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Personalized reference intervals for biochemical, hormonal, and coagulation tests: Comparison with population-based
Musab Kazar1, Murat Aksit2, Ayfer Colak2
1Tepecik Education and Research Hospital Clinics, Medical Biochemistry Department.
Objectives:
Population-based reference intervals (popRIs) used in laboratory medicine may obscure important information related to individual biological variation. This study aims to further explore this issue by deriving personalized reference intervals (prRIs) based on biological variation estimates and comparing them with popRIs for selected clinical chemistry, hormone, and coagulation measurands.
Methods:
Forty-five healthy adults (28 females, 17 males) were sampled weekly for six weeks. Analytical variation, within-subject and between-subject components were estimated according to the EFLM Biological Variation committee recommendations. prRIs were calculated from both calculated CVI, CVP, and EFLM biological variation data. The index of individuality (II) and reference interval index (RII) were used to assess the adequacy of popRIs.
Results:
PrRIs were generally narrower than popRIs, with 94.7% of RII values <1. Coagulation tests also displayed narrower prRIs than popRIs, suggesting the potential for more individualized interpretation of serial results. High individuality (II <0.6) was demonstrated for liver enzymes (ALT, AST, LDH, GGT, ALP), albumin, creatinine, ferritin, thyroid hormones (TSH, FT4) and lipids suggesting limited applicability of popRIs. Zinc and prolactin exhibited broader prRIs in some individuals, reflecting interindividual heterogeneity, while creatine kinase showed high intraindividual variability consistent with physical activity. In contrast, iron (II > 1.4) supported the validity of population-based intervals.
Conclusions:
prRIs were generally narrower than popRIs across most measurands, particularly for analytes with high individuality. These findings suggest that prRIs may provide additional information for individualized interpretation of serial laboratory results. However, their clinical utility requires further validation in diseased populations and outcome-based studies before routine implementation.
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