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

  • US 8,389,233 B2
  • Filed: 01/27/2009
  • Issued: 03/05/2013
  • Est. Priority Date: 08/06/2004
  • Status: Active Grant
First Claim
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1. A method of sampling, testing and validating test lots for microbial contamination, comprising:

  • a) collecting a plurality of portions from each of a plurality of test lots, the test lots each comprising an assemblage of one or more specimens, wherein each test lot is separately sampled by taking said plurality of portions thereof;

    b) combining the collected plurality of portions corresponding to each of the separate test lots to provide a corresponding set of separate test lot samples, wherein each separate test lot sample is attributed to a particular corresponding separate test lot;

    c) incubating the set of separate test lot samples under conditions suitable to allow levels of a target microbial agent or organism that is present in one or more of the separate test lot samples to reach detectable levels and become uniform, or substantially uniform, throughout the respective one or more separate test lot samples, to provide a set of separate test lot samples enriched for the target microbial agent or organism;

    d) removing portions of each enriched separate test lot sample, and combining the removed portions to provide a modular composite sample; and

    e) testing of the modular composite sample, and individual testing of each of the enriched separate test lot samples, using at least one suitable detection assay, for the target microbial agent or organism, wherein when such testing is negative all of said separate test lot samples are validated, and wherein when such testing is positive with respect to the modular composite sample, or with respect to an individual enriched separate test lot sample, individual separate test lots may nonetheless yet be validated by further testing of a portion of respective initially negative enriched separate test lot samples using the same or a more sensitive protocol and obtaining a negative test result.

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