Clinical Chemistry Liverpool Hospital, NSW Health Pathology, NSW Health Pathology, Liverpool, NSW, Australia.
Faculty of Medicine, The University of QLD, Saint Lucia, QLD, Australia.
Clin Chem Lab Med. 2022 Aug 29;60(11):1736-1744. doi: 10.1515/cclm-2022-0749. Print 2022 Oct 26.
To assess interlaboratory variability of total serum bilirubin (TSB) results in newborns. Initiated following a clinical incident in which a neonate was transferred to a tertiary hospital for treatment of severe hyperbilirubinemia but on arrival was reclassified into a lower risk category due to a 20% difference in TSB between laboratories.
Fresh residual plasma samples from hospital-born infants were pooled to obtain 11 samples across a range of total bilirubin concentrations. Aliquots were light-protected and measured on 7 commercial platforms at 4 accredited medical laboratories. Data from The Royal College of Pathologists of Australasia Quality Assurance Programs' (RCPAQAP) Neonatal Bilirubin program was analysed.
Twenty-four to 30% difference in results for individual samples, largely due to calibration differences between assays. When interpreted according to guidelines, results from different platforms would have led to different clinical interventions in some cases. RCPAQAP results showed significant within-method bias but were not shown to be commutable with patient samples
There are clinically significant method-dependent differences in TSB results from neonatal samples, consistent with our clinical incident. The differences are largely due to lack of standardisation of calibrator values. This has implications for healthcare resource use and possibly for the neurodevelopment of infants. Intervention is needed at a number of levels, including clinical reporting of incidents arising from discordant results, commitment by manufacturers to ensure metrological traceability of methods with sufficiently low uncertainty in the final measurements, and availability of commutable quality assurance material to monitor assay performance, especially at the clinical decision points for neonatal jaundice.
评估新生儿总血清胆红素（TSB）结果的实验室间变异性。本研究是在一个临床事件之后启动的，该事件中一名新生儿因严重高胆红素血症被转至一家三级医院治疗，但由于实验室间 TSB 差异达 20%，该新生儿到达后被重新归类为低风险类别。
收集来自医院出生婴儿的新鲜剩余血浆样本，以获得 11 个总胆红素浓度范围的样本。等分试样避光保存，并在 4 家认可的医学实验室的 7 个商业平台上进行测量。分析了澳大利亚皇家病理学家学院质量保证计划（RCPAQAP）新生儿胆红素计划的数据。
个别样本的结果差异为 24%至 30%，主要是由于测定之间的校准差异。根据指南进行解释时，在某些情况下，不同平台的结果将导致不同的临床干预。RCPAQAP 的结果显示出显著的内方法偏差，但与患者样本不具有互换性。
新生儿样本的 TSB 结果存在具有临床意义的、依赖方法的差异，与我们的临床事件一致。这些差异主要是由于校准物值缺乏标准化所致。这对医疗保健资源的使用产生了影响，并且可能对婴儿的神经发育产生影响。需要在多个层面进行干预，包括报告因不一致结果而引起的临床事件、制造商承诺确保方法具有足够低的不确定度，从而实现计量溯源性，以及提供可互换的质量保证材料，以监测分析性能，特别是在新生儿黄疸的临床决策点。
