Biological variation database: structure and criteria used for generation and update

Area of Science:

• Laboratory Medicine
• Clinical Chemistry
• Biostatistics

Background:

• Biological variation (BV) data is crucial for laboratory medicine applications.
• Key uses include analytical quality specifications, reference change values, and assessing reference value utility.
• Reliable BV data underpins accurate diagnostic and monitoring processes.

Purpose of the Study:

• To comprehensively document the methodology for evaluating the reliability of biological variation data.
• To provide a transparent and detailed account of data compilation and assessment processes.
• To establish a standardized approach for assessing the quality of published BV data.

Main Methods:

• Initiated in 1997, a comprehensive database of biological variation components was created.
• Data was integrated from relevant publications, with a scoring system to assess robustness.
• The database is updated biennially and made available online, including derived analytical quality specifications.

Main Results:

• A detailed methodology for evaluating the reliability of compiled biological variation data is presented.
• The approach systematically assesses the quality and robustness of published BV data.
• Analytical quality specifications for imprecision, bias, and total allowable error are derived and tabulated.

Conclusions:

• The documented methodology ensures the reliability of biological variation data used in laboratory medicine.
• This detailed approach enhances the utility of BV data for quality specifications and reference value generation.
• Standardizing the evaluation of BV data improves consistency and comparability across studies.