Centre for Evidence-based Health Care, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
Phoenix Children's Hospital and University of Arizona College of Medicine, Phoenix, Arizona, USA.
Cochrane Database Syst Rev. 2023 May 9;5(5):CD012660. doi: 10.1002/14651858.CD012660.pub2.
Jaundice is a very common condition in newborns, affecting up to 60% of term newborns and 80% of preterm newborns in the first week of life. Jaundice is caused by increased bilirubin in the blood from the breakdown of red blood cells. The gold standard for measuring bilirubin levels is obtaining a blood sample and processing it in a laboratory. However, noninvasive transcutaneous bilirubin (TcB) measurement devices are widely available and used in many settings to estimate total serum bilirubin (TSB) levels.
To determine the diagnostic accuracy of transcutaneous bilirubin measurement for detecting hyperbilirubinaemia in newborns.
We searched CENTRAL, MEDLINE, Embase, CINAHL and trial registries up to 18 August 2022. We also checked the reference lists of all included studies and relevant systematic reviews for other potentially eligible studies.
We included cross-sectional and prospective cohort studies that evaluated the accuracy of any TcB device compared to TSB measurement in term or preterm newborn infants (0 to 28 days postnatal age). All included studies provided sufficient data and information to create a 2 × 2 table for the calculation of measures of diagnostic accuracy, including sensitivities and specificities. We excluded studies that only reported correlation coefficients.
Two review authors independently applied the eligibility criteria to all citations from the search and extracted data from the included studies using a standard data extraction form. We summarised the available results narratively and, where possible, we combined study data in a meta-analysis.
We included 23 studies, involving 5058 participants. All studies had low risk of bias as measured by the QUADAS 2 tool. The studies were conducted in different countries and settings, included newborns of different gestational and postnatal ages, compared various TcB devices (including the JM 101, JM 102, JM 103, BiliChek, Bilitest and JH20-1C) and used different cutoff values for a positive result. In most studies, the TcB measurement was taken from the forehead, sternum, or both. The sensitivity of various TcB cutoff values to detect significant hyperbilirubinaemia ranged from 74% to 100%, and specificity ranged from 18% to 89%.
AUTHORS' CONCLUSIONS: The high sensitivity of TcB to detect hyperbilirubinaemia suggests that TcB devices are reliable screening tests for ruling out hyperbilirubinaemia in newborn infants. Positive test results would require confirmation through serum bilirubin measurement.
黄疸是新生儿中非常常见的病症,影响多达 60%的足月新生儿和 80%的早产儿在生命的第一周。黄疸是由于红细胞分解导致血液中胆红素增加引起的。测量胆红素水平的金标准是采集血样并在实验室进行处理。然而,非侵入性经皮胆红素(TcB)测量设备已广泛应用于许多环境中,用于估计总血清胆红素(TSB)水平。
确定经皮胆红素测量在检测新生儿高胆红素血症中的诊断准确性。
我们检索了 CENTRAL、MEDLINE、Embase、CINAHL 和试验注册处,截至 2022 年 8 月 18 日。我们还检查了所有纳入研究的参考文献列表和相关系统评价,以寻找其他潜在的合格研究。
我们纳入了横断面和前瞻性队列研究,评估了与 TSB 测量相比,任何 TcB 设备在足月或早产儿(出生后 0 至 28 天)中的准确性。所有纳入的研究都提供了足够的数据和信息,以便为计算诊断准确性的 2×2 表,包括敏感性和特异性,创建 2×2 表。我们排除了仅报告相关系数的研究。
两名综述作者独立应用入选标准对搜索中的所有引文进行筛选,并使用标准数据提取表从纳入的研究中提取数据。我们以叙述性的方式总结了现有结果,并在可能的情况下对研究数据进行了荟萃分析。
我们纳入了 23 项研究,涉及 5058 名参与者。所有研究的 QUADAS 2 工具评估的偏倚风险均较低。这些研究在不同的国家和环境中进行,纳入了不同胎龄和出生后年龄的新生儿,比较了各种 TcB 设备(包括 JM 101、JM 102、JM 103、BiliChek、Bilitest 和 JH20-1C)并使用了不同的阳性结果截断值。在大多数研究中,经皮胆红素测量是从额头、胸骨或两者同时进行的。各种 TcB 截断值检测显著高胆红素血症的敏感性范围为 74%至 100%,特异性范围为 18%至 89%。
TcB 检测高胆红素血症的高敏感性表明 TcB 设备是排除新生儿高胆红素血症的可靠筛查试验。阳性检测结果需要通过血清胆红素测量来确认。