Italian 
English Valutazione di un metodo POCT ad elevata sensibilità per la troponina cardiaca: confronto con una strumentazione automatizzata di laboratorio
Evaluation of a high-sensitivity cardiac troponin point-of-care assay: a comparison with a laboratory platform
AUTORI
1 SSD Biochimica ad Elevata Automazione, Azienda Ospedaliero-Universitaria di Parma
2 Laboratorio Unico Metropolitano, AUSL Bologna
ABSTRACT
Evaluation of a high-sensitivity cardiac troponin point-of-care assay: a comparison with a laboratory platform
Introduction: until recently, high-sensitivity in cTn testing has been adequately performed exclusively by laboratory platforms, whereas point-of-care systems lack the required analytical performance. The Quidel TriageTrue High Sensitivity Troponin I Test (TriageTrue) is a novel point-of-care test that meets the IFCC definition of a high-sensitivity troponin assay. The aim of this study is to evaluate the performance of the TriageTrue assay versus the Beckman Coulter Access hsTnI assay, performed in a central laboratory analyzer.
Methods: the TriageTrue assay was carried out on Quidel Triage MeterPro; the Access Troponin I-hs assay was carried out on Beckman Coulter UniCel DxI 800. The two assays have been compared by a linearity study and by evaluating the agreement through a Passing-Bablok regression analysis and a Bland-Altman plot. In addition, the analytical performance of TriageTrue itself has been checked by performing an intra-assay precision study for two levels of troponin, including values at the 99th percentile.
Results: in comparing TriageTrue versus the Beckman Coulter Access hsTnI, a satisfactory linearity for the tested range (3.13-800 ng/L) has been observed; the precision study results demonstrate that the TriageTrue CV was less than 10% for all the three concentrations tested (21.5, 124.3 and 550 ng/L respectively).
Conclusions: the definition of a high linearity can be derived from the elevated Spearman’s correlation coefficient of 1.000 (p <0.001) which indicates that the values obtained by TriageTrue and by Beckman Coulter hsTnI are highly monotonically related, and thus have a high level of comparability.