| Pros | Cons | | :--- | :--- | | Saves 50%+ time on method validation | Subscription model adds annual budget line | | CLSI EP09c, EP15, EP17 fully compliant | Overkill for labs that run only 3 tests | | "Smart Interpretation" teaches statistics | Requires basic stats knowledge to override | | Beautiful, modern graphs for presentations | No LIS integration (manual data entry still needed) |
EPE 12 includes specialized modules for all major laboratory studies, including:
This allows users to test the reportable range of assays by plotting sample values against expected values. ep evaluator 12
EP Evaluator 12 is designed to generate ready-to-sign reports that meet laboratory inspection requirements. It streamlines the documentation process for CLIA validation studies. 4. User-Friendly Interface
Ensures all validation studies meet the stringent requirements of regulatory agencies (CAP/CLIA), reducing the risk of audit findings. | Pros | Cons | | :--- |
: Validating a new diagnostic assay against a predicate or reference method (e.g., comparing SARS-CoV-2 quantitative assays). Instrument Validation
: Use the updated interface to more easily exclude problematic data points and reduce random bias errors before finalizing reports. 3. Prepare for Automated Data Acquisition To streamline the creation of multiple experiments: Use Global Filters : When running the Query Wizard Instrument Validation : Use the updated interface to
As shown in studies comparing lipoprotein(a) immunoassays, EPE 12 is critical for determining how new assays perform against established methods. It provides detailed statistical plots (e.g., regression plots, frequency distributions of ratios) to identify potential biases. Establishing Lower Limits of Quantitation (LoQ)
EP Evaluator 12 is vital for several routine and research laboratory tasks.