PB1156 - Clinical performance evaluation of the new Stago system for fibrinogen and thrombin time determination: sthemO Fib and sthemO Thrombin on sthemO 301 analyzer

Background: Fibrinogen (Fib) and Thrombin time (TT) measurements are essential tools of the hemostasis laboratory to explore fibrinogen and fibrinogenesis. To face future challenges, a new Medium-high throughput analyzer, sthemO 301 was developed with dedicated reagents. To ensure proper patient medical care continuity, the consistency of results between sthemO and STA system is compulsory to validate these new solutions.

Aims: To prove the clinical performances of sthemO Fib and sthemO Thrombin on sthemO 301, by demonstrating their substantial equivalence versus STA®-Liquid Fib and STA®-Thrombin respectively, on a STA-R® Max, in g/L unit for Fib and in seconds unit for TT.

Methods: Ninety-eight samples were included for sthemO Fib evaluation, among which normal individuals, patients with hypofibrinogenemia or hyperfibrinogenemia, and a few contrived samples*.
Ninety-nine samples were included for sthemO Thrombin evaluation, among which normal individuals, patients treated with unfractionated heparin, low molecular weight heparin or direct thrombin inhibitors, patients with hypofibrinogenemia or hyperfibrinogenemia, and contrived samples*.
*Contrived samples were used to cover the entire measuring range, they were heparinized contrived for sthemO Thrombin and spiked samples (high values) for sthemO Fib.
Normal and pathologic Quality Controls (QCs) were tested at each run. QCs were within the acceptance criteria according to the GFHT “French hemostasis and thrombosis group”.

Results: Bland & Altman (Figure 1) and Passing-Bablok regression analyses were performed to evaluate the correlation and agreement between methods.
Slope, intercept, correlation coefficient and bias are displayed in Table 1.

Conclusion(s): sthemO Fib and sthemO Thrombin evaluated on sthemO 301 passed all clinical performance criteria, and the consistency of results with STA-R® Max is proven. Therefore, the substantial equivalence of these systems is demonstrated. The intended purposes of sthemO Fib and sthemO Thrombin on sthemO 301 are validated.