Capability of detection — Part 5: Methodology in the linear and non-linear calibration cases
检测能力第5部分:线性和非线性校准情况下的方法
发布日期:
2008-05-22
ISO 11843-5:2008涉及线性或非线性校准函数。它规定了构造响应变量精度曲线的基本方法,即响应变量的标准偏差或变异系数作为净状态变量的函数的描述,将该精度曲线与校准函数一起转换为净状态变量的精度曲线,并使用后一种精度剖面来估计净状态变量的临界值和最小可检测值。
ISO 11843-5:2008所述方法可用于检查ISO 11843-2无法应用的各种测量设备对某种物质的检测。其中包括通过竞争性ELISA(酶联免疫吸附试验)对环境中的持久性有机污染物(POPs)进行检测,如二恶英、杀虫剂和激素类化学品,以及对引起人体高热的细菌内毒素进行检测。
ISO 11843中描述了净状态变量的临界值和最小可检测值的定义和适用性-
1和ISO 11843-2。ISO 11843-5:2008将ISO 11843-2中的概念扩展到非线性校准的情况。举例说明。
ISO 11843-5:2008 is concerned with calibration functions that are either linear or non-linear. It specifies basic methods to construct a precision profile for the response variable, namely a description of the standard deviation or coefficient of variation of the response variable as a function of the net state variable, transform this precision profile into a precision profile for the net state variable in conjunction with the calibration function, and use the latter precision profile to estimate the critical value and minimum detectable value of the net state variable.
The methods described ISO 11843-5:2008 are useful for checking the detection of a certain substance by various types of measurement equipment to which ISO 11843-2 cannot be applied. Included are assays of persistent organic pollutants (POPs) in the environment, such as dioxins, pesticides and hormone-like chemicals, by competitive ELISA (enzyme-linked immunosorbent assay), and tests of bacterial endotoxins that induce hyperthermia in humans.
The definition and applicability of the critical value and minimum detectable value of the net state variable are described in ISO 11843-1 and ISO 11843-2. ISO 11843-5:2008 extends the concepts in ISO 11843-2 to the cases of non-linear calibration. Examples are provided.