Single-use handheld diagnostic test device, and an associated system and method for testing biological and environmental test samples

摘要

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.

主权项

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.