Patent Publication Number: US-11385219-B2

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

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This is a divisional application of U.S. application Ser. No. 13/144,438 filed Jan. 13, 2012, which is a U.S. National Stage Application of International Application No. PCT/CA2010/000033 filed Jan. 13, 2010, which claims priority from U.S. Application No. 61/144,283 filed Jan. 13, 2009. The entireties of the above-listed applications are incorporated herein by reference. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates generally to diagnostic test devices, and more particularly, to a handheld diagnostic test device and method for use with an electronic device and a test cartridge in a rapid diagnostic test. 
     BACKGROUND OF THE INVENTION 
     Previously, rudimentary rapid tests may have been available on the market. Tests of this nature may have afforded a testing of only relatively basic parameters, such as typically may not have required any interpretation and/or a data management process in order to validate the test. More sophisticated and/or accurate rapid point-of-care tests may not heretofore have been possible, apart from at the hospital and/or in a core laboratory. This shortcoming of the prior art may have been due, in part, to the complexity of these kinds of diagnostic tests. At the same time, most prior art tests (whether simple or complex) may heretofore have required medical interpretation by qualified personnel. 
     Previously, in addition, the recordal of data in a computer for analysis and/or compilation in an electronic medical record (EMR) or healthcare repository may only have occurred in environments where there was access to a laboratory information system (LIS) or a hospital information system (HIS). That is, heretofore, automated recordal of results related to patient identification may have been, at best, very difficult and, often, impossible with simple prior art tests (e.g., lateral flow strips). 
     Though the prior art may have included a few somewhat inexpensive test readers, the functionality heretofore afforded by such readers may generally have been somewhat limited. For example, some such readers may have required a separate computer to provide any quantitative test results whatsoever. The prior art may include: a Reader  100  device which may have been previously offered by MATEST Systemtechnik GmbH of Mossingen, Germany; and a device which may have been previously offered by Alverix, Inc. of San Jose, Calif. 
     It is an object of an aspect of one preferred embodiment according to the present invention to provide a handheld diagnostic test device and method for use with an electronic device and a test cartridge in a rapid diagnostic test. 
     It is an object of an aspect of one preferred embodiment according to the present invention to provide diagnostic test devices and/or methods which may preferably combine a diagnostic test device with a conventional computing or networking electronic device. 
     It is an object of an aspect of one preferred embodiment according to the present invention to provide diagnostic test devices and/or methods which may preferably combine a diagnostic test device with a cellular telephone or other electronic device. 
     It is an object of an aspect of one preferred embodiment according to the present invention to provide an integrated diagnostic reader and cellular telephone device and/or method. 
     It is an object of an aspect of one preferred embodiment according to the present invention to provide a diagnostic test device and/or method controllable by an electronic device. 
     It is an object of an aspect of one preferred embodiment according to the present invention to provide a diagnostic test device and/or method for use with an electronic device, with little or no modification of the electronic device hardware being required. 
     It is an object of an aspect of one preferred embodiment according to the present invention to provide a diagnostic test device and/or method for use with a networking electronic device, while allowing the networking electronic device to remain partially or fully functional as such. 
     It is an object of an aspect of one preferred embodiment according to the present invention to provide a diagnostic test device and/or method which uploads onto an electronic device one or more algorithms associated with a rapid diagnostic test for use by the electronic device. 
     It is an object of an aspect of one preferred embodiment according to the present invention to provide a diagnostic test device and/or method which, with upload of algorithms therefrom, enables a data input device and/or presentation element onboard an electronic device to be utilized in association with a rapid diagnostic test. 
     It is an object of an aspect of one preferred embodiment according to the present invention to provide a diagnostic test device and/or method which may be powered by the power supply of an electronic device. 
     It is an object of an aspect of one preferred embodiment according to the present invention to provide a diagnostic test device and/or method for use with an electronic device in rapidly performing quantitative and/or qualitative diagnostic tests. 
     It is an object of an aspect of one preferred embodiment according to the present invention to provide a diagnostic test device and/or method for use with an electronic device to enable assay time counting. 
     It is an object of an aspect of one preferred embodiment according to the present invention to provide a diagnostic test device and/or method for use with an electronic device to afford a location tracking capability, preferably a geo-localization and/or global location tracking capability. 
     It is an object of an aspect of one preferred embodiment according to the present invention to provide a diagnostic test device and/or method for use with an electronic device to enable secure management of patient data. 
     It is an object of an aspect of one preferred embodiment according to the present invention to provide a diagnostic test device and/or method for use with an electronic device in infectious disease surveillance, diagnosis and emergency medical response at the point of care. 
     It is an object of an aspect of one preferred embodiment according to the present invention to reduce the number of complex features or requirements (e.g., IT infrastructure, connectivity, and/or professional interpretation of result) which may have been previously associated with substantially complete diagnostic test devices, systems and/or methods. 
     It is an object of an aspect of one preferred embodiment according to the present invention to provide substantially complete diagnostic test devices and/or methods which may preferably be used with few or no complex features or requirements, such as, for example, IT infrastructure, connectivity, and/or professional interpretation of result. 
     It is an object of an aspect of one preferred embodiment according to the present invention to provide diagnostic test devices and/or methods which afford a quality, level of result, and/or services which, heretofore, may only have been available in diagnostic tests performed in a core laboratory or hospital. 
     It is an object of an aspect of one preferred embodiment according to the present invention to provide diagnostic test devices, systems and/or methods which may preferably be used by a patient and/or customer with minimal technical or clinical knowledge concerning the device technology or the interpretation of the test results. 
     It is an object of one preferred embodiment according to the invention to provide a device and/or method for use in biological and/or medical applications. 
     It is an object of the present invention to obviate or mitigate one or more of the aforementioned mentioned disadvantages associated with the prior art, and/or to achieve one or more of the aforementioned objects of the invention. 
     SUMMARY OF THE INVENTION 
     According to the invention, there is disclosed 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. The test device is also for use an electronic device having an electronic device processor, an electronic device presentation element, and an electronic device connection element. The test device includes a test cartridge port to selectively receive the test cartridge in removable relation, a test device connection element connected with the electronic device connection element, and one or more sensors for operative detection of test data from the sample after reaction with the reagents. The test device also includes an onboard memory electronically storing one or more algorithms for electronic transmission to the electronic device, via the test device connection element and the electronic device connection element, such as to enable the electronic device processor to: (i) await elapse of a pre-determined time following reaction of the sample with the reagents; (ii) instruct 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; and (iv) present the presentation data from the electronic device presentation element to a user. 
     According to an aspect of one preferred embodiment of the invention, the test device connection element may preferably, but need not necessarily, be connected with the electronic device connection element in selectively disconnectable relation. 
     According to an aspect of one preferred embodiment of the invention, the electronic transmission of the algorithms from the onboard memory may preferably, but need not necessarily, be such as to enable the electronic device processor to generate time counting data during elapse of the pre-determined time. The time counting data may preferably, but need not necessarily, form at least part of the presentation data for presentation to the user. 
     According to an aspect of one preferred embodiment of the invention, the test data may preferably, but need not necessarily, be electronically transmitted from the sensors to the electronic device via the test device connection element and/or the electronic device connection element. The electronic transmission of the algorithms from the onboard memory may preferably, but need not necessarily, be such as to enable the electronic device processor to generate test results based on the test data. The test results may preferably, but need not necessarily, form at least part of the presentation data for presentation to the user. 
     According to an aspect of one preferred embodiment of the invention, the test device may preferably, but need not necessarily, also include a test device processor electronically receiving the test data from the sensors and/or generating test results based on the test data. The test results may preferably, but need not necessarily, be electronically transmitted from the test device connection element to the electronic device via the electronic device connection element. The electronic device processor may preferably, but need not necessarily, generate the presentation data based at least in part on the test results. 
     According to an aspect of one preferred embodiment of the invention, the electronic transmission of the algorithms from the onboard memory may preferably, but need not necessarily, be such as to enable the electronic device processor to generate treatment and/or follow-up suggestion data for presentation to the user as at least part of the presentation data. The treatment and/or follow-up suggestion data may preferably, but need not necessarily, be based at least in part on the test results. 
