The point-of-care TEG6s system demonstrated strong correlation with the conventional TEG5000 for standard hemostasis tests (R r=0.932, MA r=0.972, LY30 r=0.938).
Observational (n=457)
Yes
Does the TEG6s system provide comparable hemostasis measurements to the conventional TEG5000 in healthy volunteers and patients undergoing coronary revascularization?
The TEG6s point-of-care system provides precise and comparable hemostasis measurements to the conventional TEG5000, facilitating near-patient monitoring.
Effect estimate: R r = 0.932, MA r = 0.972, LY30 r = 0.938
Thrombelastography (TEG) measured by the TEG5000 Hemostasis Analyzer is an established but the labor-intensive method for assessing global hemostasis. The first true point-of-care TEG, the TEG6s system, uses resonance-frequency viscoelasticity measurements and a disposable multi-channel microfluidic cartridge to assess hemostasis and response to antiplatelet therapy. TEG assays (n = 5,100) were performed on the blood of healthy volunteers (n = 157) and patients undergoing coronary revascularization at three hospitals (n = 300). The results from the TEG6s were compared with the conventional TEG5000 in accordance with Clinical and Laboratory Standards Institute (CLSI) and FDA recommendations. Precision testing was conducted using blood from healthy donors, all assays were run for 5 consecutive days in duplicate using multiple operators, lots, and instruments. Reference ranges were comparable between the TEG systems.Deming regression analysis demonstrated a strong correlation between the two systems for the standard hemostasis tests (R r = 0.932, MA r = 0.972, LY30 r = 0.938). Method comparison analysis showed an acceptable agreement between PlateletMapping (PM) assays for measuring arachidonic acid (indicator of aspirin response)- and adenosine diphosphate (indicator of P2Y12 inhibitor response)-induced platelet aggregation (total agreement = 90%, and 72%, respectively). TEG6s precision testing yielded low variability (CV 0–13%) in all measures. The new point-of-care TEG6s is associated with greater ease of use than the TEG5000 and provides precise results. The results correlated between methods for all variables. TEG6s is a promising device for near-patient hemostasis monitoring and future trials of personalized therapy designed to reduce bleeding and thrombosis.
Gurbel et al. (2016) conducted an observational in Healthy volunteers and patients undergoing coronary revascularization (n=457). TEG6s system vs. TEG5000 Hemostasis Analyzer was evaluated on Correlation between TEG6s and TEG5000 for standard hemostasis tests (R r = 0.932, MA r = 0.972, LY30 r = 0.938). The point-of-care TEG6s system demonstrated strong correlation with the conventional TEG5000 for standard hemostasis tests (R r=0.932, MA r=0.972, LY30 r=0.938).