Verification of reference intervals for routine biochemical tests using the reflimR in Turkish adults

Area of Science:

• Clinical Biochemistry
• Laboratory Medicine
• Population Health

Background:

• Establishing accurate reference intervals (RIs) is crucial for interpreting clinical laboratory test results.
• Manufacturer-provided RIs may not accurately reflect diverse populations, necessitating local verification.
• The reflimR method presents a novel approach for indirect RI estimation and verification.

Purpose of the Study:

• To verify reference intervals (RIs) for 19 routine biochemistry tests in the adult Turkish population.
• To compare RIs derived using the reflimR method with manufacturer-provided RIs.
• To assess the performance of the reflimR algorithm against other indirect RI estimation methods.

Main Methods:

• Utilized the reflimR algorithm to evaluate RIs for 19 biochemical parameters analyzed on Beckman Coulter analyzers.
• Employed five indirect approaches (reflimR, refineR, KOSMIC, Hoffmann, Bhattacharya) for RI estimation in males and females.
• Applied a traffic light algorithm based on permissible uncertainty for RI limit verification.

Main Results:

• 40 of 76 RI limits calculated by reflimR were accepted, 21 required checking, and 15 were rejected against manufacturer values.
• The reflimR method showed generally concordant results with other indirect methods, except for ALT, GGT, and total bilirubin.
• Verification failures highlight potential ethnic, sex, age, and geographic variations between populations.

Conclusions:

• The reflimR algorithm provides a rapid and accessible tool for calculating and verifying RIs.
• Discrepancies in RIs underscore the importance of population-specific verification.
• Factors like ethnicity and demographics significantly influence RI establishment.