Validation Study References | CLSI, ISO 15189 & NABL Guidelines

Primary References

Clinical and Laboratory Standards Institute (CLSI)
CLSI EP19 – Framework for Using CLSI Documents to Evaluate Medical Laboratory Test Methods.
EP10-A3 – Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures.
EP05-A3 – Evaluation of Precision of Quantitative Measurement Procedures.
EP06-ED2 – Evaluation of Linearity of Quantitative Measurement Procedures.
EP15-A3 – User Verification of Precision and Estimation of Bias.
EP17-A2 – Evaluation of Detection Capability.
EP09-A3 – Measurement Procedure Comparison and Bias Estimation.
Fundamental guidance for validation and verification studies.

International Organization for Standardization (ISO)
ISO 15189:2022 – Medical laboratories — Requirements for quality and competence
Clause 7.3 (Examination Processes)
Clause 7.3.2 (Validation and Verification of Examination Procedures)

National Accreditation Board for Testing and Calibration Laboratories (NABL)
NABL 112 – Specific Criteria for Medical Laboratories
NABL 131 – Specific Guidelines for Medical Laboratories
Based on ISO 15189 requirements.

International Federation of Clinical Chemistry and Laboratory Medicine (IFCC)

IFCC recommendations on method validation, measurement uncertainty, and analytical quality.

College of American Pathologists (CAP)
CAP Accreditation Checklists for analytical method validation and verification.

References Specific to Carryover Study

CLSI EP10-A3 – Preliminary Evaluation of Quantitative Measurement Procedures.
ISO 15189:2022 – Requirements for validating examination procedures.
Manufacturer's instrument and reagent package inserts (carryover evaluation protocol and acceptance criteria).
Laboratory SOPs and validation protocols approved under the laboratory Quality Management System.

CLSI Guidelines by Validation Parameter

Validation Study	CLSI Reference
Precision	CLSI EP05 – Evaluation of Precision Performance of Quantitative Measurement Procedures
Accuracy / Bias / Method Comparison	CLSI EP09 – Measurement Procedure Comparison and Bias Estimation Using Patient Samples
Linearity	CLSI EP06 – Evaluation of Linearity of Quantitative Measurement Procedures
Detection Limit (LoB, LoD, LoQ)	CLSI EP17 – Evaluation of Detection Capability
Reference Interval	CLSI EP28 – Defining, Establishing and Verifying Reference Intervals
Interference Study	CLSI EP07 – Interference Testing in Clinical Chemistry
Carryover	CLSI EP10 – Preliminary Evaluation of Quantitative Measurement Procedures (includes carryover assessment)
Total Analytical Error	CLSI EP21 – Evaluation of Total Analytical Error
Quality Control	CLSI EP23 – Laboratory Quality Control Based on Risk Management
Risk Management	CLSI EP18 – Risk Management Techniques to Identify and Control Laboratory Error Sources
Specimen Equivalence	CLSI EP35 – Assessment of Equivalence or Suitability of Specimen Types
Extended Measuring Range	CLSI EP34 – Establishing and Verifying an Extended Measuring Interval
Verification Framework	CLSI EP19 – Framework for Using CLSI Documents to Evaluate Medical Laboratory Test Methods

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