Performance Evaluation of the Elecsys Neuron-Specific Enolase Assay

Soo-Kyung Kim; Tae-Dong Jeong; Woochang Lee; Sail Chun; Won-Ki Min

doi:10.3343/lmo.2015.5.2.63

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Kim, Jeong, Lee, Chun, and Min: Performance Evaluation of the Elecsys Neuron-Specific Enolase Assay

Original Article

Clinical Chemistry

Laboratory Medicine Online 2015; 5(2): 63-68.

Published online: 1 April 2015

DOI: https://doi.org/10.3343/lmo.2015.5.2.63

Performance Evaluation of the Elecsys Neuron-Specific Enolase Assay

Soo-Kyung Kim, M.D., Tae-Dong Jeong, M.D., Woochang Lee, M.D., Sail Chun, M.D., Won-Ki Min, M.D.

Department of Laboratory Medicine, University of Ulsan College of Medicine and Asan Medical Center, Seoul, Korea.

Corresponding author: Woochang Lee. Department of Laboratory Medicine, University of Ulsan College of Medicine and Asan Medical Center, 88 Olympic-ro 43-gil, Songpa-gu, Seoul 138-736, Korea. Tel: +82-2-3010-4506, Fax: +82-2-478-0884, wlee1@amc.seoul.kr

Received 18 July 2014 Revised 29 September 2014 Accepted 10 October 2014

(open-access):

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.

Abstract

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.

Keywords: Analytical performance, Elecsys NSE, Neuron-specific enolase

Figures and Tables

Fig. 1

Linear regression and residual plots of Elecsys NSE. The blue line represents the linear regression and the gray line depicts a theoretical line with a slope of 1.0 and a y-intercept of 0.

Fig. 2

Method comparison between Elecsys NSE and ELSA-NSE.

Table 1

Precision profile of Elecsys NSE

Analyte	Level	Mean (ng/mL)	SD (ng/mL)	CV (%)
Analyte	Level	Mean (ng/mL)	SD (ng/mL)	Within-run	Between-run	Between-day	Total
NSE	1	11.13	0.30	0.8	1.2	2.3	2.7
	2	90.65	1.54	0.8	1.0	1.1	1.7

Abbreviations: CV, coefficient of variation; NSE, neuron-specific enolase; SD, standard deviation.

Notes

This article is available from http://www.labmedonline.org

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