CLSI SCQ02

These documents can assist the clinical laboratory in meeting regulatory requirements. Verify that test performance complies with laboratory practice requirements:

• Evaluation of Qualitative Tests
• Linearity
• Interference
• Precision and Trueness
• Trueness (bias)
• Limit of Detection
• Total Error
• Quality Control

It includes the following documents:

• C24-Ed4 | Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions, 4rd Edition
• EP28-A3C | Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory, 3rd Edition
• EP31-A-IR | Verification of Comparability of Patient Results Within One Health Care System, 1st Edition, Interim Revision
• EP06-A | Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach, 1st Edition
• EP07-A2 | Interference Testing in Clinical Chemistry, 2nd Edition
• EP09-A3 | Method Comparison and Bias Estimation Using Patient Samples, 3rd Edition
• EP15-A3 | User Verification of Performance for Precision and Trueness, 3rd Edition
• EP17-A2 | Protocols for Determination of Limits of Detection and Limits of Quantitation, 2nd Edition
• EP21-Ed2 | Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures, 2nd Edition

This package is available in electronic format only.