Reference intervals for Sysmex XN hematological parameters as assessed in the Dutch Lifelines cohort

Area of Science:

• Clinical laboratory science
• Hematology
• Biomedical engineering

Background:

• Lack of established reference intervals for Sysmex XN analyzer cell population data (CPD) and functional parameters hinders accurate clinical interpretation.
• Automated hematology analyzers are crucial for routine diagnostics, necessitating validated reference ranges.

Purpose of the Study:

• To derive and report comprehensive reference intervals for all Sysmex XN hematology analyzer parameters.
• To address the gap in reference intervals for CPD and functional parameters on the Sysmex XN platform.

Main Methods:

• Analysis of blood samples from 18,484 participants in the Dutch Lifelines study using two automated Sysmex XN analyzers.
• Application of the Latent Abnormal Values Exclusion (LAVE) approach to a subgroup of 15,803 healthy individuals to refine reference intervals.
• Use of analysis of variance to determine the necessity of partitioning reference intervals by sex or age.

Main Results:

• Reference intervals were established for 105 Sysmex XN hematological parameters, with and without LAVE.
• Sex-specific partitioning was necessary for several red blood cell and hemoglobin parameters (e.g., RBC, HGB, HCT).
• Age-based partitioning was not required; BMI and smoking showed moderate influence on a subset of parameters.

Conclusions:

• This study provides essential reference intervals for all routine, CPD, and functional parameters of the Sysmex XN analyzer.
• The findings, derived from a large Dutch cohort, offer a direct and validated approach for clinical laboratories.
• These reference intervals will improve the accuracy and reliability of hematological diagnostics using Sysmex XN systems.