Modular compositing-multiple lot screening protocols for detection of pathogens, microbial contaminants and/or constituents
DCFirst Claim
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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Abstract
Provided are methods for sampling, testing and validating test lots, comprising: assembling a plurality of product portions from each of a plurality of test lots and combining the portions to provide a corresponding set of test lot samples; enriching the test lot samples; removing portions of each enriched sample, and combining the removed portions to provide a modular composite sample; and testing of the modular composite sample, and individual testing of the enriched test lot samples, using at least one suitable detection assay for a target microbe or organism, wherein when such testing is negative all test lots are validated, and wherein when such testing is positive with respect to the modular composite sample, or with respect to an individual enriched test lot sample, individual test lots may nonetheless yet be validated by further testing of a portion of respective initially-negative enriched test lot samples and obtaining negative results.
12 Citations
34 Claims
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1. A method of sampling, testing and validating test lots for microbial contamination, comprising:
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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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 33, 34)
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19. A method of sampling, testing and validating test lots for microbial contamination, comprising:
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a) collecting a plurality of portions from each of a plurality of single-unit production lots, the single-unit production lots each comprising an assemblage of one or more product specimens, wherein each single-unit production lot is separately sampled by taking said plurality of portions thereof; b) combining the collected plurality of product portions corresponding to each of the separate single-unit production lots to provide a corresponding set of separate single-unit production lot samples, wherein each separate single-unit production lot sample is attributed to a particular corresponding separate single-unit production lot; c) incubating the set of separate single-unit production 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 single-unit production lot samples to reach detectable levels and become uniform, or substantially uniform, throughout the respective one or more separate single-unit production lot samples, to provide a set of separate single-unit production lot samples enriched for the target microbial agent or organism; d) removing portions of each enriched separate single-unit production 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 single-unit production lot samples are validated, and wherein when such testing is positive with respect to the modular composite sample, or with respect to an individual separate enriched test lot sample, individual separate single-unit production lots may nonetheless yet be validated by further testing of a portion of respective initially negative enriched separate single-unit production lot samples using the same or a more sensitive protocol and obtaining a negative test result. - View Dependent Claims (32)
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Specification