Adeli Khosrow, Higgins Victoria, Seccombe David, Collier Christine P, Balion Cynthia M, Cembrowski George, Venner Allison A, Shaw Julie
Pediatric Laboratory Medicine, The Hospital for Sick Children and Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada.
Pediatric Laboratory Medicine, The Hospital for Sick Children and Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada.
Clin Biochem. 2017 Nov;50(16-17):925-935. doi: 10.1016/j.clinbiochem.2017.06.006. Epub 2017 Jun 21.
Reference intervals are widely used decision-making tools in laboratory medicine, serving as health-associated standards to interpret laboratory test results. Numerous studies have shown wide variation in reference intervals, even between laboratories using assays from the same manufacturer. Lack of consistency in either sample measurement or reference intervals across laboratories challenges the expectation of standardized patient care regardless of testing location. Here, we present data from a national survey conducted by the Canadian Society of Clinical Chemists (CSCC) Reference Interval Harmonization (hRI) Working Group that examines variation in laboratory reference sample measurements, as well as pediatric and adult reference intervals currently used in clinical practice across Canada.
Data on reference intervals currently used by 37 laboratories were collected through a national survey to examine the variation in reference intervals for seven common laboratory tests. Additionally, 40 clinical laboratories participated in a baseline assessment by measuring six analytes in a reference sample.
Of the seven analytes examined, alanine aminotransferase (ALT), alkaline phosphatase (ALP), and creatinine reference intervals were most variable. As expected, reference interval variation was more substantial in the pediatric population and varied between laboratories using the same instrumentation. Reference sample results differed between laboratories, particularly for ALT and free thyroxine (FT4). Reference interval variation was greater than test result variation for the majority of analytes.
It is evident that there is a critical lack of harmonization in laboratory reference intervals, particularly for the pediatric population. Furthermore, the observed variation in reference intervals across instruments cannot be explained by the bias between the results obtained on instruments by different manufacturers.
参考区间是检验医学中广泛使用的决策工具，作为与健康相关的标准来解释实验室检测结果。大量研究表明，参考区间存在很大差异，即使是使用同一制造商检测方法的实验室之间也是如此。不同实验室在样本测量或参考区间方面缺乏一致性，这对无论检测地点如何都能提供标准化患者护理的期望构成了挑战。在此，我们展示了加拿大临床化学家协会（CSCC）参考区间协调（hRI）工作组进行的一项全国性调查的数据，该调查考察了实验室参考样本测量的差异，以及加拿大临床实践中目前使用的儿科和成人参考区间。
通过全国性调查收集了37个实验室目前使用的参考区间数据，以检查七种常见实验室检测的参考区间差异。此外，40个临床实验室通过测量参考样本中的六种分析物参与了基线评估。
在所检测的七种分析物中，丙氨酸氨基转移酶（ALT）、碱性磷酸酶（ALP）和肌酐的参考区间变化最大。正如预期的那样，儿科人群的参考区间差异更为显著，并且在使用相同仪器的实验室之间也有所不同。不同实验室的参考样本结果存在差异，尤其是ALT和游离甲状腺素（FT4）。对于大多数分析物，参考区间的差异大于检测结果的差异。
显然，实验室参考区间严重缺乏协调性，尤其是在儿科人群中。此外，不同仪器之间观察到的参考区间差异不能用不同制造商仪器所获结果之间的偏差来解释。
