Abstract
Fully-automated coagulation analyzers are key components of a high-throughput central laboratory. The novel Atellica COAG 360 (Siemens Healthineers) is a high-volume coagulation analyzer approved for hemostasis diagnostics. The aim of the study was to evaluate the analytical performance of this coagulation analyzer in a central laboratory. Intra (n=10)- and inter (n=20)-assay precision of the Atellica COAG 360 was determined using commercially available control samples. Patient samples (n=74-104) were used for comparison analyses with the Sysmex CS-5100 (Siemens Healthineers). Effects of visual interferences on coagulation testing were assessed and the sample throughput rate of the Atellica COAG 360 was determined. Intra- and inter-assay precision of the Atellica COAG 360 showed coefficient of variations (CVs)<5% for most of the coagulation parameters comparable to CVs of the Sysmex CS-5100. Passing-Bablok and Bland-Altman analyses revealed high correlation and good agreement between both coagulation analyzers in determination of coagulation parameters. Results of coagulation measurements determined in optically abnormal samples were comparable between the Atellica COAG 360 and the Sysmex CS-5100 and were confirmed by mechanical measurements on a STart Max (Stago Diagnostics) coagulation analyzer. A sample throughput rate of about 190 tests per hour in a routine setting including five coagulation parameters was determined for the Atellica COAG 360 integrated in a total laboratory automation system. The Atellica COAG 360 provides high analytical performance as high-throughput analyzer for routine and specific coagulation parameters and is suitable to be connected to a total laboratory automation.
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