Systems and methods for multi-analysis

Patent metadata

Field	Value
Publication number	US-2016103123-A1
Application number	US-201514918090-A
Country	US
Kind code	A1
Filing date	Oct 20, 2015
Priority date	Feb 18, 2013
Publication date	Apr 14, 2016
Grant date	—

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

1 - 8 . (canceled)

9 . A benchtop device for analyzing a sample having a volume of less than about 250 microliters (μL), said device being configured to perform two or more assays on said sample, said two or more assays selected from an immunoassay, a nucleic acid assay, and a receptor-based assay, the device comprising:
a housing suitable for placement on a benchtop, containing components comprising:
a sample handling system configured to transport said sample, or portion thereof, within said housing;
one or more sample preparation stations configured to perform a plurality of sample preparation procedures on said sample or portion thereof, said sample preparation procedures comprising sample processing, and chemical processing;
one or more assay components configured to perform an immunoassay, a nucleic acid assay, and a receptor-based assay on said sample or portion thereof, wherein each assay is configured to yield a detectable optical signal; and
one or more detectors comprising at least one optical sensor, wherein said detectors are configured to detect optical signals from said two or more assays.

10 . The device of claim 9 , further comprising a cytometry station configured to perform a cytometry assay by microscopy on stationary cells in a sample portion, wherein said sample portion is fluidically isolated from other portions of said sample, wherein said device is configured to perform two or more assays on said single sample having a volume of less than about 250 μL, or portions thereof, wherein said two or more assays are selected from an immunoassay, a nucleic acid assay, a receptor-based assay, and a cytometry assay.

11 . The device of claim 10 , configured to perform three or more assays on a single sample having a volume of less than about 250 μL, or portions thereof, wherein said three or more assays are selected from an immunoassay, a nucleic acid assay, a receptor-based assay, and a cytometry assay.

12 . The device of claim 9 , configured to perform each of an immunoassay, a nucleic acid assay, and a receptor-based assay, on a single sample having a volume of less than about 250 μL, or portions thereof.

13 . The device of claim 10 , configured to perform each of an immunoassay, a nucleic acid assay, a receptor-based assay, and a cytometry assay on a single sample having a volume of less than about 250 μL, or portions thereof.

14 . The device of claim 9 , wherein at least one assay component is configured to receive one or more individually addressable assay units, each assay unit being fluidically isolated from one another, wherein at least one type of assay may be performed within said individually addressable assay unit effective to yield an optical signal.

15 . The device of claim 9 , wherein said sample handling system is configured to transport one or more individually addressable assay units to a detector.

16 . The device of claim 10 , wherein said sample handling system is configured to move at least a portion of the sample to the cytometry station.

17 . The device of claim 10 , wherein said sample handling system is configured to move an individually addressable assay unit to the cytometry station.

18 . The device of claim 9 , at least one assay component being configured to receive one or more individually addressable assay units, each assay unit being fluidically isolated from one another.

19 . The device of claim 10 , wherein said stationary cells are contained in a microscopy cuvette or slide configured to contain said stationary cells.

20 . The device of claim 9 , wherein said sample handling system comprises a fluid handling system comprising a pipette configured to transport said sample.

21 . The device of claim 20 , wherein said pipette is configured to uptake, dispense, or transfer said sample, or combinations thereof.

22 . The device of claim 20 , wherein said fluid handling system is configured to transport an individual assay unit within said housing.

23 . The device of claim 9 , further comprising a communication unit configured to receive instructions from an external device.

24 . The device of claim 9 , further comprising a communication unit configured to send data to an external device.

25 . The device of claim 9 , further comprising a communication unit configured to perform two-way communication with external devices, said communication unit being configured to a) receive instructions and b) to send data to external devices.

26 . The device of claim 23 which is configured to communicate with a Laboratory Information System (LIS), a Laboratory Information System (LIS), a Electronic Medical Records system (EMR), or combinations thereof.

27 . The device of claim 24 which is configured to communicate with a Laboratory Information System (LIS), a Laboratory Information System (LIS), a Electronic Medical Records system (EMR), or combinations thereof.

28 . The device of claim 25 which is configured to communicate with a Laboratory Information System (LIS), a Laboratory Information System (LIS), a Electronic Medical Records system (EMR), or combinations thereof.

29 . The device of claim 9 , further comprising a centrifuge.

30 . The device of claim 1 , wherein said sample has a volume of less than about 200 microliters (μL).

31 . The device of claim 9 , wherein said sample has a volume of less than about 100 microliters (μL).

32 . The device of claim 9 , wherein said sample is a biological sample selected from blood, serum, saliva, urine, gastric fluid, digestive fluid, tears, stool, semen, vaginal fluid, interstitial fluid, fluid derived from tumorous tissue, ocular fluid, sweat, mucus, earwax, oil, glandular secretions, breath, spinal fluid, hair, fingernails, skin cells, plasma, fluid obtained from a nasal swab, fluid obtained from a nasopharyngeal wash, cerebrospinal fluid, a tissue sample, fluid or tissue obtained from a throat swab, biopsy tissue, placental fluid, amniotic fluid, cord blood, lymphatic fluids, cavity fluids, sputum, pus, microbiota, meconium, and breast milk.

33 . The device of claim 9 , wherein said two or more assays comprise assays for the detection of two or more analytes.

34 . The device of claim 33 , wherein said two or more analytes comprise a first analyte having a first concentration, and a second analyte having a second concentration, wherein said first concentration and said second concentration differ from one another by more than one order of magnitude.

35 . A method of analyzing a sample, comprising:
Receiving a sample having a volume of less than about 250 microliters (μL) to a benchtop device of claim 9 ; Performing at least two of an immunoassay, a nucleic acid assay, and a receptor-based assay on said sample, or portion thereof.

36 . The method of claim 35 , wherein the device comprises a communication unit configured to perform two-way communication with external devices, further comprising a) receiving instructions regarding one or more of the assays, b) sending data regarding one or more of the assays to an external device, or both a) and b).

37 . A method of analyzing a sample, comprising:
Receiving a sample having a volume of less than about 250 microliters (μL) to a benchtop device of claim 10 ; Performing at least two of an immunoassay, a nucleic acid assay, and a receptor-based assay on said

Assignees

• Theranos Inc

Inventors

• Holmes Elizabeth A
• Balwani Sunny
• Young Daniel
• Pangarkar Chinmay
• Anekal Samartha

Classifications

• G01N35/10

  Devices for transferring samples {or any liquids} to, in, or from, the analysis apparatus, e.g. suction devices, injection devices {(G01N35/0099 takes precedence)} · CPC title

• G01N21/645

  Specially adapted constructive features of fluorimeters · CPC title

• G01N21/78

  producing a change of colour · CPC title

• G01N21/4133

  Refractometers, e.g. differential · CPC title

• G01N21/21

  Polarisation-affecting properties (G01N21/19 takes precedence) · CPC title