Abstract Number: PB0646
Meeting: ISTH 2020 Congress
Background: Viscoelastic assay is a real time analyzer of whole blood for coagulation. Thromboelastography (TEG), one of the viscoelastic assays, provides in vitro assessment of global coagulation from begging of clot formation to fibrinolysis and provides a better understanding. The TEG6s (Haemonetics Corporation, Braintree, MA) is the sequel of the TEG5000, which has the limitation of labor-intensive. The TEG6s is a newly developed cartridge based system. It is a fully automated and the first true point-of-care TEG.
Aims: In this study, we evaluated the precision of TEG6s and established reference ranges for TEG6s in Korean population.
Methods: TEG assays were performed on the blood of healthy donors (n=149) to determine TEG6s reference ranges and on the QC level 1 and level 2 materials for precision testing. The study design was developed in accordance with Clinical and Laboratory Standards Institute Guidelines (EP28-A3c, EP05-A3). Healthy subjects >18 years of age were included.
Results: TEG6s precision testing yielded low variability. Within run, between run, and total precision ranged between 0.2% and 8.6% except R, which was 11.8% due to a low value for the mean (1.02). The reference ranges 149 healthy subjects of R, MA and LY30 were similar to the manufacturer’s reference range. Some were different from those of the manufacturer, showing hypocoagulable tendency: short K and increased α (Table 1).
Conclusions: The new TEG6s has been overcome the limitations of the TEG5000. This study has shown that TEG6s has high precision for all parameters. According to the results of our population, it is thought that each institution should validate the manufacturer’s reference range before adopting TEG and set the reference range if necessary. It will be necessary to confirm whether the differences in the reference ranges are due to ethnicity and to conduct further studies on the wide range of reference ranges available in Korea.
| R | K | α | MA | LY30 | |
| Shapiro-Wilk test | 0.138 | 0.002 | 0.529 | 0.956 | <0.0001 |
| Mean ±2SD | 5.07-9.33 | 0.81-2.86 | 58.92-77.22 | 51.21-66.27 | 0-2.38 |
| Median | 7.2 | 1.8 | 68.3 | 58.7 | 0 |
| Min./Max. | 4.6/9.9 | 0.8/3.5 | 52.8/79.3 | 48.9/69.2 | 0/10.5 |
| 95% CI | 5.2-9.6 | 0.98-2.93 | 58.65-76.35 | 50.95-65.83 | 0-2.35 |
[Reference values for Kaolin assay of TEG6s (Due to the regulation of the table, the limited results are shown)]
To cite this abstract in AMA style:
Lee MY, Jang S, Park C-, Cho Y-. Establishing Reference Range and Validating Precision Performance of the TES-6s System [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/establishing-reference-range-and-validating-precision-performance-of-the-tes-6s-system/. Accessed September 21, 2023.« Back to ISTH 2020 Congress
ISTH Congress Abstracts - https://abstracts.isth.org/abstract/establishing-reference-range-and-validating-precision-performance-of-the-tes-6s-system/