Bringing on a new test for the lab? Here are some items to think about!
When you are bringing on a new test for the lab, there are several considerations you must make. We will break down the verification and validation process, discussing the needs and common road blocks that labs often come across as they proceed through their reagent evaluation with the ultimate goal of adopting a new assay.
So let’s begin with the good news!
Due to overwhelming demand, the lab has been tasked with expanding its current assay menu. After much research and investigation into all available options for the requested assay, you’ve determined how you plan to approach this new project (developing a laboratory developed test, using available ASR (analyte specific reagents) or IVD reagents, modified FDA cleared assay, etc.).
You will then need to gather the your materials and determine that you have everything necessary to begin the process.
Next comes the million dollar question…Where do I begin?
Let’s start by introducing the two main processes involved in bringing on a new assay common to all assay types applicable to CLIA regulated labs and following CAP/CLSI guidelines (College of American Pathologists/Clinical Lab Standards Institute): Verification and validation.
You’ve probably heard both of these processes mentioned interchangeably by your medical director and peers, but what is the difference between them? Which one is which? Let’s start with a brief description of each process, highlighting the main goal and purpose of each one. Please note that these are based on the following CLSI definitions, not CAP guidelines.
Verification is defined in CLSI MM3-A2 Section 4.1 as “confirmation through the provision of objective evidence that specific requirements have been fulfilled (ISO 9000).
Note: Verification is the one-time process completed to determine or confirm test performance characteristics before the test system is used for patient testing.”
In other words, this is the initial process to evaluate a new assay and determine exactly how it will work in your lab. This process includes a number of performance characteristics: Analytical Sensitivity, Analytical Specificity, Reportable Range, Precision & Reproducibility, Analytical Accuracy, and Reference Interval—just to name a few. Given the large scope of these performance characteristics, this is where the lab will spend most of their time when bringing on a new test.
Validation is defined in CLSI MM3-A2 Section 4.1 as “confirmation through the provision of objective evidence that requirements for a specific intended use or application have been fulfilled (ISO 9000).
Note 1: WHO (World Health Organization) defined validation as the action (or process) of proving that a procedure, process, system, equipment, or method used works as expected and achieves the intended result (WHO-BS/95.1793).
Note 2: The components of validation are quality control, proficiency testing, validation of employee competency, instrument calibration, and correlation with clinical findings (Clinical Accuracy).”
In other words, the goal of this process is to ensure that once a new assay has been adopted, it continues to perform as expected and achieves the intended results. As summarized Note 2 above, this involves the entire scope of activities performed after a test has been adopted that maintain its ongoing performance for routine patient testing.