本文提出了一个验证地下水样本中大肠杆菌噬菌体检测新方法的案例研究。大肠杆菌噬菌体是可用于监测粪便的微生物指标之一 地下水规则下的污染。本文描述了为替代测试程序（ATP）和基于性能的测量系统（PBMS）方法设计验证研究所需的统计考虑因素。本文评估了证明这两种方法的等效性或可接受性所需的比较次数。验证结果用于证明样本量与回收率、灵敏度（真阳性）、特异性（真阴性）、假阳性和假阳性的置信区间之间的关系 方法之间的假阴性。这与样本量和风险之间的关系形成了对比 检测使用ATP方法的方法之间差异的能力。 设计和结果 介绍了实验室间验证研究，重点是所需的样本量和 实验室之间可以检测到的差异。包括2个参考文献、表格和图表。

This paper presents a case study for the validation of a new method for detecting coliphage in groundwater samples. Coliphage is one of the microbial indicators that can be used to monitor fecal contamination under the Ground Water Rule. This paper describes the statistical considerations required in the design of a validation study for the alternative test procedure (ATP) and performance based measurements system (PBMS) approaches. The paper evaluates the number of comparisons necessary to demonstrate equivalence or acceptability by the two approaches. Results of validation were used to demonstrate the relationship between sample size and the confidence intervals around recoveries, sensitivity (true positives), specificity (true negatives), false positives and false negatives between methods. This was contrasted with the relationship between sample size and the ability to detect differences between methods using the ATP method. The design and results of an inter-laboratory validation study are presented, focusing on the sample sizes required and the differences that can be detected between laboratories. Includes 2 references, tables, figures.