An Overview of Allowable Total Error in the Clinical Laboratory.

Area of Science:

• Clinical Laboratory Science
• Analytical Chemistry
• Quality Management in Healthcare

Background:

• Allowable total error (ATE) is a critical quality metric for clinical laboratory assays, ensuring acceptable analytical performance.
• ATE limits vary based on the specific assay, testing context, and clinical application.
• ATE is routinely used in clinical laboratories for method evaluation, quality control troubleshooting, and instrument comparison.

Purpose of the Study:

• To review and describe various resources for defining allowable total error (ATE) limits in clinical laboratory assays.
• To discuss the strengths and weaknesses associated with different approaches to setting ATE.
• To inform users about the variability in ATE magnitude resulting from different definition methods.

Main Methods:

• Literature review of resources for setting allowable total error (ATE).
• Analysis of approaches including clinical outcomes, biological variation, state-of-the-art, professional guidelines, and regulatory requirements.
• Discussion of the strengths and limitations of each resource.

Main Results:

• No universal standards exist for defining maximum allowable error.
• Multiple resources (clinical outcomes, biological variation, state-of-the-art, professional organizations, regulatory bodies) can be used to set ATE.
• Each resource yields different ATE magnitudes for the same assay.

Conclusions:

• Users must be aware of the diverse resources available for setting ATE.
• Understanding the limitations of each resource is essential before establishing acceptance criteria for laboratory assays.
• Informed selection of ATE resources ensures appropriate analytical performance standards.