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IVD ASSAY and Limit of detection

When developing an assay, whether it is for basic research or for use in diagnostics, you will often be asked about your assay’s sensitivity. This is perhaps one of the most important performance characteristics you can determine for an assay, and in regulated work, such as in vitro diagnostic (IVD) development and clinical diagnostics, it is mandatory to do so.

• Limit of blank (LoB), limit of decision, limit of detection (LoD) and limit of quantitation (LoQ) and are concepts and terms used to describe the lowest concentration of a measurand that can be reliably measured by a particular measurement procedure . • The literature in this area has previously been and is unfortunately still confusing regarding concepts, nomenclature and methods.


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