ELISA, RT-PCR or lateral flow: how kit validation and batch-to-batch evaluation work, and how to get ready for them.
In vitro diagnostic kits have to perform the same way in every lab and in every batch. Validation is how manufacturers prove it.
A typical validation compares the kit against characterised reference panels, measuring sensitivity, specificity and reproducibility. Batch-to-batch evaluation then checks that production lots stay consistent over time.
Manufacturers can make the process faster by preparing clear instructions for use, a defined intended use and enough kits from more than one lot.
Working with an accredited laboratory gives the results the credibility that regulators, hospitals and investors look for.
