Open AccessClinical validation of an open-access SARS-COV-2 antigen detection lateral flow assay, compared to commercially available assays
Author(s) -
Christine Bachman,
Benjamin D. Grant,
Caitlin Anderson,
Luis F. Alonzo,
Spencer Garing,
Sam A. Byrnes,
Roberto Rivera,
Stephen Burkot,
Alexey Ball,
James W. Stafford,
Wenbo Wang,
Dipayan Banik,
Matthew D. Keller,
David M. Cate,
Kevin P. Nichols,
Bernhard H. Weigl,
Puneet Dewan
Publication year - 2021
Publication title -
plos one
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.99
H-Index - 332
ISSN - 1932-6203
DOI - 10.1371/journal.pone.0256352
Subject(s) - medicine , covid-19 , sampling (signal processing) , virology , computer science , disease , filter (signal processing) , infectious disease (medical specialty) , computer vision
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.