Why is it necessary to validate method performance when the manufacturer has already performed extensive studies?
It’s important to demonstrate that the method performs well under the operating conditions of your laboratory and that it provides reliable test results for your patients. There are many factors that can affect method performance, such as different lots of calibrators and reagents, changes in supplies and suppliers of instrument components, changes in manufacturing from the production of prototypes to final field instruments, effects of shipment and storage, as well as local climate control conditions, quality of water, stability of electric power, and, of course, the skills of the analysts. In US laboratories, method validation studies are actually required by the CLIA regulations.
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