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8 - Putting TEa into Quality

Overview

Purpose

To control quality, one must first determine what quality is needed for a test.  In this activity, participants will explore what information the fourth key number must provide to define the quality required.  Additionally, participants will use a laboratory scenario to assess if the method remains acceptable for the intended clinical use of the test result.

Key Message

  • TEA defines the quality specifications specific to the analyte being tested to make the analytical result clinically meaningful.
  • QC statistics can effectively reflect method performance if acceptable performance limits are defined and applied.
  • For clinically meaningful results, the TE should be less than the TEA for that analyte.

Self Assessment

Can you: 

  • Identify the four key numbers needed for quality?
  • Calculate error limits if given the Target Value and TEA?
  • Compare TE to TEA to determine if the method still performs within acceptable limits?


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