Instrument and system for rapid microorganism identification and antimicrobial agent susceptibility testing
Inventors
Richards, William L. • Ashby, Austin • Ketterer, Matthew • Marshall, Kevin • Harrison, Josh • Mette, Matthew • Richards, Paul • Showalter, Wayne • Cote, Jasmin • Halbert, Phillip C. • Bourgeois, Solene • Metzger, Steven W. • Hance, Ken • Mensack, Meghan • Michel, Carlos • Allers, Elke • Gamage, Dulini • Prisbrey, Landon • Gusyatin, Oleg • Shamsheyeva, Alena • Turng, Ben • Ghusson, Andrew • Reinhardt, Kurt
Assignees
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Publication Number
US-10253355-B2
Publication Date
2019-04-09
Expiration Date
Abstract
A system for automated microorganism identification and antibiotic susceptibility testing comprising a reagent cartridge, a reagent stage, a cassette, a cassette, stage, a pipettor assembly, an optical detection system, and a controller is disclosed. The system is designed to dynamically adjust motor idle torque to control heat load and employs a fast focus process for determining the true focus position of an individual microorganism. The system also may quantify the relative abundance of viable microorganisms in a sample using dynamic dilution, and facilitate growth of microorganisms in customized media for rapid, accurate antimicrobial susceptibility testing. Automated quality control test components and methods of their use are also disclosed.
Core Innovation
The invention provides an automated antibiotic susceptibility testing (AST) quality control (QC) component comprising a frame including a plurality of wells, at least one microbial isolate in at least one of the plurality of wells, and at least one clip attached to the frame where the clip interacts with a reagent cartridge. The component further includes a means of identifying the component as an AST QC test by an automated system.
The invention further provides an automated microbial identification (ID) quality control (QC) component comprising a frame including a plurality of wells and at least one clip attached to the frame. The ID QC component includes at least one target microbial nucleic acid molecule in at least one of the plurality of wells, and is configured such that the component interlocks with an antibiotic susceptibility QC component.
The automated QC components are configured for interlocking and for automated machine-readable identification so the correct QC type can be determined by the automated system. The QC design integrates the wells, clip interaction with a reagent cartridge, target microbial nucleic acid content, and interlocking relationship between the microbial ID QC component and the antibiotic susceptibility QC component.
Claims Coverage
The provided material includes two independent claims: one directed to an automated antibiotic susceptibility testing (AST) quality control (QC) component and one directed to an automated microbial identification (ID) quality control (QC) component. Each independent claim contains core inventive features centered on a frame with a plurality of wells, clip-based cartridge interaction or interlocking, and automated system identification as a QC test.
Automated AST QC component with cartridge-interacting clip and automated identification
A frame including a plurality of wells; at least one clip attached to the frame wherein the at least one clip interacts with a reagent cartridge; at least one microbial isolate in at least one of the plurality of wells; and a means of identifying the component as an AST QC test by an automated system.
Automated microbial ID QC component interlocking with an antibiotic susceptibility QC component
A frame including a plurality of wells; at least one clip attached to the frame; at least one target microbial nucleic acid molecule in at least one of the plurality of wells; the microbial ID QC component being configured to interlock with an antibiotic susceptibility QC component; and a means of identifying the component as a microbial ID QC test by an automated system.
Across the two independent claims, the key claim coverage centers on QC components built from a frame with a plurality of wells, clip structures that interact with a reagent cartridge or interlock with an antibiotic susceptibility QC component, content in the wells, and automated means of identifying each component as its corresponding QC test.
Stated Advantages
Improves an effective QC pass rate by about 20% to about 30% compared with a manual quality control test procedure.
Documented Applications
Automated AST quality control testing as an AST QC test component in an automated system.
Automated microbial identification (ID) quality control testing as a microbial ID QC test component in an automated system, configured to interlock with antibiotic susceptibility QC testing.
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