: A major enhancement based on the latest CLSI EP9 guidelines. It increased data capacity, allowing up to five replicate tests per specimen (up from two), which significantly improves mean precision and outlier detection.
The Version 12 series introduces powerful enhancements designed to modernize laboratory operations:
Beyond IM, EP Evaluator 12 also supports data import from Laboratory Information Systems (LIS) and other middleware interfaces via ODBC. It can also import reagent, control, and calibrator information from CSV files, further automating the setup process.
designed specifically for clinical laboratories to automate performance verification and regulatory compliance. Data Innovations Key Features and Enhancements in Release 12 ep evaluator 12
For high-sensitivity assays, such as those measuring low levels of C-peptide in diabetes research, EPE 12 allows users to input data from daily studies to calculate the LoQ based on laboratory-specific performance. This is crucial for evaluating manufacturer claims and ensuring technical accuracy. Why Choose EP Evaluator 12?
: Generates "inspector-ready" reports, which significantly reduces the manual effort required for laboratory audits. Statistical Analysis
Laboratories working near the lower limits of an assay's detection capabilities rely heavily on EE 12's . These tools are particularly essential in specialized studies—such as tracking residual C-peptide levels in Type 1 Diabetes research or analyzing highly sensitive cardiac biomarkers—where accuracy at trace levels dictates clinical treatment. 4. Reference Interval Verification : A major enhancement based on the latest
| CLSI Protocol | Purpose & Key Application in EP Evaluator 12 | | :--- | :--- | | | Evaluation of Precision Performance of Quantitative Measurement Procedures | | EP06-A | Evaluation of the Linearity of Quantitative Measurement Procedures | | EP07-A3 | Interference Testing in Clinical Chemistry | | EP09-A3 | Measurement Procedure Comparison and Bias Estimation Using Patient Samples | | EP10-A3 | Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures | | EP12-A2 | User Protocol for Evaluation of Qualitative Test Performance | | C28-A3c | Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory | | GP10-A | Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic (ROC) Plots |
When a lab introduces a new analyzer or assay, EP Evaluator 12 is used to verify that the manufacturer's claims hold true in the local environment, such as for lipoprotein(a) immunoassay verification.
: Enhanced connectivity with Data Innovations' Instrument Manager via ODBC, allowing labs to pull data directly into evaluation experiments. Managing Projects and Reports EP Evaluator Overview | Data Innovations It can also import reagent, control, and calibrator
: Validating a new diagnostic assay against a predicate or reference method (e.g., comparing SARS-CoV-2 quantitative assays). Instrument Validation
EP Evaluator 12 is a specialized laboratory software suite designed to automate clinical method validation and performance verification. It is widely used to ensure laboratory results meet regulatory standards such as CLIA, CAP, and The Joint Commission Data Innovations Key Capabilities and Features Regulatory Compliance