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

A method of testing a biological and/or environmental sample for use with one or more reagents carried by a universal test cartridge in a rapid diagnostic test, an ordinary networking electronic device that does not require regulatory approval as a medical device, and a handheld diagnostic test device, the method comprising:

• (a) a connecting step of connecting a universally connectable test device connection element of the test device with a universally connectable electronic device connection element of the networking electronic device;
• (b) an uploading step, after the connecting step, of electronically transmitting one or more algorithms electronically stored in an onboard memory of the test device to the networking electronic device, via the test device connection element and the electronic device connection element;
• (c) a presentation step, after the uploading step, of using the algorithms to enable an electronic device processor onboard the networking electronic device to present presentation data from an electronic device presentation element onboard the networking electronic device to a user;
• (d) a cartridge inserting step, after the connecting step and the uploading step, of inserting the test cartridge into a port in the test device, with the test cartridge serving as a substrate for reaction of the sample with the reagents;
• (e) a waiting step of using the algorithms to enable the electronic device processor to await elapse of a pre-determined time following reaction of the sample with the reagents;
• (f) a sensing step, after the waiting step and the cartridge inserting step, of using the algorithms to enable the electronic device processor to control the test device and instruct one or more sensors to detect test data from the sample;
• (g) an electronic device processing step, after the sensing step, of using the algorithms to enable the electronic device processor to generate, based on the test data, at least a portion of the presentation data presented to the user;
• and
• (h) a transmission step, after the electronic device processing step, wherein 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;
• wherein 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.