Thrombosis research · 2026
Analytical and clinical validation of the Tsmart FIB Batrox© assay on the LabPad Evolution analyzer for fibrinogen measurement in whole blood.
СтатьяВалидационное исследованиеНазвание и аннотация: Перевод в очереди
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Breteau Nina, Frère Corinne, Marlu Raphaël, Seyve Landry, Blachier Stéphane, Poher Vincent, Spiaczka Johanna, Polack Benoît
Аннотация
BACKGROUND: Fibrinogen is the first coagulation factor to drop during severe hemorrhage, making it an early biomarker for assessing bleeding severity.
OBJECTIVES: To evaluate the analytical and clinical performance of the Tsmart FIB Batrox©, a novel point-of-care test using batroxobin, a snake venom-derived enzyme insensitive to heparins and direct thrombin inhibitors, performed on the LabPad Evolution analyzer. The assay delivers results in less than 4 min from citrated whole blood, addressing unmet needs in emergency settings.
PATIENTS AND METHODS: This study included 121 residual citrated (0.109 mol/L) samples collected for routine coagulation testing. Fibrinogen levels measured by the Tsmart FIB Batrox© assay were compared against the Clauss method (gold standard), performed in the central laboratory using the same samples.
RESULTS: The Tsmart FIB Batrox© demonstrated excellent correlation with the Clauss assay (r = 0.94), particularly in the clinically critical range for severe bleeding. Bland-Altman analysis revealed negligible bias. No interference from hematocrit variations or anticoagulants was observed. At fibrinogen cut-offs of 1.0 g/L and 2.0 g/L, it exhibited high diagnostic accuracy (area under the ROC curve values of 0.99 and 0.98, respectively). Precision testing confirmed excellent repeatability and reproducibility, with coefficients of variation <10% across all ranges.
CONCLUSION: The Tsmart FIB Batrox© system enables rapid and accurate fibrinogen measurement from a single drop of citrated whole blood, even at the lowest detectable concentrations. Its strong correlation with the Clauss method, high diagnostic accuracy, and POC feasibility make it a valuable tool for real-time decision-making in hemorrhage management.
OBJECTIVES: To evaluate the analytical and clinical performance of the Tsmart FIB Batrox©, a novel point-of-care test using batroxobin, a snake venom-derived enzyme insensitive to heparins and direct thrombin inhibitors, performed on the LabPad Evolution analyzer. The assay delivers results in less than 4 min from citrated whole blood, addressing unmet needs in emergency settings.
PATIENTS AND METHODS: This study included 121 residual citrated (0.109 mol/L) samples collected for routine coagulation testing. Fibrinogen levels measured by the Tsmart FIB Batrox© assay were compared against the Clauss method (gold standard), performed in the central laboratory using the same samples.
RESULTS: The Tsmart FIB Batrox© demonstrated excellent correlation with the Clauss assay (r = 0.94), particularly in the clinically critical range for severe bleeding. Bland-Altman analysis revealed negligible bias. No interference from hematocrit variations or anticoagulants was observed. At fibrinogen cut-offs of 1.0 g/L and 2.0 g/L, it exhibited high diagnostic accuracy (area under the ROC curve values of 0.99 and 0.98, respectively). Precision testing confirmed excellent repeatability and reproducibility, with coefficients of variation <10% across all ranges.
CONCLUSION: The Tsmart FIB Batrox© system enables rapid and accurate fibrinogen measurement from a single drop of citrated whole blood, even at the lowest detectable concentrations. Its strong correlation with the Clauss method, high diagnostic accuracy, and POC feasibility make it a valuable tool for real-time decision-making in hemorrhage management.