Simone Denitto, Elia Ponchini, Nicola Baratto, Alessandro Lorenzetto, Davide Demonte, Gian Luca Salvagno, Emmanuel J Favaloro, Giuseppe Lippi
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引用次数: 0
Abstract
Objectives: We performed a comparative evaluation of analytical performance between the novel bench-top Stago sthemO 301 hemostasis analyzer and the Werfen ACL TOP 750 coagulometer using routine plasma samples.
Methods: A minimum of 100 fresh plasma samples per test were analyzed using both analytical systems. The tests included prothrombin time (PT) expressed as international normalized ratio (INR) and seconds (s), activated partial thromboplastin time (APTT) in ratio and seconds, fibrinogen, antithrombin and D-dimer. Clotting assays were performed using mechanical clot detection on sthemO and optical detection on ACL TOP. The comparative evaluation included the calculation of Spearman's correlation, Passing-Bablok regression and Bland-Altman plots.
Results: Correlation coefficients ranged between 0.76 for APTT to 0.98 for PT-INR and D-dimer, indicating a generally acceptable/good agreement. The regression slopes varied from 0.82 for D-dimer to 1.17 for APTT-s. A significant bias was observed for all tests except antithrombin, with differences for sthemO ranging between -31 % for D-dimer and 13.7 % for PT-s.
Conclusions: SthemO demonstrates acceptable global comparability with ACL TOP for routine coagulation testing. Nevertheless, reagent- and method-dependent bias has been observed, which highlight the need for additional harmonization efforts.
期刊介绍：
Diagnosis focuses on how diagnosis can be advanced, how it is taught, and how and why it can fail, leading to diagnostic errors. The journal welcomes both fundamental and applied works, improvement initiatives, opinions, and debates to encourage new thinking on improving this critical aspect of healthcare quality. Topics: -Factors that promote diagnostic quality and safety -Clinical reasoning -Diagnostic errors in medicine -The factors that contribute to diagnostic error: human factors, cognitive issues, and system-related breakdowns -Improving the value of diagnosis – eliminating waste and unnecessary testing -How culture and removing blame promote awareness of diagnostic errors -Training and education related to clinical reasoning and diagnostic skills -Advances in laboratory testing and imaging that improve diagnostic capability -Local, national and international initiatives to reduce diagnostic error
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