     According to an aspect of one preferred embodiment of the invention, the test device may preferably, but need not necessarily, be for integral use with the electronic device. The test device connection element may preferably, but need not necessarily, be physically connected with the electronic device connection element in mating relation. 
     According to an aspect of one preferred embodiment of the invention, the test device may preferably, but need not necessarily, be adapted for use with a test cartridge identification element onboard the test cartridge. At least one of the sensors may preferably, but need not necessarily, operatively detect test cartridge identification data from the test cartridge identification element. The test cartridge identification data may preferably, but need not necessarily, be such as to enable identification of the rapid diagnostic test, the reagents, and/or associated quality assurance information. 
     According to an aspect of one preferred embodiment of the invention, the test device may preferably, but need not necessarily, be adapted for use with a bar code element and/or a radio-frequency identification (RFID) element as the test cartridge identification element. 
     According to an aspect of one preferred embodiment of the invention, the electronic transmission of the algorithms from the onboard memory may preferably, but need not necessarily, be such as to enable the electronic device processor to instruct the test device to initiate a self-check, calibration and/or maintenance routine. 
     According to an aspect of one preferred embodiment of the invention, the test device may preferably, but need not necessarily, be adapted for use with a data input device onboard the electronic device. The electronic transmission of the algorithms from the onboard memory may preferably, but need not necessarily, be such as to enable the electronic device processor to: (i) electronically receive, preferably via the data input device, user and/or patient identification data associated with the rapid diagnostic test; and/or (ii) generate the presentation data based in part on the user and/or patient identification data for presentation to the user. 
     According to an aspect of one preferred embodiment of the invention, the test device may preferably, but need not necessarily, be adapted for use with a keypad as the data input device. 
     According to an aspect of one preferred embodiment of the invention, the test device may preferably, but need not necessarily, be adapted for use with a networking electronic device as the electronic device. The electronic transmission of the algorithms from the onboard memory may preferably, but need not necessarily, be such as to enable: (i) the electronic device processor to encrypt the patient identification data as encrypted data; and/or (ii) the networking electronic device to transmit, preferably without the patient identification data, at least a portion of the presentation data, the test data, and/or the encrypted data for recordal in one or more remote and/or distributed databases. 
     According to an aspect of one preferred embodiment of the invention, the transmission of the presentation data, the test data, and/or the encrypted data by the networking electronic device and/or the encryption of the patient identification data may preferably, but need not necessarily, be fully compliant with all applicable interface standards for exchanging and/or transferring health data. 
     According to an aspect of one preferred embodiment of the invention, the test device may preferably, but need not necessarily, be adapted for use with a networking electronic device as the electronic device. The electronic transmission of the algorithms from the onboard memory may preferably, but need not necessarily, be such as to enable the networking electronic device to transmit at least a portion of the presentation data and/or the test data for recordal in one or more remote and/or distributed databases. 
     According to an aspect of one preferred embodiment of the invention, the test device may preferably, but need not necessarily, be adapted for use with a geo-localization element onboard the electronic device. The electronic transmission of the algorithms from the onboard memory may preferably, but need not necessarily, be 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/or (ii) the networking electronic device to transmit the geo-localization data for recordal in the remote and/or distributed databases. 
     According to an aspect of one preferred embodiment of the invention, the test device may preferably, but need not necessarily, also include a light source element illuminating the sample after elapse of the pre-determined time following reaction with the reagents. The aforesaid at least one of the sensors may preferably, but need not necessarily, include a photodiode element. The test data may preferably, but need not necessarily, include a test image. 
     According to an aspect of one preferred embodiment of the invention, the photodiode element may preferably, but need not necessarily, include a charge coupled device (CCD) element. 
     According to an aspect of one preferred embodiment of the invention, the light source element may preferably, but need not necessarily, include a laser, a light emitting diode (LED), an optical fiber light source element, a tungsten lamp, a mercury lamp, and/or a xenon lamp. 
     According to an aspect of one preferred embodiment of the invention, the test device may preferably, but need not necessarily, be adapted for use with an electronic device memory onboard the electronic device. The electronic transmission of the algorithms from the onboard memory may preferably, but need not necessarily, be such as to enable the electronic device processor to store the presentation data and/or the test data in the electronic device memory. 
     According to an aspect of one preferred embodiment of the invention, the test device may preferably, but need not necessarily, be adapted for use with a display element as the presentation element. The electronic transmission of the algorithms from the onboard memory may preferably, but need not necessarily, be such as to enable the electronic device processor to generate the presentation data for presentation from the display element, preferably in the form of one or more visually presentable (a) textual data, (b) graphical data, and/or (c) colored indicator light data. 
     According to an aspect of one preferred embodiment of the invention, the test device may preferably, but need not necessarily, also include a test device battery to power the test device. 
     According to an aspect of one preferred embodiment of the invention, the test device may preferably, but need not necessarily, be adapted for use with an electronic device battery onboard the electronic device. The test connection element of the test device may preferably, but need not necessarily, receive power, preferably via the electronic connection element, from the electronic device battery. 
     According to an aspect of one preferred embodiment of the invention, the test device may preferably, but need not necessarily, be adapted for use with one or more of following as the electronic device: (a) a cellular telephone; (b) a mobile communications device; (c) a personal digital assistant; (d) a desktop computer; (e) a laptop computer; (f) a navigation device; (g) a digital audio player; (h) a camera; (i) a gaming device; (j) a television; and/or (k) a radio. 
     According to the invention, there is also disclosed a method of testing a biological and/or environmental sample for use with one or more reagents carried by a test cartridge in a rapid diagnostic test. The method is also for use with an electronic device and a handheld diagnostic test device. The method includes the following steps: (a) a connecting step of connecting a test device connection element of the test device with an electronic device connection element of the electronic device; (b) an uploading step, after the connecting step, of electronic transmitting one or more algorithms electronically stored in an onboard memory of the test device to the 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 electronic device to present presentation data from an electronic device presentation element onboard the 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, preferably but not necessarily after the cartridge inserting 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 instruct one or more sensors to detect test data from the sample; and (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. 
     According to an aspect of one preferred embodiment of the invention, preferably in the connecting step, the test device connection element may preferably, but need not necessarily, be connected with the electronic device connection element in selectively disconnectable relation. 
     According to an aspect of one preferred embodiment of the invention, preferably during the waiting step, the algorithms may preferably, but need not necessarily, enable the electronic device processor to generate time counting data. The time counting data may preferably, but need not necessarily, form at least a portion of the presentation data presented to the user. 
     According to an aspect of one preferred embodiment of the invention, preferably before the electronic device processing step, the test data may preferably, but need not necessarily, be electronically transmitted from the sensors to the electronic device via the test device connection element and/or the electronic device connection element. Preferably in the electronic device processing step, the algorithms may preferably, but need not necessarily, enable the electronic device processor to generate test results based on the test data. The test results may preferably, but need not necessarily, form at least part of the presentation data for presentation to the user. 
     According to an aspect of one preferred embodiment of the invention, the method may preferably, but need not necessarily, also include a test device processing step, preferably before the electronic device processing step, of using a test device processor onboard the test device to electronically receive the test data from the sensors and/or to generate test results based on the test data. Preferably before the electronic device processing step, the test results may preferably, but need not necessarily, be electronically transmitted from the test device connection element to the electronic device via the electronic device connection element. Preferably in the electronic device processing step, the algorithms may preferably, but need not necessarily, enable the electronic device processor to generate the presentation data based at least in part on the test results. 
     According to an aspect of one preferred embodiment of the invention, preferably in the electronic device processing step, the algorithms may preferably, but need not necessarily, enable the electronic device processor to generate treatment and/or follow-up suggestion data for presentation to the user as at least part of the presentation data. The treatment and/or follow-up suggestion data may preferably, but need not necessarily, be based at least in part on the test results. 
