Campbell B G
Department of Pathology, Princess Alexandra Hospital, Brisbane, Australia.
Arch Pathol Lab Med. 1989 Aug;113(8):834-7.
Analytical error limits based on two different concepts of "medical significance" are derived. The ability of the system to detect medically significant errors using standard (1(3s] and enhanced (mean and range) quality control procedures is investigated. Error detection is found to be adequate for most analytes when error limits are based on physicians' opinions and a mean and range quality control system is used. Error detection is unsatisfactory when error limits based on intraindividual biological variation are used and this cannot be improved by using better quality control systems. The limiting factor is analytical precision. The use of error limits based on biological variation as proposed by major clinical chemistry professional bodies cannot be achieved using most current types of analytical technology.
推导了基于两种不同“医学意义”概念的分析误差限。研究了该系统使用标准（1(3s]）和增强型（均值和极差）质量控制程序检测具有医学意义误差的能力。当误差限基于医生的意见并使用均值和极差质量控制系统时，发现对大多数分析物的误差检测是足够的。当使用基于个体内生物变异的误差限时，误差检测不令人满意，并且使用更好的质量控制系统也无法改善这一点。限制因素是分析精密度。使用大多数当前类型的分析技术无法实现主要临床化学专业机构提议的基于生物变异的误差限的应用。
