Πέμπτη 25 Ιανουαρίου 2018

Functional Stability of the TEG 6s Hemostasis Analyzer under Stress

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 TEG 5000 and the 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 manufacturer’s reagents and citrate-collected blood from healthy donors. Variability between devices was examined, and their performance under various motion and temperature stresses was 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 While 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 two parameters; but linear motion with sudden striking had no observed impact on results. Similarly, 7 days’ 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 lab but also to a variety of austere settings. Level of Evidence Diagnostic test, Level III. All authors are affiliated with the United States Army Institute of Surgical Research, JBSA Fort Sam Houston, Texas, 78234 Correspondence: Michael Adam Meledeo, USAISR, 3650 Chambers Pass, Bldg 3610, JBSA Fort Sam Houston, TX 78234, Fax: (210) 539-6244, Phone: (210) 539-7748. E-mail: michael.a.meledeo.civ@mail.mil The authors have no conflicts of interest to declare. This manuscript was submitted to the Journal of Trauma Acute Care Surgery THOR Supplement. The opinions or assertions contained herein are the private views of the authors and are not to be construed as official or as reflecting the views of the Department of the Army or the Department of Defense. © 2018 Lippincott Williams & Wilkins, Inc.

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