Uldall A
Department of Clinical Chemistry, University of Copenhagen, Herlev Hospital, Denmark.
Ann Ist Super Sanita. 1991;27(3):411-7.
The final analytical quality of a result is influenced by external and internal factors. The quality of external elements is influenced by the individual laboratory through its choice of method and supply; such elements are, e.g. reference materials, calibrators, control materials, reagents, reagent kits, instruments and disposables. The internal elements can be described through rules for good laboratory practice (GLP), and include all aspects of internal quality assurance. In this paper, GLP is used to describe the proper milieau in which the optimally selected method is working. The control system for acceptance or rejection of any particular batch of analysis, as well as the long-term control, are also described separately.
结果的最终分析质量受外部和内部因素影响。外部因素的质量受各个实验室方法选择和供应情况的影响；这些因素包括参考物质、校准物、质控物质、试剂、试剂盒、仪器和一次性用品等。内部因素可通过良好实验室规范（GLP）规则来描述，包括内部质量保证的各个方面。本文中，GLP用于描述最佳选择方法所运行的适宜环境。还分别描述了接受或拒收任何特定批次分析的控制系统以及长期控制。
