Establishing Sex-Dependent Reference Intervals for KL-6 in Danish Adults

Abstract

Krebs von den Lungen-6 (KL-6) is a promising biomarker for the diagnosis and prognosis of interstitial lung disease. However, reference intervals in Northern Europeans remain to be established using a latex-particle-enhanced turbidimetric immunoassay. The participants were Danish blood donors subjected to strict health requirements. Analyses were performed using the Nanopia KL-6 reagent on the cobas 8000 module c502. Sex-partitioned reference intervals were determined using a parametric quantile approach according to the Clinical and Laboratory Standards Institute guideline EP28-A3c. The study included 240 participants—121 females and 119 males. The common reference interval was 59.4–398.5 U/mL (95% confidence intervals (CI) for the lower and upper limits were 47.3–71.9 and 369.5–430.1, respectively). For females, the reference interval was 56.8–324.0 U/mL (95% CIs for the lower and upper limits were 36.1–77.6 and 303.3–344.7, respectively). For males, the reference interval was 51.5–448.7 U/mL (95% CIs for the lower and upper limits were 32.8–71.2 and 397.3–508.1, respectively). These results emphasize the importance of sex partitioning when evaluating KL-6 reference intervals. The reference intervals increase the clinical applicability of the KL-6 biomarker and provide a basis for future scientific studies of its utility in patient management.