Seawright G L, Sanders W M, Bryson M
Adv Exp Med Biol. 1981;137:145-68.
The enzyme immunoassay is a highly versatile diagnostic tool whose use is rapidly spreading throughout the world. With the number of reagents, processing steps and possible protocols involved, and the growing list of devices used to automate or semiautomate the test, there is an immediate need to develop standard procedures for evaluating test performance and making diagnostic decisions. The positive and negative reference sera against which test samples are compared must be carefully selected and evaluated to insure that they are representative of field populations. Only then will it be possible to obtain uniform results within and between test facilities.
酶免疫测定是一种用途极为广泛的诊断工具,其应用正在全世界迅速普及。鉴于涉及的试剂数量、处理步骤和可能的方案,以及用于使测试自动化或半自动化的设备清单不断增加,迫切需要制定评估测试性能和做出诊断决策的标准程序。与测试样本进行比较的阳性和阴性参考血清必须经过仔细选择和评估,以确保它们能代表现场人群。只有这样,才能在各个测试机构内部以及不同测试机构之间获得一致的结果。