     According to an aspect of one preferred embodiment of the invention, preferably in the connecting step, the test device connection element may preferably, but need not necessarily, be physically connected with the electronic device connection element in mating relation. 
     According to an aspect of one preferred embodiment of the invention, the method may preferably, but need not necessarily, also include a cartridge identification step, preferably before the electronic device processing step, of using at least one of the sensors to operatively detect test cartridge identification data from a test cartridge identification element onboard the test cartridge, and/or using the test cartridge identification data to identify the rapid diagnostic test, the reagents, and/or associated quality assurance information. 
     According to an aspect of one preferred embodiment of the invention, preferably in the cartridge identification step, a bar code element and/or a radio-frequency identification (RFID) element may preferably, but need not necessarily, be used as the test cartridge identification element. 
     According to an aspect of one preferred embodiment of the invention, the method may preferably, but need not necessarily, also include a maintenance step, preferably after the uploading step, of using the algorithms to enable the electronic device processor to instruct the test device to initiate a self-check, calibration and/or maintenance routine. 
     According to an aspect of one preferred embodiment of the invention, the method may preferably, but need not necessarily, also include a data input step, preferably after the uploading step, of using the algorithms to enable the electronic device processor to electronically receive, preferably via a data input device onboard the electronic device, user and/or patient identification data associated with the rapid diagnostic test. Preferably in the electronic device processing step, the algorithms may preferably, but need not necessarily, enable the electronic device processor to generate the presentation data based in part on the user and/or patient identification data for presentation to the user. 
     According to an aspect of one preferred embodiment of the invention, preferably in the data input step, a keypad may preferably, but need not necessarily, be used as the data input device. 
     According to an aspect of one preferred embodiment of the invention, preferably in the connecting step, the electronic device may preferably, but need not necessarily, be a networking electronic device. The method may preferably, but need not necessarily, also include an encryption step, preferably after the data input step, of using the algorithms to enable the electronic device processor to encrypt the patient identification data as encrypted data. The method may preferably, but need not necessarily, also include a networking step, preferably after the electronic device processing step and/or the encryption step, of using the algorithms to enable the electronic device to transmit, preferably without the patient identification data, at least a portion of the presentation data, the test data, and/or the encrypted data for recordal in one or more remote and/or distributed databases. 
     According to an aspect of one preferred embodiment of the invention, preferably in the networking step, the transmission of the presentation data, the test data, and/or the encrypted data by the electronic device and/or the encryption of the patient identification data may preferably, but need not necessarily, be fully compliant with all applicable interface standards for exchanging and/or transferring health data. 
     According to an aspect of one preferred embodiment of the invention, preferably in the connecting step, the electronic device may preferably, but need not necessarily, be a networking electronic device. The method may preferably, but need not necessarily, also include a networking step, preferably after the electronic device processing step, of using the algorithms to enable the electronic device to transmit at least a portion of the presentation data and/or the test data for recordal in one or more remote and/or distributed databases. 
     According to an aspect of one preferred embodiment of the invention, the method may preferably, but need not necessarily, also include a geo-localization step, preferably before the networking step, of using the algorithms to enable the electronic device processor to use a geo-localization element onboard the electronic device to obtain geo-localization data for the rapid diagnostic test. Preferably in the networking step, the algorithms may preferably, but need not necessarily, enable the networking electronic device to transmit the geo-localization data for recordal in the remote and/or distributed databases. 
     According to an aspect of one preferred embodiment of the invention, preferably in the sensing step, a light source element onboard the test device may preferably, but need not necessarily, illuminate the sample. At least one of the sensors may preferably, but need not necessarily, include a photodiode element. The test data may preferably, but need not necessarily, include a test image. 
     According to an aspect of one preferred embodiment of the invention, preferably in the sensing step, the photodiode element may preferably, but need not necessarily, include a charge coupled device (CCD) element. 
     According to an aspect of one preferred embodiment of the invention, preferably in the sensing step, the light source element may preferably, but need not necessarily, include a laser, a light emitting diode (LED), an optical fiber light source element, a tungsten lamp, a mercury lamp, and/or a xenon lamp. 
     According to an aspect of one preferred embodiment of the invention, the method may preferably, but need not necessarily, also includes a storage step, preferably after the sensing step, of using the algorithms to enable the electronic device processor to store the presentation data and/or the test data in an electronic device memory onboard the electronic device. 
     According to an aspect of one preferred embodiment of the invention, preferably in the presentation step, the presentation element may preferably, but need not necessarily, include a display element. The algorithms may preferably, but need not necessarily, enable the electronic device processor to generate the presentation data for presentation from the display element, preferably in the form of one or more visually presentable (a) textual data, (b) graphical data, and/or (c) colored indicator light data. 
     According to an aspect of one preferred embodiment of the invention, the method may preferably, but need not necessarily, also include a powering step, preferably before the uploading step, of using a test device battery onboard the test device to power the test device. 
     According to an aspect of one preferred embodiment of the invention, the method may preferably, but need not necessarily, also include a powering step, preferably before the uploading step, of using an electronic device battery onboard the electronic device to transmit power to the test connection element of the test device, preferably via the electronic connection element. 
     According to an aspect of one preferred embodiment of the invention, preferably in the connecting step, one or more of following may preferably, but need not necessarily, be used as the electronic device: (a) a cellular telephone; (b) a mobile communications device; (c) a personal digital assistant; (d) a desktop computer; (e) a laptop computer; (f) a navigation device; (g) a digital audio player; (h) a camera; (i) a gaming device; (j) a television; and/or (k) a radio. 
     Other advantages, features and characteristics of the present invention, as well as methods of operation and functions of the related elements of the method and device, and the combination of steps, parts and economies of manufacture, will become more apparent upon consideration of the following detailed description and the appended claims with reference to the accompanying drawings, the latter of which are briefly described hereinbelow. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The novel features which are believed to be characteristic of the device and method according to the present invention, as to their structure, organization, use, and method of operation, together with further objectives and advantages thereof, will be better understood from the following drawings in which presently preferred embodiments of the invention will now be illustrated by way of example. It is expressly understood, however, that the drawings are for the purpose of illustration and description only, and are not intended as a definition of the limits of the invention. In the accompanying drawings: 
         FIG. 1A  is a top front perspective view of a test device and integral electronic device according to one preferred embodiment of the invention; 
         FIG. 1B  is a top front perspective view of a test device and connected electronic device according to another preferred embodiment of the invention; 
         FIG. 2  is a schematic diagram of the test device and electronic device of  FIG. 1B ; 
         FIG. 3  is a graphic representation of data presented from a display of the electronic device of  FIG. 1A or 1B  according to the invention; 
         FIG. 4  is a flowchart of one illustrative method according to the invention; 
         FIGS. 5A to 5D , taken together, are a flowchart of another illustrative method according to the invention; 
         FIG. 6  is a graphic representation of data processed by the electronic device of  FIG. 1A or 1B  according to the invention; and 
         FIG. 7  is a schematic diagram of data management according to the invention. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     In  FIGS. 1A to 7 , there is shown a handheld diagnostic test device  200  and methods  500 ,  600  according to the present invention. The test device  200  is for use with an electronic device  100  and a test cartridge  20  carrying a biological and/or environmental test sample for reaction with one or more reagents in a rapid diagnostic test. The test cartridge  20  preferably provides components needed for performing the reaction, such as, the reagents and a sample support  22  (e.g., slide, substrate) or platform for incubation. 
     The test device  200  may preferably, according to the invention, be linked with more than one different type of electronic device  100 , and more preferably with a wide range of different types of electronic devices  100 . The electronic device  100  may be a cellular telephone (as shown in  FIGS. 1A to 2 ). According to various other preferred embodiments of the invention, the electronic device  100  may take the form of a mobile communications device (e.g., a smart phone and/or a radio-frequency chipset device), a personal digital assistant, a pocket PC, a laptop computer, a desktop computer, a navigation device, a digital audio player, a camera, a gaming device, a television, and/or a radio. According to some preferred embodiments of the invention, it may be suitable to utilize any electronic device  100  which provides a power source, a display element, a data input device, and/or the CPU capacity to run, analyze, record and/or transmit the test results. 
