Validating common reference intervals in routine laboratories.

Area of Science:

• Clinical Pathology
• Laboratory Medicine
• Reference Interval Standardization

Background:

• Individual laboratories traditionally establish their own reference intervals for numerical pathology tests.
• Common reference intervals are proposed to improve consistency and reduce variability.
• However, universal adoption requires validation within local laboratory settings.

Purpose of the Study:

• To outline the critical validation steps for implementing common reference intervals in individual laboratories.
• To emphasize the importance of local validation for ensuring the appropriateness and reliability of proposed common intervals.

Main Methods:

• Assessing methodological factors through shared samples and external quality assurance schemes to evaluate biases.
• Validating local population factors using healthy subjects or data mining techniques on routine patient results.
• Considering subject selection, statistical approaches, and acceptance criteria for validation.

Main Results:

• Method biases can be assessed using established quality assurance techniques.
• Local population validation is achievable through healthy subject studies or routine data analysis.
• Successful validation demonstrates the common interval's suitability for routine laboratory use.

Conclusions:

• Common reference intervals must be validated locally to ensure their appropriateness in diverse laboratory environments.
• Local validation encompasses method and population factors, crucial for reliable clinical application.
• Only through rigorous local validation can proposed common reference intervals achieve widespread and effective adoption.