DOAC plasma levels measured by chromogenic anti-Xa assays and HPLC-UV in apixaban- and rivaroxaban-treated patients from the START-Register
| Autor: | Sophie Testa, Daniela Poli, Rossella Marcucci, Claudia Dellanoce, Michela Cini, Benilde Cosmi, Cristina Legnani, Roberto Padrini, Giovanni De Rosa, Vittorio Pengo, Gualtiero Palareti |
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| Přispěvatelé: | Cini M., Legnani C., Padrini R., Cosmi B., Dellanoce C., De Rosa G., Marcucci R., Pengo V., Poli D., Testa S., Palareti G. |
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Male
HPLC-UV apixaban chromogenic anti-Xa assay laboratory testing rivaroxaban medicine.drug_mechanism_of_action Pyridones Clinical Biochemistry Factor Xa Inhibitor 030204 cardiovascular system & hematology Pyridone 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Edoxaban medicine Humans In patient Registries Chromatography High Pressure Liquid Rivaroxaban Chromatography Chromogenic Biochemistry (medical) Antithrombin Hematology General Medicine Plasma levels chemistry Pyrazole Pyrazoles Apixaban Female Drug Monitoring 030215 immunology medicine.drug Human Factor Xa Inhibitors |
| Popis: | Introduction: To measure direct factor Xa inhibitor (apixaban, edoxaban, rivaroxaban) concentrations, dedicated chromogenic anti-Xa assays are recommended as suitable methods to provide rapid drug quantification. Moreover, the high-performance liquid chromatography with ultraviolet detection (HPLC-UV) is reported as a reliable quantitative technique. We investigated seven anti-Xa assays and an HPLC-UV method for measurement of apixaban and rivaroxaban levels in patients enrolled in the START-Register. Methods: A total of 127 apixaban and 124 rivaroxaban samples were tested by HPLC-UV and the following anti-Xa assays: Biophen DiXaI and Heparin LRT (Hyphen BioMed), Berichrom and Innovance Heparin (Siemens), STA-Liquid Anti-Xa (Stago Diagnostics), Technochrom anti-Xa (Technoclone), and HemosIL Liquid Anti-Xa (Werfen). Each method was performed in one of the participating laboratories: Bologna, Cremona, Florence, and Padua. Results: Our data confirmed the overestimation of apixaban and rivaroxaban levels by the antithrombin-supplemented anti-Xa method (Berichrom). Performances and reproducibility of the six anti-Xa assays not supplemented with antithrombin and the HPLC-UV method were good, with limits of quantification from 8-39ng/mL (apixaban) and 15-33ng/mL (rivaroxaban). The six chromogenic methods showed good concordances with the quantitative HPLC-UV [bias: −26.9-22.3ng/mL (apixaban), −11.3-18.7ng/mL (rivaroxaban)]. Higher bias and wider range between limits of agreement were observed at higher concentrations [200ng/mL: bias −42.2-36.8ng/mL (apixaban) and −20.1-68.9ng/mL (rivaroxaban)]. Conclusion: Overall, the anti-Xa assays not supplemented with antithrombin and the HPLC-UV method proved to be suitable for apixaban and rivaroxaban quantification. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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