| Abstract [eng] |
Application of Good Laboratory Practice Principles in Monitoring Anticoagulants by anti-Xa Method Increasing rates of cardiovascular cases increase demand for anticoagulants. Generaly, routine monitoring of DOAC's is not required, but is necessary in emergency situations, raising the need of appropriate and reliable laboratory services. The aim. To find out doctors' knowledge about the research methods used for anticoagulant monitoring and the purposes of their application, to evaluate the functional characteristics of the test procedures of fondaparinux, rivaroxaban, apixaban and dabigatran, compared to the manufacturer's declared characteristics and, in case of positive results, to implement methods for clinical practice. Methods. An anonymous questionnaire was conducted and 31 Lithuanian doctors were interviewed. 5 days 5 runs 2 level samples verification study was conducted for each anticoagulant (fondaparinux, rivaroxaban and apixaban; N = 50 for each drug). Dabigatran has been tested in 8 quality-control tests (N = 16). Results. Only 52 % of physicians are aware that anti-Xa is a functional assay representing FXa inhibition and anti-Xa method calibrated for dabigatran was choosen by 68 % of respondents for monitoring of dabigatran, although no such calibration test is available. The fondaparinux assay corresponds to the manufacturer's functional characteristics (p > 0.05), the rivaroxaban and apixaban test characteristics do not match (p < 0.05), but do not exceed the reference method estimates, the dabigatran assay, despite small sample size, corresponds to the manufacturer (p > 0.05). Conclusions. Doctors lack knowledge on methods for anticoagulants monitoring and purpose of it. Assays for DOAC's (fondaparinux, rivaroxaban, apixaban and dabigatran) can be implemented and used in clinical practice. |
