Method evaluation in the clinical laboratory.

Area of Science:

• Clinical Chemistry
• Laboratory Medicine
• Quality Assurance

Background:

• Method evaluation is crucial for maintaining clinical laboratory quality.
• The journal Clinical Chemistry and Laboratory Medicine (CCLM) has a history of publishing relevant methods.
• Authors frequently encounter challenges with method evaluation and validation requirements.

Purpose of the Study:

• To provide an overview of the status, challenges, and needs in clinical laboratory method evaluation.
• To identify key aspects contributing to inconsistency in method evaluation practices.
• To propose areas for improvement in method evaluation procedures.

Main Methods:

• Literature review and analysis of editor/reviewer experiences with method evaluation submissions.
• Discussion of six critical high-level aspects of clinical laboratory method evaluation.
• Identification of areas requiring harmonization and further empirical study.

Main Results:

• Six key aspects of method evaluation lead to inconsistency: terminology standardization, selection of analytical performance specifications, experimental design, sample requirements, statistical assessment, and data reporting.
• Significant work is needed to harmonize practices in these areas.
• Current guidance documents may not be sufficiently relevant or accessible to clinical laboratories.

Conclusions:

• Harmonizing method evaluation practices is essential for consistent quality in laboratory medicine.
• Development of improved, accessible guidance documents based on empirical studies is necessary.
• Educational activities and professional collaboration are vital for advancing method evaluation procedures.