Self correction for spatial orientation and motion of portable clinical analyzers
First Claim
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1. A portable clinical system for in vitro analysis of a sample comprising whole blood, the system comprising:
- a test device comprising;
a sample entry port configured to receive the sample comprising the whole blood;
a conduit comprising at least one electrochemical sensor configured to generate an electric signal based on a concentration of a target analyte in the sample upon being contacted with the sample in the conduit; and
a pump configured to effect movement of the sample from the sample entry port through the conduit and over the at least one electrochemical sensor;
andan analyzer comprising;
at least one accelerometer;
a port configured to receive the test device;
a computing device comprising one or more processors and non-transitory machine readable storage medium;
program instructions to determine spatial orientation and motion of the analyzer during a test cycle of the test device that includes the generating the electrical signal;
program instructions to compare the determined spatial orientation to a threshold operating spatial plane for the test device;
program instructions to compare the determined motion to a threshold rate of motion for the test device; and
program instructions to apply a correction factor to the electric signal generated by the at least one electrochemical sensor, when at least one of;
(i) the determined spatial orientation exceeds the threshold operating spatial plane, and/or (ii) the determined motion exceeds the threshold rate of motion, wherein the correction factor is at least one of a blood non-homogeneity correction factor, a blood cell sedimentation correction factor, and a blood motion factor, to produce a corrected signal,wherein the program instructions are stored on the non-transitory machine readable storage medium for execution by the one or more processors.
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Abstract
The present invention covers the integration and utility of accelerometer features into a clinical analysis system. For example, measurement of dynamic acceleration and orientation of a blood-testing instrument with respect to Earth'"'"'s gravitational field may be used to determine reliability of a test procedure and optionally to provide corrective elements thereof.
35 Citations
16 Claims
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1. A portable clinical system for in vitro analysis of a sample comprising whole blood, the system comprising:
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a test device comprising; a sample entry port configured to receive the sample comprising the whole blood; a conduit comprising at least one electrochemical sensor configured to generate an electric signal based on a concentration of a target analyte in the sample upon being contacted with the sample in the conduit; and a pump configured to effect movement of the sample from the sample entry port through the conduit and over the at least one electrochemical sensor; and an analyzer comprising; at least one accelerometer; a port configured to receive the test device; a computing device comprising one or more processors and non-transitory machine readable storage medium; program instructions to determine spatial orientation and motion of the analyzer during a test cycle of the test device that includes the generating the electrical signal; program instructions to compare the determined spatial orientation to a threshold operating spatial plane for the test device; program instructions to compare the determined motion to a threshold rate of motion for the test device; and program instructions to apply a correction factor to the electric signal generated by the at least one electrochemical sensor, when at least one of;
(i) the determined spatial orientation exceeds the threshold operating spatial plane, and/or (ii) the determined motion exceeds the threshold rate of motion, wherein the correction factor is at least one of a blood non-homogeneity correction factor, a blood cell sedimentation correction factor, and a blood motion factor, to produce a corrected signal,wherein the program instructions are stored on the non-transitory machine readable storage medium for execution by the one or more processors. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14)
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15. A method comprising:
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inserting a test device for in vitro analysis of a sample comprising whole blood in a port of an analyzer, wherein the test device comprises a sample entry port, a conduit comprising at least one electrochemical sensor configured to generate an electric signal based on a concentration of a target analyte in the sample upon being contacted with the sample in the conduit, and a pump configured to effect movement of the sample from the sample entry port through the conduit and over the at least one electrochemical sensor, and the analyzer comprises a computing device and at least one accelerometer; initiating a test cycle of the test device that includes actuating the pump and moving the sample received by the test device over the at least one electrochemical sensor, and the at least one electrochemical sensor, upon being contacted with the sample in the conduit, generating the electric signal based on a concentration of a target analyte in the sample; determining spatial orientation and motion of the analyzer during the test cycle of the test device by using the at least one accelerometer; comparing the determined spatial orientation to a threshold operating spatial plane for the test device; comparing the determined motion to a threshold rate of motion for the test device; and applying a correction factor to the electric signal generated by the at least one electrochemical sensor, when at least one of;
(i) the determined spatial orientation exceeds the threshold operating spatial plane, and/or (ii) the determined motion exceeds the threshold rate of motion, wherein the correction factor is at least one of a blood non-homogeneity correction factor, a blood cell sedimentation correction factor, and a blood motion factor;
to produce a corrected signal.
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16. A portable clinical system for in vitro analysis of a sample comprising whole blood, the system comprising:
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a test device comprising; a sample entry port configured to receive the sample comprising the whole blood; a conduit comprising at least one immunosensor configured to generate an electric signal based on a concentration of a target analyte in the sample upon being contacted with the sample in the conduit; and a pump configured to effect the movement of the sample from the sample entry port through the conduit and over the at least one electrochemical sensor; and an analyzer comprising; at least one accelerometer; a port configured to receive the test device; and a computing device comprising one or more processors and non-transitory machine readable storage medium; program instructions to determine spatial orientation and motion of the analyzer during a test cycle of the test device that includes the generating the electrical signal; program instructions to compare the determined spatial orientation to a threshold operating spatial plane for the test device; program instructions to compare the determined motion to a threshold rate of motion for the test device; and program instructions to apply a correction factor to the electric signal generated by the at least one electrochemical sensor, when at least one of;
(i) the determined spatial orientation exceeds the threshold operating spatial plane, and/or (ii) the determined motion exceeds the threshold rate of motion, wherein the correction factor is at least one of a blood non-homogeneity correction factor, a blood cell sedimentation correction factor, and a blood motion factor, to produce a corrected signal,wherein the program instructions are stored on the non-transitory machine readable storage medium for execution by the one or more processors.
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Specification