     Preferably, as best seen in  FIGS. 1A and 1B , the test device  200  is for use with the electronic device  100 , and is provided with a test cartridge port  220  adapted to receive the test cartridge  20  for operative reaction of the sample with the reagents. As shown in  FIG. 2 , the test device  200  preferably has onboard memory  202  to provide electronic data storage capacity, one or more test device connection elements  204 ,  206 ,  207  for communicating with the electronic device  100 , and one or more sensors  208 ,  210  for performing a measurement or detection. 
     Depending on the technology used for detection, the sensors  208 ,  210  may preferably, and by way of a non-limiting example, be optical in nature (e.g., relying on fluorescence or colorimetry) or electrical in nature (e.g., relying on impedance effects). Preferably, many different detection technologies may be capable of use within the test device  200  (and which may be capable of modification in function, in the discoveries made, and/or in the detection field), such as, for example and among other things, one or more of the following: lateral flow strip detection technologies; nano and/or micro cytometer detection technologies; impedance sensor detection technologies; dieletrophoresis detection technologies; micro PCR detection technologies; and/or electro peptide sensor technologies. 
     The sensors  208 ,  210  preferably receive a signal which is preferably transferred through data acquisition components so as to be sent, as is described in greater detail hereinbelow, to the electronic device  100 . (In some alternate embodiments of the invention, optical fiber output or diode sensors may be used within the electronic device  100  as an excitation and/or optical sensor in place of, or in addition to, the sensors  208 ,  210  of the test device  200 . Preferably, however, the sensors  208 ,  210  are provided as part of the test device  200 .) 
     As shown in  FIG. 2 , the sensors  208 ,  210  may include a photodiode (e.g., a charge coupled device)  208  and a test identification reader  210 . Preferably, the photodiode  208  works together with a light source element (e.g., a laser)  212  of the test device  200  to operatively detect test data from the sample after reaction with the reagents. Notably, the laser  212  which is shown in  FIG. 2  is provided according to one preferred embodiment according to the present invention. Alternately, any number of different light source elements  212  might be used instead and/or in addition thereto—for example, a tungsten lamp, a mercury lamp, a xenon lamp, a light emitting diode (LED) and/or an optical fiber light source. Additionally, the charge coupled device  208  shown in  FIG. 2  is provided according to one preferred embodiment according to the present invention. Alternately, other types of photodiodes  208 , light detectors (e.g., photodetectors) and/or sensors—e.g., a CMOS camera—may be used in place thereof and/or in addition thereto. 
     According to some preferred embodiments of the invention, the test connection elements  204 ,  206 ,  207  may be provided as separate or embedded components of the test device  200 . One of the test device connection elements  204 ,  206 ,  207  may preferably connect or link the test device  200  with the electronic device  100  to enable communication therewith. The test device connection elements  204 ,  206 ,  207  may take the form of a USB port  204  and/or a short-range communications (e.g., Bluetooth) element  206  provided on the test device  200 —as shown in  FIG. 2 . The test device connection elements  204 ,  206 ,  207  may assist, facilitate and enable a transfer of data, and optical or electrical pulses. Preferably, at least one of the test device connection elements  204 ,  206 ,  207  (e.g., the USB port  204 ) may assist, facilitate and enable a transfer of energy. 
     As shown in  FIG. 2 , the onboard memory  202  may preferably be provided within the test device  200 . As is described in greater detail below, the onboard memory  202  may preferably be used to store test software algorithms  214  required to run the test—e.g., including the test method, the quality control data, the analysis process, the GUI interface instructions, and any other software applications or algorithms associated with the test—for data transfer or upload from the test device  200  to the electronic device  100 . The onboard memory  202  may preferably also be capable of storing the test data for use later. (In some embodiments of the invention, the onboard memory  202  may preferably also be associated with a test device processor  216 , or CPU capability, onboard the test device  200  to assist with or manage data transfer between the test device  200  and the electronic device  100 .) 
     In some embodiments of the invention, and as shown in  FIG. 2 , the test device  200  may include a battery or power supply  218  and a battery interface  222 . This power supply  218  may be provided, for example, in case the electronic device  100  is not capable of supporting the required or preferred power supply demands of the test device  200 . That said, the electronic device  100  preferably includes a battery (or power supply)  102  of its own as shown in  FIG. 2 , which may preferably be sufficient to provide the test device  200  with an energy source. 
     As shown in  FIG. 2 , the electronic device  100  preferably also includes one or more electronic device connection elements  104 ,  106  and an electronic device processor (or CPU capability)  108 . The electronic device processor  108  uses the software algorithms  214  to control the rapid diagnostic test. 
     The electronic device connection elements  104 ,  106  may preferably include a plug-in interface (e.g., a USB port)  104  as shown in  FIG. 2 . The electronic device connection elements  104 ,  106  may preferably be provided as any kind of interfacing element suitable to transfer data to the test device  200 . As shown in  FIG. 2 , one of the electronic device connection elements  104 ,  106  may take the form of a short-range communications (e.g., Bluetooth) element  106 . The interface between the test device  200  and the electronic device  100  may preferably utilize components which meet the connectivity requirements of the electronic device  100 . 
     Preferably, at least one of the electronic device connection elements  104 ,  106  (e.g., the plug-in interface  104 ) may be suitable to transfer energy to the test device  200 . One of the electronic device connection elements  104 ,  106  is operatively connected with a respective one of the test connection elements  204 ,  206 ,  207  in data communicating relation. According to one preferred embodiment of the invention, the USB ports  104 ,  204  are connected with one another in mating relation (as best seen in  FIG. 1B ). Preferably, the USB port  204  of the test device  200  receives power from the battery  102 , via the USB port  104 , of the electronic device  100 . The USB port  104  of the electronic device  100  is preferably capable of transferring the energy and/or power from the battery  102  of the electronic device  100  to the test device  200 . According to some preferred embodiments of the invention, the battery  102  of the electronic device may afford a power supply capability to transfer energy which may preferably be sufficient to run the test device  200 . Perhaps notably, some electronic devices  100  (e.g., including many common cellular telephones) which are contemplated for use according to the present invention may draw, but not supply, power from their USB port  104 . That said, this limitation is not common to all electronic devices  100 , nor even to all cellular telephones. As such, and as aforesaid, the test device  200  may preferably be partially and/or fully powered by the electronic device  100 . 
     Preferably, one of the test device connection elements  204 ,  206 ,  207  electronically transmits the test data to the electronic device  100  via a respective one of the electronic device connection elements  104 ,  106 . In this manner, at least one of the electronic device connection elements  104 ,  106  electronically preferably receives the test data from the test device  200 . 
     The electronic device processor  108  may preferably provide enough processing capability to control the test device  200 . Preferably, data included in the onboard memory  202  within the test device  200  may detail the minimum requirements, in terms of required processing capability, to run the test device  200 . The electronic device processor  108  operatively applies one or more of the algorithms  214  in managing the electronic device  100  and its interface with the test device  200 . For example, the algorithms  214  may include device management software and data analysis software. 
     The device management software may include graphical user interface (GUI) software and a data quality control application. The quality control application is preferably operative to check on the proper functioning of the test device  200  and/or quality assurance data  418  (as may be best appreciated from  FIG. 3 ) associated with the test cartridge  20 , or to meet regulation requirements. 
     According to the invention, the GUI software may preferably assist, facilitate or enable display of presentation data  400  to a user of the electronic device  100 . The GUI software may preferably be run, for example, inside a browser (e.g., an Internet browser)  148  and/or through another GUI window. 
     The data analysis software may include test data processing and diagnostic applications. The test data processing applications may preferably include algorithms to analyze the test data, and a data transfer protocol to enable the electronic device  100  to communicate with or download data from the test device  200 . (According to some preferred embodiments of the invention, the electronic device processor  108  may also operatively apply the test data processing applications to control the reaction of the sample with the reagents. Accordingly, by the aforesaid transmission of the test data processing applications and the test data, the test device  200  enables the electronic device processor  108  to, among other things, control the reaction of the sample with the reagents.) The testing of the sample by the test device  200  may be directly initiated by the electronic device processor  108 —e.g., by instructing the user to add the sample to the test cartridge  20 . 
