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KMID : 0985420230450040173
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Laboratory Medicine and Quality Assurance
2023 Volume.45 No. 4 p.173 ~ p.179
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Analytical Performance Evaluation of the ALFIS Cardiac Troponin I Assay
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Kang Hyun-Hye
Park Hye-Sun
Choi Ae-Ran
Lee Hye-Young
Ha Yong-Hwang
Oh Eun-Jee
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Abstract
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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.
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KEYWORD
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Troponin I, Luminescent measurements, Analytical performance, Evaluation, EDTA
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