Systems and methods for automated analysis

Patent metadata

Field	Value
Publication number	US-12025630-B2
Application number	US-202016994163-A
Country	US
Kind code	B2
Filing date	Aug 14, 2020
Priority date	Mar 15, 2016
Publication date	Jul 2, 2024
Grant date	Jul 2, 2024

Abstract

Aspects of the present disclosure include sample analysis methods and systems. According to certain embodiments, provided are methods of analyzing samples in an automated sample analysis system. The methods include introducing samples and sample preparation cartridges into the system, isolating and purifying an analyte (e.g., nucleic acids and/or proteins) present in the samples at a sample preparation station, and performing analyte detection assays in assay mixtures that include the purified analyte. Also provided are automated sample analysis systems that find use, e.g., in performing the methods of the present disclosure. In certain aspects, the methods and systems provide for continuous operator access during replenishment or removal of one or any combination of samples, bulk fluids, reagents, commodities, waste, and/or the like.

First claim

What is claimed is:

1. An automated sample analysis system, comprising:
a sample loading area comprising two or more sample loading positions, each sample loading position structurally engages with a sample tube rack comprising sample tubes so as to receive the sample tube rack;
a sample processing (SP) cartridge loading area comprising two or more SP cartridge loading positions, each SP cartridge loading position structurally engages an SP cartridge so as to receive the SP cartridge, the SP cartridge comprising one or more sample wells, each sample well adapted to receive a sample;
an SP cartridge bulk reagent filling station comprising two or more SP cartridge filling positions, each SP cartridge filling position structurally engages an SP cartridge so as to position the SP cartridge for filling one or more bulk reagents in the SP cartridge;
an SP cartridge sample filling station comprising two or more SP cartridge sample filling positions, each SP cartridge sample filling position structurally engages an SP cartridge so as to position the SP cartridge for receiving a sample from the robotic pipettor;
a robotic pipettor aspirates samples from the sample tubes from the sample loading area and dispenses the samples into the SP cartridges at the SP cartridge sample filling station;
a sample preparation station comprising two or more SP cartridge sample preparation positions, each SP cartridge sample preparation position structurally engages with an SP cartridge so as to position the SP cartridge for engaging with hardware that processes a sample in the SP cartridge for analysis;
a robotic SP cartridge handler that transports an SP cartridge between various positions in the SP cartridge loading area, the SP cartridge bulk reagent filling station, the SP cartridge sample filling station, and the sample preparation station;
a sample analysis station comprising two or more sample analysis units, each sample analysis unit comprising one or more sample analysis wells and a hardware that analyzes an analyte; and
a sample analysis system control center controls the automated sample analysis system,
wherein, duplication of positions within each of the sample loading area, the SP cartridge loading area, the SP cartridge bulk reagent filling station, the SP cartridge sample filling station, and the sample preparation station allows for continuous access by an operator without ceasing sample analysis in the system for replenishment or removal of: sample tube racks, SP cartridges, bulk reagents, and waste generated during sample preparation and analysis of the samples.

2. The automated analysis system of claim 1 , wherein the system is adapted to perform two or more different assays on any of the one or more samples.

3. The automated analysis system of claim 1 , wherein the two or more sample loading positions comprise two or more lanes, each lane adapted to receive a sample tube rack comprising one or more sample tubes.

4. The automated analysis system of claim 3 , wherein the sample loading area comprises from 2 to 20 lanes, each lane adapted to receive a sample tube rack.

5. The automated analysis system of claim 1 , wherein the sample loading area comprises a sample tube identification code reader.

6. The automated analysis system of claim 1 , wherein the sample tube identification code reader reads an identification code present on sample tubes present in a sample tube rack as the sample tube rack is loaded into the system.

7. The automated analysis system of claim 1 , wherein the sample loading area comprises a sample tube rack identification code reader.

