WS/T 228-2002 in English

在新方法、新试剂、新仪器用作体外诊断前，常常有必要对它的可接受性做出初步决定。这个初步的方法性能检查，既不是对方法长期性能的严格评价，也不是评价影响设备产生结果的多种因素。本标准的首要目标是有助于发现问题，并要求立即予以纠正，或询问厂商，或作进一步评估。本标准规定了一种对临床检验方法的线性、偏倚、线性漂移、样品交叉污染和精密度作初步评价的方法。在新方法用于检测病人样品前、或者在对方法作任何改进后，必须进行初步评价。这些试验原意是用于自动化仪器的评价，但也可用于试剂盒、手工方法或其他体外诊断设备的评估。只做10例样品的重复实验，通过绘制实验点，作一些简单的计算，即可评价性能特性。使用多线性回归分析统计技术，可进一步获取影响不精密度因素的信息（如样品交叉污染和线性漂移）。因为提供了简单数据分析的说明，所以无需使用计算机。本实验用于仪器性能特性的初步估计，已确定设备最终的可接受性，实验结果仅可确定设备是否具有严重的不可接受性能。标准中简述了所用的材料和方法。此基本实验可能有多方面的改变（如延长实验天数、剔去有问题的样品）。随设备的复杂性、方法的特性和用户的有用资源而改变。

Scope

Before a new method, new reagent, or new instrument is used for in vitro diagnostics, it is often necessary to make a preliminary decision on its acceptability. This preliminary method performance check is neither a rigorous evaluation of the long-term performance of the method nor an evaluation of the many factors that influence the results produced by the equipment. The primary goal of this standard is to help identify problems and require immediate correction, consultation with the manufacturer, or further evaluation. This standard specifies a method for preliminary evaluation of linearity, bias, linear drift, sample cross-contamination and precision of clinical testing methods. A preliminary evaluation must be performed before a new method is used to test patient samples, or after any modifications to the method are made. These tests are intended for the evaluation of automated instruments but may also be used for the evaluation of kits, manual methods, or other in vitro diagnostic devices. Only repeat experiments on 10 samples. By plotting the experimental points and making some simple calculations, the performance characteristics can be evaluated. Using multiple linear regression analysis statistical techniques, further information on factors affecting imprecision (such as sample cross-contamination and linear drift) can be obtained. No computer is required because instructions for simple data analysis are provided. This test is used for a preliminary estimate of the instrument's performance characteristics to determine the final acceptability of the device. The test results can only determine whether the device has serious unacceptable performance. The materials and methods used are briefly described in the standard. There may be many changes to this basic experiment (such as extending the experimental days, removing problematic samples). Varies with the complexity of the device, the nature of the method, and the resources available to the user.