Modular point-of-care devices, systems, and uses thereof
The present invention provides devices and systems for use at the point of care. The methods devices of the invention are directed toward automatic detection of analytes in a bodily fluid. The components of the device are modular to allow for flexibility and robustness of use with the disclosed methods for a variety of medical applications.
1. A method for transferring a reagent to an assay unit, comprising:
A) inserting a cartridge into an instrument, wherein the cartridge comprises i) an identifier, ii) an assay unit configured to run a chemical reaction that yields a signal indicative of an analyte, and iii) a reagent unit comprising a reagent, and wherein the instrument comprises a fluid transfer device comprising a programmable processor and a head configured to adhere to a pipette tip;
B) reading the identifier on the cartridge and transmitting the identity of the identifier from the instrument to an external device, the external device being external from the instrument;
C) receiving by the programmable processor of the fluid transfer device a protocol from the external device, wherein the protocol is associated with the identifier and comprises instructions for transferring the reagent to the assay unit;
D) transferring by the fluid transfer device a selected volume of the reagent to the assay unit, wherein the selected volume is provided in the protocol, and wherein the fluid transfer device is operable to transfer different volumes of the reagent into the assay unit; and
E) engaging the assay unit with the head of the fluid transfer device and transporting by the fluid transfer device the assay unit from a first location to a second location in the instrument.
2. The method of claim 1 , wherein the cartridge further comprises a bodily fluid sample.
3. The method of claim 2 , further comprising transferring by the fluid transfer device a selected volume of bodily fluid sample to the assay unit, wherein the selected volume is provided in the protocol.
4. The method of claim 3 , wherein the bodily fluid sample is diluted prior to being transferred to the assay unit.
5. The method of claim 3 , further comprising prior to transferring the selected volume of bodily fluid sample to the assay unit, processing the bodily fluid sample to remove red blood cells from the sample.
6. The method of claim 3 , wherein the quantity of reagent transferred to the assay unit is selected based on the concentration of the analyte in the sample.
7. The method of claim 1 , wherein the external device is configured to permit modification of the protocol by a user.
8. The method of claim 1 , wherein the external device stores a plurality of protocols including the protocol associated with the identifier, and wherein the external device is configured to send to the instrument the protocol associated with the identifier from among the plurality of protocols.
9. The method of claim 1 , wherein the second location is a detection assembly.
10. The method of claim 2 , wherein the assay unit is a first assay unit configured to run a chemical reaction that yields a signal indicative of a first analyte, wherein the cartridge further comprises a second assay unit configured to run a chemical reaction that yields a signal indicative of a second analyte, wherein the method further comprises transferring by the fluid transfer device a first selected volume of the bodily fluid sample to the first assay unit and transferring by the fluid transfer device a second selected volume of the bodily fluid to the second assay unit, wherein the first and second selected volumes are different volumes, and wherein the first and second selected volumes are provided in the protocol.
11. The method of claim 1 , wherein the cartridge of step A) is a first cartridge, the method further comprising:
F) inserting a second cartridge into the instrument, wherein the second cartridge comprises i) an identifier, ii) an assay unit and iii) a reagent unit, and wherein the assay unit and reagent unit of the second cartridge contain the same contents as the assay unit and reagent unit of the first cartridge, respectively;
G) reading the identifier on the second cartridge and transmitting the identity of the identifier from the instrument to the external device;
H) receiving by the programmable processor of the fluid transfer device a protocol from the external device, wherein the protocol is associated with the identifier of the second cartridge and comprises instructions for transferring the reagent of the second cartridge to the assay unit of the second cartridge;
I) based on the protocol of step H), transferring by the fluid transfer device a selected volume of the reagent in the second cartridge to the assay unit in the second cartridge.
12. The method of claim 11 , wherein a different volume of reagent is transferred to the assay unit in the second cartridge than is transferred to the assay unit in the first cartridge.
13. The method of claim 12 , wherein the identifier on the first cartridge and the identifier on the second cartridge are the same.