Development of nation-wide reference intervals using an indirect method and harmonized assays.

Area of Science:

• Clinical Laboratory Science
• Biostatistics
• Medical Diagnostics

Background:

• Traditional reference interval (RI) determination relies on direct sampling or biochemical screening.
• Indirect calculation methods using patient data are gaining prominence, endorsed by the IFCC.
• Accurate RIs are crucial for interpreting laboratory test results.

Purpose of the Study:

• To establish a comprehensive dataset of age and gender-specific reference intervals (RIs) using an indirect calculation method.
• To leverage big data for more robust and inclusive RI determination.
• To facilitate accurate interpretation of laboratory tests across all age groups.

Main Methods:

• Utilized a large database of 72 million patient test results from Laboratory Corporation of America.
• Employed a modified indirect calculation method (Hoffmann) for RI determination.
• Ensured representation of diverse US populations across various age demographics (neonatal to geriatric).

Main Results:

• Generated reference intervals for 266 analytes across approximately 2,700 age categories.
• The dataset represents a nationwide, unbiased sample regarding age, gender, race, and geography.
• This large-scale indirect calculation provides statistically powerful results.

Conclusions:

• This work represents the largest collection of indirectly calculated RIs to date.
• The derived RIs are robust and suitable for clinical chemistry, endocrinology, coagulation, and hematology.
• This method enhances the determination of pediatric and geriatric RIs, overcoming limitations of traditional approaches.