Reagent cartridge mixing tube method

Inventors

Vincent, KathleenTalmer, MarkSchroeder, Gerhardt P.

Assignees

Biokit SA

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Publication Number

US-9636647-B2

Patent

Publication Date

2017-05-02

Expiration Date


Abstract

A clinical instrument analyzer system for automated analysis of patient samples with a system for suspending particles or methods for the separation of particles, such as magnetic particles, is described herein. The system for suspending particles comprises a reagent cartridge comprising a reagent holder for holding a plurality of tubes. The plurality of tubes comprise a mixing tube for holding particles, rotatably mounted in the holder and a motor operatively connectable to a slot longitudinally positioned on the lower section of the mixing tube. The particles in the mixing tube are suspended when the mixing tube rotates in accordance with the embodiments of the invention. The analyzer can be used to analyze bodily fluid samples, such as blood, plasma, serum, urine or cerebrospinal fluid.

Core Innovation

The invention relates to a clinical analyzer system that uses a disposable reagent cartridge and a reagent holder containing a rotatably mounted mixing tube. The mixing tube is used for uniformly suspending magnetic particles in a solution within the cartridge, including for biological fluids such as blood, plasma, serum, urine, and cerebrospinal fluid.

The mixing tube comprises a cylinder with a first agitating member and a second agitating member, and includes internal and external structural features for turbulence generation. The agitation members include longitudinal grooves or blades, and optional additional agitating members may be provided to generate turbulence for suspension of magnetic particles.

In the lower section of the mixing tube, at least one slot is longitudinally positioned and has one end open on the lower section of the tube. The lower section is engaged with a motor operatively connected to the slot, where the motor comprises a linear actuator for engaging the slot, and a set of pins may engage the lower section to rotate the tube.

Suspension is presented as important for downstream magnetic separation and luminometric immunoassays. The document further describes mixing protocols using bidirectional rotation or oscillation with multi-phase sequences, including phases that include complete rotations and predetermined complete or partial rotations, to obtain a suspension of the magnetic particles in the solution.

Claims Coverage

The independent claim covers a method of suspending magnetic particles in a solution using a mixing tube structure with first and second agitating members and a lower-section slot driven by a motor with a linear actuator, where rotation follows a mixing protocol. The claim coverage also includes turbulence generation and bidirectional multi-phase mixing protocols.

Suspending magnetic particles in a mixing tube with first and second agitating members

Providing a magnetic particle solution in a mixing tube, wherein the mixing tube comprises a cylinder with a first agitating member and a second agitating member, having a top end and a lower section positioned on an end opposite to the top end.

Lower-section slot engaged by a motor with a linear actuator

Providing the mixing tube where the lower section further comprises at least one slot longitudinally positioned on the lower section and having one end positioned and open on the lower section of the tube; engaging the lower section with a motor operatively connected to the slot, the motor comprising a linear actuator for engaging the slot.

Rotating the mixing tube according to a mixing protocol

Rotating the mixing tube via the motor according to a mixing protocol to obtain a suspension of the magnetic particles in the solution.

Bidirectional multi-phase mixing protocol

Rotating the mixing tube first in a first direction for a first period of time and then in a second direction for a second period of time, including multiple phases where each phase rotates a predetermined number of complete or partial rotations in one direction and then rotates in a different direction.

Turbulence generation using rotating or oscillating agitating members

Rotating or oscillating first and second agitating members with the mixing tube to create turbulence in the solution.

Motor pin engagement of the lower section

The motor includes at least one pin that engages the lower section of the mixing tube to actuate its rotation.

Overall, the claim coverage centers on suspending magnetic particles by using a mixing tube with first and second agitating members for turbulence, a lower-section slot engaged by a motor having a linear actuator, optionally with pins, and performing a mixing protocol that includes bidirectional multi-phase rotation or oscillation.

Stated Advantages

Uniform suspension of magnetic particles.

Suspension that is important for downstream magnetic separation and luminometric immunoassays.

Documented Applications

Clinical analyzer system using a disposable reagent cartridge and reagent holder for luminometric immunoassays using magnetic separation.

Suspension of magnetic particles in biological fluids including blood, plasma, serum, urine, and cerebrospinal fluid for downstream magnetic separation and luminometric detection.

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