FUNCTION VERIFICATION CARTRIDGE FOR USE WITH DEVICE FOR THE RAPID DETECTION OF ANALYTES

• US 20190317116A1
• Filed: 04/16/2018
• Published: 10/17/2019
• Est. Priority Date: 04/16/2018
• Status: Active Grant

• Current Assignee: Fundamental Solutions Corporation
• Original Assignee: Fundamental Solutions Corporation
• Inventors: PHELAN, Christopher T., LAWSON, Stephan M., WEIMAN, Andrew, WILLIAMS, Marvin R., MCBRAIRTY, Charles, LWANDE, Joel S.
• Granted Patent: US 10,866,254 B2
• Time in Patent Office: Days
• CPC Class Codes: B01L 2200/025 Align devices or objects to ensure defined positions relative to each other
• CPC Class Codes: B01L 2200/026 Fluid interfacing between devices or objects, e.g. connectors, inlet details
• CPC Class Codes: B01L 2200/143 Quality control, feedback systems
• CPC Class Codes: B01L 2300/022 Transponder chips
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2400/0478 pistons
• CPC Class Codes: B01L 3/502707 characterised by the manufacture of the container or its components by shaping or joining plastic parts B29C59/00, B29C65/00; by laminating B32B37/00; manufacture of microstructural devices in general B81C
• CPC Class Codes: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: B01L 3/50273 characterised by the means or forces applied to move the fluids micropumps F04B19/006, of the membrane type F04B43/043
• CPC Class Codes: B01L 3/527 for a plurality of reagents
• CPC Class Codes: G01N 2021/0325 Cells for testing reactions, e.g. containing reagents
• CPC Class Codes: G01N 2035/00346 Heating or cooling arrangements
• CPC Class Codes: G01N 21/76 Chemiluminescence; Bioluminescence
• CPC Class Codes: G01N 21/77 by observing the effect on a chemical indicator
• CPC Class Codes: G01N 2201/0221 Portable; cableless; compact; hand-held
• CPC Class Codes: G01N 35/00623 of instruments
• CPC Class Codes: G01N 35/00871 Communications between instruments or with remote terminals
• CPC Class Codes: G01N 35/1002 Reagent dispensers

Abstract

A system that rapidly detects the presence of a target analyte in a biological test sample, which includes a sensor for measuring a detectable signal generated upon the reaction of a biosensor reagent with a specific target analyte within the sample; a reservoir card that includes the biosensor reagent that further includes living, engineered biological cells, and wherein the reservoir card is configured to interface with a test cartridge base; a test cartridge base configured to accept the reservoir card and to be placed within the testing device, wherein the test cartridge base further includes a reaction chamber adapted to receive both the biosensor reagent and the sample and a fluid displacement mechanism that includes a dispensing plunger, wherein actuation of the dispensing plunger displaces the biosensor reagent in the reservoir into the reaction chamber where the biosensor reagent is mixed with the sample; and a function verification cartridge adapted to be received and recognized by the testing device, and that is operative to confirm the proper functioning of the plunger and the sensor.

Claims

1. ) A system for conducting an assay that rapidly detects the presence of a target analyte in a biological sample, comprising:

(a) a testing device, wherein the testing device includes a sensor for measuring a detectable signal that is generated upon the reaction of a biosensor reagent with a specific target analyte within a biological sample;

(b) a reservoir card, wherein the reservoir card includes a biosensor reagent, wherein the biosensor reagent includes living, engineered biological cells, and wherein the reservoir card is configured to interface with a test cartridge base;

(c) a test cartridge base, wherein the test cartridge base is configured to accept the reservoir card and to be placed within the testing device, wherein the test cartridge base further includes a reaction chamber that is adapted to receive both the biosensor reagent and the biological sample, and a fluid displacement mechanism that includes a dispensing plunger, and wherein actuation of the dispensing plunger displaces the biosensor reagent in the reservoir into the reaction chamber where the biosensor reagent is mixed with the biological sample; and

(d) a function verification cartridge adapted to be received and recognized by the testing device, wherein the function verification cartridge is operative to confirm the proper functioning of the plunger and the sensor prior to conducting an assay for rapidly detecting the presence of the target analyte in the biological sample, and wherein confirmation of proper functioning is based on predetermined operational parameters.

2. ) The system of claim 1, wherein the detectable signal includes light, wherein the sensor includes a photomultiplier tube, and wherein the function verification cartridge is operative to determine sensitivity of the photomultiplier tube.

3. ) The system of claim 2, wherein the function verification cartridge generates a calibrated light output of a predetermined quantity that is recognized by the testing device as representing a proper amount of light output from the photomultiplier tube.

4. ) The system of claim 1, wherein the testing device further includes a heater for heating the reaction chamber, and wherein the function verification cartridge is operative to confirm proper functioning of the heater, and wherein confirmation of proper functioning is based on predetermined operational parameters.

5. ) The system of claim 4, wherein the proper functioning of the heater is determined by resistance thermometer;

thermistor;

thermocouple;

infrared device;

or combinations thereof.

6. ) The system of claim 1, wherein the function verification cartridge is operative to determine displacement of the dispensing plunger, and wherein displacement of the dispensing plunger is determined by linear potentiometer;

optical distance sensing;

ultrasonic distance sensing;

capacitive distance sensing;

inductive/eddy current distance sensing;

limit or break beam switches;

or combinations thereof.

