Group testing is widely used to improve screening efficiency in populations with low prevalence, but pooling may reduce assay sensitivity through dilution. Existing statistical work often incorporates this effect as a modeling assumption or design constraint, while the question of whether a dilution effect is present in a specific testing procedure is less often treated as a formal inferential problem. This paper develops a hypothesis testing framework for assessing dilution effects under a binary measurement error model. Dilution is represented by an increase in the group-specific false negative rate as pool size increases, with specificity assumed to remain stable across pool sizes. We derive closed-form estimators and one-sided test statistics for both unknown- and known-prevalence settings, using normal and Poisson approximations together with null-bootstrap critical-value calibration. Simulation studies show that the proposed procedures control type I error reasonably well and gain power as the dilution effect becomes stronger, although detection is more difficult under very low prevalence. Applications to infectious disease screening settings and SARS-CoV-2 pooled NAAT data illustrate how the framework can quantify evidence for reduced sensitivity under pooling.
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关键词
Group testing,Pooled testing,Dilution effect,Measurement error,False negative rate,Bootstrap calibration