Abstract
IntroductionThe aim of the study was to perform analytical verification and comparison of chromogenic assays for determination of dabigatran, rivaroxaban and apixaban concentration on BCSXP and STA Compact Max analysers.Materials and methodsPrecision, linearity, measurement uncertainty estimation and determination of limit of blank, limit of determination and limit of quantification were calculated. Analytical performance specifications were set according to manufacturer specifications and literature data on between laboratory variability. Comparison of the methods was done using Bland-Altman and Passing-Bablok regression analysis.ResultsObtained results have shown acceptable precision on STA Compact Max only for dabigatran (CV = 3.5%) at lower concentration level comparing to manufacturer declaration (CV = 3.6%). On BCSXP, the highest coefficient of variation has been shown for apixaban (6.1%) at lower concentration level. Within laboratory precision was not met on STA Compact Max for all assays. Bland-Altman analysis has shown statistically significant bias for dabigatran (23.2%, 95%CI 11.2 – 35.3; P < 0.001) and apixaban (8.4%, 95%CI 1.2 – 15.6; P = 0.023). Passing-Bablok regression analysis has shown systematic and proportional deviation between methods for rivaroxaban (y = 6.52 (2.94 to 11.83) + 0.84 (0.80 to 0.89) x.ConclusionChromogenic assays for dabigatran, rivaroxaban and apixaban on BCSXP and STA Compact Max analysers are shown as methods with satisfactory long-term analytical performance specifications for determination of direct oral anticoagulants in clinical laboratories. However, we cannot recommend interchangeable use because of the significant bias between assays.
Highlights
The aim of the study was to perform analytical verification and comparison of chromogenic assays for determination of dabigatran, rivaroxaban and apixaban concentration on BCSXP and STA Compact Max analysers
Obtained results have shown acceptable precision on STA Compact Max only for dabigatran (CV = 3.5%) at lower concentration level comparing to manufacturer declaration (CV = 3.6%)
Bland-Altman analysis has shown statistically significant bias for dabigatran (23.2%, 95%CI 11.2 – 35.3; P < 0.001) and apixaban (8.4%, 95%CI 1.2 – 15.6; P = 0.023)
Summary
The aim of the study was to perform analytical verification and comparison of chromogenic assays for determination of dabigatran, rivaroxaban and apixaban concentration on BCSXP and STA Compact Max analysers. High intra-individual and inter-individual variability in drug response has been shown, depending on different factors [1]. It is recommended to measure DOAC concentration in blood in certain clinical situations. Current guidelines do not recommend routine monitoring of DOAC concentrations but sporadic measuring in specific cases such as an emergency surgical operation, sudden extensive bleeding, thromboembolic events, etc. Since global coagulation tests have been shown as non-specific for the evaluation of the anticoagulant effect of DOACs, specific assays have been developed with the accent on liquid chromatography coupled with tandem mass spectrometry method (LC-MS/MS) as the most accurate for the determination of DOAC concentration [3,4,5]. One of the most important factors in determination of the DOAC concentration, in recommended situations, is Biochem Med (Zagreb) 2020;30(1):010706
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