IP Library Granted Patent US 10,564,211
Granted Patent B1
US 10,564,211 · App. 16/448,696 · Granted Feb 18, 2020

Systems and methods for assessing electrical connectivity between elements of assay devices

Inventor: Roger Harry Taylor (San Diego, CA)
Assignee: GENMARK DIAGNOSTICS, INC.
G01R31/043
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Quick Facts
Patent No.
US 10,564,211
App. No.
16/448,696
Granted
Feb 18, 2020
Kind
B1
Abstract

Disclosed are devices, systems and methods for assessing the integrity of electrical connections between elements of interfacing electronic devices. In some aspects, a system includes an analysis device having electronics that interface with an assay cartridge inserted into the analysis device, wherein the analysis device is configured to conduct a preflight test in which impedance values for each circuit between the assay cartridge and analysis device are rearranged and assessed to determine the electrical connection integrity of the assay cartridge to the analysis device prior to implementing the assay.

Claims (38)

1. An assay processing device comprising:

an electronic unit to electronically interface with a printed circuit board (PCB) on an assay cartridge;

an impedance module comprising a signal generator and an impedance measurement device; and

an analysis module comprising a processor and memory, wherein the analysis module comprises a pattern module and a qualifier module, wherein the qualifier module comprises a quality factor,

wherein, when the quality factor is at or above a predetermined standard, the electronic unit is electrically connected with the PCB on the assay cartridge.

2. The assay processing device of claim 1 , wherein the pattern module comprises re-ordered data blocks.

3. The assay processing device of claim 1 , wherein the pattern module comprises impedance values organized into a lowest-to-highest monotonical sequence, or into a highest-to-lowest monotonical sequence.

4. The assay processing device of claim 1 , further comprising a communication module.

5. The assay processing device of claim 1 , wherein the qualifier module comprises an affinity array.

6. The assay processing device of claim 1 , wherein the qualifier module comprises organized data blocks.

7. The assay processing device of claim 1 , wherein the qualifier module produces a command signal.

8. The assay processing device of claim 1 , wherein the qualifier module produces an error message.

9. The assay processing device of claim 1 , wherein the qualifier module produces a pass message.

10. The assay processing device of claim 1 , wherein the electronic unit comprises a plurality of electrical conductor sites to contact at least some of a plurality of electrical interface connections of the assay cartridge.

11. The assay processing device of claim 1 , wherein, when the is quality factor below the predetermined standard, the electronic unit is not electrically connected with the PCB on the assay cartridge.

12. An assay processing device comprising:

an impedance module to measure impedance values across electrical interfaces between the assay processing device and an assay cartridge;

an analysis module to analyze the measured impedance values acquired from the impedance module, wherein the analysis module comprises a pattern module and a qualifier module; and

an electronic unit to electronically interface with a printed circuit board (PCB) on the assay cartridge,

wherein the qualifier module comprises a quality factor,

wherein, when the quality factor below a predetermined standard, the electronic unit is not electrically connected with the PCB on the assay cartridge.

13. The assay processing device of claim 12 , wherein, when the quality factor is at or above the predetermined standard, the electronic unit is electrically connected with the PCB on the assay cartridge.

14. The assay processing device of claim 12 , wherein the analysis module further comprises a comparator module.

15. The assay processing device of claim 14 , wherein the comparator module comprises a reference order for impedance values.

16. The assay processing device of claim 12 , wherein the qualifier module sends a command signal for ejecting the assay cartridge when the quality factor is below the predetermined standard.

17. The assay processing device of claim 12 , wherein the qualifier module sends a command signal for processing the assay cartridge when the quality factor is at or above the predetermined standard.

18. The assay processing device of claim 12 , wherein the quality factor is based on one or more parameters selected from a group consisting of a correlation coefficient (R2), a scaled error of fit for an electrode (EFT), a standard error of fit for a run (RFT), slope of the line created by a new data stream, intercept of the line created by a new data stream, and a tolerance difference value, wherein the tolerance difference value comprises a difference of an R2 associated with a different assay cartridge and the R2 associated with the assay cartridge, or a difference of an RFT associated with a different assay cartridge and the RFT associated with the assay cartridge, or a difference of an EFT associated with a different assay cartridge and the EFT associated with the assay cartridge.

19. An assay processing device electronically interfaced to an assay cartridge, wherein the assay cartridge comprises a patient sample, and wherein the assay processing device comprises:

an impedance module comprising a signal generator and an impedance measurement device wherein the impedance module measures an electrical signal to determine impedance values associated with at least some circuits between the assay processing device and the assay cartridge; and

an analysis module comprising a pattern module and a qualifier module, wherein the qualifier module comprises a quality factor, and wherein, when the quality factor is at or above the predetermined standard, the assay processing device is electrically connected with a printed circuit board (PCB) on the assay cartridge.

20. The assay processing device of claim 1 , wherein the quality factor is based on one or more parameters selected from a group consisting of a correlation coefficient (R2), a scaled error of fit for an electrode (EFT), a standard error of fit for a run (RFT), slope of the line created by a new data stream, intercept of the line created by a new data stream, and a tolerance difference value, wherein the tolerance difference value comprises a difference of an R2 associated with a different assay cartridge and the R2 associated with the assay cartridge, or a difference of an RFT associated with a different assay cartridge and the RFT associated with the assay cartridge, or a difference of an EFT associated with a different assay cartridge and the EFT associated with the assay cartridge.

21. An assay processing device comprising:

an electronic unit to electronically interface with a printed circuit board (PCB) on an assay cartridge;

an impedance module comprising a signal generator and an impedance measurement device; and

an analysis module comprising a processor and memory, wherein the analysis module comprises a pattern module and a qualifier module, wherein the qualifier module comprises a quality factor,

wherein, when the quality factor is below a predetermined standard, the electronic unit is not electrically connected with the PCB on the assay cartridge, and

wherein, when the quality factor is at or above the predetermined standard, the electronic unit is electrically connected with the PCB on the assay cartridge.

22. The assay processing device of claim 21 , wherein the quality factor is based on one or more parameters selected from a group consisting of a correlation coefficient (R2), a scaled error of fit for an electrode (EFT), a standard error of fit for a run (RFT), slope of the line created by a new data stream, intercept of the line created by a new data stream, and a tolerance difference value, wherein the tolerance difference value comprises a difference of an R2 associated with a different assay cartridge and the R2 associated with the assay cartridge, or a difference of an RFT associated with a different assay cartridge and the RFT associated with the assay cartridge, or a difference of an EFT associated with a different assay cartridge and the EFT associated with the assay cartridge.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 18, 2021
From: GENMARK DIAGNOSTICS, INC.
To: ROCHE MOLECULAR SYSTEMS, INC.
Reel/Frame 058189/0563 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 21, 2019
From: TAYLOR, ROGER HARRY
To: GENMARK DIAGNOSTICS, INC.
Reel/Frame 049551/0984 →
Continuity (1)
Continuation 16152181 · Oct 4, 2018
Cited By (1)
US 12,586,679