What is the challenge associated with establishing the Limit of Blank (LOB) or Limit of Detection (LOD)?

Establishing the Limit of Blank (LOB) or Limit of Detection (LOD) involves quantifying the level of background noise present in a measurement system, which directly impacts sensitivity. Creating validation samples that accurately measure this background noise is vital because it sets the baseline against which the actual signal (or detection of the substance of interest) is compared. If the background noise is not accurately assessed, it can lead to misinterpretation of what constitutes a true positive or negative result.

By focusing on the background noise, it allows for a clear differentiation between what is noise and what is a true signal. This is crucial, especially in fields such as cytometry, where accurate detection of low abundance markers can be critical for diagnostics and research. Consequently, a careful and methodical approach to creating these validation samples ensures the LOB and LOD are established with reliability and accuracy.