INTRODUCTION 

There is much discussion within the market of biosensors and IVDs on how low a concentration of analyte a sensor or IVD can measure. There is often an issue or concern due to a confusion in terms and phrases used to discuss these detection limits. 

On this page we are discussing detection limits or detection capability and specifically in the context of sensors and IVDs. There are at least three terms to define when thinking about detection capability these are:

• Limit of blank (LoB) - This is the upper end of the range of signals expected when measuring blank samples.
• Limit of detection (LoD) - This is the concentration of an analyte that can be detected with a yes/no manner, i.e. is it present or not.
• Limit of quantification (LoQ) - This is the minimal detectable concentration of analyte versus a pre-established accuracy goal.