Systems and Methods of Sample Processing and Fluid Control in a Fluidic System
This invention is in the field of medical devices. Specifically, the present invention provides portable medical devices that allow real-time detection of analytes from a biological fluid. The methods and devices are particularly useful for providing point-of-care testing for a variety of medical applications.
1 . A cartridge configured to perform an assay, comprising:
a sample collection unit configured to receive a biological fluid sample;
a metering channel configured to meter a volume of the biological fluid sample;
a mixing chamber configured to be brought into fluidic communication with the metering channel and to receive a portion of the biological fluid sample;
a reagent chamber having a volume of less than 100 microliters and including a dried reagent to be liquefied upon initiation of the assay, the reagent chamber being configured to be brought into fluid communication with the mixing chamber; and
a plurality of reaction sites in fluid communication with the reagent chamber, each reaction site comprising a reactant bound thereto and configured to generate an optical signal in response to reacting with an analyte present in the biological fluid sample.
2 . The cartridge of claim 1 , wherein the optical signals generated are detectable by a charge coupled device.
3 . The cartridge of claim 1 , wherein the optical signals generated are fluorescent signals.
4 . The cartridge of claim 1 , further comprising a fluidic channel connecting the mixing chamber and the reagent chamber.
5 . The cartridge of claim 4 , wherein the fluidic channel further comprises a burstable seal.
6 . The cartridge of claim 1 , further comprising a fluidic channel connecting the reagent chamber with the plurality of reaction sites.
7 . The cartridge of claim 6 , wherein the fluidic channel further comprises a burstable seal.
8 . The cartridge of claim 1 , further comprising:
a dilution chamber configured to receive a diluent and being configured to be brought into and out of fluidic communication with the metering channel.
9 . The cartridge of claim 1 , wherein the mixing chamber comprises a lysing assembly configured to lyse cells present in the bodily fluid sample.
10 . The cartridge of claim 9 , wherein the mixing chamber is configured to receive a diluent from a dilution chamber and receive a portion of the biological fluid sample.
11 . The cartridge of claim 10 , the mixing chamber comprising a movable mixing element configured to cause the mixing of the portion of the biological fluid sample with the diluent.
12 . The cartridge of claim 1 , the mixing chamber comprising a movable mixing element configured to mechanically mix the sample.
13 . The cartridge of claim 12 , wherein the movable mixing element is magnetically controlled.
14 . A system configured to detect an optical signal indicating the presence of an analyte in a bodily fluid sample, comprising:
a cartridge configured to perform an assay, comprising:
a sample collection unit capable of receiving the bodily fluid sample;
a metering channel configured to meter a volume of the bodily fluid sample;
a mixing chamber configured to be brought into fluidic communication with the metering channel and to receive a portion of the bodily fluid sample to be mixed;
a reagent chamber having a volume of less than 100 microliters and including a dried reagent to be liquefied upon initiation of the assay, the reagent chamber being configured to be brought into fluid communication with the mixing chamber; and
a plurality of reaction sites in fluid communication with the reagent chamber, each reaction site comprising a reactant bound thereto and configured to generate an optical signal in response to reacting with the analyte present in the bodily fluid sample; and
a reader assembly configured to receive the cartridge and configured to detect the optical signals; and
a communication assembly for transmitting said an indication that the optical signals were detected to an external device.
15 . The system of claim 14 , wherein the cartridge is configured to run a specific assay based on an assay protocol transmitted to the reader assembly from the external device, wherein a first reaction site of the plurality of reaction sites comprises a first reactant, and wherein a second reaction site of the plurality of reaction sites comprises a second reactant different from the first reactant.
16 . The system of claim 15 , wherein the assay protocol is transmitted via a wired connection from the external device.
17 . The system of claim 14 , wherein the cartridge further comprising an identifier readable by the reader assembly and configured to provide the identity of the cartridge.
18 . The system of claim 17 , wherein the assay protocol varies depending on the identifier.
19 . The system of claim 14 , wherein said system is configured to monitor more than one pharmacological parameter.
20 . The system of claim 14 , the reader assembly further comprising a charge coupled device configured to detect the optical signal.