SYSTEMS AND METHODS FOR SAMPLE USE MAXIMIZATION
First Claim
Patent Images
1. A method of detecting the presence or concentration of an analyte in a sample fluid contained in a container comprising:
- (a) illuminating the container along a first region having a first path length to yield a first measurement of light intensity transmitted across the first path length;
(b) moving the sample fluid to another region in the container having another path length if the first measurement falls outside a predetermined dynamic range of transmitted light intensity;
(c) illuminating the container along the another region to yield another measurement of light intensity transmitted across the another path length; and
optionally(d) repeating steps (b) and (c) until a measurement of light intensity falls within the predetermined dynamic range, thereby detecting the presence or concentration of the analyte.
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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.
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Citations
91 Claims
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1. A method of detecting the presence or concentration of an analyte in a sample fluid contained in a container comprising:
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(a) illuminating the container along a first region having a first path length to yield a first measurement of light intensity transmitted across the first path length; (b) moving the sample fluid to another region in the container having another path length if the first measurement falls outside a predetermined dynamic range of transmitted light intensity; (c) illuminating the container along the another region to yield another measurement of light intensity transmitted across the another path length; and
optionally(d) repeating steps (b) and (c) until a measurement of light intensity falls within the predetermined dynamic range, thereby detecting the presence or concentration of the analyte. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
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13. A method of measuring an analyte concentration in a sample fluid comprising:
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(a) providing the sample contained in a container dimensioned with a plurality of distinct widths to permit transmission of light along a plurality of varying path lengths that correspond to the plurality of distinct widths; (b) illuminating the container along at least one of the plurality of path lengths; and (c) imaging the container to measure a first light intensity transmitted across said at least one of the plurality of path lengths, for the determination of the concentration of the analyte based on the measured first light intensity. - View Dependent Claims (14, 15, 16, 17, 18, 19, 20)
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21. An automated system for separating one or more components in a biological fluid comprising:
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(a) a pipette tip or closed tube adapted to engage with an aspirator wherein said pipette tip or tube comprises two opposing ends, at least one of which is closed or sealable; and (b) a centrifuge configured to receive said sealed pipette tip or closed tube to effect said separating of one or more components in a biological fluid. - View Dependent Claims (22, 23, 24, 25, 26, 27)
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28. A method for isolating components in a sample comprising:
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(a) loading a sample into a pipette tip or a tube comprising two opposing ends, at least one of which is sealable or sealed; (b) sealing the pipette tip or the tube on the at least one end of the pipette tip; (c) centrifuging the sealed pipette tip or the tube, thereby forming an interfacial region that separates the sample into a supernatant and a pellet; (d) imaging the centrifuged pipette tip or the tube to determine the location of the interfacial region; and (e) automatically aspirating the supernatant based on the location of the interfacial region. - View Dependent Claims (29, 30, 31, 32, 33)
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34. A method for characterizing an analyte suspected to be present in a sample comprising:
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(a) obtaining a digital image of the sample, wherein the digital image comprises at least a two-dimensional array of pixels, and wherein each pixel comprises a plurality of intensity values, each of which corresponds to a distinct detection spectral region; (b) correlating, with the aid of a programmable device, the obtained intensity values with a predetermined set of values that define a dynamic range of each detection spectral region; and (c) predicting the presence and/or quantity of said analyte in the sample based on said correlating of the obtained intensity values with a predetermine set of values. - View Dependent Claims (35, 36, 37)
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38. A method for characterizing an analyte suspected to be present in a sample of biological fluid comprising:
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(a) providing said sample of biological fluid; (b) allowing said analyte to react with one or more reagents that specifically react with said analyte to generate an optically detectable signal; and (c) measuring said optically detectable signal with a plurality of detection spectral regions, wherein the presence of said optically detectable signal within a dynamic range of at least one detection spectral region is indicative of the concentration of said analyte in said sample of biological fluid. - View Dependent Claims (39, 40, 41, 42, 43, 44, 45)
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46. A method for increasing the accuracy of an assay comprising:
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(a) imaging a sample in a first tip to determine the volume of the first sample; (b) imaging one or more reagents in a second tip to determine the volume of the one or more reagents; (c) mixing the sample and the one or more reagents to form a reaction mixture; (d) imaging the reaction mixture; (e) calibrating based on said determined volumes of the sample and the one or more reagents; and (f) calculating a concentration of an analyte using the calibration. - View Dependent Claims (47, 48, 49, 50, 51, 52)
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53. An automated system for separating one or more components in a biological fluid comprising:
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(a) a centrifuge comprising one or more bucket configured to receive a container to effect said separating of one or more components in a fluid sample; and (b) the container, wherein the container includes one or more shaped feature that is complementary to a shaped feature of the bucket. - View Dependent Claims (54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64)
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65. A setup, comprising:
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a vessel configured to accept and confine a sample, wherein the vessel comprises an interior surface, an exterior surface, an open end, and an opposing closed end; and a tip configured to extend into the vessel through the open end, wherein the tip comprises a first open end and second open end, wherein the second open end is inserted into the vessel, wherein the vessel or the tip further comprises a protruding surface feature that prevents the second open end of the tip from contacting the bottom of the interior surface of the closed end of the vessel. - View Dependent Claims (66, 67, 68)
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69. A sample processing apparatus comprising:
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a sample preparation station, assay station, and/or detection station; a control unit having computer-executable commands for performing a point-of-service service at a designated location with the aid of at least one of said sample preparation station, assay station and detection station; and at least one centrifuge configured to perform centrifugation of a sample from a fingerstick. - View Dependent Claims (70, 71)
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72. A method for dynamic feedback, said method comprising:
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taking an initial measurement of a sample within a container using a detection mechanism; based on said initial measurement, determining, using a processor, whether the sample concentration falls into a desired range, and determining, using a processor, (a) a degree of dilution to be performed if the sample concentration is higher than the desired range or (b) a degree of concentration to be performed if the sample concentration is lower than the desired range; and adjusting the sample concentration according to the determined degree of dilution or the determined degree of concentration. - View Dependent Claims (73, 74, 75, 76, 77, 78, 79, 80, 81, 82)
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83. A method for providing quality control, said method comprising:
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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. - View Dependent Claims (84, 85, 86, 87, 88, 89, 90, 91)
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Specification