Manufacturer Signal-to-Cutoff Threshold Underestimates Cumulative Incidence of SARS-CoV-2 Infection: Evidence from the Los Angeles Firefighters Study

Creators: Toubat, Omar; Berg, Anders H.; Sobhani, Kimia; Mulligan, Karen; Hori, Acacia M.; Bhattacharya, Jay; Sood, Neeraj

Abstract

While SARS-CoV-2 serologic testing is used to measure cumulative incidence of COVID-19, appropriate signal-to-cut off (S/Co) thresholds remain unclear. We demonstrate S/Co thresholds based on known negative samples significantly increases seropositivity and more accurately estimates cumulative incidence of disease compared to manufacturer-based thresholds.

Additional Information

The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. This version posted April 23, 2021. Data Availability: The primary data included in the manuscript may be available upon request through email of the corresponding author of the research team. Competing Interest Statement: Dr. Sood reported receiving funding and in kind support from Burns and Allen Research Institute at the Cedars Sinai Medical Center, the Mayoral Office of the City of Los Angeles, the Rockefeller Foundation, Abbott Diagnostics, and the Conrad R. Hilton Foundation for the study. Dr. Sood also reported serving as a scientific advisor to Payssurance, the American Medical Association, and has received grants from the Agency for Healthcare, Research, and Quality, the National Institutes of Health, the Health Care Services Corporation, and the Patient-Centered Outcomes Research Institute outside the submitted work. Omar Toubat is supported in part by the National Heart, Lung, and Blood Institute of the National Institutes of Health under award number F30HL154324 outside of the submitted work. This work was supported by the Rockefeller Foundation, Conrad N. Hilton Foundation, Burns and Allen Research Institute at Cedars-Sinai Medical Center, and Office of Mayor Eric Garcetti, City of Los Angeles. Funding organizations and donors had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. Author Declarations: I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes. The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The Los Angeles County Department of Public Health Institutional Review Board approved this study. All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived. Yes. I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes. I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes.

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