Decentralized clinical trial design usingblood microsampling technology for serumbioanalysis: supplementary materials

Background: Alternatives to phlebotomy in clinical trials increase options for patients and cliniciansby simplifying and increasing accessibility to clinical trials. The authors investigated the technical andlogistical considerations of one technology compared with phlebotomy. Methodology: Paired sampleswere collected from 16 donors via a second-generation serum gel microsampling device and conventionalphlebotomy. Microsamples were subject to alternative sample handling conditions and were evaluatedfor quality, clinical testing and proteome profiling. Results: Timely centrifugation of blood serummicrosamples largely preserved analyte stability. Conclusion: Centrifugation timing of serummicrosamplesimpacts the quality of specific clinical chemistry and protein biomarkers. Microsampling devices withremote centrifugation and refrigerated shipping can decrease patient burden, expand clinical trialpopulations and aid clinical decisions.

背景：临床试验中的静脉采血（phlebotomy）替代方案通过简化流程、提升临床试验可及性，为患者与临床医师增加了更多选择。本研究团队对比了某款技术与静脉采血在技术及后勤保障层面的考量要素。
研究方法：本研究从16名供体身上采集配对样本，分别采用第二代血清凝胶微采样装置（microsampling device）与常规静脉采血方式获取样本。微样本被置于多种差异化样本处理条件下，并针对样本质量、临床检测及蛋白质组谱分析开展评估。
研究结果：对血清微样本及时进行离心操作，可在较大程度上维持分析物的稳定性。
研究结论：血清微样本的离心时机，会对特定临床化学指标与蛋白质生物标志物的质量产生影响。搭载远程离心功能并支持冷链运输的微采样装置，可减轻患者负担、拓展临床试验招募人群范围，并辅助临床决策制定。