Evaluación de la troponina I en el analizador Pathfast®

Abstract

Introduction The Pathfast® (Mitsubishi Kagaku Iatron) is a compact chemiluminescent immunoassay analyser that is capable of processing either plasma or blood samples. Objectives In this study we have evaluated some operational characteristics such as within assay variability, between-day variability, reference values, comparison with another method (Dimension® RxL, Dade Behring), analytical sensitivity, quantitation limits, endogenous interferences by triglycerides, haemoglobin and bilirubin, and false positives in other diseases. Materials and Methods The evaluation of Troponin l was designed as a multicentre study in which the emergency laboratories of four Spanish Hospitals took part. Results The within assay coefficient of variation (CV) was lower than 5% whereas the between-day CV did not exceed 10%. The overall analytical sensitivity for the four laboratories was between 0.003 and 0.008 ng/ml. The quantitation limit was 0.025 ng/ml. The regression obtained between plasma and blood was Troponin I (plasma)=−0.0008+0.9499×Troponin I (blood), and between Pathfast® and the comparison method was Troponin I (Pathfast)=−0.0019+0.2903×Troponin I (Dimension RxL). Tests of endogenous interferences showed that the results are not altered significantly in the presence of triglyceride, bilirubin or free haemoglobin. The study of other clinical diseases (Renal Impairment, Stroke, Multiple trauma) did not show any differences in the method comparison. Discussion In summary, the Pathfast® analyser is reliable, precise and easy to handle, useful for laboratories of small and average size, or for emergency laboratories.