8. The automated analysis system of claim 1 , wherein the robotic SP cartridge handler transports an SP cartridge from the SP cartridge loading area to one of the two or more positions of the SP cartridge bulk reagent filling station.

9. The automated analysis system of claim 8 , wherein the robotic SP cartridge handler transports an SP cartridge from the SP cartridge bulk reagent filling station to one of the two or more positions of the SP cartridge sample filling station.

10. The automated analysis system of claim 9 , wherein the robotic SP cartridge handler transports an SP cartridge from the SP cartridge sample filling station to one of the two or more positions of the sample preparation station.

11. The automated analysis system of claim 1 , comprising a pipette tip storage area.

12. The automated analysis system of claim 11 , wherein the robotic pipettor picks up a disposable pipette tip from the pipette tip storage area, aspirates a sample from a sample tube present at the sample loading area, and dispenses the sample into one of the one or more sample wells of the SP cartridge.

13. The automated analysis system of claim 1 , further comprising an ancillary reagent tube in an ancillary reagent loading area, and wherein the robotic pipettor aspirates the ancillary reagent from the ancillary reagent tube present in the ancillary reagent loading area of the system and dispenses the ancillary reagent into a sample well from the one or more sample wells of the SP cartridge.

14. The automated analysis system of claim 13 , wherein the ancillary reagent includes magnetic particles.

15. The automated analysis system of claim 14 , wherein the ancillary reagent loading area further comprises a mixing motor, and wherein the magnetic particles are maintained in suspension by the mixing motor in the ancillary reagent loading area.

16. The automated analysis system of claim 15 , wherein a bottom portion of the ancillary reagent tube is inserted into the mixing motor, and the mixing motor alternatingly rotates the ancillary reagent tube in counterclockwise and clockwise directions to maintain the magnetic particles in suspension.

17. The automated analysis system of claim 12 , wherein the robotic pipettor aspirates a purified sample from the one of the one or more sample wells of the SP cartridge that has been subjected to an analyte purification process in the sample preparation station, and dispenses the purified sample into an assay reagent well of an assay reagent plate.

18. The automated analysis system of claim 17 , wherein the assay reagent well comprises lyophilized assay reagents.

19. The automated analysis system of claim 18 , wherein the robotic pipettor transfers a mixture comprising the purified sample and assay reagents from the assay reagent plate to a reaction vessel.

20. The automated analysis system of claim 19 , wherein the reaction vessel is present in the SP cartridge.

21. The automated analysis system of claim 19 , wherein the robotic pipettor picks up a reaction vessel cap and caps the reaction vessel.

22. The automated analysis system of claim 21 , wherein the robotic pipettor picks up the capped reaction vessel and transports the capped reaction vessel to a well of the one or more wells of one of the sample analysis units of the sample analysis station.

23. The automated analysis system of claim 1 , wherein the system is an automated nucleic acid analysis system, comprising a thermal cycler and a fluorescence detector.

24. The automated analysis system of claim 23 , wherein the sample preparation station is a nucleic acid isolation and purification station, comprising reagents for isolation and purification of nucleic acids from samples.

25. The automated analysis system of claim 24 , wherein the sample preparation station is a magnetic particle-based nucleic a

Assignees

• Abbott Molecular Inc

Inventors

• Bryant Jason E
• Casazza Daniel P
• Harris Daniel J
• Johnson Brett W
• Nana Sonal S
• Patno Timothy J
• Pawlowski Frank
• Peters David M
• Skinner Joseph P
• Talmer Mark

Classifications

• G01N2035/0401

  Sample carriers, cuvettes or reaction vessels · CPC title

• G01N2021/6439

  with indicators, stains, dyes, tags, labels, marks · CPC title

• G01N2021/6432

  Quenching · CPC title

• G01N35/04

  Details of the conveyor system {(G01N35/021 - G01N35/028 take precedence)} · CPC title

• G01N35/026

  having blocks or racks of reaction cells or cuvettes · CPC title