(272) Real-World Performance of SARS-CoV-2 Serology Tests in the United States

Saturday, August 27, 2022

8:00 AM – 6:00 PM CEST

Location: Hall C

Publication Number: 946

Presenting Author(s)

Carla V. Rodriguez-Watson
– Reagan-Udall Foundation for the FDA, Washington, District of Columbia, United States

Co-Author(s)

Anthony Louder, PhD, RPh
– Sr Principal Scientist Data Science, Janssen, United States
Carly Kabelac
– Aetion, United States
Christopher Frederick
– Director of Strategic Partnerships, Regenstrief Institute, Carmel, IN, United States
Natalie E. Sheils
– Optum Labs, MN, United States
Elizabeth H. Eldridge, MPH
– Scientist, Epidemiology, Health Catalyst, Salt Lake City, UT, United States
Nancy D. Lin
– IQVIA, Inc., United States
Jennifer Gatz, PhD
– Director, Industry Research Office, and Staff Scientist, Regenstrief Institute, Indianapolis, IN, United States
Shaun J. Grannis, MD MS
– Professor of Family Medicine, Indiana University, United States
Rohit Vashisht
– Clinical Data Scientist, University of California San Francisco, CA, United States
Benjamin Pollock, PhD, MSPH
– Mayo Clinic, FL, United States
Kanwal Ghauri
– Reagan-Udall Foundation for the FDA, United States
Camille Knepper
– Mayo Clinic, United States
Sandy Leonard, MPH
– SVP, Partnerships and Real World Data, HealthVerity, Philadelphia, PA, United States
Peter J. Embi
– Professor and Chair, VUMC, United States
Garrett Jenkinson
– Mayo Clinic, United States
Reyna J. Klesh, MS
– Vice President, Data Insights & Analytics, HealthVerity, Inc., Philadelphia, PA, United States
Ayan Patel
– Lead Data Scientist, Center for Data-driven Insights & Innovation, University of California Health, Oakland, CA, United States
Lisa Dahm, PhD
– DIRECTOR, HEALTH DATA AND ANALYTICS, University of California Health, CA, United States
Carrie L. Byington, MD
– EVP, Univeristy of California, Oakland, CA, United States
Bridgit Crews
– University of California, CA, United States
Atul J. Butte
– Priscilla Chan and Mark Zuckerberg Distinguished Prof, Director (BCHI), Chief Data Scientist (UC), University of California, San Francisco, CA, United States
Jeff Allen
– President & CEO, Friends of Cancer Research, Washington, DC, United States

Background: The broad marketing of COVID-19 diagnostic tests under Emergency Use Authorization (EUA) fuels a need to understand their real-world performance.

Objectives: We describe overall trends in the performance of serology tests in the context of real-world implementation.

Methods: Six health systems estimated the odds of seropositivity and positive percent agreement (PPA) of serology test among people with confirmed SARS-CoV-2 infection by molecular test. In each dataset, we present the odds ratio and PPA, overall and by key clinical, demographic, and practice parameters.

Results: A total of 15,615 people across all datasets were observed to have at least one serology (total or IgG only) test 14-90 days after a positive molecular test for SARS-CoV-2. We observed higher PPA in Hispanic (79-96%) as compared to non-Hispanic (60-89%) patients; in those presenting with at least one COVID-19 related symptom (69-93%) as compared to no such symptoms (63-91%); and in the inpatient (70-97%) and emergency department (93-99%) compared to outpatient (63-92%) settings. PPA was highest in those with pre-existing diabetes (75-94%) and kidney disease (83-95%); and lowest in those with auto-immune conditions or who are immunocompromised (56-93%). The odds ratio for seropositivity was higher in Hispanics compared to non-Hispanics (2.59-3.86), patients with diabetes (1.49-1.56), and obesity (1.63-2.23); and lower in those with immunocompromised or autoimmune conditions (0.25-0.70), as compared to those without those comorbidities. In a subset of three datasets with robust information on serology test name, seven tests were used, two of which were used in multiple settings and met the EUA requirement of PPA ≥87%. Tests performed similarly across datasets. However, the name of the molecular test reference was largely missing.

Conclusions: Although the EUA requirement does not appear to have been 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.