Single-use handheld diagnostic test device, and an associated system and method for testing biological and environmental test samples
First Claim
1. An electronic device and single-use handheld diagnostic test device system, for use with a biological and/or environmental test sample, the system comprising:
- (a) a single-use handheld diagnostic test device adapted to receive and operatively react the sample with one or more reagents, with the test device having;
(i) at least one sensor operatively detecting test data from the sample after reaction with the reagents; and
(ii) a test connection element; and
(b) an electronic device having;
(i) a mating electronic connection element operatively connected with the test connection element and electronically receiving the test data from the test device;
(ii) a processor operatively applying data analysis and quality control algorithms to control the reaction of the sample with the reagents, and operatively applying the data analysis and quality control algorithms to the test data to generate quantitative test results and presentation data based on the quantitative test results; and
(iii) a presentation element operatively presenting to a user the presentation data based on the quantitative test results;
wherein the test device is adapted to test a single one said sample and is adapted for disposal, or for sterilization and re-use of the sensor and/or the test connection element, after the electronic device receives the test data; and
wherein the test device has onboard memory which electronically stores the quality control algorithm and the test data; and
wherein the processor of the electronic device operatively receives the test data and the quality control algorithms from the test device via the test and electronic connection elements.
1 Assignment
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Accused Products
Abstract
In a single-use handheld diagnostic test device and an associated system and method, a biological and/or environmental test sample is received and reacted with reagents. The test device tests a single sample and includes a sensor to detect test data. The test device mates with, and transmits the test data to, an electronic device. A processor of the electronic device applies algorithms to the test data to generate highly sensitive and accurate quantitative test results. A presentation element of the electronic device presents the test results to a user. The test device is adapted for disposal, or for sterilization and re-use, after the electronic device receives the test data. The electronic device may be, for example, a mobile communications device, a personal digital assistant, a laptop computer, a navigation device, a digital audio player, a camera, or a gaming device.
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Citations
22 Claims
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1. An electronic device and single-use handheld diagnostic test device system, for use with a biological and/or environmental test sample, the system comprising:
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(a) a single-use handheld diagnostic test device adapted to receive and operatively react the sample with one or more reagents, with the test device having; (i) at least one sensor operatively detecting test data from the sample after reaction with the reagents; and (ii) a test connection element; and (b) an electronic device having; (i) a mating electronic connection element operatively connected with the test connection element and electronically receiving the test data from the test device; (ii) a processor operatively applying data analysis and quality control algorithms to control the reaction of the sample with the reagents, and operatively applying the data analysis and quality control algorithms to the test data to generate quantitative test results and presentation data based on the quantitative test results; and (iii) a presentation element operatively presenting to a user the presentation data based on the quantitative test results; wherein the test device is adapted to test a single one said sample and is adapted for disposal, or for sterilization and re-use of the sensor and/or the test connection element, after the electronic device receives the test data; and wherein the test device has onboard memory which electronically stores the quality control algorithm and the test data; and
wherein the processor of the electronic device operatively receives the test data and the quality control algorithms from the test device via the test and electronic connection elements. - View Dependent Claims (2, 3, 4)
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5. An electronic device and single-use handheld diagnostic test device system, for use with a biological and/or environmental test sample, the system comprising:
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(a) a single-use handheld diagnostic test device adapted to receive and operatively react the sample with one or more reagents, with the test device having; (i) at least one sensor operatively detecting test data from the sample after reaction with the reagents; and (ii) a test connection element; and (b) an electronic device having; (i) a mating electronic connection element operatively connected with the test connection element and electronically receiving the test data from the test device; (ii) a processor operatively applying data analysis and quality control algorithms to control the reaction of the sample with the reagents, and operatively applying the data analysis and quality control algorithms to the test data to generate quantitative test results and presentation data based on the quantitative test results; and (iii) a presentation element operatively presenting to a user the presentation data based on the quantitative test results; wherein the test device is adapted to test a single one said sample and is adapted for disposal, or for sterilization and re-use of the sensor and/or the test connection element, after the electronic device receives the test data and the quality control algorithm from the test device; further comprising an identification element operative to identify the user, with the identification element provided in the form of a standalone identification component and/or integrally with the electronic device and/or the test device; wherein the electronic device stores user identification data associated with the user and/or an owner of the electronic device, and wherein the identification element automatically accesses the user identification data stored in the electronic device; and adapted for use with an account associated with the user identification data, and further comprising a billing element operatively debiting the account in association with the generation of the quantitative test results. - View Dependent Claims (6, 7, 8, 9, 10, 11)
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12. A single-use handheld diagnostic test device system, for use with an electronic device having an electronic connection element, a presentation element, and a processor for operative application of data analysis and quality control algorithms, with the test device adapted to receive and operatively react a biological and/or environmental test sample with one or more reagents, wherein the test device comprises:
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(a) at least one sensor operatively detecting test data from the sample after reaction with the reagents; and (b) a mating test connection element operatively connected with, and electronically transmitting the quality control algorithm and the test data to the electronic device via, the electronic connection element;
such as to enable the processor to operatively apply the data analysis and quality control algorithms to control the reaction of the sample with the reagents, and operatively apply the data analysis and quality control algorithms to the test data for generation of quantitative test results and presentation data based on the quantitative test results, and such as to enable the presentation element to operatively present to a user the presentation data based on the quantitative test results; andwherein the test device is adapted to test a single one said sample and is adapted for disposal, or for sterilization and re-use of the sensor and/or the test connection element, after the electronic transmission of the test data to the electronic device; and further comprising onboard memory which electronically stores at least one of the quality control algorithm and the test data; and
wherein the test connection element electronically transmits the quality control algorithms to the electronic connection element of the electronic device. - View Dependent Claims (13, 14, 15)
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16. A single-use handheld diagnostic test device for use with an electronic device having an electronic connection element, a presentation element, and a processor for operative application of the data analysis and quality control algorithms, with the test device adapted to receive and operatively react a biological and/or environmental test sample with one or more reagents, wherein the test device comprises:
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(a) at least one sensor operatively detecting test data from the sample after reaction with the reagents; and (b) a mating test connection element operatively connected with, and electronically transmitting at least one of the quality control algorithm and the test data to the electronic device via, the electronic connection element;
such as to enable the processor to operatively apply the data analysis and quality control algorithms to control the reaction of the sample with the reagents, and operatively apply the data analysis and quality control algorithms to the test data for generation of quantitative test results and presentation data based on the quantitative test results, and such as to enable the presentation element to operatively present to a user the presentation data based on the quantitative test results;wherein the test device is adapted to test a single one said sample and is adapted for disposal, or for sterilization and re-use of the sensor and/or the test connection element, after electronic transmission of the test data and the quality control algorithm from the test device to the electronic device; further comprising an identification element operative to identify the user, with the identification element provided in the form of a standalone identification component and/or integrally with the sensor and/or the test connection element; adapted for use with user identification data which is stored in the electronic device and is associated with the user and/or an owner of the electronic device, wherein the identification element automatically accesses the user identification data stored in the electronic device; and
adapted for use with an account associated with the user identification data, and further comprising a billing element operatively debiting the account in association with the generation of the quantitative test results. - View Dependent Claims (17, 18, 19, 20, 21, 22)
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Specification