinical decision in patients with IL-6-mediated diseases. It could also reduce healthcare costs and enable the development of future various biomolecule point-of-care tests for different clinical scenarios.
白细胞介素-6（IL-6）与多种危及生命的疾病进程相关。开发一种即时检测平台，用于即时准确检测IL-6浓度，可能为改善IL-6介导疾病患者的临床管理提供有价值的工具。利用来自35名因新冠肺炎住院患者的现有生物样本库，一种新型量子磁传感平台被用于测定血浆IL-6浓度。通过QDTI10x测量的IL-6水平与Luminex检测法之间（r = 0.70，p值<0.001）以及QDTI80x与Luminex之间（r = 0.82，p值<0.001）观察到强相关性。为了在IL-6测量准确性方面验证QDTI相对于Luminex的非劣效性，选择了两个临床参数——入住重症监护病房的需求和机械通气的需求。就这些临床结果比较了两种检测法测量的IL-6浓度。结果显示两种检测法之间具有比较性的预测性能，相关系数显著。结论：简而言之，QDTI检测法有望作为一种潜在工具用于IL-6介导疾病患者的快速临床决策。它还可以降低医疗成本，并促进未来针对不同临床场景开发各种生物分子即时检测。
