Clinical diagnostic systems

• US 9,625,465 B2
• Filed: 05/15/2013
• Issued: 04/18/2017
• Est. Priority Date: 05/15/2012
• Status: Active Grant

• Current Assignee: Pharma CINQ LLC
• Original Assignee: Defined Diagnostics LLC
• Inventors: Cook, Richard Alan, Cho, Sang, Davis, Charles Quentin, Dorsey, Kevin E, Harley, Jason Charles, Leland, Jonathan, Matikyan, Rober Krikor, Otten, Sjef, Peterman, Jeffrey Howard, Thomas, Brian B
• Primary Examiner(s): WHITE, DENNIS MICHAEL
• Application Number:
  US14/401,278
• Publication Number:
  US 20150132861A1
• Time in Patent Office: 1,434 Days
• CPC Class Codes: B01L 2200/10 Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
• CPC Class Codes: B01L 2300/0645 Electrodes
• CPC Class Codes: B01L 2300/0672 Integrated piercing tool
• CPC Class Codes: B01L 2300/0681 Filter
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: G01N 33/536 with immune complex formed in liquid phase
• CPC Class Codes: G01N 33/543 with an insoluble carrier for immobilising immunochemicals
• CPC Class Codes: G01N 33/58 involving labelled substances G01N33/53 takes precedence
• CPC Class Codes: G01N 33/582 with fluorescent label
• CPC Class Codes: Y10T 436/147777 Plural nitrogen in the same ring [e.g., barbituates, creatinine, etc.]
• CPC Class Codes: Y10T 436/25 including sample preparation
• CPC Class Codes: Y10T 436/2575 Volumetric liquid transfer

Abstract

A diagnostic system is provided herein that includes an instrument comprising an electrochemiluminescence (ECL) detector, and a cartridge configured to fit within a portion of the instrument, wherein the cartridge includes at least one reagent including an ECL label and a blood collection holder. Also provided herein is a system that includes a diagnostic instrument, which includes a pump, an ECL detector, an incubator, a magnet, and an output device, and a cartridge configured to fit within a portion of the diagnostic instrument, a sample holder configured to fit within the cartridge, and a closed fluidic loop between the diagnostic instrument and the cartridge when the cartridge is fit within a portion of the diagnostic instrument, wherein the cartridge is configured to accept a sample from the sample holder and place the sample in fluidic communication with the diagnostic instrument via the closed fluidic loop.

Claims

1. A diagnostic system, comprising:

an instrument comprising an electrochemiluminescence (ECL) detector; and

a cartridge configured to fit within a portion of the instrument, wherein the cartridge comprises;

at least one reagent including an ECL label;

a blood collection holder;

at least one blood collection holder needle;

a blood collection holder structure; and

a closed fluidic path between the blood collection holder and the instrument;

wherein the closed fluidic path provides the at least one reagent from the cartridge to the instrument, and then provides the at least one reagent from the instrument to the cartridge.

2. The diagnostic system of claim 1, wherein the instrument further comprises a pump, an incubator, a sensor, a magnet, and an output device.

3. The diagnostic system of claim 1, wherein the cartridge further comprises a filter or a discard reservoir,

wherein the filter, if present, filters plasma from whole blood, and

wherein the discard reservoir, if present, gathers the at least one reagent including the ECL label and contents from the blood collection holder.

4. The diagnostic system of claim 1, wherein the blood collection holder comprises a blood collection tube.

5. A system, comprising:

a diagnostic instrument comprising;

a pump;

an electrochemiluminescence (ECL) detector;

an incubator;

a magnet; and

an output device; and

a cartridge configured to fit within a portion of the diagnostic instrument;

a sample holder configured to fit within the cartridge; and

a closed fluidic path between the diagnostic instrument and the cartridge when the cartridge is fit within a portion of the diagnostic instrument, wherein the cartridge is configured to accept a sample from the sample holder and place the sample in fluidic communication with the diagnostic instrument via the closed fluidic path,

wherein the ECL detector comprises;

at least two electrodes; and

a gasket, wherein the gasket separates the at least two electrodes, and wherein a measurement containment area is formed by the gasket and the at least two electrodes, and wherein the ECL detector measures ECL labels within the measurement containment area.

6. The system of claim 5,

wherein the gasket maintains a predetermined spacing between the at least two electrodes to form the measurement containment area, and

wherein the gasket comprises an elastomeric material.

7. The system of claim 5, wherein the incubator comprises:

one or more sensors; and

one or more heating and/or cooling elements, wherein the one or more sensors and the one or more heating and/or cooling elements provide a predetermined temperature to a portion of the closed fluidic channel within the cartridge.

