[Patient data for evaluating reference values].

Area of Science:

• Clinical chemistry and laboratory medicine.
• Biostatistics and data analysis in healthcare.
• Biomarker discovery and validation.

Context:

• Establishing accurate reference intervals for clinical assays is crucial for correct diagnosis and treatment.
• Traditional methods for determining reference intervals may not always reflect the target patient population.
• Utilizing existing patient data offers a potentially more efficient and representative approach.

Purpose:

• To explore the efficacy of using patient data to evaluate reference intervals for clinical assays.
• To determine reference intervals for serum calcium (Ca) and phosphorus (P) using a selected patient population.
• To compare these derived reference intervals with institutional and manufacturer values.

Summary:

• A study analyzed data from 836 admissions, selecting 156 cases based on specific criteria (urea, creatinine, albumin levels) to ensure data quality.
• Serum Ca and P were assayed with adequate precision. The selected population showed significantly reduced variability in Ca and P levels compared to the total population.
• Reference intervals derived from the selected population were compared to institutional and manufacturer values, falling intermediately and leading to a reduction in abnormal test results.

Impact:

• The study demonstrates that using data from a selected patient population is a reliable method for evaluating reference intervals.
• The derived reference intervals for Ca and P were comparable to, and in some cases improved upon, existing values.
• This data-driven strategy offers a practical and potentially more accurate alternative to conventional methods for establishing clinical assay reference values.