Modular compositing-multiple lot screening protocols for detection of pathogens, microbial contaminants and/or constituents

A method of sampling and testing products for microbe(s) in multiple separate lots, comprising:

• a) separately collecting multiple independent samples from each of multiple separate single production lots, wherein each separate single production lot is separately sampled by taking said multiple independent samples thereof;
• b) separately compositing the collected multiple independent samples from each of the separate lots to provide a corresponding set of separate composited single production lot samples, wherein each of the separate composited single production lot samples is attributed to a particular corresponding separate single production lot;
• c) enriching of the separate composited single production lot samples to provide a set of separate composited single production lot samples enriched for the target microbe(s);
• d) removing portions of each separate enriched composited single production lot sample, and combining the removed portions to provide a pooled modular composite sample;
• and
• e) testing of the pooled modular composite sample, using a suitable detection assay, for the target microbe(s), wherein when such testing is negative all of said samples that were composited to form the separate composited single production lot samples are deemed negative for the target microbe(s) and each of the multiple separate single production lots is validated, and wherein when such testing is positive, each of the individual separate composited single production lot samples that were used to form the pooled modular composite sample are individually tested to determine which of the separate composited single production lot samples is positive for the target microbe(s), wherein the single production lots corresponding to any negatively testing composited single production lot samples are validated.