Defining allowable total error limits in the clinical laboratory

Area of Science:

• Clinical Chemistry and Laboratory Medicine
• Analytical Toxicology
• Diagnostic Assay Development

Background:

• Allowable total error (ATE) represents crucial performance specification limits for laboratory analytes.
• ATE is essential for assay validation, patient/instrument data evaluation, and quality control strategy design.

Purpose of the Study:

• To review and compare diverse resources for selecting allowable total error (ATE).
• To discuss the distinction between allowable total error (ATE) and observed total analytical error (TAE).

Main Methods:

• Review of existing literature and guidelines for ATE determination.
• Comparative analysis of different ATE resources, including legal requirements, proficiency testing, expert groups, and biological variation.
• Conceptual differentiation between ATE and observed total analytical error (TAE).

Main Results:

• Multiple resources exist for selecting ATE, including legal standards, proficiency testing (PT) and external quality assessment schemes (EQAS), expert consensus, and biological variation.
• There is ongoing discussion regarding the preferred source for ATE selection.
• The abstract highlights the importance of distinguishing between predefined ATE limits and the actual observed total analytical error (TAE) of an assay.

Conclusions:

• Understanding and selecting appropriate ATE is critical for reliable laboratory testing.
• The choice of ATE resource can impact assay acceptance and quality control.
• Clarifying the difference between ATE and TAE is vital for accurate interpretation of assay performance.