Point of Sampling Kit and Method for Assessing Endotoxin Contamination

A point-of-use kit is designed for optically detecting and quantifying bacterial endotoxin by employing specific formulations of Limulus amebocyte lysate (LAL), each formulation designed to optimize results with different sample classes. Kits are pre-certified for use with a variety of environmental...

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Bibliographic Details
Main Authors Paus, Erik J, Novitsky, Thomas J
Format Patent
LanguageEnglish
Published 27.10.2022
Subjects
INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIRCHEMICAL OR PHYSICAL PROPERTIES
MEASURING
PHYSICS
TESTING
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Summary:A point-of-use kit is designed for optically detecting and quantifying bacterial endotoxin by employing specific formulations of Limulus amebocyte lysate (LAL), each formulation designed to optimize results with different sample classes. Kits are pre-certified for use with a variety of environmental, industrial, and clinical samples, each sample category having a unique kit design and containing a unique lysate reagent formulation. Pre-certification transfers time and reagent consuming tasks, such as assessment of sample compatibility and sample effect on reagent sensitivity to endotoxin from the user to the kit producer. A fixed dilution/sample treatment is employed, eliminating the need for a comparative water standard and for a sample positive control. The kit has LAL reagent prepackaged in dry polyethylene capped tubes, which retains reagent shelf life and optical clarity for accurate and reproducible results using a portable spectrophotometer/optical reader.
Bibliography:Application Number: US202217660039