Systems and methods for multi-analysis

Patent metadata

Field	Value
Publication number	US-9810704-B2
Application number	US-201414183500-A
Country	US
Kind code	B2
Filing date	Feb 18, 2014
Priority date	Feb 18, 2013
Publication date	Nov 7, 2017
Grant date	Nov 7, 2017

Abstract

Systems and methods are provided for sample processing. A device may be provided, capable of receiving the sample, and performing one or more of a sample preparation, sample assay, and detection step. The device may be capable of performing multiple assays. The device may comprise one or more modules that may be capable of performing one or more of a sample preparation, sample assay, and detection step. The device may be capable of performing the steps using a small volume of sample.

First claim

What is claimed is:

1. A point-of-service, benchtop biological sample processing device comprising:
a housing containing therein:
an automated sample handling system comprising a fluid handling apparatus comprising a pipette having a nozzle configured to: a) engage and hold a pipette tip and b) to engage and hold a microscopy cuvette, wherein said microscopy cuvette is configured to engage said pipette nozzle;
a first detection station comprising an electronic optical sensor;
a second detection station comprising a light source and an electronic optical sensor or sensing device;
a cytometry station comprising an imaging device and a stage for receiving said microscopy cuvette;
a centrifuge;
a convective flow unit to provide thermally conditioned airflow to maintain a desired air temperature range in the housing;
one or more temperature sensors to provide feedback to a controller to adjust air temperature;
a fan for exhausting air flow through a filtered outlet on the housing;
a cartridge receiving location;
wherein the automated sample handling system is configured to have fluid handling apparatus movable to individually access each of the following: first detection station, second detection station, cytometry station, centrifuge, and cartridge receiving location.

2. The biological sample processing device of claim 1 , wherein the biological sample has a volume of no greater than 500 microliters.

3. The biological sample processing device of claim 1 , wherein the second detection station comprises a nucleic acid assay station, wherein the light source and electronic optical sensor or sensing device of the second detection station are contained within the nucleic acid assay station.

4. The biological sample processing device of claim 3 , wherein the nucleic acid assay station comprises a thermal block.

5. The biological sample processing device of claim 3 , wherein the nucleic acid assay station comprises at least a first well and a second well, and the first well is configured for the measurement of the fluorescence of samples and the second well is configured for the measurement of the turbidity of samples.

6. The biological sample processing device of claim 1 , wherein the biological sample processing device further comprises a third detection station, wherein the cartridge further contains a fourth assay unit, wherein the fourth assay unit comprises gear teeth, and wherein the biological sample processing device is configured to transport the fourth assay unit to the third detection station by using a gear mechanism to engage the gear teeth in the assay unit.

7. The biological sample processing device of claim 1 , wherein the biological sample processing device further contains therein a barometer.

8. The biological sample processing device of claim 1 , wherein the electronic optical sensor is selected from the group of electronic optical sensors consisting of photodiodes, photomultiplier tubes (PMTs), Charge-Coupled Devices (CCDs), super-cooled CCD arrays, CMOS sensors, photodetectors, photon counting detectors, avalanche photodiodes, avalanche photodiode arrays, pin diodes, spectrophotometers, and electronic cameras.

9. A method for performing multiple assays with a biological sample, the method comprising:
providing a point-of-service, benchtop biological sample processing device
comprising a housing containing therein:
an automated sample handling system comprising a fluid handling apparatus comprising a pipette having a nozzle configured to: a) engage and hold a pipette tip and b) to engage and hold a microscopy cuvette, wherein said microscopy cuvette is configured to engage said pipette nozzle;
a first detection station comprising an electronic optical sensor;
a second detection station comprising a light source and an electronic optical sensor;
a cytometry station comprising an imaging device and a stage for receiving said microscopy cuvette; and a cartridge, wherein the cartridge is insertable into and removable from the biological sample processing device, and wherein the cartridge contains i) a biological sample, ii) at least a first, a second, and a third fluidically isolated assay unit, and iii) all reagents that are required to perform a first, second, and third assay comprising A) at least one luminescence assay; B) at least one absorbance, turbidimetric, fluorescence, or colorimetric assay; and C) at least one cytometry assay, and wherein the first assay unit is configured to perform a luminescence assay, the second assay unit is configured to perform an absorbance, turbidimetric, fluorescence, or colorimetric assay, the third assay unit is configured to perform a cytometry assay, and
transferring, by the fluid handling apparatus of the automated sample handling system, said microscopy cuvette to said stage of said cytometry station;
transferring by the automated sample handling system at least a portion of the biological sample to each of the first, second, and third assay units;
transferring by the automated sample handling system the first assay unit containing biological sample to the first detection station;
transferring by the automated sample handling system the second assay unit containing biological sample to the second detection station;
transferring by the automated sample handling system the third assay unit containing biological sample to the cytometry station, wherein said third assay unit comprises said microscopy cuvette configured to perform a cytometry assay, said microscopy cuvette having at least one cavity configured to accept a sample, and having at least one pick-up interface configured to engage with said fluid handling apparatus, said transferring comprising said pipette nozzle engaging and holding said pick-up interface of said microscopy cuvette and moving said microscopy cuvette by said pipette while said microscopy cuvette is held by said pipette nozzle; and
transferring from the cartridge to the first, second, and third assay units, respectively, all reagents required for the performance of the first, second, and third assays to the respective assay units;
wherein the sample processing device also contains a centrifuge;
a convective flow unit to provide thermally conditioned airflow to maintain a desired air temperature range in the housing;
one or more temperature sensors to provide feedback to a controller to adjust air temperature;
a fan for exhausting air flow through a filtered outlet on the housing.

10. The method of claim 9 , wherein the biological sample has a volume of no greater than 500 microliters.

11. The method of claim 9 , wherein a turbidimetric assay is performed in the second assay unit, and wherein the turbidity of the turbidimetric assay is measured over a period of time.

12. The method of claim 9 , wherein the electronic optical sensor is selected from the group of electronic optical sensors consisting of photodiodes, photomultiplier tubes (PMTs), Charge-Coupled Devices (CCDs), super-cooled CCD arrays, CMOS sensors, photodetectors, photon counting detectors, avalanche photodiodes, avalanche photodiode arrays, pin diodes, spectrophotometers, and electronic cameras.

13. The method of claim 9 , wherein the cytometry assay comprises determining the number of at least one type of cell per selected volume of biological sample, the at least one type of cell being selected from the group consisting of: monocytes, lymphocytes, neutrophils, basophils, and eosinophils.

14. The method of claim 9 , wherein the biological sample is from a subject, and wherein prior to insertion of the cartridge into the biological sample processing device, the subject's insu

Assignees

• Theranos Inc

Inventors

• Holmes Elizabeth A
• Balwani Sunny
• Chen Michael
• Frankovich John K
• Frenzel Gary
• Anekal Samartha
• Lath Adrit
• Loo Alexander
• Pangarkar Chinmay
• Roy Joy
• Smith Timothy
• Young Daniel

Classifications

• B01L2300/1827

  using resistive heater · CPC title

• G01N35/0092 Primary

  Scheduling · CPC title

• C12Q1/6883

  for diseases caused by alterations of genetic material · CPC title

• G01N33/54306

  Solid-phase reaction mechanisms · CPC title

• B01L3/021

  Pipettes, i.e. with only one conduit for withdrawing and redistributing liquids · CPC title