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SARS-CoV2 Testing: The Limit of Detection Matters

Ramy Arnaout, Rose A. Lee, Ghee Rye Lee, Cody Callahan, Christina F. Yen, Kenneth P. Smith, Rohit Arora, View ORCID ProfileJames E. Kirby
doi: https://doi.org/10.1101/2020.06.02.131144
Ramy Arnaout
aDepartment of Pathology, Beth Israel Deaconess Medical Center, Boston, MA, USA
cHarvard Medical School, Boston, MA, USA
fDivision of Clinical Informatics, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA USA 02215
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  • For correspondence: jekirby@bidmc.harvard.edu
Rose A. Lee
aDepartment of Pathology, Beth Israel Deaconess Medical Center, Boston, MA, USA
bDivision of Infectious Diseases, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA, USA
cHarvard Medical School, Boston, MA, USA
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Ghee Rye Lee
eDepartment of Surgery, Beth Israel Deaconess Medical Center, Boston, MA, USA 02215
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Cody Callahan
dDepartment of Radiology, Beth Israel Deaconess Medical Center, Boston, MA, USA 02215
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Christina F. Yen
bDivision of Infectious Diseases, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA, USA
cHarvard Medical School, Boston, MA, USA
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Kenneth P. Smith
aDepartment of Pathology, Beth Israel Deaconess Medical Center, Boston, MA, USA
bDivision of Infectious Diseases, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA, USA
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Rohit Arora
aDepartment of Pathology, Beth Israel Deaconess Medical Center, Boston, MA, USA
cHarvard Medical School, Boston, MA, USA
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James E. Kirby
aDepartment of Pathology, Beth Israel Deaconess Medical Center, Boston, MA, USA
cHarvard Medical School, Boston, MA, USA
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  • ORCID record for James E. Kirby
  • For correspondence: jekirby@bidmc.harvard.edu
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Abstract

Resolving the COVID-19 pandemic requires diagnostic testing to determine which individuals are infected and which are not. The current gold standard is to perform RT-PCR on nasopharyngeal samples. Best-in-class assays demonstrate a limit of detection (LoD) of ~100 copies of viral RNA per milliliter of transport media. However, LoDs of currently approved assays vary over 10,000-fold. Assays with higher LoDs will miss more infected patients, resulting in more false negatives. However, the false-negative rate for a given LoD remains unknown. Here we address this question using over 27,500 test results for patients from across our healthcare network tested using the Abbott RealTime SARS-CoV-2 EUA. These results suggest that each 10-fold increase in LoD is expected to increase the false negative rate by 13%, missing an additional one in eight infected patients. The highest LoDs on the market will miss a majority of infected patients, with false negative rates as high as 70%. These results suggest that choice of assay has meaningful clinical and epidemiological consequences. The limit of detection matters.

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The copyright holder for this preprint is the author/funder, who has granted bioRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC-ND 4.0 International license.
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Posted June 04, 2020.
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SARS-CoV2 Testing: The Limit of Detection Matters
Ramy Arnaout, Rose A. Lee, Ghee Rye Lee, Cody Callahan, Christina F. Yen, Kenneth P. Smith, Rohit Arora, James E. Kirby
bioRxiv 2020.06.02.131144; doi: https://doi.org/10.1101/2020.06.02.131144
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SARS-CoV2 Testing: The Limit of Detection Matters
Ramy Arnaout, Rose A. Lee, Ghee Rye Lee, Cody Callahan, Christina F. Yen, Kenneth P. Smith, Rohit Arora, James E. Kirby
bioRxiv 2020.06.02.131144; doi: https://doi.org/10.1101/2020.06.02.131144

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