Table 3. CLSI guidelines for validation performance characteristic.

Source of guidelines: https://clsi.org/

validation performance characteristic	CLSI guideline
Accuracy	EP09c: Measurement Procedure Comparison and Bias Estimation Using Patient Samples EP15-A3: User Verification of Precision and Estimation of Bias
Precision	EP05-A3: Evaluation of Precision of Quantitative Measurement Procedures EP15-A3: User Verification of Precision and Estimation of Bias
Detection capability	EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures
Analytical specificity	EP7-A3: Interference Testing in Clinical Chemistry
Reportable range	EP6-A: Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach
Reference intervals	EP28-A3C: Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory
Diagnostic accuracy	EP24-A2: Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves, 2nd Edition