Application of Sigma Metrics for Assessing Analytical Performance of Drug Assay in Patient Care

The study emphasizes the importance of thorough analysis and documentation in handling analytes with poor Sigma scores to mitigate laboratory errors and ensure reliability. It recommends root cause analysis and corrective action plans to achieve world-class Sigma goals. However, challenges remain in selecting the appropriate method for calculating Sigma metrics and TEa before harmonizing Sigma metrics across laboratories to minimize confusion.