Key result
ALFIS point-of-care cTnI assay correlates with the Atellica IM TnIH assay at ~0.85.
Why the study?
The authors sought to evaluate the analytical performance of ALFIS, a recently developed point-of-care chemiluminescence immunoassay for detecting cardiac troponin I.
The ALFIS point-of-care cardiac troponin I assay demonstrates acceptable imprecision but requires further optimization in analytical sensitivity, calibration, and EDTA interference management for clinical acute myocardial injury diagnosis.
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Cautions on EDTA interference with ALFIS cTnI assay; leaves open clinical reliability pending outcome validation.
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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Kang et al. (2023) studied Myocardial injury (cardiac troponin I detection) (n=41). ALFIS cardiac troponin I assay vs. Atellica IM TnIH assay was evaluated on Method comparison (Pearson correlation coefficient) (Pearson correlation coefficient 0.8478, p=<0.0001). The ALFIS cardiac troponin I assay demonstrated a Pearson correlation coefficient of 0.8478 compared to the Atellica IM TnIH assay, with coefficients of variation consistently below 10%.
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