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Principal Investigator: Charlotte Gaydos, MS, MPH, DrPH

Research Question:

Our study will evaluate the impact of improved diagnostic assays in the ED by assessing the performance characteristics of a novel rapid technology and modeling the impact of the added information derived from such information (i.e. improved time to detection, sensitivity, viral or bacterial genome load, and range of detection). Our specific research question is what is the relative impact of this novel rapid diagnostic on clinical decision making, and both medical system and public health system preparedness for both routine and catastrophic respiratory infectious disease events outbreaks (e.g. seasonal respiratory infections, avian flu, SARS, novel H1N1).

Novel molecular diagnostic tools hold unmet promise for improving clinician’s ability to make earlier specific diagnoses, critical for medical preparedness and response in the setting of a naturally occurring or manmade biologic outbreak. Translation of these assays into clinical settings has unfortunately lagged to date. Benefits of more timely specific diagnosis (4-8 hr) are apparent at the individual level, but are not yet fully understood at the level of medical system preparedness and public health system.

Potential added value of these tools to Homeland Security includes the use of new molecular diagnostics to achieve effective allocation of limited resources in medical settings. Previous crude models assessing the gain in lives saved associated with employing biosensors or syndromic surveillance methods suggest significant gain; the impact of earlier diagnosis afforded by novel diagnostic assays remains largely unknown (see Figure 1); Potential Impact of Technologies on Earlier Diagnosis; (yellow bar represents theoretical gain associated with use of novel laboratory diagnostic assays). Our project will answer this question.

Analytic Approach

We hypothesize that reconfiguration of the T5000 kit for both viral, bacterial and potential BT agents can provide a universal sensing platform for early detection of biological agents in an ED setting and that modeling the results of a clinical study using such technology can provide data to determine the potential clinical and public health preparedness/response improvements. Our analytic approach is to reconfigure the Ibis T5000 platform kit for rapid pan bacterial and viral respiratory infectious disease surveillance/detection (to include common circulating agents as well as biothreat agents). We will first perform a clinical study to determine the performance characteristics of the novel Ibis T5000 platform for detecting common respiratory threats (including influenza and an array of viral and bacterial agents). Studies will include blinded mock-ups with various BT surrogates and determination of the limits of detection and reproducibility of a viral quantification assay such as for influenza.