Outcome-based analytical performance specifications: current status and future challenges.

Area of Science:

• * Clinical Chemistry
• * Laboratory Medicine
• * Medical Diagnostics

Background:

• * Analytical performance specifications (APS) are crucial for ensuring laboratory tests benefit patients by exceeding potential harm.
• * Defining analytical performance is challenging without first establishing clinical performance requirements linked to patient management.
• * The link between laboratory testing, clinical decisions, and patient health outcomes necessitates outcome-based APS.

Purpose of the Study:

• * To discuss key definitions, concepts, and considerations for deriving outcome-based Analytical Performance Specifications (APS), specifically Model 1b.
• * To review existing methods for deriving Model 1b APS, evaluating their advantages, limitations, and transferability.
• * To provide guidance on systematically defining clinical performance requirements and addressing future challenges in outcome-based APS.

Main Methods:

• * Review of published methods for deriving Model 1b APS based on clinical outcomes.
• * Discussion of simulation-based studies used to assess the impact of analytical performance on clinical outcomes.
• * Analysis of criteria for the transferability of Model 1b APS across different settings.

Main Results:

• * The definition of a clinically acceptable misclassification rate is central to deriving Model 1b APS.
• * Simulation studies are frequently employed to link analytical performance to clinical outcome probabilities.
• * Transferability of Model 1b APS depends on specific criteria and setting considerations.

Conclusions:

• * Establishing clinical performance requirements is a prerequisite for defining appropriate outcome-based APS.
• * A systematic approach is needed to define clinical performance requirements for laboratory tests.
• * Further research is required to address challenges in providing outcome-based APS for laboratory testing.