     The electronic device processor  108  operatively receives the test data, and applies the test data processing applications to the test data to generate highly sensitive and accurate quantitative and/or qualitative test results and/or presentation data based on the quantitative test data. In so doing, according to some preferred embodiments of the invention, the test results may be quantified as high, medium, and/or low results (e.g., a low intensity of infection result). Perhaps notably, the “highly sensitive and accurate quantitative test results” which are generated according to the present invention have comparable accuracy and sensitivity with those which have been previously quantified in a laboratory or hospital setting. Advantageously, therefore and due in part to the portability inherent in the handheld test device  200  and the electronic device  100 , the present invention enables the generation of highly sensitive and accurate quantitative and qualitative test results outside of such laboratory and hospital settings. 
     It may also be worthwhile to note that the presentation data  400  presented to the user may preferably include treatment and follow-up suggestion data (not shown) based on the test results. The test device  200  is preferably adapted for use with, and to aid in the generation of, such presentation data  400 . The treatment and follow-up suggestion data is preferably determined with reference to one or more of the algorithms  214  uploaded to the electronic device  100  or stored on the test device  200 , or in remote and/or distributed databases and/or servers (not shown). 
     Preferably, the onboard memory  202  of the test device  200  electronically stores the test data and one or more of the algorithms  214 . Preferably, one of the test device connection elements  204 ,  206 ,  207  electronically transmits the algorithms  214  to a corresponding one of the electronic device connection elements  104 ,  106 . In this manner, the electronic device processor  108  operatively receives the algorithms  214  from the test device  200  via the test and electronic device connection elements,  204 ,  206 ,  207  and  104 ,  106  respectively. 
     As shown in  FIG. 2 , the electronic device  100  preferably also has a presentation element  110 , and further connectivity components. As shown in  FIGS. 1A to 3 , the presentation element  110  preferably includes a display element  112  which has a display capability (e.g., a display screen and/or a printer) and/or which offers a graphical user interface (or GUI). Preferably, the algorithms  214  generate the quantitative and/or qualitative test results and/or the presentation data for presentation by the electronic device  100  in the form of visually and/or audibly presentable data. Audibly presentable data may take the form of a verbal, musical, tonal and/or other alert sounds. 
     Visually presentable data may take the form of text, graphics and/or colored indicator lights.  FIG. 3  illustrates one form of visually presentable data which is contemplated according to the present invention, namely, visually presentable textual data. Among other things, the display element  112  might also present graphical data which may include charts and other comparative visual representations of the quantitative test results. By way of example, and among other things, visually and/or audibly presentable data may also include descriptive and/or numerical data. Exemplary types of descriptive data may include the treatment and follow-up suggestion data and/or intensity information. Intensity data may be shown in textual and/or graphical format. Exemplary types of numerical data may include the quantitative test results. Other visually presentable data may include textual data, and/or colored indicator light data. Preferably, the display element  112  enables display of the presentation data  400 . (In some embodiments of the invention, a printer, a speaker  122  onboard the electronic device  100  or other kinds of output systems are used for visualization or presentation.) The presentation element  110  operatively presents the presentation data  400  to the user. Accordingly, by the aforesaid transmission of the test data processing applications and the test data, the test device  200  also enables generation and presentation of the presentation data  400  by the electronic device processor  108  and the presentation element  110 . 
     The electronic device  100  is preferably a networking electronic device and is provided with a communication subsystem  114  to afford connectivity and/or communications (e.g., network connection, GSM, satellite connection, Internet) capabilities. As shown in  FIG. 2 , the communication subsystem  114  networks with an external network  300  which may be a satellite network (e.g., GPS networks), a terrestrial wireless network (e.g., a cellular telephone network, a local wireless network), the Internet, and/or a laboratory and/or hospital information system network. The electronic device  100  may preferably be in wireless (and/or wired) communication with at least one external network  300 . 
     The communication subsystem  114  which is provided may preferably depend on the type or version of the electronic device  100 . In the case of a cellular telephone, for example, its wireless capability may be used to transmit data via a cellular telephone network to one of the remote databases. In the case of a laptop (or pocket PC), the communication subsystem  114  may preferably be an intranet connection, or a wired or wireless Internet connection. 
     The electronic device  100  may preferably also have the ability to connect quickly and easily to LIS/HIS networks via, for example, the local wireless network (e.g., a Bluetooth network) and/or a USB cable. Preferably, the electronic device  100  automatically transmits the test data, the presentation data  400  (e.g., test results  412 ) and/or encrypted data  426  for recordal in one or more remote and/or distributed databases or servers (e.g., in a LIS/HIS network). Additionally, transmission of the test data, the presentation data  400  (e.g., the test results  412 ) and/or the encrypted data  426  by the electronic device  100 , via the communication subsystem  114  over the network  300 , may be initiated directly and/or indirectly by the user by controlling a dedicated button or a context dependent programmable button or key. Preferably, the electronic device  100  may be provided with an electronic device memory (e.g., a flash memory)  118  which is able to record the test results  412  related to each test. The remote and/or distributed databases and/or servers may also be used for various tests or patients and are preferably linkable with the data stored on the electronic device  100 . 
     Various databases may interface with the communications subsystem  114 , preferably including, software applications databases (e.g., clinical software applications, database software applications, download portals, quality control central databases), and various test result databases (e.g., healthcare providers database, governmental agency databases, military department databases). Notably, the databases may include, without limitation, epidemiologic databases, UN and major/international healthcare institution databases, healthcare and emergency infrastructure databases, education and economic databases, news databases, demographic databases, communication and military infrastructure databases, and weather and topographic databases. The databases may preferably serve as an additional repository for the test results  412  (test result databases), and/or as an additional source for the electronic device to acquire the algorithms  214  and/or updates to the algorithms  214  (e.g., test processing algorithms and software applications)—i.e., from software applications databases. 
     Communication functions, including data and voice communications, may be performed through the communication subsystem  114 . The communication subsystem  114  preferably acts as both a receiving element and a transmitting element. 
     As shown in  FIG. 2 , the test device  200  and/or the electronic device processor  108  may also interact with additional subsystems of the electronic device  100 , such as a random access memory (RAM)  116 , the flash memory  118 , other presentation elements (e.g., the speaker  122 ), the short-range communications system  106 , a GPS subsystem  124 , a data input device  126  (e.g., a keypad  128 , a trackball, a microphone  130 , a touchscreen  132 , a camera  134 ), one or more auxiliary input/outputs  136 , and/or a data port  138 . Operating system software for the standard functions of the electronic device  100  used by the electronic device processor  108  may typically be stored in a persistent store such as the flash memory  118 . Specific device applications  142  may also be stored in the flash memory  118  and may include GPS map applications  144  and image related applications  146 , among others. Those skilled in the art will appreciate that the operating system, specific device applications, or parts thereof, may be temporarily loaded into a volatile store, such as the RAM  116 , for processing by electronic device processor  108 . 
       FIG. 1A  depicts the diagnostic test device (alternately herein, a “test reader” or “diagnostic reader”)  200  with the electronic device  100  integrated therein. In  FIG. 1A , the electronic device  100  is shown integrally embedded in a cavity formed in a housing of the test device  200 . The physical connection between the electronic device  100  and the test device  200  may include a “plug-in-plug”, cabled, wired, and/or hardwired connection. Preferably, though not necessarily, the data communication link between the electronic device  100  and the test device  200  may be selectively severed and/or disconnected. Preferably, though not necessarily, the electronic device  100  may be selectively removable (i.e., physically) from the test device  200 . Alternately, as shown in  FIG. 1B , it is within the scope of the present invention for the electronic device  100  to be physically connected to, but located outside of, the test device by way of a “plug-in-plug”, cabled, and/or wired connection. Still further, and though not shown in the accompanying drawings, it is within the scope of the present invention for the electronic device  100  to be wirelessly connected to and located remotely of the test device  200 , with the connection between the two being a wireless data communication connection  302  (best shown in  FIG. 2 ). That is, the test device  200  and the electronic device  100  may be located remotely of one another, with the sole connection between the two being the wireless data communication connection  302 . The test device  200  and electronic device may preferably be connected to one another via the USB ports  104 ,  204  and/or via any available port able to provide data transfer and/or energy supply (including Bluetooth in case the device is not physically integrated in with the reader, but rather communicates from a distance). 
