Performance Evaluation of the Elecsys Neuron-Specific Enolase Assay

Abstract

This article is available from http://www.labmedonline.org 2015, Laboratory Medicine Online This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. Background: Neuron-specific enolase (NSE) is an enzyme specifically found in neurons and neuroendocrine tissue. It is a common marker for small cell lung cancer diagnosis and is also useful as a predictor of brain damage. This study evaluates the performance of Elecsys NSE (Roche Diagnostics, Switzerland), an electrochemiluminescent immunoassay. Methods: The precision, linearity, limit of detection, and reference interval of the Elecsys NSE, as well as the correlation between Elecsys NSE and ELSA-NSE (Cis-Bio International, France) were evaluated in accordance with the Clinical Laboratory Standards Institute (CLSI) guidelines. PreciControl Tumor Marker (Roche Diagnostics), patient sera, and sera from healthy individuals were used for the analysis. Results: The measured coefficient of variation for the assay was below 3%, and it demonstrated linearity from 0.20 to 234.5 ng/mL. The detection limit was 0.032 ng/mL and the reference interval ranged from 0.05 to 16.3 ng/mL. Compared with the ELSA-NSE assay, the correlation coefficient was 0.9128. Conclusions: The Elecsys assay showed suitable precision, linearity, limit of detection and reference range for clinical laboratory use; however, the correlation coefficient of Elecsys NSE as compared to ELSA-NSE was below 0.975. This result may be associated with the use of different monoclonal antibodies in the two different NSE assays. Elecsys NSE demonstrated a high sensitivity without the use of radioactive reagents; therefore, Elecsys NSE will be quite useful for NSE analysis in the clinical laboratory setting.