Lab Med Qual Assur.  2023 Dec;45(4):173-179. 10.15263/jlmqa.2023.45.4.173.

Analytical Performance Evaluation of the ALFIS Cardiac Troponin I Assay

• Kang H
• Park HS
• Choi AR
• Lee H
• Ha Y
• Oh EJ

• KMID: 2549792
• DOI: http://doi.org/10.15263/jlmqa.2023.45.4.173

Abstract

Background
We evaluated the analytical performance of ALFIS (Boditech Med Inc., Korea), a recently developed point-of-care (POC) chemilumine scence 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.

Keyword

Troponin I; Luminescent measurements; Analytical performance; Evaluation; EDTA