Methods Mol Biol. 2009;516:517-41. doi: 10.1007/978-1-60327-254-4_13.
In this chapter, the use of control charts to both continuously evaluate testing in individual laboratories as well as provide data for external monitoring is examined in detail. The data is based on the publication by D. E. Rebeski' et al., "Charting methods to monitor the operational performance of ELISA method for the detection of antibodies against trypanosomes" in Veterinary Parasitology, 2001, 96, 11-50, and is a detailed example of the investigation of the performance of four indirect ELISAs for the detection of antibodies against trypanosomes using Trypanosoma congolense and T. vivax antigen-precoated plates in 15 veterinary diagnostic laboratories in Africa and Europe. The study shows the practical use of charting methods with respect to assessing the operational performance of each ELISA. Data from standardized internal quality control (IQC) samples were used to assess ELISA performance indicators with reference to expected upper and lower control limits, as determined from studies by the kit producer (tentative values). Based on unprocessed (optical density) and normalized absorbance values (calculated as a percentage positivity of a control), dispersion of values from the expected data range were estimated though plotting the location and deviation of the values. In addition, assay precision was estimated by plotting the distribution of coefficients of variation <10% of the IQCs. Binding ratios of various controls were calculated to estimate the assay proficiency with respect to the accuracy of assessing whether the IQC samples tested positive or negative in the test proper. The graphical analysis of dispersion of absorbance values in combination with assay precision and proficiency criteria were considered satisfactory to allow the evaluation of the operational performances of the ELISAs, and provide useful decision-making criteria for plate acceptance and rejection. The establishment of standardized and transparent IQC data charting methods for the indirect ELISAs provided an increased measure of confidence to national laboratories with respect to their reports on disease occurrence. Moreover, the relative assay performances among all laboratories were examined, using summary data charts, with reference to the performance criteria described. The IQC data were also examined using modified Youden plot analysis, demonstrating that indirect ELISA methods can be successfully applied at diagnostic laboratories in the tropics for monitoring trypanosomosis control programs.
在本章中，将详细探讨控制图在持续评估单个实验室检测以及为外部监测提供数据方面的应用。数据基于D. E. Rebeski等人发表于《兽医寄生虫学》2001年第96卷第11 - 50页的文章“用于监测检测锥虫抗体的ELISA方法操作性能的图表方法”，该数据是在非洲和欧洲的15个兽医诊断实验室中，使用刚果锥虫和活跃锥虫抗原预包被板，对四种间接ELISA检测锥虫抗体性能进行调查的详细示例。该研究展示了图表方法在评估每种ELISA操作性能方面的实际应用。来自标准化内部质量控制（IQC）样本的数据用于参照试剂盒生产商研究确定的预期上下控制限（暂定值）来评估ELISA性能指标。基于未处理的（光密度）和标准化吸光度值（计算为对照的阳性百分比），通过绘制值的位置和偏差来估计值与预期数据范围的离散程度。此外，通过绘制变异系数<10%的IQC分布来估计检测精密度。计算各种对照的结合率，以评估检测在正确检测中评估IQC样本呈阳性或阴性准确性方面的熟练程度。吸光度值离散度的图形分析与检测精密度和熟练程度标准相结合，被认为足以评估ELISA的操作性能，并为板的接受和拒收提供有用的决策标准。为间接ELISA建立标准化和透明的IQC数据图表方法，增强了国家实验室对其疾病发生报告的信心。此外，使用汇总数据图表，参照所述性能标准，检查了所有实验室之间的相对检测性能。还使用改良的尤登图分析对IQC数据进行了检查，表明间接ELISA方法可成功应用于热带地区的诊断实验室，以监测锥虫病控制项目。
