Abstract
This study aimed to verify whether blood drawn into six different commercial coagulation tubes generated comparable results of thrombin generation. Blood was sequentially collected from 20 healthy subjects into different brand and draw volume 3.2% sodium citrate tubes (4.3 mL Sarstedt, 3.0 mL Greiner, 2.7 mL Becton Dickinson, 2.0 mL Kima, 1.8 mL Sarstedt and 1.0 mL Greiner). Thrombin generation was measured in plasma with the fully-automated ST Genesia analyzer using the weakest trigger (STG-BleedScreen). Different values of lag time (LT), time to reach thrombin peak (TP), thrombin peak height (PH) and endogenous thrombin potential (ETP) were commonly found in different tubes. Thrombin generation was the lowest in 4.3 mL Sarstedt tubes and the highest in 1.0 mL Greiner tubes. Other tubes displayed intermediate values. In multiple comparisons, LT was significantly different in 6/15 cases (40%), whilst PH, TP and ETP were significantly different in 14/15 (93%), 13/15 (87%) and 13/15 (87%) cases. The mean percent bias of LT, PH, TP and ETP ranged between -6% and +1%, -27% and +116%, -22% and +8%, and between -18% and +65%. The intra-assay imprecision of LT, PH, TP and ETP was exceeded in 0/15 (0%), 13/15 (87%), 6/15 (40%) and 13/15 (87%) comparisons. The correlation of LT, PH, TP and ETP values in different tubes ranged between 0.718-0.971, 0.570-0.966, 0.725-0.977 and 0.101-0.904. Blood collection for thrombin generation assays requires local standardization using identical tubes for brand and draw volume, and reference ranges calculated according to type of tubes.
Highlights
Laboratory hemostasis represents an essential part of diagnostic reasoning and clinical decision making in patients with hemostasis disorders, either hemorrhagic or thrombotic [1]
The highest thrombin generation in plasma was instead found in 1.0 mL Greiner blood tubes, as reflected by the shortest values of lag time (LT) and thrombin peak (TP) as well as by the highest values of peak height (PH) and endogenous thrombin potential (ETP)
In multiple comparisons among the different blood tubes (Table II), LT was found to be significantly different in 6/15 cases (40%), whilst PH, TP and ETP were found to be significantly different in 14/15 (93%), 13/15 (87%) and 13/15 (87%) cases, respectively
Summary
Laboratory hemostasis represents an essential part of diagnostic reasoning and clinical decision making in patients with hemostasis disorders, either hemorrhagic or thrombotic [1]. The main aspects evaluated with the standardized CAT assay include the lag time (LT; reflecting the time necessary for initial thrombin generation after adding the trigger), the time to reach the thrombin peak (TP; mirroring the speed of thrombin generation), the thrombin peak height (PH; reflecting the highest value of thrombin generated) and the endogenous thrombin potential (ETP; underscoring the total amount of thrombin generated) The combination of these different parameters contributes to accurately define the hemostatic potential in the test plasma, as reflected by the speed and amount of thrombin that can be generated [5]
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