7. ) The system of claim 1, wherein the function verification cartridge is operative to determine travel speed of the dispensing plunger, and wherein travel speed of the plunger is determined by a microcontroller-based timer;

a real time clock;

external oscillator;

or combinations thereof.

8. ) The system of claim 1, wherein the function verification cartridge includes a radio-frequency identification tag that communicates with the testing device.

9. ) The system of claim 1, wherein the function verification cartridge communicates with the testing unit through visible light.

10. ) The system of claim 1, wherein upon recognition of the function verification cartridge by the testing device, the function verification cartridge immediately initiates performance testing of the testing device, and wherein errors detected by the function verification cartridge are reported in the form of light pulses that are captured by the sensor in the testing device.

11. ) A system for conducting an assay that rapidly detects the presence of a target analyte in a biological sample, comprising:

(a) a portable testing device, wherein the portable testing device includes a sensor for measuring a detectable light signal that is generated upon the reaction of a biosensor reagent with a specific target analyte within a biological sample;

(b) a reservoir card, wherein the reservoir card includes a biosensor reagent, wherein the biosensor reagent includes living, engineered biological cells, and wherein the reservoir card is configured to interface with a test cartridge base;

(c) a test cartridge base, wherein the test cartridge base is configured to accept the reservoir card and to be placed within the portable testing device, wherein the test cartridge base further includes a reaction chamber that is adapted to receive both the biosensor reagent and the biological sample, and a fluid displacement mechanism that includes a dispensing plunger, and wherein actuation of the dispensing plunger displaces the biosensor reagent in the reservoir into the reaction chamber where the biosensor reagent is mixed with the biological sample; and

(d) a function verification cartridge adapted to be received and recognized by the portable testing device, wherein the function verification cartridge is operative to determine displacement and travel speed of the dispensing plunger and functionality of the sensor prior to conducting an assay for rapidly detecting the presence of the target analyte in the biological sample.

12. ) The system of claim 11, wherein the sensor includes a photomultiplier tube, and wherein the function verification cartridge generates a calibrated light output of a predetermined quantity that is recognized by the testing device as representing a proper amount of light output from the photomultiplier tube.

13. ) The system of claim 11, wherein the testing device further includes a heater for heating the reaction chamber, wherein the function verification cartridge is operative to confirm proper functioning of the heater, and wherein the proper functioning of the heater is determined by resistance thermometer;

thermistor;

thermocouple;

infrared device;

or combinations thereof.

14. ) The system of claim 11, wherein the displacement of the dispensing plunger is determined by linear potentiometer;

optical distance sensing;

ultrasonic distance sensing;

capacitive distance sensing;

inductive/eddy current distance sensing;

limit or break beam switches;

or combinations thereof and wherein the travel speed of the plunger is determined by a microcontroller-based timer;

a real time clock;

external oscillator;

or combinations thereof.

15. ) The system of claim 11, wherein the function verification cartridge communicates with the testing unit through radio-frequency identification, through visible light, or a combination thereof.

16. ) The system of claim 11, wherein upon recognition of the function verification cartridge by the testing device, the function verification cartridge immediately initiates performance testing of the testing device, and wherein errors detected by the function verification cartridge are reported in the form of light pulses that are captured by the sensor in the testing device.

17. ) A system for conducting an assay that rapidly detects the presence of a target analyte in a biological sample, comprising:

(a) a portable testing device, wherein the portable testing device includes a photomultiplier tube for measuring a detectable light signal that is generated upon the reaction of a biosensor reagent with a specific target analyte within a biological sample;

(b) a reservoir card, wherein the reservoir card includes a biosensor reagent, wherein the biosensor reagent includes living, engineered biological cells, and wherein the reservoir card is configured to interface with a test cartridge base;

(c) a test cartridge base, wherein the test cartridge base is configured to accept the reservoir card and to be placed within the portable testing device, wherein the test cartridge base further includes a reaction chamber that is adapted to receive both the biosensor reagent and the biological sample, and a fluid displacement mechanism that includes a dispensing plunger, and wherein actuation of the dispensing plunger displaces the biosensor reagent in the reservoir into the reaction chamber where the biosensor reagent is mixed with the biological sample;

(d) a function verification cartridge adapted to be received and recognized by the portable testing device, wherein the function verification cartridge is operative to determine displacement and travel speed of the dispensing plunger and functionality and sensitivity of the photomultiplier tube prior to conducting an assay for rapidly detecting the presence of the target analyte in the biological sample; and

(e) a heater for heating the reaction chamber, wherein the function verification cartridge is further operative to confirm proper functioning of the heater based on predetermined operational parameters.

18. ) The system of claim 18, wherein the function verification cartridge generates a calibrated light output of a predetermined quantity that is recognized by the testing device as representing a proper amount of light output from the photomultiplier tube.

19. ) The system of claim 19, wherein the proper functioning of the heater is determined by resistance thermometer;

thermistor;

thermocouple;

infrared device;

or combinations thereof.

20. ) The system of claim 20, wherein the displacement of the dispensing plunger is determined by linear potentiometer;

optical distance sensing;

ultrasonic distance sensing;

capacitive distance sensing;

inductive/eddy current distance sensing;

limit or break beam switches;

or combinations thereof; and

wherein the travel speed of the plunger is determined by a microcontroller-based timer;

a real time clock;

external oscillator;

or combinations thereof.