Assay cartridge with reaction well

• US 9,274,132 B2
• Filed: 01/23/2013
• Issued: 03/01/2016
• Est. Priority Date: 07/23/2010
• Status: Expired due to Fees

• Current Assignee: Beckman Coulter Incorporated (Danaher Corporation)
• Original Assignee: Beckman Coulter Incorporated (Danaher Corporation)
• Inventors: Wilson, Brian D., Anderson, David L., Davis, Matthew S., Erickson, Matthew D., Johnson, Alan N., Maurer, Garrick A., Rosen, Michael J., Sauerburger, Mark F., Schmidt, Daniel R., Wiltsie, Joshua D.
• Primary Examiner(s): Warden, Jill
• Assistant Examiner(s): WHATLEY, BENJAMIN R
• Application Number:
  US13/747,697
• Publication Number:
  US 20130130369A1
• Time in Patent Office: 1,133 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: B01L 2200/025 Align devices or objects to ensure defined positions relative to each other
• CPC Class Codes: B01L 2200/0642 Filling fluids into wells by specific techniques
• CPC Class Codes: B01L 2200/0668 Trapping microscopic beads
• CPC Class Codes: B01L 2200/12 Specific details about manufacturing devices
• CPC Class Codes: B01L 2200/147 Employing temperature sensors
• CPC Class Codes: B01L 2300/021 Identification, e.g. bar codes
• CPC Class Codes: B01L 2300/022 Transponder chips
• CPC Class Codes: B01L 2300/024 Storing results with means integrated into the container
• CPC Class Codes: B01L 2300/042 Caps; Plugs
• CPC Class Codes: B01L 2300/044 pierceable, e.g. films, membranes
• CPC Class Codes: B01L 2300/045 whereby the whole cover is slidable
• CPC Class Codes: B01L 2300/046 Function or devices integrated in the closure
• CPC Class Codes: B01L 2300/0654 Lenses; Optical fibres
• CPC Class Codes: B01L 2300/0851 Bottom walls
• CPC Class Codes: B01L 2300/123 Flexible; Elastomeric
• CPC Class Codes: B01L 2300/18 Means for temperature control
• CPC Class Codes: B01L 2300/1822 using Peltier elements
• CPC Class Codes: B01L 2300/1827 using resistive heater
• CPC Class Codes: B01L 2400/043 magnetic forces
• CPC Class Codes: B01L 3/021 Pipettes, i.e. with only one conduit for withdrawing and redistributing liquids
• CPC Class Codes: B01L 3/0275 : Interchangeable or disposable dispensing tips
• CPC Class Codes: B01L 3/50825 : Closing or opening means, corks, bungs closures for containers B65D; means for removing stoppers B67B7/02
• CPC Class Codes: B01L 3/5085 : for multiple samples, e.g. microtitration plates
• CPC Class Codes: B01L 3/50851 : specially adapted for heating or cooling samples laboratory heating apparatus B01L7/00; incubators C12M
• CPC Class Codes: B01L 3/52 : Containers specially adapted for storing or dispensing a reagent B01L3/02 takes precedence; containers for medical or pharmaceutical purposes A61J1/00; containers in general B65D; storing or dispensing test elements G01N33/4875; automated reagent dispensing G01N35/1002
• CPC Class Codes: B01L 3/545 : for laboratory containers
• CPC Class Codes: B01L 7/52 : with provision for submitting samples to a predetermined sequence of different temperatures, e.g. for treating nucleic acid samples amplification or hybridisation processes per se C12Q1/68; controlling sequential reactions for synthesis B01J19/0046
• CPC Class Codes: C12M 41/12 : of temperature controlling the temperature of chemical or physical processes B01J19/0013, heating or cooling apparatus for laboratory use B01L7/00
• CPC Class Codes: C12P 19/34 : Polynucleotides, e.g. nucleic acids, oligoribonucleotides
• CPC Class Codes: C12Q 1/68 : involving nucleic acids
• CPC Class Codes: C12Q 1/686 : Polymerase chain reaction [PCR]
• CPC Class Codes: C12Q 3/00 : Condition responsive control processes apparatus therefor C12M1/36; controlling or regulating in general G05
• CPC Class Codes: G01F 23/24 : by measuring variations of resistance of resistors due to contact with conductor fluid
• CPC Class Codes: G01F 23/26 : by measuring variations of capacity or inductance of capacitors or inductors arising from the presence of liquid or fluent solid material in the electric or electromagnetic fields
• CPC Class Codes: G01N 1/31 : Apparatus therefor
• CPC Class Codes: G01N 1/38 : Diluting, dispersing or mixing samples
• CPC Class Codes: G01N 2035/00435 : Refrigerated reagent storage
• CPC Class Codes: G01N 2035/00752 : bar codes
• CPC Class Codes: G01N 2035/00851 : process control parameters
• CPC Class Codes: G01N 2035/0413 : moving in one dimension
• CPC Class Codes: G01N 2035/0415 : moving in two dimensions in a horizontal plane
• CPC Class Codes: G01N 2035/0436 : with pre-packaged reagents, i.e. test-packs
• CPC Class Codes: G01N 2035/0465 : Loading or unloading the conveyor
• CPC Class Codes: G01N 2035/0475 : electric, e.g. stepper motor, solenoid
• CPC Class Codes: G01N 2035/1013 : Confirming presence of tip
• CPC Class Codes: G01N 2035/1025 : Fluid level sensing
• CPC Class Codes: G01N 2035/1048 : using the transfer device for another function
• CPC Class Codes: G01N 2035/1051 : for transporting containers, e.g. retained by friction
• CPC Class Codes: G01N 2035/1076 : plurality or independently movable heads
• CPC Class Codes: G01N 35/00732 : Identification of carriers, materials or components in automatic analysers
• CPC Class Codes: G01N 35/0092 : Scheduling
• CPC Class Codes: G01N 35/0098 : involving analyte bound to insoluble magnetic carrier, e.g. using magnetic separation magnetic particles used in immunoassays G01N33/54326; magnetic separation in general B03C
• CPC Class Codes: G01N 35/04 : Details of the conveyor system G01N35/021 - G01N35/028 take precedence
• CPC Class Codes: G01N 35/1002 : Reagent dispensers
• CPC Class Codes: G01N 35/1011 : Control of the position or alignment of the transfer device
• CPC Class Codes: G01N 35/1016 : Control of the volume dispensed or introduced
• CPC Class Codes: G01N 35/1081 : characterised by the means for relatively moving the transfer device and the containers in an horizontal plane G01N35/1011 takes precedence
• CPC Class Codes: G05B 13/02 : electric
• CPC Class Codes: G05B 13/0205 : not using a model or a simulator of the controlled system
• CPC Class Codes: G16B 25/20 : Polymerase chain reaction [PCR]; Primer or probe design; Probe optimisation
• CPC Class Codes: G16B 99/00 : Subject matter not provided for in other groups of this subclass
• CPC Class Codes: Y10T 436/113332 : with conveyance of sample along a test line in a container or rack

