Analytical and clinical validation of the Tsmart FIB Batrox© assay on the LabPad Evolution analyzer for fibrinogen measurement in whole blood.

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.