A point-of-care diagnostic for differentiating Ebola from endemic febrile diseases.

Hemorrhagic fever outbreaks such as Ebola are difficult to detect and control because of the lack of low-cost, easily deployable diagnostics and because initial clinical symptoms mimic other endemic diseases such as malaria. Current molecular diagnostic methods such as polymerase chain reaction require trained personnel and laboratory infrastructure, hindering diagnostics at the point of need. Although rapid tests such as lateral flow can be broadly deployed, they are typically not well-suited for differentiating among multiple diseases presenting with similar symptoms. Early detection and control of Ebola outbreaks require simple, easy-to-use assays that can detect and differentiate infection with Ebola virus from other more common febrile diseases. Here, we developed and tested an immunoassay technology that uses surface-enhanced Raman scattering (SERS) tags to simultaneously detect antigens from Ebola, Lassa, and malaria within a single blood sample. Results are provided in <30 min for individual or batched samples. Using 190 clinical samples collected from the 2014 West African Ebola outbreak, along with 163 malaria positives and 233 negative controls, we demonstrated Ebola detection with 90.0% sensitivity and 97.9% specificity and malaria detection with 100.0% sensitivity and 99.6% specificity. These results, along with corresponding live virus and nonhuman primate testing of an Ebola, Lassa, and malaria 3-plex assay, indicate the potential of the SERS technology as an important tool for outbreak detection and clinical triage in low-resource settings.

Continuous glucose monitoring using a novel glucose/galactose binding protein: results of a 12-hour feasibility study with the becton dickinson glucose/galactose binding protein sensor.

AIM: This study evaluated the performance characteristics of a prototype Becton Dickinson (BD) (Franklin Lakes, NJ) glucose/galactose binding protein (GGBP) sensor placed intradermally (BD-ID) or subcutaneously (BD-SC) for continuous glucose monitoring. MATERIALS AND METHODS: The performance characteristics of the prototype BD GGBP sensor after intradermal or subcutaneous placement were assessed, and its accuracy was compared with that of a glucose oxidase (GOx)-based sensor and a standard laboratory method (YSI STAT2300 analyzer, Yellow Springs Instrument, Yellow Springs, OH) under glucose clamp conditions and during an off-clamp meal challenge in 40 patients with type 1 or 2 diabetes in a 12-h feasibility study. RESULTS: BD-ID and BD-SC sensors performed as well as or better than the GOx-based sensor (differences in median absolute percentage error 2-4 points in hyperglycemic and euglycemic regions, ≥ 10 points in the hypoglycemic region). For glucose values ≤ 100 mg/dL, the percentage of measurement values in consensus error plot Zone A was substantially higher with the GGBP sensors than the GOx-based sensor. CONCLUSIONS: The BD prototype sensor demonstrated competitive accuracy relative to a GOx-based sensor and a YSI blood standard with a single calibration and minimal warm-up. Current development work is focused on the design and manufacture of a commercially feasible device that will include marked enhancements to device robustness and longevity.