Systems and methods for sample use maximization

• US 10,876,956 B2
• Filed: 05/02/2017
• Issued: 12/29/2020
• Est. Priority Date: 01/21/2011
• Status: Active Grant

• Current Assignee: Labrador Diagnostics LLC (SoftBank Group Corp.)
• Original Assignee: Labrador Diagnostics LLC (SoftBank Group Corp.)
• Inventors: Nugent, Anthony J., Young, Daniel L., Holmes, Elizabeth A., Siegel, Michael, Wistort, Ryan
• Primary Examiner(s): Smith, Maurice C
• Application Number:
  US15/584,974
• Publication Number:
  US 20170363536A1
• Time in Patent Office: 1,337 Days
• CPC Class Codes: B01L 2300/168 Specific optical properties, e.g. reflective coatings
• CPC Class Codes: B01L 3/0275 Interchangeable or disposable dispensing tips
• CPC Class Codes: B04B 5/0421 pivotably mounted
• CPC Class Codes: C12Q 1/42 involving phosphatase
• CPC Class Codes: C12Q 1/48 involving transferase
• CPC Class Codes: C12Q 1/52 involving transaminase
• CPC Class Codes: C12Q 1/6806 Preparing nucleic acids for analysis, e.g. for polymerase chain reaction [PCR] assay C12Q1/6804 takes precedence
• CPC Class Codes: C12Q 1/6809 Methods for determination or identification of nucleic acids involving differential detection
• CPC Class Codes: C12Q 1/689 for bacteria
• CPC Class Codes: C12Q 2600/158 Expression markers
• CPC Class Codes: G01N 1/4077 by other techniques involving separation of suspended solids
• CPC Class Codes: G01N 2001/4083 sedimentation
• CPC Class Codes: G01N 2035/00495 Centrifuges
• CPC Class Codes: G01N 2035/1018 Detecting inhomogeneities, e.g. foam, bubbles, clots
• CPC Class Codes: G01N 21/00 Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light G01N3/00 - G01N19/00 take precedence
• CPC Class Codes: G01N 21/0303 Optical path conditioning in cuvettes, e.g. windows; adapted optical elements or systems; path modifying or adjustment G01N21/031 - G01N21/15 take precedence
• CPC Class Codes: G01N 21/51 inside a container, e.g. in an ampoule G01N21/53 takes precedence
• CPC Class Codes: G01N 21/59 Transmissivity G01N21/25 takes precedence
• CPC Class Codes: G01N 2333/575 Hormones derived from pro-opiomelanocortin, pro-enkephalin or pro-dynorphin G01N2333/665, corticotropin G01N2333/695
• CPC Class Codes: G01N 2333/62 Insulins
• CPC Class Codes: G01N 2333/91188 : transferring nitrogenous groups (2.6)
• CPC Class Codes: G01N 2333/96463 : Blood coagulation factors not provided for in a preceding group or according to more than one of the proceeding groups
• CPC Class Codes: G01N 33/5308 : for analytes not provided for elsewhere, e.g. nucleic acids, uric acid, worms, mites
• CPC Class Codes: G01N 33/54326 : Magnetic particles
• CPC Class Codes: G01N 33/54393 : Improving reaction conditions or stability, e.g. by coating or irradiation of surface, by reduction of non-specific binding, by promotion of specific binding
• CPC Class Codes: G01N 33/56972 : White blood cells
• CPC Class Codes: G01N 33/56983 : Viruses
• CPC Class Codes: G01N 33/573 : for enzymes or isoenzymes
• CPC Class Codes: G01N 33/74 : involving hormones or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors
• CPC Class Codes: G01N 33/743 : Steroid hormones
• CPC Class Codes: G01N 33/80 : involving blood groups or blood types or red blood cells white blood cells G01N33/56972
• CPC Class Codes: G01N 33/82 : involving vitamins or their receptors
• CPC Class Codes: G01N 33/92 : involving lipids, e.g. cholesterol , lipoproteins, or their receptors steroid hormones G01N33/743
• CPC Class Codes: G01N 35/10 : 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 Class Codes: G06T 2207/30004 : Biomedical image processing
• CPC Class Codes: G06T 2207/30168 : Image quality inspection
• CPC Class Codes: G06T 3/4084 : in the transform domain, e.g. fast Fourier transform [FFT] domain scaling
• CPC Class Codes: G06T 7/0002 : Inspection of images, e.g. flaw detection
• CPC Class Codes: G06T 7/0012 : Biomedical image inspection
• CPC Class Codes: G16C 20/20 : Identification of molecular entities, parts thereof or of chemical compositions
• CPC Class Codes: H04N 23/64 : 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

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.

Claims

1. A method of processing a sample, the method comprising:

a) inserting a cartridge into a sample processing device,

wherein the cartridge comprises;

a first assay unit and a second assay unit, wherein the first assay unit and second assay unit are each independently movable from the cartridge, wherein at least the first assay unit has the shape of a pipette tip, wherein the cartridge further comprises reagents for performing a first assay in the first assay unit and for performing a second assay in the second assay unit, and

wherein the sample processing device comprises;

a detection station comprising at least one of a;

spectrophotometer, PMT, photodiode, camera, CCD sensor, or CMOS sensor;

a fluid handling system comprising a nozzle configured to interface with a pipette tip and configured to move the sample; and

an imaging device configured to obtain images of said nozzle and said pipette tip,

b) dividing the sample into at least a first portion and a second portion in the sample processing device;

c) retaining the first portion of the sample in a first module and transporting by the fluid handling system the second portion of the sample to the second assay unit,

d) obtaining an image of the nozzle and of the pipette tip within the sample processing device, effective to provide information regarding whether there are undesirable condition(s) associated with the pipette tip; and

e) processing the sample.

2. The method of claim 1 wherein the undesirable condition(s) includes one or more of the following:

bubbles in the sample.

3. The method of claim 1 wherein the undesirable condition(s) includes one or more of the following:

particles that interfere with measurement of characteristic(s) of the sample.

4. The method of claim 1 wherein the undesirable condition(s) includes one or more of the following:

debris that interferes with measurement of characteristic(s) of the sample.

5. The method of claim 1 wherein the undesirable condition(s) includes one or more of the following:

precipitates that interfere with measurement of characteristic(s) of the sample.

6. The method of claim 1 wherein the undesirable condition(s) includes one or more of the following:

bubbles, particles, fibers, debris, and precipitates that interfere with measurement of characteristic(s) of the sample.

7. The method of claim 1 wherein the pipette tip has a conical, tapered shape.

8. The method of claim 1, wherein the sample processing device further comprises a centrifuge, and at least a portion of the sample is centrifuged in the centrifuge.

9. The method of claim 1, wherein the sample processing device transfers information from the detection station to an external device.

10. The method of claim 1, wherein the sample is blood, and wherein dividing the sample into at least a first portion and a second portion comprises dividing the blood into a plasma portion and a red blood cell-containing portion.

11. The method of claim 10, wherein the first portion comprises the plasma portion and the second portion comprises the red blood cell-containing portion.