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Elecsys Neuron-Specific Enolase의 수행능 평가

Performance Evaluation of the Elecsys Neuron-Specific Enolase Assay

민원기|정태동|이우창|전사일|김수경
대한진단검사의학회 (Korean Society For Laboratory Medicine)|2015.04|Laboratory Medicine Online|제5권 제2호|pp. 63-68

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키워드

Analytical performanceNeuron-specific enolaseElecsys NSE

초록

배경: 신경원특이에놀라제(neuron specific enolase, NSE)는 신경세포와 말초 신경내분비세포에 존재하며, 특히 소세포폐암의 표지자 및 뇌손상의 예측인자로 유용한 것으로 알려져 있다. Elecsys NSE (Roche Diagnostics, Switzerland)는 NSE를 전기화학적발광면역법으로 측정하는 검사법으로, 본 연구는 이의 수행능을 평가하고자 하였다. 방법: CLSI 지침에 따라 Elecsys NSE 검사법의 정밀도, 직선성, 검출한계, 참고구간, 기존 장비와의 상관성을 평가하였다. 정밀도 평가를 위해 Elecsys NSE의 전용 대조물질인 PreciControl Tumor Marker 1과 2 (Roche Diagnostics)를 사용하였고, 직선성 평가를 위해 고농도 환자 검체와 PreciControl Tumor Marker 1을 사용하였다. 검출한계는 완충액 및 희석한 환자검체를 사용하였다. 참고 구간검증은 정상인 검체를 사용하였다. 기존장비와의 상관성평가는 환자 검체를 사용하여 RIA 방법인 ELSA-NSE (Cis-Bio International, France)와 비교하였다. 결과: NSE의 총 정밀도는 저농도와 고농도에서 모두 3% 이내였고, 0.20-234.5 ng/mL 범위에서 직선성을 나타내었다. 검출한계는 0.032 ng/mL였다. 참고구간은 0.05-16.3 ng/mL로 제조사가 제시한 구간을 만족하였다. RIA와의 상관성 평가에서 상관계수는 0.9128이었다. 결론: Elecsys NSE는 NSE 측정에 있어 정밀도, 직선성이 우수하였고, 제조사의 검출한계와 참고구간을 만족하였다. 다만, 기존 RIA 장비와의 상관성이 낮았는데, 이는 검사키트마다 서로 다른 단일클론항체를 사용한 것이 원인일 수 있다. Elecsys NSE는 방사성동위원소로 인한 위험이 없으며, 민감도가 높아 일선 검사실에서의 NSE 분석장비로써 적합할 것으로 판단되었다.

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.

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