Abstract
BACKGROUND: Diagnosis of bleeding disorders includes correct analysis of coagulation factors VIII, IX, XI, XII, XIII, II, V, VII, and X and von Willebrand antigen and activity. The aim of this study was to evaluate the analytical performance of the Atellica COAG 360 analyzer in a specialized coagulation laboratory with focus on specific coagulation parameters involved in the diagnosis of bleeding disorders. METHODS: Verification included assessment of precision, reference interval, and method comparison according to local guidelines. For FVIII (Chromogenix) and FIX (Rossix), extended verifications were performed with additional assessment of linearity, detection limit, and comparability to BCS-XP. RESULTS: The precision was below 5% (normal levels) and below 10% (abnormal levels) and either improved or similar when compared to expected target values from a BCS-XP. The locally established reference range agreed well (≥80% of measured values within manufacturer's assigned ranges) for most of the methods. The lower limit of quantification was calculated to below 0.01 IU/ml for FVIII chromogenic (Chromogenix) and FIX chromogenic (Rossix), both with acceptable linearity. Bland-Altman analyses revealed generally good agreement between Atellica COAG 360 and BCS-XP in the determination of coagulation parameters, and differences between the two instruments did not result in any diagnostic change. CONCLUSIONS: The results of the evaluation show that the Atellica COAG 360 analyzer performs as expected to target values and equivalent to BCS-XP for the diagnosis of bleeding disorders in a specialized coagulation laboratory providing service to a hemophilia treatment center (HTC).