[Laboratory diagnostics in medicine].

Area of Science:

• Clinical diagnostics
• Laboratory medicine
• Evidence-based medicine

Background:

• Clinical decisions increasingly rely on evidence-based medicine.
• This necessitates diagnostic methods with proven informativity and scientific validity.
• Laboratory research must align with these rigorous standards.

Purpose of the Study:

• To emphasize the scientific validity required for clinical laboratory diagnostics.
• To highlight the importance of probabilistic interpretation tools for laboratory results.
• To guide the selection and application of laboratory research based on biomarker characteristics.

Main Methods:

• Focus on the concept of indefiniteness (analytical, biological, clinical) in laboratory result interpretation.
• Utilize scientifically proven biomarker characteristics: sensitivity, specificity, and predictive value.
• Analyze the probabilistic relationship between biomarkers and clinical events, outcomes, and risks.

Main Results:

• Laboratory research inclusion in guidelines should be based on validated biomarker performance.
• Interpretation must consider analytical, biological, and clinical indefiniteness.
• Biomarker characteristics are probabilistic and quantifiable.

Conclusions:

• Clinical laboratory diagnostics must adhere to evidence-based medicine principles.
• The selection of laboratory tests should prioritize scientifically proven biomarker characteristics.
• Probabilistic interpretation of laboratory results is essential for accurate clinical decision-making.