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1. Clinical validation of an open-access SARS-COV-2 antigen detection lateral flow assay, compared to commercially available assays.

Author

Christine M Bachman, Benjamin D Grant, Caitlin E Anderson, Luis F Alonzo, Spencer Garing, Sam A Byrnes, Rafael Rivera, Stephen Burkot, Alexey Ball, James W Stafford, Wenbo Wang, Dipayan Banik, Matthew D Keller, David M Cate, Kevin P Nichols, Bernhard H Weigl, and Puneet Dewan

Subjects
Medicine, Science
Abstract

Rapid tests for SARS-COV-2 infection are important tools for pandemic control, but current rapid tests are based on proprietary designs and reagents. We report clinical validation results of an open-access lateral flow assay (OA-LFA) design using commercially available materials and reagents, along with RT-qPCR and commercially available comparators (BinaxNOW® and Sofia®). Adult patients with suspected COVID-19 based on clinical signs and symptoms, and with symptoms ≤7 days duration, underwent anterior nares (AN) sampling for the OA-LFA, Sofia®, BinaxNOW ™, and RT-qPCR, along with nasopharyngeal (NP) RT-qPCR. Results indicate a positive predictive agreement with NP sampling as 69% (60% -78%) OA-LFA, 74% (64% - 82%) Sofia®, and 82% (73% - 88%) BinaxNOW™. The implication for these results is that we provide an open-access LFA design that meets the minimum WHO target product profile for a rapid test, that virtually any diagnostic manufacturer could produce.

Published
2021
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2. Clinical validation of an open-access SARS-COV-2 antigen detection lateral flow assay, compared to commercially available assays

Author

Burkot Stephen Thomas Graves, Wenbo Wang, Sam A. Byrnes, Christine Bachman, Dipayan Banik, Benjamin D. Grant, Luis F. Alonzo, James W. Stafford, Spencer Garing, Rafael Rivera, David M. Cate, Caitlin E Anderson, Matthew D. Keller, Kevin Paul Flood Nichols, Alexey Ball, Puneet Dewan, and Bernhard H. Weigl

Subjects
RNA viruses, Viral Diseases, Coronaviruses, Social Sciences, Artificial Gene Amplification and Extension, Polymerase Chain Reaction, Nucleocapsids, Medical Conditions, Nasopharynx, Medicine and Health Sciences, Psychology, Medicine, Sampling (medicine), Antigens, Viral, Pathology and laboratory medicine, Virus Testing, Immunoassay, Multidisciplinary, medicine.diagnostic_test, Viral Load, Medical microbiology, Anterior nares, Smell, Infectious Diseases, medicine.anatomical_structure, Area Under Curve, Viruses, RNA, Viral, Sensory Perception, SARS CoV 2, Pathogens, Viral load, Research Article, SARS coronavirus, Coronavirus disease 2019 (COVID-19), Point-of-Care Systems, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Science, Signs and symptoms, Viral Structure, Research and Analysis Methods, Real-Time Polymerase Chain Reaction, Microbiology, Sensitivity and Specificity, Antigen, Diagnostic Medicine, Virology, Humans, Molecular Biology Techniques, Immunoassays, Molecular Biology, SARS-CoV-2, business.industry, Organisms, Viral pathogens, Cognitive Psychology, Biology and Life Sciences, COVID-19, Covid 19, Microbial pathogens, ROC Curve, Immunologic Techniques, Cognitive Science, Perception, business, Nuclear medicine, Viral Transmission and Infection, Neuroscience
Abstract

Rapid tests for SARS-COV-2 infection are important tools for pandemic control, but current rapid tests are based on proprietary designs and reagents. We report clinical validation results of an open-access lateral flow assay (OA-LFA) design using commercially available materials and reagents, along with RT-qPCR and commercially available comparators (BinaxNOW® and Sofia®). Adult patients with suspected COVID-19 based on clinical signs and symptoms, and with symptoms ≤7 days duration, underwent anterior nares (AN) sampling for the OA-LFA, Sofia®, BinaxNOW ™, and RT-qPCR, along with nasopharyngeal (NP) RT-qPCR. Results indicate a positive predictive agreement with NP sampling as 69% (60% -78%) OA-LFA, 74% (64% - 82%) Sofia®, and 82% (73% - 88%) BinaxNOW™. The implication for these results is that we provide an open-access LFA design that meets the minimum WHO target product profile for a rapid test, that virtually any diagnostic manufacturer could produce.

Published
2021

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