AB0370 COMPARISON OF A NEW RANDOM-ACCESS SOLUTION FOR THERAPEUTIC DRUG MONITORING OF ADALIMUMAB TO THE REFERENCE ELISA TEST

Background Despite numerous studies, Therapeutic Drug Monitoring (TDM) of biological therapies is still debated partly motivated by the accessibility to a ready-to-use monotest device capable delivering accurate results in timely manner without burden sample batching, therefore allowing immediate decision making. Objectives We aimed at comparing new Chorus Promonitor Adalimumab running fully automated random-access TRIO system reference ELISA test ADL run Triturus system. Methods (Diesse Diagnostica Danese, Italy) an immunoassay kit for quantitative detection adalimumab (ADL) human serum using disposable applied on instrument, single multiparametric immuno-colorimetric assays. The implements same specific reagents as (Progenika, Spain) (Grifols, system, ensuring analytical specificity and applicability patient monitoring previously demonstrated with predicate ELISA. contains all necessary perform assay, lot-specific master curve method used calibrating. comparison was performed set 53 samples from patients under therapy that covered entire drug trough concentrations found clinical practice (up 30 ug/mL). Pearson’s correlation, Bland-Altman Passing-Bablok regression analysis were study association between methods. Results Time first result 2 hours 45 min minutes after this delivered every seconds. Positive negative percent agreements both tests 100%. A high correlation (coefficient 0.959, p<0.01). determined excellent comparability data sets slope 1.032 (0.952-1.129) intercept -0.428 (-1.292-0.053). Figure 1. Conclusion represents evolution gold-standard technology into enables quick turnaround time facilitate TDM aid Disclosure Interests None declared