Analytical and Stability Validation Studies for Basophil Activation Test according to IVDR
The poster reports that the Flow CAST® assay demonstrates robustness in handling variations in sample volumes and incubation times. Precision and reproducibility are enhanced with higher percentages of basophil activation. Internal validation studies, conducted in accordance with CLSI guidelines EP05-A3 and ISO standard 15197:2013, have revealed within-laboratory precision and reproducibility levels of less than 25%. These findings underscore the reliability and accuracy of the Flow CAST® assay in clinical laboratory settings.
Experimental and Theoretical approaches to understand the Technical Cut-Off in Basophil Activation Test
Our rigorous research has refined the performance of the Flow CAST® assay. It suggests an appropriate technical cut-off at 5% and indicates lower rates of IgE non-responder than previously reported in the literature. Additionally, it provides guidance on the appropriate number of basophil acquisitions for robust data. In summary, these insights reinforce the accuracy and reliability of the Flow CAST® assay.
Automated Gating Strategies for Basophil Activation Test a comparison to Manual Data Analysis
The research on automated gating has proven to be feasible, reproducible, and robust. This marks the initial phase in the development of automated software for Flow CAST® analysis, laying the foundation for future advancements in streamlining and enhancing diagnostic processes.
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