Performance evaluation of Stago sthemO 301 hemostasis analyzer for routine testing, coagulation factors, and inhibitors.

The sthemO 301 is a new hemostasis analyzer developed by Diagnostica Stago, combining simultaneously three different methodologies (i.e. clotting, chromogenic and immunological assays) on a single platform. The objective of this evaluation was to assess the analytical performances of the sthemO 301 and to compare it with the STA R Max on a selection of 20 hemostasis parameters (PT, aPTT with two reagents, Clauss fibrinogen, thrombin time, D-dimer, anti-Xa, factors II, V, VII, X, VIII, IX and XI, antithrombin, protein C and protein S). Within-run and inter-laboratory precisions have been evaluated using quality controls. Method comparisons were performed using a minimum of 100 plasma samples, collected across multiple sites, and compared to the STA R Max analyzer. Reference intervals were determined or verified based on published data. Within-run and inter-laboratory precisions were respectively below 5.2 and 7.6% whatever the parameter and the sample used. Pearson correlation coefficient was above 0.976 for all assays and slopes ranged from 0.94 to 1.07 for all but thrombin time, which was at 0.86. Bias at levels of interest were less than 6% for most routine coagulation parameters, coagulation factors and inhibitors. We reported the precision, accuracy and reference intervals of 20 parameters on the sthemO 301, half of these being reported for the first time, which include anti-Xa, factors II, V, VII, X, VIII, IX, XI, protein S free antigen and activity. The sthemO 301 analyzer offers satisfactory analytical performance and a good comparability with the STA R Max for all parameters.