     Preferably, when the electronic device  100  is a networking electronic device, it remains at least partially, and more preferably fully, functional as such. The test device  200  may preferably be controlled via the electronic device  100 . Little or no modification of the hardware of the electronic device  100  is required. 
     Preferably, the algorithms  214  are operatively loaded onto the electronic device  100 . The electronic device  100  may preferably be provided (natively and/or when it is operatively loaded with the algorithms  214 ) with the browser  148 . A keypad (alternately herein a “keyboard”)  126  and/or the display element  112  of the electronic device  100  may preferably be utilized in association with the test device  200  and/or the algorithms  214 . 
     As shown in  FIG. 2 , the battery  102  of the electronic device  100  is preferably provided with a battery interface  150  utilized and may be provided with a smart power management function. Power management of the test  200  device may be effected in numerous different ways according to the present invention. The test device  200  may power itself, it may be powered by the electronic device  100 , or it may be powered both by itself and by the electronic device  100 . 
     The test device  200  (together with the electronic device  100 ) and the methods  500 ,  600  which are provided according to the present invention are preferably adapted for use in association with infectious disease surveillance, diagnosis and emergency medical response at the point of care in developed and developing countries, refugee camps, etc. 
     The test device  200  (together with the electronic device  100 ) and the methods  500 ,  600  which are provided according to the present invention are preferably adapted to rapidly perform quantitative and/or qualitative diagnostic tests, and to enable assay time counting, among other things. It will be appreciated from the disclosures herein that the test device  200  and the methods  500 ,  600  are preferably be available for deployment and/or purchase at a reasonable price—i.e., a potentially important factor in many of the areas of the world where infectious disease surveillance may be of primary concern. 
     As aforesaid, the electronic device  100  is preferably a networking electronic device. It is preferably equipped with a global communication capability (e.g., according to a GSM and/or GPRS protocol), and with a location tracking capability via a geo-localization element (e.g., a global location tracking element and/or a GPS subsystem)  140  provided onboard the electronic device  100 . 
     As described elsewhere herein, the test device  200  (together with the electronic device  100 ) and the methods  500 ,  600  are preferably adapted to enable smart patient data management, in full compliance with all applicable interface standards for exchanging and/or transferring health data—e.g., the HL7 and/or ASTM standards. 
     As best shown in  FIGS. 1A to 2 , the test cartridge (alternately herein the “test cassette” and/or “test strip”)  20  may preferably be provided with a test cartridge identification element (alternately herein the “test ID strip”)  24 —for example, a barcode as shown in  FIGS. 1A and 1B . Alternately, though not shown in the accompanying drawings, the test cartridge identification element  24  may be a radio-frequency identification (RFID) tag. The test cartridge identification element  24  enables identification of the test cartridge  20 . Preferably, before analysis of the sample and/or before conclusion of its reaction with the reagents, the test cartridge  20  is identified using data associated with the test cartridge identification element (e.g., barcode and/or RFID tag)  24 . 
     Use of the test cartridge identification element  24  enables certain quality control (QC) and/or quality assurance (QA) features according to the present invention. For example, assay quality control data  418  and other test cartridge identification data  416  is preferably encoded by the test cartridge identification element  24 . Preferably, but not necessarily, the test cartridge identification data  416  includes cassette ID, lot number, expired data, assay cut-off, assay calibration curves, etc. In the case of the barcode  24 , it may preferably be positioned beside test and control strips (or lines)  26 . The barcode  24  and the test and control lines  26  may preferably, but need not necessarily, be captured in one image by the charge-coupled device (CCD)  208  or by a camera. The quality control data  418  may preferably be required before making any diagnostic decision. During image processing, the quality control data  418  encoded by the barcode  24  is preferably decoded first, with the test results  412  being thereafter calculated. 
     Ideally, the above-described combination of the test device  200  and the electronic device  100  may preferably allow a patient and/or healthcare provider to readily perform—preferably at their fingertips and/or in the palm of their hand—one or more diagnostic tests with substantially the same analytic capability as other substantially more unwieldy prior art high-tech diagnostic devices. 
     Preferably, and as aforesaid, some preferred embodiments of the invention may involve use of a mobile or cellular telephone as the electronic device  100 —i.e., in association with the test device  200 . 
     As best seen in  FIG. 1B , according to some embodiments of the invention, the test device  200  may also be connected with the electronic device via a USB cable  30  and the USB ports  104 ,  204  and/or via any other available port to provide data transfer and/or energy supply. Similarly, though not shown in the drawings, the test device  200  may be used with a laptop computer, a desktop computer and/or a pocket PC according to the present invention. As in the case of the electronic device  100  (discussed above), the test device  200  may also be connected with the laptop computer, the desktop computer and/or pocket PC via a USB port and/or via any other available port to provide data transfer and/or energy supply. 
     With reference to the various embodiments of the system  100  which are shown in the drawings, it will be appreciated by one skilled in the art that, although some components, relations, processes and aspects of same are only discussed with reference to one or more specific drawings, same may be used and/or adapted for use in association with embodiments shown in other ones of the drawings. 
       FIGS. 4 and 5A-5D  show, schematically by way of overview, two preferred methods  500 ,  600  of testing the sample, for use with the reagents, the electronic device  100 , and the test device  200 . The methods  500 ,  600  preferably include the following steps, among others: a connecting step (not shown); a powering step  504 ,  604 ; an uploading step (not shown) after the connecting step and the powering step  504 ,  604 ; a maintenance step  508 ,  608  after the uploading step; a presentation step  510 ,  610  after the uploading step; a cartridge inserting step  512 ,  612  after the connecting step and the uploading step; a data input step  516 ,  616  after the uploading step; a cartridge identification step (not shown); a waiting step  518 ,  618 ; a sensing step  520 ,  620  after the waiting step  518 ,  618  and the cartridge inserting step  512 ,  612 ; a test device processing step  522 ,  622 ; a geo-localization step (not shown); one or more electronic device processing steps  625 ,  626 ,  628  after the cartridge identification step  614 , the sensing step  520 ,  620  and the test device processing step  522 ,  622 ; an encryption step (see method steps  536 ,  636  in  FIGS. 5D and 6 ) after the data input step  516 ,  616 ; a storage step  630  after the sensing step  520 ,  620 ; and/or a networking step  536 ,  636  after the geo-localization step, the electronic device processing steps  625 ,  626 ,  628  and the encryption step. 
     In the connecting step (not shown), at least one of the test connection elements  204 ,  206 ,  207  establishes a connection with the electronic device  100 . According to some preferred embodiments of the invention, one of the electronic device connection elements (e.g., the USB port)  104  may be plugged in and/or physically connected, in mating relation, with the test device  200 . As best shown in  FIG. 1A , the physical connection may be such as to integrally provide the electronic device  100  partially or wholly within a housing of the test device  200 . Alternately, as shown in  FIG. 1B , the USB cable  30  or other connectivity interface element may preferably be plugged into the test device  200 . The USB cable  30  may be considered to be part of the test device  200 , the electronic device  100 , or a standalone component. 
     The powering step  504 ,  604  preferably occurs after the connecting step. In the powering step, one of the test device connection elements (e.g., the USB port)  204  is preferably used to receive, via one of the electronic device connection elements (e.g., the USB port)  104 , power from the electronic device battery  102  via a battery interface  150  onboard the electronic device  100 . In the powering step  504 ,  604 , after the uploading step (which is described in greater detail hereinbelow), the user may selectively turn on the power for the test device  200 , and/or awake the test device  200  from standby mode, using the electronic device  100 ). 
