Chemical Pathology Laboratory, Department of Pathology, Hong Kong Children's Hospital, Kowloon Bay, Hong Kong.
Chemical Pathology Laboratory, Department of Pathology, Princess Margaret Hospital, Laichikok, Hong Kong.
Hong Kong Med J. 2019 Aug;25(4):295-304. doi: 10.12809/hkmj197943. Epub 2019 Aug 12.
Reference intervals (RIs) are essential tool for proper interpretation of results. There is a global trend towards implementing common RIs to avoid confusion and enhance patient management across different laboratories. However, local practices with respect to RIs lack harmonisation.
We have conducted the first local survey regarding RIs for 14 general chemistry analytes in 10 chemical pathology laboratories that employ four different analytical platforms (Abbott Architect, Beckman Coulter AU, Roche Cobas, and Siemens Dimension EXL). Analytical bias was assessed by an inter-laboratory results comparison of external quality assurance programmes.
Sufficient inter-laboratory and inter-platform agreement regarding the 10 analytes (albumin, alanine aminotransferase, aspartate aminotransferase, chloride, gamma-glutamyl transferase, phosphate, potassium, sodium, total protein, and urea) were demonstrated. However, the RIs were heterogeneous across all laboratories, with percentage differences of the upper RI value of up to 47% for aspartate aminotransferase (absolute difference of 16 U/L), 29% for urea (1.8 mmol/L), and 18% for potassium (0.8 mmol/L). The percentage difference between lower RI values was up to 24% for urea (0.6 mmol/L), 22% for phosphate (0.16 mmol/L), and 8% for total protein (5 g/L). The coefficients of variation of the upper RI values of potassium and sodium were 1.2 times and 1.0 times of their corresponding between-subject biological variation, respectively, representing unnecessary variations that are overlooked and unchecked in current practice.
We recommend the use of common RIs for general chemistry analytes in Hong Kong to prevent interpreter confusion, improve electronic data transfer, and unite laboratory practice. This is the first local study on this topic, and our data can lay the groundwork for increasing harmonisation of RIs across more laboratory tests.
参考区间(RIs)是正确解释结果的重要工具。全球范围内存在实施通用 RIs 以避免不同实验室之间的混淆并改善患者管理的趋势。然而,对于 RIs 的本地实践缺乏协调。
我们对 10 家采用 4 种不同分析平台(雅培 Architect、贝克曼库尔特 AU、罗氏 Cobas 和西门子 Dimension EXL)的化学病理学实验室的 14 种常规化学分析物的 RIs 进行了首次本地调查。通过对外部质量保证计划的实验室间结果比较评估分析偏差。
对于 10 种分析物(白蛋白、丙氨酸氨基转移酶、天冬氨酸氨基转移酶、氯、γ-谷氨酰转移酶、磷酸盐、钾、钠、总蛋白和尿素),证明了足够的实验室间和平台间一致性。然而,所有实验室的 RI 均存在异质性,天门冬氨酸氨基转移酶的 RI 值上限差异高达 47%(绝对差异 16 U/L),尿素为 29%(1.8 mmol/L),钾为 18%(0.8 mmol/L)。尿素的 RI 值下限差异高达 24%(0.6 mmol/L),磷酸盐为 22%(0.16 mmol/L),总蛋白为 8%(5 g/L)。钾和钠的 RI 值上限的变异系数分别是其相应个体间生物学变异的 1.2 倍和 1.0 倍,代表了当前实践中被忽视和未检查的不必要变异。
我们建议在香港使用通用的常规化学分析物 RIs,以防止解释者混淆,改善电子数据传输,并统一实验室实践。这是该主题的首次本地研究,我们的数据可以为增加更多实验室测试的 RIs 协调奠定基础。