Real-world performance of SARS-Cov-2 serology tests in the United States, 2020.
Carla V Rodriguez-WatsonAnthony M LouderCarly KabelacChristopher M FrederickNatalie E SheilsElizabeth H EldridgeNancy D LinBenjamin D PollockJennifer L GatzShaun J GrannisRohit VashishtKanwal GhauriCamille KnepperSandy LeonardPeter J EmbiGarrett JenkinsonReyna J KleshOmai B GarnerAyan PatelLisa DahmAiden BarinDan M CooperTom AndriolaCarrie L ByingtonBridgit O CrewsAtul Janardhan ButteJeff D AllenPublished in: PloS one (2023)
Although the EUA requirement was not consistently met, more investigation is needed to understand how serology and molecular tests are used, including indication and protocol fidelity. Improved data interoperability of test and clinical/demographic data are needed to enable rapid assessment of the real-world performance of in vitro diagnostic tests.