Evaluación de la medición de bilirrubina total en el analizador GEM®Premier™ 4000

Abstract

IntroductionThe exact and precise measurement of bilirubin is fundamental in the diagnosis and treatment of neonatal jaundice. ObjectiveTo evaluate the measurement of total bilirubin on the co-oximetry module of the Gem® Premier™ 4000 analyser (Instrumentation Laboratory), in order to use it in our hospital. A total of 113 samples of serum and 90 of blood from new-borns (NB), and 111 serum and 64 blood samples from adults, with a range of total bilirubin between 2–20 and 1.5–42 mgldL respectively, were measured. The results were compared with the 2,5-dichlorophenyldiazonium method on the Cobas® 711 analyser (Roche Diagnostics). Comparisons of procedures were calculated with linear regression analysis according to the Passing-Bablok equation and the assessment agreement of methods was analyzed with the Bland-Altman plots. ResultsThe total imprecision (CV) was less than 4%. No significant differences were found in the study of the adult samplesIn samples of newborns the slopes of the regression lines were 1.076 (1.035 to 1.097) in the newborn serum samples and 1.093 (1.028 to 1.148) in blood samples. The absolute difference between the methods was 0.6 (-1.3 to 2.6) mg/dL in serum and 0.3 (-1.3 to 1.9) mg/dL in blood. ConclusionsThere were no significant differences between the procedures evaluated in adult samples. In NB whole blood samples the proportional error was 9,3%, with discrepancies > 2 mg/dL compared to the routine method in 3,3% of them. The GEM® Premier™ 4000 analyzer could be a suitable alternative for the quantification of bilirubin in blood samples from new-borns in the neonatal units and clinical laboratories.