Cartridge for diagnostic testing
First Claim
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1. A method of detecting a concentration of Troponin in a whole blood sample, the method comprising:
- inserting a diagnostic cartridge containing the whole blood sample in a sample chamber into a reader, the diagnostic cartridge having Troponin reporter antibody amended with an enzyme label in the sample chamber and/or in a detection channel; and
operating the reader tomove the sample out of the sample chamber into the detection channel and across an electrode array in the detection channel, a first electrode of the electrode array having affixed thereon an anti-Troponin capture antibody,move the sample out of the detection channel,move a wash liquid from a first reservoir in the cartridge into the detection channel,move the wash liquid out of the detection channel, andmove a substrate solution out of a second reservoir into the detection channel, the substrate solution comprising a component reactive with the enzyme amended to the reporter antibody; and
detect a reaction between the Troponin reporter antibody amended with enzyme and the substrate solution to measure the concentration of Troponin in the whole blood sample with a limit of detection of 3 pg/mL.
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Abstract
The present invention relates to a cartridge for conducting diagnostic assays. The cartridge consists of an assembly of components that are easily assembled. The cartridge provides means for receiving a patient sample, precisely controlling fluid introduction, onboard storage of assay fluid and conducting different assay protocols and detection of a plurality of analytes. Methods of use for the cartridge are described. The disclosed invention is suitable for point of care environments or any place where rapid, ultrasensitive testing is required.
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Citations
31 Claims
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1. A method of detecting a concentration of Troponin in a whole blood sample, the method comprising:
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inserting a diagnostic cartridge containing the whole blood sample in a sample chamber into a reader, the diagnostic cartridge having Troponin reporter antibody amended with an enzyme label in the sample chamber and/or in a detection channel; and operating the reader to move the sample out of the sample chamber into the detection channel and across an electrode array in the detection channel, a first electrode of the electrode array having affixed thereon an anti-Troponin capture antibody, move the sample out of the detection channel, move a wash liquid from a first reservoir in the cartridge into the detection channel, move the wash liquid out of the detection channel, and move a substrate solution out of a second reservoir into the detection channel, the substrate solution comprising a component reactive with the enzyme amended to the reporter antibody; and detect a reaction between the Troponin reporter antibody amended with enzyme and the substrate solution to measure the concentration of Troponin in the whole blood sample with a limit of detection of 3 pg/mL. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15)
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16. A cartridge for detecting a concentration of Troponin in a whole blood sample, the cartridge comprising:
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a cartridge body adapted to be inserted into a cartridge reader; a sample chamber within the cartridge body and comprising an opening for depositing a whole blood sample; a detection channel within the cartridge body and communicating with the sample chamber to receive the whole blood sample from the sample chamber in response to actuation by the cartridge reader; Troponin reporter antibody amended with an enzyme label disposed in the sample chamber and/or in the detection channel; an analyte sensor in the detection channel, the analyte sensor comprising an electrode array, a first electrode of the electrode array comprising a sensor electrode having affixed thereon an anti-Troponin capture antibody; a wash liquid disposed in a first reservoir in the cartridge body and communicating with the detection channel; a reagent solution disposed in a second reservoir in the cartridge body and communicating with the detection channel; and a waste compartment in the cartridge body and communicating with the detection channel; the cartridge being operable by the cartridge reader to detect a reaction between the Troponin reporter antibody as amended with the enzyme and the substrate solution to measure a concentration of Troponin in the whole blood sample with a limit of detection of 3 pg/mL. - View Dependent Claims (17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31)
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Specification