: Release 12.1 introduces enhanced licensing and deeper connectivity with Instrument Manager , allowing for smoother data imports and a more unified user experience.
is a professional laboratory software suite used primarily for clinical chemistry quality assurance, method evaluation, and regulatory compliance (such as CLIA and CAP requirements).
In clinical diagnostics, accuracy and precision are non-negotiable. Laboratories must rigorously validate and verify their testing methods to meet strict regulatory standards like —a complex, data-intensive process traditionally prone to manual errors. EP Evaluator 12 directly addresses these challenges by automating these critical workflows.
Once you provide more details (field of use, intended audience, purpose of the paper), I can draft a structured paper including:
In Release 12.1 and later, users can acquire data directly from Instrument Manager without manual data entry or complex DSN setups. Key Modules and Capabilities
EP Evaluator 12 is comprehensive software designed specifically for clinical laboratory scientists to analyze data generated during method validation, method comparison, and quality control studies. It helps laboratories comply with regulatory standards such as CLIA, CAP, and ISO 15189 by providing a structured, automated approach to calculating performance metrics. Key functionalities include:
| 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 |
Features include passing-bablok regression, Deming regression, and Bland-Altman plots to evaluate bias.
EP Evaluator 12 streamlines this process by offering automated, robust statistical analysis, making it the industry benchmark for laboratory data verification. Key Features and Enhancements in EP Evaluator 12
Determining the effective refractory period (ERP) of the atria, AV node, or ventricle is fundamental to EP studies. EP Evaluator 12 provides a dedicated refractory period module. Users can mark S1-S2 coupling intervals and automatically visualize where S2 fails to capture. The software calculates ERP, functional refractory period (FRP), and Wenckebach cycles.
: In Instrument Manager, create a security group (e.g., "OBC") and grant it "all" access to ODBC functionality. Create an EP Evaluator User
EP Evaluator 12 is used across various specialties, including chemistry, immunology, and molecular diagnostics. Method Comparison Studies