Abstract

Systems and methods for processing and analyzing samples are disclosed. The system may process samples, such as biological fluids, using assay cartridges which can be processed at different processing locations. In some cases, the system can be used for PCR processing. The different processing locations may include a preparation location where samples can be prepared and an analysis location where samples can be analyzed. To assist with the preparation of samples, the system may also include a number of processing stations which may include processing lanes. During the analysis of samples, in some cases, thermal cycler modules and an appropriate optical detection system can be used to detect the presence or absence of certain nucleic acid sequences in the samples. The system can be used to accurately and rapidly process samples.

Claims

1. An assay cartridge, comprising:

an elongated body, comprising;

(a) a reaction well formed in the elongated body and including a first sidewall, a second sidewall, a first endwall, a second endwall, and a well floor arranged to receive a reaction mixture, the first sidewall, the second sidewall, the first endwall, and the second endwall forming an open end, and the first sidewall and the second sidewall being generally parallel to an axis of the assay cartridge,

(b) a plurality of reagent compartments formed in the elongated body, each reagent compartment including an upper end and respectively comprising a plurality of reagents useful for extracting a nucleic acid,

(c) a barrier film covering the upper ends of the plurality of reagent compartments,

(d) a film piercer capable of piercing the barrier film, and

(e) a retaining location in the elongated body formed to hold the film piercer,

wherein the first endwall includes a first segment and a second segment, the first and second segment joined by a bend, at least one of the first segment and second segment being tapered so that a cross section of the reaction well decreases closer to the well floor,

wherein a mid-plane is defined by the first sidewall and the second sidewall, and the second segment has a radius about the mid-plane to create a culvert, and

wherein the retaining location comprises the open end of the reaction well and holds the film piercer, such that the film piercer substantially covers the open end of the reaction well.