     The uploading step (not shown) occurs after the connecting step and preferably before the maintenance step  508 ,  608 , the presentation step  510 ,  610 , the cartridge preparation steps  611   a ,  611   b , the cartridge inserting step  512 ,  612 , the cartridge identification step  614 , and the data input step  516 ,  616 , among others. In the uploading step, the test device  200  preferably transfers, to the electronic device  100 , some data concerning use of the test device  200  and one or more of the algorithms  214  to process and/or analyze test data using the electronic device  100 . That is, in the uploading step, the algorithms  214  are electronically transmitted to the electronic device processor  108 , via one of the electronic device connection elements  104 ,  106 , using one of the test device connection elements  204 ,  206 ,  207  of the test device  200 . 
     In the maintenance step  508 ,  608 , the test device  200  may preferably perform a self-check (e.g., LED power and some key components), calibration and/or maintenance routine. The maintenance step  508 ,  608  may preferably be initiated by the electronic device  100 . The test device  200  may then indicate whether or not it is ready to the electronic device  100 . The maintenance step  508 ,  608 , may also include a self-checking process performed by the electronic device  100 . The self-checking performed by the electronic device  100  may include a network signal query  100  which returns a yes/no result indicating whether or not the electronic device is ready for the networking step  536 .  636 . It may be worthwhile to additionally note that data may be sent from the electronic device  100  to the test device  200  to re-calibrate the test device  200 . This data may also include information on the type of test to be run, and the test device  200  could then use this data to cross-correlate with information from the test cartridge  20  to ensure the correct test is run and/or to change the calibration routine, the length of the test, the length of excitation exposure, etc. 
     The sample is collected and loaded onto the test cartridge  20  in one or more cartridge preparation steps  611   a ,  611   b  (as shown in  FIG. 5B ). In a cartridge inserting step  512 ,  612 , the user (e.g., a patient, nurse and/or doctor) may preferably then insert the test cartridge  20  in a test cartridge insertion direction as indicated by arrow “A” in  FIGS. 1A and 1B , into the test cartridge port  220  of the test device  200 . 
     Prior to the cartridge inserting step, in cartridge preparation steps  611   a ,  611   b , the electronic device  100  may (using its presentation element  110 ) present instructions to the user concerning preparation of the cartridge  20 —e.g., “Take Cartridge” in cartridge preparation step  611   a , and “Add Sample” in cartridge preparation step  611   b . In the cartridge inserting step  512 ,  612 , the user may selectively insert the test cartridge  20  into the test device  200  for analysis. 
     In the data input step  516 ,  616 , the electronic device  100  is used to store user identification data  406  associated with the user and/or an owner of the electronic device  100 , and/or patient identification data  410  associated with the host from whence the sample was collected. Preferably in the data input step  516 ,  616 , the patient or user may preferably record his or her ID information directly through the keypad  128  of the electronic device  100 , or through the camera  134 , the touchscreen  132 , or the microphone  130  which may be provided in association with the electronic device  100 . In the data input step  516 ,  616 , using the electronic device  100  (e.g., keyboard, display), before and/or during the assay, the user may input one or more of the following: a patient ID  410 , an address, a user ID  406 , a reagent ID  414 , a reader ID  408 , etc. 
     In the cartridge identification step (not shown), the test cartridge ID data  416  including the quality assurance information  418  is read from the cartridge ID element  24  of the test cartridge  20 . During image analysis, the quality assurance information  418  is preferably decoded before the test data from the test and control strips  26 . If the decoded quality assurance information  418  indicates that the test cartridge  20  is expired, then according to a preferred embodiment of the invention, no test results  412  will be presented from the electronic device  100 . 
     In the waiting step  518 ,  618 , after receiving confirmation of the commencement of the reaction of the sample with the reagents (preferably, but not necessarily, via insertion of the test cartridge  20  into the test device  200 ), the electronic device  100  may then begin an assay time-counting function wherein time counting data  424  is presented to the user from the presentation element  110  in the form of an “Elapsed Time” and/or “Time Remaining”. Preferably, this information is displayed on the display element  112  of the electronic device  100 . Preferably, by no later than when the “Time Remaining” equals zero, the test will be automatically completed. 
     Thereafter, the electronic device processor  108  preferably sends a request or instruction to the test device processor  216  for sensing and analysis of the test. (Alternately, the electronic device processor  108  might be utilized for analysis according to the present invention, with the electronic device processor  108  sending the aforesaid request directly to one or more of the sensors  208 ,  210 .) Test detection may, for example, involve fluorescence of the test and control strips  26 . Preferably, however, many different types of detection technologies may be capable of use as a detection platform inside of the test device  200 . The sending of the aforesaid request or instruction by the electronic device processor  108  is preferably operative, in the sensing step  520 ,  620 , to activate at least one of sensors  208 ,  210  (e.g., to open an electronic shutter in the CCD  208  to take an image of the test and control strips  26 ) so as to detect the test data from the test cartridge  20 . It is additionally contemplated that the camera  134  of the electronic device  100  might be used as the detection device. 
     In the test device processing step  522 ,  622 , image analysis and/or biomarker (e.g., pathogen) concentration calculation may preferably be performed by the test device processor  216 . In this manner, and since the test device processor  216  may thus provide the test results  412  and interpretation, the time required for regulatory approval of the test device  200  (e.g., by the U.S. Food and Drug Administration or FDA) may be substantially and advantageously reduced. 
     The methods may also include a test device storage step (not shown) which may preferably occur before test device transmission step  524 ,  624   a ,  624   b . In the test device storage step, the test data may preferably be electronically stored using the onboard memory  202  of the test device  200 . In the test device transmission step  524 ,  624   a ,  624   b , the test device processor  216  may preferably transmit the test data and/or the test results  412  to the electronic device processor  108 —e.g., via a USB interface—for subsequent display to the user by the electronic device display element  112 . 
     In the electronic device processing steps  625 ,  626 ,  628 , the electronic device  100  may preferably (according to some preferred embodiments of the invention) receive and analyze test data—and/or the test results  412  in some preferred embodiments of the invention—for subsequent presentation of the data to the user. That is, in the processing steps  625 ,  626 ,  628 , one or more of the algorithms  214  may preferably be applied to the test data and/or to the test results  412  using the processor  108  of the electronic device  100  to generate either the test results  412  and/or the presentation data  400  based on the test results  412 . The presentation data  400  so generated preferably includes the treatment and follow-up suggestion data based on the test results  412 . As aforesaid, the treatment and follow-up suggestion data is preferably determined with reference to one or more of the algorithms  214  stored onboard the electronic device  100  or the test device  200 , or in one of the remote and/or distributed databases and/or servers. Preferably, one or more of the algorithms  214  generate the test results  412  and/or the presentation data  400  for presentation from the display element  112  in the form of one or more visually presentable textual data, graphical data, or colored indicator light data. Data compilation and report design is performed, preferably using the presentation data  400 . 
     Preferably thereafter, in the presentation step  510 ,  610 , the user may preferably be provided with access to the test results  412 , preferably via the display element  112  of the electronic device  100 . That is, the presentation data  400  (e.g., the test results  412  and treatment and follow-up suggestion data) are presented to the user using the presentation element  110  of the electronic device  100 . Preferably, in the presentation step  510 ,  610 , the presentation data  400  are presented from the display element  112  of the presentation element  110 . 
     The electronic device processor  108  may preferably be operative, in the presentation step  510 ,  610 , to display combined test information, including the test results  412  together with time and date data  402  and geo-localization data  404  for the test, and with the patient ID data  410  and other information inputted in the data input step  516 ,  616  from the electronic device screen  112 . 
     Thereafter, in a test strip release step  532 , the electronic device processor  108  may be operative to display a “Release Test Strip” message as a pop-up window on the electronic device screen  112 , and/or to eject the test cartridge  20  from the test device  200 . 
