Sanders G T, Dijkman J H, Sturk A, Jansen R T
Academisch Medisch Centrum, afd. Klinische Chemie, Amsterdam.
Ned Tijdschr Geneeskd. 1997 Feb 1;141(5):234-6.
Laboratory analyses in multicentre safety studies of new drugs usually are performed in central laboratories outside the Netherlands. Patient care requires local (hospital) laboratory tests. In the so-called Virtually Centralized Laboratory the Dutch local laboratories report their results after data communication and data transformation in such a way that they seem to form one laboratory. The local analytical results are transformed by calibrating the local methods using standard preparations, thus reducing the inter laboratory variation. This concept may lead to one set of national reference values for all general clinical chemical and haematological laboratory tests.
新药多中心安全性研究中的实验室分析通常在荷兰境外的中央实验室进行。患者护理需要进行当地(医院)实验室检测。在所谓的虚拟集中实验室中,荷兰当地实验室在进行数据通信和数据转换后报告其结果,使得它们看起来像是一个实验室。通过使用标准制剂校准当地方法来转换当地分析结果,从而减少实验室间差异。这一概念可能会为所有一般临床化学和血液学实验室检测带来一套全国性参考值。