Systems and methods for sample use maximization

Patent metadata

Field	Value
Publication number	US-11199489-B2
Application number	US-201514831838-A
Country	US
Kind code	B2
Filing date	Aug 20, 2015
Priority date	Jan 20, 2011
Publication date	Dec 14, 2021
Grant date	Dec 14, 2021

Abstract

The present invention provides systems, devices, and methods for point-of-care and/or distributed testing services. The methods and devices of the invention are directed toward automatic detection of analytes in a bodily fluid. The components of the device can be modified to allow for more flexible and robust use with the disclosed methods for a variety of medical, laboratory, and other applications. The systems, devices, and methods of the present invention can allow for effective use of samples by improved sample preparation and analysis.

First claim

What is claimed is:

1. A method for providing quality control, said method comprising:
receiving a cartridge in an instrument, wherein the cartridge comprises a sample;
moving at least a portion of the sample from the cartridge into a sample container;
moving the sample container to an image capture device via a fluid transfer device comprising a pipette, wherein the instrument comprises the image capture device, and wherein the pipette is configured with a first section having a first diameter and a first taper angle, and a second section having a second diameter and a second taper angle;
during a chemical reaction involving the sample:
moving the sample to the first section of the pipette;
illuminating the sample at a first illumination wavelength across the first section of the pipette;
capturing a first image of conditions under which a detection mechanism measures a characteristic of the sample under illumination by the first illumination wavelength;
determining, based on the capturing of the first image, that a condition is met;
moving, in response to the determining, the sample to the second section of the pipette;
illuminating the sample at a second illumination wavelength across the second section of the pipette, the second illumination wavelength being different from the first illumination wavelength; and
capturing a second image of conditions under which the detection mechanism measures the characteristic of the sample under illumination by the second illumination wavelength; and

using a processor:
performing first image analysis of the captured first image that includes identifying a first plurality of light intensities of a plurality of pixels of the captured first image, and correlating the first plurality of light intensities with a predetermined set of values that define a dynamic range of a plurality of detection spectral regions;
performing second image analysis of the captured second image that includes identifying a second plurality of light intensities of a plurality of pixels of the captured second image, and correlating the second plurality of light intensities with the predetermined set of values;
determining, based on the first image analysis and the second image analysis, whether there is an undesirable condition under which the detection mechanism is operated; and
predicting, based on the first image analysis and the second image analysis, at least one of a presence or a quantity of an analyte in the sample; and

moving the sample container to a sample processing station for starting an assay.

2. The method of claim 1 , wherein the undesirable condition includes a presence of one or more undesirable materials.

3. The method of claim 2 , wherein the one or more undesirable materials include one or more of: bubbles, particles, fibers, debris, and precipitates that interfere with the measurement of the characteristic of the sample.

4. The method of claim 1 , wherein the detection mechanism is a different mechanism from a mechanism used to capture the first and second images.

5. The method of claim 1 , wherein the first and second images are captured using a camera.

6. The method of claim 1 , further comprising providing an alert in response to determining the undesirable condition.

7. The method of claim 1 , further comprising adjusting the sample if the undesirable condition is determined.

8. The method of claim 1 , wherein the first and second images include an image of the sample.

9. The method of claim 8 , wherein the first and second images each include an image of one or more of: the sample container or the detection mechanism.

10. The method of claim 1 , further comprising determining, by the processor, whether a concentration of an assay fluid is within a predetermined acceptable range based on the first image analysis and second image analysis.

11. The method of claim 1 , wherein the first image analysis and second image analysis include determining light intensities of a plurality of pixels in the captured first and second images, and wherein the predicting is performed based on the light intensities.

12. A method of performing an analysis on a blood sample, comprising:
receiving a cartridge in an instrument, wherein the cartridge includes the blood sample;
moving at least a portion of the blood sample from the cartridge into a sample container via a fluid transfer device comprising a pipette, wherein the instrument comprises an image capture device coupled to the sample container, and wherein the pipette is configured with a first section having a first diameter and a first taper angle, and a second section having a second diameter and a second taper angle;
during a chemical reaction involving the blood sample:
moving the blood sample to the first section of the pipette;
illuminating the blood sample at a first illumination wavelength across the first section of the pipette;
capturing a first image of the blood sample in the sample container with the image capture device under illumination by the first illumination wavelength;
determining, based on the capturing of the first image of the blood sample, that a condition is met;
moving, in response to the determining, the blood sample to the second section of the pipette;
illuminating the blood sample at a second illumination wavelength across the second section of the pipette, the second illumination wavelength being different from the first illumination wavelength; and
capturing a second image of conditions under which a detection mechanism measures characteristics of the blood sample under illumination by the second illumination wavelength;

performing a first image analysis of the captured first image of the blood sample that includes identifying a first plurality of light intensities of a plurality of pixels of the captured first image of the blood sample, and correlating the first plurality of light intensities with a predetermined set of values that define a dynamic range of a plurality of detection spectral regions;
performing a second image analysis of the captured second image that includes identifying a second plurality of light intensities of a plurality of pixels of the captured second image, and correlating the second plurality of light intensities with the predetermined set of values;
determining, based on the first image analysis and the second image analysis, a quality of the blood sample;
detecting, based on the first image analysis and the second image analysis, a presence or absence of an undesirable quality in the blood sample for performing an assay on the blood sample;
predicting, based on the first image analysis and the second image analysis, at least one of a presence or a quantity of an analyte in the blood sample;
providing an alert in response to detecting the presence of the undesirable quality; and
moving the sample container to a sample processing station in the instrument for performing the assay in response to detecting the absence of the undesirable quality.

13. The method of claim 12 , wherein the blood sample is a blood sample obtained by a fingerstick.

14. The method of claim 12 , wherein the undesirable quality is selected from lipemia, icteria, hemolysis, presence of precipitates, incorrect sample type, incorrect sample volume, presence of bubbles, and non-uniformity of color.

15. The method of claim 14 , wherein the undesirable quality is insufficient sample volume.

16. The method of claim 12 , wherein the sample container is a sample tip.

17. The method of claim 12 , wherein the instrument includes an assay unit

Assignees

• Theranos Ip Co Llc
• Labrador Diagnostics Llc

Inventors

• Gibbons Ian
• Nugent Anthony
• Delacruz Anthony
• Young Daniel
• Holmes Elizabeth A
• Drake Andrew
• Kemp Timothy Michael
• Balwani Sunny
• Pangarkar Chinmay

Classifications

• H04N23/64

  Computer-aided capture of images, e.g. transfer from script file into camera, check of taken image quality, advice or proposal for image composition or decision on when to take image · CPC title

• G01N21/0303 Primary

  Optical path conditioning in cuvettes, e.g. windows; adapted optical elements or systems; path modifying or adjustment (G01N21/031 - G01N21/15 take precedence) · CPC title

• G01N21/07 Primary

  Centrifugal type cuvettes (G01N21/09 takes precedence) · CPC title

• G16C20/20

  Identification of molecular entities, parts thereof or of chemical compositions · CPC title

• G01N21/59

  Transmissivity (G01N21/25 takes precedence) · CPC title