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

  • US 9,637,771 B2
  • Filed: 08/28/2014
  • Issued: 05/02/2017
  • Est. Priority Date: 08/06/2004
  • Status: Active Grant
First Claim
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1. A method of sampling and testing products for microbes in multiple separate lots, comprising:

  • a) separately collecting multiple independent samples from each of multiple separate lots, wherein each separate 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 lot samples, wherein each of the separate composited lot samples is attributed to a particular corresponding separate lot;

    c) enriching each of the separate composited lot samples to provide a set of separate composited lot samples enriched for the target microbe(s);

    d) removing portions of each separate enriched composited 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 lot samples are deemed negative for the target microbe(s) and each of the multiple separate lots is validated, and wherein when such testing is positive, each of the individual separate composited lot samples that were used to form the pooled modular composite sample are individually tested to determine which of the separate composited lot samples is positive for the target microbe(s), wherein the lots corresponding to any negatively testing composited lot samples are validated.

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