1.1本规程建立了计算99的标准 %/95 % 实验室间检测评估（IDE），并提供有关适当使用和应用的指导。本规程中涉及的计算可使用DQCALC进行，DQCALC是ASTM提供的基于Microsoft Excel的软件。 2. 1.2 IDE计算为90%时的最低浓度 % 从实验室间研究中代表的合格实验室群体中选择的实验室的单个测量值的真实检测概率至少为95 % 真正的未检测概率至少为99 % （测量空白样品时）。 1.3合作研究的基本假设是，研究中测试的介质、测试的浓度和遵循的方案为书面测试方法的范围和适用性提供了代表性和公平的评估。当正确应用时，IDE过程确保99 %/95 % IDE具有以下属性: 1.3.1 常规可实现的IDE值- 大多数实验室能够在常规分析中，使用标准测量系统，以合理的成本实现IDE检测性能。 为了使检测限切实可行，需要这种特性。数据中必须包含代表性实验室，以计算IDE。 1.3.2 说明的常规误差源- IDE应实际包括测量过程中常见的偏差和变化源。这些来源包括但不限于:固有仪器噪声、一些典型的遗留误差量，以及实验室、分析员、样品制备和仪器中的差异。 1.3. 3. 排除可避免的误差源- IDE应实际排除可避免的偏差和变化源，即在常规现场测量中可以合理避免的偏差和变化源。可避免的来源包括但不限于:对已验证方法的样本、测量程序或测量设备的修改，以及严重且易于识别的转录错误（前提是有方法检测、纠正或消除这些错误）。 1.3.4 错误检测概率低- IDE是与测量浓度阈值（临界测量值）一致的真实浓度，该阈值将提供高概率99 %, 真实未检测（错误检测概率低， α = 1. %). 因此，当测量空白样品时，未检测到分析物的概率为99 %. 为了有用，必须证明这适用于所使用的特定基质，而不仅仅适用于试剂水。 1.3.5 低误检概率- IDE应为高概率的真实浓度，至少为95 %, 真实检测的概率（错误未检测的概率较低， β = 5. %, 在IDE），同时具有较低的错误检测概率（参见 1.3.4 ). 因此，在IDE上测量样本时，检测概率至少为95 %. 为了有用，必须证明这适用于所使用的特定基质，而不仅仅适用于试剂水。 注1 — 参考概率α和β是基于风险的检测限评估的关键参数。 1.4 IDE适用于相对于其他源校准误差较小的测量方法，例如当主要变化源为以下之一时（带注释）: 1.4.1 样品制备， 校准标准不必经过样品制备。 1.4.2 分析师的分歧， 分析员几乎没有机会影响校准结果（例如自动校准）。 1.4.3 实验室的差异， 无论出于何种原因，可能很难识别和消除。 1.4.4 工具差异 （测量设备），可能表现为制造商、型号、硬件、电子设备、采样率、化学处理率、积分时间、软件算法、内部信号处理和阈值、有效样本量和污染水平的差异。 1.5 替代数据质量目标- α的其他值， β ，置信度等可用于计算IDE；然而，此过程仅处理99 %/95 % 石斑鱼类。 ====意义和用途====== 5.1本规程的适当应用应能使大多数实验室正确使用所研究的试验方法实现IDE。本IDE为合格实验室对试验方法的任何预期使用提供了基础，以可靠检测与本规程中研究的相同分析物和相同介质（基质）的低浓度。 5.2 IDE值可用于比较分析同一基质中相同分析物的不同方法的检测能力。 5.3 IDE提供高概率（约95 %) 所研究方法的结果值超过IDE，表示样品中存在分析物，且高概率（约99 %) 空白样本不会导致检测。 5.4当实验室间检测对数据使用很重要时，应使用IDE程序为方法的任何应用建立实验室间检测能力。 IDE的目的不是设置报告限制。

1.1 This practice establishes a standard for computing a 99 %/95 % Interlaboratory Detection Estimate (IDE) and provides guidance concerning the appropriate use and application. The calculations involved in this practice can be performed with DQCALC, Microsoft Excel-based software available from ASTM. 2 1.2 The IDE is computed to be the lowest concentration at which there is 90 % confidence that a single measurement from a laboratory selected from the population of qualified laboratories represented in an interlaboratory study will have a true detection probability of at least 95 % and a true nondetection probability of at least 99 % (when measuring a blank sample). 1.3 The fundamental assumption of the collaborative study is that the media tested, the concentrations tested, and the protocol followed in the study provide a representative and fair evaluation of the scope and applicability of the test method as written. When properly applied, the IDE procedure ensures that the 99 %/95 % IDE has the following properties: 1.3.1 Routinely Achievable IDE Value— Most laboratories are able to attain the IDE detection performance in routine analyses, using a standard measurement system, at reasonable cost. This property is needed for a detection limit to be practically feasible. Representative laboratories must be included in the data to calculate the IDE. 1.3.2 Routine Sources of Error Accounted For— The IDE should realistically include sources of bias and variation which are common to the measurement process. These sources include, but are not limited to: intrinsic instrument noise, some typical amount of carryover error, plus differences in laboratories, analysts, sample preparation, and instruments. 