Description:
OBJECTIVE: The objective is to develop a device to collect and analyze biological data to enable real time disease surveillance. The system developed should be small, lightweight, rugged, not require external power for>8 hours, and be able to directly transmit data to a central depository. DESCRIPTION: Rapid-Diagnostic-Tests (RDTs) are based on antibody-antigen interactions to specifically detect ligands of interest (e.g., bacterial or viral pathogens, toxins, or other biomarkers) (1). There are multiple formats for these tests with lateral flow (hand-held assays), flow through, agglutination, and solid phase (dipstick) formats most common. While the protocols for conducting the tests vary between formats, the end result in most cases is the presence or absence of a colored line for a positive control and another for the test sample. The test line(s) is visually evaluated; a line at the positive control position to indicate a valid result, and the presence or absence of a line at the test location to indicate presence or absence of the ligand. RDTs are used worldwide for diagnostics, disease surveillance, and epidemiology)(2) and are available for many pathogens, including potential biowarfare agents (3, 4). At least one vendor offers a reader (4) to reduce the chance of false negative results by using digital imaging to increase contrast between the line and background. This reader also documents the test result, records the date and time and can directly email the results. The disadvantages of this device are that it is heavy (>2 pounds), has a limited battery life (5 hours), depends on Wi-Fi internet access for communications, and can only read diagnostic strips of a given size and shape. Since RDTs are produced by many vendors and come in a range of sizes and shapes, the latter by itself is a serious limitation. Recent advances in electronic imaging and communications technologies suggest that it is feasible to make universal readers that capture spatiotemporal information, interpret test results, and transmit all the data, raw and interpreted, to a central collection point. At the central collection point the spatiotemporal information and test result could be visualized in an easily comprehensible manner. With many detection units in the field, such a system would enable real-time monitoring of the spread of an epidemic or of chemical or biothreat agents. PHASE I: Demonstrate proof of concept that a small device can consistently read RDTs produced by a variety of manufacturers (at least 4 different formats) with sensitivity that equals or exceeds that of normal visual detection; that test results can be captured, processed, and accurately (>95%) interpreted on the device; that spatiotemporal data can be collected and linked directly with test results; that data from hundreds of tests can be stored and fully accessible locally; and, complete data sets can be transmitted to a central collection point automatically, or manually if desired. PHASE II: Develop a prototype device that is cost-effective (<$500), light weight (<8 oz), rugged and can be used in the field to read and interpret the major RDTs that are commercially available. The device must work continuously for>8 hours without external power sources. It should recognize the inserted RDT (manufacturer, test type) and prevent operation unless the RDT is inserted properly. The device should be simple to use and require minimal training. After the RDT is read, the device should store the data and when possible, automatically transmit test results (raw and interpreted) and spatiotemporal data to one or more central collection points that can be set by the user. If unable to transmit immediately, the data should remain stored on the device until transmission is possible. The field device should seamlessly communicate with the central collection point (e.g., server) without user input. The device should not require internet access to transmit data, although ability to transmit via the internet or the presence of Bluetooth capabilities would be a plus. The target for the data transmission should be specifiable by the user in order to adapt on the fly to local (national) and international data collection procedures/requirements, including the ability to transmit data to more than one receiving point. In addition to full data set transmission, users must have the ability to select"personally identifiable"or"de-identified"for each individual receiving point. PHASE III: Construct ROC curves and validate the frequencies of false positive and false negative results obtained. Use appropriate methods to minimize these frequencies and improve accuracy. Determine the minimum telecommunication infrastructure requirements needed for basic functionality as well as the maximize storage capacity for a typical device as well as the number of diseases/tests that can currently be evaluated given the parameters of the device and the commercial availability of RDTs at this time. PHASE III DUAL USE APPLICATIONS: Inexpensive readers with the ability to exceed visual detection limits and to document test results would find extensive use by first responders, in civilian medical facilities, in the public health field, and for point of care diagnostics in remote regions throughout the world. REFERENCES: 1) http://www2.wpro.who.int/sites/rdt/home.htm 2) http://www.rapid-diagnostics.org/index.htm 3) http://www.tetracore.com 4) http://www.coleparmer.com/Category/Biowarfare_Agent_Detection_Devices_BADD/40362 5) http://www.southernscientific.co.uk/store/public/application/file//document/Tetracore_BioThreat_Alert_Reader.pdf
