A comparison of the new ROTEM ® sigma with its predecessor, the ROTEM delta

Summary Thromboelastometry point‐of‐care coagulation testing facilitates optimised management of bleeding. Previous thromboelastometry systems required the blood sample and liquid reagents to be pipetted in several manual steps by trained personnel. The ROTEM sigma coagulation analyser is a fully automated point‐of‐care device. We aimed to assess the reference ranges of the new device and to compare the results with those of the predecessor device, the ROTEM delta . We took blood from healthy volunteers and from hyper‐ or hypocoagulable patients; blood samples from healthy volunteers served to determine reference ranges for the most important parameters for the ROTEM sigma : CT EXTEM 48–61 s; A5 EXTEM 30–51 mm; MCF EXTEM 54–70 mm; CT INTEM 138–174 s; MCF INTEM 51–67 mm and MCF FIBTEM 5–24 mm. We then used blood samples from patients to compare the results obtained between the old and the new device. We found a strong correlation between the same tests performed on two ROTEM sigma devices and between the ROTEM sigma and the ROTEM delta with respect to the determination of thromboelastometry parameters of hyper‐ and hypocoagulable patients (all p < 0.001 and R > 0.8). Performance evaluation for the ROTEM sigma device showed very high precision (R > 0.99, p < 0.001). Our reference ranges can serve as an important aid for other hospitals using this new device.