Mobile device for disease diagnosis and data tracking in resource-limited settings.

BACKGROUND: Collection of epidemiological data and care of patients are hampered by lack of access to laboratory diagnostic equipment and patients' health records in resource-limited settings. We engineered a low-cost mobile device that combines cell-phone and satellite communication technologies with fluid miniaturization techniques for performing all essential ELISA functions. METHODS: We assessed the device's ability to perform HIV serodiagnostic testing in Rwanda and synchronize results in real time with electronic health records. We tested serum, plasma, and whole blood samples collected in Rwanda and on a commercially available sample panel made of mixed antibody titers. RESULTS: HIV testing on 167 Rwandan patients evaluated for HIV, viral hepatitis, and sexually transmitted infections yielded diagnostic sensitivity and specificity of 100% and 99%, respectively. Testing on 40 Rwandan whole-blood samples-using 1 mu L of sample per patient-resulted in diagnostic sensitivity and specificity of 100% and 100%. The mobile device also successfully transmitted all whole-blood test results from a Rwandan clinic to a medical records database stored on the cloud. For all samples in the commercial panel, the device produced results in agreement with a leading ELISA test, including detection of weakly positive samples that were missed by existing rapid tests. The device operated autonomously with minimal user input, produced each result 10 times faster than benchtop ELISA, and consumed as little power as a mobile phone. CONCLUSIONS: A low-cost mobile device can perform a blood-based HIV serodiagnostic test with laboratory-level accuracy and real-time synchronization of patient health record data. (C) 2012 American Association for Clinical Chemistry