STEP 421: Lot-to-lot Variation: How to Detect it, Measure it and Evaluate it (CE: 0.5)


Shifts in patient results due to reagent lot changes (lot-to-lot variation, L2L) are a major issue for laboratories, and their investigation is both time-consuming and expensive. The effect that reagent lot-to-lot changes can have on patient results and how these shifts, if large enough, could lead to misdiagnosis and inappropriate treatment. This article discusses a way to detect those analytes that in the past, have been seen to vary from lot to lot and proposes a way to measure changes due to L2L variation.


Learning Objectives:

  • Discuss how to measure changes due to L2L variations
  • Describe how to detect analytes
  • Reflect on the use of validating a new lot



David Plaut

Nathlie Page


Launched: 2015