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Allowable total error (ATE) defines acceptable assay limits for laboratory analytes. This review examines various ATE resources and differentiates ATE from observed total analytical error (TAE).

Keywords:
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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.