EUAdb

EUAdb provides a standardized relational database of FDA Emergency Use Authorization RT-qPCR and high-complexity molecular SARS-CoV-2 diagnostic test protocols and metadata to support comparability, reproducibility, and analysis of reagents, primer sequences, instruments, controls, interpretation criteria, and limits of detection (LoD).

Key Features:

• Standardized ontology: Stores EUA-issued test information using a controlled schema to address non-standardized, prose-format FDA listings.
• Comprehensive test metadata: Captures RT-qPCR and molecular test protocols including reagents, controls, instruments, targeted SARS-CoV-2 genes, primer sequences, criteria for positive results, and limits of detection.
• Relational architecture: Organizes curated data in a relational database to enable structured queries and joins across tests, components, and metadata.
• Coverage of EUA records: Includes tests and details omitted from FDA summaries, including entries not listed prior to March 31, 2020 and missing primer information.
• Support for comparative analyses: Enables systematic comparison of assay components and performance parameters across RT-qPCR and high-complexity molecular tests.

Scientific Applications:

• Comparability: Compare reagents, instruments, gene targets, primer sequences, interpretation criteria, and LoD across EUA RT-qPCR and molecular assays.
• Reproducibility: Reconstruct and replicate published RT-qPCR and laboratory-developed test protocols using captured protocols, controls, and instrument specifications.
• Assay development and validation: Inform design, optimization, and validation of SARS-CoV-2 diagnostic assays by referencing curated protocol components and performance metrics.

Methodology:

Curated test information is encoded in a standardized ontology and stored in a relational database architecture that supports structured data curation and simple query retrievals.