1.3.3 Avoidable Sources of Error Excluded— The IDE should realistically exclude avoidable sources of bias and variation, that is, those which can reasonably be avoided in routine field measurements. Avoidable sources would include, but are not limited to: modifications to the sample, measurement procedure, or measurement equipment of the validated method, and gross and easily discernible transcription errors (provided there was a way to detect and either correct or eliminate them). 1.3.4 Low Probability of False Detection— The IDE is a true concentration consistent with a measured concentration threshold (critical measured value) that will provide a high probability, 99 %, of true nondetection (a low probability of false detection, α = 1 %). Thus, when measuring a blank sample, the probability of not detecting the analyte would be 99 %. To be useful, this must be demonstrated for the particular matrix being used, and not just for reagent water. 1.3.5 Low Probability of False Nondetection— The IDE should be a true concentration at which there is a high probability, at least 95 %, of true detection (a low probability of false nondetection, β = 5 %, at the IDE), with a simultaneous low probability of false detection (see 1.3.4 ). Thus, when measuring a sample at the IDE, the probability of detection would be at least 95 %. To be useful, this must be demonstrated for the particular matrix being used, and not just for reagent water. Note 1 — The referenced probabilities, α and β, are key parameters for risk-based assessment of a detection limit. 1.4 The IDE applies to measurement methods for which calibration error is minor relative to other sources, such as when the dominant source of variation is one of the following (with comment): 1.4.1 Sample Preparation, and calibration standards do not have to go through sample preparation. 1.4.2 Differences in Analysts, and analysts have little opportunity to affect calibration results (such as with automated calibration). 1.4.3 Differences in Laboratories, for whatever reasons, perhaps difficult to identify and eliminate. 1.4.4 Differences in Instruments (measurement equipment), which could take the form of differences in manufacturer, model, hardware, electronics, sampling rate, chemical processing rate, integration time, software algorithms, internal signal processing and thresholds, effective sample volume, and contamination level. 1.5 Alternative Data Quality Objectives— Other values forα, β , confidence, etc. may be chosen for calculating an IDE; however, this procedure addresses only the 99 %/95 % IDE. ====== Significance And Use ====== 5.1 Appropriate application of this practice should result in an IDE achievable by most laboratories properly using the test method studied. This IDE provides the basis for any prospective use of the test method by qualified laboratories for reliable detection of low-level concentrations of the same analyte as the one studied in this practice and same media (matrix). 5.2 The IDE values may be used to compare the detection power of different methods for analysis of the same analyte in the same matrix. 5.3 The IDE provides high probability (approximately 95 %) that result values of the method studied which exceed the IDE represent presence of analyte in the sample and high probability (approximately 99 %) that blank samples will not result in a detection. 5.4 The IDE procedure should be used to establish the interlaboratory detection capability for any application of a method where interlaboratory detection is important to data use. The intent of IDE is not to set reporting limits.