A model for a multicentre approach to the derivation of reference intervals for thyroid hormones and testosterone for...

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.