Assessment of agreement and interchangeability between the TEG5000 and TEG6S thromboelastography haemostasis analysers: a prospective validation study

Abstract

Background TEG6S ® and TEG5000 ® (Haemonetics Corp, USA) are haemostasis analysers that measure viscoelasticity properties of whole blood. Both use different mechanisms to assess similar components of the coagulation process. The aim of this study was to assess agreement and interchangeability between the TEG6S and TEG5000 analysers. Methods 3.5 mL whole blood was collected from 25 adult patients in a tertiary intensive care unit (ICU). Analysis was performed using TEG6S and TEG5000 haemostatic platforms. Agreement between platforms was measured using Lin’s concordance coefficient (Lin’s CC), further validated using intraclass correlation coefficients and reduced major axis regression (RMAR). Results Sixteen (64%) patients were male; mean (range) age: 59yo (23–86). TEG6S and TEG5000 systems were broadly interchangeable. The majority of TEG variables demonstrated almost perfect or substantial agreement and minimal proportional bias (maximum amplitude demonstrated a fixed bias). LY30%, however, demonstrated poor agreement and a proportional bias. Lin’s CC coefficients (95% CI, RMAR slope, intercept) between TEG6S and TEG5000 variables were: R time: 0.78 (0.64–0.92, 0.76, 0.92); K time: 0.82 (0.69–0.94, 1.30, − 0.93); alpha angle: 0.79 (0.64–0.95, 1.04, − 1.43); maximum amplitude (MA): 0.90 (0.83–0.96, 0.99, − 5.0); LY30%: 0.34 (0.1–0.58, 0.43, 0.04). Conclusions Adult patients with critical illness demonstrate almost perfect agreement in the R time and MA, substantial agreement in K time and alpha angle, but poor agreement in LY30%, as measured by the TEG6S and TEG5000 analysers. With the exception of LY30%, the TEG6S and TEG5000 platforms appear interchangeable. This has important implications for use in clinical practice and multi-site research programs. Trial registration ANZCRT number: 12617000062325 , registered 12/Jan17. Retrospectively registered. Electronic supplementary material The online version of this article (10.1186/s12871-019-0717-7) contains supplementary material, which is available to authorized users.

Assessing TEG6S reliability between devices and across multiple time points: A prospective thromboelastography validation study

“…Thromboelastography analysis. As previously described, the TEG6S global haemostasis system provides four assays in one multi-channel cartridge, with each assay measuring a specific component of the coagulation process 9 . The first assay is citrated kaolin (CK), containing the coagulation activator, kaolin, providing clot reaction time (R time: the time from the start of analysis until thrombus amplitude reaches 2 mm), clot kinetics (K time: the time from thrombus amplitude reaching 2 mm until amplitude reaches 20 mm), thrombus generation angle (alpha angle: slope of a tangent line from the tracing at the midpoint between the R and the K time), thrombus maximum amplitude (MA: absolute thrombus strength) and percentage of fibrinolysis (LY30%).…”

“…Having previously determined the agreement between the existing TEG5000 and TEG6S devices 9 , this study aimed to assess reliability and clinical interchangeability of the TEG6S coagulation parameters when assessed by different TEG6S devices (i.e. interdevice agreement).…”

Basic principles of viscoelastic testing

“…20 TEG 6S has also been found to have superior within-device repeatability as compared to TEG 5000. 21 The relatively recently FDA-approved Quantra system (HemoSonics, Charlottesville, VA) uses SEER ultrasound technology to monitor the evolving shear modulus of a developing clot. Its QPlus cartridge system allows for directly spiking a citrated specimen tube onto the cartridge without the need for transfer pipetting.…”

Viscoelastic monitoring in trauma resuscitation

“…With the advent of point-of-care devices such as the TEG 6s, 73,74 ROTEM Sigma, 75 and Hemosonics Quantra 76 and validation of the TEG 6s in trauma patients, 77 several of the above barriers to widespread VEM use may be eliminated. 78 In particular, sample preparation and transport are eliminated with point-of-care devices, and the technical challenges of sample handling and testing are greatly reduced.…”

“…Notably, the TEG 6s has been tested in simulated environments of aeromedical evacuation 71,79,80 and ground transport. 81 Although point-of-care assays correlate relatively well with traditional VEM assays, 73,74,77,[80][81][82] correlation is variable and environment dependent. 71,80,81 As such, further work is required to develop data-driven thresholds for point-of-care VEM guided resuscitation in the trauma bay and pre-hospital setting.…”