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Handheld diagnostic test device and method for use with an electronic device and a test cartridge in a rapid diagnostic test

  • US 9,805,165 B2
  • Filed: 01/13/2010
  • Issued: 10/31/2017
  • Est. Priority Date: 01/13/2009
  • Status: Active Grant
First Claim
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1. A handheld diagnostic test device for use with a test cartridge containing one or more reagents to be reacted with a biological and/or environmental sample in a rapid diagnostic test, and with an ordinary networking electronic device that does not require regulatory approval as a medical device, the networking electronic device having an electronic device processor, an electronic device presentation element, and a universally connectable electronic device connection element, with the test device comprising:

  • (a) a universal test cartridge port to selectively receive the test cartridge in removable relation;

    (b) a universally connectable test device connection element connected with the electronic device connection element;

    (c) one or more sensors for operative detection of test data from the sample after reaction with the reagents; and

    (d) an onboard memory electronically storing one or more algorithms for electronic transmission to the networking electronic device, via the test device connection element and the electronic device connection element, that when uploaded from the test device to the networking electronic device cause the electronic device processor to;

    (i) await elapse of a pre-determined time following reaction of the sample with the reagents;

    (ii) control the test device and instructs at least one of the sensors to detect the test data after elapse of the pre-determined time following reaction of the sample with the reagents;

    (iii) generate presentation data based at least in part on the test data;

    (iv) present the presentation data from the electronic device presentation element to a user;

    (v) electronically receive at least one of user identification data or patient identification data associated with the rapid diagnostic test; and

    (vi) encrypt the patient identification data as encrypted data;

    such that all or substantially all processing and management of the test data, and all processing and management of the presentation data, is performed remotely of the test device;

    such that the networking electronic device transmits, without the patient identification data and fully compliant with all applicable interface standards for exchanging and transferring health data, at least a portion of the presentation data, the test data, and the encrypted data for recordal in one or more remote and/or distributed databases;

    such that the test device is adapted for use with a test cartridge identification element onboard the test cartridge, wherein at least one of the sensors operatively detects test cartridge identification data from the test cartridge identification element, and wherein the test cartridge identification data is such as to enable identification of the rapid diagnostic test, the reagents, and/or associated quality assurance information; and

    such that the test device is adapted for use with a geo-localization element onboard the electronic device, and wherein the electronic transmission of the algorithms from the onboard memory is such as to enable;

    (i) the electronic device processor to use the geo-localization element to obtain geo-localization data for the rapid diagnostic test; and

    (ii) the networking electronic device to transmit the geo-localization data for recordal in the remote and/or distributed databases.

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