Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Definitions
5 Stages of Evaluation
6 Determination of Instrument Options
7 Timescale
8 Preliminary Evaluation
9 Preacquisition Assessment by the End User
9.1 Instrument Specifications
9.2 Specifications of the Device That are Provided by
the Manufacturer to the Laboratory
9.3 Assessment of the Laboratory Characteristics and
Environment by the Manufacturer
9.4 Assessment of Operational Requirements of the Device
by the Laboratory
9.5 Selection of Assays for Preacquisition Assessment
9.6 Selection of Reagents for Preacquisition Assessment
10 Performance Validation by the End User
10.1 Selection of Specimens for Validation
10.2 Selection of Assays for Validation
10.3 Selection of Reagents for Validation
10.4 Precision Testing
10.5 Accuracy
10.6 Reference Intervals
10.7 Comparability
10.8 Carryover
10.9 Statistical Analysis
10.10 Quality Control Ranges and Stability of Calibration
Curve
10.11 On-Instrument Reagent Stability
10.12 Efficiency Assessment
10.13 Site's Operational Throughput
10.14 Reliability
11 Implementation (Procedure Manuals, Training, Education,
LIS Interface)
11.1 Method Validation of All Tests
11.2 Calculation of Reference Intervals and Therapeutic
Ranges
11.3 Dissemination of New Ranges
11.4 Procedure Manual
11.5 Instrument Operator Training
11.6 LIS Testing
References
Additional References
Appendix A. Carryover Procedure
Appendix B. Statistical Analysis for Comparability
The Quality Management System Approach
Related CLSI/NCCLS Publications