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Pekrul, Isabell; Pfrepper, Christian; Calatzis, Geli; Giebl, Andreas; Siegemund, Annelie; Grützner, Stefanie and Spannagl, Michael (2021): Approximation of emicizumab plasma levels in emergency situations. A practical approach. In: Haemophilia, Vol. 27, No. 2, E214-E220

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Introduction: A dedicated emicizumab assay based on the modified one-stage factor VIII (FVIII) assay (mOSA) is mainly available in haemophilia treatment centres (HTC). A method to estimate emicizumab plasma levels based on a widely available assay would be desirable, especially for emergency situations. Aim: A method for emicizumab plasma level approximation (ELA) using a routine FVIII activity measurement with standard one-stage assay (sOSA) was developed and evaluated. Method: Within this pilot study, 59 samples from patients with severe haemophilia A with (n = 8) and without (n = 8) inhibitors under emicizumab treatment were analysed using sOSA following a manual 1:8 sample pre-test dilution with saline. The sOSA was determined in two different laboratories, using two different analyser platforms each. Results: The results demonstrated an excellent correlation of approximated emicizumab plasma levels (ELA) with the emicizumab plasma concentration determined with mOSA (r > .9;p < .05). The ELA showed a sensitivity of 93.3% and a specificity of 89.6% to predict a pre-defined cut-off-value of <= 30 mu g/ml for the discrimination between subtherapeutic and therapeutic emicizumab plasma levels. Conclusion: Approximation of emicizumab levels by standard one-stage FVIII assay discriminates between subtherapeutic and therapeutic emicizumab levels and might facilitate clinical decision-making in emergency situations, such as bleeding, trauma or urgent surgery in case that dedicated emicizumab assays are not available.

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