Course Content


13 - Introduction to Method Validation and Verification



Before a method can be placed into routine service, it must be evaluated to ensure that the measurement procedure meets defined criteria, such as sensitivity, specificity, precision, accuracy, and linearity.   In this activity, participants will perform method verification experiments and assess data to determine if the method is acceptable or not.

Key Message

  • Even though manufacturers test their methods extensively, there are many factors in an individual laboratory that can affect the actual precision and accuracy of the method.
  • Method evaluation is performed to reveal the amount of error present in the new method.
  • Once the performance of the method has been judged to be acceptable from method evaluation studies, then statistical QC procedures need to be selected that can detect medically important errors.

Self Assessment

Can you: 

  • List the steps required to introduce a new method?
  • Collect and analyze the experimental data needed to quantify the error present?
  • Judge if the method meets pre-defined quality requirements?
  • Verify a reference interval?