Analytical Performance Evaluation of the ALFIS Cardiac Troponin I Assay

Hyunhye Kang; Hye-Sun Park; Ae-Ran Choi; Hyeyoung Lee; Yonghwang Ha; Eun-Jee Oh

doi:10.15263/jlmqa.2023.45.4.173

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Original Article

Lab Med Qual Assur 2023; 45(4): 173-179

Published online December 31, 2023

https://doi.org/10.15263/jlmqa.2023.45.4.173

Analytical Performance Evaluation of the ALFIS Cardiac Troponin I Assay

Hyunhye Kang^1,2 , Hye-Sun Park¹ , Ae-Ran Choi¹ , Hyeyoung Lee³ , Yonghwang Ha⁴ , and Eun-Jee Oh^1,2

¹Department of Laboratory Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea; ²Research and Development Institute for In Vitro Diagnostic Medical Devices of Catholic University of Korea, Seoul; ³Department of Laboratory Medicine, Catholic Kwandong University International St. Mary’s Hospital, Incheon; ⁴Research and Development Center, Boditech Med Inc., Chuncheon, Korea

Correspondence to:Eun-Jee Oh
Department of Laboratory Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, 222 Banpo-daero, Seocho-gu, Seoul 06591, Korea
Tel +82-2-2258-1641
E-mail ejoh@catholic.ac.kr

Received: November 13, 2023; Revised: November 25, 2023; Accepted: November 27, 2023

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

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Abstract

Background: We evaluated the analytical performance of ALFIS (Boditech Med Inc., Korea), a recently developed point-of-care (POC) chemiluminescence immunoassay for the detection of cardiac troponin I (cTnI).
Methods: Following the Clinical and Laboratory Standards Institute guidelines, we evaluated the imprecision, analytical sensitivity, method comparison, cross-reactivity, and interference of the assay kit.
Results: The imprecision analysis yielded coefficients of variation (CVs) consistently below 10%. The assay’s limit of blank and limit of detection values were 4 ng/L and 10 ng/L, respectively. The 10% CV was at 30 ng/L. The cTnI results between Atellica IM TnIH and ALFIS showed a Pearson correlation coefficient of 0.8478. The other cardiac biomarkers were not significantly cross-reactive, except for NT-proBNP mixed with low levels of cTnI. In the interference study, negative interference (>20% recovery) was evident with ethylenediaminetetraacetic acid at all tested concentrations of quality material.
Conclusions: The ALFIS cTnI can be used as a POC diagnostic device for acute myocardial injury diagnosis, made possible by enhancing analytical performance parameters.

Keywords: Troponin I, Luminescent measurements, Analytical performance, Evaluation, EDTA