Raggatt P R
Department of Clinical Biochemistry, Addenbrooke's Hospital, Cambridge, UK.
Ann Clin Biochem. 1989 Jan;26 ( Pt 1):26-37. doi: 10.1177/000456328902600104.
The nature, frequency, statistics and methods of detection of both Gaussian and catastrophic errors in immunoassay are described. The method of sequential analysis is applied to the rates of catastrophic errors and is used to calculate the number of results which must be examined in order to achieve a stated confidence that the error rate is acceptable so that a rational decision on use of duplicate or singleton assay can be made. A simple computer program is described, which allows computation of the precision profile and an analysis of errors using accumulated data from duplicate assays. These methods have been applied to an enzyme amplification immunometric assay for thyroid-stimulating hormone (TSH) and an analysis is made of the errors detected in a sample of 1419 patient results.
本文描述了免疫分析中高斯误差和灾难性误差的性质、频率、统计数据及检测方法。序贯分析方法应用于灾难性误差率,用于计算为达到规定的误差率可接受的置信度而必须检查的结果数量,以便对使用双份检测或单份检测做出合理决策。文中介绍了一个简单的计算机程序,它可以根据双份检测的累积数据计算精密度曲线并分析误差。这些方法已应用于促甲状腺激素(TSH)的酶放大免疫分析,并对1419例患者结果样本中检测到的误差进行了分析。