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Establishing Reference Range and Assessing Precision Performance of the TEG6s System; Verification of TEG6s to Introduce to Clinical Laboratory by Min-Young Lee, Seongsoo Jang, Chan-Jeoung Park, Young-Uk Cho

Background: Thromboelastography (TEG) provides assessment of global coagulation. The TEG6s (Haemonetics Corporation) is a newly developed cartridge-based system, fully automated and the first true point-of-care TEG. In this study, we evaluated the precision and established the reference intervals (RIs) for TEG6s.
Methods: TEG assays were performed on the blood of healthy donors to determine RIs and on the QC materials for precision testing. The study design was developed in accordance with Clinical and Laboratory Standards Institute Guidelines.
Results: TEG6s precision testing yielded low variability except R, due to a low value for the mean. The newly established RIs of R, MA, and LY30 were similar to the manufacturer’s RIs. Some were different, showing short K and increased α.
Conclusions: This study has shown that TEG6s has high precision and each institution should verify the manufacturer’s RIs before adopting TEG6s and establish RIs if necessary.

DOI: 10.7754/Clin.Lab.2021.210919