8. The system of claim 5, wherein the cartridge further comprises:

at least one sample holder needle; and

a sample holder structure, wherein the sample holder fits within the sample holder structure and the sample is accessible to the closed fluidic path via the at least one sample holder needle.

9. The system of claim 5, wherein the cartridge further comprises a filter within the closed fluidic path, wherein the filter is configured to separate portions of the sample.

10. The system of claim 5, wherein the cartridge further comprises a discard reservoir within the closed fluidic path, wherein the discard reservoir is configured to hold contents of the closed fluidic path, and wherein the system is a self-contained diagnostic system.

11. A method of providing Point of Care (POC) services, comprising:

providing a biological sample;

introducing the biological sample to a cartridge;

providing the cartridge to a diagnostic instrument comprising an electrochemiluminescence (ECL) detector;

mixing the biological sample with a reagent in the cartridge to form a biological sample-reagent mixture;

providing at least a portion of the biological sample-reagent mixture from the cartridge to the diagnostic instrument in a closed fluidic path;

analyzing the biological sample-reagent mixture using the ECL detector;

outputting the results from the analyzing step; and

providing at least a portion of the biological sample-reagent mixture from the diagnostic instrument to the cartridge in the closed fluidic path.

12. The method of claim 11, wherein the introducing the biological sample to a cartridge comprises:

inserting a blood collection holder containing the biological sample into a preconfigured area of the cartridge; and

allowing the biological sample from the blood collection holder to be available to fluidic channels within the cartridge.

13. The method of claim 12, wherein the inserting of the blood collection holder into the preconfigured area of the cartridge comprises inserting the blood collection holder into a blood collection holder mount that includes at least one blood collection needle that allows the biological sample to be available to fluidic channels within the cartridge.

14. The method of claim 11, wherein the providing the cartridge to a diagnostic instrument comprising an ECL detector comprises:

fitting the cartridge into a preconfigured area of the diagnostic instrument, wherein the preconfigured area of the diagnostic instrument is a slot in the diagnostic instrument shaped specifically for the cartridge.

15. The method of claim 11, wherein the mixing the biological sample with a reagent in the cartridge to form a biological sample-reagent mixture comprises:

mixing the biological sample with the reagent, wherein mixing moves the biological sample together with the reagent within a fluidic channel to form detectable complexes in the biological sample-reagent mixture.

16. The method of claim 11, wherein the analyzing the biological sample-reagent mixture using the ECL detector comprises:

introducing the biological sample-reagent mixture into the ECL detector;

applying a light source to the biological sample-reagent mixture within a measurement containment area of the ECL detector; and

detecting the number of ECL labels within the biological sample-reagent mixture using the ECL detector.

17. The method of claim 11, wherein the outputting the results from the analyzing step comprises:

gathering results from the analyzing step; and

outputting results to the diagnostic instrument to supply a user with the results.

18. The method of claim 11, further comprising filtering the biological sample by:

flowing the biological sample through a filtration module within the cartridge to divide the biological sample into a testing sample and a waste product.

19. The method of claim 18, wherein the flowing of the biological sample through a filtration module comprises flowing the biological sample through one or more filtration layers.

20. The method of claim 18, wherein the providing at least a portion of the biological sample-reagent mixture from the diagnostic instrument to the cartridge comprises collecting the testing sample in a testing sample cache within the cartridge.

21. The method of claim 18, wherein the providing at least a portion of the biological sample-reagent mixture from the diagnostic instrument to the cartridge comprises collecting the waste product in a waste product collector within the cartridge.

22. The method of claim 11, further comprising incubating the biological sample-reagent mixture by:

heating and/or cooling with one or more heating and/or cooling elements the biological sample-reagent mixture;

sensing with one or more sensors a temperature of the biological sample-reagent mixture; and

adjusting a temperature of the incubator to a predetermined temperature.

23. The method of claim 11, further comprising washing the biological sample-reagent mixture by:

positioning the biological sample-reagent mixture within a portion of the cartridge within an electromagnetic field of a magnet of the diagnostic instrument;

magnetically attracting a first portion of the biological sample-reagent mixture to the magnet; and

washing away a second portion of the biological sample-reagent mixture with a rinsing fluid to expose the detectable complex for analyzing.

24. The method of claim 11, further comprising analyzing the biological sample-reagent mixture using an internal standard (IS) detector.

25. The method of claim 24, further comprising providing a failsafe mechanism by comparing results from the analyzing of the biological sample-reagent mixture by the IS detector with results from the analyzing of the biological sample-reagent mixture by the ECL detector.