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

{
  "publication_number": "US10352983B1",
  "country": "US",
  "kind": "B1",
  "title": "Systems and methods for assessing electrical connectivity between elements of assay devices",
  "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": [
    "1. A method for assessing electrical connection integrity of an assay cartridge interfaced with an assay processing device, comprising: establishing an electrical connection between the assay cartridge and the assay processing device; measuring electrical signals to determine impedance values associated with at least two circuits between the assay cartridge and the assay processing device; organizing the impedance values to form a new data stream; analyzing the new data stream to determine a quality factor; and sending a command signal for initiating an assay procedure when the quality factor is at or above a predetermined standard, 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 the new data stream, intercept of the line created by the 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.",
    "2. The method of claim 1, further comprising: sending a command signal for ejecting the assay cartridge from the assay processing device when the quality factor is below the predetermined standard.",
    "3. The method of claim 1, wherein organizing the impedance values comprises reordering the impedance values into a lowest-to-highest monotonical sequence, or wherein organizing the impedance values comprises reordering the impedance values into a highest-to-lowest monotonical sequence.",
    "4. The method of claim 1, further comprising, prior to or after organizing the impedance values, excluding one or more impedance values.",
    "5. The method of claim 1, wherein organizing the impedance values comprises reordering the impedance values based on a predetermined reference order or a plurality of predetermined reference orders.",
    "6. The method of claim 5, wherein the predetermined reference order or plurality of predetermined reference orders is produced from an analysis of internal and external data that define a pattern of impedance values.",
    "7. The method of claim 1, wherein organizing the impedance values comprises reordering the impedance values based on a prior reference order at least partially determined by an average of prior valid runs on the assay processing device.",
    "8. The method of claim 1, wherein the assay cartridge comprises reagents to assay a panel of respiratory pathogens, central nervous system pathogens, gastrointestinal pathogens, fungal pathogens, HCV pathogens, gram positive bacterial pathogens, or gram negative bacterial pathogens from a patient sample.",
    "9. A method for assessing electrical connection integrity of a first device and second device comprising: establishing an electrical connection between the first device and second device; measuring electrical signals to determine a first data block associated with at least three electrodes on the first device; organizing the first data block to form a second data block; analyzing the second data block according to a first factor; and sending a signal for initiating a procedure when the first factor is at or above a predetermined standard, wherein the first 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 the second data block, intercept of the line created by the second data block, and a tolerance difference value, wherein the tolerance difference value comprises a difference of an R2 associated with a different device and the R2 associated with the first or second device, or a difference of an RFT associated with a different device and the RFT associated with the first or second device, or a difference of an EFT associated with a different device and the EFT associated with the first or second device.",
    "10. The method of claim 9, further comprising: sending a signal for disconnecting the first device from the second device when the first parameter is below the predetermined standard.",
    "11. The method of claim 9, wherein organizing the impedance values comprises reordering the impedance values monotonically or based on a predetermined reference order.",
    "12. The method of claim 9, wherein organizing the impedance values comprises reordering the impedance values based on more than one predetermined reference order.",
    "13. The method of claim 9, wherein the electrical signal is applied at a frequency between 10 kHz and 100 kHz.",
    "14. The method of claim 9, further comprising: analyzing the second data block according to a second factor and sending a signal for initiating a procedure when the first factor and second factor satisfy a predetermined standard.",
    "15. An assay processing device for assaying a patient sample, comprising: an electronic unit that interfaces with a printed circuit board (PCB) on an assay cartridge, an impedance module, a pattern module, and a qualifier module, wherein the impedance module is configured to measure an electrical signal to determine an impedance value associated with at least some circuits between the assay cartridge and assay processing device; (ii) wherein the pattern module organizes the impedance values to form a new data stream, (iii) wherein the qualifier module analyzes the new data stream to evaluate a quality factor and sends a command signal for initiating an assay procedure when the quality factor is at or above a predetermined standard, 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 the new data stream, intercept of the line created by the 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.",
    "16. The assay processing device of claim 15, wherein the qualifier module sends a command signal to a control module for ejecting the assay cartridge from the assay processing device when the quality factor is below the predetermined standard.",
    "17. The assay processing device of claim 15, wherein the pattern module organizes the impedance values into a lowest-to-highest monotonical sequence, or into a highest-to-lowest monotonical sequence or on a predetermined reference order.",
    "18. The assay processing device of claim 15, wherein the pattern module and qualifier module are on a remote device."
  ],
  "description_excerpt": "This patent document relates to medical devices and, more particularly, to medical devices for the detection and/or analysis of target analytes from patient samples.\n\nPreventable medical errors are now the third leading cause of death in the United States at more than 250,000 per year. For example, preventable medical errors can arise when automated detection systems for nucleic acid or other biomolecular testing do not perform accurately. But, placing strict controls on detection systems may prevent valid sample from being processed resulting in waste and time delay. This can lead to serious problems for a patient whose sample must be analyzed rapidly. For example, critical time could be lost to obtain new samples from the patient and re-run a test. In some cases, such a delay can be deadly, such as for detection systems which detect organisms that cause sepsis. Recent studies have shown that patients with severe sepsis or septic shock showed an increased likelihood of death of 7.6% for every hour in which antibiotic therapy is not applied, such as shown in Liang et al., Empiric Antimicrobial Therapy in Severe Sepsis and Septic Shock: Optimizing Pathogen Clearance, Curr Infect Dis Rep. 2015 July; 17(7): 493. Survival rates could increase if detection systems performed accurately.",
  "cpc": [
    "G01R 31/68",
    "B01L 2200/04",
    "B01L 2200/143",
    "B01L 3/502715",
    "G01R 31/043"
  ],
  "ipc": [
    "G01R 31/04"
  ],
  "assignees": [
    "Genmark Diagnostics Inc"
  ],
  "inventors": [
    "Roger Harry Taylor"
  ],
  "filing_date": "2018-10-04",
  "publication_date": "2019-07-16",
  "grant_date": "2019-07-16",
  "priority_date": "2018-10-04",
  "application_number": "US-201816152181-A",
  "family_id": "67220224",
  "cited_by_count": 7,
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}