Abstract
BackgroundTranscutaneous bilirubinometry is a widely used screening method for neonatal hyperbilirubinemia. Deviation of the transcutaneous bilirubin concentration (TcB) from the total serum bilirubin concentration (TSB) is often ascribed to biological variation between patients, but variations between TcB meters may also have a role. This study aims to provide a systematic evaluation of the inter-device reproducibility of TcB meters.Materials and MethodsThirteen commercially available TcB meters (JM-105 and JM-103) were evaluated in vitro on phantoms that optically mimic neonatal skin. The mimicked TcB was varied within the clinical range (0.5–181.3 μmol/L).ResultsAbsolute differences between TcB meter outcomes increased with the measured TcB, from a difference of 5.0 μmol/L (TcB = 0.5 μmol/L phantom) up to 65.0 μmol/L (TcB = 181.3 μmol/L phantom).ConclusionThe inter-device reproducibility of the examined TcB meters is substantial and exceeds the specified accuracy of the device (±25.5 μmol/L), as well as the clinically used TcB safety margins (>50 µmol/L below phototherapy threshold). Healthcare providers should be well aware of this additional uncertainty in the TcB determination, especially when multiple TcB meters are employed in the same clinic. We strongly advise using a single TcB meter per patient to evaluate the TcB over time.ImpactKey message: The inter-device reproducibility of TcB meters is substantial and exceeds the clinically used TcB safety margins.What this study adds to existing literature: The inter-device reproducibility of transcutaneous bilirubin (TcB) meters has not been reported in the existing literature. This in vitro study systematically evaluates this inter-device reproducibility.Impact: This study aids in a better interpretation of the measured TcB value from a patient and is of particular importance during patient monitoring when using multiple TcB meters within the same clinical department. We strongly advise using a single TcB meter per patient to evaluate the TcB over time.
Highlights
Jaundice is a common and potentially harmful condition in neonates
Adequate and reproducible performance of the Transcutaneous bilirubin (TcB) meters would ideally result in exactly the same TcB value for each phantom across all TcB meters
We observe a large dependency of the measured TcB value on TcB meter
Summary
Jaundice is a common and potentially harmful condition in neonates. Severe jaundice, or hyperbilirubinemia, may result in Kernicterus Spectrum Disorders (KSDs), causing irreversible brain damage to the patient.[1]. Transcutaneous bilirubinometry is a widely used non-invasive and instantaneous method for this purpose. This method can reduce the number of invasive total serum bilirubin (TSB) determinations, which is considered as the golden standard.[4] Transcutaneous bilirubin (TcB) measurements cannot completely replace TSB determinations, since the TcB concentration is a physiologically different parameter than the TSB.[5]. Transcutaneous bilirubinometry is a widely used screening method for neonatal hyperbilirubinemia. This study aims to provide a systematic evaluation of the inter-device reproducibility of TcB meters. MATERIALS AND METHODS: Thirteen commercially available TcB meters (JM-105 and JM-103) were evaluated in vitro on phantoms that optically mimic neonatal skin. We strongly advise using a single TcB meter per patient to evaluate the TcB over time
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