A-148 Performance Evaluation ofthe Zybio EXT 4800: A Novel Optical-Magnetic Coagulation Analyzer

Abstract Background Coagulation analysis, crucial in clinical diagnostics, predominantly employs optical and Mechanical methods. Optical methods are preferred for their simplicity and cost-effectiveness but are susceptible to hemolysis, icterus, and lipemia interferences. Mechanical methods, considered more accurate, are hindered by higher costs and operational complexity. This study evaluates the Zybio EXT 4800, a novel analyzer integrating both technologies(U.S. Patent:US11022558 B2), to harness their collective benefits. Methods The study compared optical, mechanical, and integrated optical-mechanical detection methods for Prothrombin Time (PT) testing, particularly under interference conditions such as chyle. To ensure reagent reliability, a comprehensive open-vial stability assessment was conducted for Zybio's reagents. Additionally, a clinical correlation study compared Zybio EXT 4800 with Siemens CS-2000i Systems, covering multiple parameters. Through this rigorous methodology, the study sought to establish the accuracy, reliability, and clinical applicability of these advanced coagulation analysis technologies. Results In the presence of lipemia interferents during PT testing, notable fluctuations were observed with the optical method, resulting in deviations ranging from 80% to 104% from the set values. Conversely, when utilizing the integrated optical-mechanical approach for analysis, the instrument automatically identifies interferences in the sample, intelligently switching the detection method from optical to mechanical.This intelligent adaptation to interference exhibits strong anti-interference capabilities. The experimental results of mechanical testing show deviations ranging from 0.8% to 1.7%, while the experimental results of optical retesting after high-speed centrifugation of samples show deviations ranging from 1.1% to 2.3%. Regarding reagent stability, Zybio's reagents showcased exceptional durability. Following an accelerated aging process of 50 days at 37°C, Zybio reagents exhibited smaller relative deviations compared to the comparator reagents, underscoring the remarkable stability and reliability offered by Zybio's reagents. Furthermore, in a clinical correlation analysis between Zybio's “EXT 4800 Automated Coagulation Analyzer” and Siemens' “CS-2000i Systems,” strong correlations were observed. The R-squared values perform well, with determinations of exemplary quantitative parameters: FIB for 0.985, D-Dimer for 0.983, and AT for 0.980. These results not only validate the performance equivalence between the two systems but also highlight the advanced stability and anti-interference capabilities of the EXT 4800, positioning it as a formidable alternative to existing solutions. Conclusions The EXT 4800 coagulation analyzer effectively merges optical and mechanical methodologies, offering high sensitivity, accuracy, and reduced susceptibility to interferences. It presents as a cost-effective, reliable alternative in coagulation analysis, with strong performance correlations to established systems and superior reagent stability, making it a valuable addition to clinical laboratories.