A-388 Evaluation of Performance of the nBili Assay on the RAPIDPoint®500e Analyzer Compared to the Total Bilirubin Assay for the Dimension EXL200 and Atellica CH Analyzers in Neonates Blood Samples

Abstract

Abstract Background Neonatal hyperbilirubinemia is very common, with 60% of term newborns (NB) and 80% of premature neonates developing this condition. If not diagnosed and treated, can lead to severe complications, with bilirubin encephalopathy (BAE) being one of the most feared outcomes. Analysis of whole blood samples measured by the RapidPoint®500 Blood Gas Analyzer (RP500) is a technology option that provides rapid bilirubin results with a small sample volume and can also measure other important analytes. However, it is still unclear whether the blood gas analyzer can be used for biochemical dosage of bilirubin in newborns. Objective This study aimed to evaluate the clinical and analytical reliability of the method for detecting bilirubin in infants in comparison with classic biochemical analyzers such as Atellica® CH 930 and Dimension® EXL200. Methods A comparative clinical study was performed to evaluate the acceptable analytical agreement of total bilirubin results from 41 samples from neonatal patients between Atellica® CH 930, Dimension® EXL200 and RapidPoint®500 analyzers. Data were analyzed using Vericheck® software. Results Forty-one whole blood samples from newborn patients were analyzed for total bilirubin measurement. The range of analyzed results was from 2.7 to 20.8 mg/dL. Were considered for the analysis of clinical data: gestational age, weight, age, visual assessment of the newborn, criteria for hospitalization, whether phototherapy was performed and how long it took. In the regression analysis, it was possible to obtain a Pearson regression coefficient of 0.9806 between the Atellica® CH 930 and RP500 analyzer. The average of the values obtained with the RP500 was 10.8 and for the Atellica® CH930 it was 11.10, obtaining a percentage difference of means of 2.70%. In comparison with the Dimension®EXL200 analyzer, it was possible to obtain a Pearson correlation coefficient of 0.9814. The average of the values obtained with the RP500 was 10.8 and for the Dimension it was 9.32, resulting in a percentage difference of mean of 15.83%. Conclusion The study showed good results for analytical comparability between analyzers. There was no change in the clinical management according to the criteria analyzed in conjunction with the laboratory analyses, making it possible to guarantee the safety of using the RP500 platform in the diagnosis and follow-up of newborns with suspected hyperbilirubinemia.