BMC Infectious Diseases (Jun 2021)
Evaluation of serological lateral flow assays for severe acute respiratory syndrome coronavirus-2
- Bianca A. Trombetta,
- Savannah E. Kandigian,
- Robert R. Kitchen,
- Korneel Grauwet,
- Pia Kivisäkk Webb,
- Glenn A. Miller,
- Charles G. Jennings,
- Sejal Jain,
- Samara Miller,
- Yikai Kuo,
- Thadryan Sweeney,
- Tal Gilboa,
- Maia Norman,
- Daimon P. Simmons,
- Christopher E. Ramirez,
- Melissa Bedard,
- Catherine Fink,
- Jina Ko,
- Esmarline J. De León Peralta,
- Gerald Watts,
- Emma Gomez-Rivas,
- Vannessa Davis,
- Rocky M. Barilla,
- Jianing Wang,
- Pierre Cunin,
- Samuel Bates,
- Chevaun Morrison-Smith,
- Benjamin Nicholson,
- Edmond Wong,
- Leena El-Mufti,
- Michael Kann,
- Anna Bolling,
- Brooke Fortin,
- Hayden Ventresca,
- Wen Zhou,
- Santiago Pardo,
- Megan Kwock,
- Aditi Hazra,
- Leo Cheng,
- Q. Rushdy Ahmad,
- James A. Toombs,
- Rebecca Larson,
- Haley Pleskow,
- Nell Meosky Luo,
- Christina Samaha,
- Unnati M. Pandya,
- Pushpamali De Silva,
- Sally Zhou,
- Zakary Ganhadeiro,
- Sara Yohannes,
- Rakeisha Gay,
- Jacqueline Slavik,
- Shibani S. Mukerji,
- Petr Jarolim,
- David R. Walt,
- Becky C. Carlyle,
- Lauren L. Ritterhouse,
- Sara Suliman
Affiliations
- Bianca A. Trombetta
- Department of Neurology, Massachusetts General Hospital, Harvard Medical School
- Savannah E. Kandigian
- Department of Neurology, Massachusetts General Hospital, Harvard Medical School
- Robert R. Kitchen
- Department of Medicine, Harvard Medical School
- Korneel Grauwet
- Cardiology Division, Massachusetts General Hospital
- Pia Kivisäkk Webb
- Department of Neurology, Massachusetts General Hospital, Harvard Medical School
- Glenn A. Miller
- Mass General Brigham Innovation
- Charles G. Jennings
- Cardiology Division, Massachusetts General Hospital
- Sejal Jain
- Department of Medical Oncology and Center for Cancer-Genome Discovery, Dana-Farber Cancer Institute
- Samara Miller
- Department of Medicine, Harvard Medical School
- Yikai Kuo
- Department of Neurology, Massachusetts General Hospital, Harvard Medical School
- Thadryan Sweeney
- Cardiology Division, Massachusetts General Hospital
- Tal Gilboa
- Wyss Institute for Biologically Inspired Engineering, Harvard University
- Maia Norman
- Wyss Institute for Biologically Inspired Engineering, Harvard University
- Daimon P. Simmons
- Division of Rheumatology, Inflammation and Immunity, Brigham and Women’s Hospital
- Christopher E. Ramirez
- Department of Neurology, Massachusetts General Hospital, Harvard Medical School
- Melissa Bedard
- Division of Rheumatology, Inflammation and Immunity, Brigham and Women’s Hospital
- Catherine Fink
- Medical Diagnostic Technology Evaluation, LLC
- Jina Ko
- Wyss Institute for Biologically Inspired Engineering, Harvard University
- Esmarline J. De León Peralta
- Department of Pathology, Massachusetts General Hospital
- Gerald Watts
- Division of Rheumatology, Inflammation and Immunity, Brigham and Women’s Hospital
- Emma Gomez-Rivas
- Division of Rheumatology, Inflammation and Immunity, Brigham and Women’s Hospital
- Vannessa Davis
- Department of Pathology, Brigham and Women’s Hospital, Harvard Medical School
- Rocky M. Barilla
- Evergrande Center for Immunologic Diseases, Brigham and Women’s Hospital
- Jianing Wang
- Cardiovascular Division, Department of Medicine, Brigham and Women’s Hospital
- Pierre Cunin
- Division of Rheumatology, Inflammation and Immunity, Brigham and Women’s Hospital
- Samuel Bates
- Functional Genomics Laboratory, Channing Division of Network Medicine, Brigham and Women’s Hospital
- Chevaun Morrison-Smith
- Department of Pathology, Brigham and Women’s Hospital, Harvard Medical School
- Benjamin Nicholson
- Center for Cancer Research, Massachusetts General Hospital, Harvard Medical School
- Edmond Wong
- Center for Cancer Research, Massachusetts General Hospital, Harvard Medical School
- Leena El-Mufti
- Department of Neurology, Massachusetts General Hospital, Harvard Medical School
- Michael Kann
- Center for Cancer Research, Massachusetts General Hospital, Harvard Medical School
- Anna Bolling
