Direct to Consumer

To aid in the fight against the COVID-19 pandemic, the Direct-to-Consumer (DTC) working group came together to identify rapid diagnostics and mobile health solutions with potential to be deployed within our healthcare system and beyond. An overview of these efforts, which were accomplished through the collective altruism from the researchers, clinicians and staff from across the MGB healthcare system along with collaborators from around the country and the globe, is highlighted below. The full details of this work can be found in this medRxiv manuscript. Results from our clinical evaluations of these products will be posted as they become are available.

COVID-19 Rapid Tests

In response to the urgent public health need for accurate, effective, low-cost, and scalable COVID-19 testing technology, the Direct-To-Consumer (DTC) working group within the Mass General Brigham (MGB) Center for COVID-19 Innovation was tasked with identifying viable diagnostic solutions with potential for use as a DTC product. To identify potential products, we performed a deep horizon scan for antigen and serology based diagnostics and down selected to the most promising. Product evaluations are based entirely on company provided data. Those that passed our first scoring algorithm based on Specificity and Sensitivity data were then further evaluated by our second scoring algorithm based on additional technical specifications in combination with data about the company and distribution capacity. The results of these efforts are displayed in the table below. All blank fields represent information we were unable to obtain. The performance metrics for some of the high scoring products are currently being validated in-house through the Diagnostics Accelerator. Once complete, this data will be made available. 

Antibody Tests: Horizon Scanning Results

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Horizon Scan: Workflow

Infographic: Eileen Debenham, Go Big Branding

Horizon Scan: Methodology

A total of 303 candidate tests were identified through a deep horizon scan utilizing existing sources including FIND, FDA, Johns Hopkins University, RTT News and ARTG. Initial screening removed 125 tests as duplicates (different sources provided slightly different company or product names for the same test). Additional triage identified 90 tests (17 antigen and 73 antibody) with potential for use outside of a healthcare setting (e.g. specimens could be easily collected and specialized lab equipment was not required for performance or interpretation of the test) and were either currently in-use or had significant regulatory activity. For these potentially viable DTC tests, sensitivity and specificity values were obtained from publicly available information. For antigen tests, publicly available information was severely limited, likely due to the early stage of development of these products, so further evaluation was restricted to antibody tests.  Application of Score 1 (see table 1) resulted in 25 tests with Score 1 ≥ 1, which were further subjected to a deep-dive gathering of information, including requesting additional information from the companies. Based on this information, Score 2 (see table 1) was applied to provide a scored list of tests for in-house evaluation by the Diagnostics Accelerator and Validation working group.  
Table 1: Scoring Metrics

Contact Tracing Assessment

Effective contact tracing is an essential aspect of managing and containing the spread of a highly contagious disease like COVID-19. Proliferation of smartphones in the population has enabled the development of solutions that can aid manual contact tracing efforts. Such solutions can provide valuable information that can be used by users and public health officials for rapid and accurate contact tracing. However, these solutions capture sensitive data (e.g. proximity, location, phone number) and therefore present a risk to privacy.  We performed a detailed assessment of more than 40 solutions that fell in three categories: smartphone apps, online surveys and data aggregators. These solutions were assessed for characteristics like type of data captured, privacy policy, location tracing requirement, development status and geographical availability. We found significant differences between solutions and identified several limitations that can be addressed to improve the sensitivity and specificity of the information.  In order for technology-based contact tracing to be successful, solutions will have to (1) be adopted by a large portion of the population (around 40-60%), (2) be based on strong privacy and security standards, (3) minimize fragmentation and encourage data sharing, and (4) capture confirmation of diagnosis.

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