Parametric and non-parametric estimation of reference intervals for routine laboratory tests: an analysis of health check-up data for 260 889 young men in the South Korean military

OBJECTIVES: Determination of reference intervals (RIs) using big data faces several obstacles due to heterogeneity in analysers, period and ethnicity. The present study aimed to establish the RIs for routine common blood count (CBC) and biochemistry laboratory tests in homogeneous, healthy, male Korean soldiers in their 20s using a large health check-up data set, comparing parametric and non-parametric estimation. DESIGN: A multicentre, cross-sectional study. SETTING: Seven armed forces hospitals in South Korea. PARTICIPANTS: A total of 609 649 men underwent health examination when promoted to corporal between January 2015 and September 2021. 260 889 eligible individuals aged 20–25 were included in the analysis. MAIN OUTCOMES AND MEASURES: The RIs were established by parametric and non-parametric methods. In the parametric approach, maximum likelihood estimation was applied to measure the Box-Cox transformation parameter and the values at the 2.5th and 97.5th percentiles were recalculated. The non-parametric approach adopted the Tukey’s exclusion test and the values at the 2.5th and 97.5th percentiles were obtained. Classification by body mass index was also performed. RESULTS: The obtained RIs for haematology parameters were comparable between devices. If the values followed a Gaussian distribution, parametric and non-parametric methods were well matched for haematology and biochemical markers. When the values were right-skewed, the upper limits were higher with parametric than with non-parametric methods. Participants with obesity showed higher RIs for CBC, some liver function tests and some lipid profiles than participants without obesity. CONCLUSIONS: Using data from healthy, male Korean soldiers in their 20s, we proposed the RIs for CBC and biochemical parameters, comparing parametric and non-parametric estimation. As such approaches based on large data sets become more prevalent, further studies are needed to discriminate eligible individuals and determine RIs in an extrapolated sample.