Diagnostic Accuracy of Portable, Handheld Point-of-Care Tests vs Laboratory-Based Bilirubin Quantification in Neonates

Author:

Westenberg Lauren E. H.1,Been Jasper V.123,Willemsen Sten P.24,Vis Jolande Y.5,Tintu Andrei N.5,Bramer Wichor M.6,Dijk Peter H.7,Steegers Eric A. P.2,Reiss Irwin K. M.1,Hulzebos Christian V.7

Affiliation:

1. Division of Neonatology, Department of Pediatrics, Erasmus MC Sophia Children’s Hospital, University Medical Center Rotterdam, Rotterdam, the Netherlands

2. Department of Obstetrics and Gynecology, Erasmus MC Sophia Children’s Hospital, University Medical Center Rotterdam, Rotterdam, the Netherlands

3. Department of Public Health, Erasmus MC, University Medical Center Rotterdam, Rotterdam, the Netherlands

4. Department of Biostatistics, Erasmus MC, University Medical Center Rotterdam, Rotterdam, the Netherlands

5. Department of Clinical Chemistry, Erasmus MC, University Medical Center Rotterdam, Rotterdam, the Netherlands

6. Medical Library, Erasmus MC, University Medical Center Rotterdam, Rotterdam, the Netherlands

7. Division of Neonatology, Department of Pediatrics, Beatrix Children’s Hospital, University Medical Center Groningen, Groningen, the Netherlands

Abstract

ImportanceQuantification of bilirubin in blood is essential for early diagnosis and timely treatment of neonatal hyperbilirubinemia. Handheld point-of-care (POC) devices may overcome the current issues with conventional laboratory-based bilirubin (LBB) quantification.ObjectiveTo systematically evaluate the reported diagnostic accuracy of POC devices compared with LBB quantification.Data SourcesA systematic literature search was conducted in 6 electronic databases (Ovid MEDLINE, Embase, Web of Science Core Collection, Cochrane Central Register of Controlled Trials, CINAHL, and Google Scholar) up to December 5, 2022.Study SelectionStudies were included in this systematic review and meta-analysis if they had a prospective cohort, retrospective cohort, or cross-sectional design and reported on the comparison between POC device(s) and LBB quantification in neonates aged 0 to 28 days. Point-of-care devices needed the following characteristics: portable, handheld, and able to provide a result within 30 minutes. This study was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-analyses reporting guideline.Data Extraction and SynthesisData extraction was performed by 2 independent reviewers into a prespecified, customized form. Risk of bias was assessed using the Quality Assessment of Diagnostic Accuracy Studies 2 tool. Meta-analysis was performed of multiple Bland-Altman studies using the Tipton and Shuster method for the main outcome.Main Outcomes and MeasuresThe main outcome was mean difference and limits of agreement in bilirubin levels between POC device and LBB quantification. Secondary outcomes were (1) turnaround time (TAT), (2) blood volumes, and (3) percentage of failed quantifications.ResultsTen studies met the inclusion criteria (9 cross-sectional studies and 1 prospective cohort study), representing 3122 neonates. Three studies were considered to have a high risk of bias. The Bilistick was evaluated as the index test in 8 studies and the BiliSpec in 2. A total of 3122 paired measurements showed a pooled mean difference in total bilirubin levels of −14 μmol/L, with pooled 95% CBs of −106 to 78 μmol/L. For the Bilistick, the pooled mean difference was −17 μmol/L (95% CBs, −114 to 80 μmol/L). Point-of-care devices were faster in returning results compared with LBB quantification, whereas blood volume needed was less. The Bilistick was more likely to have a failed quantification compared with LBB.Conclusions and RelevanceDespite the advantages that handheld POC devices offer, these findings suggest that the imprecision for measurement of neonatal bilirubin needs improvement to tailor neonatal jaundice management.

Publisher

American Medical Association (AMA)

Subject

Pediatrics, Perinatology and Child Health

Cited by 2 articles. 订阅此论文施引文献 订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3