Diagnostic instrument and flow process
Inventors
Thomas, Richard A. • Brochu, JR., Michael W. • Brochu, SR., Michael L. • Thomas, Ernest R. • Thomas, Michael A.
Assignees
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Publication Number
US-9568428-B2
Publication Date
2017-02-14
Expiration Date
Abstract
A diagnostic instrument having a cellular analysis system capable of running standardized immune monitoring panels. The system could include an automated and integrated specimen sampling method through a continuous flow process. The instrument could include a probe washer station, scheduler, cassette autoloader, bar coding system, and/or containment area common interface. An improved optimization test is proposed for instrument and flow cytometer quality assurance. The proposed method analyzes population separation for measuring instrument performance and/or sample quality. Such a method may also use population separation for measuring sample and/or run quality.
Core Innovation
The invention relates to a compact diagnostic instrument for analyzing a cellular sample in a specimen tube using fluorescence-based cellular analysis and a flow cytometer. The system integrates automated specimen handling with fluorescence-based flow cytometry to support standardized immune monitoring panels and automated immune monitoring workflows. A processor controls the instrument components to coordinate specimen movement, sample preparation handling, and flow cytometer aspiration and analysis.
The system directs a mixing station to move and orient specimen tubes using a rocker having an axis of rotation. A probe is displaceable above the rocker and above the well and transfers the cellular sample from an upright specimen tube to a well. The flow cytometer is coupled to the well, and the processor is programmed to control the mixing station, the probe, and the flow cytometer to aspirate from the well and analyze the cellular sample.
In addition, the instrument incorporates automated specimen sampling and reagent handling features such as an autoloader with cassette/autoloading, bar coding/tracking, mixing station operations, probe washing, and a common containment interface between sample prep and analysis. Automated data analysis is used to gate/population separation, verify and flag suspect results, and support quality assurance associated with resolution and sensitivity sufficiency.
Claims Coverage
Independent claim clm-00001 provides a workflow system with coordinated mechanical tube mixing/orientation, probe-based transfer into a well, and flow cytometer aspiration and cellular analysis. The independent claim is supported by multiple dependent claims that refine the inventive features by adding specific handling mechanisms and sample preparation actions.
Processor-coordinated rocking, orienting, probe transfer, and flow cytometer analysis
A processor controls a mixing station with a rocker to displace the specimen tube in a rocking motion about an axis of rotation perpendicular to the probe longitudinal axis, orient the specimen tube upright, displace the probe to transfer the cellular sample from the upright specimen tube to the well, and direct a flow cytometer to aspirate from the well and analyze the cellular sample.
Autoloader supplying tube cassettes to a cassette holder of the mixing station
An autoloader with a cassette queue is provided that holds a tube cassette and delivers the tube cassette to the cassette holder of the mixing station.
Probe piercing to transfer sample from a capped specimen tube
The system includes a specimen tube with a cap, and the processor directs a probe to pierce the cap to transfer the cellular sample.
Reagent station transferring reagent and scheduling incubation prior to aspiration
A reagent station transfers reagent from a reagent vial using a displaceable probe, schedules an incubation time for the reagent mixed with the cellular sample in a well, and directs the flow cytometer to aspirate from the well after incubation.
Multiwell interface mechanism with plate rotation axis and single-axis track alignment
An interface mechanism includes a plate base and rotation axis supporting multiple wells, and a processor positions and rotates the plate base so that each plurality of wells can be aligned beneath a deposit position via a single-axis track coupled to the well.
Across the independent claim and its refinements, the core coverage emphasizes a processor-directed coordinated system that rocks and orients a specimen tube, transfers a cellular sample via a displaceable probe into a well, and enables flow cytometer aspiration and analysis, with dependent claims further specifying autoloading/cassette delivery, cap piercing, reagent transfer with incubation scheduling, and multiwell interface alignment.
Stated Advantages
Reduced clinician labor by using automated specimen handling and a common containment interface between sample prep and analysis.
Quality assurance related to instrument and/or sample/run quality, including assessment using population separation and a Population Accuracy Value to address shortcomings of traditional bead-and-reagent QC tests.
Support for clinically relevant resolution/sensitivity sufficiency by correlating population separation metrics to resolution/sensitivity needs.
Documented Applications
Standardized immune monitoring panels using fluorescence-based flow cytometry with automated specimen handling workflows.
Quality assurance and optimization testing for flow cytometers using known patient control samples and population separation metrics (e.g., Population Accuracy Value) to assess instrument and/or sample/run quality and correlate to clinically relevant resolution/sensitivity sufficiency.
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