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TEG 6s 血栓弹力图分析仪在压力下的功能稳定性。

Functional stability of the TEG 6s hemostasis analyzer under stress.

机构信息

From the United States Army Institute of Surgical Research (M.A.M., G.C.P., C.S.M., C.R.V., J.A.B., A.P.C.), Joint Base San Antonio, Fort Sam Houston, Texas.

出版信息

J Trauma Acute Care Surg. 2018 Jun;84(6S Suppl 1):S83-S88. doi: 10.1097/TA.0000000000001810.

DOI:10.1097/TA.0000000000001810
PMID:29370064
Abstract

BACKGROUND

Viscoelastic measurements of coagulation provide much needed information, including guidance for triage and insight into bleeding disorders. The current clinical standards for these devices are the thromboelastogram (TEG) 5000 and the rotational thromboelastometer (ROTEM) delta, but a new product, the TEG 6s, has recently come to market, designed to simplify the user experience, reduce the required blood volume, and conduct multiple assays simultaneously. This study compares the performance of these three devices and examines the resiliency of the TEG 6s under various stresses.

METHODS

The variances of coagulation metrics obtained by the TEG 6s (prototype and production models), TEG 5000, and ROTEM delta were compared using manufacturers' reagents and citrate-collected blood from healthy donors. Variability between devices was examined, and their performances under various motion and temperature stresses were compared by placing one unit on a linear or orbital shaker, in the cold, or in the heat while a counterpart remained stationary at room temperature.

RESULTS

Although most comparable parameters had low degrees of variance, there were small but significantly increased variances found in some ROTEM delta and TEG 5000 parameters versus comparable TEG 6s parameters. Orbital rotation of the TEG 6s had no effect on means of any parameter but resulted in increased variance of 2 parameters, but linear motion with sudden striking had no observed impact on results. Similarly, 7-day exposure to heat (45°C) or cold (4°C) only resulted in minor deviations within normal ranges of the TEG 6s.

DISCUSSION

The TEG 6s provides several improvements over other coagulation analyzers: it is easier to use and robustly resilient against motion and temperature stresses. These features suggest that it may be capable of deployment not only in the clinical laboratory but also to a variety of austere settings.

LEVEL OF EVIDENCE

Diagnostic test, level III.

摘要

背景

粘弹性凝血测量提供了非常需要的信息,包括分诊指导和出血性疾病的深入了解。目前这些设备的临床标准是血栓弹性描记仪(TEG)5000 和旋转血栓弹性计(ROTEM)delta,但最近市场上出现了一种新产品,TEG 6s,旨在简化用户体验、减少所需血量并同时进行多种检测。本研究比较了这三种设备的性能,并研究了 TEG 6s 在各种压力下的弹性。

方法

使用制造商的试剂和枸橼酸盐采集的健康供体血液,比较 TEG 6s(原型和生产模型)、TEG 5000 和 ROTEM delta 获得的凝血指标的方差。检查设备之间的差异,并通过将一个单元放在线性或轨道振荡器上、在冷或热中以及在室温下的对应物保持静止来比较它们在各种运动和温度压力下的性能。

结果

尽管大多数可比参数的方差较低,但与可比的 TEG 6s 参数相比,某些 ROTEM delta 和 TEG 5000 参数的方差略有增加,但差异较小。TEG 6s 的轨道旋转对任何参数的平均值均无影响,但导致 2 个参数的方差增加,但线性运动与突然撞击无明显影响。同样,7 天暴露于热(45°C)或冷(4°C)仅导致 TEG 6s 在正常范围内出现轻微偏差。

讨论

TEG 6s 相对于其他凝血分析仪具有多项改进:它更易于使用,并且对运动和温度压力具有稳健的弹性。这些特性表明,它不仅可以在临床实验室中使用,而且可以在各种恶劣环境中使用。

证据水平

诊断测试,III 级。

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