Division of Neonatology, Department of Pediatrics, Erasmus MC Sophia Children's Hospital, University Medical Center Rotterdam, Rotterdam, the Netherlands.
Department of Obstetrics and Gynecology, Erasmus MC Sophia Children's Hospital, University Medical Center Rotterdam, Rotterdam, the Netherlands.
JAMA Pediatr. 2023 May 1;177(5):479-488. doi: 10.1001/jamapediatrics.2023.0059.
Quantification 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.
To systematically evaluate the reported diagnostic accuracy of POC devices compared with LBB quantification.
A 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.
Studies 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 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.
The 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.
Ten 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.
Despite 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.
血液中胆红素的定量对于新生儿高胆红素血症的早期诊断和及时治疗至关重要。手持式即时检测 (POC) 设备可能克服传统基于实验室的胆红素 (LBB) 定量的当前问题。
系统评估 POC 设备与 LBB 定量相比的报告诊断准确性。
对 6 个电子数据库（Ovid MEDLINE、Embase、Web of Science 核心合集、Cochrane 对照试验中心注册库、CINAHL 和 Google Scholar）进行了系统文献检索，截至 2022 年 12 月 5 日。
如果前瞻性队列研究、回顾性队列研究或横断面研究报告了 POC 设备与新生儿（0 至 28 天）的 LBB 定量之间的比较，则本系统评价和荟萃分析将包括这些研究。POC 设备需要以下特征：便携式、手持式、并能在 30 分钟内提供结果。本研究遵循《系统评价和荟萃分析报告的首选报告项目》的报告指南进行。
由 2 名独立评审员将数据提取到预先指定的、定制的表格中。使用 Quality Assessment of Diagnostic Accuracy Studies 2 工具评估偏倚风险。使用 Tipton 和 Shuster 方法对主要结局进行了多个 Bland-Altman 研究的荟萃分析。
主要结果是 POC 设备与 LBB 定量之间胆红素水平的平均差异和一致性界限。次要结果是（1）周转时间 (TAT)，（2）血量和（3）定量失败百分比。
符合纳入标准的有 10 项研究（9 项横断面研究和 1 项前瞻性队列研究），代表了 3122 名新生儿。有 3 项研究被认为存在高偏倚风险。Bilis tick 被评估为 8 项研究中的指标检测，BiliSpec 被评估为 2 项研究中的指标检测。共有 3122 对配对测量值显示总胆红素水平的汇总平均差异为 -14 μmol/L，汇总 95%置信区间为 -106 至 78 μmol/L。对于 Bilistick，汇总平均差异为 -17 μmol/L（95%置信区间，-114 至 80 μmol/L）。与 LBB 定量相比，POC 设备更快地返回结果，而需要的血量更少。与 LBB 相比，Bilis tick 更有可能出现定量失败。
尽管手持式 POC 设备具有优势，但这些发现表明，新生儿胆红素测量的不精确性需要改进，以定制新生儿黄疸的管理。
