Verifying the performance characteristics of the TEG5000 thromboelastogram in the clinical laboratory

To verify the manufacturer performance claims of the TEG5000 with traditional laboratory methods.

Samples were concurrently measured using the TEG5000 analyzer and either PT, APTT, fibrinogen, factor activities, platelet count, or platelet function testing using whole blood or platelet-rich plasma methods.

Within-run imprecision yielded coefficient of variation (CV) of <5%. There was no correlation of PT or APTT with R time. Only Factor VIII and factor XII activity significantly correlated with R time. There was significant correlation between k and angle with FBG, PLT count, and factor levels. There was weak inverse correlation between angle results and measures of platelet function. All laboratory methods were significantly correlated with MA. There were significant differences between citrated whole blood and fresh citrated plasma for angle and MA, and between fresh and frozen plasma for R time and MA. We demonstrated a high % inhibition noted with normal, drug naïve donors, especially with ADP PLT mapping (50% inhibition), but less so with AA PLT mapping (20% inhibition). For TEG platelet mapping, 19/22 (86.3%) and 17/22 (77.3%) results were concordant with traditional aggregation results.

We demonstrated both the lack of, and strong correlation between laboratory tests and the TEG parameters.