     In the encryption step, the algorithms  214  operatively loaded onto the electronic device processor  108  may be automatically operative to encrypt the test information into encrypted information, using methods described elsewhere herein, so as to make it HL7 and/or ASTN compliant. The encryption step may, according to some or all of the preferred embodiments of the invention, also be performed prior to storage of any data onboard the electronic device  100 . In this manner, no patient ID data  410  will reside, in an un-encrypted form, in the memory of the electronic device  100 . 
     According to some alternate embodiments of the invention, upon removal of the test strip, the user may be automatically presented with a remote transmission query  534  which affords a wireless transmission option (e.g., a “Transmit Data?” query and the option to select “Yes” or “No”) on the electronic device screen  112 . If “No” is selected in response to remote transmission query  534 , the electronic device processor  108  may preferably skip the networking step, i.e., without wireless transmission of any data. Preferably, however, the user is not presented with such an option and wireless transmission to a remote and/or distributed database and/or server takes place automatically (in accordance with the networking step  536 ,  636 ). 
     In the networking step  536 ,  636 , the electronic device  100  may send the encrypted data  426  to a remote and/or distributed database and/or server. According to some preferred embodiments of the invention, the remote and/or distributed database and/or server may preferably (but need not necessarily) include one or more remote laboratory and/or hospital information systems. 
     After that, according to some embodiments of the invention, prior to the encryption and networking steps  536 , the electronic device  100  may preferably provide an option—e.g. via presentation of a remote transmission query  534  on the display element  112 —to transfer onboard data to the remote and/or distributed databases and/or servers. Though not shown in the drawings, according to some alternate embodiments of the invention, the user may also be presented with an option to keep the data inside the electronic device  100 , and/or to keep the data inside the test device  200 . 
     In the encryption and networking steps  536 ,  636 , the electronic device  100  is preferably used to automatically transmit the test data, the test results  412 , the presentation data  400 , and/or the encrypted data  426  for recordal in one or more of the remote and/or distributed databases and/or servers (e.g., laboratory and/or hospital information systems). 
     Thereafter, the user is preferably automatically presented with an option to obtain information concerning recommended treatment (e.g., by way of a treatment information query  540  and the option to select “Yes” or “No”) on the electronic device screen  112 . If “Yes” is selected in response to the treatment information query  540 , treatment information may be provided via database(s) internal and/or external to the integrated device, and presented from the presentation element  110  of the electronic device  100 . On the other hand, if “No” is selected in response to the treatment information query  540 , the electronic device processor  108  may proceed directly to a print test results query  544 , i.e., without providing any treatment information. 
     The print test results query  544  may preferably be automatically presented to the user and affords an option to print or otherwise output the test information in a print test results step  546 . 
     Thereafter, in a test completion step  548 ,  648 , the electronic device processor  108  finishes processing of the test data detected from the test cartridge  20 , freeing processing capability to process the test data from another test cartridge  20   
     It may be appreciated that, once the algorithms  214  are uploaded to the electronic device  100 , the electronic device  100  performs key functions which effectively control all, or at least a substantial portion, of the process described herein. 
     It may be understood the test device  200  may preferably function as a universal rapid diagnostic test device. That is, any prior art test which makes use of a known assay and/or reagents may be performed using the test device  200  according to the present invention. Moreover, the test cartridge identification data  416  encoded by the barcode (or other test cartridge identification element)  24  may enable the electronic device processor  108 , after upload of the algorithms  214 , to ascertain which prior art rapid diagnostic test, assay and/or reagents is to be performed and the appropriate calibration and assay time counting which is to be associated therewith. 
     Preferably, the data collected according to the present invention may be managed largely via the algorithms  214  which are operatively loaded onto the electronic device  100 . According to the present invention, and as best seen in  FIGS. 6 and 7 , sensitive patient ID information  410  is advantageously encrypted prior to transmission of any collected data by the user to the remote and/or distributed database. Also,  FIGS. 6 and 7  are illustrative of the advantageous de-encryption of the user&#39;s and/or the device&#39;s previously collected data (e.g., whether maintained by the user or otherwise) which may preferably be performed, according to the present invention, when the encrypted patient ID information  410  is received back—i.e., received by the same user and/or device that had previously collected the patient ID information  410 —from a local, remote and/or distributed database. 
     The decryption (alternately herein “de-encryption”)—which may be performed as part of a receiving and decryption step  638  according to the present invention—may be portably associated with the test device  200 , the electronic device  100 , and/or the user. According to some preferred embodiments of the invention, each user may be provided with their own de-encryption tool associated with their user ID information  406 , so that they can still access and de-encrypt data which they may have previously collected using a different test device  200  and/or electronic device  100 . 
     Preferably, according to the present invention, an encrypted and/or anonymized database may be created which may enable certain health providers to download and de-encrypt the data relating to their specific patients. Preferably, such a database may permit sale of anonymized data while still favorably improving the ability of such health providers to provide a patient-specific emergency medical response (EMR). 
     The encrypted and/or anonymized database may also preferably enable pharmaceutical and other companies to indirectly request patient enrollment in clinical trials, by requests sent via patients&#39; healthcare providers. This mechanism may afford increased security over patient data, and/or improved peace of mind amongst patients and healthcare providers—not giving any cause for worry over companies having direct access to patient information without permission. 
     It may be appreciated from the foregoing that, according to the present invention, the test device  200  is a medical device and the electronic device  100  is preferably an electronic network and/or communication device. As such, the test device  200  may require regulatory approval by a governmental body or other organization prior to deployment in the field. Perhaps notably, the electronic device  100  need not obtain such approval. According to some preferred embodiments of the present invention, the electronic device  100  may be responsible for providing one or more of the following: display of diagnostic data, management of patient IDs, diagnostic profiling, HL7 and/or ASTM compliant processes, transfer of data to the remote database, communication with the test device processor  216  and the remote database, data storage, assay time countdown and display, treatment information, and/or various other interfaces. According to some preferred embodiments of the present invention, the test device  200  on the other hand may be responsible for providing one or more of the following: raw data acquisition, self-checking functionality, assay cut-off values, test result algorithms, assay calibration curves, communication with and data transfer to the electronic device processor  108 , and/or a printer. It may be important to note that the above-listed functionalities of the electronic device  100  and test device  200 , respectively, are preferred functionalities and need not necessarily be so. It should be appreciated that another potential advantageous utility afforded by the present invention is that it enables an ordinary electronic device  100  to be used without requiring its special regulatory approval. Additionally, the speed and costs associated with bringing to market new test devices  200  according to the present invention may be advantageously reduced. 
     It may be appreciated by persons having ordinary skill in the art that, with utilization of the test device  200  and methods  500 ,  600  (together with the functionalities specified herein for the electronic device  100  operatively loaded with the algorithms  214 ) according to the present invention, it may preferably be possible to greatly improve upon the limited functionality which may have been afforded by prior test devices. 
     The test device  200  and methods  500 ,  600  (together with the functionalities specified herein for the electronic device  100  operatively loaded with the algorithms  214 ) according to the present invention are unlike anything in the prior art—in a number of important ways (as may be appreciated by persons having ordinary skill in the art in view of the disclosures elsewhere herein). For example, the test device  200  and the electronic device  100  (operatively loaded with the algorithms  214  according to the present invention) together provide a compact envelope which houses powerful patient data management capabilities, in ready and facile combination with network communication and/or location positioning system capabilities. 
     When all of the foregoing functionalities are combined with the relatively low total cost associated with the test device  200 , it may additionally be appreciated that same may be affordable for use in developing countries. 
     This concludes the description of presently preferred embodiments of the invention. The foregoing description has been presented for the purpose of illustration and is not intended to be exhaustive or to limit the invention to the precise form disclosed. Other modifications, variations and alterations are possible in light of the above teaching and will be apparent to those skilled in the art, and may be used in the design and manufacture of other embodiments according to the present invention without departing from the spirit and scope of the invention. It is intended the scope of the invention be limited not by this description but only by the claims forming a part of this application and/or any patent issuing herefrom.