Background: The coagulation tests are primarily used to assess the blood clotting function in patients. Modern analyzers allow measurement of the components responsible for coagulation in order to contribute to the diagnosis and monitoring of bleeding disorders.

Aims: The aim was to evaluate the analytical performance of Atellica COAG 360 (Siemens Healthineers) for prothrombin time (PT), international normalized ratio (INR), activated partial thromboplastin time (aPTT), thrombin time (TT), fibrinogen, antithrombin (AT), D-dimer and anti-Xa activity.

Methods: We used citrate blood samples collected from randomly selected patients. The validation was performed within two weeks. Patient samples (n = 410) were used for comparison analyses with the routinely used analyzer BCS XP1 (Siemens Healthineers). First, we tested the samples on the routinely used BCS XP 1 analyzer as a reference method and then on the Atellica COAG 360 analyzer as a test method. On the new Atellica COAG 360 coagulation analyzer, using the reference material (positive, negative control) we performed an experimental model 5×5 (repeatability test and intermediate inaccuracy-ANOVA analysis) for the following tests: prothrombin time (PT), international normalized ratio (INR), activated partial thromboplastin time (aPTT),thrombin time(TT), fibrinogen, antithrombin (AT), D-dimer and anti-Xa activity.

Results: The results of statistical analysis of the reproducibility and inaccuracy of the control material within one day (5 measurements for each test) and between 5 days showed good repeatability and precision, since the coefficient of variability (CV) between batches and within batches ranges within very narrow limits. The results of the statistical analysis of the method of comparing the test results between the analyzers showed a high correlation between the analyzers, because the results of the correlation coefficients range between 0.922 and 0.996.

Conclusions: Based on the results, we find that Atellica COAG 360 is suitable for routine use for all of these tests.

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ISTH Congress Abstracts - https://abstracts.isth.org/abstract/validation-of-the-atellica-coag-360-coagulation-analyzer/