Laboratory testing demands accurate and reliable methods - this is where Method Validation and Method Verification come in. Laboratories must verify that their results are trustworthy before conducting routine testing. This blog aims to differentiate the key differences between Method Validation and Method Verification - two sets of procedures with the same goal but with distinct differences.
Let’s begin by defining what a method is:
A method is a systematic process done to collect, analyze and interpret data. The use of standardized method is crucial in a laboratory to ensure results are not only consistent but comparable both within the same laboratory and across different laboratories. Hence, this is why MVs are crucial to confirm that a method is fit for its intended purpose.
Method Validation vs Method Verification
To make the distinction between the validation and verification simple, remember that Validation answers the question: “does this method work at all?” while Verification answers: “does this method work here?”
Method Validation is a rigorous and comprehensive process that confirms an analytical method is reliable, accurate and works according to intended function. Performance characteristics are established during this process thus a wider range of samples and conditions are expected to be used.
When is Validation Done?
Full method validation is required in the following scenarios:
- Developing a new analytical method
- Transferring a method between two laboratories
- Significant Method Modifications to be adapted to a specific use
- When regulatory bodies require validation
One common laboratory scenario where Method Validation is required is for the development of Laboratory Developed Tests or LDTs. LDTs are tests designed, manufactured and used within a laboratory for their own use, often in situations where there are no commercial tests available. This makes it quite difficult to standardize. LDTs require Method Validation to ensure that the results produced by the new test are valid and can be used for clinical decision-making.
Method Verification is a more streamlined study that confirms an already established method works as intended in a new enviornment. It's basically a trial run to ensure reliable performance before conducting actual testing with real patient samples.
Verification process involves comparing the laboratory's results to those obtained using a reference or previous Method Validation. If the results are within an acceptable error range, the method is considered verified.
When is Verification Done?
Verification is carried out in the following scenarios:
- When an already validated instrument is introduced to the laboratory
- Implementing FDA-Approved Methods
The most common laboratory scenario requiring method verification is when a laboratory purchases a new analyzer with previously validated methods. Rather than conducting robust testing from scratch, the laboratory uses the manufacturer's claims as reference values to verify that the method performs as intended under the new laboratory conditions.
Which Performance Characteristics are Tested?
Method validation and verification involve several experiments to evaluate whether a method is reliable for routine use. Table I below summarizes the most common performance characteristics being measured:
Performance Characteristic | Purpose | Experiment Performed |
Accuracy | measures closeness of results to the true value | Method Comparison |
Precision | assessing the reproducibility of the results | Replication Experiment |
Analytical Specificity | assesses the method's ability to accurately detect the target analyte in the presence of other compounds | Interference Experiment |
Detection Limit | identifies the lowest concentration of the analyte that can be reliably detected | Detection Limit Experiments - Limit of Blank (LoB), Limit of Detection (LoD), Limit of Quantitation (LoQ) |
Linearity | measures the method’s ability to provide proportional results to the actual concentration | Linearity Experiment |
Table I. MV Performance Characteristics
The Value of Accreditation
Accreditation bodies establish a framework of standards which serve as the benchmark for quality in laboratory testing. The accreditation process involves submitting an application to third-party bodies who evaluates a laboratory’s quality management and competence. Although a voluntary process, accreditation signals to patients and providers that a lab is committed to the highest level of competency and quality assurance.
Accreditation, therefore, is more than meeting quality standards - it’s managing risks, reducing errors, and ensuring patient safety and diagnostic reliability.
To help you explore these organizations and find the right fit for your laboratory, Table II compiles a summary of accreditation bodies including a direct link to their website for more information:
Accreditation Body | Function | Website |
International Organization for Standardization (ISO) | Develops and publishes standards for various industries, including laboratories, providing a framework for method verification and promoting high-quality laboratory operations. | https://www.iso.org/home.html |
Commission on Office Laboratory Accreditation (COLA) | Accredits medical laboratories to ensure compliance with regulations and standards, with many laboratories voluntarily seeking COLA accreditation as a demonstration of their commitment to quality. Their regulations are set by CLIA. | https://cola.org/ |
College of American Pathologists (CAP) | Accredits medical laboratories in the United States and internationally, evaluating laboratory methods through on-site inspections, proficiency testing, and document review. | https://www.cap.org/ |
Centers for Medicare & Medicaid Services (CMS) | Regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA) program. | https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments |
Table II: Accreditation Bodies
SUMMARY
Navigating the world of Method Validation and Verification are crucial processes to ensure that a laboratory method meets quality standards for patient testing.
While these procedures may have different goals, they follow different procedures. Knowing the key differences is also critical to help your lab decide when to do validation versus when to do verification.These procedures provide confidence in the results produced by laboratories, which is essential for clinical decision-making and patient care.
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REFERENCES
Danigelis, A. (2019, October 15). Method Validation vs. Verification: Breaking Down the Difference. IDEXX Inc. https://www.idexxcurrents.com/en/latest/method-validation-vs-verification-breaking-down-the-difference/
Wong, W. W. (2009, September 8). Method validation and Verification. Retrieved from: https://www.slideshare.net/slideshow/method-validation-and-verification-pdf/257819884
Genemod. (2022, April 26). What Are the Different Types of Laboratory Accreditation?. https://genemod.net/blog/lab-accreditation