- Department of Neurology, Massachusetts General Hospital, Harvard Medical School
- Brooke Fortin
- Department of Neurology, Massachusetts General Hospital, Harvard Medical School
- Hayden Ventresca
- Cardiovascular Division, Department of Medicine, Brigham and Women’s Hospital
- Wen Zhou
- Division of Nephrology and Endocrine Unit Department of Medicine, Massachusetts General Hospital
- Santiago Pardo
- Department of Neurology, Massachusetts General Hospital, Harvard Medical School
- Megan Kwock
- Cancer Center Protocol Office, Massachusetts General Hospital
- Aditi Hazra
- Department of Medicine, Harvard Medical School
- Leo Cheng
- Radiology and pathology, Massachusetts General Hospital, Harvard Medical School
- Q. Rushdy Ahmad
- Wyss Institute for Biologically Inspired Engineering, Harvard University
- James A. Toombs
- Brigham Research Institute, Brigham and Women’s Hospital
- Rebecca Larson
- Immunology Program, Harvard Medical School
- Haley Pleskow
- Center for Cancer Research, Massachusetts General Hospital, Harvard Medical School
- Nell Meosky Luo
- Folia Health, Inc.
- Christina Samaha
- Folia Health, Inc.
- Unnati M. Pandya
- Department of Medicine, Harvard Medical School
- Pushpamali De Silva
- Wellman Center for Photomedicine, Massachusetts General Research Institute
- Sally Zhou
- Department of Biology, Northeastern University
- Zakary Ganhadeiro
- Department of Biology, Northeastern University
- Sara Yohannes
- Brigham Research Institute, Brigham and Women’s Hospital
- Rakeisha Gay
- Brigham Research Institute, Brigham and Women’s Hospital
- Jacqueline Slavik
- Brigham Research Institute, Brigham and Women’s Hospital
- Shibani S. Mukerji
- Department of Neurology, Massachusetts General Hospital, Harvard Medical School
- Petr Jarolim
- Department of Pathology, Harvard Medical School
- David R. Walt
- Wyss Institute for Biologically Inspired Engineering, Harvard University
- Becky C. Carlyle
- Department of Neurology, Massachusetts General Hospital, Harvard Medical School
- Lauren L. Ritterhouse
- Department of Pathology, Massachusetts General Hospital
- Sara Suliman
- Division of Rheumatology, Inflammation and Immunity, Brigham and Women’s Hospital
- DOI
- https://doi.org/10.1186/s12879-021-06257-7
- Journal volume & issue
-
Vol. 21,
no. 1
pp. 1 – 14
Abstract
Abstract Background COVID-19 has resulted in significant morbidity and mortality worldwide. Lateral flow assays can detect anti-Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) antibodies to monitor transmission. However, standardized evaluation of their accuracy and tools to aid in interpreting results are needed. Methods We evaluated 20 IgG and IgM assays selected from available tests in April 2020. We evaluated the assays’ performance using 56 pre-pandemic negative and 56 SARS-CoV-2-positive plasma samples, collected 10–40 days after symptom onset, confirmed by a molecular test and analyzed by an ultra-sensitive immunoassay. Finally, we developed a user-friendly web app to extrapolate the positive predictive values based on their accuracy and local prevalence. Results Combined IgG + IgM sensitivities ranged from 33.9 to 94.6%, while combined specificities ranged from 92.6 to 100%. The highest sensitivities were detected in Lumiquick for IgG (98.2%), BioHit for both IgM (96.4%), and combined IgG + IgM sensitivity (94.6%). Furthermore, 11 LFAs and 8 LFAs showed perfect specificity for IgG and IgM, respectively, with 15 LFAs showing perfect combined IgG + IgM specificity. Lumiquick had the lowest estimated limit-of-detection (LOD) (0.1 μg/mL), followed by a similar LOD of 1.5 μg/mL for CareHealth, Cellex, KHB, and Vivachek. Conclusion We provide a public resource of the accuracy of select lateral flow assays with potential for home testing. The cost-effectiveness, scalable manufacturing process, and suitability for self-testing makes LFAs an attractive option for monitoring disease prevalence and assessing vaccine responsiveness. Our web tool provides an easy-to-use interface to demonstrate the impact of prevalence and test accuracy on the positive predictive values.
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