Diagnostic Devices Research and Development, Laboratory Corporation of America Holdings, Pleasanton, CA, United States.
Center for Esoteric Testing, Laboratory Corporation of America Holdings, Burlington, NC, United States.
J Appl Lab Med. 2023 Nov 2;8(6):1042-1053. doi: 10.1093/jalm/jfad071.
The increased demand for decentralized blood sample collection presents numerous operational challenges for diagnostics providers. Sample degradation including sample hemolysis due to time, temperature, and handling between collection and laboratory analysis leads to limited test menus and unreliable results. Here we introduce the lightweight, portable Labcorp TrueSpin™ for rapid point-of-care blood separation using commercially available microvolume blood collection tubes. The TrueSpin is a class I FDA-registered device designed for untrained users. The centrifuge runs on AA batteries and separates a blood sample in 5 minutes.
Here we describe a series of studies evaluating sample quality and analyte stability in serum samples collected into gel microtubes and processed using the TrueSpin. Hemolysis, residual red blood cell concentration, sample volume, and serum-based chemistry analyte stability were evaluated.
No significant difference was seen in hemolysis or residual red blood cell concentration in serum samples prepared by TrueSpin compared to the reference method. Additionally, capillary and venous blood samples separated using the TrueSpin and exposed to International Safe Transit Association 3A-simulated shipping conditions were shown to yield acceptable sample volume and quality for laboratory analysis. Finally, we show that many common serum-based chemistry analytes have limited (< 1 day) stability if uncentrifuged but improve to ≥ 3-day stability following TrueSpin separation and refrigerated or room temperature storage.
These findings suggest that the TrueSpin is a simple and effective solution for remote sample separation and may enable broader test menus and increased test result reliability for decentralized sample collection pursuits.
分散式血液样本采集需求的增加给诊断服务提供商带来了诸多运营挑战。样本降解，包括采集和实验室分析之间的时间、温度和处理导致的样本溶血，导致测试菜单有限且结果不可靠。在这里，我们介绍了轻巧便携的 Labcorp TrueSpin™，可使用市售微量采血管快速进行即时护理血液分离。TrueSpin 是一种 I 类 FDA 注册设备，专为未经培训的用户设计。该离心机使用 AA 电池运行，可在 5 分钟内分离血液样本。
在这里，我们描述了一系列评估凝胶微管采集的血清样本质量和分析物稳定性的研究，并使用 TrueSpin 进行处理。评估了溶血、残留红细胞浓度、样本量和基于血清的化学分析物稳定性。
与参考方法相比，使用 TrueSpin 制备的血清样本中溶血或残留红细胞浓度没有显著差异。此外，使用 TrueSpin 分离并暴露于国际安全运输协会 3A 模拟运输条件下的毛细血管和静脉血样本可提供可接受的实验室分析用样本量和质量。最后，我们表明，许多常见的基于血清的化学分析物如果不离心，其稳定性有限（<1 天），但在 TrueSpin 分离后冷藏或室温储存可提高至≥3 天的稳定性。
这些发现表明 TrueSpin 是一种简单有效的远程样本分离解决方案，可为分散式样本采集提供更广泛的测试菜单和更高的测试结果可靠性。
