Introduction:
In Spring 2025 a small pilot study was performed on testing for Bivalirudin. The meaning of this pilot study was to investigate the feasibility of an external quality assessment survey for Bivalirudin.
Materials and Methods:
Two different samples with different Bivalirudin concentrations (resp. 1.7 and 3.1 µg/mL) were distributed to the participants. Participants were asked to measure the Bivalirudin concentration in these two plasmas.
Results:
Twenty-one laboratories took part in this pilot survey, of which 14 laboratories submitted results. Only one laboratory used an APTT test for just screening the presence of bivalirudin.
Thirteen laboratories performed a quantitative test of which 8 laboratories used a clot-base test and 5 laboratories a chromogenic assay. The average measured concentration in the two samples was resp. 1.6 and 2.9 µg/mL. The between-laboratory variation was resp. 10.6 and 7.7%.
Conclusion:
This pilot study has demonstrated the feasibility and need for regular external quality control for bivalirudin.