Clinical chemistry reference intervals in clinically validated healthy individuals: A large single-center study

Area of Science:

• Clinical Biochemistry
• Laboratory Medicine
• Reference Interval Determination

Background:

• Accurate laboratory test reference intervals (RIs) are crucial for effective clinical practice.
• There is a need for refined RIs to enhance clinical decision-making.
• A study was conducted using extensively evaluated healthy participants to measure biochemical markers.

Purpose of the Study:

• To establish age- and sex-specific reference intervals for 36 biochemical assays.
• To provide refined RIs for improved clinical interpretation of laboratory results.

Main Methods:

• A single-center study involving descriptive, quantitative, a priori direct sampling.
• Data collected from 8380 healthy adults aged 18 years and older.
• 18,701 determinations were analyzed to establish age- and sex-specific RIs for 36 biochemical assays.

Main Results:

• Serum concentrations of some biochemical assays (e.g., total calcium, chloride, sodium) were constant across adult age ranges and similar between sexes.
• Other assays (e.g., alanine-amino transferase, triglycerides) showed age- and sex-dependent variations.
• These findings highlight the influence of age and sex on biochemical assay results.

Conclusions:

• Age- and sex-specific reference intervals for 36 biochemical assays were established for the first time in Europe.
• The RIs were derived from data of extensively clinically validated healthy participants.
• These findings contribute to more accurate interpretation of laboratory test results in clinical settings.