ANALYZER AND DISPOSABLE CARTRIDGE FOR MOLECULAR IN VITRO DIAGNOSTICS

• US 20130331298A1
• Filed: 06/06/2013
• Published: 12/12/2013
• Est. Priority Date: 06/06/2012
• Status: Abandoned Application

• Current Assignee: Vela Diagnostics Holding Pte. Ltd.
• Original Assignee: Great Basin Scientific
• Inventors: Rea, Larry
• Application Number:
  US13/911,878
• Publication Number:
  US 20130331298A1
• Time in Patent Office: Days
• US Class Current: 506/16
• CPC Class Codes: B01L 2200/0684 Venting, avoiding backpressure, avoid gas bubbles
• CPC Class Codes: B01L 2200/10 Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
• CPC Class Codes: B01L 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 2300/0672 Integrated piercing tool
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/0867 Multiple inlets and one sample wells, e.g. mixing, dilution
• CPC Class Codes: B01L 2400/0481 squeezing of channels or chambers
• CPC Class Codes: B01L 2400/0683 mechanically breaking a wall or membrane within a channel or chamber
• CPC Class Codes: B01L 2400/086 using baffles or other fixed flow obstructions
• CPC Class Codes: B01L 3/5027 by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip B01L3/5023 takes precedence; micromixers B01F33/30; microreactors for synthesis B01J19/0093; microcapillary devices in general B81B1/00
• 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: B01L 9/527 for microfluidic devices, e.g. used for lab-on-a-chip
• CPC Class Codes: C12Q 1/6844 Nucleic acid amplification reactions

Abstract

An in vitro diagnostics analyzer and assay cartridge for carrying out biochemical assays is disclosed. The analyzer includes a tilted clamp assembly for holding an assay cartridge, upper and lower motor assemblies for manipulating the assay cartridge, and an optical reader. The cartridge includes an injection port for receiving a biological sample, a central channel through which the sample passes, one or more processing chambers, one or more reagent containers, a detection chamber, and optionally a waste chamber. The analyzer and cartridge may be used for detection of a variety of analytes, including pathogens for medical diagnostics.

Claims

1. An assay cartridge comprising:

an injection port for receiving a sample;

a central channel originating at the injection port;

a plurality of processing chambers connected to the central channel;

a plurality of reagent containers connected to the central channel; and

a waste chamber.

2. The assay cartridge of claim 1, further comprising at least one bubble trap for removing air from the sample, the bubble trap being in fluid communication with the central channel or a fluid channel.

3. The assay cartridge of claim 2, further a second bubble trap in fluid communication with at least one of the plurality of reagent containers.

4. The assay cartridge of claim 1, wherein the plurality of chambers include:

a first mixing chamber for sample preparation;

an amplification chamber for amplifying a target genomic DNA suspected of being present in the biological sample, the chamber further comprising lyophilized amplification enzymes; and

a detection chamber having an array of probes immobilized on a silicon chip surface.

5. The assay cartridge of to claim 4, wherein the amplification chamber contains lyophilized thermophilic helicase-dependent enzyme.

6. The assay cartridge of claim 1, wherein the plurality of reagent containers include:

a first washing reagent container containing a washing medium;

a conjugating reagent container containing a conjugating agent; and

a precipitating reagent container containing precipitating reagent.

7. The assay cartridge of claim 6, wherein the plurality of reagent containers also include:

a dilution reagent container containing a dilution medium; and

a hybridization reagent container containing a hybridizing reagent.

8. The assay cartridge of claim 6, wherein the conjugating agent includes biotin-labeled primers complementary with some sequence within a variable region of a specific gene in the target genomic DNA.

9. The assay cartridge of claim 7, wherein the hybridizing reagent is anti-biotin antibody conjugated to the horseradish peroxidase enzyme.

10. The assay cartridge of claim 6, wherein the precipitating reagent is 3,3′

,5,5′

-tetramethylbenzidine.

11. The assay cartridge of claim 4, wherein the assay cartridge is tilted such that the detection chamber is at a higher elevation than the injection port.

12. The assay cartridge of claim 1, further comprising a plurality of thermal pads located adjacent to one or more of the processing chambers that require heating.

13. The assay cartridge of claim 1, further comprising one or more stirring rods, each of which is located in a processing chamber for mixing reagents and a sample.

14. An in vitro diagnostics analyzer comprising:

a tilted clamp assembly configured to hold an assay cartridge;

upper and lower motor assemblies operably connectable to one or more control valves, lances, and blister packs;

an optical reader.

15. The analyzer of claim 14 further comprising a plurality of optical sensors for measuring fluid flow through the cartridge.