2. The assay cartridge of claim 1, wherein the first segment is closer to the open end than the second segment and has a first taper, and the second segment is farther from the open end than the first segment and has a second taper, the second taper being greater compared to the first taper so as to decrease the cross section of the reaction well at a greater rate.

3. The assay cartridge of claim 1, wherein the culvert is further defined by a segment of a frusto-conical surface.

4. The assay cartridge of claim 1, wherein the first sidewall includes a tapered segment adjacent to the well floor, the tapered segment being arranged to decrease the cross section of the reaction well close to the well floor.

5. The assay cartridge of claim 1, wherein the well floor is tapered, and the second segment is adjacent to the well floor.

6. The assay cartridge of claim 2, wherein the first taper comprises a first interior surface, the first interior surface facing a center of the well, and the second taper comprises a second interior surface, the second interior surface facing the center of the well, the first interior surface and the second interior surface having obtuse angles relative to a vertical axis of the reaction well.

7. The assay cartridge of claim 2, wherein the first taper comprises a first interior surface, the first interior surface facing a center of the well, and angled from 150°

to 170°

relative to a vertical axis of the reaction well, and wherein the second taper comprises a second interior surface, the second interior surface facing the center of the well and angled from 135°

to 155°

relative to the vertical axis of the reaction well.

8. The assay cartridge of claim 2, wherein the first taper comprises a first interior surface, the first interior surface facing a center of the well and angled about 160°

relative to a vertical axis of the reaction well, and wherein second taper comprises a second interior surface, the second interior surface facing the center of the well and angled about 145°

relative to the vertical axis of the reaction well.

9. The assay cartridge of claim 1, further comprising an additional compartment formed in the elongated body that contains at least one of a pipette tip, a reaction vessel, a magnetically responsive particle, and a reagent.

10. The assay cartridge of claim 1, further comprising an additional compartment holding a pipette tip.

11. The assay cartridge of claim 1, wherein the first and second sidewalls taper toward a midline of the assay cartridge.

12. The assay cartridge of claim 1, further comprising:

first and second longitudinal walls, and first and second transverse walls,

wherein the first and second longitudinal walls and the first and second transverse walls surround the open end of the reaction well and form a containment region.

13. The assay cartridge of claim 1, wherein the assay cartridge comprises a proximal end and a distal end, and wherein the first endwall is a proximal endwall.

14. The assay cartridge of claim 13, wherein the reaction well is arranged at the proximal end of the assay cartridge and an additional compartment is arranged at the distal end of the reagent cartridge.

15. The assay cartridge of claim 1, further comprising a vertical web formed in the elongated body.

16. The assay cartridge of claim 15, further comprising a keying feature formed in the vertical web.

17. The assay cartridge of claim 1, wherein the elongated body further comprises a tip compartment in the elongated body, the tip compartment including a pipette tip.

18. The assay cartridge of claim 17, wherein the film piercer includes a closed end and a gripping end, the closed end including a piercing element, and the gripping end being formed for engaging a mandrel of a pipettor.

19. The assay cartridge of claim 18, wherein the piercing element includes a pyramidal blade.

20. The assay cartridge of claim 1, wherein the elongated body further comprises a floor connecting the upper ends of each reagent compartment of the plurality of reagent compartments, a skirting wall lateral to and parallel to the mid-plane and extending from the floor above the upper ends, and a cartridge flange parallel to the floor and extending lateral to the skirting wall, wherein the plurality of reagent compartments and the reaction well align with each other in a single file.

21. The assay cartridge of claim 20, wherein the cartridge flange is not coplanar with the floor.