What Validation Studies Should Be Performed in a Medical Laboratory? | Complete List & Guidelines

A method validation or performance verification study in a medical laboratory ensures that a test method consistently produces accurate, reliable, and clinically acceptable results before routine patient testing. As per ISO 15189:2022, CLSI guidelines, and NABL requirements, the following validation studies are commonly performed.

Validation Study	Purpose
Accuracy (Trueness)	Determines how close test results are to the true or reference value.
Precision (Repeatability & Reproducibility)	Evaluates consistency of results when the same sample is tested repeatedly.
Linearity	Verifies that test results remain proportional across the analytical measurement range.
Analytical Measurement Range (AMR) / Reportable Range	Confirms the range over which the analyzer provides accurate results without dilution.
Carryover Study	Determines whether a high-concentration sample affects the result of the next sample.
Limit of Detection (LoD)	Identifies the lowest analyte concentration that can be reliably detected.
Limit of Quantitation (LoQ)	Determines the lowest concentration that can be measured with acceptable precision and accuracy.
Reference Interval Verification	Confirms that the manufacturer's or published reference intervals are appropriate for the laboratory's patient population.
Method Comparison / Correlation Study	Compares results of a new method with an existing validated method or reference method.
Bias Estimation	Measures systematic error between the observed value and the true value.
Recovery Study	Evaluates whether the analyte can be accurately recovered after adding a known amount to a sample.
Interference Study	Assesses the effects of hemolysis, lipemia, icterus, medications, or other interfering substances.
Specificity / Analytical Specificity	Confirms that the method measures only the intended analyte without interference from similar substances.
Sensitivity (where applicable)	Evaluates the method's ability to detect low concentrations of the analyte.
Robustness / Ruggedness	Determines whether small changes in testing conditions affect results.
Stability Study	Verifies specimen and reagent stability under different storage and handling conditions.
Measurement Uncertainty (MU)	Estimates the uncertainty associated with quantitative test results, as required by ISO 15189.

Additional studies commonly performed in laboratories

Instrument Verification after installation
Calibration Verification
Reagent Lot-to-Lot Verification
Quality Control (IQC) Verification
External Quality Assessment (EQAS/PT) participation
Delta Check Validation (where applicable)

Validation requirements by department

Clinical Chemistry:
Accuracy, Precision, Linearity, AMR, Carryover, LoD/LoQ, Method Comparison, Reference Interval Verification.

Hematology:
Precision, Accuracy, Carryover, Linearity (where applicable), Method Comparison.

Immunology/ELISA:
Precision, Accuracy, Sensitivity, Specificity, Cut-off Verification.

Microbiology:
Precision (where applicable), Accuracy, Method Comparison, Sensitivity/Specificity.

Molecular Biology (PCR):
Accuracy, Precision, LoD, Analytical Specificity, Contamination/Carryover Assessment, Reproducibility.

Reference guidelines

Refer to the Qualityveda blog and the attached links for more information.

https://www.qualityveda.co/blog/validation-study-references-clsi-iso-15189-nabl-guidelines

These studies form the core of a complete validation or verification package required before introducing a new analyzer, reagent, or test method into routine laboratory practice.

Qualityveda provides end-to-end support for validation studies, documentation, compliance, and quality management.
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