Andrew C E, Hanning I, McBain A M, Moody D, Price A
Department of Chemical Pathology, Barnet General Hospital, Herts, UK.
Clin Chem Lab Med. 2000 Oct;38(10):1013-9. doi: 10.1515/CCLM.2000.150.
Ideally, every laboratory should derive their own reference intervals for all analytes, but this is difficult in practice. A survey, by questionnaire, of UK laboratories using the Chiron Diagnostics ACS:180 (Chiron Diagnostics Limited, Halstead, Essex, UK), for thyroid function tests, showed that 10% of laboratories derived their own reference intervals, 60% quoted values "adapted" from intervals for previous methods, whilst the remaining 40% quoted (often incorrectly) reference intervals supplied by the manufacturer. In addition only 13% of respondent laboratories derived their own reference intervals for testosterone. As a result of this survey, a study was devised to enable the users of the Chiron Diagnostics ACS:180 immunoassay system to develop and use within-method, between-laboratory reference intervals for thyroid hormones and testosterone. Laboratory collaboration provided the recommended minimum number of data points by establishing a reference sample group. This sample group was used for the calculation of appropriate reference intervals for each hormone according to the guidelines published by the IFCC. We propose this approach as a model for laboratories using identical instrumentation to produce, through collaboration, within-method, between laboratory reference intervals.
理想情况下，每个实验室都应为所有分析物制定自己的参考区间，但实际上这很难做到。通过问卷调查对英国使用Chiron Diagnostics ACS:180（英国埃塞克斯郡哈尔斯特德市Chiron Diagnostics有限公司）进行甲状腺功能测试的实验室进行的一项调查显示，10%的实验室制定了自己的参考区间，60%引用了从先前方法的区间“改编”而来的值，而其余40%引用了（通常不正确）制造商提供的参考区间。此外，只有13%的受访实验室制定了自己的睾酮参考区间。作为这项调查的结果，设计了一项研究，以使Chiron Diagnostics ACS:180免疫分析系统的用户能够制定并使用甲状腺激素和睾酮的方法内、实验室间参考区间。实验室合作通过建立一个参考样本组提供了建议的最少数据点数。根据国际临床化学和检验医学联合会（IFCC）发布的指南，该样本组用于计算每种激素的适当参考区间。我们建议这种方法作为使用相同仪器的实验室通过合作产生方法内、实验室间参考区间的一个模型。
