Systems and methods for sample use maximization

Patent metadata

Field	Value
Publication number	US-2016006928-A1
Application number	US-201514831838-A
Country	US
Kind code	A1
Filing date	Aug 20, 2015
Priority date	Jan 20, 2011
Publication date	Jan 7, 2016
Grant date	—

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

1 - 82 . (canceled)

83 . A method for providing quality control, said method comprising:
capturing an image of conditions under which a detection mechanism measures a characteristic of a sample; and determining, using a processor, based on the image whether there are undesirable conditions under which the detection mechanism is operated.

84 . The method of claim 83 wherein the undesirable conditions includes the presence of one or more undesirable materials.

85 . The method of claim 84 wherein the undesirable materials includes one or more of the following: bubbles, particles, fibers, debris, and precipitates that interfere with the measurement of the characteristic of the sample.

86 . The method of claim 83 wherein the detection mechanism is a different mechanism from a mechanism used to capture the image.

87 . The method of claim 83 wherein the image is captured using a camera.

88 . The method of claim 83 further comprising providing an alert if an undesirable condition is detected.

89 . The method of claim 83 further comprising adjusting the sample if an undesirable condition is detected.

90 . The method of claim 83 wherein the image includes an image of the sample.

91 . The method of claim 90 wherein the image includes an image of one or more of the following: the sample container or the detection mechanism.

92 . A method of performing an analysis on a blood sample, comprising:
capturing an image of a blood sample in a sample container with an image capture device contained in an instrument, wherein the instrument further comprises:
one or more assay units for performing the one or more assays on the blood sample, and
one or more reagents for performing the one or more assays;
determining quality of the blood sample based on the image; and providing an alert if an undesirable quality is detected for performing the one or more assays on the blood sample; or performing the one or more assays in the instrument if an undesirable quality is not detected.

93 . The method of claim 92 , wherein the blood sample is a blood sample obtained by a fingerstick.

94 . The method of claim 92 , wherein the blood sample has a volume of 200 μl or less.

95 . The method of claim 92 , 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.

96 . The method of claim 95 , wherein the undesirable quality is insufficient sample volume.

97 . The method of claim 92 , wherein the sample container is a sample tip.

98 . The method of claim 92 , wherein the instrument further comprises a cartridge and wherein the cartridge comprises the one or more assay units for performing the one or more assays on the blood sample and the one or more reagents for performing the one or more assays on the blood sample.

99 . The method of claim 98 , wherein the cartridge comprises all reagents for performing the one or more assays on the blood sample.

100 . The method of claim 92 , wherein the instrument further comprises a centrifuge.

101 . The method of claim 100 , wherein the blood sample is centrifuged in the centrifuge to obtain a column of packed red cells in a total sample column.

102 . The method of claim 101 , wherein the undesirable quality is insufficient plasma volume, and plasma volume is determined by measuring, based on the image, (a) length of the total sample column, (b) length of the column of packed red cells, and (c) known volume of the sample container.

103 . The method of claim 92 , wherein the instrument further comprises a detector for detecting a signal from the one or more assays indicative of the presence of an analyte in the blood sample.

104 . The method of claim 103 , wherein the instrument further comprises a fluid transfer device.

105 . The method of claim 104 , wherein the fluid transfer device (a) transfers at least a portion of the blood sample into the one or more assay units, (b) engages with the one or more assay units, and (c) moves the one or more assay units to the detector.

106 . The method of claim 92 , wherein the instrument further comprises control reagents for performing one or more control assays in parallel with the one or more assays on the blood sample.

107 . The method of claim 104 , wherein the instrument further comprises one or more tips and the fluid transfer device engages with the one or more tips.

108 . A system for performing an analysis on a blood sample, comprising:
one or more assay units for performing one or more assays on the blood sample; one or more reagents for performing the one or more assays on the blood sample; and an instrument comprising:
an image capture device for capturing an image of the blood sample prior to performing the one or more assays on the blood sample; and
a detector for detecting a signal from the one or more assays indicative of the presence of an analyte in the blood sample.

109 . The system of claim 108 , further comprising a cartridge comprising the one or more assay units and the one or more reagents for performing the one or more assays.

110 . The system of claim 108 , wherein the instrument further comprises a fluid transfer device.

111 . The system of claim 108 , further comprising control reagents for performing one or more control assays in parallel with the one or more biological assays on the blood sample.

112 . The system of claim 108 , wherein the instrument further comprises a centrifuge.

Assignees

• Theranos Inc

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

• G01N33/56972

  White blood cells · CPC title

• C12Q1/689

  for bacteria · CPC title

• G01N2333/62

  Insulins · 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