Distribution of serum neuron-specific enolase and the establishment of a population reference interval in healthy adults.

Qian Liu,Fumeng Yang,Aiguo Xu,Wenjun Wang,Yan Li,Jilong Fan,Wei Liang,Li Yao

doi:10.1002/jcla.22863

Abstract

BackgroundNeuron‐specific enolase (NSE) is an important tumor marker in the serum of patients with lung cancer. Elevated serum NSE levels are also associated with many other diseases. However, there is no unified population reference interval for serum NSE. This study aimed to investigate the distribution of serum NSE in healthy Chinese adults aged 20‐79 years and to establish its reference interval in Chinese population.MethodsA total of 10 575 healthy subjects were in line with the requirements of this study. The concentration of serum NSE was detected by a fully automated Cobas e602 analyzer with matching reagents. The population reference interval for serum NSE was established using the unilateral 95th percentile (P 95) according to standard guidelines.ResultsThe distributions of serum NSE were not significantly different between males and females (P > 0.05) and also did not differ by age (P > 0.05). Therefore, the population reference interval for serum NSE was established as upper limit 25.4 ng/mL (90% confidence interval: 24.5‐26.2 ng/mL).ConclusionsWe established the first population reference interval for serum NSE in a large healthy Chinese adult cohort, which was higher than that recommended by Roche Diagnostics GmbH. This new reference interval is more practical and applicable in Chinese adults.

Highlights

Neuron‐specific enolase (NSE) is an important tumor marker in the serum of patients with lung cancer
This study aimed to investigate the distribution of serum NSE in healthy Chinese adults aged 20‐79 years and to establish its reference interval in Chinese population
In order to establish a more specific and reliable popu‐ lation reference interval of serum NSE for Chinese population, we measured serum NSE in a large number of healthy adult subjects aged 20‐79 years and established the population reference inter‐ val of serum NSE according to Clinical and Laboratory Standards Institute (CLSI) CA28‐A3.12

Summary

Introduction

Neuron‐specific enolase (NSE) is an important tumor marker in the serum of patients with lung cancer. There is no unified population reference interval for serum NSE. This study aimed to investigate the distribution of serum NSE in healthy Chinese adults aged 20‐79 years and to establish its reference interval in Chinese population. The population reference interval for serum NSE was established as upper limit 25.4 ng/ mL (90% confidence interval: 24.5‐26.2 ng/mL). Conclusions: We established the first population reference interval for serum NSE in a large healthy Chinese adult cohort, which was higher than that recommended by Roche Diagnostics GmbH. This new reference interval is more practical and applica‐ ble in Chinese adults

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