Background: Fully automated thrombin generation on the Ceveron® t100 analyzer is a valuable tool for investigating blood coagulation activity, elevated thrombin activity suggesting a thrombotic tendency or depressed activity suggesting a bleeding tendency, when using standardized Ceveron® TGA kits. In addition to precise measurements between laboratories, easy result interpretation via normalization improves accessibility to diagnosticians.

Aims: Evaluate assay performance on the new Ceveron® t100 instrument regarding between-run imprecision for Peak Thrombin values and for the newly introduced normalization of Peak Thrombin values.

Methods: Two pathological samples (protein S deficiency and haemophilia A representing thrombotic and bleeding tendencies respectively) and a normal plasma for normalization were measured on 20 consecutive days on a Ceveron® t100. Two samples from patients on direct FXa inhibitors were also measured and normalized Peak thrombin (N-Peak) evaluated. Imprecision was calculated for Peak thrombin and N-Peak. A calibration curve was made at the beginning of the study using the standard analyzer settings for TGA calibration.

Results: CV for Peak thrombin of sample 1 improved from 7.12% to 6.72% when converted to N-Peak. Sample 2 had a Peak thrombin CV of 6.05%, improving to 5.38% for N-Peak. The normal sample had N-Peak value of 105%, the thrombophilic sample with protein S deficiency had 194% N-Peak and the haemophilic sample had 11.5% N-Peak. N-Peak and N-Lag ratio for the patient sample with 288ng/mL Apixaban were 41% and 2.0 respectively, and the sample with 322ng/mL Rivaroxaban 20% and 2.5 respectively.

Conclusions: These data demonstrate that automated TGA parameter normalization on Ceveron^® series instruments improves analytical precision. Reference ranges for TGA parameters vary widely so normalization has potential to facilitate clearer understanding and interpretation of complex data sets. Further studies are required to generate reference ranges and anticipated ranges in thrombotic and bleeding disorders.

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ISTH Congress Abstracts - https://abstracts.isth.org/abstract/performance-evaluation-of-automated-thrombin-generation-measurement-on-ceveron-t100-with-normalized-tga-parameters/