MODULAR COMPOSITING-MULTIPLE LOT SCREENING PROTOCOLS FOR DETECTION OF PATHOGENS, MICROBIAL CONTAMINANTS AND/OR CONSTITUENTS
First Claim
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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Accused Products
Abstract
Particular aspects provide a method of sampling, testing and validating test lots (e.g., single-unit production lots), comprising: assembling a plurality of product portions from each of a plurality of test lots and combining the collected product portions to provide a corresponding set of test lot samples (wherein each test lot sample is attributed to a particular corresponding test lot); enriching the set of test lot samples; removing equal portions of each enriched sample, and combining the removed portions to provide a modular composite sample; and testing of the modular composite sample for the target agent/organism, wherein where such testing is positive, individual test lots may nonetheless yet be validated by further testing of a respective enriched test lot sample and obtaining a negative test result. The methods have broad utility for monitoring all sorts of test lots (e.g., environmental lots, production lots, pharmaceutical lots, etc.) and for efficiently affecting informed, targeted remedial measures.
0 Citations
38 Claims
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1. A method of sampling and testing products for microbes in multiple separate lots, comprising:
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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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 21, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36)
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20. A method of sampling and testing products for microbe(s) in multiple separate lots, comprising:
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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. - View Dependent Claims (22, 37, 38)
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Specification