What Validation Studies Should Be Performed in a Medical Laboratory? | Complete List & Guidelines
Published 30 Jul 2026
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.
🌐 www.qualityveda.co
📞 +91 8882509194
