Archives of pathology & laboratory medicine · 2025
Challenges in Structuring SARS-CoV-2 Emergency Use Authorization Diagnostics Data: Leveraging Findable, Accessible, Interoperable, and Reusable Principles for the Next Era of Diagnostic Data Transparency.
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Phillips Alexander J, Glieberman Aaron L, Gallegos Christina, Morrison Anthony, Reed Michael R, Baron Veronique T, Dinakar Karthik, Borchers Anna, Okda Faten A, Stone Webb, Lellupitiyage Don Sujeewa Sampath, Ishack Stephanie N, Rajesh Sameer V, Creager Richard S, Weinstock Samantha Bates, Luu Hung S, Lin Asiyah Yu, Merrick Riki
Аннотация
CONTEXT.—: The US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for SARS-CoV-2 assays encompassed both in vitro diagnostic and laboratory-developed tests. Related testing data and documents from EUAs were published on the FDA website as PDF files, constituting a rich data resource.
OBJECTIVE.—: To highlight the value of structured descriptive and validation data and provide recommendations on improving the quality, accessibility, and shareability of the FDA's digital resources.
DESIGN.—: SARS-CoV-2 diagnostics EUAs and related files were acquired from the FDA, and data were extracted through an iterative manual or automated process with quality assurance in accordance with a set of data entry definitions to generate a data product (ie, data analysis and presentation of data into tables, graphs, and reports, optionally including different data sets) that could be disseminated.
RESULTS.—: Four challenges limited the usability of FDA EUA data, including (1) distinguishing EUA tests owing to similar names or inconsistent naming conventions; (2) document location and tracking owing to inconsistent EUA document identifiers, resource locators, and versioning; (3) data location and retrieval owing to heterogeneous structure and data formatting within EUA documentation; and (4) maintenance of existing data owing to lack of clear and traceable communication around EUA amendments.
CONCLUSIONS.—: Converging efforts from disparate groups to extract and synthesize FDA test data reveal an unaddressed need for better organization and communication. Existing FDA data reporting systems must be improved and adapted for the demands of the connected data science era.
OBJECTIVE.—: To highlight the value of structured descriptive and validation data and provide recommendations on improving the quality, accessibility, and shareability of the FDA's digital resources.
DESIGN.—: SARS-CoV-2 diagnostics EUAs and related files were acquired from the FDA, and data were extracted through an iterative manual or automated process with quality assurance in accordance with a set of data entry definitions to generate a data product (ie, data analysis and presentation of data into tables, graphs, and reports, optionally including different data sets) that could be disseminated.
RESULTS.—: Four challenges limited the usability of FDA EUA data, including (1) distinguishing EUA tests owing to similar names or inconsistent naming conventions; (2) document location and tracking owing to inconsistent EUA document identifiers, resource locators, and versioning; (3) data location and retrieval owing to heterogeneous structure and data formatting within EUA documentation; and (4) maintenance of existing data owing to lack of clear and traceable communication around EUA amendments.
CONCLUSIONS.—: Converging efforts from disparate groups to extract and synthesize FDA test data reveal an unaddressed need for better organization and communication. Existing FDA data reporting systems must be improved and adapted for the demands of the connected data science era.