Challenges in Structuring SARS-CoV-2 Emergency Use Authorization Diagnostics Data: Leveraging Findable, Accessible,...

Area of Science:

• Medical Diagnostics
• Regulatory Science
• Data Science

Background:

• The US Food and Drug Administration (FDA) issued Emergency Use Authorizations (EUAs) for SARS-CoV-2 assays.
• EUA data and documents were published as PDF files on the FDA website, creating a valuable data resource.

Purpose of the Study:

• To emphasize the importance of structured data for SARS-CoV-2 diagnostic tests.
• To offer recommendations for enhancing the quality, accessibility, and shareability of FDA digital resources.

Main Methods:

• Acquired SARS-CoV-2 diagnostics EUAs and related files from the FDA.
• Extracted data through manual or automated processes with quality assurance.
• Generated a data product for dissemination, including data analysis and presentation in tables, graphs, and reports.

Main Results:

• Identified four key challenges hindering the usability of FDA EUA data: test name ambiguity, inconsistent document tracking, heterogeneous data structure, and difficulties in maintaining data due to unclear amendment communications.
• Similar test names and inconsistent naming conventions made distinguishing between EUA tests difficult.
• Inconsistent document identifiers, locators, and versioning complicated document tracking.
• Heterogeneous data structure and formatting within EUA documentation hindered data retrieval.
• Lack of clear communication around EUA amendments made data maintenance challenging.

Conclusions:

• Synthesizing FDA test data highlights a critical need for improved data organization and communication.
• Existing FDA data reporting systems require enhancement to meet the demands of the data science era.