SARS-CoV-2 emergency use authorization published sensitivity differences do not correlate with positivity rate in a hospital/reference laboratory setting.

Diagn Microbiol Infect Dis

Department of Laboratory Medicine and Pathology, Mayo Clinic, 200 1st Street Southwest, Rochester, MN 55905, United States. Electronic address:

Published: February 2024

During the first year of the COVID-19 pandemic skyrocketing demand for testing in the United States, coupled with supply chain issues, necessitated the use of multiple SARS-CoV-2 molecular testing platforms at many health centers. At our institution these platforms consisted of 8 ordered services for sample triage, using 9 emergency use authorized (EUA) SARS-CoV-2 RNA nucleic acid amplification tests resulting in 10 possible ordered service/EAU combinations. Here we review the results of the first ∼2.9 million samples tested and note the variability in positivity rates. We conclude that differences in reported limit of detection did not translate to differences in positivity rate or show correlation to discordant results observed. This highlights the importance of balancing patient testing capacity needs with the desire to have more sensitive tests.

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http://dx.doi.org/10.1016/j.diagmicrobio.2023.116157DOI Listing

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