AJSE White Paper on COVID Testing Now Released Here

COVID-19 Diagnostic Testing requires Objective Symptom Screening to Re-Open the Economy

Adam J. Simon, Ph.D.

Executive Summary

Assumptions:  1. The goal is to open economic activity and restore consumer confidence expeditiously while protecting public health during the COVID-19 (COVID) pandemic. 2. Balancing the scales between human health and robust economic activity is an optimization challenge requiring the mechanism of a public health policy feedback loop. 3. Governments and businesses need to ensure “screened” zones for employees and patrons by implementing a daily pre-entry screening for COVID symptoms. 4. Until an effective vaccine or therapy is clinically deployed, the U.S. will remain in a “Diagnostic Test/Isolate/Trace” (DTIT) phase with non-pharmaceutical interventions (NPIs) for the next 24 to 36 months. 5. This pandemic will pass with consumer confidence restored when: an effective (a) vaccine or (b) antiviral has been clinically deployed, or (c) “herd immunity” achieved while we DTIT with NPIs.

Novel Symptom Screening Step:  This paper introduces a multimodal objective symptom screening (OSS) step, which generalizes the late May 2020 CDC guidance to include temperature checks in some settings. This intermediate OSS would enter the COVID diagnostic algorithm after an individual’s symptom self-report and before COVID diagnostic testing. Symptom measurements would be focused on objectively quantifying more than one item from the CDC symptom list. This OSS would consist of a set of fit-for-purpose network-connected medical devices to include, minimally: (i) temporal non-contact infrared thermometer (NCIT, Tcore); (ii) pulse oximeter (%SpO2, Heart Rate) and (iii) spirometer (FVC, FEV1) to check for shortness of breath; (iv) possibly, microphone analysis for cough or sneeze; (v) automated image analysis of throat, tongue or rash; as well as (iv) novel screening technology that emerges from an NIH RADx-like competition to develop contactless and rapid (e.g. <15 seconds) novel screening technologies at the point of use. In addition, it is advised to create online COVID data dashboards that display key COVID health metrics down to the individual county level. Dashboards should de-emphasize the total number of infections and emphasize the effective reproduction number Re, to enable not only health care policy decision-makers but also the public to understand the real-time COVID situation.

Figure 3.1. Schematic of comprehensive screening and diagnostic algorithm. The screening battery should be fit-for-purpose, enabling the construction of a battery suitable to the risk level desired.

Which medical devices and data: Preferably FDA 510(k) cleared NCITs, pulse oximeters, spirometers, and other devices would be employed in a fit-for-purpose fashion, wirelessly connected to a mobile app on a mobile device. Data from each screened subject is uploaded into a private database for enhanced predictive analytics classifying each subject as “WNL” (within normal limits) or “NFA” (needs further assessment). WNL subjects can proceed into the “screened” zone (school, office, factory, airport) while NFA subjects are barred entry and directed to their nearest COVID diagnostic testing provider.

Links to Diagnostic Testing & Contact Tracing:  Once a subject undergoes molecular or antigen COVID diagnostic testing, the results would immediately be reported to the government databases for automated flow into the DTIT workflow, including the necessary contact tracing implemented at that time in each geographic locale. Also, data could be transmitted to each patient’s healthcare provider at their request.

Accessibility and Cost: All businesses, schools, entertainment centers, governments, transportation centers, meeting spaces interested in creating a COVID “screened” zone within their control in space and time. Certain small businesses may be permitted to opt-out using a governmental risk-based assessment. OSS is 1000-fold less expensive than equivalent diagnostic testing. The OSS savings (in percent of diagnostic testing cost) is effectively ScreenSavings% ~ 100 – FPSX – TPSX, where FPSX is the screen False Positive rate (%) and TPSX is the screen True Positive rate (%).

What the Objective Symptom Screen means for employers/schools/public: What the Objective Symptom Screen means for employers/schools/public: Daily symptom checklists are a good self-report tool but cannot be relied upon solely. Temporal temperature alone is insufficient and will miss too many cases. A fit-for-purpose multimodal objective symptom screening step enables the immediate (< few minutes) assessment of a subject’s suitability to enter a “screened” space. This should build consumer confidence to engage in economic activities towards a sustainable normal level until antiviral therapy or COVID vaccines are commonly available and utilized.

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