Quality specifications for the extra-analytical phase of laboratory testing: Reference intervals and decision limits

Area of Science:

• Clinical Laboratory Science
• Medical Diagnostics

Background:

• Reference intervals and decision limits are essential components of clinical laboratory reports.
• Their correct utilization is key to verifying post-analytical quality in laboratory testing.

Purpose of the Study:

• To identify critical indicators for evaluating the appropriate use of reference intervals and decision limits.
• To highlight the importance of gender- and age-specific reference intervals in clinical diagnostics.

Main Methods:

• Evaluation of four key indicators for post-analytical quality assessment.
• Analysis of the necessity for gender-related reference intervals for common serum measurands.
• Assessment of the requirement for age-related reference intervals, with a focus on pediatric populations.

Main Results:

• The study identifies four critical indicators for assessing the use of reference intervals and decision limits.
• Emphasis is placed on the need for gender-specific intervals for numerous serum measurands.
• The necessity of pediatric-specific reference intervals for a wide range of common serum measurands is underscored, while specific intervals for the elderly are not recommended.

Conclusions:

• The appropriate use of reference intervals and decision limits is vital for post-analytical quality.
• Implementing gender- and age-related reference intervals, especially for pediatric patients, is critical.
• Failure to provide appropriate reference intervals poses significant risks to patient safety and diagnostic accuracy.