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Background: The SF-8200 is a new coagulation analyzer developed by Beijing Succeeder Technology Inc., China. The SF-8200 is able to perform clotting, chromogenic, and immunoturbidimetric tests. System capability is a throughput of up to 360 tests per hour, 60 sample tubes can be loaded at any time, and its reaction cuvette capacity is 1,000. The analyzer also has an optional cap piercing module to reduce manual sampling time. We aimed to perform an analytical performance comparison study between Succeeder SF-8200 and Stago Compact Max3 because fully automated coagulation analyzers have become one of the most essential components of clinical laboratories.
Methods: Routine coagulation tests were assessed, which are the most ordered in laboratories such as PT, aPTT, and fibrinogen. Stago Compact Max-3 was accepted as the reference instrument in the comparison study. The assay precisions were assessed using fresh and pooled plasma samples or consumer internal quality controls. Hemolysis, lipemia, and icterus interferences were also verified.
Results: The coefficients of variation assessed in the intra and inter-assay precision analyses were below 5% representatively for assessed parameters. The inter‐analyser comparison demonstrated good results. Results obtained by the SF-8200 showed high comparability predominantly to used reference analyzers, with correlation coefficients ranging from 0.953 to 0.976. In our routine laboratory setting, SF-8200 reached a sample throughput rate of 360 tests per hour. No considerable influence on tests was found for elevated levels of free hemoglobin, bilirubin, or triglycerides.
Conclusions: In conclusion, the SF-8200 was an accurate, precise, and reliable coagulation analyzer in routine testing. According to our study, the results demonstrated excellent technical and analytical performance.
DOI: 10.7754/Clin.Lab.2021.210151
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