PLoS ONE (Jan 2021)

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

  • 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,
  • Puneet Dewan

DOI
https://doi.org/10.1371/journal.pone.0256352
Journal volume & issue
Vol. 16, no. 8
p. e0256352

Abstract

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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.