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Accuracy and Reliability of Whole Blood Bilirubin Measurements Using a Roche Blood Gas Analyzer for Neonatal Hyperbilirubinemia Screening and Risk Stratification

BACKGROUND: Accurate bilirubin measurements are essential for appropriate management of neonatal hyperbilirubinemia. This study aimed to evaluate the accuracy and reliability of whole blood bilirubin measurements obtained using a Roche blood gas analyzer (Roche TBiL), with total serum bilirubin (TSB...

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Autores principales: Wang, Qing, Zhang, Tianyi, Lin, Yuanxi, Jiang, Li, Zhou, Wenlong, Zong, Xiaolong
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9289128/
https://www.ncbi.nlm.nih.gov/pubmed/35859945
http://dx.doi.org/10.3389/fped.2022.910566
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author Wang, Qing
Zhang, Tianyi
Lin, Yuanxi
Jiang, Li
Zhou, Wenlong
Zong, Xiaolong
author_facet Wang, Qing
Zhang, Tianyi
Lin, Yuanxi
Jiang, Li
Zhou, Wenlong
Zong, Xiaolong
author_sort Wang, Qing
collection PubMed
description BACKGROUND: Accurate bilirubin measurements are essential for appropriate management of neonatal hyperbilirubinemia. This study aimed to evaluate the accuracy and reliability of whole blood bilirubin measurements obtained using a Roche blood gas analyzer (Roche TBiL), with total serum bilirubin (TSB) measurements determined by the Ortho VITROS 4600 chemistry system (Ortho TSB) serving as a reference. MATERIALS AND METHODS: Medical records of hospitalized neonates that underwent simultaneous Roche TBiL and Ortho TSB measurements were reviewed for eligibility selection and data collection. The correlations and differences between two sets of results were determined using Passing–Bablok regression analysis and a Bland–Altman plot, respectively. For eligible newborns, the risk of developing severe hyperbilirubinemia was assessed using the Bhutani nomogram. Weighted kappa analysis was used to evaluate the agreement between risk prediction by the two methods. RESULTS: We obtained 618 paired Roche TBiL and Ortho TSB results from 309 neonates. Roche TBiL and Ortho TSB measurements showed a good correlation (r = 0.923; 95% CI: 0.905–0.938). Passing–Bablok regression analysis yielded the following equation: Roche TBiL = 0.794 × Ortho TSB + 1.255 mg/dL, with a slope of 0.794 (95% CI: 0.763–0.825) and intercept of 1.255 (95% CI: 1.042–1.417). The average difference between the two methods was 0.1 ± 1.448 mg/dL. A total of 207 neonates were eligible for evaluation of the agreement between the risk-grading methods. Although kappa analysis showed good agreement between the methods, with a weighted kappa of 0.681 (95% CI: 0.610–0.751) across all populations, the values for approximately half of the neonates at intermediate and high risk of hyperbilirubinemia (33/72) were underestimated by Roche TBiL. CONCLUSION: Our results indicate that Roche TBiL and Ortho TSB measurements in the neonatal population are not consistent. As a point-of-care and trace blood assay, Roche blood gas bilirubin measurements can facilitate primary screening of neonatal hyperbilirubinemia, but it seems to lack accuracy regarding risk stratification, particularly for high-risk newborn individuals.
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spelling pubmed-92891282022-07-19 Accuracy and Reliability of Whole Blood Bilirubin Measurements Using a Roche Blood Gas Analyzer for Neonatal Hyperbilirubinemia Screening and Risk Stratification Wang, Qing Zhang, Tianyi Lin, Yuanxi Jiang, Li Zhou, Wenlong Zong, Xiaolong Front Pediatr Pediatrics BACKGROUND: Accurate bilirubin measurements are essential for appropriate management of neonatal hyperbilirubinemia. This study aimed to evaluate the accuracy and reliability of whole blood bilirubin measurements obtained using a Roche blood gas analyzer (Roche TBiL), with total serum bilirubin (TSB) measurements determined by the Ortho VITROS 4600 chemistry system (Ortho TSB) serving as a reference. MATERIALS AND METHODS: Medical records of hospitalized neonates that underwent simultaneous Roche TBiL and Ortho TSB measurements were reviewed for eligibility selection and data collection. The correlations and differences between two sets of results were determined using Passing–Bablok regression analysis and a Bland–Altman plot, respectively. For eligible newborns, the risk of developing severe hyperbilirubinemia was assessed using the Bhutani nomogram. Weighted kappa analysis was used to evaluate the agreement between risk prediction by the two methods. RESULTS: We obtained 618 paired Roche TBiL and Ortho TSB results from 309 neonates. Roche TBiL and Ortho TSB measurements showed a good correlation (r = 0.923; 95% CI: 0.905–0.938). Passing–Bablok regression analysis yielded the following equation: Roche TBiL = 0.794 × Ortho TSB + 1.255 mg/dL, with a slope of 0.794 (95% CI: 0.763–0.825) and intercept of 1.255 (95% CI: 1.042–1.417). The average difference between the two methods was 0.1 ± 1.448 mg/dL. A total of 207 neonates were eligible for evaluation of the agreement between the risk-grading methods. Although kappa analysis showed good agreement between the methods, with a weighted kappa of 0.681 (95% CI: 0.610–0.751) across all populations, the values for approximately half of the neonates at intermediate and high risk of hyperbilirubinemia (33/72) were underestimated by Roche TBiL. CONCLUSION: Our results indicate that Roche TBiL and Ortho TSB measurements in the neonatal population are not consistent. As a point-of-care and trace blood assay, Roche blood gas bilirubin measurements can facilitate primary screening of neonatal hyperbilirubinemia, but it seems to lack accuracy regarding risk stratification, particularly for high-risk newborn individuals. Frontiers Media S.A. 2022-07-04 /pmc/articles/PMC9289128/ /pubmed/35859945 http://dx.doi.org/10.3389/fped.2022.910566 Text en Copyright © 2022 Wang, Zhang, Lin, Jiang, Zhou and Zong. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Pediatrics
Wang, Qing
Zhang, Tianyi
Lin, Yuanxi
Jiang, Li
Zhou, Wenlong
Zong, Xiaolong
Accuracy and Reliability of Whole Blood Bilirubin Measurements Using a Roche Blood Gas Analyzer for Neonatal Hyperbilirubinemia Screening and Risk Stratification
title Accuracy and Reliability of Whole Blood Bilirubin Measurements Using a Roche Blood Gas Analyzer for Neonatal Hyperbilirubinemia Screening and Risk Stratification
title_full Accuracy and Reliability of Whole Blood Bilirubin Measurements Using a Roche Blood Gas Analyzer for Neonatal Hyperbilirubinemia Screening and Risk Stratification
title_fullStr Accuracy and Reliability of Whole Blood Bilirubin Measurements Using a Roche Blood Gas Analyzer for Neonatal Hyperbilirubinemia Screening and Risk Stratification
title_full_unstemmed Accuracy and Reliability of Whole Blood Bilirubin Measurements Using a Roche Blood Gas Analyzer for Neonatal Hyperbilirubinemia Screening and Risk Stratification
title_short Accuracy and Reliability of Whole Blood Bilirubin Measurements Using a Roche Blood Gas Analyzer for Neonatal Hyperbilirubinemia Screening and Risk Stratification
title_sort accuracy and reliability of whole blood bilirubin measurements using a roche blood gas analyzer for neonatal hyperbilirubinemia screening and risk stratification
topic Pediatrics
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9289128/
https://www.ncbi.nlm.nih.gov/pubmed/35859945
http://dx.doi.org/10.3389/fped.2022.910566
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